functional outcomes in the aged with hip fracture: a … · iii acknowledgements i would like to...

FUNCTIONAL OUTCOMES IN THE AGED WITH HIP

FRACTURE: A SYSTEMATIC REVIEW OF RANDOMIZED

CLINICAL TRIALS

By

Amy Milena Hoang-Kim, BscH, MA

A thesis submitted in conformity with the requirements for the degree of Masters of Science

Department of the Institute of Medical Sciences

University of Toronto

©Copyright by Amy Hoang-Kim, 2009

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Functional Outcomes in the Aged with Hip Fracture: A systematic review of randomized clinical trials

Master’s of Science, 2009

Amy Hoang-Kim Institute of Medical Sciences

University of Toronto

ABSTRACT

Hip fracture trials have used a wide range of patient-reported outcomes (PRO) suggesting a lack of

consensus among clinicians on what are considered the most relevant functional outcomes. We conducted

a systematic review to identify the outcomes used in hip fracture randomized controlled trials (RCTs). We

hypothesized that there had been an increase in numbers of PROs over time and the health status measure,

SF-36, would be used the most. A database search and screening yielded 86 original trials. The mean

Detsky score (and standard error) for quality was: 75.8% ± 1.76%. There was a trend in the increase of

functional outcome; however, the SF-36 was used only in (10 out of 86) 11.6% trials. Both the ADL-Katz

Index and HHS have lower respondent burden than the SF36 which may contribute to their frequent use in

hip RCTs. There is a lack of applicable measures suitable for patients with dementia.

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Acknowledgements

I would like to acknowledge and thank my mentor, Dr. Emil Schemitsch (Supervisor), and my Program

Advisory Committee members, Dr. Dorcas Beaton, Dr. Mohit Bhandari and Dr. Abhaya Kulkarni (and in

particular Dr. Beaton who has motivated me to write down my future goals for the next ten years). I am

deeply grateful for the academic enrichment they were able to provide, as well as their guidance and

unwavering support throughout this project.

I am thankful to have received funding from the Orthopaedic Division-Wellesley central site at St.

Michael’s Hospital in the form of the David Hastings Award for the Ontario Scholarship of Science and

Technology.

I would also like to thank my friends and colleagues who have helped me shape this project: David Santone

who screened the articles and extracted data, Professor Antonio Moroni from the Rizzoli Orthopaedic

Institute, Bologna, Italy and as well as my colleagues at the Mobility Clinical Program (Kelly, Taucha and

Katherine) at St. Michael’s Hospital, Toronto for their words of encouragement.

I would like to dedicate the thesis to my ‘parents’ Hai and Marisa and especially Hai who leads me through

the right and wrong turns in my life; because he is always by my side. I am extremely grateful to Andrea

for his patience, love and unwavering support over the years. It is because of them that I have had the

strength to see the project through to the end.

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TABLE OF CONTENTS

Abstract .................................................................................................................................................... ii Acknowledgements................................................................................................................................... iii Table of Contents...................................................................................................................................... iv List of Tables............................................................................................................................................ vi List of Figures........................................................................................................................................... vii List of Appendices.................................................................................................................................... viii List of Abbreviations ................................................................................................................................ ix CHAPTER 1: INTRODUCTION ............................................................................................................. 1 1.1 Objectives............................................................................................................................................. 4 1.2 Implications.......................................................................................................................................... 4 1.3 Overview of Thesis............................................................................................................................... 5 1.4 Keypoints from Chapter 1 ..................................................................................................................... 6 CHAPTER 2: BACKGROUND ............................................................................................................... 7 2.1 Introduction .......................................................................................................................................... 7 2.2 Defining physical function .................................................................................................................... 7 2.3 Conceptual frameworks ........................................................................................................................ 8 2.3.1 The Nagi scheme of disablement......................................................................................................... 9 2.3.2 The Verbrugge and Jette Model.......................................................................................................... 11 2.3.3 The Wilson and Cleary Framework ....................................................................................................13 2.3.4 The International Classification of Functioning, Disability and Health (ICF)...................................... 14 2.4 Discussion ............................................................................................................................................ 17 2.5 Summary .............................................................................................................................................19 2.6 Keypoints from Chapter Two ................................................................................................................ 20 CHAPTER 3: METHODS ........................................................................................................................ 21 3.1 Introduction .......................................................................................................................................... 21 3.1.1 Definition of the research question..................................................................................................... 22 3.1.2 Identification of the search strategy.................................................................................................... 22 3.2 Data extraction......................................................................................................................................25 3.3 Detsky Quality assessment scale ........................................................................................................... 25 3.4 Statistical analysis.................................................................................................................................26 3.5 Results.................................................................................................................................................. 26 3.5.1 Study Characteristics......................................................................................................................... 28 3.5.2 Quality assessment............................................................................................................................. 28 3.5.3 Outcome instruments.......................................................................................................................... 30 3.5.4 High quality RCTs vs. Low quality RCTs............................................................................................ 32 3.6 Discussion ............................................................................................................................................ 39 3.6.1 Randomization................................................................................................................................... 39 3.6.2 Sample size calculation...................................................................................................................... 40 3.6.3Identification of outcome ....................................................................................................................40 3.6.4Follow-up........................................................................................................................................... 40 3.6.5 Statistical methods............................................................................................................................. 41 3.7 Summary..............................................................................................................................................41 3.8 Keypoints from Chapter Three .............................................................................................................. 43 CHAPTER 4: RESULTS.......................................................................................................................... 44 4.1 Introduction .......................................................................................................................................... 44 4.2 Methods................................................................................................................................................ 44 4.3 Results.................................................................................................................................................. 47 4.3.1 Measures of Activity and Participation............................................................................................... 47 Physical Performance Test......................................................................................................................... 47 Timed-Up-and-Go-Test............................................................................................................................... 49

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6 Minute Walk Test..................................................................................................................................... 50 4.3.2 Activities of Daily Living.................................................................................................................... 51 Index of Katz.............................................................................................................................................. 51 Barthel Index.............................................................................................................................................. 51 OARS Fillenbaum ADL............................................................................................................................... 53 Klein Bell ADL........................................................................................................................................... 54 Disability Rating Index............................................................................................................................... 55 Lawton and Brody IADL............................................................................................................................. 56 Functional status Index...............................................................................................................................56 4.3.3 Composite scores............................................................................................................................... 57 Harris Hip score......................................................................................................................................... 58 Stinchfield hip assessment........................................................................................................................... 59 Charnley Hip classification......................................................................................................................... 59 Matta functional score................................................................................................................................ 59 Hip Rating Questionnaire........................................................................................................................... 59 Salvati and Wilson score............................................................................................................................. 59 Oxford Hip Score........................................................................................................................................ 59 4.3.4 Generic Measures of Health Status..................................................................................................... 59 The Short-Form 36..................................................................................................................................... 60 Functional Status Questionnaire................................................................................................................. 61 Swed-Qual.................................................................................................................................................. 62 Nottingham Health Profile.......................................................................................................................... 63 London Handicap Scale.............................................................................................................................. 64 4.3.5 Measures of Utility............................................................................................................................. 66 EuroQol-5D............................................................................................................................................... 66 4.4 Discussion ............................................................................................................................................ 69 4.5 Summary..............................................................................................................................................72 4.6 Keypoints in Chapter Four .................................................................................................................... 73 CHAPTER 5: SUBGROUP ANALYSES................................................................................................. 74 5.1 Introduction .......................................................................................................................................... 74 5.2 Methods................................................................................................................................................ 75 5.3 Results.................................................................................................................................................. 76 5.3.1 Trials including & excluding patients with dementia........................................................................... 76 5.3.2 Diagnosis and screening dementia..................................................................................................... 77 5.3.3 Diagnosing emotional status.............................................................................................................. 77 5.3.4 Outcome measures............................................................................................................................. 77 5.4 Discussion ............................................................................................................................................ 78 5.5 Ethical considerations ........................................................................................................................... 79 5.6 Summary .............................................................................................................................................80 5.7 Keypoints from Chapter Five ................................................................................................................ 87 CHAPTER 6: CONCLUSIONS ............................................................................................................... 88 6.1 Implications of findings ........................................................................................................................ 88 6.2 Limitations ........................................................................................................................................... 88 6.3 Future directions................................................................................................................................... 89 6.4 Summary..............................................................................................................................................90 REFERENCES......................................................................................................................................... 91 APPENDICES .......................................................................................................................................... 105

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LIST OF TABLES

Table 2.1 The domains of Activities and Participation component of the ICF.............................................. 15 Table 3.1 The Levels of Evidence .............................................................................................................. 23 Table 3.2 Characteristics of the 86 included studies listed in alphabetical order........................................... 29

Table 3.3 Data extraction of outcome measurements................................................................................... 35 Table 4.1 Composite scores........................................................................................................................ 59 Table 4.2 Trials with generic health status or utility measures ..................................................................... 65 Table 4.3 Instrument characteristics measuring health-status or utility......................................................... 68

Table 5.1 The spectrum of cognitive impairment ........................................................................................ 75

Table 5.2 List of trials with outcomes stratified by patient subtype.............................................................. 82 Table 5.3 Group A trials including patients with severe co-morbidities ....................................................... 84

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LIST OF FIGURES Figure 2.1 Verbrugge and Jette’s model of the Disablement Process ........................................................... 12

Figure 2.2 The ICF .................................................................................................................................... 17

Figure 3.1 Search strategy.......................................................................................................................... 27

Figure 3.2 Comparison of Category 1 versus Category 2 trials .................................................................... 31

Figure 3.3 Frequency use of instruments .................................................................................................... 32

Figure 3.4 The number of RCTs that measure each ICF concept ................................................................. 33 Figure 3.5 The prevalence of investigator-developed instruments................................................................ 34 Figure 4.1 Composite scores contain different ICF concepts ....................................................................... 58 Figure 4.2 The applicability of instrument types ......................................................................................... 67 Figure 5.1 Diagnostic tools used to assess co-morbidity in high quality trials .............................................. 81 Figure 5.2 Diagnostic tools used to assess cognitive impairment in high quality trials ................................. 81

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LIST OF APPENDICES Appendix 1 Search strategy........................................................................................................................ 106

Appendix 2 21-point Detsky scoring system............................................................................................... 109

Appendix 3 Quality assessment scores ....................................................................................................... 110

Appendix 4 Included trials ......................................................................................................................... 112

Appendix 5 Inclusion and exclusion criteria ............................................................................................... 123

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LIST OF ABBREVIATIONS

AAS Ambulation activity score

ADL Activities of Daily Living

ADL – KATZ Katz index of Activities of Daily Living

ASA American Anesthesiologist Society

BADL Barthel Index of Activities of Daily Living

BDR Blessed Dementia Rating

BMD Bone Mineral Density

CAM Confusion Assessment Method

CBI Chinese Barthel Index

COVS Swedish version of clinical outcome variables

DRI Disability Rating Index

DSM-III-R Diagnostic and statistic manual of mental disorders

EBM Evidence-based medicine

EQ-5D EUROQOL 5D

FAC Functional Ambulation Classification

FIM Functional Independence Measure

FPM Functional Performance Measure

FRT Functional Reach Test

FSI Functional Status Index

FSQ Functional Status Questionnaire

HHS Harris Hip Score

HRQ Hip Rating Questionnaire

HRQL Health-Related Quality of Life

IADL Instrumental Activities of Daily Living

ICF International Classification of Functioning, Disability and Health

ICIDH International Classification of Impairments, Disability and Handicaps

LEP Leg extensor power rig

MBI Modified Barthel Index

MCS Mental Component Score

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LIST OF ABBREVIATIONS

MFA Musculoskeletal Functional Assessment

MMSE Mini Mental State Examination

MTS Mental Test Score

MWT Minute walk test

NHP Nottingham Health Profile

OARS Older American’s Resources and Services

OHS Oxford hip score

PCS Physical Component Score

POMA Performance Oriented Assessment of Balance

PPME Physical Performance and Mobility Examination

PPT Physical Performance Test

PRO Patient-reported Outcomes

RCT Randomized Controlled Trial

RM Repeated Measure

ROM Range of Motion

RSA Radiostereometric Analysis

SF-36 Short Form 36

SIP Sickness Impact Profile

SPMSQ Short portable mental status questionnaire

SWED-QUAL Swedish Health-Related Quality of Life Survey

TAD Tip Apex Distance

TUG Timed up and Go Test

VAS Visual Analogue Scale

WHO World Health Organization

WHO-QOL BREF World Health Organization Quality of Life

WOMAC Western Ontario and McMaster Universities Index

1

CHAPTER 1

INTRODUCTION

In Canada, the percentage of the population over 65 years of age is projected to increase to 15% in 2011

and to 25% by the year 2036.1,2 The incidence of hip fractures also increases substantially with age, rising

from 22.5 and 23.9 per 100,000 population at age 50 to 630.2 and 1289.3 per 100,000 population by age

80, for men and women respectively.3-6

The elderly are at a major risk for a first hip fracture. The normal decrease in bone mineral density may

account for 60% to 85% of the variation in fracture risk.7 In a recent analysis addressing fracture rates in

the province of Ontario, it has been reported that since 1997 the hip fracture rate has begun to decrease and

the population projections suggested that this decrease will continue to a rate of 33.1 per 10,000 in 2005.

The suggestion was in fact confirmed in an updated projection with actual data for hip fractures in 2003-

2005.8,9 In Ontario, Canada there is universal health care; and as such, BMD testing increased ten-fold and

prescriptions for bone-sparing medications also increased from 12, 298 in 1996 to 225, 580 in 2003 which

can account for the falling hip fracture rates.8 Other contributing factors for first-time hip fractures include

cognitive impairment as well as impaired mobility and poor visual depth perception.7,10 In contrast,

dizziness and poor or fair self-perceived health care characteristics are predictive of a second hip fracture.10

In another study, the investigators found that the rate of Parkinson’s disease, dementia and audiovisual

impairment was statistically higher before the second operation.11 The one-year risk of a subsequent

fracture varies from approximately 2% to 10%.12-14 The lifetime risk of a second hip fracture has been

estimated at 20% but may be as high as 55%.15

The consequences of these fractures are considerable both for patients and healthcare services. Only half of

these patients regain full autonomy.16 Healthcare resources include initial hospitalization, re-

hospitalization, rehabilitation, chronic care, home care, long-term care (LTC) and informal care. The total

annual economic implications of hip fractures in Canada are estimated to be $650 million currently and are

expected to rise to $2.4 billion by 2041.16 A longitudinal cohort study analyzing levels of health service

2

use, institutional care and their associated costs, found that one year costs were significantly different for

patients who returned to the community ($21385) versus those who were transferred to ($44156) or

readmitted to LTC facilities ($33729).16 In the absence of an appropriate comparison group, all costs during

the period following hospital discharge are likely to be attributed to the hip fracture, while in reality, the

presence of co-morbidities in the aged have a considerable impact.17 A study by Bernardini, investigated

co-morbidity and adverse clinical events in patients over the age of 65 admitted to a geriatric rehabilitation

unit after proximal hip fracture.18 These patients had complex, multiple, interacting pathologies, with 78%

having significant co-morbidity. Hip fractures are the second leading cause of hospitalization for the aged

and the added co-morbidity in these patients lengthen hospital stays.19-20

Traditionally, clinical success in the treatment of hip fracture has been measured in terms of mortality,

physiologic changes or improvement in physical function.21-23 In a recent ten-year review of the

orthopaedic literature, there was an overall 10% increase in the use of patient-reported outcomes (PRO) in

observational and randomized controlled trials.24 The use of PROs could minimize the bias associated with

collecting information about the functional result following surgery, since it has been known that patients

are not inclined to report actual functional information to the surgeon who they respect because he

performed the intervention.25 The limitations of a patient-reported outcome is that it provides subjective

information but gathering objective data is equally important. Functional outcomes can provide the best

possible basis for quantifying the expected outcomes, and these must be considered in the context of the

patient’s values and preferences about the expected outcomes of a decision.26, 27 Jette defines recovery from

functional disability as encompassing psychological and social recovery as well as physical recovery.28 The

four target domains that contribute to functional outcomes can be viewed as physical, mental, emotional

and social in nature.28 In treating the aged with hip fractures, there is a need to facilitate clinical decisions

where surgeons must weigh, either explicitly or implicitly, the expected benefits of a particular intervention

whether surgical, medical or rehabilitative against the potential harm and cost.27, 29 However, without a

common metric to measure these targets we would be unable to compare results across trials and guide

clinical decision-making.

3

According to McDowell and Newell, the measurement of a concept like health or functional recovery relies

on collating information from various indicators representing components of the overall concept.30 In

addition, a dimension (or domain) refers to the area of experience or behaviour one is trying to measure.31

From a theoretical standpoint, “a person does not have a disability, a person experiences it”.32 The high

degree of variability is attributed to the perception that biology provides the foundation for impairment

which subsequently causes the disability.33-36 The choice of an appropriate disability conceptual framework

to classify different domains and instruments will be later discussed in Chapter Two.

The detailed methodology will be reported in Chapter Three. A systematic review of randomized trials if

conducted with rigour in identifying, critically appraising and synthesizing data of the best available

evidence can facilitate clinical decision-making.37 The evidence retrieved may potentially contradict

clinical expertise, physiologic rationale and medical training.

The design and conduct of good comparative studies in this context relies upon the choice of valid

instruments that are reliable, and responsive.38 Should the instrument assessing functional outcomes prove

to have good psychometric properties, the value of the published literature would be enhanced.25 However,

pragmatic qualities such as the applicability of such instruments in hip fracture trials should also be

considered in addition to the psychometric properties. In Chapter Four, we will compare the logistical

choice of functional outcome instruments. In particular, whether the instrument was a burden to administer,

require additional training, and have an adequate score distribution as well as format compatibility.

Furthermore as different and severe co-morbidities exist in older patient populations, clinical results may

not be representative of all patient types presenting with hip fractures. If patient-reported outcomes are

used only for healthy and lucid patients, PROs will be ineffective in the 31 to 45% of patients in Geriatric

Orthopedic Rehabilitation Units who are reported to have cognitive impairment.39 Patients that fall into this

category are often challenging to deal with because of a lack of compliance or mortality rates that lead to a

loss in follow-up. Randomized controlled trials should diagnose co-morbidities and screen patients for

either inclusion or exclusion according to the research question and monitor higher degrees of disability via

4

functional outcome assessment. In a literature review, Wells et al concluded with evidence that: 1) frail

older rehabilitation candidates with mild to moderate dementia should not be excluded from rehabilitation

and 2) frail older patients should be screened for cognitive impairment.20 This patient subtype will be

further explored in hip fracture trials in Chapter Five.

1.1 Objectives

The purpose of our study was to conduct a systematic review of the instruments used to assess functional

outcomes in randomized controlled trials in the aged with hip fractures. We believe that the patient’s

perspective on their functional ability to perform daily activities following hip fracture treatment is a

critical factor and indicator of treatment effectiveness. We hypothesized that over time there had been an

increase in instruments assessing functional outcome. We also wanted to see if the increase over time

would correlate with a common metric for measuring functional outcome in patients with hip fracture.

1.2 Implications

Functional outcome or the ability to carry out an individual’s daily activity represents a way to quantify the

burden of having a hip fracture. Functional outcome is a challenge that can neither be determined directly

nor described by a single variable but it is important to identify a common metric to assess the

postoperative management of hip fracture patients in order to validate research findings. Impaired physical

function has been linked to many indicators of increased health services utilization and has become

fundamental for researchers, clinicians and funding agencies

We can gain greater understanding of the patient’s perspective by using the appropriate instruments that

measure all aspects of functional recovery. Health in the aged is often compromised by various co-

morbidities of differing levels of severity. These areas need to be further investigated with the aim of

finding a common metric to assess specific populations implicating a change in the future conduct of

Evidence Based Medicine. My thesis will clarify whether patients with dementia were included in hip

fracture randomized trials. The implications of obtaining results which are not representative of all patients

are major, and future research needs to investigate the potential use of proxy responders.

5

1.3 Overview of the Thesis

The overall aim of this thesis is to focus on finding a common metric to assess functional outcome in those

with hip fractures over the age of 65 years.

This thesis is presented in a series of 6 chapters. Chapter 2 defines the concepts related to outcome using

the International Classification of Functioning, Disability and Health (ICF) to classify the domains and

instruments found in the randomized controlled trials. Chapter 3 describes the methodology used to define

and identify articles to be used for a systematic review of outcomes and to describe those articles. Chapter

4 describes the taxonomy relevant to the applicability of instruments and describes those instruments used.

The objective of Chapter 5 is to identify a common metric in those trials, which have included patients with

severe cognitive impairment. Chapter 6 will describe the implications of the systematic review and

limitations of the study. This final chapter also addresses the possibilities for future investigation.

6

Keypoints from Chapter 1 • This is a systematic review aimed to review the

outcomes assessed in RCTs evaluating the aged following a hip fracture

• Our research questions: 1) Is there an increase in the use of functional

outcome assessment in studies of hip fracture management and rehabilitation from 1990 to 2007?

2) What outcome measures are being fielded in RCTs of hip fracture? Are there differences between high and low quality trials?

3) How practical are these to use in the aged with hip fracture? In those with dementia? What are the benefits of investigator-developed vs. non-investigator developed instruments and performance-based vs. impairment-based composite scores vs. multi-attribute scoring systems?

• Implications of this research: • Care will be based on EB Guideline care maps • Outcomes need to be broad enough to describe

the full impact • The exclusion of those with dementia can create

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CHAPTER 2

BACKGROUND

2.1 Introduction

Variability in functional outcome reporting in hip fracture management could create challenges in the

comparison of results across trials. In order to better define functional outcome, we believed that the ICF

framework would be appropriate to understand function which encompasses 4 principle domains: physical,

mental, social and vocational. In this chapter, four frameworks for disability are reviewed and compared.

The International Classification of functioning, Disability and Health (ICF) conceptual framework is an

accepted language and framework, to describe and classify concepts and domains as well as regions of

overlap and their relationship to one another.40, 41 We used this model to discriminate trials without

functional outcomes (Category 1) from those trials containing functional outcomes (Category 2). For

instance, those trials reporting on radiographic analysis and screw osteointegration would not contain any

functional outcomes. These measure the concept of impairment under the category of Body Function and

Structure within the ICF model.

2.2 Defining physical function

There is a lack of consistent language and uniform definitions when defining physical function. Words such

as physical function, functional status, physical ability, and disability have all been used interchangeably.21,

42-44 Undeniably, consistent terminology is fundamental because the scope and content of measures used to

quantify physical function often originate or are derived from the terms used to define physical function.

For example, the definition of disability is operationalized when researchers use Activities of Daily Living

(ADL) 45 and Instrumental Activities of Daily Living (IADLs).46 The scale of IADL extends the ADLs to

cover activities that require higher levels of cognition and/or finer motor skills. For example, IADL can rate

individuals on their ability to carry out eight activities, the ability to use the telephone, shopping, food

preparation, housekeeping, laundry, ability to travel (by car or public transit), responsibility for taking own

medication, and ability to handle finances. Scores range from 0 (complete independence) to 8 (complete

dependence).46 These terms have led to a wide variety of measures with different content. These scales

8

have helped in better defining different phases within the disablement process for the elderly in terms of

which level of activity involving the higher levels of cognition have not been recovered following a hip

fracture treatment. In understanding those patient subtypes, those not capable of performing IADLs and

capable of performing ADLs could be a better measure of outcome based on the patient’s functional

recovery.

Physical function has been evaluated using varied modalities including self-report, proxy report (from

family or medical professionals), and observed physical activities (i.e. measured distance walks or timed

sit-to-stand). This ultimately makes comparison across studies difficult resulting in potential confusion

regarding what is actually being measured.47

Furthermore, there is often a difference between what a person can do, or is capable of doing and what they

actually do and this difference may be affected by how questions are worded or how much encouragement

is given to a patient during a test.48, 49 Finally, within each of these modalities, there are a number of issues

such as framing of questionnaires or whether questionnaires are self- or investigator-administered.

2.3 Conceptual frameworks

In the past, much of the medical literature was conceptually based upon a clinical paradigm which focused

on etiology, pathology, and clinical outcome.35 In turn, disability in the biomedical model was assumed to

be a problem related to the individual that medical management would solve. The biomedical model

sharply contrasts with the biopsychosocial paradigm or the “quality of life” model. The social paradigm

views overall functioning and well-being as a measure of complex behaviours and feelings. For instance,

Nagi defines disability as a social construction and therefore additional factors such as the interaction of a

person with his or her environment are considered.50

Over the years, many attempts have been made to fuse the two schools of thought. For example, the Wilson

and Cleary model adopts a single taxonomy of patient outcome according to underlying health concepts.35

The ICF offers an alternative perspective adopting a dynamic interaction that is based on a biopsychosocial

9

conception of disability. The selection of the ICF model for the classification of functional outcomes was

chosen because it could place outcome in the context of variables important to physical function.

A conceptual framework or scheme goes beyond just representing a scientific model that defines major

concepts. It is also used to generate hypotheses about the interrelationships of different variables included

in the scheme. Not in the least, these models are guidance for subsequent measurement. The problem is the

lack of a universally accepted framework; however, the main purpose of the ICF to provide a common

language to describe disability concepts has made the framework widely popular.51 However, what remains

fundamental in scientifically testing and in determining the importance of clinical variables is conceptual

clarity, 52 these models will now be examined in greater detail.

2.3.1 The Nagi Scheme of Disablement

In the early 1960’s Saad Nagi described a framework for disablement distinguishing between four

concepts: active pathology, impairment, functional limitations and disability (Figure 1). Nagi’s basic

framework was subsequently adopted by the Institute of Medicine (IOM) and is now often referred to as the

IOM scheme and has been adapted by the National Centre for Medical and Rehabilitation Research.53

Nagi first began by attempting to define the relationships between active pathology, sickness and illness,

impairments, functional limitations, and disability. Nagi differentiated between active pathology (a term he

used to describe the behaviour resulting from an acute condition of usually short duration and ‘Illness’) or

‘sickness’ (a term resulting from chronic conditions). 54 According to Nagi, ‘Disability’ can be present in

the absence of disease. Disability can result from genetic factors or injury that give rise to permanent

impairment, but are not considered sickness or illness. 54

Active Pathology may result from an infection, trauma, or metabolic or degenerative disease and “involves

an interruption or interference with normal processes, and the simultaneous efforts of the organism to a

10

regain a normal state”.54 The efforts to regain a normal state can be impeded by a compromised immune

system (for example), or aided by medical or surgical intervention.54

Impairment indicates an anatomical, physiological, mental or emotional, loss or abnormality. The

distinction between an active pathology and impairment is that pathology is considered impairment, while

not all impairment results from pathology (as in the case of congenital abnormalities). Impairments affect

function at the cellular level and vary in their degree of impact. Manifestation of impairment is influenced

by the course of the underlying pathology, prognosis, progression or recovery, and point of onset in the

lifestyle of the individual. A hip fracture patient following an intervention could exhibit confusion and

depression which implies either a mental impairment combined with an emotional one.

Functional Limitations are “limits in performance at the level of the whole organism or person”. 54 The

difference between impairment and functional limitation is the level at which the limitations are

manifested. Functional limitations result from the cumulative effect of one or more impairments to the

point where the function of the individual is affected. For example, the inability to walk up stairs may be

the result of nerve or muscle cells damage, or may be the result of heart or lung impairment. Functional

limitations are noticeable manifestations of one or more underlying impairments.54

Disability is “a limitation in performance of socially defined roles and tasks within a socio-cultural and

physical environment”. 54 Not all impairments or functional limitations result in a disability and a disability

may be restricted to specific areas of social functioning and not affect others. A patient with hip fracture

may be unable to integrate back into the community by not being able to organize an event as efficiently as

before. Nagi identifies several factors that influence the severity of a disability such as the reaction and

expectations of the individual and those significant to them, and characteristic of the environment and the

social and cultural barrier within it. 54

11

2.3.2 The Disablement Process – Verbrugge and Jette

Lois Verbrugge and Alan Jette present a socio-medical model of disability referred to as the Disablement

Process.42

The Disablement Process model is designed to be applicable to chronic, acute, and acquired illnesses across

the lifespan. Verbrugge and Jette have defined “Disablement” as to “the impact that chronic and acute

conditions have on both body systems and on people’s ability to function in the expected and desired way

of their society”.42 The Disablement Process combines the underlying framework of the Nagi scheme and is

designed for ease of use in medical research.50, 55 One of the most obvious differences between the

Verbrugge and Jette model and those preceding it is the inclusion of risk factors and extra and intra-

individual factors that mediate and influence the progression of the disability through the main pathway.42

Specifically, in the Disablement model, Pathology is defined as “biochemical and physiological

abnormalities that are detected and medically labeled as disease, injury, or congenital/developmental

conditions”.42 Pathologies can be acute such as short-term disease or injury (defined as less than 3 months

duration), or chronic, such as injuries with long consequences or degenerative diseases. Pathology is

usually identified as medical diagnoses, and examples include osteoporosis, cancer, cataracts, and cerebral

palsy. Pathologies can also be congenital or biochemical and may be detected through signs, symptoms, or

specialized tests.

12

Figure 1 Verbrugge and Jette’s model of the Disablement Process

*Figure adapted from with permission from Verbrugge and Jette (1994)

Impairments are defined as “dysfunctions and structural abnormalities that are significant enough to have

consequences for physical, mental or social functioning”.42 Impairments can be immediate or delayed and

can occur in the same location as the underlying pathology or may manifest in secondary sites. Here, an

impairment can be considered a loss of balance as measured by the Berg balance test or pain measured by a

visual analogue scale.

Functional Limitations are defined as restrictions in fundamental physical and mental activities.42

Fundamental physical activities include overall mobility, discrete motions and strengths, trouble seeing,

hearing, and communicating. Fundamental mental activities include central cognitive and emotional

processes. Difficulties in these activities can manifest themselves diversely, as in the ability to climb stairs,

read large print, produce intelligible speech, be oriented in time and place, lift objects or remain alert.

Pathology Impairments Functional Limitations Disability

Extra-Individual Factors Medical care and rehabilitation Medications and other therapeutic regimens External supports Built, physical, and social environments

Intra-individual factors Lifestyle & behaviour changes Psychosocial attributes & coping Activity accommodations

Risk Factors

13

Functional limitations can be moderated by external factors Verbrugge termed “extra-individual and intra-

individual”.42 These factors serve to lessen the impact of the functional limitation on the individual and

reduce the extent of the observable disability. Extra-individual factors include medical care and

rehabilitation, medications and other therapeutic regimens, external supports, and modifications to

structural, physical and social environments. A hip fracture patient with the aid of a walking cane can walk

to the grocery store. Intra-individual factors are changes or modifications the individual is capable of

making and include lifestyle and behavior changes, psychological attributes and coping mechanisms, and

activity accommodations. For instance, one may take be able to complete an activity by increasing the

length of time.

2.3.3 The Wilson and Cleary Framework

In the Wilson and Cleary framework, the assessment of biological and physiological factors focuses on

“the function of cells, organs and organ systems”.35 Examples include diagnoses such as pulmonary

tuberculosis, inflammatory bowel disease, or laboratory values such as serum hemoglobin or creatinine;

measures of physiological function such as pulmonary function tests; and physical examination findings

such as systolic ejection murmur, pulmonary wheezes, or splenomegaly.

A Symptom is the patient’s perception of “an abnormal physical, emotional, or cognitive state”. 35

Psychophysical symptoms have been referred to as symptoms “primarily associated with mental health” or

symptoms not clearly physical or psychological in origin.

Functional status assesses the ability of the individual to perform particular defined tasks. Four domains of

functioning that are commonly measured are physical function, social function, role function, and

psychological function. Here, measures of symptoms that are specific to the hip will prove to be excellent

predictors of function.

General health perceptions are strong predictors of mortality and also of the use of general medical and

mental health services. Overall quality of life is the assessment of the respondents’ subjective well-being

14

with general measures of how happy and/or satisfied they are with their life as a whole. Patient preferences

or values are evident at several levels in this model and in particular with general health perceptions and

overall quality of life. Certain symptoms are more burdensome than others, and those individuals will

prefer not to have those symptoms even if they may have to tolerate others.

Utility assessment is a methodology that elicits patients’ values for particular states of health, and utilities

are often used as an overall measure of health-related quality of life (HRQL). Whereas most HRQL

measures assess particular health states, utility measures assess the value that individuals assign to different

states. One of the conceptual problems with using utility assessment to measure HRQL is the way utilities

are measured. That is, they involve other factors beyond just health status, including the value patients

place on life, their risk aversion, or their attitudes toward certain types of medical intervention.

2.3.4 The International Classification of Functioning, Disability and Health (ICF)

The WHO began work on The International Classification of Functioning, Disability and Health 40 (ICF),

an update of the ICIDH55, and formally known as the International Classification of Impairments, Disability

and Handicaps—version 2 (ICIDH-2). The ICF was ratified in 2001 and is a classification of disablements

that group consequences associated with diseases, disorders or injuries, and puts greater emphasis on the

role played by social and environmental factors. Functioning and disability are described in the ICF in

terms of the dynamic interaction between health condition, personal factors, and the environment (Figure

2).42 The ICF is not only a classification system for the impact of disease it is also a theoretical framework

for a relationship between variables. The ICF places the emphasis on function rather than condition or

disease. The ICF provides a description of situations with regard to human functioning and its restrictions.

The information is organized in two parts: Part 1 deals with Functioning and Disability; while, Part 2

covers Contextual Factors.40 Each part has two components:

The Body component comprises two classifications, one for functions of body systems, and one for body

structures. Activities may be limited in nature, duration and quality.42 Activity limitations are referred to as

disabilities and are scaled by difficulties and whether assistance is needed in order to carry out the activity.

15

The ICF has been identified by the American National Committee on Vital and Health Statistics (NCVHS)

as the only viable code set for reporting functional status.56 The ICF has limitations and is not in common

use because of unclear definitions of concepts.42 In fact, recently there are suggestions for new components

within the Activity and Participation ICF Classification according to Badley’s new interpretation of the

ICF.57 According to Badley, Activity and Participation is divided into three components: Acts, Tasks and

Societal Involvement.57 Acts are the general things that a person can do independent of context or purpose.

Tasks are the purposeful things people do in daily life in a specific context. 57 Societal involvements is the

individual in the context of society and acknowledged areas of human endeavor. 57 The social role is what

defines societal involvement and not the acts and tasks that may or may not be involved. 57

The Activities and Participation component of the ICF covers aspects of functioning from both an

individual and a societal perspective. There are 617 activity items that fall under the nine domains shown in

Table 1.

Table 1 The domains for the Activities and Participation component of the ICF

Learning and applying knowledge

General tasks and demands

Communication

Mobility

Self-care

Domestic Life

Interpersonal interactions and Relationships

Major life areas

Community, social and civic life

16

In the ICF scheme, Participation is involvement in a life situation. Activity Limitations are difficulties an

individual may have in executing activities.40 Participation Restrictions are problems an individual may

experience in involvement in life situations.40

The components of contextual factors of the ICF have been subdivided into Environmental Factors, which

has an impact on all components of functioning and disability and are organized in sequence from the

individual’s most immediate environment to the general environment, and Personal Factors, also a

component of contextual factors but are not classified in the ICF because of the large social and cultural

variance associated with them.40

The components of Functioning and Disability in the ICF can be used to indicate problems (e.g.

impairment, activity limitation or participation restriction which describe an overall state of disability) or

they do not indicate a problematic aspect of health and health-related states summarized under the umbrella

term functioning. Body functions and structures can be interpreted by means of changes in physiological

systems or in anatomical structures.40

For the Activities and Participation component, two constructs are available: capacity and performance. A

person’s functioning and disability is conceived as a dynamic interaction between Impairment (Body

Function and Structure), Activity Limitation, Participation Restriction and Contextual Factors. As

indicated above, Contextual Factors include both personal and environmental factors. ICF includes a

comprehensive list of environmental factors as an essential component of the classification. Environmental

Factors interact with all the components of functioning and disability. The basic construct of the

Environmental Factors component is the facilitating or hindering impact of features of the physical, social

and attitudinal world.40

17

Figure 2 The ICF *Figure adapted with permission from (WHO 2001)40

2.4 Discussion

All of the frameworks described above are similar with respect to their gross categorization of disability

progression from the cellular level to social functioning. All models describe some form of disruption in

the usual function of the human body at the cellular level, be it through injury, genetic or congenital

abnormality, or acute or chronic disease. The disease or pathology then disrupts normal function of an

organ or system to the point where it becomes noticed by the individual and may be diagnosed and some

treatment (where possible) may be instigated. Subsequently there is an interference with performing

activities considered normal for a particular age-gender population, and some modification of the physical

environment is often required to ameliorate the issues presented.

In the Verbrugge and Jette scheme, disability refers to an individual’s capacity to perform daily activities in

life. 42 This ultimately takes into consideration the involvement of the individual based on what social

activities or household chores they are typically involved in based on their age and sex group due to a

health or physical problem.42 In comparison to the Nagi schemes and more in keeping with the ICF,

Verbrugge and Jette place a greater emphasis on the inter-relatedness of the different aspects of their model

Health Condition (Disorder or Disease)

Body Function And Structures

Activity Limitation

Participation Restriction

Environmental Factors Personal Factors

18

and the inter-connectedness with the personal and environmental factors. However, they have been

criticized for lacking enough distinction between functional limitations and disability.48 For instance, if an

individual is asked about climbing stairs, this could be considered a functional limitation rather than being

classified as disability which places an emphasis on the daily social activity of using stairs to get to the

subway platform for instance. The latter example could lead to some confusion.

Similarly, distinguishing between the ICF’s categories of Activity Limitation and Participation Restriction

can be challenging. In a recent analysis, Badley states that these distinctions are not equally divided and in

reality are more staggered because the definitions are not exactly the same.57 The validity of Badley’s

interpretation still is questionable because it is recent and has not been validated or accepted as a universal

modification of the ICF. However in the future, the ICF classifications may need to be adjusted to reflect

the multi-item scales and summary scale scores that may not clearly fit these sub-domains. For example,

some instruments claim to measure “health-related quality of life” or “quality of life”. An examination of

the domains and items included may demonstrate that the domains are precisely those that focus

specifically on disability or other aspects of physical or cognitive functioning. It is therefore necessary to

go to the domain level and review the items that are actually included before making a judgment about

what an instrument measures. Furthermore, certain domains may be too specific in structure or functions

and may require specialized information that individuals are unable to self-report in a valid way. It may

therefore be that self-reported information on acts, tasks and societal involvement is a better operational

way of measuring the underlying health concept even if these are proxy measures of the health state. For

the purposes of this thesis, we will blend the two categories of Activity Limitation and Participation

Restriction into one category Activity and Participation. Ultimately, functional recovery will be assessed by

instruments classified by their domains under the umbrella term Activity and Participation which will

represent an individual’s expectation in being able to perform activities in both their daily and social life

with the burden of a hip fracture.

19

2.5 Summary

We propose for the current study the use of the ICF Model, a universal language to discern concepts from

the domains in the instruments found in the systematic review. Furthermore, it is critical to use a conceptual

framework that contains definitions of functional outcome, which could better clarify areas of overlap and

neglect in RCTs enrolling aged patients with hip fractures. According to the literature, measurement has

four major purposes: classification, discrimination between groups, prediction, and evaluating change.58

However, the definitions of the conceptual frameworks are still lacking in clarity and the problem is that

the instruments developed prior to the conceptual frameworks are trying to be fit into new concepts. The

direct application of a framework like ICF is problematic because of misfit between its concepts and the

current instrument targets and content. The future could lead to a rethinking of the framework or the choice

of instruments to fit the unique domains within the framework.

20

Keypoints from Chapter Two

• Functional outcome is the assessment of an individual’s capacity to carry out daily activities

• Several conceptual frameworks used to define disablement are reviewed. 1) The Wilson and Cleary is a biomedical model, both 2) Nagi and 3) Verbrugge are a socio-medical model, and 4) the ICF is a biopsychosocial model

• We used the International Classification of functioning, Disability and Health (ICF) model because it is an accepted universal language

• Activities and Participation domains are: learning and applying knowledge, general tasks and demands, communication, mobility, self-care, domestic life, interpersonal interactions and Relationships, major life areas, community, social and civic life

• In the future, the ICF may need to adjust to reflect the multi-item scales and summary scale scores that may not clearly fit these sub-domains

21

CHAPTER 3 METHODS

3.1 Introduction Systematic reviews are concise summaries of the best available evidence that address sharply defined

clinical questions.37 Clinical decision-making is then facilitated by empirical evidence which may well

contradict clinical expertise, physiologic rationale and medical training. EBM allows a quantitative and

“blind” approach to evaluating treatment outcomes. Because there is an overwhelming amount of published

literature, it is important to be able to extract relevant data in a systematic way and to eliminate “noise” or

data from lower quality studies. Indeed, the hierarchy of evidence levels was adopted by the Journal of

Bone and Joint Surgery as a way to classify the published articles. In Table 1 the classification of Levels of

Evidence for Primary Research Question for therapeutic trials investigating the results of treatment are

included (this excludes diagnostic studies, prognostic studies, and economic analyses).59 According to this

hierarchy for therapeutic trials, Level 1 randomized trials contribute the highest scientific value. On the

opposite pole, expert opinion whether from the surgeon’s perspective or from the scientist or researcher is

considered to contribute the least value and classified as Level 5.

A randomized controlled trial (RCT) is defined by the random allocation of patients to intervention group

and followed over time for an outcome of interest. An RCT, when conducted properly, can avoid selection

or confounding biases and provide the most objective basis for quantifying treatment effectiveness.

Randomization minimizes the difference between two comparative groups so that the effects of treatment

are not confounded by differences. Usually these would be patient characteristics such as age, co-morbidity

and severity of illness that are relatively evenly distributed within the two groups and thus do not affect

results. This reduces the confounding bias. In prospective studies (Level II), data can be collected

specifically for the purposes of the study which adds to the accuracy of the data whereas retrospective

cohorts may present insufficient quality data to address the specific research question. In a case-control

study (Level III) the exposure is measured, reconstructed or recollected after the development of the

disease.

22

3.1.1 Defining the research question

For a systematic review, one formulates a focused clinical question as opposed to a question broad in scope

typical of a narrative review. For the purposes of this study, we conducted a systematic review of

randomized clinical therapeutic trials (Level 1) in the aged with hip fractures in order to identify the

functional outcome instruments utilized in these studies. Functional outcomes are used to quantify a

person’s capacity to perform certain daily activities; therefore, we wanted to identify those instruments

used to assess functional outcomes following surgical treatment of a hip fracture. This would allow us then

to determine the EBM guidelines for the aged with hip fracture by determining a common metric across the

trials.

3.1.2 Identifying the search strategy

A systematic review comprise a comprehensive and explicit search strategy, whereas a narrative review

does not usually specify an explicit search strategy which could potentially bias the results. In our study, a

comprehensive search of the literature from 1950 to 2007 (week 38) was conducted independently by a

librarian at St. Michael’s Hospital Medical Library (Toronto, Canada) using multiple electronic databases

such as PUBMED, OVID Medline, EMBASE, Cochrane, Ovid Healthstar, and CINAHL [Appendix 1].

The search strategy used included subject headings such as: ‘hip fracture’, and the narrower terms and

keywords such as ‘trochanteric, subtrochanteric, intertrochanteric, pertrochanteric, intracapsular,

extracapsular fracture’ with age “age 65 and over”. Studies in the English language were included if

patients had had surgical treatment of a hip fracture, were randomized, and a mean age of at least 65 years

old.

Studies were excluded based on the following criteria: patients had fractures other than hip, if the minimum

age at patient enrolment was less than 50 years old and if only pre-operative or peri-operative measures

were investigated. Only one reason was sufficient for exclusion. The combined searches from all the

electronic sources were placed in a Reference Manager database (Reference Manager Professional Edition

23

Table 1 Levels of Evidence for the Primary Research Question for therapeutic studies adapted from the

Journal of Bone and Joint Surgery59

Level 1 • High quality randomized controlled trial with statistically significant

difference or no statistically significant difference but narrow confidence intervals

• Systematic review of Level I randomized controlled trials (and study results were homogeneous)

Level II • Lesser-quality randomized controlled trial (e.g. <80% follow-up, no blinding

or improper randomization) • Prospective comparative study • Systematic review of Level II studies or Level-I studies with inconsistent

results

Level III

• Case-control study • Retrospective comparative study • Systematic review of Level-III studies

Level IV • Case series

Level V • Expert opinion

System, Version 11). Abstracts and titles were hand searched independently by two reviewers (AHK,

DS). Potentially eligible articles were retrieved and references were screened for any other relevant studies.

We used the ICF model, an accepted universal language and framework, to describe and classify concepts

and domains as well as regions of overlap.40, 41 Outcomes are classified into two main categories: 1) Body

Function and Structure and 2) Activity and Participation. Functional recovery following hip fracture can be

determined through improvements that are physical, mental, social and vocational in nature.60 For the

purpose of evaluating functional outcomes we further excluded those trials with only radiographic

parameters (Category 1) such as x-ray analysis to observe unions or non-unions.

Trials, which contained outcomes related to Activity and Participation (Category 2), were further separated

into three intervention groups: surgical, medical or rehabilitation. Surgical trials included intracapsular

fractures treated with conservative versus surgery, surgical techniques, internal fixation device A versus B,

24

replacement versus fixation, arthroplasty. Surgical trials included extracapsular fractures treated with

conservative versus surgery, surgical techniques including condylocephalic nails (Ender nails etc),

cephalocondylic nails (Gamma nail etc) and arthroplasty. Specific medical therapies included

supplementation and the use of drug therapy. Medical therapy trials also included secondary prevention

including the use of antibiotics, wound drapes, surgical drains, and thromboembolic prophylaxis.

Rehabilitation trials included those evaluating interdisciplinary programmes with early supported

discharge, gait retraining, mobility exercise, nutritional supplementation, patient education and early

mobilization, prevention including fall prevention and education on how to fall, use of protective devices,

modification of the environment and prophylactic infection of osteoconductive materials. Discordance for

inclusion of the trials in the systematic review was resolved by discussion, if not resolved then a third party

would decide.

25

3.2 Data Extraction

All relevant data from each of the RCT studies were abstracted by two investigators and re-checked for

accuracy. The data included (1) first author, (2) year of publication, (3) total sample size, (4) intervention

type, (5), maximum follow-up, (6) intention-to-treat (7) domains measured, (7b) instruments used, (8)

references of functional outcome instruments, (9) mode of administration, and (10) description of outcome

instruments. An investigator-developed instrument was defined either as a development of a scale, without

prior validation, or modifications to an existing instrument for the specific randomized trial evaluating the

aged with hip fractures. An investigator-developed instrument also includes item omissions as well as

changes to wording and scoring systems.

3.3 Detsky Quality assessment scale

Author, institution, journal, country, industry and other sources of funding were blinded by one of the

reviewers using Adobe. The quality of the trial was then assessed independently by a second reviewer.

Each eligible study was assessed for quality using the 21-Detsky scale.61 The Detsky scale was chosen over

other commonly-used scales, such as the Jadad and Chalmers scales, because there is less emphasis on lack

of blinding which would have penalized the surgical trials included in our review.62 The Detsky scale

focuses on five principle areas: randomization, outcome measures, inclusion and exclusion criteria,

interventions, and statistics (Appendix 2). Assessment of randomization includes the determination of

whether randomization was carried out, whether it was described in sufficient detail, and whether the

randomization was conducted in a concealed manner. The article is then evaluated on whether objective

outcome measures were used, whether the outcome measures were adequately described, and whether the

outcome assessor was blinded to treatment group. With respect to the inclusion and exclusion criteria,

studies will obtain a better score if these criteria are clear and well defined and if an inclusion and exclusion

report was maintained during the course of the trial in order to assess for sampling bias. Description of both

the control and treatment groups was also evaluated. And statistical analysis focuses on whether the

investigators performed a sample size calculation prior to trial initiation and whether the P value was stated

26

and the analysis was conducted properly. A maximum of 20 points could be obtained for positive trials and

21 points for negative trials. In the case of negative trials, subsequent questions regarding post hoc power

calculations or confidence intervals were asked. As was done in previous trials, the scores between positive

and negative trials were converted to percentages for purposes of comparison.63, 64 Studies scoring more

than 75% on the Detsky Scale were designated high quality and those studies scoring less than 75% on the

Detsky scale were designated low quality.

3.4 Statistical analysis

The Kappa coefficient was used as a measure of chance-corrected agreement between raters in the

screening phase of selecting the articles for appraisal.65, 66 Kappa > 0.65 was considered good agreement.67

Analysis of variance was used to compare the differences in mean quality scores among the surgical,

medical and rehabilitation trials (SAS software version 9.1). The mean score per area of the Detsky scale

was determined to identify areas of weaknesses. A chi-squared test was used to evaluate the number of

publications with functional outcomes (Activity and Participation) over time (SAS software version 9.1).

The level of all tests was set at 0.05 and reported with 95% confidence intervals.

3.5 Results

In the electronic databases, 2451 citations were found when limited to randomized controlled trials

performed on subjects with a mean age of 65 (Figure 1). Of these, 551 studies appeared potentially relevant

and were retrieved in full. Application of the criteria for eligibility further eliminated 254 articles: 72 were

not only hip fractures, 57 articles did not focus on post-operative outcomes, 29 were not RCTs, 27 articles

were not in the English language, 18 articles did not include the aged and 24 remaining articles were

duplicate and not original trials. Of the remaining 211 articles, 122 (58.7%) articles only contained

radiographic measures of impairment (Category 1). Eighty-six (41.3%) unique trials contained measures of

Activity and Participation (Category 2) were included and assessed for quality (Appendix 3): 71 (83%)

were identified from computerized database searches; twelve (14%) from bibliography searches and three

27

(3%) from content experts (Appendix 4). The agreement in selecting these articles was very high (kappa,

0.92; 95% confidence interval, 0.87 to 0.98).

28

Figure 1 Search strategy conducted from 1950 to 2007 (week 38)

Initial Literature Search “Hip Fracture”

N=2451

Cross references & Content experts

N=15

Excluded Using Database Search

Filters Not RCT, English, Mean

age > 65 yrs N=2034

Potentially Eligible Trials N=551

Eligible Trials N=211

RCT (Category 1) Trials Radiographic Parameters

N=122

Duplicate Publication N=3

Excluded N=254 72 other fx types

57 prevention-fracture risk 29 not RCTs

27 not English 18 age

24 duplicate

RCT (Category 2) Trials Functional Outcome Measures

N=86 71 Database search 12 Cross references 3 Content experts

29

3.5.1 Study Characteristics

Nine trials had negative outcome results and thus were scored out of 21 points. Fifteen trials included

intention-to-treat analysis (Table 2). Follow-up ranged from 7 days to 13 years. The studies varied in

follow-up periods, the majority of the trials (15.1 %) had a maximum of 2 years follow-up, 17.4% of the

trials had a maximum 6 months follow-up, and 8.1% of the trials had a maximum follow-up of 3mths. The

mean completeness of patient follow-up was 84.1% (20% - 100%). Forty studies concealed randomization

to the investigator with the use of sealed envelopes. The mean patient sample size was 162 (43-455

patients) for surgical trials, 97.7 (18-243 patients) for medical trials, and 118 (24-319 patients) for

rehabilitation trials.

3.5.2 Quality Assessment

86 studies were included for quality assessment (Appendix 3). Twelve of these were retrieved by screening

the references of the included trials. 59 (68.6%) trials scored more than 75% in quality (30 surgical, 11

medical and 18 rehabilitation trials) and 27 (31.4%) trials scored less than 75% in quality (18 surgical, 2

medical and 7 rehabilitation trials). The mean score (and standard error) for the quality of all the

randomized trials was: 75.8% ± 1.76% (95% confidence interval, 72.3-79.3%). Medical trials had a higher

mean quality score than did surgical trials (83.7% compared with 72.7%, p=0.025). Quality assessment

ranged from 25% to 95%. The three areas of poorest quality were: poor reporting of treatment group

concealment to the investigator (62% of the 86 trials), no blinded outcome assessment (63% of the 86

trials) and no inclusion of an a-priori sample size calculation (71% of the 86 trials). The four areas of best

quality was (3a) inclusion/exclusion criteria well defined, (4a) the therapy was fully described for the

treatment group and (4b) the therapy was fully described for the controls and (5b) the statistical analysis

was appropriate.

30

Table 2 Characteristics of the 86 included studies listed in alphabetical order

Eligible Randomization concealment

Blinding Follow-up Withdrawals/ Dropouts/ Excluded patients

ITT Quality

Author (year)

Yes Yes Method Patient Outcome Assessor

% Yrs Reported Yes %

Adams (2001)68 X X Envelope ? ? 80 1 X 95 Ahrengart (2002)69 X X Envelope ? ? 87 3 X X 80 Bach (2004)70 X X ? X ? 78 1 X X 90 Bachrach-Lindstrom (2000)71

X ? ? No No 75 1 X X 75

Baker (2006)72 X X Envelope ? ? 85 3 X 90 Bal (2005)73 X X Shipping of

implants X X 89 2 Not

reported 30

Bannister (1990)74 X No No No No 65 1 X 30 Binder (2004)75 X X ? ? ? 76 6mths X X 80 Blomfeldt (2005)76 X X Envelope X No 95 4 X 90 Blomfeldt (2005b)77 X ? Envelope ? ? 80 2 X 85 Blomfeldt (2007)78 X X Envelope No Yes 82.5 1 X X 85 Boonen (2002)79 X ? ? X ? 99 6mths None 65 Bruce (2003)80 X ? ? ? ? 92 2mths X X 52 Burns (2007)81 X No No No No 90 6mths X 85 Calder (1995)82 X ? ? ? ? 67 6mths X 65 Calder (1996)83 X X ? ? ? 80 2 X 75 Cornell (1998)84 X X Envelope X X 98 6mths X 90 Crotty (2002)85 X X ? No X 100 4mths Not

Reported 81

Crotty (2003)86 X X Envelope ? X 99 1 X 90 Davison (2001)87 X X ? ? Yes 100 3 ? 55 Desjardins (1993)88 X ? ? ? X 85.8 1 X 65 Di (2007)89 X X ? ? No 100 1mth None 45 Dujardin (2001)90 X ? ? No ? 80 6.5mth

s X 65

Efstathopoulos (2007)91

X X Envelope ? ? 96 6mths X 85

El-Abed (2005)92 X ? Admission ? ? 78 3 X 60 Espaulella (2000)93 X X Envelope X ? 93 6mths X 95 Foss (2005)94 X X ? X X 99 5days X 95 Hagsten (2004)95 X X Envelope X X 85 2mths X 95 Hagsten (2006)96 X X Envelope X X 75 2mths X 90 Hallan (2006)97 X X Envelope ? X 70 2 X 86 Hardy (1998)98 X No Even/odd No ? 70 1 X X 65 Hardy (2003)99 X ? ? No ? 80 3 X 70 Harrington (2002)100 X X Envelope ? X 80 1 X 85 Hauer (2002)101 X ? ? X X 80 3mths X 70 Hedstrom (2002)102 X X Envelope No ? 1 X X 75 Huang (2005)103 X X ? X X 89 3mths X 85 Huusko (2002)104 X X Envelope X X 88 3mths X X 95 Janzing (2002)105 X X Envelope No No 72 1 X 85 Johansson (2000)106 X X Envelope No No 90 2 X 75 Johansson (2006)107 X X Envelope ? ? 71 2 X 85 Jonsson (1996)108 X X Envelope No No 75 2 X 45 Karn (2006)109 X No No No No 100 6mths None 55 Keating (2005)110 X X ? No No 85 2 X 95 Keating (2006)111 X X No No X 63 2 X 95 Kim (2005)112 X X ? ? X 100 2 X 85 Krichbaum (2007)113 X X Envelope ? Yes 69 1 X 80 Kuisma (2002)114 X X Envelope X X 92.6 1 X 80 Lamb (2002)115 X X Envelope X X 88 3mths X 95 Lauridsen (2002)116 X ? ? ? Yes 58 ? X X 57 Mangione (2005)117 X X ? ? X 80.4 3mths X 85 Mattsson (2005)118 X X Envelope ? X 83 6mths X X 90

31

Mattsson (2006)119 X X Envelope ? ? 36.4 2 X 85 Miedel (2005)120 X X Envelope ? Yes 97 1 X 90 Moroni (2004)121 X X Envelope ? ? 99 6mths X 70 Naglie (2002)122 X X Envelope X X 99.6 6mths X 80 Neumann (2004)123 X X ? X X 100 3mths None 80 Oldmeadow (2006)124

X ? ? ? ? 100 7 days Not Reported

65

Oude Voshaar (2006)125

X ? ? X X 64 6mths X X 55

Ovesen (2006)126 X X Envelope ? ? 96 6mths X 95 Pajarinen (2005)127 X X Envelope ? ? 70 4mth X 80 Papasimos (2005)128 X ? ? ? ? 85 1 X 65 Parker (2000)129 X X Envelope No No 100 3 X X 80 Parker (2002)130 X X Envelope No ? 99 3 X 90 Peterson (2004)131 X ? ? ? X 99 1 X 75 Peyser (2007)132 X X Envelope No No 82 1 X 85 Raia (2003)133 X X ? X ? 95 1 X 80 Ravikumar (2000)134 X No Day of

week No No 93 13 X 70

Resnick (2007)135 X X ? ? ? 74.5 1 X X 75 Rogmark (2002)136 X X Envelope ? No 100 2 ? X 80 Santini (2005)137 X No Alternate

days ? ? 74.5 1 Not

Reported 25

Sherrington (2003)138

X X ? ? ? 96 2wks X X 86

Sherrington (2004)139

X X Envelope ? No 95 4mth X X 85

Shyu (2005)140 X No ? ? No 80 3mths X 70 Sikorski (1981)141 X No Card from

box ? ? 20 2 Not

Reported 55

Soreide (1976)142 X No Date of Birth

? ? 64 2 X 65

Stenvall (2007)143 X X Envelope ? No 84.2 1 X 85 Tidermark (2003)144 X X Envelope ? X 80 2 X 80 Tidermark (2004)145 X X Envelope X X 88 1 X 95 Tinetti (1999)146 X X ? ? X 100 1 X 85 Tsauo (2005)147 X ? ? ? ? 46 6mths X 55 Utrilla (2005)148 X X Envelope X X 95 1 X 80 Van der Lely (2000)149

X X ? X X 68.5 6mths X 95

Van Dortmont (2000)150

X X Envelope X X 100 2 None X 80

Van Vugt (1993)151 X ? ? ? ? 98 3 X 55 Vidan (2005)152 X ? X ? 97 1 X 76 Vidyadhara (2007)153 No ? ? ? Yes 90 2 Not

Reported 35

? - Unclear

3.5.3 Outcome instruments

Over time there was a trend, although not significant, in the increase in the use of instruments assessing

function in the aged with hip fractures (chi-square = 2.904, df = 1, p=0.09) (Figure 2). We found

considerable variability in the selection of outcome measures across studies (Table 3). Of 86 included

studies, 48 trials assessed radiographic parameters, 29 trials gait pattern, 19 trials pain, 14 trials gait speed,

34 trials activities of daily living. 14 trials at most used the same instrument, the Katz- ADL Index45 and 16

trials at most used the same impairment-based scoring system, the Harris hip score154 and 10 trials used

32

Parker’s New mobility score155 (Figure 3). The utlity measure, EQ-5d, was used in 8 trials and the health

status measure, the SF-36 was used in 10 trials.

The instruments, found in each Category 1 (N=122) and 2 (N=86) randomized trials, were classified

according to the ICF concepts (Figure 2). The 86 randomized controlled clinical trials contained measures

of Body Function and Structure as well as Activities and Participation (Category 2 trials). Seven out of the

86 RCTs were rehabilitation trials which only contained measures of Activities and Participation.

Figure 2 A comparison of Category 1 trials only assessing radiographic parameters versus Category 2

Trials with Measures assessing Activity and Participation over the last two decades

33

Figure 3 The number of times a scale is used in one of the 86 RCTs and showing the most commonly-

used scales.

High quality Randomized Controlled Trials

In the 59 included trials, which scored above 75% on the Detsky scale, 70% of the surgical trials used

composite scores. Eight trials used the Euroqol-5d (EQ-5D) 156 for utility and 8 used the Short-Form 36

(SF-36)157 health status measures. Of the SF-36 health status measures, one additional trial was found

that reported both the chronic and acute form of the SF-36 and one trial used only the physical function

subscale of the SF-36. Three out of the nine trials reported the SF-36 summary scores such as the

Mental Component Score and Physical Component Score. Eight high quality trials at most used the

same impairment-based composite score: 8 (13.6%) trials used the Harris hip score (HHS), the

Charnley hip score158 (6 trials), Oxford hip score159 (1 trial) and the Hip rating questionnaire160 (4

trials). The impairment based composite scores were predominantly used in surgical trials with the

HHS also used in two medical trials. 13 (22.0%) high quality trials used the Katz ADL Index and 7

(11.9%) trials used Parker’s New mobility score. 3(5%) high quality trials adopted investigator-

developed instruments (Figure 5).

1614

10 10 86

0

5

10

15

20

Harris hipscore

ADL-Katz New MobilityScore -Parker

SF-36 EQ5D TUG

Commonly used instruments

Nu

mb

er o

f R

CT

s in

clu

din

g t

he

scal

e (N

=86

)

34

Figure 4 The number of RCTs (N=208) that measure each ICF concept

Low quality randomized controlled trials

27 trials scored less than 75% according to the Detsky scale, and were considered low quality. 5 trials

scored in the intermediate range of 70-75%. Only 6 trials included measures of health status (SF-36,

Nottingham health profile161, Sickness Impact Profile188 and the WHO-QOL BREF162). The majority of

the low quality trials (N=10) used the Harris hip score and 8 (30%) used investigator-developed

instruments (Figure 5). None in the intermediate quality assessment range adopted investigator-

developed instruments.

Number of RCTs measuring ICF concepts

59%

41%

3%0%

10%20%30%40%50%60%70%

Only Body Function &Structure

Both BodyFunction/Structure &Activity Participation

Only ActivityParticipation

ICF concept

Num

ber

of R

CT

s m

eas

urin

g

ICF

con

cep

ts (%

)

35

Figure 5 The prevalence of investigator-developed instruments in low and high quality trials.

36

Table 3 Data extraction of outcome instruments fielded in the included trials that met acceptability criteria.

Outcome categories

Instruments Instrument named/described Method of administration described

Cited reference on psychometric properties/protocol

Assessed but no details given Total number of studies

Radiographic parameters (union, fracture healing, reduction, implant positioning)

X-ray, RSA a)implant positioning [118H,77H,127H,144H,69H]; TAD [118H,99L,100H,68H,121L,153L]; Miedel’s classification mod. [126H];b) Cementing grade [72H]; c)acetabular erosion [72H,87L]; d)avascular necrosis Ficat[118H] e)osteolysis[73L]f)loosening [87L] g)scintimetry [151L]

n/a 19[126Ha,72Hb,118Ha,d,77H,127H,144H,99L, 69H,100H,68H,150H,78H,132H,112H,148H,73L, 121L, 87L,153L]

29 [91H, 148H,72Hc, 107H, 111H,120H,133H,130H,136H,90L,106H, 129H,83H,84H,110H,141L,119H, 134L,145H,101L,109L,137L,98L,74L, 82L,88L,128L,92L,108L]

48

Bone mineral density

a)Dual energy x-ray absorptiometry; b)single energy photon absorption c)Qct d)ultrasound

Singh index [90L, 112H,101L,153L, 105H];4[145Ha,79La,104Hb,102Ha, c,d,75Ha]

n/a n/a n/a 10

Range of motion

Goniometer Merle D’aubigne [119H] 4[76H,69H,119H,140L,147L]

1[119H] 8[76H,69H,129H,84H,141L,140L, 98L,147L]

9

Balance a)step test; b)postural stability c)functional reach d) force plate e)berg balance scale f)activities-specific balance confidence scale g)progressive Romberg test h)timed single-stance-limb stance

8[115Hb,81Hc,131Hc,139Ha-d, 85He,f,75He,g,h, 125Lc,101Lg]

2[115Hb,139Ha-d] 7[115Hb,81Hc,139Ha-d,85He,f,75He,g,h,125Lc,101Lg]

1[101Lg] 8

Gait pattern a) Use of walking aid/walking ability/ Functional ambulation classification, b)walking distance c) New mobility score

16 [127Ha, 91Hc, 48Hc, 99Lc, 130Hc, 105H, 129Hc, 94Hc, 93Ha,c, 152Ha,139Ha,c,114Ha, 101La,99Lc,98Lc,74L]

11[72Hb,76H,130Hc,68H,78H,94H, 104Ha,93Ha,c,152Ha,139Ha,c,108La]

11 [91Hc, 148Hc, 99Lc, 130Hc, 129Hc, 94Hc, 93Ha,c, 152Ha, 139Hc, 99Lc, 98Lc]

17[126H,76H,69Ha, 100Ha,68H, 83H,78H, 104Ha, 114Ha, 101La, 116La, 74L, 124La,b, 88L, 108La, 105H, 151L]

29

Pain Visual Analogue Score b)Mobility pain subscale c) SF-McGill pain

12[118H,119H,132H,104H,102H,115Hb, 81Hc,d, 101L, 125Ld, 140Le, 89L, 105H]

4[118H,99L,132H, 105H] 9[118H,119H,132H,102H,115Hb,81Hc,d,101L, 125Ld, 140Le]

9[99L,69H, 136H, 100H,98L, 74L, 89L, 108L, 151L]

19

37

Outcome categories




questionnaire d)Wong-Baker pain rating scale e)numerical scale

Grip strength Dynanometer (Jamar)

2[145H,79L] 2[145H,79L] 1[145H] 1

Hip muscle strength

Dynanometer; b) Leg extensor Power rig c)1RM d)spring balance e) lateral step-up ability f)MICROFETZ

10[118H,119H,115Hb,117H,131H,139Hd,e,146Hc, 140Le, 101Lc, 147L]

2[139Hd,e,140Le] 7[117H,115H,131H,139Hd,e,146Hc,101Le,147L]

1[140Le] 10

Performance a) Timed up and go test; b) Functional performance battery c)PPME d)modPPT e)POMA f)step height g)chair stand h)stair climbing

11[84H,70Hb,81Ha,131Ha,86Ha,139Hc, 85Ha, 146Hb, 75Hd, 125Lb, 101La,e-h]

n/a 8[84H,81Ha,131Ha,86Ha,139Hc,85Ha, 125Lb, 101La,e-h]

3[70Hb,146H,75Hd] 10

Gait speed 6 minute walk test, 3m, 4m, 6m, 10ft, 50ft, free/maximal, step count, S-COVS-walking ability item, step length

14[84H,79Lb,102H,115H,81H,117H,131H, 86H, 75H, 135H, 143H, 125L, 101L, 147L]

3[84H,86H,135H] 8[79Lb,102H,81H,131H,89L,143H,125L,101L]

3[84H,75H,147L] 14

Activities of Daily Living a) Barthel Index, b)

Katz Index c)OARS-Fillenbaum d)klein bell e)CBI

29[149H, 118H, 76Hb, 77Hb, 120Hb, 144Hb,78Hb,145Hb, 104Hb,102Hb,98Ha,71Hb,93Ha,9a,152Hb, 86Ha, 104Hb, 85Hb, 122H, 146Hc, 75Hc, 143Hb, 95H, 25L, 140Le, 80Lb, 101La, 87La]

15[149H, 118H, 76Hb, 77Hb, 144Hb,78Hb, 145Hb,104Hb,71Hb,93Ha,85Hb,122H, 146Hc,140Le]

25[76Hb,77Hb,120Hb,144Hb,78Hb, 145Hb,104Hb,102Hb,98Ha,71Hb,93Ha, 103, 152H, 86Ha, 104Hb, 85Hb, 122H, 146Hc, 143Hb, 95H, 140Le, 80Lb, 101Le, 87La]

7[129H,150H,119H,112H,75Hc,125L,108L]

34

Instrumental activities of daily living

a)Lawton b)Hamrin c) klein bell

7[104Ha,71Hb,104Ha,122H,95Hc,140La,101La]

4[104Ha,71Hb,122H,140La] 7[104Ha,71Hb,104Ha,122H,95Hc,140La, 101La]

7

Functional Index Measure Mobility subscale [123H]

1[123H] 1[123H] 1[123H] 1

Disability Rating Index Modified

2[96H,95H] 2[96H,95H] 2

Total functional score

1[137L] 1[137L] 1

38

Outcome categories




Musculoskeletal Function Assessment Mobility subset [133H]; ADL subset [133H]

1[133H] 1[133H] 1[133H] 1

WOMAC modified 1[109L] 1[109L] 1[109L] 1 Impairment-based composite scoring systems Oxford hip score 1[72H] 1[72H] 1[72H] 1 Harris hip score;

Modified [109L] 17[68H,106H,83H,78H,134L,112H, 148H,102H, 71H, 109L, 73L, 121L, 87L, 153L, 82L, 89L, 147L]

1[68H] 12[68H,78H,112H,148H,71H,109L, 73L,121L, 87L, 153L, 89L,147L]

5[107H,106H,83H,134L,82L] 18

Hip rating questionnaire; Modified [111H, 110H, 75H]

4[111H,84H,110H,75H] 1[110H] 1[84H] 3[111H,110H,75H] 4

Matta hip functional score

1[92L] 1[92L] 1

Stinchfield’s hip assessment system

1[142L] 1[142L] 1

Functional status index

1[113H] 1[113H] 1[113H] 1

Charnley’s score Pain subscale [130H,129H]

6 [76H, 77H, 120H, 144H, 130H, 129H]

4[76H,77H,144H,130H] 6[76H,77H,120H,144H,130H,129H] 6

Van Vugt score 1[151L] 1 Salvati and Wilson 2[90L, 128L] 2[90L,128L] 2 Generic health-status

SF-36; a) Physical function subscale; b)acute & chronic form

12 [117Ha, 72H, 118H,133H,103H, 131Hb, 86H,85H, 75H, 121L, 140L, 92L]

4[72H, 118H,133H, 140L] 10 [72H,118H, 133H, 103H,117Ha, 86H,85H,75H140L, 92L]

1[131Hb] 12

Sickness Impact Profile; a) Mobility and activity subscales

3 [70H,125La,92L] 3[70H, 125La, 92L] 3

WHO-QOL Bref 1[147L] 1[147L] 1[147L] 1 Functional Status

Questionnaire a) ADL subscale

1[75Ha] 1[75Ha] 1

London Handicap Scale

1[85H] 1[85H] 1[85H] 1

SWED-QUAL 1[96H] 1[96H[ 1 Nottingham Health 1[82L] 1[82L] 1

39

Outcome categories




Profile Utility Euro-QOL 5D 8[111H, 76H, 77H, 120H, 144H,

110H, 78H, 145H] 5[76H,144H, 110H, 78H, 145H]

8[111H, 76H,77H, 120H, 144H, 110H, 78H, 145H]

8

Social role functioning

Social Activity Scale

1[146H] 1[146H] 1[146H] 1

Exercise tolerance

Yale physical activity survey a)Exercise subscale

1[89La] 1[89La] 1[89La] 1

*H – denotes high quality trials scoring > 75% on the Detsky scale, L denotes low quality trials scoring < 75% on the Detsky scale; N.B. Trials with only measures of impairment have been excluded from this systematic review

40

3.6 Discussion

We found 86 studies of which 59 were deemed to be high quality, scoring more than 75% on the Detsky

scale and included measures with domains under Activity and Participation. Furthermore, quality

assessment of the trials revealed that high quality trials (those scoring more than 75% on the Detsky scale)

relied less on investigator-developed instruments. These were more commonly found in low quality trials

which also reflected on their poor study conduct seen in the quality scores. Investigator-developed

instruments typically are those that were designed for the specific purpose of the trial and often lack proper

references to the development of the instrument. The development of the instrument would contain

information regarding its conceptual basis as well as its primary purpose and target population which will

be further discussed in Chapter Four.

Our results indicate that generic health status measures and measures of utility are tested more and

standardized than measures based on performance such as the TUG or impairment such as the HHS or even

single domains such as Activities of Daily Living. Clinical trials, especially those with surgical intervention

as the primary research question, were dominated by impairment-based scoring systems. Impairment-based

scoring systems can be found in rehabilitative trials; whereas, performance-based instruments are not

typically found in surgical trials. This indicates the future possibility of utilizing impairment-based scoring

systems across different trial types. Indeed, we found a positive trend in the use of functional outcome

instruments over time. Interestingly, the SF-36 contrary to our hypothesis was not widely used. An

assessment of practical characteristics defining these instruments in the following Chapter will elucidate the

benefits of these different instrument types.

3.6.1 Randomization

Most patients enrolled in the trials were assigned randomly; however, many trials did not conceal the

treatment group to the investigator. Concealment is achieved by taking adequate steps to ensure those

responsible for assessing patient eligibility for trial enrolment are kept unaware of whether the patient will

be allocated to the control or experimental group. Authors should provide adequate description of the

41

concealment of randomization results. For example, was patient enrolment randomized via a computer-

generated list and was concealed in a sealed envelope just prior to surgery?

Furthermore, in order to preserve the effects of randomization, it is important that patients are followed and

evaluated within the group to which they were initially allocated, regardless of whether they received or

completed the intended treatment. This is an intention-to-treat analysis. If only 17% (15/86) of the trials

explicitly stated an “intention-to-treat” analysis, it leaves us to suspect the possibility of crossover and

drop-out biases.

Data collection often was not blinded, presumably due to obvious radiographic or other evidence indicating

which treatment was received for a given patient. Subjective assessments are always construed as having

some degree of bias when the assessor is not blinded to the treatment allocation. This is challenging but

there are several new studies that suggest ways to overcome this. For instance, leaving personnel unaware

of the study hypotheses or masking the implant on radiographs could ensure that this criterion is met.163

3.6.2 Sample size calculation

We also found that the majority of the trials neglected inclusion of an a-priori sample size calculation. It is

believed that the larger the sample size for the trial, the larger the number of outcome events and the greater

our confidence that the true relative risk reduction is close to what is observed.164 However, the smaller

patient populations typical of medical trials could serve their purpose of providing confident, definitive

answers to important questions. In this scenario, it is the number of events rather than the number of

patients that count.165 Even these small, indeterminate trials (with large confidence intervals) can prompt us

to question conventional but untested therapeutic wisdom. Furthermore, these small trials even when

individually inconclusive can serve as the basis for convincingly conclusive overviews and meta-analyses.

True enough, in order for these trials to be considered they must be registered at their inceptions rather than

left unreported at their conclusions.166 The selection of appropriate population for estimating the sample

size is important and should in principle be made based on the primary endpoint.

42

3.6.3 Identification of outcome

Primary and secondary outcomes should also be clearly defined and when applicable any methods used to

enhance the quality of the measurements. An example of what should be described, are multiple

observations and training of assessors.167

3.6.4 Follow-up

In order for the results to be valid, the study must have a sufficiently long and complete follow-up. The

number of patients lost to follow-up can potentially impact the validity of an article. If the information is

not available on the prognosis of patients lost to follow up and they represent a significant proportion of the

studies’ overall population, it is impossible to estimate the overall success of the intervention.164 It has been

reported that if less than 5% of the patients were lost to follow-up the effect on the outcome is considered

minimal or negligible and if 20% or more of the patients are lost to follow-up the validity of the trial is

significantly threatened.165 However, one should consider all patients lost to follow-up as the worst-case

scenario and re-analyze the results with those patients’ added as failures or adverse events. If this

significantly alters the results, then the validity can be considered poor and it is important to determine the

magnitude of the treatment effect. This is especially important, because the way in which the results are

presented can alter the impact of the intervention making the treatment effect look very small or quite large.

3.6.5 Statistical methods

The majority of trials reported p values and in the case of negative outcomes the confidence interval. These

are two frequently encountered statistical measures of study precision. The p-value is the probability that

the treatment effect can occur in a long run of identical trials as a result of chance alone. If the p-value is

less than or equal to 0.05 it will be statistically significant. Although useful, the p-value does not convey

the range over which the effect can possibly occur.168 The latter is addressed with the concept of the

confidence interval, which is the range of values within which we can be confident that the true value for

the whole population lies. Typically, a standard confidence interval of 95% is reported. This means that

43

there is 95% certainty that the true value of the measured variable lies within the stated range. As the

sample size of a trial increases so does the number of events and subsequently the 95% CI interval should

get smaller.22

3.7 Summary

Consistent with other systematic reviews including surgical trials, there are particular deficiencies in the

published hip fracture literature including poor concealment of allocation, sample-size calculations, and

very few explicitly report an intention-to-treat analysis in the trial. There is also limited information on

patients who withdrew or for whom follow-up was incomplete. Overall, medical trials are more rigorous

and have better quality scores than either rehabilitation or surgical trials. The latter may be due to the

facilitation of blinding following drug treatment in the hip fracture trials. Rehabilitation trials have the

shortest follow-up endpoint.

In the years of publication between 1950 and 2007, there had been an increase in the use of instruments

assessing function in the aged with hip fractures. Based on the evidence gathered from this systematic

review, it is clear that very few randomized clinical trials use the same index or questionnaire. Measures

such as the SF-36, contrary to our hypothesis, were not commonly used in hip fracture RCTs. Furthermore,

the use of investigator-developed instruments are used predominantly in trials scoring less than 75% on the

Detsky scale when compared to those trials scoring more than 75% in the latter. In the next chapter, the

characteristics of the instruments will be explored to elucidate what clinicians have been quantifying as

functional recovery in hip fracture trials.

44

Keypoints from Chapter Three

• An RCT can avoid selection or confounding biases and provide an objective basis for quantifying study outcomes

• 86 unique trials were identified and assessed using the 21-point Detsky quality scale

• Overall, there were poor reporting of treatment group concealment to the investigator, no blinded outcome assessment and no inclusion of an a-priori sample size calculation

• There were more investigator-developed instruments in the low quality trials when compared to the high quality trials

• There was an increase in the use of functional outcome instruments over time, although standardized measures such as the SF-36 was not widely used

45

CHAPTER 4

Instrument Characteristics: Pragmatic considerations

4.1 Introduction

Selection of the most appropriate measurement tools involves pragmatic as well as psychometric

considerations.25, 169 The pragmatic aspect of an instrument is defined as having the advantages of easy

administration to either respondent or examiner in addition to a simple score that can be interpreted in the

aged following a hip fracture. In a recent review of the evidence on measurement tool appraisal in geriatric

rehabilitation, Auger et al coined the term ‘applicability’ of a measurement tool for a given population or in

a specific context, defined by four dimensions: respondent burden, examiner burden, score distribution and

format compatibility.169 We believe that the most commonly used functional outcome instruments found in

randomized hip fracture trials have good pragmatic qualities. The objective of this chapter is to examine the

characteristics of the measurement tools found in RCTs, which in turn could assist clinicians and

researchers in creating proper EBM care maps. EBM care maps can be made once an appropriate

instrument is found to be applicable and psychometrically tested such that treatment effectiveness can be

measured and the burden of a hip fracture followed over time. An instrument which ranks high in

applicability will achieve minimal burden to the respondent and examiner, adequate score distribution and a

format that is compatible with the respondents’ age, culture, language and abilities.169

4.2 Methods

We extracted the measurement tools assessing functional outcomes from 86 randomized clinical trials

identifying the aged undergoing postoperative hip fracture treatment and rehabilitation. Furthermore, the

text and reference lists of the identified articles were screened in order to compile relevant literature on the

instrument used in the RCT. Consequently, those instruments that were developed for the unique purpose

of the trial and not cited in the references were termed as ‘investigator-developed’ and excluded. Should the

instrument not reference the original development article, the reference cited by the authors was still used.

The latter would have been an indication of either poor availability of the instrument to the authors

46

conducting the trial subsequently leading to a poor decision on the part of the clinicians or researchers to

include the instrument without obtaining complete information. We extracted the following characteristics

of the instrument: 1) Source or year of initial publication 2) Purpose or stated purpose for the development

of the instrument and the intended population 2) Description including the number of items in the index,

number of components 3) Response options whether dichotomous or use of a visual analogue score 4)

Adequate scoring distribution 5) Respondent burden 6) Examiner burden and 7) Format compatibility.

Items 4-7 will take into consideration the recommendations by Auger et al169. We also compared the

applicability of the instrument used in the hip fracture trials to note any modifications of the original scale

or index. We then rated overall measures in the categories of performance-based, activities of daily living,

impairment-based and multi-attribute aggregate scoring systems based on their applicability in hip fracture

trials. 10 points were allotted to poor applicability of the measure, 5 points indicated moderate applicability

and 0 points indicated good applicability in each of the four dimensions further described below.

According to Auger,169 the definitions used to assess the pragmatic criteria or applicability of measurement

tools in the hip fracture literature were the following:

Respondent burden components include invasiveness which can be either physical or emotional in origin

towards the respondent. A low respondent burden is optimal for an instrument.169 It takes into account how

long it takes to complete the questionnaire or scale or activity, whether all items are completed, what does

the individual being administered the instrument feel about the questions or tasks in regards to his condition

of having a hip fracture. Another factor to consider is the overall perception of the score by the respondent.

Examiner burden takes into account if specific training is required in administering the instrument to assess

the functional outcome in a patient with hip fracture. Are there requirements for specific props in order to

administer the instrument? How popular is the test and how often is it cited in the hip fracture literature?

Can the examiner interpret the scores and is he given appropriate detailed instructions in a standardized

fashion? Is there a cost in obtaining the instrument and are there copyright restrictions that could limit its

47

use in the particular setting? A tool with minimal examiner burden demonstrates better potential for being

applicable.169

Adequate score distribution is one indication of the applicability of a measurement tool. When the score of

scale represents a wide spectrum of behaviours or performance levels of a target population, it is applicable

to them. For continuous variables, it involves comparing the distribution of scores to the normal curve and

for categorical data, choosing a threshold value at the bottom or top of the scale representing a possible

floor or ceiling effect.169

Format compatibility refers to the appreciation of the compatibility between the target population

characteristics and the assessment format to avoid age, gender, cultural or disability biases.170 Format

compatibility components include the characteristics of the tested population (age, gender, culture,

language), abilities required to accomplish the test and format types available. Abilities required to

accomplish a test such as intellectual, emotional, physical requirements, can be empirically verified. If the

difficulty threshold is too high, there will be a large proportion of missing data. Format types include self-

report, performance-based, clinical judgment scales, as well as alternate formats (assistance, answer cards,

large print, validated translations). The availability of validated translations (language and culture) of

measurement tools further ensures an accurate interpretation of results.

The focus of many therapeutic interventions whether surgical, medical or rehabilitative, is the attention

towards the individual’s ability to perform certain activities as well as they would like to. We will adopt the

ICF scheme to identify those instruments that measure functional outcome. The latter is defined by those

measures used to quantify activities one can perform in their daily life as well as the societal impact one has

to deal with when recovering from the burden of a hip fracture. There are many composite scores that cut

across many different domains. The ICF codes will be used to express in percentages the number of

components in the composite scoring systems and classify them as either Body Function and Structure or

Activity and Participation.36 Impairment-aggregate scores are defined as those composite scores which

consisted solely of components of Body Function and Structure. Multi-attribute aggregate scores are

48

defined as those composite scores which consist of all categories in the ICF (Body Function and Structure

as well as Activities and Participation and External Factors).

The appropriate choice of a functional outcome instrument is fundamental in order to ensure that results are

obtained which reflect the patient. Should the instrument be inapplicable to those enrolled in hip fracture

RCTs, the methodology and results could be replicated but not informative. Furthermore, the difficulty in

choosing an appropriate instrument stems partially from the lack of a taxonomy that describes the practical

issues encountered in choosing these instruments for an RCT.

4.3 Results

Overall, 81 different instruments were identified measuring both Body Function and Structure and Activity

and Participation. 36 instruments were used to measure Body Structure alone such as radiographic

parameters or bone mineral density. 24 instruments measured Body Function, 13 evaluated measures of

Activity and Participation and 8 different composite scoring systems were identified. All the instruments

differ in their items and scales as well as scoring distribution and response options.

4.3.1 Measures of Activity and Participation Mobility measures include changing and maintaining body position, carrying, moving and handling objects,

walking and moving, moving around using transportation. Those measures that were performance-based

and rated by an external observer were predominantly utilized in rehabilitation trials.

Physical Performance Test171

Source: Reuben 1990

Purpose: The PPT assesses multiple domains of physical function using observed performance of tasks

that simulate activities of daily living of various degrees of difficulty. The PPT was designed to assess

strength, mobility, dexterity, and stamina through direct observation of the elderly person’s performance of

specified activities.

Description: Two versions are presented: a nine-item scale that includes writing a sentence, simulated

eating, turning 360 degrees, putting on and removing a jacket, lifting a book and putting it on a shelf,

49

picking up a penny from the floor, a 50-foot walk test, and climbing stairs (scored as two items); and a

seven-item scale that does not include stairs. The PPT was tested in a clinical practice (one Parkinson’s

disease patient), a board-and-care home, and a senior citizens’ apartment.

Response options: The PPT can be completed in less than 10 minutes and requires only a few simple

props. The test was administered by an observer according to a protocol.

Scoring: PPT scores are the sum of the 5-point scales for each of the items, varying from ‘most capable or

fastest’ to ‘unable to do’.

Respondent burden: Physical or emotional invasiveness and the respondent may not feel that the score

actually reflects their capacity to complete a task. For instance, the aged may take longer to completing a

task but end up finishing it given more time. Furthermore, the aged may feel uneasy performing these tasks

not in their home or accustomed setting.

Examiner burden: Training is required and instructions are unclear. The framing of the instructions to

study subjects is not accurately described: Were subjects aware they were being timed? Were they told to

complete the tasks as fast as they could or as carefully and accurately as they could? According to the

author, but unspecified in the listed reference: patients were instructed to complete the tasks at their usual

pace and in their usual manner and were informed that they were being timed.

Availability: environmental requirements

Popularity in hip fracture trials: A physical performance test was used in one study (Boonen 2002) and

modified because stairs were not available.

Adequate score distribution: moderate but may have ceiling effects for those who are unable to complete

all tasks or are typically immobile or inactive.

Format compatibility: Cultural and disability bias. The potential effects of sensory loss (visual and

hearing impairment) and limited education (illiteracy) were not evaluated. The format may not be

applicable to those with cognitive difficulties.

50

The timed-up and go test (TUG)172

Source: Podsiadlo 1991

Purpose: The TUG measures basic mobility skills including a sequence of functional maneuvers used in

everyday life.

Description: The TUG includes basic mobility skills, such as rising from a chair, walking 3 metres, turning

and sitting down on the same chair. The original description of the ‘get up and go’ test by Mathias173 was

later modified by Podsiadlo and Richardson172 who developed a scaling system based on the observer’s

perception of the patient’s fall risk. It describes a realistic mobility assessment including potential fall

situations, such as transfer in and out of a chair, walking and turning. Podsiadlo validated the TUG in 60

elderly patients from a geriatric day hospital.

Response options: The TUG can be completed in less than 12 seconds in community-dwelling versus a

maximum of 50 seconds for those that are institutionalized. This test requires only a few simple props. The

test is administered by an observer according to a protocol. Subjects are observed and timed from the

instant they rise from an armchair, walk 3 metres, navigate an obstacle on the floor (placed at a distance of

4 metres from the chair). Subjects wear their regular footwear and are allowed to use the arms of the chair

to get up. Subjects begin the test on the word ‘go’ and are instructed to ‘walk at a comfortable fast and

secure pace’. Subjects perform the TUG three times on the same day, after one practice trial.

Scoring: The TUG is a staff-completed functional test. The final score is the trial at which the subject is

able to carry out the test the quickest of the three timed trials. Graded on a 5-point scale (a=normal,

5=severely abnormal), a score of 3 or more indicates a person is at risk of falling.

Respondent burden: High: physical or emotional invasiveness

Examiner burden: High: Training required

Availability: environmental requirements include a chair, measuring tape, video camera (to record each

performance), and stopwatch (if using timed scores).

Popularity in hip fracture trials: The TUG was used in five trials (Crotty 2002, 2003, Burns 2007, Peterson

2004, Hauer 2001)

51

Adequate score distribution: Moderate: 3 performance groups are defined depending on duration of test

in seconds (Group 1: < 20 seconds; Group 2: 20-30 seconds; Group 3: >30 seconds)

Format compatibility: Poor: co-morbidity bias.

The 6-minute-walk test (6MWT)174

Source: Guyatt 1985

Purpose: The 6MWT is used to objectively measure the exercise capacity in patients with chronic heart

failure. Previously tested and developed for patients with respiratory disease.175

Description: The walking tests were conducted in an enclosed corridor on a 33m-long course. The patients

were instructed to walk from end to end, covering as much ground as they could during the allotted time.

At the end of the test the supervisor calls out ‘stop’ and the distance walked is recorded.

Response options: Distance covered.

Scoring: The mean score on the last four walks was used to compare with established norms.

Respondent burden: physical or emotional invasiveness. Some patients expressed dissatisfaction with the

study: ‘I felt ill after the walking tests”, “The walks didn’t seem to be beneficial”; “A doctor wasn’t

present” and dropped out.174

Examiner burden: Training is required and instructions are not standardized whether encouragement or no

encouragement should be given by the examiner.

Availability: no environmental requirements

Popularity in hip fracture trials: The 6MWT was used in two trials (Mangione 2005, Peterson 2004).

Because of concerns for patient fatigue, only one trial per patient was conducted (Mangione 2005).

Adequate score distribution: comparison with established norms

Format compatibility: Psychiatric disease bias.

52

4.3.2 Activities of Daily Living

Index of activities of daily living45

Source: Katz 1963

Purpose: The index is used to measure the functional status both in research and in daily care.

Description: The index of independence in Activities of Daily Living (Index of ADL) is a scale whose

grades reflect profiles of behavioral levels of six sociobiological functions: bathing, dressing, toileting,

transfer, continence, and feeding.

Response options: 4-point scale ranging from A) without any difficulty to D) only with the help of others.

Scoring: Each category was scored on a dichotomous rating scale (0=independent, 1=dependent).

Respondent burden: none

Examiner burden: No training required, should the patient have difficulties in reading, interviewer will

call the categories.


Popularity in hip fracture trials: Surgical Trials: Blomfeldt 2005, 2007, Tidermark 2003, 2003b; Medical

Trials: Tidermark 2004, Bachrach-Lindstrom 2000, Huusko 2002, Hedstrom 2002; Rehabilitative Trials:

Vidan 2005, Stenvall 2007.

Adequate score distribution: Each category was scored on a dichotomous rating scale (0=independent,

1=dependent).

Format compatibility: The index was first tested among patients in hospitals, where clinicians rated the

patients’ ability to perform six tasks. It is now currently in use for community dwelling, non-

institutionalized, elderly individuals, and also as a self-report measure instead of an assessment tool for

clinicians. Compatible with respondents’ age, culture, language and abilities

Barthel Index176, Modified Barthel Index177

Source: Mahoney 1965 (Original Barthel Index), Shah 1989 (Modified Barthel Index)

Purpose: The Barthel Index is designed to rate the level of independent functioning for ten ADLs in

individuals with neuromuscular or musculoskeletal disorders or other chronic disorders

53

Description: The Original Barthel Index is a 10-item staff completed generic ADL assessment. The items

include: feeding, chair/bed transfers, grooming, toilet, bathing, walking, stairs, dressing, bowels, and

bladder. The modified Barthel Index has the same ten items with the addition of wheelchair in alternative to

walking.

Response options: Values assigned to each item is based on time and amount of physical assistance

required to perform the activity. Original Barthel Index has a 3-point scale (unable, with help, and

independent). The Modified Barthel Index has a 5-point scale (unable, attempts but unsafe, moderate help,

minimal help, fully independent).

Scoring: In the original Barthel Index there is an ordinal measurement score. Weighting for chair/bed

transfers and walking were scored 0 points for unable, 5-10 with help and 15 for independent. Bathing is 0

points for unable and with help, and 5 points for independent. All other items are scored 0-points unable, 5

points= with help, and 10 points=independent. For the modified Barthel Index, unable is scored 0 points for

all items. 0, 2, 5, 8, 10 points from unable to fully independent are allocated for the items such as feeding,

toilet, stairs, dressing, bowels, bladder. 0, 3, 8, 12, 15 points from unable to fully independent are allocated

for items such as chair/bed transfers and walking. 0, 1, 3, 4, 5 points from unable to fully independent are

allocated for items such as grooming, bathing, wheelchair. A higher score correlates with greater

independence.

Respondent burden: It takes 5 minutes to complete.

Examiner burden: No training required and is designed for use by all professional staff involved with the

patient.


Popularity in hip fracture trials: 2 trials used the Barthel ADL [MT: Espaulella 2000; RT: Huang 2005]. 4

trials used the modified Barthel Index [ST: van der Lely 2000; RT: Crotty 2003, Naglie 2002, and Binder

2004].

Adequate score distribution: More options with the Modified Barthel Index.

Format compatibility: Barthel Index includes several items less likely to be affected by a fracture, such as

“feeding”, “personal toilet”, “bowel” and “bladder control”.

54

OARS scale178

Source: Fillenbaum 1981179

Purpose: The IADL Scale is a generic instrument that can be applied in persons with or without disability

and is constructed to measure instrumental ADL in detail.

Description: The IADL scale provides information about an individual’s level of independence when

performing global ADL tasks. It includes 14 items: seven items assess BADL (eating, dressing and

undressing, grooming, walking, getting in and out of bed, bathing and continence), and seven items that

assess IADL (using the telephone, travel, shopping, meal preparation, housework, taking medicine, and

management of finances).

Response options: Each item is rated on a 3-point scale: performs the activity without help (2) performs

the activity with some help (1), or completely unable to perform the activity (0). The item on continence is

rated as no problem (2), sometimes has trouble getting to the bathroom on time (1), and has catheter or

colostomy (0). Higher scores indicate a lower level of functioning in IADL such as making a phone call or

shopping.

Scoring: Three summary scales are computed by summing the scores of items: (1) a total score, the sum of

all 14 items (range 0-28), (2) a BADL score, the sum of the 7 BADL items (range 0-14) and (3) an IADL

score, the sum of the 7 IADL items (range 0-14). An ordinal score can also be computed based on the

OARS scoring algorithm, with five categories: good-excellent (no impairment), mild, moderate, severe, and

total impairment. In the Tinetti (1999) study, each self-care and home management ADL was scored 0

(does not do), 1 (does with human help), or 2 (does without human help). These scores were aggregated

into a composite self-care ADL score that ranged from 0 to 14, and a home management ADL score that

also ranged from 0 to 14. For both outcomes, a proportion of participants performed all activities without

human help (complete independence) and a proportion scored at least as well at follow-up as before the

fracture (recovered).

Respondent burden: Irrelevant questions

55

Examiner burden: A semi-structured interview is administered to the patient.


Popularity in hip fracture trials: 1 rehabilitation trial used the Fillenbaum ADL [Tinetti 1999].

Adequate score distribution: Good

Format compatibility: Good

Klein-Bell ADL index180,181

Source: Klein 1979180

Purpose: The Klein-Bell ADL scale is a generic instrument that can be applied in persons with or without

disability and is constructed to measure basic ADL in detail.

Description: It can measure a patient’s level of independence in basic ADL with a raw score or with a

weight score in 170 items. The items in the scale are divided into six dimensions: dressing, elimination,

mobility, bathing and hygiene, eating and emergency telephone use. The majority of items (162 items)

measure ADL (dressing, bladder and bowel management, mobility, hygiene, eating and drinking and using

the telephone), whereas eight items measure body function (bladder and bowel emptying, bladder and

bowel incontinence, chewing and swallowing food, swallowing liquids, verbalizing telephone messages).

Response options: Each item was rated in an empirical manner on a five-point scale with four criteria: 1)

How difficult is it for average able-bodied persons? 2) How difficult is it for the average able-bodied

person to perform this activity for someone else (to provide maximum assistance)? 3) How much time does

it take to perform this activity? 4) How injurious to one’s health would it be if the activity could not be

performed?

Scoring: A weight scheme (1 to 3) was used under the assumption that some items are more difficult, time

consuming etc than others was used. Weight 3 is given to the most complex items. Raw sum scores

obtained.




56

Popularity in hip fracture trials: 1 rehabilitation trial used the Klein Bell ADL index [Hagsten 2004]. The

authors chose 75 observation points considered relevant for hip fracture patients within 4 areas: dressing,

toilet visits, mobility and bathing-hygiene. The occupational therapist watched the patient perform each

specified activity and scored it as either failure (assistance required, 0 points) or achieved (activity

performed without verbal or physical assistance from another person, but with technical aids required). The

grading according to Klein-Bell was then used.

Adequate score distribution: A data program called the ADL diagram compiles the raw score to

recommendations in the K-B Scale Manual. Raw sum scores may make it more difficult to interpret results

as patients can get the same scores in spite of different needs of assistance.

Format compatibility: Has been translated into Swedish. Great ceiling effects obtained across different

populations.

Disability Rating Index182

Source: Salén 1994

Purpose: The DRI was originally developed for assessment of patients with back pain. The items selected

were intended to be applicable both to disability due to pain or impairment of hip and knee function and to

impairment of gross body movements due to pain and muscular or neurological deficits. The DRI has been

applied and developed in an academic orthopaedic department and in several rehabilitation units throughout

Sweden.

Description: The DRI covers 12 items concerning physical function only: dressing (without help), outdoor

walks, climbing stairs, sitting for an extended time, standing bent over a sink, carrying a bag, making a bed,

running, light work, heavy work, lifting heavy objects, participating in exercise/sports.

Response options: the DRI is a self-administered form, where patients mark a 100-mm visual analogue

scale in accordance to his/her presumed ability to perform the daily physical activities in question. The

anchor points are without difficulty = 0 and not at all = 100. The 12 items are divided into three sections: 1-

4, common basic activities of daily life; 5-8, more demanding daily physical activities; 9-12, work-related

or more vigorous activities. The questions are arranged in increasing order of physical demand, particularly

with reference to lower-back pain.

57

Scoring: An index is achieved by measuring the distance in mm between the zero points and the patient’s

markings on the VAS. The mean of these measurements provides the DRI expressed in percent of the

highest possible rating. The 12 counts may be presented in a graph as a Disability Rating Profile (DRP) and

the typical average profiles for different conditions may be calculated.

Conceptual basis: The DRI aims to assess disability as defined by the ICIDH – WHO (1980). The DRI

can be used alone or with questionnaires concerning psychological well-being, social health scales and

quality-of-life assessment scales.

Comprehensiveness: The different activities covered by the DRI represent gross movement or static

physical stress and reflect function of the spine, legs and arms. This makes the DRI applicable to common

conditions of the musculoskeletal system, such as back pain, neck pain, impairments of the shoulder, hip or

knee and muscle weakness.

Hip fracture trials: Two rehabilitation trials (Hagsten 2004, 2006) used a modified DRI. Lawton and Brody IADL scale46

Source: Lawton and Brody 1969 Purpose: The Lawton and Brody IADL Scale is an assessment of performance in eight daily activities that

are essential to maintain independence in the community.

Description: The items include telephone use, shopping, transportation use, meal preparation, housework,

laundry, medication use, and finances.

Scoring: Each item was scored either 1 or 0. A maximum score of 8 is generated if they are competent in

all eight tasks.




Popularity in hip fracture trials: 1 rehabilitation trial used a modified version of the IADL (Lawton and

Brody) including seven items instead of eight [Binder 2004].

Adequate score distribution: Dichotomous scale

Format compatibility: Good

58

Functional Status Index182

Source: Jette 1980 Purpose: The functional status index is a self-report of function which is defined as the degree of

dependence, the degree of difficulty, and the amount of pain experienced in performing specific activities

of daily living.

Description: The participant is asked to assess his or her average performance during the past 7 days in

relation to 18 tasks comprising ADLs and IADLs. Participants rate their performance in each task on three

dimensions: the difficulty they had in performing the task (a scale of 1 to 4, with 4 being the greatest

difficulty), the amount of pain they experienced while performing the task (1 to 4, with 4 being the most

pain), and the amount of assistance they needed (1 to 5, with 5 being the most) to complete the task.

Scoring: Using average scores on each dimension to score a given person on that dimension. The ‘average’

difficulty score is based on the difficulty ratings the person provides as his or her assessment of the

difficulty encountered when performing each of the 17 ADLs and/or IADLs.

Respondent burden: Irrelevant questions for hip fracture patients such as the use of public transportation

prior to surgery.

Examiner burden: None.


Popularity in hip fracture trials: 1 rehabilitation trial used the Functional Status Index (FSI) [Krichbaum

2007].


Format compatibility: Used in hip fracture patients and good indicator of cognitive ability and pre-morbid

participation.

4.3.3 Composite scores

Composite scores are composed of a combination of ICF concepts including Impairment, Activity &

Participation as well as External Factors (Figure 4). The majority of the trials used the Harris Hip score,

followed by the Charnley hip score and the Hip rating questionnaire. An individual trial used the Oxford

59

hip score and the Functional status index (Table 1). The advantages of these questionnaires directed at hip

fracture patients are their ability to detect more focused types of changes.

Figure 1 Composite scores contain different ICF concepts

Harris Hip Score154

Source: Harris 1964 Purpose: The primary focus of the score is to measure hip functionality in the clinical outcome of hip

replacement.

Description: It is 100-point scale score questionnaire with 4 major dimensions of functionality

administered by the physician.

Respondent burden: Low.



Adequate score distribution: High score indicates normal range of function. These are the scores for the

following: pain (44 points), function (47), range of motion (5) and absence of deformity (4).

Format compatibility: Widely used in hip fracture studies. However, for those patients who have no pain

prior to surgery and may be more affected in areas of participating in activities and social life, may have a

score that is not representative of them.

60

Table 1 Composite scores

Stinchfield hip assessment system (modified Judet point system)

Harris hip scale

Charnley’s classification

Matta Scoring System

Hip Rating Questionnaire

Salvati and Wilson score

Oxford hip score

Year of initial publication

Judet 1952183

Stinchfield 1957184

1969 1972 1986 1992 1973 1996

Reference to First development

184, 185 154 158 186 160 187 159

Development population

Hip Arthroplasty

Hip arthroplasty

Hip arthroplasty

Fractures of the acetabulum

THR Hip THR

Number of items

3 4 3 3 13 + VAS 4 12

Domains Pain Movement Walking

Pain Function Range of Motion Absence of deformity

Pain Movement Walking ability

Pain Ambulation ROM

Global Pain Walking Ability to perform daily functions

Pain Walking ability Muscle power and motion function

General pain level, bathing, getting in/out of car, putting on socks, shopping, walking, stairs, standing, limp, severe/sudden pain, work, pain at night

Response 6-point scale

Weighted point scale

6-point ordinal scale

6-point scale

100-point VAS for overall impact

6 possible responses for each

5 possible responses (least to most difficult)

Scoring Classified into: excellent (16 points or more), good (12-15 points), fair (9-11 points), poor (8 points or less)

Max 100 (pain 44, function 47, absence of deformity 4, range of motion 5)

Each domain graded on a scale of 1 to 6, with 1 indicating total disability and 6 indicating a normal state

Highest possible score 6, lowest score1. Clinical Grade (Total points): Excellent, 18; Good, 15-17; Fair, 12-14; Poor 3-11

Max 100 Max 40, each item considered separate

Best score, 12 ; Worst score, 60

Administration Physician Physician Physician Physician Patient Physician Patient

4.3.4 Generic measures of health status

Generic measures quantify a patient’s perception of his or her overall health state (Table 4 and 5). Many

have more than one dimension, usually distinguishing physical, emotional, and social functioning. The

primary purpose of these questionnaires is to quantify overall health rather than that related to a specific

condition. They tend to be less sensitive to changes in the specific orthopaedic disorder.

61

Health-status The Short-Form 36 (SF-36)157

Source: Ware 1992

Purpose: The SF-36 measures the effects that could be a direct function of disease and treatment (general

health).

Description: The generic tool most commonly used in the hip fracture literature is the SF-36 item

instrument. The SF-36 is a 36-item survey that measures eight domains of health: physical functioning, role

limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role

limitations due to emotional problems, and mental health. It yields scale scores for each of these eight

health domains, and two summary measures of physical and mental health: the physical component

summary (PCS) and mental component summary (MCS). The SF-36 is available in both standard (4 weeks)

and acute (1-week) recall versions. The acute form was developed for cases in which health status would be

measured weekly or biweekly. It was created by changing the recall period for six of the eight scales [Role-

Physical, Bodily Pain, Vitality, Social Functioning, Role-Emotional and Mental Health] from ‘the past four

weeks’ to ‘the past week’. Two scales, physical functioning and General Health do not have a recall period;

the items and instructions for these scales are identical across acute and standard forms.

Scoring: All but one of the 36 items (self-reported health transition) is used to score the eight SF-36 scales.

Each item is used in scoring only one scale

Respondent burden: Irrelevant questions for hip fracture patients and length is problematic



Popularity in hip fracture trials: In the 9 RCT trials that used the SF-36, 4 were used in surgical trials and 5

in rehabilitation trials. 5 trials used the SF36, 2 trials used the summary scores and 1 trial used the chronic

and acute forms of the SF-36. 1 trial used only the physical function subscale from the SF-36.

Adequate score distribution: Good. With the release of version 2 in 1996, the norms were updated using

data from the 1998 National Survey Functional health status and norm-based scoring (NBS) algorithms

were introduced for all eight scales. NBS employs a linear T-score transformation with mean = 50 and

62

standard deviation = 10, which makes it possible to meaningfully compare scores for the eight scale profile

and the physical and mental summary measures in the same graph. Furthermore, the availability of a

scoring software minimizes the bias of incomplete questionnaires for more respondents.

Format compatibility: Used in hip fracture patients. The SF-36 acute form could be more sensitive to

recent changes in health status, but developers feel that higher mean scores resulting from the SF-36 acute

form would have implications on the norm-based interpretation of acute form scores. The benefit of this

instrument is its portability across different disease states.

Functional Status Questionnaire60

Source: Jette 1980

Purpose: The FSQ is a patient-completed questionnaire designed to provide assessment of physical,

psychological, social and role function in ambulatory patients.

Description: There are 34 core items to give a computerized report of one page. It is used for screening

and monitoring.

Scoring: The items are scored to produce 6 summary scale scores (VAS with warning zones to indicate

areas of functional disability) and single-item scores.

Respondent burden: Irrelevant questions for hip fracture patients

Examiner burden: Training implies that the questionnaire is used by doctors in primary care situations but

could also be used by allied health professionals.



Format compatibility: Any person with a chronic disabling condition (musculoskeletal, orthopaedic,

rheumatological) for community, inpatients, rehabilitation and outpatients.

Popularity in hip fracture trials: Physical function subscale of the FSQ was used in one trial Binder (2004).

63

Sickness Impact Profile188

Source: Bergner revised in 1981

Purpose: A generic, functional and quality of life measure used to evaluate the impact of disease on

physical and emotional functioning.

Description: The SIP-NH includes 136 items that patients check in two overall domains (physical and

psychosocial). There are 12 dimensions of daily activity. Physical dimensions are ambulation, mobility,

body care and movement. Psychosocial dimensions are social interaction, communication, alertness

behaviour, emotional behaviour, sleep and rest, eating, home management, recreation and pastimes,

employment.

Scoring: An overall SIP score can be computed.


Examiner burden: Training none



Format compatibility: The SIP is used for many different medical conditions.

Popularity in hip fracture trials: Bach (2004) used the SIP-NH. SWED-QUAL198

Source: Brorsson 1993

Purpose: A subjective patient-based assessment of health-related quality of life

Description: A brief Swedish HRQOL instrument translating selected measures from the Medical

Outcomes Study. It consists of 61 items that form 11 multi-item scales tapping aspects of physical

functioning, role functioning, emotional well-being, pain, sleep, family functioning and general health

perceptions. Physical functioning is assessed by limitations in a variety of physical activities, ranging from

strenuous to basic, due to health (seven items). Also includes one item concerning mobility and one item

concerning satisfaction with level of physical health. Role functioning is defined by limitations in major

role activities due to physical (three items) and mental health problems (three items). Pain (six items) was

included to capture differences in physical discomfort. Emotional well-being is assessed in terms of

64

positive and negative affect (six items are included for each). The overall sleep problems scale (six items)

addresses problems with sleep initiation and maintenance, respiratory problems, sleep adequacy and

somnolence. Family functioning is assessed with regards to satisfaction with family life (four items),

quality of relationship with spouse or partner (six items) and sexual functioning (four items). The measure

of general health perceptions taps into the patient’s own ratings of their current health (three items), prior

health (two items), resistance to illness (two items) and health concern (one item). All items are

administered using a ‘during the last week’ or ‘now’ time frame. Both positive and negative health states

are tapped by these measures.

Scoring: Items were all scored so that a high score indicated better health. The ‘don’t know’response

category was scored as intermediate between the ‘partly agree’ and ‘partly disagree’ categories and

between the ‘fairly satisfied’ and ‘fairly dissatisfied’ categories. The ‘not applicable’ response is coded as

missing data. Scale scores are constructed by summing items measuring the same construct into a single

scale score. These are then transformed linearly to a 0-100 possible range.





Format compatibility:

Popularity in hip fracture trials: 1 rehabilitation trial used the SWED QUAL (Hagsten 2006). Nottingham Health Profile161, 190

Source: Hunt 1980

Purpose: Patient-completed questionnaire to determine and quantify perceived health problems.

Description: Two parts 1) 38 weighted statements covering 6 areas (sleep, mobility, energy, pain,

emotional reactions, and social isolation); 2) 7 statements regarding specific aspects of daily life

(employment, household chores, social life, relationships, sex life, hobbies, holidays).

Scoring: Completed by Yes/No tick boxes.

65





Format compatibility: Older people, the chronically ill, pregnant women, those with limb fractures, minor

non-acute conditions, fit working men, peripheral vascular disease, osteoarthritis and a random community

sample.

London Handicap Scale191

Source: Harwood 1994

Purpose: Patient-complete interval level postal questionnaire for patients experiencing a health-related

handicap.

Description: Based on the ICIDH, it uses part utilities (a matrix of scale weights) relating to different

levels of disadvantage for 6 dimensions.

Scoring: There is a formula for combining these into an overall handicap score. The scale is meant for

comparisons between groups of subjects and problems arise if trying to make individual comparisons.





Format compatibility: All patients with a health-related handicap.

66

Table 2 RCTs measuring health-related quality of life using the SF-36 and EQ5D. Author (year) N Intervention Body function and

structure Activity Limitations and participation restriction

Composite scores

Mattson118 (2005) 112 Surgical Radiographs Global pain: “How is your hip pain today?” VAS- pain

Isometric hip abductor muscle strength ADL (6 parameters) SF-36

Baker72 (2006) 81 Surgical Radiographs

Walking distance SF-36 MCS SF-36 PCS

OHS

Raia133 (2003) 115 Surgical Radiographs Mobility subset (MFA) ADL subset (MFA) SF-36

Tidermark144 (2003) 95 Surgical Radiographs Pain (mod. Charnley)

ADL (Katz) Independently walking without aids EQ5D SF-36

Huang103 (2005) 126 Rehabilitation ADL (Barthel) SF-36

Crotty86 (2003) 66 Rehabilitation TUG MBI SF-36 PCS* SF-36 MCS*

Crotty85 (2002) 66 Rehabilitation TUG Berg Balance Scale Activities-specific Balance confidence scale MBI London Handicap Scale Use of mobility aids Physical dependence Social dependence SF-36

Mangione117 (2005) 33 Rehabilitation Lower-extremity force Mental status

Free gait speed SF36 physical function subscale 6MWT

Peterson131 (2004) 70 Rehabilitation 1RM

Gait 6MWT TUG Transfer in and out of bed SF-36 chronic & acute forms FRT

Miedel120 (2005) 217 Surgical Radiographs EQ5D

Charnley score

Blomfeldt78 (2007) 120 Surgical Radiographs Mobility ADL (Katz) EQ5D

HHS

Keating111 (2006) 296 Surgical Radiographs EQ5D Mod HRQ

Blomfeldt76 (2005) 102 Surgical Radiographs ADL Ability to walk independently EQ5D

Charnley score

Blomfeldt77 (2005b) 60 Surgical Radiographs ADL (proxy) Walking capability (proxy) EQ5D (proxy)

Charnley score

Tidermark145 (2004) 60 Medical DXA ADL (Katz) EQ5D

Tidermark144 (2003) 102 Surgical Radiographs Mobility ADL (Katz) Domestic independence ability to walk with or without walking aids

Charnley score

Keating110 (2005) 207 Surgical Radiographs EQ5D HRQ

67

4.3.4 Measures of Utility EuroQol-5D (EQ-5D)156

Source: The EuroQol Group, 1990

Purpose: A generic instrument for assessing quality of life.

Description: It identifies 243 possible health states. It is a patient-completed instrument for describing and

valuing health-related quality of life, giving a single index score for each health state measured. A 2-part

questionnaire, respondents answer five questions on their health status as measured by mobility, self-care,

main activity (i.e. work), leisure activity, pain and anxiety.

Scoring: There are three possible levels of response for each item. Each state carries a utility value, which

is calculated using time trade-offs. Perfect health and death have utility values of one and zero,

respectively, and states worse than death (<0) are possible. Part 2 is a visual analogue scale- 0 being worse

imaginable and 100 being best imaginable health status.

Respondent burden: Irrelevant questions for hip fracture patients. The questionnaire takes 1 minute to

complete.




Format compatibility: Older people, the chronically ill, pregnant women, those with limb fractures, minor

non-acute conditions, fit working men, peripheral vascular disease, osteoarthritis and a random community

sample.

Popularity in hip fracture trials: Eight trials (13.6%) used EQ-5D for utility (Miedel 2005, Keating 2005,

2006, Blomfeldt 2005, 2005b, 2007, Tidermark 2003, 2003b, 2004). Eight of those trials were surgical and

one was medical (Tidermark 2004). In the RCT by Blomfeldt 2005b, the EQ5D was administered using

proxy. The EQ5D was used in combination with the Charnley hip score (Miedel 2005), the Charnley hip

score, ADL and ability to walk independently (Blomfeldt 2005) and in a similar combination except with

the use of proxy responses for the ADL, walking capability and living status (Blomfeldt 2005b); the Harris

68

hip score, ADL and mobility (Blomfeldt 2007); with a modified Hip Rating Questionnaire (Keating 2006).

The aim of one study (Tidermark 2003) was to evaluate the responsiveness of the EQ5D and SF-36

instruments, i.e. their ability to capture clinically important changes in elderly patients with a displaced

femoral neck fracture.

Figure 2 The applicability of instrument types such as performance-based, Activities of Daily Living,

Impairment-based composite scores and Multi-item composite scores and the trendline of respondent

burden across measures (10 points = poor, 5 points = moderate, 0 points = good).

69

Table 3 Instrument characteristics measuring health-status or utility

Functional Status Questionnaire

Nottingham Health Profile

Short Form-36 WHOQOL-BREF

EQ5D

Year of initial publication

1978 1981 1994 1996 1990

Reference to First development

60 161, 190 157 162 156

Development population

Generic Generic Generic Generic Generic

Number of items 34 38 36 26 5 Domains Basic ADL

Int. ADL Mental health Work performance Social activity Quality of interaction 6 individual questions (work status, bed days, restricted days, sexual relationships, feelings about health, social activity)

Part I: Pain Physical mobility Sleep Energy Social life Emotion Part II: Daily activities

Limitations in physical activities Bodily pain Limitations in usual role activities Limitations in usual role activities because of emotional problems General mental health Limitations in social activities because of physical or emotional problems Vitality General health perceptions

Physical health Psychological health Social relationships Environment

Mobility Self-care Usual activities Pain or discomfort Anxiety/depression

Response 4, 5, 6-point ratings are used, referring to health in the past month, standardized to a 0 to 100 range

Dichotomous scale

Five-point scales and dichotomous scale

5-point response scales cover intensity, capacity, or frequency. For the subjective questions a satisfied-dissatisfied scale was used.

Each dimension in part I has 3 levels: no problems, some problems, severe problems, the resulting 1-digit number expresses the level selected for that dimension creating a 5-digit profile number; part II includes VAS 0 to 100

Scoring 6 summary functional status scores 6 single-item scores

Six scores each out of 100, weighted

Two sets of scores are derived: 8 section scores and two summary scores, one for physical component and one for mental component scores. Each subscore 0 to 100.

Highest domain score 20

EQ5d index score-0 indicates worst possible health state and a value of 1 indicates full health

Administration Patient Patient Patient Patient Patient

70

4.8 Discussion

In the past, the assessment of clinical outcome following a hip fracture relied primarily upon radiographic

parameters and range of motion in hip flexion to measure surgical success or the patient’s impairment.

Functional parameters such as quality of life and satisfaction from the perspective of the patient rather than

the surgeon were overlooked. We believe that in order to select an appropriate instrument for a study it is

crucial to evaluate the pragmatic characteristics as well as the psychometric properties of measurement

tools. Despite the rise over the recent decades in the use of functional outcome instruments in the aged

with hip fractures, the inclusion of hastily developed instruments can compromise the quality of the scales

and its psychometric properties. We believe that our results demonstrate that trialists could be using

measures quantifying activities of daily living because they are on average moderate across the four

dimensions of applicability (Figure 2). Likewise, the use of impairment-based composite scores, such as the

Harris hip score, could be because of its minimal respondent burden and good format compatibility (Figure

2). Multi-attribute scores, which include health status measures such as the SF-36, may be poor in score

distribution; have high examiner burden and poor format compatibility that altogether contribute to their

infrequent use in hip fracture randomized controlled trials.

There are important factors to consider when choosing appropriate measures in hip fracture trials such as

the patient’s perspective. Patient-reported outcomes (PRO’s) are reports coming directly from patients

about how they function or feel in relation to a health condition and its therapy, without interpretation of

the patient’s responses by a physician or anyone else. On the other hand, a performance measure is one in

which an individual is asked to perform a specific task that is evaluated in a standardized manner using

predetermined criteria, such as counting repetitions or timing the activity. The timed-up-and-go test (TUG)

does not focus on a single specific impairment such as the hip joint in itself, but rather on multiple domains

(including balance and strength). These measure the interaction of these factors on the performance of

activities of daily living.192 The TUG, which measures the concept of Activities and Participation, does not

in itself provide a comprehensive evaluation of the many factors involved in functional recovery.172 Several

authors have shown that physical performance measures have not been as thoroughly developed and tested

71

to the extent of the patient-reported outcomes and hence, modest to poor correlations can exist between

performance measures included in a battery of tests.69, 171, 172, 193,195,196 A composite score obtained from a

battery of performance tests may not be measuring the intended concept.

Several trials do not fully report on the specific index or instrument used to measure functional outcomes.

This can further attest to some of the heterogeneous results obtained from the RCTs which make them

incomparable. Our results indicate that poorly-conducted studies also use investigator-developed indices.

Some investigator-developed indices reported a few questions on activities of daily living which can

produce results that are often qualitative and ambiguous, are of unknown reliability and validity, and have

only localized usage.196 In the current RCT hip fracture trials, modifications to existing scales could

undermine their measurement properties. For instance, the word “arthritis” was replaced with “hip fracture”

in the hip rating questionnaire.111, 180 Abbreviated versions also need to be better understood as accuracy

may be sacrificed. Seven out of the twelve items of the Disability Rating Index182 were used because the

remaining 5 items were not considered relevant to elderly hip fracture patients and hence replaced by seven

other items.95,96

The setting and mode of administration is also important in keeping with the conceptual development of the

original scale. For instance, while the BI has been used to obtain detailed information regarding the

patient’s ability to perform ADL in the home, this may not equate with the individual’s recorded ability in

the rehabilitation center.177 The MBI however reflects the patient’s ability in self-care during medical

rehabilitation. This is important because of the influence of factors in the home, and the community

environment e.g. doorway widths, wheelchair access, attitudes of the patient and the caregivers and their

relationship.177 Furthermore, if a measurement is adequately tested, a manual to describe it should be

available. These should include a full description of the purpose of the method, the population for which it

is designed, the populations on which it has been tested and the intended use for the data collected.

72

Composite events pose problems in interpretation.197 The problematic nature of a simple aggregate or

composite index could assume equal weighting of tasks, and does not differentiate the contribution of

specific tasks to cumulative disability (Table 1). For instance, the total BI score is generally not as

significant or meaningful in treatment as the scores on individual items, since these indicate where the

deficiencies are.176, 215 In recent years, the scoring of health measures are also being scrutinized and score

responses that do not represent a breadth of performances are becoming unacceptable.30 The composite

score of some instruments are consistently reported without the relative weighting of specific items within

clusters of roughly equivalent item sets as those of the (I)ADL scales.198 The opposite dilemma can occur

when validated parts are put together in a battery of performance measures such as the FPM battery, thus

making them of unproven validity. In this scenario, Bach claimed that it was difficult to determine how this

composite measure might have contributed to the negative outcome of the trial.70 Indeed, the variability

found in measured function, regardless of the scale, cannot be explained by a single condition or illness and

is a dynamic multi-construct system which warrants future research.

Not only is there a need to adopt reliable methods to assess patient recovery following a hip fracture, but it

is also important to capture all aspects including Body Function and Structure as well as Activity and

Participation. Furthermore, measures that address function in patients with hip fracture can result in good

applicability for the specific population while generic health-status measures can allow for comparisons

across different target populations (Table 2). Consideration of functional outcome measures that include

measures of impairment that are either physician-rated or observer-based, together with measures of

activity limitations and participation restrictions that are either patient self-report or observer-based can

place the effectiveness of the intervention within the context of important and expected outcomes from the

perspective of the patient. Health-status measures cover at least the physical, emotional, and social

dimensions of health but may cover much more (Table 3). In addition to physical, mental, and social well-

being, the Euroqol also covers usual activities. The SF-36 includes work and role performance. The FSQ

overlaps with the SF36 in its measurement of physical function but also encompasses interactions with

family and friends and the WHOQOL additionally asks about spiritual well-being, transportation, and

environmental factors under the umbrella term of health-related quality of life. It is our belief that the SF36,

73

although widely used in clinical studies, may be challenging for the aged with hip fracture who present

various co-morbidities such as dementia and may be difficult to assess with a significant loss to follow-up.

In scoring the EQ5D, a persons’ health state is first summarized by a five-digit profile, indicating the score

on each of the five dimensions including mobility, pain or anxiety-depression, self-care and performance of

usual activities. Subsequently, the scores can be converted into a summary index using a utility-weighted

scoring system. In addition to the self-report version, the EQ5D also exists in observer, proxy versions.

Patient-completed and proxy versions are moderately good but overall, studies have shown a lack of

responsiveness of the EQ5D in those patients found at the upper ends of the health spectrum that may be

attributed in part to the composite scoring system which negates a finer discriminative response scale.30, 199

In contrast, there is good reliability of the well- validated SF-36 in the cognitively impaired.199 However,

the appropriateness of the item wording in the SF36 such as “running and lifting heavy objects” has been

criticized for not being appropriate for the aged.199 In all clinical measures, a ceiling effect may occur when

a subject reaches the maximum score that can be attained within a measure but can still surpass that

score.200

4.5 Summary In examining the practical aspects of the instruments, it is possible to draw some conclusions about their

reported frequency in hip fracture trials. Ideally, an instrument should be low in examiner and respondent

burden as well as have good scoring distributions and format compatibility. However, in addition to the

applicability of instruments it is also important to evaluate the patient’s perspective and to use instruments

that fit the needs of the target population. In the future, we recommend instruments that measure across

Body Function and Structure as well as Activity and Participation. Multiple instruments may be necessary

to address this as composite scores may lack in interpretability of the overall score for the respondent.

Future research should evaluate the psychometric properties of the identified instruments. Finally

composite scores may not fit entirely in the present ICF framework and this is a limitation to the present

study. In the future, we recommend modification of the existing framework to encompass these

instruments. This may include a further breakdown of the components Activity and Participation such to

distinguish between acts that are general things that a person can do independent of context or purpose and

74

Tasks which are done purposefully in their daily life in a specific environment.57 Also societal involvement

may be represented as the context of society and acknowledged areas of human endeavour.57

75

Keypoints in Chapter Four

• Pragmatic as well as psychometric properties should be assessed in the use and development of instruments

• Clinicians in hip fracture trials have mostly adopted measures of ADL. These measures scored on average moderate in all four dimensions of applicability.

• Measures of health-status and utility measures for hip fracture patients were not used consistently in the randomized hip fracture trials. These measures were also ranked high in examiner burden and poor format compatibility.

• We recommend multiple measures that assess both Body Function and Structure as well as Activity and Participation

• An optimal instrument should have minimal examiner and respondent burden and a good score distribution and format compatibility

76

CHAPTER 5

SUBGROUP ANALYSES

5.1 Introduction

Patients diagnosed with dementia represent a substantial proportion of patients with hip fractures that

clinicians will encounter. The prevalence of dementia increases dramatically with age and about one-half of

all nursing home residents have some form of cognitive impairment.200-3 Hip fractures are the second

leading cause of hospitalization in the aged and the added co-morbidity only lengthens hospital stays.19, 20

In a previous systematic review, Wells concluded that frail older rehabilitation candidates with mild to

moderate dementia should not be excluded from rehabilitation and should be screened for cognitive

impairment.20 Table 1 represents the various types of dementia present in the aged.

Older adults with co-morbid chronic conditions are more likely than younger adults to be at a higher risk of

having poor outcomes.204 Besides the increased risk of dislocation; patients with severe cognitive

dysfunction pose significant challenges to the treating surgeon such as a lack of compliance, problems in

completing rehabilitation regimens and further complications with other co-morbidities. Surgeons need

evidence of the impact of different treatment alternatives for this patient population. There is good reason

to believe that relative treatment effectiveness will be different in patients with dementia compared to

patients without dementia. For example, in a rehabilitative trial a patient with dementia will forget not to

weight-bear immediately following hip fracture surgery and without reminders from family or caregivers

the patient may jeopardize early rehabilitation and path to recovery.

Appropriate screening followed by early intervention can promote better informed decision-making. In the

past, a condition such as dementia was a main predictor of mortality; it is now a main predictor of higher

degrees of disability.205-8 Functional assessment is integral to determine the ability of individuals to

complete successfully daily living tasks and live in their usual physical, social, and cultural environment.

Furthermore, traditional mental status screening tools such as the Mini-Mental State Examination (MMSE)

which focus on cognitive functions are not suited for monitoring the progression of the everyday

77

manifestations related to cognitive impairment.209 It is important not to bias the results of hip fracture trials,

by not assessing all patient subtypes i.e. measuring only healthy lucid patients. In a subgroup analysis of

the studies identified in our systematic review, we wanted to identify those trials that potentially included

those with severe cognitive impairment. Our primary objectives were to identify those trials with and

without patients with dementia via the descriptions of inclusion and exclusion criteria reported. We also

wanted to identify the functional outcome instruments in those trials reporting patients with dementia and

hip fracture.

5.2 Methods

In this study, we classified the hip fracture trials into two Groups based on the entry criteria stated in each

trial. Group A trials did not explicitly state exclusion of any patients with co-morbidities. Group B trials

excluded patients diagnosed with one or more co-morbidities or a diagnosis of dementia or those unable to

provide informed consent. To answer our primary question, we examined what instruments measuring

functional outcome were used in Group A vs. Group B trials. In order to ascertain whether the trials

included patients with dementia, the following data was extracted from Group A trials: 1) any terms

including “dementia” and “severe cognitive impairment”, 2) type of diagnostic instrument used, 3)

inclusion and exclusion criteria and 4) functional outcome instruments 5) time points for assessment and 6)

statistical analysis in Group A trials.

Table 1 The spectrum of cognitive impairment

The Spectrum of Cognitive Impairment

Age-related cognitive decline: Decline in cognition consequent to the aging process that is within normal

limits given the person’s age. There may be complaints of mild short-term memory loss manifested by

problems remembering names or appointments; slowed responses; prolonged complex reaction times;

difficulties in solving complex problems; and decreased creativity

Amnestic mild cognitive impairment: Presence of a memory complaint preferably corroborated by an

informant. There is objective memory impairment but otherwise normal general cognitive function.

Activities of daily living should be intact and the patient cannot meet criteria for dementia.

78

Multi-domain mild cognitive impairment: Memory impairment plus deterioration in at least one additional

nonmemory cognitive domain but otherwise normal general cognitive function. Activities of daily living

should be intact and the patient cannot meet criteria for dementia.

Dementia of the Alzheimer’s type: The development of multiple cognitive deficits manifested b (1)

memory impairment and (2) one or more of (a) aphasia (language disturbance), (b) apraxia (impaired motor

skills in absence of primary motor dysfunction), (c) agnosia (failure to recognize objects despite intact

sensory function), and/or (d) disturbance in executive functioning (i.e. initiating, planning, organizing,

sequencing, abstracting). The deficits are severe enough to cause significant loss of social or occupational

functioning and are a decline from a previous level of functioning

Source: American Psychiatric Association210, 2000, Petersen211, 2004

5.3 Results

58 trials were included for data extraction. 1 trial by Hallan (2004) was excluded from the original 59

included studies because of inadequate reporting of inclusion and exclusion criteria.

5.3.1 Group A trials vs. Group B trials

Group A included 15/58 (25.9%) trials, which included patients with dementia and the remaining 43/58

(74.1%) trials excluded patients with dementia (Table 2). One trial included only patients with dementia

and one trial included only hip fracture patients with severe cognitive impairment.77, 150 Two trials explicitly

stated that dementia was not an exclusion criterion.107, 152 2 trials included instruments which accounted for

patients with cognitive impairments or used proxy or caregivers to answer questions.152 The other 9 trials

had mixed cases of patients with different co-morbidities.

Three trials excluded patients with severe co-morbidities that included respiratory or cardiovascular failure

or cerebrovascular disease which could affect mobility (Appendix 4). If patients were dependent in all basic

ADLs or non-ambulatory prior to fracture or unable to walk distance they were excluded from mostly

rehabilitation trials (6 rehabilitation trials, 3 surgical and 1 medical). Terminal illness was considered an

79

exclusion criterion in 6 trials (4 were rehabilitation trials). Living status either independent or alone less

than 4hrs per day or in long-term facility or had pre-fracture hospitalization, was considered an exclusion

criterion in 6 trials.

5.3.2 Diagnosing patients with co-morbidities in RCTs

24 out of 58 (41.3%) trials used diagnostic instruments to assess patients with co-morbidities (Figure 1).

The majority of which used the ASA classification212 (11/58 trials).

19 out of 58 (32.8%) trials diagnosed cognitive impairment (Figure 2). The majority of the trials (7/58)

used the Mini Mental State Examination (MMSE).213-4 Only one trial examined patients both preoperatively

and postoperatively administering the MMSE.112 There was no consistency found in the thresholds used to

exclude patients even within each intervention type (Appendix 4). 7 trials out of 58 did not specify any

cut-off points in the trial methodology. Only two surgical trials used cognitive screening for the purpose of

including patients with dementia.77, 150

5.3.3 Diagnosing emotional status

Only three studies examined the effect of depression and anxiety on rehabilitation in the elderly with hip

fractures using the Geriatric Depression Scale, the Hospital Anxiety and Depression scale and the CES-D.

But no patients with either depression or anxiety were excluded from RCTs.81, 113, 131

5.3.4 Outcome measures Based on the inclusion and exclusion criteria reported in the high quality RCTs, nine types of outcome

measures were commonly used in those trials (Group A) assessing all patient subtypes (Table 2). Upon data

extraction, one trial (Miedel 2005) which used a quality of life or utility measure such as the EQ5D was

subsequently excluded from Group A trials since the authors reported the administration of EQ5D (proxy)

did not include those patients with severe cognitive impairment (Table 3).120 Another trial used the EQ5D

proxy in patients with severe cognitive impairment.77 Group A measures found to assess all patient

subtypes were: Harris hip score, range of movement, pain, mobility, ADL, MBI and IADL. Other outcome

80

measures included: the use of support and accommodation. The use of a proxy or caregiver was utilized in

four trials in Group A and in three trials in Group B.

5.4 Discussion

In our systematic review the majority of the randomized controlled clinical trials excluded patients who

were cognitively impaired. However, in a study by Van Dortmont, with all hip fracture patients diagnosed

with dementia using the DSM-III-R, the authors in accordance with their previous work and other authors,

claimed that mental health state does indeed appear to be a significant prognostic factor for operative

treatment for intracapsular femoral neck fractures.215 In the study by Blomfeldt, the authors used the

Euroqol-5D despite referencing papers that do not support its use in those patients with severe cognitive

impairment. This is because of its poor correlations with outcome and ceiling effect.77 Ceiling effects were

reported to be attributed to the lack of finer discriminative response options found in this utility measure

thus resulting in low responsiveness.199 None of these trials include any measurement of quality of life even

if administered to a proxy or caregiver. Bachrach-Lindstrom utilized a proxy. Using a proxy has been

shown to be a reliable way to collect valuable information even when working with patients with mental

impairment.71, 216 All RCTs that included patients with dementia incorporate outcomes of mobility, living

status, activities of daily living and measures of impairment such as fracture fixation and reduction or other

parameters measured radiographically and measures of pain. The assessment of pain is challenging in

mentally impaired patients and the authors based their findings on anamnestic data in combination with a

physical examination using the Harris Hip Scale.71

Dementia is characterized by losses in cognitive function making it challenging to perform complex tasks

of daily living.205 Consequently, persons with dementia may have significant problems in their social,

occupational, self-care, cognitive and communicative abilities.217-9 However, randomized controlled trials

still need to substantiate their findings regarding patients with significant co-morbidity by capturing all

relevant measures in these patients groups. In one rehabilitation trial, there were no significant differences

81

in functional recovery in the groups.152 A subgroup analysis, revealed that the effect of geriatric

intervention on short-term functional recovery was greater in the subgroup of patients without dementia

(65% and 47% in the intervention and control groups respectively, p=0.006) and in the group of patients

who walked independently before the fracture (62% and 48%, P=0.03) than in those with dementia and

those who did not walk independently before the fracture.152 However, these results must be cautiously

interpreted because the analysis was not previously specified and the number of patients in each subgroup

was small.

Several reports claim that classifying the pre-fracture mental condition based on a postoperative

examination like the Mini Mental State Examination is not reliable due to the high incidence of temporary

postoperative delirium in this group of patients.71, 220 Several papers report that age, sex, location at time of

injury, pre-injury status, preoperative complications, time until surgery, and presence or absence of

dementia are poor prognostic factors.221-3

Likewise, the ASA was designed to categorize physical status in order to create a uniform system for

statistical analysis. Interestingly, it was never intended to represent peri-operative risk of morbidity for any

individual patient considering the many other influential factors such as the surgical procedure, patient

preparation, variability of surgeons and equipment used in different institutions that can affect outcome.224

Ward and colleagues reported that the ASA classification was a good predictor of mortality, and the 3-year

mortality was significantly less for ASA I and II patients than for ASA III, IV, and V patients.225 However,

the ASA classification is subjective and is dependent on the surgeon, internists, and anesthesiologists in

particular to discern classes ASA II, III, III and IV. In a study by Mak, the authors found that the

percentage of agreement was between 31 to 85%.224 Overall correlation was only fair in all groups (Kappa

indices: 0.21 – 0.4). The current pattern of inter-observer inconsistency of classification was similar to that

20 years ago and exaggerated between locally and overseas trained specialists (P <0.05). Overall, we do not

recommend the use of the ASA classification to include or exclude patients. Although it is used frequently

in studies to assess co-morbidity, its usefulness is questionable and a new more precise scoring system is

needed.

82

5.5 Ethical considerations

Cognitive impairment does not lead necessarily to an assessment of incompetence. Cognitively impaired

elderly people may still be able to make morally responsible decisions, based on different degrees of

decision-making and on their personal history.226 The solution is more complex and assessment instruments

need to be used with caution when dealing with multiple interactions between medical personnel, patients

and their family members. With regard to the ethical considerations and care of patients with dementia, the

approach needs to encompass the patient’s feeling of being cared for and approached as competent or free

individuals. As the elderly are regarded as a vulnerable group, it is important to use a method that can

protect those who cannot decide, and provide the opportunity to participate in research for those who are

able to decide for themselves. Especially because the law prohibits scientific research on incompetent

patients, unless special conditions are fulfilled, a closer investigation on the issue of informed consent is

needed, and should be recommended for future research. Patients with mild to moderate dementia still have

moral capacity. In our systematic review, the majority of rehabilitation trials focusing on patients with

dementia in specialized treatment centers have reported that significant improvement in postoperative

functional status can be achieved. Furthermore, protocols that have included these patient subtypes have

clearly relied upon one major concept of disability: activities of daily living and accommodation or living

status and the use of support for walking. These measures, do not provide adequate clinical judgment on

treatment effectiveness even for patients enrolled in the study who are healthy. Proxy and patient responses

are not interchangeable; however, proxy responses can provide an option for assessing function and health

status in patients who are unable to respond on their own behalf. In a prospective longitudinal study,

examining agreement between patient and proxy respondents using the Health Utilities Mark 2 and Mark 3

over time during a 6 month recovery after hip fracture, the authors reported ICC values from 0.50 to 0.85

(p<0.001) for physically based observable dimensions of health status and from 0.32 to 0.66 (P<.01) for

less observable dimensions. Future investigation of the proxy inter-rater agreement in the use of health

status instruments is needed.227

83

5.6 Summary

Although trials in patients with hip fractures can and should include patients with co-morbidities, the

majority of the trials we identified systematically exclude this important group of patients. Furthermore, in

trials that did include patients with co-morbidities the thresholds that defined inclusion were not consistent.

84

Figure 1 Diagnostic tools used to assess co-morbidity in high quality RCTs

0

2

4

6

8

10

12

ASA Ceder Charlson Co-morbiditygrade

Unspecified

Diagnostic tools for comorbidity

** ASA American Anesthesiologist Society

Figure 2 Frequently used measures for diagnosing cognitive status in high quality RCTs

0

1

2

3

4

5

6

7

8

MMSE MTS SPMSQ BDR CAM other

Diagnostic tools for cognitive impairment

**MMSE, Mini Mental status examination; MTS, Mental Test Score; SPMSQ, short portable mental status questionnaire; BDR,

blessed Dementia Rating; CAM, Confusion Assessment Method

85

Table 2 List of measures stratified by group based on inclusion and exclusion criteria alone. Group A trials did not explicitly state exclusion of patients with co-morbidities. Group B trials excluded patients with hip fractures diagnosed with one or more co-morbidities. Group A (N = 14)

Group B (N=27)

EQ5d 1 2 EQ5D (proxy) 2 SIP-NH 1 SWED-QUAL SF-36 3 SF-36 (chronic and acute forms)

1

PCS (SF-36) only 2 PCS (proxy-SF36)only 1 MCS (SF36)only 2 MCS (SF36 proxy)only 1 Charnley hip score 2 Harris hip score 2 2 Hip Rating Questionnaire

1

Mod HRQ 1 Oxford hip score 1 MFA full Yale physical activity survey

1

Outcome expectations for exercise scale

1

Questionnaire about health and functional abilities

1

Global health self-ratings

1

Functional Independence Measure (Mobility subscale)

1

Functional performance battery

1

Physical performance test

2

PPME 1 Physical function subscale (FSQ)

1

Level of satisfaction 1 Level of satisfaction (proxy)

1

ROM 1 3 Pain 5 4 Short form McGill pain questionnaire

1

Wong Baker pain rating scale

1

Mod pain Charnley

86

Pain (Charnley) 1 Balance 3 Balance scale (Berg) 1 Postural stability 2 Strength 6 Functional reach 2 Functional ambulation classification

1

FAC (proxy) 1 Functional Status Index 1 Falls Efficacy Scale 1 Mod falls efficacy scale 1 Mobility 6 15 Mobility (proxy) 1 Gait component (POMA)

Step Activity Monitor 1 ADL 4 6 Mod ADL 1 ADL (proxy) 2 MBI 1 2 IADL 3 1 London Handicap Scale 1 Disability Rating scale (DRI)

DRI modified Use of support 2 5 Caregiver strain index 2 Living situation 5 2 * Excluded 1 medical trial for not clearly reported inclusion and exclusion criteria (Hallan, 2006), ** 1 trial in Group A limited the use of EQ5D to those patients without severe cognitive dysfunction but included all patient types in the trial (Miedel, 2005).

87

Table 3 Group A trials including patients with severe co-morbidities such as dementia

Primary Author

Year Intervention Diagnostic tool, grade (definition of cognitive impairment), N patients

Types of outcomes Time points

Peyser132 2007 Surgical ASA 1(normal healthy)=1 2(patient with mild systemic disease)=46 3(severe but not incapacitating disease)=49 4(severe, incapacitating systemic condition that is a constant threat to life)=7 5(near death)=0

• Stability of fixation

• Pain (VAS) • Weight-bearing

index

6, 12, 24 wks & 24 mths

Stenvall143 2007 Rehab MMSE Dementia= 64 Cancer= 29 Stroke=49 Depression (GDS)=78 Diabetes= 40 Cardiovascular disease = 110 Hearing loss= 76 Vision loss = 64

• Mobility (S-COVS)

• Living conditions • ADL (Katz)

4, 12 mths

Krichbaum113 2007 Rehab MMSE < 24 = 1 • Living conditions • Global health self

ratings • Functional status

index

1, 3, 6 and 12 mths

Ovesen126 2004 Surgical ASA 1 = 39 2 = 39 3 = 51 4 = 17

• Reduction and implant positioning

• Walking ability • Accommodation • Need for walking

aid • Mortality

4 (need for walking aid), 12 mths

Johansson107 2006 Surgical Mod Norton scale 4(fully oriented)= 90 1-3 (no contact, cannot answer adequately, occasionally confused)= 56

• Dislocation • Pain (HHS) • Accommodation • Harris hip score • Costs • Mortality

3mths, 1 & 2 yrs

Kim112 2005 Surgical MMSE = NR ASA = NR

• Quality of reduction

• Bipolar cup migration

• Erosion of acetabular cartilage

• Stem stability • Bone quality

(Singh index)

• Pain (HHS) • MMSE • ADL (Katz) • HHS • Costs

Pre-op, 2yrs

88

Primary Author



Miedel120 2005 Surgical Ceder Co-morbidity scale Group A= 45 (41%) Group B = 48 (44%) SPMSQ > 4 (cognitive function intact, mildly impaired, moderately impaired) At inclusion = 162 At 4mths = 142 At 1 year = 134 NB 66(13%) lost to f-u Absent because of advanced age, illness or dementia

• Fracture reduction

• Screw position • Wound infection • Mobility • ADL (Katz) • Charnley’s

numerical classification

• EQ5D (only presented in those without severe cognitive dysfunction SPMSQ ≥ 3

4, 12 mths

Vidan152 2005 Rehab Chart review or interview of patient’s nurse Cardiovascular disease = 73 Diabetes mellitus = 64 Hypertension = 134 Dementia = 78 Delirium assessed by CAM = NR

• Wound infection, prosthesis luxation

• Functional Ambulation Classification (FAC)

• ADL (Katz) • Discharge

location • Composite

functional status outcome (ADL + FAC)

3, 6, 12 mths

Blomfeldt77 2005 Surgical SPMSQ 0-2 cognitive function severely impaired = 60 Co-morbidities Ceder C, another illness which affected rehabilitation = 60

• Fracture healing • Hip

complications

• Charnley’s numerical classification

• EQ5D • ADL (Katz)

4, 24 mths

Ahrengart69 2002 Surgical ASA 1=76.8 2=172.4 3=147 4=29.4 5=None

• Fracture healing • Leg-length

discrepancy

• Cut-out • Pain around hip • Hip rotation • Use of walking

aids • Living conditions

6mths

Janzing105 2002 Surgical ASA 1=2 2=40 3=39 4=2

• BMD (Singh) • Fracture healing • Pain (VAS) • Need of walking

aids • Living conditions

3, 6 & 12mths

89

Primary Author



• Mortality Naglie122 2002 Rehab SMSQ 3 to 6 = 74

• MBI • IADL (Lawton &

Brody)

3 & 6 mths

Van Dortmont150

2000 Surgical DSM-III-R = 60 Co-existing conditions Neurological = 17 Cardiovascular = 16 Metabolic=11 Pulmonary=7 Rheumatoid=1 Malignancy, treated= 6 Other= 13

• Reduction and fixation

• Blood loss • Wound

complications

• No. of secondary interventions

• ADL • Mortality

4 mths, 1 and 2 yrs

Bachrach-Lindstrom71

2000 Medical Mod Norton Scale 1-3 = mentally impaired = 41

• Body weight (Nutritional status)

• Triceps skinfold thickness (Nutritional status)

• Mid-arm circumference (Nutritional status)

• Serum albumin • ADL (Katz) • IADL (Hamrin) • Arm muscle

circumference (Nutritional status)

• HHS • Mortality

1,3 mths & 1 yr, Pain at 3mths & 1 yr

90

Keypoints from Chapter Five

• ADLs are critical for monitoring disease progression such as dementia, determining the need for health services, and evaluating the efficacy of therapeutic interventions

• The measurement of function using Daily Living activities should be measured as per categories of activities of daily living, instrumental activities of daily living and mobility related to walking and to managing stairs

• The majority of trials excluded patients with cognitive impairment such as dementia

• Use of proxy was underutilized in patients with cognitive impairment

• As a result, assessment of health-status and utility were not adequately captured in these patients

91

Chapter 6

CONCLUSIONS

6.1 Implications of study

There are numerous functional instruments that include an individual’s ability to carry out basic and

instrumental activities of daily living as well as their participation in those activities. Complications arise if

the instruments were developed without a conceptual basis which makes it challenging to apply the

composite score to reflect the functional recovery of the aged with hip fractures. Our systematic review, for

instance demonstrated a wide range of mobility measures applied to this target population. This reflects the

limitation of a time-consuming scale, questions which are redundant, or are either too easy or too difficult

or altogether irrelevant. Furthermore, the different rating scales, scores, different administration and scoring

options make outcomes results across trials difficult to compare. In this particular fragile and aged

population, co-morbidity increases respondent burden and examiner burden. The pragmatic considerations

of an instrument can lead to obvious disability bias as those with dementia are then not included in trials.

Functional outcomes are consequently measured for the most part in healthy lucid individuals. We believe

that a proxy can be utilized to the advantage of trialists in order to obtain information on all patients,

including those with severe cognitive impairment, who otherwise are not represented.

There is not only a need to adopt reliable methods to assess patient recovery following a hip fracture, it is

also important to capture with the use of multiple instruments domains under the categories of Body

Function and Structure as well as Activity and Participation according to the ICF scheme. Consideration of

functional outcome measures that include measures of impairment that are either physician-rated or

observer-based, together with measures of activity limitations and participation restrictions that are either

patient self-report or observer-based can place the effectiveness of the intervention within the context of

important and expected outcomes from the perspective of the patient.

6.2 Limitations

In this study, the quality assessment of trials relied upon the judgment and experience of one reviewer.

However potential bias was minimized since the trials were masked and the criteria for the Detsky-scale

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were carefully adhered to. Another potential limitation encountered was the choice of the ICF framework

and blending the categories Activities and Participation together. Although we believe that clear

distinctions between these two categories could not be identified, distinct underlying concepts with two

different definitions are presented in the ICF framework. For the purposes of this review, we found

blending the categories of Activities and Participation when evaluating activities of daily living cut across

the different subdomains. The two different concepts can be operationalized using qualifiers of

performance and capacity to aid with the distinction. Perhaps in the future, modifications to the ICF may

address the gaps present in the current framework used. Furthermore, we have not considered in depth the

measurement properties such as internal validity, responsiveness, and reliability that are critical in selecting

the appropriate instruments.25 However, because of the scarcity of literature on many of these instruments,

we believe that assessing the pragmatic qualities of the instruments could provide valuable information as

to which instruments deserve further psychometric testing if needed.

6.3 Future directions

Implementing a universal language such as the ICF and more specifically the domains which can be coded

to three decimal places and specific categorizations of impairment, activity limitation and participation

restriction is worth further investigation. For instance in a recent publication by Jette and Haley, a core set

of 124 Basic Mobility items and 65 Daily Activity items were chosen for inclusion in an Activity Measure

for Post-Acute Care (AM-PAC) item bank based on a comprehensive review of items from existing

instruments, the ICF framework, a review by 10 measurement and content experts and suggestions from

several focus groups of individuals with disabilities.228 In turn, these will be completed in a self-report

tablet computer provided to the patients in the waiting room prior to their therapy visit. This system uses an

algorithm that selects items from the AM-PAC items banks directly tailored to the person, and shortens or

lengthens the test to achieve either the desired precision or a pre-assigned item stopping rule.

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6.3 Summary

Clinical trials are still dominated by impairment-based scoring systems although our results show a positive

trend over time in the use of functional outcome instruments. Disease, generic and utility measures tend to

be more standardized than measures assessing activities of daily living, performance-base and impairment-

base scoring systems. Although disease, generic and utility measures have undergone more field-testing,

their use in hip fracture clinical trials remains limited. This may be in part due to poor format compatibility

for this specific age group with co-morbidities as well as dealing with the burden of a hip fracture. Low

respondent burden is also critical; however, a good instrument with relevant items pertaining to the hip

fracture may compensate. Furthermore, the use of proxy responders could be useful in identifying treatment

and management gaps in patients with co-morbidities. The results of using PROs in clinical practice have

been inconsistent, and ascertaining the circumstances under which PROs are truly helpful beyond research

settings remains a challenge.

94

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108

APPENDICES

109

Appendix 1 Search strategy Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1950 to Present

# Searches 1 exp hip fractures/ 2 (exp fractures, bone/ and femur$.mp.) or femoral$.mp. [mp=title, original title, abstract, name

of substance word, subject heading word] 3 exp fractures, bone/ and trochant$.mp. [mp=title, original title, abstract, name of substance

word, subject heading word] 4 exp fractures, bone/ and intertrochant$.mp. [mp=title, original title, abstract, name of substance

word, subject heading word] 5 exp fractures, bone/ and subtrochant$.mp. [mp=title, original title, abstract, name of substance

word, subject heading word] 6 exp fractures, bone/ and intracapsul$.mp. [mp=title, original title, abstract, name of substance

word, subject heading word] 7 exp fractures, bone/ and pertrochant$.mp. [mp=title, original title, abstract, name of substance

word, subject heading word] 8 exp fractures, bone/ and extracapsul$.mp. [mp=title, original title, abstract, name of substance

word, subject heading word] 9 exp fractures, bone/ and exp hip/ 10 exp hip/ and (pin$ or screw$ or plate$ or arthroplast$ or internal fix$ or fracture fix$).mp. 11 or/1-10 12 exp Randomized Controlled Trials as Topic/ 13 exp Prospective Studies/ or exp Treatment Outcome/ 14 15 exp Clinical Trials as Topic/ 16 exp "Recovery of Function"/ 17 Range of motion.mp. or exp "Range of Motion, Articular"/ 18 exp Mobility Limitation/ 19 exp Disability Evaluation/ 20 musculoskeletal evaluation.mp. 21 exp Health Status Indicators/ 22 exp Cross-Over Studies/ 23 exp "Activities of Daily Living"/ 24 exp Diagnostic Errors/ 25 exp questionnaires/ 26 11 and (or/12-25) 27 limit 26 to (english language and ("all aged (65 and over)" or "aged (80 and over)")) 28 limit 27 to randomized controlled trial

Ovid Healthstar

# Searches 1 exp hip fractures/ 2 (exp fractures, bone/ and femur$.mp.) or femoral$.mp. [mp=title, original title, abstract, name

of substance word, subject heading word]

110

3 exp fractures, bone/ and trochant$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

4 exp fractures, bone/ and intertrochant$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

5 exp fractures, bone/ and subtrochant$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

6 exp fractures, bone/ and intracapsul$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

7 exp fractures, bone/ and pertrochant$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

8 exp fractures, bone/ and extracapsul$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

9 exp fractures, bone/ and exp hip/ 10 exp hip/ and (pin$ or screw$ or plate$ or arthroplast$ or internal fix$ or fracture fix$).mp. 11 or/1-10 11 exp Treatment Outcome/ 12 exp Prospective Studies/ or 14 exp Double-Blind Method/ or double blind.mp. 15 16 exp "Recovery of Function"/ 17 Range of motion.mp. or exp "Range of Motion, Articular"/ 18 exp Mobility Limitation/ 19 exp Disability Evaluation/ 20 musculoskeletal evaluation.mp. 21 exp Health Status Indicators/ 22 exp Cross-Over Studies/ 23 exp "Activities of Daily Living"/ 24 exp Diagnostic Errors/ 25 exp questionnaires/ 26 11 and (or/12-25) 27 limit 26 to (english language and ("all aged (65 and over)" or "aged (80 and over)")) 28 limit 27 to randomized controlled trial

CINAHL

# Searches 1 exp hip fractures/ 2 exp fractures/ and (femur$ or femoral$).mp. [mp=title, subject heading word, abstract,

instrumentation] 3 exp fractures/ and trochant$.mp. [mp=title, subject heading word, abstract, instrumentation] 4 exp fractures/ and intertrochant$.mp. 5 (exp fractures,/ and pertrochant$.mp.) or subtrochant$.mp. 6 exp fractures/ and intracapsul$.mp. 7 exp fractures/ and extracapsul$.mp. [mp=title, subject heading word, abstract, instrumentation] 8 exp fractures,/ and exp hip/

111

9 hip fracture$.mp. 10 exp hip/ and (pin$ or screw$ or plate$ or arthroplast$ or internal fix$ or fracture fix$).mp. 11 or/1-10 12 Prospective Studies/ or exp Treatment Outcome/ 13 exp Clinical Nursing Research/ 14 exp Functional Status/ 15 Recovery of Function.mp. 16 Range of Motion.mp. or exp "Range of Motion"/ 17 exp Physical Mobility/ or Mobility Limitation.mp. 18 exp Disability Evaluation/ 19 musculoskeletal evaluation.mp. 20 exp Health Status Indicators/ 21 exp "Activities of Daily Living"/ 22 21 or 17 or 12 or 20 or 15 or 14 or 18 or 13 or 16 or 19 23 22 and 11 24 limit 23 to (research and english) 25 limit 24 to (aged <65 to 79 years> or "aged <80 and over>")

EMBASE 1973-1979, 1980 to 2007 Week 38

# Searches 1 exp hip fractures/

2 exp fracture/ and ((femur$ or femor$ or trochant$ or intertrochant$ or pertorchant$ or extracap$ or intercap$).mp. or exp/hip) [mp=ti, ab, sh, hw, tn, ot, dm, mf]

3 1 or 2

4 exp Prospective Study/

5 exp Outcomes Research/ or exp Treatment Outcome/ or outcome study.mp.

6 Functional Status.mp. or exp Functional Assessment/ or exp Functional Status/ or exp Scoring System/ or exp Prognosis/ or exp Health Status/

7 Recovery of Function.mp. or exp Convalescence/

8 exp PHYSICAL MOBILITY/ or exp JOINT MOBILITY/

9 Disability Evaluation.mp. or exp Disability/

10 Activities of Daily Living.mp. or exp Daily Life Activity/

11 musculoskeletal evaluation.mp.

12 3 and (or/4-11)

13 limit 12 to (human and english language and aged <65+ years>)

14 Randomized Controlled Trial/

15 13 and 14

112

Appendix 2 The 21-Detsky scale used to assess quality in the randomized controlled clinical trials.

Randomization 1a) Were the patients assigned randomly?

Yes-1 No-0

1b) Was randomization adequately described?

Yes-2 Partly-1 No-0

1c) Was treatment group concealed to investigator?

Yes-1 No-0

Description of outcome measurement 2a) Was the description of outcome measurement adequate?

Yes-1 No-0

2b) Was the outcome measurement objective?

Yes-2 Partly-1 No-0

2c) Were the assessors blind to treatment?

Yes-1 No-0

Inclusion/Exclusion criteria 3a) Were inclusion/exclusion criteria well defined?

Yes-2 Partly-1 No-0

3b) Were the number of excluded patients and reasons for exclusion provided?

Yes-2 Partly-1 No-0

Description of treatment 4a) Was the therapy fully described for the treatment group?

Yes-2 Partly-1 No-0

4b) Was the therapy fully described for the controls?

Yes-2 Partly-1 No-0

Statistics 5a) Was the test stated and a p value given?

Yes-1 No-0

5b) Was the statistical analysis appropriate?

Yes-2 Partly-1 No-0

5c) If the trial was negative, were confidence intervals of post hoc power calculations performed?

Yes-1 No-0

5d) Was the sample size calculated before the study?

Yes-1 No-0

Total Negative trial- 21 Positive trial- 20 Percentage

113

Appendix 3 Quality assessment scores according to Detsky Author 1a 1b 1c 2a 2b 2c 3a 3b 4a 4b 5a 5b 5c 5d Total % Neg

Adams (2001) 1 2 1 1 2 1 2 2 2 2 1 2 1 0 20 95 X Ahrengart (2002)

1 1 0 1 1 1 2 2 2 2 1 2 0 0 16 80

Bach (2004) 1 1 1 1 1 1 2 2 2 2 1 2 1 1 19 90 X Bachrach-Lindstrom (2000)

1 1 0 1 1 0 2 2 2 2 1 2 - 0 15 75

Baker (2006) 1 2 1 1 1 0 2 2 2 2 1 2 - 1 18 90 Bal (2005) 0 0 1 0 1 1 0 0 1 1 0 1 - 0 6 30 Bannister (1990)

1 0 0 1 2 0 0 1 0 0 1 0 0 0 6 30

Binder (2004) 1 1 0 1 2 0 2 2 2 2 1 2 0 0 16 80 Blomfeldt (2005)

1 2 0 1 2 1 2 2 2 2 1 2 0 0 18 90

Blomfeldt (2005b)

1 2 0 1 2 0 2 2 2 2 1 2 0 0 17 85

Blomfeldt (2007)

1 2 1 1 1 1 2 2 2 2 1 2 0 1 17 85

Boonen (2002) 1 0 0 1 2 0 2 0 2 2 1 2 - 0 13 65 Bruce (2003) 0 1 0 1 1 0 2 0 2 2 1 1 0 0 11 52 X Burns (2007) 1 1 0 1 1 0 2 2 2 2 1 2 1 1 17 85 Calder (1995) 1 0 0 1 2 0 2 2 1 1 1 2 0 0 13 65 Calder (1996) 1 1 0 1 1 0 2 2 2 2 1 2 0 0 15 75 Cornell (1998) 1 2 1 1 2 1 2 2 2 2 1 2 0 0 19 90 X Crotty (2002) 1 1 1 1 1 1 2 0 2 2 1 2 1 1 17 81 X Crotty (2003) 1 2 1 1 2 0 2 2 2 2 1 2 0 0 18 90 Davison (2001) 1 0 0 0 1 0 2 0 2 2 1 2 - 0 11 55 Desjardins (1993)

1 1 0 1 2 1 2 0 2 2 1 0 0 0 13 65

Di Lorenzo (2007)

1 1 0 1 1 0 1 0 1 1 1 1 0 0 9 45

Dujardin (2001)

1 0 0 1 1 0 2 2 2 2 1 1 0 0 13 65

El-Abed (2005)

0 0 0 0 0 0 2 2 1 2 1 2 0 1 12 60

Espaulella (2000)

1 2 1 1 1 1 2 2 2 2 1 2 1 1 20 95 X

Efstathopoulos (2007)

1 2 0 1 2 0 2 2 2 2 1 1 0 1 17 85

Foss (2005) 1 2 1 1 2 1 2 2 2 2 1 2 - 1 20 95 Hagsten (2004)

1 2 1 1 1 1 2 2 2 2 1 2 - 1 19 95

Hagsten (2006)

1 2 1 1 1 1 2 2 2 2 1 2 0 0 18 90

Hallan (2006) 1 2 1 1 2 1 0 2 2 2 1 2 1 0 18 86 X Hardy (1998) 0 1 0 1 2 0 1 2 2 2 1 2 - 0 13 65 Hardy (2003) 1 0 0 1 1 0 2 2 2 2 1 2 0 0 14 70 Harrington (2002)

1 2 0 1 2 0 2 2 2 2 1 2 1 0 18 85 X

Hauer (2002) 1 1 0 1 1 1 2 2 1 1 1 2 0 0 14 70 Hedstrom (2002)

1 1 0 1 2 0 2 2 2 2 1 1 0 0 15 75

Huang (2005) 1 2 0 1 2 0 2 2 2 2 1 2 0 0 19 85 Huusko (2002) 1 2 1 1 1 1 2 2 2 2 1 2 1 1 20 95 Janzing (2002) 1 2 1 1 1 0 2 2 2 2 1 2 0 0 17 85 Johansson (2000)

1 1 0 1 1 0 2 2 2 2 1 2 0 0 15 75

Johansson (2006)

1 1 0 1 2 1 2 2 2 2 1 2 0 0 17 85

Jonsson (1996) 1 2 0 0 1 0 1 0 1 2 1 0 - 0 9 45 Karn (2006) 1 0 0 1 1 0 1 0 2 2 1 2 0 0 11 55 Keating (2005) 1 2 1 1 2 0 2 2 2 2 1 2 0 1 19 95 Keating (2006) 1 2 1 1 1 1 2 2 2 2 1 2 1 1 20 95

114

Kim (2005) 1 1 1 1 1 1 2 2 2 2 1 2 - 0 17 85 Krichbaum (2007)

1 2 1 1 1 1 1 2 2 1 1 2 0 0 16 80

Kuisma (2002) 1 2 1 1 1 0 2 0 2 2 1 2 - 1 16 80 Lamb (2002) 1 2 1 1 2 1 2 2 2 2 1 2 0 0 19 95 Lauridsen (2002)

1 0 0 0 0 0 2 2 2 2 1 2 0 0 12 57 X

Mangione (2005)

1 1 1 1 1 1 2 2 2 2 1 2 0 0 17 85

Mattson (2005)

1 2 0 1 2 1 2 2 2 2 1 2 0 0 18 90

Mattsson (2006)

1 2 0 1 1 0 2 2 2 2 1 2 0 1 17 85

Miedel (2005) 1 2 0 1 1 1 2 2 2 2 1 2 0 1 18 90 Moroni (2004) 1 1 0 1 2 0 2 0 2 2 1 2 0 0 14 70 Naglie (2002) 1 2 1 1 2 1 2 2 2 2 1 2 0 0 16 80 Neumann (2004)

1 0 1 1 2 1 2 0 2 2 1 2 0 1 16 80

Oldmeadow (2006)

1 1 0 1 1 0 2 0 2 2 1 1 0 1 13 65

Oude Voshaar (2006)

1 0 0 1 0 0 2 0 2 2 1 2 0 0 11 55

Ovesen (2006) 1 2 0 1 2 0 2 2 2 2 1 2 0 0 19 95 Pajarinen (2005)

1 1 0 1 2 0 2 2 2 2 1 2 0 0 16 80

Papasimos (2005)

1 0 0 1 1 0 2 1 2 2 1 2 0 0 13 65

Parker (2000) 1 2 0 1 1 0 2 2 2 2 1 2 1 0 17 80 Parker (2002) 1 2 1 1 2 0 2 2 2 2 1 2 0 0 18 90 Peterson (2004)

1 0 1 1 1 1 2 1 2 2 1 2 - 0 15 75

Peyser (2007) 1 2 0 1 1 0 2 2 2 2 1 2 0 1 17 85 Raia (2003) 1 1 0 1 2 0 2 2 2 2 1 2 0 0 16 80 Ravikumar (2000)

1 0 0 1 2 0 2 1 2 2 1 2 0 0 14 70

Resnick (2007) 1 0 1 1 1 1 1 2 2 2 1 2 0 0 15 75 Rogmark (2002)

1 2 0 1 2 0 2 2 1 1 1 2 0 1 16 80

Santini (2005) 0 0 0 0 1 0 2 0 1 1 0 0 - 0 5 25 Sherrington (2003)

1 2 0 1 1 0 2 2 2 2 1 2 1 1 18 86

Sherrington (2004)

1 2 1 1 1 0 2 2 2 2 1 2 1 0 18 85 X

Shyu (2005) 1 0 0 1 1 0 2 2 2 2 1 2 - 0 14 70 Sikorski (1981)

1 1 0 1 2 0 1 2 1 1 1 0 - 0 11 55

Soreide (1976) 1 2 0 0 1 0 1 0 1 2 1 0 - 0 9 45 Stenvall (2007) 1 2 1 1 1 0 2 2 2 2 1 2 1 0 18 85 Tidermark (2003)

1 1 0 1 2 0 2 2 2 2 1 2 0 0 16 80

Tidermark (2004)

1 2 1 1 2 1 2 2 2 2 1 2 0 0 19 95

Tinetti (1999) 1 0 1 1 1 1 2 2 2 2 1 2 0 1 17 85 Tsauo (2005) 1 0 0 1 1 0 0 1 2 2 1 2 0 0 11 55 Utrilla (2005) 1 1 0 1 2 0 2 2 2 2 1 2 0 0 16 80 Van der Lely (2000)

1 2 1 1 1 1 2 2 2 2 1 2 1 1 20 95 X

Van Dortmont (2000)

1 2 1 1 1 0 2 2 2 2 1 2 - 0 17 80 X

Van Vugt (1993)

1 0 0 1 1 0 1 1 2 1 1 2 0 0 11 55

Vidan (2005) 1 0 1 1 1 1 2 2 2 1 1 2 0 1 16 76 X Vidyadhara (2007)

1 0 0 1 1 0 0 0 2 2 0 0 0 0 7 35

*b- denotes British journal

115

Appendix 4. Included trials

Adams 2001

Adams CI. Prospective randomized controlled trial of an intramedullary nail versus dynamic screw and plate for intertrochanteric fractures of the femur. J Orthop Trauma 2001; 15(6):394-400.

Ahrengart 2002

Ahrengart L. A randomized study of the compression hip screw and gamma nail in 426 fractures. Clin Orthop Relat Res 2002; 401:209-22.

Bach 2004

Bach MA. The Effects of MK-0677, an oral growth hormone secretagogue, in patients with hip fracture. J American Geriatrics Soc 2004; 52(4):516-23.

Baker 2006

Baker RP. Total Hip Arthroplasty and Hemiarthroplasty in Mobile, Independent Patients with a Displaced Intracapsular Fracture of the Femoral Neck. A Randomized, Controlled Trial. J Bone Joint Surg 2006; 88(12):2583-9.

Bal 2005

Bal, S. Ceramic-on-ceramic versus ceramic-on-polyethylene bearings in total hip arthroplasty: Results of a multicenter prospective randomized study and update of modern ceramic total hip trials in the United States. Ceramics in Orthopaedics 2005 ;( 101-8).

Bannister 1990

Bannister, G. C. The Fixation and Prognosis of Trochanteric Fractures. A Randomized Prospective Controlled Trial. Clinical Orthopaedics & Related Research 1990; 254:242-6.

Binder 2004

Binder EF. Effects of Extended Outpatient Rehabilitation After Hip Fracture: A Randomized Controlled Trial. JAMA 2004; 292(7):837-46.

Blomfeldt 2005b

Blomfeldt R. Internal Fixation Versus Hemiarthroplasty for Displaced Fractures of the Femoral Neck in Elderly Patients with Severe Cognitive Impairment. JBJS Br 2005; 87(4):523-9.

116

Blomfeldt 2007

Blomfeldt R. A Randomised Controlled Trial Comparing Bipolar Hemiarthroplasty with Total Hip Replacement for Displaced Intracapsular Fractures of the Femoral Neck in Elderly Patients. JBJS -Br 2007; 89(2):160-5.

Boonen 2002

Boonen S. Musculoskeletal Effects of the Recombinant Human IGF-I/IGF Binding Protein-3 Complex in Osteoporotic Patients with Proximal Femoral Fracture: A Double-Blind, Placebo-Controlled Pilot Study. J Clin Endocrinology & Metabolism 2002; 87(4):1593-9.

Bruce 2003

Bruce, D. Nutritional Supplements After Hip Fracture: Poor Compliance Limits Effectiveness. Clinical Nutrition 2003; 22(5):497-500.

Burns 2007

Treatment and Prevention of Depression After Surgery for Hip Fracture in Older People: Randomized, Controlled Trials. J American Ger Soc 2007; 55(1):75-80.

Calder 1996

Calder SJ. Unipolar Or Bipolar Prosthesis for Displaced Intracapsular Hip Fracture in Octogenarians: A Randomised Prospective Study. JBJS Br 1996; 78(3):391-4.

Cornell 1998

Cornell CN. Unipolar Versus Bipolar Hemiarthroplasty for the Treatment of Femoral Neck Fractures in the Elderly. Clin Orthop Relat Res 1998; 348:67-71.

Crotty 2002

Crotty M. Early Discharge and Home Rehabilitation After Hip Fracture Achieves Functional Improvements: A Randomized Controlled Trial. Clin Rehab 2002; 16(4):406-13.

Crotty 2003

Crotty M. Patient and Caregiver Outcomes 12 Months After Home-Based Therapy for Hip Fracture: A Randomized Controlled Trial. Archives of Physical Medicine and Rehabilitation 2003; 84(8):1237-9.

117

Davison 2001

Davison, J. N. Treatment for Displaced Intracapsular Fracture of the Proximal Femur. A Prospective, Randomised Trial in Patients Aged 65 to 79 Years. Journal of Bone & Joint Surgery - British Volume 2001; 83(2):206-12.

Calder, S. J. A Subjective Health Indicator for Follow-Up. A Randomised Trial After Treatment of Displaced Intracapsular Hip Fractures. Journal of Bone & Joint Surgery - British Volume 1995; 77(3):494-6.

Desjardins 1993

Desjardins, A. L. Unstable Intertrochanteric Fracture of the Femur. A Prospective Randomised Study Comparing Anatomical Reduction and Medial Displacement Osteotomy. Journal of Bone & Joint Surgery - British Volume 1993; 75(3):445-7.

Di 2007

Di L. Low back pain after unstable extracapsular hip fractures: randomised control trial on a specific training. Europa Medicophysica 2007; 43(3):349-57.

Dujardin 2001

Dujardin, F. H. Prospective Randomized Comparison between a Dynamic Hip Screw and a Mini-Invasive Static Nail in Fractures of the Trochanteric Area: Preliminary Results. Journal of orthopaedic trauma 2001; 15(6):401-6.

Efstathopoulos 2007

Efstathopoulos NE, Nikolaou V. S, Lazarettos J. T. Intramedullary Fixation of Intertrochanteric Hip Fractures: A Comparison of Two Implant Designs. International orthopaedics 2007; 31(1):71-6.

El-Abed 2005

El-Abed, K. Comparison of Outcomes Following Uncemented Hemiarthroplasty and Dynamic Hip Screw in the Treatment of Displaced Subcapital Hip Fractures in Patients Aged Greater than 70 Years. Acta Orthopaedica Belgica 2005; 71(1):48-54.

Espaulella 2000

Espaullella J. Nutritional Supplementation of Elderly Hip Fracture Patients. A Randomized, Double-Blind, Placebo-Controlled Trial. Age & Ageing 2000; 29(5):425-31.

118

Foss 2005

Foss NB. Effect of Postoperative Epidural Analgesia on Rehabilitation and Pain After Hip Fracture Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesthesiology 2005; 102(6):1197-204.

Hagsten 2004

Hagsten, B., Svensson O., and Gardulf A. Early Individualized Postoperative Occupational Therapy Training in 100 Patients Improves ADL After Hip Fracture: A Randomized Trial. Acta Orthopaedica Scandinavica 2004; 75(2):177-83.

Hagsten 2006

Hagsten B. Health-Related Quality of Life and Self-Reported Ability Concerning ADL and IADL After Hip Fracture: A Randomized Trial. Acta Orthopaedica 2006; 77(1):114-9.

Hallan 2006

Hallan G. Palamed G Compared with Palacos R with Gentamicin in Charnley Total Hip Replacement. A Randomised, Radiostereometric Study of 60 HIPS. Journal of Bone & Joint Surgery - British Volume 2006; 88(9):1143-8.

Hardy 1998

Hardy, D. C. Use of an Intramedullary Hip-Screw Compared with a Compression Hip-Screw with a Plate for Intertrochanteric Femoral Fractures. A Prospective, Randomized Study of One Hundred Patients. Journal of Bone & Joint Surgery - American Volume 1998; 80(5):618-30.

Hardy 2003

Hardy D. Slotted intramedullary hip screw nails reduce proximal mechanical unloading. Clin Orthop 2003; 406:176-184.

Harrington 2002

Harrington P. Intramedullary Hip Screw Versus Sliding Hip Screw for Unstable Intertrochanteric Femoral Fractures in the Elderly. Injury 2002; 33(1):23-8.

Hauer 2002

Hauer, K. Intensive Physical Training in Geriatric Patients After Severe Falls and Hip Surgery. Age & Ageing 2002; 31(1):49-57.

119

Hedstrom 2002

Hedstrom M. Positive Effects of Anabolic Steroids, Vitamin D and Calcium on Muscle Mass, Bone Mineral Density and Clinical Function After a Hip Fracture. A Randomised Study of 63 Women. Journal of Bone & Joint Surgery - British Volume 2002; 497-503.

Huang 2005

Huang TT, Liang SH. A Randomized Clinical Trial of the Effectiveness of a Discharge Planning Intervention in Hospitalized Elders with Hip Fracture due to Falling. J of clin nursing 2005; 14(10):1193-201.

Huusko 2002

Huusko TM. Intensive Geriatric Rehabilitation of Hip Fracture Patients: A Randomized, Controlled Trial. Acta Orthopaedica Scandinavica 2002; 73(4):425-31.

Huusko TM, Karppi P, Avikainen V et al. Randomised, clinically controlled trial of intensive geriatric rehabilitation in patients with hip fracture: Subgroup analysis of patients with dementia. BMJ 2000; 321: 1107-1111.

Janzing 2002

Janzing HM. The Gotfried PerCutaneous Compression Plate Versus the Dynamic Hip Screw in the Treatment of Pertrochanteric Hip Fractures: Minimal Invasive Treatment Reduces Operative Time and Postoperative Pain. Journal of Trauma-Injury Infection & Critical Care 2002; 52(2):293-8.

Johansson 2006

Johansson T. The Total Costs of a Displaced Femoral Neck Fracture: Comparison of Internal Fixation and Total Hip Replacement. A Randomised Study of 146 Hips. International orthopaedics 2006; 30(1):1-6.

Bachrach-Lindstrom, M. Nutritional status and functional capacity after femoral neck fractures: a prospective randomized one-year follow-up study. Aging-Clinical & Experimental Res 2000; 12(5):366-74.

Johansson T, et al. Internal fixation versus total hip arthroplasty in the treatment of displaced femoral neck fractures: a prospective randomized study of 100 hips. Acta Orthopaedica Scandinavica 2000; 71 (6): 597-602

Jonsson 1996

Jonsson, B. Social Function After Cervical Hip Fracture. A Comparison of Hook-Pins and Total Hip Replacement in 47 Patients. Acta Orthopaedica Scandinavica 1996; 67(5):431-4.

120

Karn 2006

Karn, N. K. Comparison between External Fixation and Sliding Hip Screw in the Management of Trochanteric Fracture of the Femur in Nepal. The Journal of bone and joint surgery. British volume 2006; 88(10):1347-50.

Keating 2006

Keating JF et al. Randomized Comparison of Reduction and Fixation, Bipolar Hemiarthroplasty, and Total Hip Arthroplasty. Treatment of Displaced Intracapsular Hip Fractures in Healthy Older Patients. Journal of Bone & Joint Surgery - American Volume 2006; 88(2):249-60. Keating JF et al. Displaced intracapsular hip farctures in fit, older people: a randomized comparison of reduction and fixation, bipoar hemiarthroplasty and total hip arthroplasty. Health technology assessment (Winchester, England) 2005; 9(41): 1-65

Kim 2005

Kim S Y, Kim Y G, and Hwang JK.. Cementless Calcar-Replacement Hemiarthroplasty Compared with Intramedullary Fixation of Unstable Intertrochanteric Fractures. A Prospective, Randomized Study. J of Bone & Joint Surgery - American Volume 2005; 87(10):2183-92.

Krichbaum 2007

Krichbaum, K. GAPN postacute care coordination improves hip fracture outcomes. Western Journal of Nursing Research 2007; 29(5):523-44.

Kuisma 2002

Kuisma, R. A Randomized, Controlled Comparison of Home Versus Institutional Rehabilitation of Patients with Hip Fracture. Clinical rehabilitation 2002; 16(5):553-61.

Lamb 2002

Lamb SE. Neuromuscular Stimulation of the Quadriceps Muscle After Hip Fracture: A Randomized Controlled Trial. Archives of Physical Medicine & Rehabilitation 2002; 83(8):1087-92.

Lauridsen 2002

Lauridsen UB. Intensive physical therapy after hip fracture: a randomized clinical trial. Dan Med Bull 2000; 49:70-2.

121

Mangione 2005

Can elderly patients who have had a hip fracture perform moderate- to high-intensity exercise at home. Phys.Ther 2005; 85(8):727-39.

Mattsson 2005

Mattsson, P. Resorbable Cement for the Augmentation of Internally-Fixed Unstable Trochanteric Fractures. A Prospective, Randomised Multicentre Study. Journal of Bone & Joint Surgery - British Volume 2005; 87(9):1203-9.

Mattsson 2006

Mattsson P, and Larsson S. Calcium Phosphate Cement for Augmentation did Not Improve Results after Internal Fixation of Displaced Femoral Neck Fractures: A Randomized Study of 118 Patients. Acta Orthopaedica 2006; 77(2):251-6.

Miedel 2005

Miedel, R. The Standard Gamma Nail or the Medoff Sliding Plate for Unstable Trochanteric and Subtrochanteric Fractures. A Randomised, Controlled Trial. Journal of Bone & Joint Surgery - British Volume 2005; 87(1):68-75.

Moroni 2004

Moroni, A. HA-Coated Screws Decrease the Incidence of Fixation Failure in Osteoporotic Trochanteric Fractures. Clinical Orthopaedics & Related Research 2004; 425:87-92.

Naglie 2002

Naglie, G. Interdisciplinary Inpatient Care for Elderly People with Hip Fracture: A Randomized Controlled Trial. Canadian Medical Association Journal 2002; 167(1):25-32.

Neumann 2004

Neumann, M. Provision of High-Protein Supplement for Patients Recovering from Hip Fracture. Nutrition 2004; 20(5):415-9.

Oldmeadow 2006

Oldmeadow, L. B. No Rest for the Wounded: Early Ambulation After Hip Surgery Accelerates Recovery. ANZ Journal of Surgery 2006; 76(7):607-11.

122

Oude Voshaar 2006

Oude Voshaar, R. C. Fear of Falling More Important than Pain and Depression for Functional Recovery After Surgery for Hip Fracture in Older People. Psychological medicine 2006; 36(11):1635-45.

Ovesen 2006

Ovesen O. The trochanteric gamma nail versus the dynamic hip screw: A prospective randomised study. One-year follow-up of 146 intertrochanteric fractures. Hip International 2006; 16(4):293-8.

Pajarinen 2005

Pajarinen, J. Pertrochanteric Femoral Fractures Treated with a Dynamic Hip Screw or a Proximal Femoral Nail. A Randomised Study Comparing Post-Operative Rehabilitation. Journal of Bone & Joint Surgery - British Volume 2005; 87(1):76-81.

Papasimos 2005

Papasimos, S. A Randomised Comparison of AMBI, TGN and PFN for Treatment of Unstable Trochanteric Fractures. Archives of Orthopaedic & Trauma Surgery 2005; 125(7):462-8.

Parker 2002

Parker MJ. Hemiarthroplasty versus Internal Fixation for Displaced Intracapsular Hip Fractures in the Elderly. A Randomised Trial of 455 Patients. Journal of Bone & Joint Surgery - British Volume 2002; 84(8):1150-5.

Parker MJ and GA Pryor. Internal fixation or arthroplasty for displaced cervical hip fractures in the elderly: A randomized controlled trial of 208 patients. Acta Orthopaedica Scandinavica 2000; 71 (5): 440-6

Peterson 2004

Peterson, MG. High-intensity exercise training following hip fracture. Topics in Geriatric Rehabilitation 2004; 20(4):273-284.

Peyser 2007

A Prospective, Randomised Study Comparing the Percutaneous Compression Plate and the Compression Hip Screw for the Treatment of Intertrochanteric Fractures of the Hip. Journal of Bone & Joint Surgery - British Volume 2007; 89(9):1210-7.

Raia 2003

Raia FJ. Unipolar or Bipolar Hemiarthroplasty for Femoral Neck Fractures in the Elderly? Clin Orthop Res 2003; 414:259-65.

123

Ravikumar 2000

Ravikumar KJ, Marsh G. Internal Fixation versus Hemiarthroplasty Versus Total Hip Arthroplasty for Displaced Subcapital Fractures of Femur--13 Year Results of a Prospective Randomised Study. Injury 2000; 31(10):793-7.

Resnick 2007

Resnick, B. Testing the Effectiveness of the Exercise Plus Program in Older Women Post-Hip Fracture. Ann Behav Medicine 2007; 34(1):67-76.

Rogmark 2002

Rogmark C. A Prospective Randomised Trial of Internal Fixation versus Arthroplasty for Displaced Fractures of the Neck of the Femur. Functional Outcome for 450 Patients at Two Years. Journal of Bone & Joint Surgery - British Volume 2002; 84(2):183-8.

Santini 2005

Santini S. Hip fractures in elderly patients treated with bipolar hemiarthroplasty: Comparison between cemented and cementless implants. Journal of Orthopaedics and Traumatology 2005; 6(2):80-7.

Sherrington 2004

Sherrington C, Lord SR, Herbert RD. A Randomized Controlled Trial of Weight-Bearing versus Non-Weight-Bearing Exercise for Improving Physical Ability after Usual Care for Hip Fracture. Archives of Physical Medicine & Rehabilitation 2004; 85(5):710-6.

Sherrington, C., Lord, S. R.and Herbert R. D. A Randomised Trial of Weight-Bearing versus Non-Weight-Bearing Exercise for Improving Physical Ability in Inpatients after Hip Fracture. Australian Journal of Physiotherapy 2003; 49(1):15-22.

Shyu 2005

Shyu YI. A Pilot Investigation of the Short-Term Effects of an Interdisciplinary Intervention Program on Elderly Patients with Hip Fracture in Taiwan. Journal of the American Geriatrics Society 2005; 53(5):811-8.

Sikorski 1981

Sikorski, J. M., and Barrington R. Internal Fixation versus Hemiarthroplasty for the Displaced Subcapital Fracture of the Femur. A Prospective Randomised Study. Journal of Bone & Joint Surgery - British Volume 1981; 63(3):357-61.

124

Soreide 1980

Soreide O. Internal fixation versus endoprosthesis in the treatment of femoral neck fractures in the elderly. A prospective analysis of the comparative costs and the consumption of hospital resources. Acta Orthop Scand 1980; 51:827-31.

Stenvall 2007

Stenvall, M. Improved Performance in Activities of Daily Living and Mobility after a Multidisciplinary Postoperative Rehabilitation in Older People with Femoral Neck Fracture: A Randomized Controlled Trial with 1-Year Follow-Up. Journal of rehabilitation medicine 2007; 232-8.

Tidermark 2003

Tidermark, J. Internal Fixation Compared with Total Hip Replacement for Displaced Femoral Neck Fractures in the Elderly. A Randomised, Controlled Trial. Journal of Bone & Joint Surgery - British Volume 2004; 23(4):587-96.

Blomfeldt R. Comparison of Internal Fixation with Total Hip Replacement for Displaced Femoral Neck Fractures. Randomized, Controlled Trial Performed at Four Years. 2005; 87(8):1680-8.

Tidermark 2004

Tidermark, J. Effects of Protein-Rich Supplementation and Nandrolone in Lean Elderly Women with Femoral Neck Fractures. Clinical Nutrition 2004; 23(4):587-96.

Tinetti 1999

Tinetti ME. Home-based multicomponent rehabilitation program for older persons after hip fracture: a randomized trial. Arch Phys Med Rehabil 1999; 80(8):916-22.

Tsauo 2005

Tsauo, J. Y., Effects on Function and Quality of Life of Postoperative Home-Based Physical Therapy for Patients with Hip Fracture. Archives of Physical Medicine and Rehabilitation 2005; 86(10):1953-7.

Utrilla 2005

Utrilla, A. L. Trochanteric Gamma Nail and Compression Hip Screw for Trochanteric Fractures: A Randomized, Prospective, Comparative Study in 210 Elderly Patients with a New Design of the Gamma Nail. Journal of orthopaedic trauma 2005; 19(4):229-33.

Van Der Lely 2000

Van der Lely, A. Use of Human GH in Elderly Patients with Accidental Hip Fracture. European Journal of Endocrinology 2000; 143:585-92.

125

Van Dortmont 2000

van Dortmont, L. M. Cannulated Screws Versus Hemiarthroplasty for Displaced Intracapsular Femoral Neck Fractures in Demented Patients. Annales Chirurgiae et Gynaecologiae 2000; 89(2):132-7.

van Vugt 1993

van Vugt, A. B., Oosterwijk, W. M and Goris R. J. Osteosynthesis vs endoprosthesis in the treatment of unstable intracapsular hip fracture in the elderly. A randomized clinical trial. Archives of Orthopaedic & Trauma Surgery 1993; 113(1):39-45.

Vidan 2005

Vidan, M. Efficacy of a Comprehensive Geriatric Intervention in Older Patients Hospitalized for Hip Fracture: A Randomized, Controlled Trial. Journal of the American Geriatrics Society 2005; 53(9):1476-82.

Vidyadhara 2007

Vidyadhara, S. and Rao, S. K. One and two femoral neck screws with intramedullary nails for unstable trochanteric fractures of femur in the elderly--randomised clinical trial. Injury 2007; 38(7):806-14.

Other studies used as reference

1. Bhandari M, Devereaux PJ, Swiontkowski MF et al. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg- American volume 2003; 85-A (9): 1673-81.

2. Lu-Yao GL, Keller RB, Littenberg B et al. Outcomes after displaced fractures of the femoral neck. A meta-analysis of one hundred and six published reports. J Bone Joint Surg American Volume 1994; 76 (1): 15-25

3. Parker MJ, Gurusamy K. Internal fixation versus arthroplasty for intracapsular proximal

femoral fractures in adults. 2008; Cochrane Library.

4. Parker MJ, Gurusamy K. Arthorplasties (with and without bone cement) for proximal femoral fractures in adults. Cochrane Database of Systematic Reviews 2004.

5. Parker MJ, Stockton G. Internal fixation implants for intracapsular proximal femoral fractures in adults. Cochrane Database of Systematic Reviews 2001.

6. Tidermark J. Quality of life and femoral neck fractures. Acta Orthopaedica. 2003; 74(2):1-62.

7. Handoll HH, Sherrington C. Mobilisation strategies after hip fracture surgery in adults. Cochrane Database Syst Rev. 2007 Jan 24;(1)

126

Appendix 5 Study characteristics and patient demographics meeting inclusion and exclusion criteria.

Characteristic Surgical trials, n Medical Trials, n Rehabilitation Trials, n

Number of trials 30 11 17

Sample size population 1-50 1 2 2 51-100 6 4 8 101-500 23 5 7 Inclusion Criteria No age limitations specified

5 1

Minimum age (yrs) 80 1 75 3 1 1 70 9 2 2 65 6 4 11 60 5 3 2 50 1 Maximum age (yrs) 90 1 Hip fracture type Extracapsular fractures 11 2 2 Intracapsular fractures 19 1 2 Both 1 Unspecified 7 13 Mechanism of Injury Falling 2 Residence Living inside region of hospital

1

Independent living status

4 3 3

Community dweller 4 Nursing home 1 Discharge destination Community 1 Nursing home 1 Mobility Ability to walk ≥ 0.8 km 1 Walking without support

5 1 4

New mobility score ≥ 3 1 PPT 12-28 1 Previously ambulatory 1 2 1 Mental score DSM-III-R 1 Abbrev. MMTS 1 MMTS > 6 1 MMT ≥ 7 1 MTS ≥ 5/13 1

127

MTS ≥ 6/13 1 SPMSQ 3/10 correct 2 2 MMSE unspecified 1 MMSE > 24 3 MMSE > 20 1 1 MMSE > 15 1 Lucid 1 Blessed Dementia Rating ≥ 4

1

Mental & physical capacity to participate in rehabilitation program

2

Weight Too frail for any operative treatment

1

BMI ≤ 24 kg2 1 Other Home environment suitable for rehab

2

Completion of PT 1 Needed a formal rehab program

2

Exclusion criteria Hepatic dysfunction 2 Renal dysfunction 2 3 1 Uncontrolled diabetes mellitus

1

Abnormal thyroid function

1

Systolic BP > 200 or diastolic BP > 100

1

Malignancy 4 2 Stroke 1 Parkinson’s 1 1 1 Clotting disorder 2 Rheumatoid arthritis 11 3 Osteoarthritis 11 1 Paget’s disease 3 Diabetes 1 Uncontrolled hypertension

3

Cardiac heart failure 3 1 Hearing impairment 1 1 Visual impairment 1 ASA score V 2 Major medical conditions

2 2

Co-morbidities 1 Taking salmon calcitonin therapy

1

Bone-active therapy 1 Corticosteroid treatment 3 2 Needing intravenous 1

128

nutrition Non-ambulatory prior to fx

3 1 3

Dependence on person for ambulation

1

Inability to walk 50 feet 1 Dependency in all basic ADLs

1

Pre-fracture hospitalization

1

Long-term care facility 2 2 ICU 2 Independent or alone > 4hrs per day

1

Respiratory or cardiovascular failure preventing them to walk 50 ft

1

Cerebrovascular disease affecting mobility

1

Co-morbidity precluding ability to exercise

1

Neurosensory, neuromuscular or musculoskeletal deficiency

2 1 1

Mental or physical co-morbidities limiting walking distance to 0.8 km

1

Taking hypnotics, sedatives, muscle relaxants

1

Non-weight bearing or touch weight bearing

1

Clinical depression 1 Acute mental illness 1 Dementia 4 2 1 Advanced dementia 1 Mental instability 2 Cognitive impairment 1 1 Confusion 1 Cognitive impairment determined by first author

1

Terminal illness life expectancy < 12

1 3

Terminal illness < 6 mths

1

Terminal illness 1 Inability to provide informed consent

1

Alcohol or substance abuse

1 2

129

Smokers 1 *PPT denotes physical performance test; MMTS, Mini mental test score; SPMSQ Short portable mental status questionnaire; MMSE, mini mental status examination; BMI, Body Mass Index; PT, Physical therapy

functional outcomes in the aged with hip fracture: a … · iii acknowledgements i would like to...

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