video decision aids to assist with advance care planning: arandomized controlled trials about the...

For peer review only

Video Decision Aids to Assist with Advance Care Planning: a

Systematic Review and Meta-analysis

Journal: BMJ Open

Manuscript ID: bmjopen-2014-007491

Article Type: Research

Date Submitted by the Author: 18-Dec-2014

Complete List of Authors: Jain, Ashu; University of Toronto, Corriveau, Sophie; McMaster University, Quinn, Kathleen; McMaster University, Gardhouse, Amanda; University of Toronto, Brandt Vegas, Daniel; McMaster University, You, John; McMaster University, Medicine

<b>Primary Subject Heading</b>:

Patient-centred medicine

Secondary Subject Heading: Evidence based practice

Keywords: advance care planning, shared decision making, video, systematic review

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December 18, 2014 1

Video Decision Aids to Assist with Advance Care Planning: a Systematic

Review and Meta-analysis

Ashu Jain, family medicine resident

Department of Family and Community Medicine, University of Toronto, 500 University

Avenue, 5th Floor, Toronto, Ontario, Canada M5G 1V7

Sophie Corriveau, respirology resident

Division of Respirology, Department of Medicine, McMaster University, St. Joseph’s

Healthcare, 50 Charlton Avenue East, Hamilton, Ontario, Canada L8N 4A6

Kathleen Quinn, internal medicine resident

Department of Medicine, McMaster University, Room 3W10A-C, 1280 Main Street West,

Hamilton, Ontario, Canada L8S 4K1

Amanda Gardhouse, geriatric medicine resident

Division of Geriatric Medicine, Department of Medicine, University of Toronto, 2975

Bayview Avenue, Room H481, Toronto, Ontario, Canada, M4N 3M5

Daniel Brandt Vegas, clinical scholar

Division of General Internal Medicine, Department of Medicine, McMaster University, St.

Joseph’s Healthcare, Room F533, 50 Charlton Avenue East, Hamilton, Ontario, Canada L8N

4A6

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December 18, 2014 2

John J. You, associate professor (corresponding author)

Departments of Medicine, and Clinical Epidemiology & Biostatistics, McMaster University,

1280 Main Street West, Room HSC-2C8, Hamilton, Ontario, Canada, L8S 4K1; telephone:

905-525-9140 ext. 21858; e-mail: [email protected]

Keywords: advance care planning; decision aids; video recording; cardiopulmonary

resuscitation; end of life care

Word count (excluding title page, abstract, acknowledgements, references, tables, figures):

3,115

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December 18, 2014 3

ABSTRACT

Objective: Advance care planning (ACP) can result in end-of-life care that is more

congruent with patients’ values and preferences. There is increasing interest in video

decision aids to assist with ACP. The objective of this study was to evaluate the impact of

video decision aids on patients’ preferences regarding life-sustaining treatments (primary

outcome).

Design: Systematic review and meta-analysis of randomized controlled trials.

Data sources: MEDLINE, EMBASE, PsycInfo, CINAHL, AMED, and CENTRAL, between 1980

and February 2014, and correspondence with authors.

Eligibility criteria for selecting studies: Randomized controlled trials of adult patients

that compared a video decision aid to a non-video based intervention to assist with choices

about use of life-sustaining treatments and reported at least one ACP-related outcome.

Data extraction: Reviewers worked independently and in duplicate to screen potentially

eligible articles, and to extract data regarding risk of bias, population, intervention,

comparator, and outcomes. Reviewers assessed quality of evidence (confidence in effect

estimates) for each outcome using the Grading of Recommendations Assessment,

Development and Evaluation (GRADE) framework.

Results: Ten trials enrolling 2,220 patients were included. Low quality evidence suggests

that patients who use a video decision aid are less likely to indicate a preference for

cardiopulmonary resuscitation (pooled risk ratio, 0.50 [95% CI, 0.27 to 0.95]; I2=65%).

Moderate quality evidence suggests that video decision aids result in greater knowledge

related to ACP (standardized mean difference, 0.58 [95% CI, 0.38 to 0.77]; I2=0%). No study

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December 18, 2014 4

reported on the congruence of end-of-life treatments with patients’ wishes. No study

evaluated the effect of video decision aids when integrated into clinical care.

Conclusions: Video decision aids may improve some ACP-related outcomes. More evidence

is needed to confirm these findings and to evaluate the impact of video decision aids when

integrated into patient care.

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December 18, 2014 5

ARTICLE SUMMARY

Strengths and limitations of this study

• This systematic review provides a synthesis of the available evidence from 10

randomized controlled trials about the impact of video decision aids to assist with

ACP.

• There is low to moderate quality evidence suggesting that video decision aids lead

to greater knowledge related to ACP, and preferences for less aggressive care at

end-of-life.

• To date, no studies have examined the effect of ACP video decision aids on

congruence of end-of-life treatment with patients’ preferences, nor have they

evaluated their impact when integrated into clinical care.

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December 18, 2014 6

INTRODUCTION

Individuals will often face important decisions about their care as they approach the

end of life, but many will lose capacity to make these decisions for themselves.1 Advance

care planning (ACP) offers a solution to this problem. ACP can be defined as a

communication and decision-making process which allows individuals to clarify their

values and preferences for future care and communicate their wishes to loved ones,

surrogate decision-makers, and healthcare providers.2 ACP may increase the likelihood

that patients’ wishes are known and respected at end of life, improve quality of life for

patients, and reduce caregiver regret during bereavement.3-5 Because of its potential

benefits, leading medical organizations have called for greater uptake of ACP to enhance

the quality of end-of-life care.6,7

Decision aids can increase patients’ knowledge of treatment options and outcomes,

help patients to clarify their own values, and increase patients’ participation in medical

decision making.8 As such, they may help increase the quality of ACP; however, a recent

overview of decision aids for ACP concluded that, while many decision aids are widely

available, there is need for greater evaluation of their effectiveness.9 Video decision aids for

ACP have garnered appreciable interest in the academic community, amongst health

policymakers, and in the popular press.10-12 Videos may assist with ACP because they can

dynamically depict diminishing health states and the nature of different treatment options,

and may help individuals to become more informed and confident about their preferences

for care at end of life. We conducted a systematic review to determine, amongst adult

patients, the impact of video decision aids on patients’ preferences for life sustaining

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December 18, 2014 7

treatments and other ACP-related outcomes, compared with non-video-based

interventions.

METHODS

Data Sources and Searches

A medical librarian searched MEDLINE, EMBASE, PsycInfo, CINAHL, the Allied and

Complementary Medicine Database (AMED), and the Cochrane Central Register of

Controlled Trials (CENTRAL) using terms such as “advanced care planning”, “video”, and

“end of life” for relevant articles published in any language between 1980 and February

2014 (see Web Appendix for detailed search strategy). The systematic review was not

registered with a central database.

Study Selection

Articles were eligible for inclusion if they reported original data from a randomized

controlled trial (RCT) which met each of the following criteria: (i) enrolled adult patients

(age 18 years or older) in an inpatient or outpatient setting; (ii) included an arm evaluating

an ACP video decision aid to assist with choices about future use of life-sustaining

treatments (e.g., cardiopulmonary resuscitation, intensive care unit admission); (iii)

included a comparator arm with no ACP video decision aid component (e.g. sham video,

traditional methods of decision support such as verbal description, pamphlets, usual care,

or no discussion); and (iv) reported data on at least one outcome of interest. The primary

outcome of interest for this review was patients’ preferences regarding the use of life-

sustaining treatments. We selected this primary outcome because patients are often

misinformed about the nature of life-sustaining treatments,13 such as CPR, and thus

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December 18, 2014 8

hypothesized that video decision aids aimed at assisting with choices about life-sustaining

treatments would have an effect on patients’ preferences.14 Secondary outcomes of interest

were: patients’ knowledge related to ACP (including knowledge about life sustaining

treatments), patients’ confidence in any decision made about future use of life-sustaining

treatments, completion of an advance directive, actual use of life-sustaining treatments at

end of life, whether the use of life-sustaining treatments at end of life was congruent with

patients’ prior expressed wishes, health resource use at end of life, and, for patients

allocated to the video intervention arm, patients’ comfort watching the video.

Using web-based systematic review software (DistillerSR™, Ottawa, Canada) paired

reviewers (A.J. and K.Q., A.G. and S.C.) independently conducted screening: first title and

abstracts, then full texts of articles in which either reviewer judged that titles or abstracts

appeared potentially eligible. Any disagreements between reviewers regarding final

eligibility at full-text review were resolved by discussion and additional consultation with a

third reviewer (J.J.Y.) when necessary.

Data Extraction and Quality Assessment

Two pairs of reviewers (A.J. and J.J.Y.; D.B.V. and J.J.Y.) assessed the methodological

quality of eligible studies and extracted data regarding the patient population,

interventions, comparators and outcomes using a standardized, pilot-tested data extraction

form developed by the investigators for this review. We assessed risk of bias using

Cochrane systematic review guidelines, which include an assessment of random sequence

generation, allocation concealment, blinding (of patients, healthcare providers, outcome

assessors, and analysts), and loss to follow-up.15 Any discrepancies during data extraction

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December 18, 2014 9

were resolved by discussion between reviewers. We contacted authors if we required

clarification of issues related to the conduct of the trial or missing data.

For each outcome of interest, we assessed the quality of evidence, defined as

confidence in the estimate of effect, using the Grading of Recommendations Assessment,

Development and Evaluation (GRADE) framework. In this approach, randomized controlled

trials begin as high quality evidence, but may be rated down due to limitations related to

risk of bias, indirectness, inconsistency (i.e., heterogeneity), imprecision and publication

bias.16

Data Synthesis and Analysis

For each outcome of interest, when possible, data were pooled to obtain a summary

estimate of effect. When data for a given outcome measure were collected at more than one

follow-up time point, we used data from the longest available follow-up time. When

outcome data were missing, we used a complete case analysis (i.e., subjects with missing

outcome data were excluded from the analysis if these data could not be obtained from

authors). For the primary outcome of patients’ preferences for use of life-sustaining

treatments, 4 studies elicited preferences in a dichotomous fashion (CPR versus no CPR),17-

20 and 3 studies elicited preferences using 3 response options: life prolonging care

(includes CPR), limited care (does not include CPR), or comfort care (does not include

CPR)21-23. In our pooled analyses, we treated patient preferences from the latter 3 studies

as a dichotomous outcome: CPR (life prolonging care), or no CPR (limited care or comfort

care).

For dichotomous outcome data, we used random effects models to calculate a

pooled risk ratio and 95% confidence interval, using the Mantel-Haenszel method. For

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December 18, 2014 10

continuous outcome data, we used random effects models to calculate a pooled

standardized mean difference and 95% confidence interval, using the inverse variance

method. Heterogeneity was assessed using a chi-squared test for heterogeneity and the I2

statistic. When there was evidence of substantial heterogeneity, defined as I2 statistic of

50% or greater, we conducted post-hoc sensitivity analyses to explore potential

explanations for heterogeneity. Analyses were performed using Review Manager (RevMan)

version 5.2 (Cophenhagen, The Nordic Cochrane Centre: The Cochrane Collaboration,

2012). We considered a P value of 0.05 to be statistically significant.

RESULTS

Of 3,980 citations identified from primary electronic databases, 583 were

duplicates, leaving 3,397 original publications. Of these, 125 underwent full-text screening,

and 10 RCTs were eligible for our review (Figure 1).17-26 Six of the studies were conducted

by the same group of investigators and published within the past 5 years.18-23 The other 4

studies were published in the late 1990s by 4 different research groups.17;24-26 Of the 6

authors we contacted, we received additional information from 4 (67%).

The 10 eligible RCTs enrolled a total of 2,220 patients, 1,092 of whom were

allocated to the video arm and 1,128 of whom were allocated to the control arm. Patients

were most often recruited from outpatient primary care or oncology settings (all in the

United States of America) and had a mean age between 51 and 81 years old (Table 1).

Videos used in the different studies were between 2 and 15 minutes in length, with some

videos focusing on the creation of advance directives,17;24-26 some including a visual

description of advanced dementia,22;23 some focusing on the delineation of 3 options for

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medical care (life prolonging care, limited medical care, and comfort care)18;21;23, and some

focusing on a description of CPR and the likelihood of its success in patients with advanced

cancer19;20 (Table 1). In 2 of the 10 trials, study procedures included a step which provided

an opportunity for patients to engage in some form of discussion with a healthcare

professional (their own physician,17 or a study nurse26) after they were exposed to the

study intervention (video or control). No study evaluated the impact of a video decision aid

when integrated into clinical workflow.

Risk of bias for the 10 included trials is summarized in Figure 2. Two studies

adequately concealed allocation.20;26 The remaining 8 studies either: did not conceal

allocation (n=1);17 used envelopes, but without procedures in place to enforce or audit

adherence to the allocation sequence (n=5);18;19;21-23 or did not report whether allocation

was concealed (n=2).24;25 In 6 of the studies,17;18;21-23;25 outcome assessors were not

blinded. Duration of follow-up was variable across the eligible studies. Seven studies

reported data on participants’ preferences for use of life sustaining treatments immediately

after receiving the study intervention,17-23 whereas some studies also elicited preferences

after 2 to 4 weeks follow-up (1 study),17 or 6 to 8 weeks follow-up (2 studies)19;22.

Completion of advance directive completion was assessed at 2 to 4 weeks in one study,17 at

3 months in 2 studies,25;26 and at 6 months in another study.20 Loss to follow-up was low

(0% to 11%) in 7 of the 10 included studies, whereas the studies by Siegert et al,24 Yamada

et al,17 Volandes et al,19 had higher rates of 14%, 23%, and 55% loss to follow-up,

respectively.

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Table 1. Characteristics of included studies

Study Population Video group Control group Video Control

Participants,

n

Mean age Participants,

n

Mean age

Epstein

201320

Patients with

progressive

pancreatic or

hepatobiliary

cancer from

outpatient

oncology clinics

in New York City

30 65 y 26 66 y 3 minute video

providing a narrative

description of CPR,

and likelihood of its

success in patients

with advanced cancer.

Images include

simulated CPR,

endotracheal

intubation, and a

sedated patient being

mechanically

ventilated in an ICU.

Verbal description of

CPR by research staff

(same script as video

arm).

Volandes

201319

Patients with

advanced cancer

from outpatient

clinics at 4

oncology centers

in Boston, New

York City, and

Nashville

70 63 y 80 62 y Verbal description by

research staff of CPR,


success in patients

with advanced cancer,

followed by a 3 minute

video. The video

repeats the same

narrative description

of CPR and included

images of simulated

CPR and endotracheal

intubation, and a

ventilated patient

receiving intravenous

medicines.




arm).

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Volandes

201221

2 skilled nursing

facilities in

Boston


describing and

depicting 3 options for

care (life-prolonging

care, limited medical

care, comfort care).


the same 3 options for

care as the video.

Volandes

201123

Primary care

clinic in rural

Louisiana

33 73 y 43 75 y Verbal description of

advanced dementia

and 3 options for care

(life-prolonging care,

limited medical care,

comfort care),


video. The video

describes and depicts

features of advanced

dementia and the 3

options for care.


advanced dementia



arm).

El-Jawahri

201018

Patients with

malignant glioma

from outpatient

oncology clinics

in Boston

23 56 y 27 51 y Verbal description of 3

options for care (life-

prolonging care,


comfort care),

followed by 6 minute

video. The video


3 options for care.

Verbal description of 3

options for care (same

script as video arm).

Volandes

200922

Four primary

care clinics

affiliated with

teaching

hospitals in

Boston


principal features of

advanced dementia,


video. The video

depicts the principal


dementia.



advanced dementia


arm).

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Brown

199926

Primary care

clinic in Colorado

619 81 y 628 81 y Mailed package

including a videotape

(Peace of Mind:

Advance Directives), of

9 patient or family

member interviews,

plus the same printed

materials as control.

Mailed package of

printed materials

including an

educational pamphlet

(You and Your

Choices), a Colorado

Advance Directive

Guide, and forms for

execution of a durable

power of attorney for

health care, a living

will, and a CPR

directive.

Yamada

199917

General internal

medicine clinic of

a Veterans Affairs

Medical Center in

Michigan

62 74 y 55 74 y 10 minute video about

advance directives

(Advance Directives:

Guaranteeing Your

Health Care Rights), a

handout about CPR

and its outcomes, plus

the same handout as

control.

Handout describing

advance directives

only (i.e., not CPR).

Landry

199725

General internal

medicine clinic of

a military

teaching hospital

in Maryland


detailing advance

directives. The video

was part of a 60

minute seminar which

also included a

didactic presentation

about advance

directives, interactive

question and answer

session, and review of

a recommended

advance directive

form.

Mailed advance

directive form and

information pamphlet.

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Siegert

199624

Nursing home

care unit of a

Veterans Affairs

Medical Center in

North Carolina

16 69 y 20 69 y 14 minute video (The

Right to Die … The

Choice is Yours) about

advance directives.

25 minute sham video

(I Am Joe’s Heart)

about heart disease

prevention strategies.

CPR, cardiopulmonary resuscitation; ICU, intensive care unit

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Patient preferences for use of life-sustaining treatments

Seven studies reported on patient preferences for use of life-sustaining

treatments.17-23 Low quality evidence (rated down for risk of bias and inconsistency)

suggests that, after receiving the video intervention, patients were less likely to indicate a

preference for CPR compared to those in the control arm (risk ratio, 0.50 [95% CI, 0.27 to

0.95]; I2 = 65%; heterogeneity P = 0.01) (Figure 3). The substantial heterogeneity across

studies appears to be driven by the study by Yamada et al,17 which was published over a

decade earlier than the 6 other RCTs which reported on this outcome, and had a much

higher proportion of patients indicating a preference for CPR than the other studies. In a

post hoc sensitivity analysis which excluded this study, patients allocated to the video arm

were again less likely to indicate a preference for CPR compared to those in the control arm

and there was no significant heterogeneity (risk ratio, 0.42 [95% CI, 0.26 to 0.67]; I2 = 0%;

heterogeneity P = 0.44).

Knowledge related to advance care planning

One study found that a video decision aid increased the proportion of patients with

correct responses to questions about the interventions included with CPR (intravenous

fluid, endotracheal intubation, mechanical ventilation, defibrillation), the likely outcomes of

CPR, and about advance directives; however, with the exception of increased knowledge

about advance directives, other estimates of effect were imprecise and not statistically

significant.17

Five studies reported on knowledge related to different aspects of ACP using a

variety of measurement scales.18-20;22;24 One study assessed knowledge about living wills

and cardiopulmonary resuscitation,24 another study assessed knowledge about advanced

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dementia,22 and 3 studies assessed knowledge about CPR.18-20 One of the latter studies

(Epstein et al.) did not report sufficient detail to allow inclusion in our pooled analysis; this

study found no significant difference in knowledge between the intervention and control

arms.20 In the 4 studies with poolable data, there was moderate quality evidence (rated

down for risk of bias) that video decision aids resulted in greater knowledge scores

compared to control (standardized mean difference, 0.58 [95% CI, 0.39 to 0.77]; I2 = 0%;

heterogeneity P = 0.99) (Figure 4).

Completion of advance directives

Four trials reported data on completion of advance directives.17;20;25;26 Low quality

evidence (rated down for risk of bias and imprecision) suggests there may be a small effect

of video decision aids on this outcome, but with a wide 95% confidence interval including

no effect (risk ratio, 1.11 [95% CI, 0.85 to 1.46]; I2 = 44%; heterogeneity P = 0.15) (Figure

5).

Other outcomes

El-Jawahri and colleagues found that a video decision aid led to greater confidence

in patients’ decisions about future use of life sustaining treatments compared to control, as

measured using the uncertainty subscale of the Decisional Conflict Scale (0=complete

uncertainty, 15=perfect certainty)27 (mean scores 13.7 in video group vs. 11.5 in control

group, p=0.002). In 5 of the studies, patients in the video arm were asked to rate their

comfort with watching the video.18-22 The majority of patients indicated that they were very

comfortable (83%18, 69%20), or at least somewhat comfortable (85%22, 90%21, 93%19)

watching the video.

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One study included in this review, a pilot RCT, reported data on use of life-

sustaining treatments and resource use at the end-of-life, and found that a video decision-

aid was not associated with a statistically significant difference in hospital admissions at 6

month follow-up (or until time of death), or hospital length of stay.20 However, this study

may not have been adequately powered to show a difference in these outcomes and does

not exclude the possibility of an effect. In this study, there were no intensive care unit

admissions during 6 month follow-up for the 30 subjects randomized to the video arm, and

3 intensive care unit admissions in the 26 subjects randomized to control; during 6 month

follow-up there was 1 episode of CPR or mechanical ventilation in the video arm and 3

episodes of CPR or mechanical ventilation in the control arm. No studies reported whether

the use of video decision aids affected the congruence of life-sustaining treatments at end-

of-life with patients’ prior expressed wishes.

DISCUSSION

In this systematic review of randomized controlled trials, we found low to moderate

quality evidence suggesting that video decision aids lead to greater knowledge related to

ACP and preferences for less aggressive care at end-of-life. Studies of ACP video decision

aids to date provide little or no data on other important outcomes related to ACP, such as

confidence in decision-making, the actual use of life sustaining treatments at end-of-life, or

the congruence of end-of-life treatments with patients’ wishes.

Strengths of our review include adherence to the Preferred Reporting Items for

Systematic Reviews and Meta-Analyses (PRISMA) standards for conduct and reporting of a

systematic review, including a comprehensive literature search and a systematic approach

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for categorizing confidence in the effect estimates (GRADE).15;16;28 There are limitations

regarding the studies included in our review. First, there are differences across the eligible

RCTs. Studies clustered into a group of more recent studies conducted by the same group of

investigators (Volandes et al) and a group of studies published in the 1990s. Our intention

for this systematic review was to be comprehensive and inclusive of the entire body of

RCTs regarding video decision aids for ACP, but we acknowledge that the older studies may

have differed from more recent ones in several important ways. For instance, the focus of

the video interventions in the 1990s was on the creation of advance directives, whereas

more recent video interventions have focused on clarifying preferences for goals of care

(life prolonging care, limited care, or comfort care) or CPR. Eligible studies also elicited

preferences in different ways and it is possible that framing of response options as a binary

choice (CPR versus no CPR) or as choice between 3 options (life prolonging care, limited

care, or comfort care) may have influenced participants’ stated preferences. Another

limitation of the existing studies is that they report little or no data on other outcomes

relevant to ACP, such as confidence in decision-making, resource use at end-of-life, and

congruence of end-of-life care with patient wishes.

Butler et al recently completed a technical brief, commissioned by the Agency for

Healthcare Research and Quality in the United States, to provide an overview of a broad

range of ACP decision aids for adults.9 The report provides a state-of-the art review of the

field but, because it used technical brief methodology, it did not include a synthesis or

meta-analysis of outcomes, ratings of risk of bias or assessment of the quality of evidence.

It also did not include several randomized controlled trials of video decision aids for ACP

that were identified in our review, including several recent trials.18-21 Our review provides

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complementary and contemporary data on a well-specified clinical question (Amongst

adult patients, do video decision aids have an effect on outcomes related to ACP, when

compared to non-video-based interventions?), including assessments of risk of bias, quality

of evidence, and a synthesis of outcomes.

We found a large and statistically significant effect of video decision aids on patients’

preferences for CPR, with those exposed to the video intervention being half as likely to

prefer CPR as those exposed to a non-video based intervention. It is possible that some of

this effect is a result of bias introduced by incomplete concealment of allocation or

unblinded outcome assessment, as opposed to a true effect of the video decision aid. It is

also possible that some of the observed effect is attributable to the “dose” of information

received in the intervention arms: 4 of the 7 studies which reported on patients’

preferences presented the same information twice in the intervention arm (once as a

verbal description and once in video format) compared to once in the control arm (verbal

description only). Finally, it is possible that there is a true effect of video decision aids on

patients’ preferences for CPR.

It is notable that only 1 of the 10 studies (by Yamada et al) included a process

through which patients could engage in deliberation or discussion with their usual

healthcare provider after watching the video; despite this, few participants in this study

(12%) reported discussing the content of the video with their physician.17 Most notably,

none of the studies in our review evaluated the impact of a video decision aid when

integrated into clinical care. To have a measurable impact on downstream outcomes

related to ACP, such as resource use at end of life and congruence of end-of-life care with

patient wishes, we posit that video decision aids need to be embedded in a larger shared

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decision-making process which includes not only information exchange (the focus of the

video-based interventions to date) but also engages patients in a process of deliberation

with their healthcare provider and surrogate decision maker, and documentation of any

decisions made in the medical record.29

In conclusion, there is low to moderate quality evidence suggesting that video

decision aids may result in greater knowledge related to ACP and preferences for less

aggressive care at end of life. It remains unknown whether these tools can increase

congruence of end-of-life care with patient wishes. While video decision aids appear to be

promising tools to assist with ACP, further evaluation, especially when integrated into

clinical care, is needed before their widespread adoption into practice.

ACKNOWLEDGEMENTS

The authors thank Ms. Neera Bhatnagar for her assistance in the design and conduct

of the literature search for this systematic review, and Drs. Gordon Guyatt and Jason Busse

for their methodological advice. Dr. John You is supported by a Research Early Career

Award from Hamilton Health Sciences.

Contributors: AJ and JJY conceived of and designed the study. JJY is guarantor. AJ, KQ, SC,

and AG screened titles, abstracts, and full-text articles for eligibility. AJ, DBV and JJY

extracted data from eligible articles. SC and JJY analyzed the data. All authors participated

in: interpretation of data, drafting of the manuscript, and gave final approval of the version

to be published. All authors had full access to all of the data in the study and can take

responsibility for the integrity of the data and the accuracy of the data analysis.

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Competing interests: All authors have completed the Unified Competing Interest form at

www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author).

All authors declare that: they have no relationships with companies that might have an

interest in the submitted work in the previous 3 years; their spouses, partners, or children

have no financial relationships that may be relevant to the submitted work; and they have

no non-financial interests that may be relevant to the submitted work.

Ethics approval: Ethics approval was not required for this study.

Funding: This research received no specific grant from any funding agency in the public,

commercial or not-for-profit sectors.

Transparency declaration: JJY (the manuscript's guarantor) affirms that the manuscript

is an honest, accurate, and transparent account of the study being reported; that no

important aspects of the study have been omitted; and that any discrepancies from the

study as planned have been explained.

Data sharing: The study dataset is available from the corresponding author at

[email protected].

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REFERENCES

(1) Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate

decision making before death. N Engl J Med 2010;362:1211-1218.

(2) Sudore RL, Fried TR. Redefining the "planning" in advance care planning:

preparing for end-of-life decision making. Ann Intern Med 2010;153:256-261.

(3) Detering KM, Hancock AD, Reade MC, et al. The impact of advance care planning on

end of life care in elderly patients: randomised controlled trial. BMJ

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(4) Wright AA, Zhang B, Ray A et al. Associations between end-of-life discussions,

patient mental health, medical care near death, and caregiver bereavement

adjustment. JAMA 2008;300:1665-1673.

(5) Mullick A, Martin J, Sallnow L. An introduction to advance care planning in

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(6) Cook D, Rocker G, Heyland D. Enhancing the quality of end-of-life care in Canada.

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(7) IOM (Institute of Medicine). Dying in America: Improving quality and honoring

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(8) Stacey D, Legare F, Col NF et al. Decision aids for people facing health treatment or

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(9) Butler M, Ratner E, McCreedy E, et al. Decision aids for advance care planning: an

overview of the state of the science. Ann Intern Med 2014;161:408-418.

(10) Hostetter M, Klein S. Helping Patients Make Better Treatment Choices with

Decision Aids. Quality Matters. Available from: The Commonwealth Fund. Accessed

at http://www.commonwealthfund.org/Newsletters/Quality-

Matters/2012/October-November/In-Focus.aspx on February 4, 2014.

(11) Volandes AE, Barry MJ, Chang Y, et al. Improving decision making at the end of life

with video images. Med Decis Making 2010;30:29-34.

(12) Sun LH. Videos aim to inform patients about their medical options at the end of

life. The Washington Post. Accessed at

http://www.washingtonpost.com/national/health-science/videos-aim-to-inform-

patients-about-their-medical-options-at-the-end-of-life/2014/06/02/b0eae002-

c63f-11e3-8b9a-8e0977a24aeb_story.html on June 2, 2014.

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(13) Heyland DK, Frank C, Groll D et al. Understanding cardiopulmonary resuscitation

decision making: perspectives of seriously ill hospitalized patients and family

members. Chest 2006;130:419-428.

(14) Murphy DJ, Burrows D, Santilli S, et al. The influence of the probability of survival

on patients' preferences regarding cardiopulmonary resuscitation. N Engl J Med

1994;330:545-549.

(15) Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0

[updated March 2011]. www cochrane-handbook org [serial online] 2011;

Available from: The Cochrane Collaboration.

(16) Guyatt GH, Oxman AD, Kunz R, et al. What is "quality of evidence" and why is it

important to clinicians? BMJ 2008;336:995-998.

(17) Yamada R, Galecki AT, Goold SD, et al. A multimedia intervention on

cardiopulmonary resuscitation and advance directives. J Gen Intern Med

1999;14:559-563.

(18) El-Jawahri A, Podgurski LM, Eichler AF, et al. Use of video to facilitate end-of-life

discussions with patients with cancer: a randomized controlled trial. J Clin Oncol

2010;28:305-310.

(19) Volandes AE, Paasche-Orlow MK, Mitchell SL, et al. Randomized controlled trial of

a video decision support tool for cardiopulmonary resuscitation decision making

in advanced cancer. J Clin Oncol 2013;31:380-386.

(20) Epstein AS, Volandes AE, Chen LY, et al. A randomized controlled trial of a

cardiopulmonary resuscitation video in advance care planning for progressive

pancreas and hepatobiliary cancer patients. J Palliat Med 2013;16:623-631.

(21) Volandes AE, Brandeis GH, Davis AD, et al. A randomized controlled trial of a goals-

of-care video for elderly patients admitted to skilled nursing facilities. J Palliat Med

2012;15:805-811.

(22) Volandes AE, Paasche-Orlow MK, Barry MJ, et al. Video decision support tool for

advance care planning in dementia: randomised controlled trial. BMJ

2009;338:b2159.

(23) Volandes AE, Ferguson LA, Davis AD, et al. Assessing End-of-Life Preferences for

Advanced Dementia in Rural Patients Using an Educational Video: A Randomized

Controlled Trial. J Palliat Med 2011;14:169-177.

(24) Siegert EA, Clipp EC, Mulhausen P, et al. Impact of advance directive videotape on

patient comprehension and treatment preferences. Arch Fam Med 1996;5:207-

212.

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(25) Landry FJ, Kroenke K, Lucas C, et al. Increasing the use of advance directives in

medical outpatients. J Gen Intern Med 1997;12:412-415.

(26) Brown JB, Beck A, Boles M, et al. Practical methods to increase use of advance

medical directives. J Gen Intern Med 1999;14:21-26.

(27) O'Connor AM. Validation of a decisional conflict scale. Med Decis Making

1995;15:25-30.

(28) Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic

reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:264-

9.

(29) Heyland DK, Tranmer J, Feldman-Stewart D. End-of-life decision making in the

seriously ill hospitalized patient: an organizing framework and results of a

preliminary study. J Palliat Care 2000;16 Suppl:S31-S39.

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Figure1.Summaryofarticleselection

Potentially relevant articles from primary

databases (n = 3980)

Articles evaluated at title and abstract

screening (n = 3397)

Duplicates (n = 583)

Excluded (n = 3272) Reasons: not on video

decision aids, not an RCT, not about ACP

Articles evaluated at full‐text screening

(n = 125) Excluded (n = 115)

Reasons: not on video decision aids, no control arm data, does not report on an outcome of interest, not an

RCTEligible RCTs included in

review (n = 10)

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Figure 2. Risk of bias in eligible studies

Legend

Low risk of bias

High risk of bias

Unclear risk of bias

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jyou

Typewritten Text

Figure 3. Effect of video decision aids on patient preferences for cardiopulmonary resucitation

jyou

Typewritten Text



Figure 4. Effect of video decision aids on knowledge related to advance care planning

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Figure 5. Effect of video decision aids on completion of advance directives

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1

Web Appendix 1. Detailed description of literature search strategy

The following search strategy was used for Medline and was adapted for CENTRAL, EMBASE,

PsycInfo, AMED and CINAHL.

Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R)

<1980 to Present>

--------------------------------------------------------------------------------

1. Videotape Recording/

2. video*.mp.

3. (VHS or DVD* or blue-ray disc* or Compact Disc* or CDs or audiovisual).mp.

4. ((interactive or digital) adj5 media).mp.

5. or/1-4

6. exp advance care planning/ or life support care/ or palliative care/ or exp terminal care/ or

advance directives/ or living will/

7. (Advance Care Planning or ACP or care at the end of life initiative or CEOL or Goals of care

or GCD or end of life or living will*).mp.

8. or/6-7

9. exp Resuscitation/

10. Resuscitat*.mp.

11. CPR.mp.

12. exp Respiration, Artificial/

13. (Ventilator* or Ventilation*).mp.

14. exp Ventilators, Negative-Pressure/

15. (bilevel positive airway pressure or BiPAP or BPAP).mp.

16. (positive pressure* or positivepressure*).mp.

17. (Respiratory or Respiration*).mp.

18. exp Intubation/

19. Airway Management/

20. (intubate* or intubation).mp.

21. Esophageal.mp.

22. (Laryngeal mask or LMA).mp.

23. (Tracheostom* or Tracheotom*).mp.

24. Enteral Nutrition/

25. ((enter* or nasogastric or NG) adj5 (feed* or nutrition* or immunonutrition*)).mp.

26. nasoduodenal tube*.mp.

27. Feeding Methods/

28. exp Parenteral Nutrition/

29. ((Parenteral* or intravenous) adj3 (feeding* or nutrition)).mp.

30. (TPN or PN).mp.

31. ((Nasogastric or NG or gastrostomy or jejunostomy or gastric or orogastric or nasoenteric

or nasojejunal or nasointestinal or transabdominal) adj3 (intubat* or tube* or feed*)).mp.

32. ((artificial or force or tube) adj3 (feeding* or nutrition)).mp.

33. tube feeding/

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2

34. (Percutaneous endoscopic gastrostomy or PPEG).mp.

35. ((RIG or PEG) and (Percutaneous or endoscopic or gastrostomy)).mp.

36. exp Renal Replacement Therapy/

37. Kidney, Artificial/ or artificial kidney*.mp.

38. (dialyzer or hemodialysis or dialysis).mp.

39. Critical Care/

40. Critical Illness/

41. exp Intensive Care Units/

42. ICU*.mp.

43. ((critical or intensive) adj3 (care or illness)).tw.

44. (ACLS or Advanced cardiovascular life support).mp.

45. Defibrillation.mp.

46. or/9-45

47. exp Patient Satisfaction/ or patient centered care/ or exp choice behavior/ or attitude to

health/ or attitude to death/ or personal autonomy/ or patient participation/ or patient

education as topic/

48. ((patient* or Individual* or caregiver* or care-giver*) adj10 (wish* or value* or desire* or

desirability or selection or prefer* or decide* or decision* or choice* or chose* or want* or

participat*)).mp.

49. exp Decision Making/ or Decision Support Techniques/ or decision aid*.mp.

50. exp Patients/ or patient*.mp. or caregivers/ or caregiver*.mp. or care-giver*.mp.

51. 49 and 50

52. 47 or 48 or 51

53. 5 and 8

54. 5 and 46 and 52

55. 53 or 54

***************************

Life-sustaining treatments of interest:

1. Cardiopulmonary resuscitation (CPR)

2. Mechanical ventilation

3. Respirator

4. Ventilator

5. Endotracheal intubation

6. Enteral feeding

7. Enteral nutrition

8. Total parenteral nutrition

9. Nasogastric tube feeding

10. Tube feeding

11. Percutaneous endoscopic gastrostomy (PEG) tube

12. Hemodialysis

13. Dialysis

14. Intensive care unit

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3

15. Critical care unit

16. Advanced cardiac life support (=ACLS)

17. Advanced cardiovascular life support (=ACLS)

18. Defibrillation

19. Cardiac defibrillation

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PRISMA 2009 ChecklistPRISMA 2009 ChecklistPRISMA 2009 ChecklistPRISMA 2009 Checklist

Section/topic # Checklist item Reported on page #

TITLE

Title 1 Identify the report as a systematic review, meta-analysis, or both. 1

ABSTRACT

Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.

3-4

INTRODUCTION

Rationale 3 Describe the rationale for the review in the context of what is already known. 6

Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).

6-7

METHODS

Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.

7

Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered,

language, publication status) used as criteria for eligibility, giving rationale. 7-8

Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.

7

Search 8 Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.

Web Appendix

Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).

8-9

Data collection process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.

8-9

Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.

7-9

Risk of bias in individual studies

12 Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.

8

Summary measures 13 State the principal summary measures (e.g., risk ratio, difference in means). 9-10

Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency

(e.g., I2) for each meta-analysis.

9-10

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Risk of bias across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).

--

Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.

16

RESULTS

Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.

Fig 1

Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations.

Table 1

Risk of bias within studies 19 Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). p.11; Figure 2

Results of individual studies 20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.

p. 16-18; Figs 3-5

Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. p. 16-18; Figs 3-5

Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see Item 15). --

Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). 16

DISCUSSION

Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers).

18-21

Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias).

19

Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research. 18-21

FUNDING

Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review.

22

From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097

For more information, visit: www.prisma-statement.org.

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Video Decision Aids to Assist with Advance Care Planning: a

Systematic Review and Meta-analysis

Journal: BMJ Open

Manuscript ID: bmjopen-2014-007491.R1

Article Type: Research

Date Submitted by the Author: 03-May-2015

Complete List of Authors: Jain, Ashu; University of Toronto, Corriveau, Sophie; McMaster University, Quinn, Kathleen; McMaster University, Gardhouse, Amanda; University of Toronto, Brandt Vegas, Daniel; McMaster University, You, John; McMaster University, Medicine

<b>Primary Subject Heading</b>:

Patient-centred medicine

Secondary Subject Heading: Evidence based practice

Keywords: advance care planning, shared decision making, video, systematic review


BMJ Open on A

pril 8, 2020 by guest. Protected by copyright.

http://bmjopen.bm

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May 3, 2015 1

Video Decision Aids to Assist with Advance Care Planning: a Systematic

Review and Meta-analysis

Ashu Jain, family medicine resident

Department of Family and Community Medicine, University of Toronto, 500 University

Avenue, 5th Floor, Toronto, Ontario, Canada M5G 1V7

Sophie Corriveau, respirology resident

Division of Respirology, Department of Medicine, McMaster University, St. Joseph’s

Healthcare, 50 Charlton Avenue East, Hamilton, Ontario, Canada L8N 4A6

Kathleen Quinn, internal medicine resident

Department of Medicine, McMaster University, Room 3W10A-C, 1280 Main Street West,

Hamilton, Ontario, Canada L8S 4K1

Amanda Gardhouse, geriatric medicine resident

Division of Geriatric Medicine, Department of Medicine, University of Toronto, 2975

Bayview Avenue, Room H481, Toronto, Ontario, Canada, M4N 3M5

Daniel Brandt Vegas, clinical scholar

Division of General Internal Medicine, Department of Medicine, McMaster University, St.

Joseph’s Healthcare, Room F533, 50 Charlton Avenue East, Hamilton, Ontario, Canada L8N

4A6

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May 3, 2015 2

John J. You, associate professor (corresponding author)

Departments of Medicine, and Clinical Epidemiology & Biostatistics, McMaster University,

1280 Main Street West, Room HSC-2C8, Hamilton, Ontario, Canada, L8S 4K1; telephone:

905-525-9140 ext. 21858; e-mail: [email protected]

Keywords: advance care planning; decision aids; video recording; cardiopulmonary

resuscitation; end of life care

Word count (excluding title page, abstract, acknowledgements, references, tables, figures):

3,525

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May 3, 2015 3

ABSTRACT

Objective: Advance care planning (ACP) can result in end-of-life care that is more

congruent with patients’ values and preferences. There is increasing interest in video

decision aids to assist with ACP. The objective of this study was to evaluate the impact of

video decision aids on patients’ preferences regarding life-sustaining treatments (primary

outcome).

Design: Systematic review and meta-analysis of randomized controlled trials.

Data sources: MEDLINE, EMBASE, PsycInfo, CINAHL, AMED, and CENTRAL, between 1980

and February 2014, and correspondence with authors.

Eligibility criteria for selecting studies: Randomized controlled trials of adult patients

that compared a video decision aid to a non-video based intervention to assist with choices

about use of life-sustaining treatments and reported at least one ACP-related outcome.

Data extraction: Reviewers worked independently and in duplicate to screen potentially

eligible articles, and to extract data regarding risk of bias, population, intervention,

comparator, and outcomes. Reviewers assessed quality of evidence (confidence in effect

estimates) for each outcome using the Grading of Recommendations Assessment,

Development and Evaluation (GRADE) framework.

Results: Ten trials enrolling 2,220 patients were included. Low quality evidence suggests

that patients who use a video decision aid are less likely to indicate a preference for

cardiopulmonary resuscitation (pooled risk ratio, 0.50 [95% CI, 0.27 to 0.95]; I2=65%).

Moderate quality evidence suggests that video decision aids result in greater knowledge

related to ACP (standardized mean difference, 0.58 [95% CI, 0.38 to 0.77]; I2=0%). No study

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reported on the congruence of end-of-life treatments with patients’ wishes. No study

evaluated the effect of video decision aids when integrated into clinical care.

Conclusions: Video decision aids may improve some ACP-related outcomes. Before

recommending their use in clinical practice, more evidence is needed to confirm these

findings and to evaluate the impact of video decision aids when integrated into patient

care.

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ARTICLE SUMMARY

Strengths and limitations of this study

• This systematic review provides a synthesis of the available evidence from 10

randomized controlled trials about the impact of video decision aids to assist with

advance care planning (ACP).

• There is low to moderate quality evidence suggesting that video decision aids lead

to greater knowledge related to ACP, and preferences for less aggressive care at

end-of-life.

• To date, no studies have examined the effect of ACP video decision aids on

congruence of end-of-life treatment with patients’ preferences, nor have they

evaluated their impact when integrated into clinical care.

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INTRODUCTION

Individuals will often face important decisions about their care as they approach the

end of life, but many will lose capacity to make these decisions for themselves.1 Advance

care planning (ACP) offers a solution to this problem. ACP can be defined as a

communication and decision-making process which allows individuals to clarify their

values and preferences for future care and communicate their wishes to loved ones,

surrogate decision-makers, and healthcare providers.2 ACP may increase the likelihood

that patients’ wishes are known and respected at end of life, improve quality of life for

patients, and reduce caregiver regret during bereavement.3-5 Because of its potential

benefits, leading medical organizations have called for greater uptake of ACP to enhance

the quality of end-of-life care.6,7

Decision aids can increase patients’ knowledge of treatment options and outcomes,

help patients to clarify their own values, and increase patients’ participation in medical

decision making.8 As such, they may help increase the quality of ACP; however, a recent

overview of decision aids for ACP concluded that, while many decision aids are widely

available, there is need for greater evaluation of their effectiveness.9 Video decision aids for

ACP have garnered appreciable interest in the academic community, amongst health

policymakers, and in the popular press.10-12 Videos may assist with ACP because they can

dynamically depict diminishing health states and the nature of different treatment options,

and may help individuals to become more informed and confident about their preferences

for care at end of life. We conducted a systematic review to determine, amongst adult

patients, the impact of video decision aids on patients’ preferences for life sustaining

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treatments and other ACP-related outcomes, compared with non-video-based

interventions.

METHODS

Data Sources and Searches

A medical librarian searched MEDLINE, EMBASE, PsycInfo, CINAHL, the Allied and

Complementary Medicine Database (AMED), and the Cochrane Central Register of

Controlled Trials (CENTRAL) using terms such as “advance care planning”, “video”, and

“end of life” for relevant articles published in any language between 1980 and February

2014 (see Web Appendix for detailed search strategy). The systematic review was not

registered with a central database.

Study Selection

Articles were eligible for inclusion if they reported original data from a randomized

controlled trial (RCT) which met each of the following criteria: (i) enrolled adult patients

(age 18 years or older) in an inpatient or outpatient setting; (ii) included an arm evaluating

an ACP video decision aid to assist with choices about future use of life-sustaining

treatments (e.g., cardiopulmonary resuscitation, intensive care unit admission); (iii)

included a comparator arm with no ACP video decision aid component (e.g. sham video,

traditional methods of decision support such as verbal description, pamphlets, usual care,

or no discussion); and (iv) reported data on at least one outcome of interest. The primary

outcome of interest for this review was patients’ preferences regarding the use of life-

sustaining treatments. We selected this primary outcome because patients are often

misinformed about the nature of life-sustaining treatments,13 such as CPR, and thus

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hypothesized that video decision aids aimed at assisting with choices about life-sustaining

treatments would have an effect on patients’ preferences.14 Secondary outcomes of interest

were: patients’ knowledge related to ACP (including knowledge about life sustaining

treatments), patients’ confidence in any decision made about future use of life-sustaining

treatments, completion of an advance directive (as defined by the authors of the individual

studies), actual use of life-sustaining treatments at end of life, whether the use of life-

sustaining treatments at end of life was congruent with patients’ prior expressed wishes,

health resource use at end of life, and, for patients allocated to the video intervention arm,

patients’ comfort watching the video.

Using web-based systematic review software (DistillerSR™, Ottawa, Canada) paired

reviewers (A.J. and K.Q., A.G. and S.C.) independently conducted screening: first title and

abstracts, then full texts of articles for which either reviewer judged that titles or abstracts

appeared potentially eligible. Any disagreements between reviewers regarding final

eligibility at full-text review were resolved by discussion and additional consultation with a

third reviewer (J.J.Y.) when necessary.

Data Extraction and Quality Assessment

Two pairs of reviewers (A.J. and J.J.Y.; D.B.V. and J.J.Y.) assessed the methodological

quality of eligible studies and extracted data regarding the patient population,

interventions, comparators and outcomes using a standardized, pilot-tested data extraction

form developed by the investigators for this review. We assessed risk of bias using

Cochrane systematic review guidelines, which include an assessment of random sequence

generation, allocation concealment, blinding (of patients, healthcare providers, outcome

assessors, and analysts), and loss to follow-up.15 Any discrepancies during data extraction

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May 3, 2015 9

were resolved by discussion between reviewers. We contacted authors if we required

clarification of issues related to the conduct of the trial or missing data.

For each outcome of interest, we assessed the quality of evidence, defined as

confidence in the estimate of effect, using the Grading of Recommendations Assessment,

Development and Evaluation (GRADE) framework. In this approach, randomized controlled

trials begin as high quality evidence, but may be rated down due to limitations related to

risk of bias, indirectness, inconsistency (i.e., heterogeneity), imprecision and publication

bias.16

Data Synthesis and Analysis

We used Cohen’s kappa to assess chance-corrected inter-rater agreement of

reviewers’ decisions about potential eligibility of articles at title and abstract screening,

and about the eligibility of articles at full-text review. For each outcome of interest, when

possible, data were pooled to obtain a summary estimate of effect. When data for a given

outcome measure were collected at more than one follow-up time point, we used data from

the longest available follow-up time. When outcome data were missing, we used a complete

case analysis (i.e., subjects with missing outcome data were excluded from the analysis if

these data could not be obtained from authors). For the primary outcome of patients’

preferences for use of life-sustaining treatments, 4 studies elicited preferences in a

dichotomous fashion (CPR versus no CPR),17-20 and 3 studies elicited preferences using 3

response options: life prolonging care (includes CPR), limited care (does not include CPR),

or comfort care (does not include CPR)21-23. In our pooled analyses, we treated patient

preferences from the latter 3 studies as a dichotomous outcome: CPR (life prolonging care),

or no CPR (limited care or comfort care).

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For dichotomous outcome data, we used random effects models (using the method

of DerSimonian and Laird) to calculate pooled risk ratios and 95% confidence intervals. For

continuous outcome data, we used random effects models to calculate a pooled

standardized mean difference and 95% confidence interval. Heterogeneity was assessed

using a chi-squared test for heterogeneity and the I2 statistic. Analyses were performed

using Review Manager (RevMan) version 5.2 (Cophenhagen, The Nordic Cochrane Centre:

The Cochrane Collaboration, 2012). We considered a P value of 0.05 to be statistically

significant.

RESULTS

Of 3,980 citations identified from primary electronic databases, 583 were

duplicates, leaving 3,397 original publications. Of these, 125 were deemed potentially

eligible (kappa 0.29) and underwent full-text screening. Of these 125 full-text articles, 10

RCTs were eligible for our review (kappa 0.48) (Figure 1).17-26 Six of the studies were

conducted by the same group of investigators and published within the past 5 years.18-23

The other 4 studies were published in the late 1990s by 4 different research groups.17;24-26

Of the 6 authors we contacted, we received additional information from 4 (67%).

The 10 eligible RCTs enrolled a total of 2,220 patients, 1,092 of whom were

allocated to the video arm and 1,128 of whom were allocated to the control arm. Patients

were most often recruited from outpatient primary care or oncology settings (all in the

United States of America) and had a mean age between 51 and 81 years old (Table 1).

Videos used in the different studies were between 2 and 15 minutes in length, with some

videos focusing on the creation of advance directives,17;24-26 some including a visual

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description of advanced dementia,22;23 some focusing on the delineation of 3 options for

medical care (life prolonging care, limited medical care, and comfort care)18;21;23, and some

focusing on a description of CPR and the likelihood of its success in patients with advanced

cancer19;20 (Table 1). In 2 of the 10 trials, study procedures included a step which provided

an opportunity for patients to engage in some form of discussion with a healthcare

professional (their own physician,17 or a study nurse26) after they were exposed to the

study intervention (video or control). No study evaluated the impact of a video decision aid

when integrated into clinical workflow.

Risk of bias for the 10 included trials is summarized in Figure 2. Two studies

adequately concealed allocation.20;26 The remaining 8 studies either: did not conceal

allocation (n=1);17 used envelopes, but without procedures in place to enforce or audit

adherence to the allocation sequence (n=5);18;19;21-23 or did not report whether allocation

was concealed (n=2).24;25 In 6 of the studies,17;18;21-23;25 outcome assessors were not

blinded. Duration of follow-up was variable across the eligible studies. Seven studies

reported data on participants’ preferences for use of life sustaining treatments immediately

after receiving the study intervention,17-23 whereas some studies also elicited preferences

after 2 to 4 weeks follow-up (1 study),17 or 6 to 8 weeks follow-up (2 studies)19;22.

Completion of advance directive completion was assessed at 2 to 4 weeks in one study,17 at

3 months in 2 studies,25;26 and at 6 months in another study.20 Loss to follow-up, i.e., the

percentage of participants with missing outcome data, was low (0% to 11%) in 7 of the 10

included studies, whereas the studies by Siegert et al,24 Yamada et al,17 Volandes et al,19 had

higher rates of 14%, 23%, and 55% loss to follow-up (missing outcome data), respectively.

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Table 1. Characteristics of included studies

Study Population Video group Control group Video Control

Participants,

n

Mean age Participants,

n

Mean age

Epstein

201320

Patients with

progressive

pancreatic or

hepatobiliary

cancer from

outpatient

oncology clinics

in New York City


providing a narrative

description of CPR,


success in patients

with advanced cancer.

Images include

simulated CPR,

endotracheal

intubation, and a

sedated patient being

mechanically

ventilated in an ICU.




arm).

Volandes

201319

Patients with

advanced cancer

from outpatient

clinics at 4

oncology centers

in Boston, New

York City, and

Nashville

70 63 y 80 62 y Verbal description by

research staff of CPR,


success in patients

with advanced cancer,


video. The video

repeats the same

narrative description

of CPR and included

images of simulated

CPR and endotracheal

intubation, and a

ventilated patient

receiving intravenous

medicines.




arm).

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Volandes

201221

2 skilled nursing

facilities in

Boston


describing and

depicting 3 options for

care (life-prolonging

care, limited medical

care, comfort care).


the same 3 options for

care as the video.

Volandes

201123

Primary care

clinic in rural

Louisiana


advanced dementia


(life-prolonging care,


comfort care),


video. The video



dementia and the 3

options for care.


advanced dementia



arm).

El-Jawahri

201018

Patients with

malignant glioma

from outpatient

oncology clinics

in Boston

23 56 y 27 51 y Verbal description of 3

options for care (life-

prolonging care,


comfort care),


video. The video


3 options for care.

Verbal description of 3

options for care (same

script as video arm).

Volandes

200922

Four primary

care clinics

affiliated with

teaching

hospitals in

Boston



advanced dementia,


video. The video

depicts the principal


dementia.



advanced dementia


arm).

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Brown

199926

Primary care

clinic in Colorado

619 81 y 628 81 y Mailed package

including a videotape

(Peace of Mind:

Advance Directives), of

9 patient or family

member interviews,

plus the same printed

materials as control.

Mailed package of

printed materials

including an

educational pamphlet

(You and Your

Choices), a Colorado

Advance Directive

Guide, and forms for

execution of a durable

power of attorney for

health care, a living

will, and a CPR

directive.

Yamada

199917

General internal

medicine clinic of

a Veterans Affairs

Medical Center in

Michigan

62 74 y 55 74 y 10 minute video about

advance directives

(Advance Directives:

Guaranteeing Your

Health Care Rights), a

handout about CPR

and its outcomes, plus

the same handout as

control.

Handout describing

advance directives

only (i.e., not CPR).

Landry

199725

General internal

medicine clinic of

a military

teaching hospital

in Maryland


detailing advance

directives. The video

was part of a 60

minute seminar which

also included a

didactic presentation

about advance

directives, interactive

question and answer

session, and review of

a recommended

advance directive

form.

Mailed advance

directive form and

information pamphlet.

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Siegert

199624

Nursing home

care unit of a

Veterans Affairs

Medical Center in

North Carolina

16 69 y 20 69 y 14 minute video (The

Right to Die … The

Choice is Yours) about

advance directives.

25 minute sham video

(I Am Joe’s Heart)

about heart disease

prevention strategies.

CPR, cardiopulmonary resuscitation; ICU, intensive care unit

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Patient preferences for use of life-sustaining treatments

Seven studies reported on patient preferences for use of life-sustaining

treatments.17-23 Low quality evidence (rated down for risk of bias and inconsistency)

suggests that, after receiving the video intervention, patients were less likely to indicate a

preference for CPR compared to those in the control arm (risk ratio, 0.50 [95% CI, 0.27 to

0.95]; I2 = 65%; heterogeneity P = 0.01) (Figure 3). The substantial heterogeneity across

studies may have been driven by the study by Yamada et al,17 which was published over a

decade earlier than the 6 other RCTs which reported on this outcome, and had a much

higher proportion of patients indicating a preference for CPR than the other studies.

Knowledge related to advance care planning

One study found that a video decision aid increased the proportion of patients with

correct responses to questions about the interventions included with CPR (intravenous

fluid, endotracheal intubation, mechanical ventilation, defibrillation), the likely outcomes of

CPR, and about advance directives; however, with the exception of increased knowledge

about advance directives, other estimates of effect were imprecise and not statistically

significant.17

Five studies reported on knowledge related to different aspects of ACP using a

variety of measurement scales.18-20;22;24 One study assessed knowledge about living wills

and cardiopulmonary resuscitation,24 another study assessed knowledge about advanced

dementia,22 and 3 studies assessed knowledge about CPR.18-20 One of the latter studies

(Epstein et al.) did not report sufficient detail to allow inclusion in our pooled analysis.20 In

the 4 studies with poolable data,18;19;22;24 there was moderate quality evidence (rated down

for risk of bias) that video decision aids resulted in greater knowledge scores compared to

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May 3, 2015 17

control (standardized mean difference, 0.58 [95% CI, 0.39 to 0.77]; I2 = 0%; heterogeneity

P = 0.99) (Figure 4).

Completion of advance directives

Four trials reported data on completion of advance directives.17;20;25;26 One study

defined advance directives as “any document that instructed caregivers on details of future

care”,20 another study provided no definition,17 and two other studies reported data on the

completion of both living wills and durable powers of attorney for health care. For the

latter two studies, we used the data related to the completion of living wills.25,26 Low

quality evidence (rated down for risk of bias and imprecision) suggests there may be a

small effect of video decision aids on this outcome, but with a wide 95% confidence interval

including no effect (risk ratio, 1.11 [95% CI, 0.85 to 1.46]; I2 = 44%; heterogeneity P = 0.15)

(Figure 5).

Other outcomes

El-Jawahri and colleagues found that a video decision aid led to greater confidence

in patients’ decisions about future use of life sustaining treatments compared to control, as

measured using the uncertainty subscale of the Decisional Conflict Scale (0=complete

uncertainty, 15=perfect certainty)27 (mean scores 13.7 in video group vs. 11.5 in control

group, p=0.002). In 5 of the studies, patients in the video arm were asked to rate their

comfort with watching the video.18-22 The majority of patients indicated that they were very

comfortable (83%18, 69%20), or at least somewhat comfortable (85%22, 90%21, 93%19)

watching the video.

One study included in this review, a pilot RCT, reported data on use of life-

sustaining treatments and resource use at the end-of-life, and found that a video decision-

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aid was not associated with a statistically significant difference in hospital admissions at 6

month follow-up (or until time of death), or hospital length of stay.20 However, this study

may not have been adequately powered to show a difference in these outcomes and does

not exclude the possibility of an effect. In this study, there were no intensive care unit

admissions during 6 month follow-up for the 30 subjects randomized to the video arm, and

3 intensive care unit admissions in the 26 subjects randomized to control; during 6 month

follow-up there was 1 episode of CPR or mechanical ventilation in the video arm and 3

episodes of CPR or mechanical ventilation in the control arm. No studies reported whether

the use of video decision aids affected the congruence of life-sustaining treatments at end-

of-life with patients’ prior expressed wishes.

DISCUSSION

In this systematic review of randomized controlled trials, we found low to moderate

quality evidence suggesting that video decision aids lead to greater knowledge related to

ACP and preferences for less aggressive care at end-of-life. Studies of ACP video decision

aids to date provide little or no data on other important outcomes related to ACP, such as

confidence in decision-making, the actual use of life sustaining treatments at end-of-life, or

the congruence of end-of-life treatments with patients’ wishes. Although an important

aspect of ACP is to clarify patients’ preferences for life-sustaining treatments, including

CPR, ACP involves several other important processes. In contemporary thinking, the focus

of ACP is shifting away from making decisions about future treatment choices and putting

more emphasis on the need to prepare future surrogate decision makers for “in-the-

moment” decision-making.2 In this way, ACP can be seen as a broader set of behaviours,

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including: choosing a surrogate decision maker, deciding what matters most in life

(clarifying values and, in some cases, future wishes for treatments such as CPR), and

communicating these values and wishes to surrogate decision makers to better prepare

them to engage in future “in-the-moment” medical decision-making when the patient

becomes incapable. We did not find any RCTs of video decision aids that examined ACP

from this perspective. However, web-based decision aids have recently been designed to

change these different behaviours related to ACP.28-30

Strengths of our review include adherence to the Preferred Reporting Items for

Systematic Reviews and Meta-Analyses (PRISMA) standards for conduct and reporting of a

systematic review, including a comprehensive literature search and a systematic approach

for categorizing confidence in the effect estimates (GRADE).15;16;31 Our systematic review

also has limitations. First, we restricted our search strategy to articles published in 1980 or

later and it is possible that we missed older, relevant articles. However, none of the trials

included in our review were published before 1996 and the concepts of advance directives

and advance care planning did not gain widespread attention until the 1990s (e.g., after the

introduction of the U.S. Patient Self-Determination Act in 1990). Second, for studies with

missing outcome data, we did not use imputation methods. By including only patients with

non-missing data (complete case analysis) in our meta-analyses, our resultant estimates of

effect could be biased if patients lost to follow-up were systematically different in ways that

were related to our outcomes of interest (e.g., if they were systematically more or less

likely to prefer CPR). Finally, our review also has limitations due to the limitations of the

studies included in our review. First, there are differences across the eligible RCTs. Studies

clustered into a group of more recent studies conducted by the same group of investigators

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(Volandes et al) and a group of studies published in the 1990s. Our intention for this

systematic review was to be comprehensive and inclusive of the entire body of RCTs

regarding video decision aids for ACP, but we acknowledge that the older studies may have

differed from more recent ones in several important ways. For instance, the focus of the

video interventions in the 1990s was on the creation of advance directives, whereas more

recent video interventions have focused on clarifying preferences for goals of care (life

prolonging care, limited care, or comfort care) or CPR. Eligible studies also elicited

preferences in different ways and it is possible that framing of response options as a binary

choice (CPR versus no CPR) or as choice between 3 options (life prolonging care, limited

care, or comfort care) may have influenced participants’ stated preferences. Another

limitation of the existing studies is that they report little or no data on other outcomes

relevant to ACP, such as confidence in decision-making, resource use at end-of-life, and

congruence of end-of-life care with patient wishes. This narrower focus of the existing

trials on the elicitation of treatment preferences or creation of advance directives, rather

than the broader range of activities that are part of ACP, and the fact that all the included

studies were done in the U.S. raise questions about the applicability of the available

evidence in other countries and in the context of changing definitions of ACP.

Butler et al recently completed a technical brief, commissioned by the Agency for

Healthcare Research and Quality in the United States, to provide an overview of a broad

range of ACP decision aids for adults.9 The report provides a state-of-the art review of the

field but, because it used technical brief methodology, it did not include a synthesis or

meta-analysis of outcomes, ratings of risk of bias or assessment of the quality of evidence.

It also did not include several randomized controlled trials of video decision aids for ACP

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that were identified in our review, including several recent trials.18-21 Our review provides

complementary and contemporary data on a well-specified clinical question (Amongst

adult patients, do video decision aids have an effect on outcomes related to ACP, when

compared to non-video-based interventions?), including assessments of risk of bias, quality

of evidence, and a synthesis of outcomes.

We found a large and statistically significant effect of video decision aids on patients’

preferences for CPR, with those exposed to the video intervention being half as likely to

prefer CPR as those exposed to a non-video based intervention. It is possible that some of

this effect is a result of bias introduced by incomplete concealment of allocation or

unblinded outcome assessment, as opposed to a true effect of the video decision aid. Future

trials could overcome these methodological limitations by using centralized telephone or

web-based randomization to preserve allocation concealment and blinding the outcome

assessors to allocation.32 It is also possible that some of the observed effect is attributable

to the “dose” of information received in the intervention arms: 4 of the 7 studies which

reported on patients’ preferences presented the same information twice in the intervention

arm (once as a verbal description and once in video format) compared to once in the

control arm (verbal description only). Finally, it is possible that there is a true effect of

video decision aids on patients’ preferences for CPR.

It is notable that only 1 of the 10 studies (by Yamada et al) included a process

through which patients could engage in deliberation or discussion with their usual

healthcare provider after watching the video; despite this, few participants in this study

(12%) reported discussing the content of the video with their physician.17 Most notably,

none of the studies in our review evaluated the impact of a video decision aid when

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integrated into clinical care. To have a measurable impact on downstream outcomes

related to ACP, such as resource use at end of life and congruence of end-of-life care with

patient wishes, we posit that video decision aids need to be embedded in a larger shared

decision-making process which includes not only information exchange (the focus of the

video-based interventions to date) but also engages patients in a process of deliberation

with their healthcare provider and surrogate decision maker, and documentation of any

decisions made in the medical record.33

In conclusion, there is low to moderate quality evidence suggesting that video

decision aids may result in greater knowledge related to ACP and preferences for less

aggressive care at end of life. It remains unknown whether these tools can increase

congruence of end-of-life care with patient wishes. While video decision aids appear to be

promising tools to assist with ACP, further evaluation, especially when integrated into

clinical care, is needed before their widespread adoption into practice.

ACKNOWLEDGEMENTS

The authors thank Ms. Neera Bhatnagar for her assistance in the design and conduct

of the literature search for this systematic review, Drs. Gordon Guyatt and Jason Busse for

their methodological advice, and Dr. Lawrence Mbuagbaw for biostatistical advice. Dr. John

You was supported by a Research Early Career Award from Hamilton Health Sciences.

Contributors: AJ and JJY conceived of and designed the study. JJY is guarantor. AJ, KQ, SC,

and AG screened titles, abstracts, and full-text articles for eligibility. AJ, DBV and JJY

extracted data from eligible articles. SC and JJY analyzed the data. All authors participated

in: interpretation of data, drafting of the manuscript, and gave final approval of the version

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to be published. All authors had full access to all of the data in the study and can take

responsibility for the integrity of the data and the accuracy of the data analysis.

Competing interests: All authors have completed the Unified Competing Interest form at

www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author).

All authors declare that: they have no relationships with companies that might have an

interest in the submitted work in the previous 3 years; their spouses, partners, or children

have no financial relationships that may be relevant to the submitted work; and they have

no non-financial interests that may be relevant to the submitted work.

Ethics approval: Ethics approval was not required for this study.

Funding: This research received no specific grant from any funding agency in the public,

commercial or not-for-profit sectors.

Transparency declaration: JJY (the manuscript's guarantor) affirms that the manuscript

is an honest, accurate, and transparent account of the study being reported; that no

important aspects of the study have been omitted; and that any discrepancies from the

study as planned have been explained.

Data sharing: The study dataset is available from the corresponding author at

[email protected].

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FIGURE LEGENDS

Figure 1. Summary of article selection

Abbreviations: RCT, randomized controlled trial; ACP, advance care planning.

Figure 2. Risk of bias in eligible studies

Review authors’ judgements about each risk of bias item for each included study. Green

circles = low risk of bias; red circles = high risk of bias; empty boxes = unclear risk of bias.

Figure 3. Effect of video decision aids on patient preferences for cardiopulmonary

resuscitation

Effect of the video intervention in individual studies and the pooled effect across studies

from a random effects model are expressed as risk ratios and 95% confidence intervals. A

risk ratio less than 1.0 means that patients in the video arm were less likely to prefer

cardiopulmonary resuscitation compared to those in the control arm.

Figure 4. Effect of video decision aids on knowledge related to advance care

planning


from a random effects model are expressed as standardized mean differences and 95%

confidence intervals. A standardized mean difference greater than zero means that

knowledge about advance care planning was greater for patients in the video arm

compared to those in the control arm.

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Figure 5. Effect of video decision aids on completion of advance directives


from a random effects model are expressed as risk ratios and 95% confidence intervals. A

risk ratio greater than 1.0 means that patients in the video arm were more likely to

complete an advance directive compared to those in the control arm.

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c63f-11e3-8b9a-8e0977a24aeb_story.html on June 2, 2014.

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(13) Heyland DK, Frank C, Groll D et al. Understanding cardiopulmonary resuscitation

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[updated March 2011]. www cochrane-handbook org [serial online] 2011;

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of-care video for elderly patients admitted to skilled nursing facilities. J Palliat Med

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advance care planning in dementia: randomised controlled trial. BMJ

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Advanced Dementia in Rural Patients Using an Educational Video: A Randomized

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(24) Siegert EA, Clipp EC, Mulhausen P, et al. Impact of advance directive videotape on

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(25) Landry FJ, Kroenke K, Lucas C, et al. Increasing the use of advance directives in

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as a process of health behavior change. J Am Geriatr Soc 2009;57:1547-1555.

(29) Sudore RL, Stewart AL, Knight SJ et al. Development and validation of a

questionnaire to detect behavior change in multiple advance care planning

behaviors. PLoS One 2013;8:e72465.

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Symptom Manage 2014;47:674-86.

(31) Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic

reviews and meta-analyses: the PRISMA statement. Ann Intern Med 2009;151:264-

9.

(32) Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending

against deciphering. Lancet 2002;359:614-18.

(33) Heyland DK, Tranmer J, Feldman-Stewart D. End-of-life decision making in the

seriously ill hospitalized patient: an organizing framework and results of a

preliminary study. J Palliat Care 2000;16 Suppl:S31-S39.

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Figure 1

117x127mm (300 x 300 DPI)

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Figure 2

230x559mm (300 x 300 DPI)

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Figure 3

54x16mm (300 x 300 DPI)

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Figure 4

38x8mm (300 x 300 DPI)

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Figure 5

43x10mm (300 x 300 DPI)

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1

Web Appendix 1. Detailed description of literature search strategy

The following search strategy was used for Medline and was adapted for CENTRAL, EMBASE, PsycInfo, AMED and CINAHL.

Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1980 to Present> -------------------------------------------------------------------------------- 1. Videotape Recording/ 2. video*.mp. 3. (VHS or DVD* or blue-ray disc* or Compact Disc* or CDs or audiovisual).mp. 4. ((interactive or digital) adj5 media).mp. 5. or/1-4 6. exp advance care planning/ or life support care/ or palliative care/ or exp terminal care/ or advance directives/ or living will/ 7. (Advance Care Planning or ACP or care at the end of life initiative or CEOL or Goals of care or GCD or end of life or living will*).mp. 8. or/6-7 9. exp Resuscitation/ 10. Resuscitat*.mp. 11. CPR.mp. 12. exp Respiration, Artificial/ 13. (Ventilator* or Ventilation*).mp. 14. exp Ventilators, Negative-Pressure/ 15. (bilevel positive airway pressure or BiPAP or BPAP).mp. 16. (positive pressure* or positivepressure*).mp. 17. (Respiratory or Respiration*).mp. 18. exp Intubation/ 19. Airway Management/ 20. (intubate* or intubation).mp. 21. Esophageal.mp. 22. (Laryngeal mask or LMA).mp. 23. (Tracheostom* or Tracheotom*).mp. 24. Enteral Nutrition/ 25. ((enter* or nasogastric or NG) adj5 (feed* or nutrition* or immunonutrition*)).mp. 26. nasoduodenal tube*.mp. 27. Feeding Methods/ 28. exp Parenteral Nutrition/ 29. ((Parenteral* or intravenous) adj3 (feeding* or nutrition)).mp. 30. (TPN or PN).mp. 31. ((Nasogastric or NG or gastrostomy or jejunostomy or gastric or orogastric or nasoenteric or nasojejunal or nasointestinal or transabdominal) adj3 (intubat* or tube* or feed*)).mp. 32. ((artificial or force or tube) adj3 (feeding* or nutrition)).mp. 33. tube feeding/

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34. (Percutaneous endoscopic gastrostomy or PPEG).mp. 35. ((RIG or PEG) and (Percutaneous or endoscopic or gastrostomy)).mp. 36. exp Renal Replacement Therapy/ 37. Kidney, Artificial/ or artificial kidney*.mp. 38. (dialyzer or hemodialysis or dialysis).mp. 39. Critical Care/ 40. Critical Illness/ 41. exp Intensive Care Units/ 42. ICU*.mp. 43. ((critical or intensive) adj3 (care or illness)).tw. 44. (ACLS or Advanced cardiovascular life support).mp. 45. Defibrillation.mp. 46. or/9-45 47. exp Patient Satisfaction/ or patient centered care/ or exp choice behavior/ or attitude to health/ or attitude to death/ or personal autonomy/ or patient participation/ or patient education as topic/ 48. ((patient* or Individual* or caregiver* or care-giver*) adj10 (wish* or value* or desire* or desirability or selection or prefer* or decide* or decision* or choice* or chose* or want* or participat*)).mp. 49. exp Decision Making/ or Decision Support Techniques/ or decision aid*.mp. 50. exp Patients/ or patient*.mp. or caregivers/ or caregiver*.mp. or care-giver*.mp. 51. 49 and 50 52. 47 or 48 or 51 53. 5 and 8 54. 5 and 46 and 52 55. 53 or 54 ***************************

Life-sustaining treatments of interest:

1. Cardiopulmonary resuscitation (CPR) 2. Mechanical ventilation 3. Respirator 4. Ventilator 5. Endotracheal intubation 6. Enteral feeding 7. Enteral nutrition 8. Total parenteral nutrition 9. Nasogastric tube feeding 10. Tube feeding 11. Percutaneous endoscopic gastrostomy (PEG) tube 12. Hemodialysis 13. Dialysis 14. Intensive care unit

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15. Critical care unit 16. Advanced cardiac life support (=ACLS) 17. Advanced cardiovascular life support (=ACLS) 18. Defibrillation 19. Cardiac defibrillation

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TITLE

Title 1 Identify the report as a systematic review, meta-analysis, or both. 1

ABSTRACT

Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number.

3-4

INTRODUCTION

Rationale 3 Describe the rationale for the review in the context of what is already known. 6

Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study design (PICOS).

6-7

METHODS

Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information including registration number.

7

Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report characteristics (e.g., years considered,

language, publication status) used as criteria for eligibility, giving rationale. 7-8

Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the search and date last searched.

7

Search 8 Present full electronic search strategy for at least one database, including any limits used, such that it could be repeated.

Web Appendix

Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in systematic review, and, if applicable, included in the meta-analysis).

8-9

Data collection process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and confirming data from investigators.

8-9

Data items 11 List and define all variables for which data were sought (e.g., PICOS, funding sources) and any assumptions and simplifications made.

7-9

Risk of bias in individual studies

12 Describe methods used for assessing risk of bias of individual studies (including specification of whether this was done at the study or outcome level), and how this information is to be used in any data synthesis.

8

Summary measures 13 State the principal summary measures (e.g., risk ratio, difference in means). 9-10

Synthesis of results 14 Describe the methods of handling data and combining results of studies, if done, including measures of consistency

(e.g., I2) for each meta-analysis.

9-10

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Risk of bias across studies 15 Specify any assessment of risk of bias that may affect the cumulative evidence (e.g., publication bias, selective reporting within studies).

--

Additional analyses 16 Describe methods of additional analyses (e.g., sensitivity or subgroup analyses, meta-regression), if done, indicating which were pre-specified.

16

RESULTS

Study selection 17 Give numbers of studies screened, assessed for eligibility, and included in the review, with reasons for exclusions at each stage, ideally with a flow diagram.

Fig 1

Study characteristics 18 For each study, present characteristics for which data were extracted (e.g., study size, PICOS, follow-up period) and provide the citations.

Table 1

Risk of bias within studies 19 Present data on risk of bias of each study and, if available, any outcome level assessment (see item 12). p.11; Figure 2

Results of individual studies 20 For all outcomes considered (benefits or harms), present, for each study: (a) simple summary data for each intervention group (b) effect estimates and confidence intervals, ideally with a forest plot.

p. 16-18; Figs 3-5

Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency. p. 16-18; Figs 3-5

Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see Item 15). --

Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]). 16

DISCUSSION

Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g., healthcare providers, users, and policy makers).

18-21

Limitations 25 Discuss limitations at study and outcome level (e.g., risk of bias), and at review-level (e.g., incomplete retrieval of identified research, reporting bias).

19

Conclusions 26 Provide a general interpretation of the results in the context of other evidence, and implications for future research. 18-21

FUNDING

Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review.

22

From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097

For more information, visit: www.prisma-statement.org.

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