abstract of dissertation entitled - school of nursing sze ming.pdf · abstract of dissertation...
TRANSCRIPT
Abstract of dissertation entitled
‘An Evidence-based protocol on using abdominal massage in management of
constipation among medical patients’
Submitted by
CHOW SZE MING
for the Degree of Master of Nursing
at The University of Hong Kong
in July 2016
Constipation was one of the most common complaints in hospital and occupied
one of the top three most distressing symptoms. It affects half of the medical
patients over the world, causing severe impacts on their physical and
psychosocial aspects. This health issue also brought a heavy financial burden
on society.
Medications is the commonest treatment to treat constipation, but most of them
had poor evidence support with lots of side effects. However, abdominal
massage has been proved to alleviate constipation symptoms effectively, which
is simple, inexpensive and non-invasive alternatives. Therefore, it is worth to
introduce into the current practice by establishing an evidence-based protocol
to enhance patients’ outcomes.
The objectives of this thesis are to review existing evidence on using abdominal
massage in alleviation of constipation symptoms, to establish an evidence-
based practice protocol for using abdominal massage for constipation
management, to assess the transferability and feasibility of implementing a
nurse-led abdominal massage protocol in a public hospital in Hong Kong, to
develop a plan for implementation and evaluation of the protocol.
Abdominal massage is introduced in this thesis with evidence support by four
high quality randomized-control trials. After assessing the implementation
potential, an evidence-based protocol is established. A comprehensive
implementation plan is produced and a pilot study plan is implemented among
patients in medical ward in one of the local hospital to evaluate the
effectiveness of the protocol.
An Evidence-based protocol on using abdominal massage in management of
constipation among medical patients
By
CHOW SZE MING
BSc(Hons)NURS,R.N.
A dissertation submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong
July 2016
i
Declaration
I declare that this thesis represents my own work, except where due
acknowledgement is made, and that it has not been previously included in a
thesis, dissertation or report submitted to this University or to any other
institution for a degree, diploma or other qualifications.
Signed __________________________________
CHOW SZE MING
ii
Acknowledgements
I would like to express my sincere appreciation to my supervisor, Dr. Athena Hong for
her enlightenment, guidance and ongoing support throughout this two years. This
dissertation could not be accomplished without her guidance and support.
I would also like to extend special thanks to my family for their unconditional love and
support. I would like to share the honour with them.
iii
Contents
Declaration……………………………………………………………………………. i
Acknowledgements……………………………………………………………………ii
Table of Contents……………………………………………………………………..iii
List of Appendices……………………………………………………………………vi
Abbreviations………………………………………………………………………...vii
Chapter 1 – Introduction
1.1 Background…………………………………………………………………..1
1.2 Affirming the Need…………………………………………………………..3
1.2.1 Factors associated with constipation…………………………………3
1.2.2 Poor evidence support in current practice……………………………4
1.2.3 Innovation…………………………………………………………….4
1.3 Research question, Objectives and Significance……………………………..6
1.3.1 Research question…………………………………………………….6
1.3.2 Significance…………………………………………………………..6
1.3.3 Objectives…………………………………………………………….7
Chapter 2 – Critical Appraisal
2.1 Search and Appraisal Strategies……………………………………………...8
2.1.1 Selection criteria……………………………………………………...8
2.1.2 Search strategies……………………………………………...............8
2.1.3 Data Extraction………………………………………….....................9
2.1.4 Appraisal Strategies…………………………………………………..9
2.2 Results………………………………………………………………………10
2.2.1 Search Results……………………………………………………….10
2.2.2 Study characteristics…………………………………………………10
2.2.3 Overview of the selected studies…………………………………….11
2.2.4 The strengths criteria in internal validity…………………................12
2.2.5 The weakness criteria in internal validity…………………………....13
2.2.6 Summary of quality appraisal……………………………………….14
2.3 Summary and Synthesis………………………………………………….....14
2.3.1 Comparison between the selected studies…………………………...14
2.3.2 Summary of data………………………………………………….....15
2.3.3 Synthesis of data……………………………………………………..16
2.3.4 Implications for practice……………………………………………..20
iv
Chapter 3 - Implementation Potential and Clinical Guideline
3.1 Target Audience…………………………………………………………..…22
3.2 Target Setting………………………………………..………………………22
3.3 Transferability of the Findings………………………………………………23
3.3.1 Demographic data……………………………………………………23
3.3.2 Philosophy of care……………………………………………………24
3.3.3 The severity of constipation patients…………………………………25
3.3.4 Time to implement and evaluate……………………………………..25
3.4 Feasibility…………………………………………………………………...26
3.4.1 Administration support………………………………………………26
3.4.2 Nurse support………………………………………………………...27
3.4.3 Resistance to implement……………………………………………..27
3.4.4 Equipment needed……………………………………………………28
3.5 Cost-Benefit Ratio of the innovation………………………………………...28
3.5.1 Potential risks and benefits of the innovation………………………...28
3.5.2 Potential risks of maintaining current practices………………………29
3.5.3 Potential material costs………………………………………………29
3.5.4 Potential non-material costs………………………………………….30
3.6 Evidence-based protocol…………………………………………………….31
3.6.1 Background…………………………………………………………..31
3.6.2 Title of the Evidence-based Practice Protocol………………………..31
3.6.3 Target Population…………………………………………………….32
3.6.4 Target Users of the Protocol………………………………………….32
3.6.5 Aim of the Protocol…………………………………………………..32
3.6.6 Objectives of the Protocol……………………………………………32
3.6.7 Practice Recommendations…………………………………………..32
Chapter 4 - Implementation Plan
4.1 Communication Plan………………………………………………………...36
4.1.1 Identifying the stakeholders………………………………………….36
4.1.2 The process of communication plan………………………………….37
4.1.3 Initiating, guiding and sustaining the change………………………...39
4.2 Pilot Study Plan……………………………………………………………...39
4.2.1 Objectives……………………………………………………………40
4.2.2 Target population…………………………………………………….40
4.2.3 Time frame…………………………………………………………...40
4.2.4 Method……………………………………………………………….41
v
4.2.5 Pilot study evaluation………………………………………………...41
4.3 Evaluation Plan……………………………………………………………...42
4.3.1 Outcomes to be achieved……………………………………………..42
4.3.2 Evaluation Design……………………………………………………44
4.3.3 Nature and number of patients involved……………………………..44
4.3.4 Data collection……………………………………………………….45
4.3.5 Data analysis…………………………………………………………45
4.3.6 Basis for implementation…………………………………………….45
Chapter 5 – Conclusion 47
Appendices 48
References 82
vi
List of Appendices
1 PRISMA 2009 flow diagram………………………………………………48
2 Table of Evidence………………………………………………………….49
3 SIGN Controlled Trials checklist for Doreen, M., Suzanne, H., Stanley, H.
& Andrea, L. S. (2011)………………………………….…………………52
4 SIGN Controlled Trials checklist for Kristina, L., Lars, L., Hans, S.,
Birgitta, E. & Catrine, J. (2009)………………………….………………..55
5 SIGN Controlled Trials checklist for Lai, T. K. T, Cheung, M. C., Lo, C. K.,
Ng, K. L., Fung, Y. H., Tong, M. & Yau, C.C. (2011)…………………....58
6 SIGN Cohort studies checklist for Ayas, S., Leblebici, B., Sozay, S.,
Bayramoglu, M. & Niron, EA. (2006)…………………………………….61
7 SIGN Controlled Trials checklist for Emly, M., Cooper, S. & Vail.
(1998)……………………………………………………………………...65
8 Tables of SIGN comparison……………………………………………….68
9 Reference of 4 selected studies……………………………………………73
10 Rome II diagnostic criteria for Functional Constipation………….……….74
11 Key to evidence statements and grades of recommendations……………..75
12 Constipation Assessment Scale (CAS)……………………………………76
13 Estimated costs for the abdominal massage protocol (Annually)…………77
14 Time frame for Communication Plan and Pilot Study Plan (6 months)…..78
15 Client Satisfaction Questionnaire-8 (CSQ-8)……………………………...80
vii
Abbreviations
Abbreviations Full text
APN Advanced practice nurse
C Control group
CAS Constipation assessment scale
CI Confidence interval
COS Chief of Service
CSQ-8 Client Satisfaction Questionnaire
CSS The constipation Scoring System
DOM Department Operation Manager
EN Enrolled nurse
GSRS Gastrointestinal Symptoms Rating Scale
HA Hospital Authority
I Intervention group
MO Medical officer
n Number
PICO Patient or Population, Intervention, Comparison, Outcome
PT Physiotherapist
RCT Randomized controlled trial
RN Registered nurse
SD Standard deviation
SMO Senior medical officer
SPSS Statistical Package for The Social Sciences
WG Working group
WM Ward manager
1
Chapter 1
Introduction
1.1 Background
In a healthy population, a number of people may suffer from constipation due to
unhealthy diet and lack of exercise. In Sweden, 20% of women and 8 % of men aged
31 - 76 years old had constipation (Kristina et al., 2009). Women and the aged are
more likely to have constipation (Higgins & Johanson, 2004). Constipation is a
common and unpleasant condition, which has even worse effect in medical patients.
45-69% of multiple sclerosis patients in Northern Ireland (Doreen et al., 2011), half of
the patients in hospices in the United Kingdom (Joyce, 2002) and 50-80% of palliative
care patients in Hong Kong had constipation (Lai et al., 2011). Constipation was one
of the most common complaints in hospitals in the United States (Martin et al., 2006)
and occupied one of the top three most distressing symptoms (Doreen et al., 2011; Lai
et al., 2011). Constipation affects severely the well-being of the patients and thus
reduces their quality of life significantly (Doreen et al., 2011; Lai et al., 2011). Also,
it brought a heavy financial burden on society towards this health issue. In the United
States, approximately $129 million was used on constipation management annually
(Martin et al., 2006).
In physical aspects, the consequence of chronic constipation may cause fecal impaction
(Lai et al., 2011) and increase the risk of colon cancer (Harrington & Haskvitz, 2006).
Hard stool is formed and impacted, which must need to be removed manually or by
enema. Fecal impaction in long term causes other complications, including fecal
incontinence, hemorrhoids, fissures and rectal prolapse (Lai et al., 2011). If fecal
2
impaction is undiagnosed and untreated, nausea, vomiting, fever and bowel obstruction
may then result (Lai et al., 2011).
In psychological aspects, patients’ quality of life is influentially diminished by
constipation. Quality of life is defined as the perception of an individual based on
their position in life in their culture and value associated with their expectations, goals,
standards and concerns (Lai et al., 2011). Illness indirectly leads to constipation and
causes patients suffered both physically and psychologically if any effective bowel
management (Lai et al., 2011).
Impacts on physical aspects are inter-correlated with that on psychological aspects.
Since considerable symptoms due to constipation, including the feeling of bloatedness,
headache, loss of appetite, nausea and vomiting, pain, overflow incontinence and
bladder dysfunction, patients are preoccupied with the undesirable symptoms (Doreen
et al., 2011). In a study among spinal cord injury patients (Ayas et al., 2006),
constipation symptoms deterred patient from travel or outdoor activities and increased
patients’ dependency on others. Constipation does not only influence their normal
daily lives, but also cause them to become psychosocial disability.
Administrating medication, such as osmotic laxatives is the gold standard for
physicians to relieve constipation (Kristina et al., 2009). In Sweden, nearly 50-75%
of old aged home residents were diagnosed constipation and used laxatives regularly
(Kristina et al., 2009) while 80% of palliative care patients need laxatives regularly (Lai
et al., 2011). However, these medication could cause several side effects, such as
nausea and abdominal cramps, and unable to solve the original causes of leading
constipation (Lamas et al., 2011; Kendra & Esther, 2006). Thus, constipation become
3
a vicious circle among these patients. Due to the above reasons, researchers started to
consider and endeavor to explore non-pharmacological methods to help patients to
solve the uncomfortable constipation symptoms (Doreen et al., 2011; Kristina et al.,
2009; Lai et al., 2011; Ayas et al., 2006; Emly et al., 1998). Abdominal massage was
then recommended to implement in management of constipation.
1.2 Affirming the Need
1.2.1 Factors associated with constipation
Constipation is divided into three types, including primary, secondary and
iatrogenically induced constipation (Myra et al., 2008). Primary constipation is due
to insufficient intake of fiber and fluid and decrease in mobility (Lai et al., 2011).
Since some of patients were generally weak and easy to fatigue, they were reluctant or
unable to move, and hence resulting the lack of activity (Doreen et al., 2011). Also,
especially in cancer patients, while losing their appetite, the intake of fiber and fluid
decreased. Besides, because of the change on bowel open methods in hospital, such
as defecation by using bedpan or napkins and lack of privacy, patients might avoid
toileting (Doreen et al., 2011). These psychological factors not only reduced
peristalsis, but also made slower the bowel transit time, causing dryer and harder stool
than normal (Doreen et al., 2011). Difficult and painful defecation was thus resulted
and patients had chronic constipation in long term (Doreen et al., 2011).
Secondary constipation is due to pathological changes, including partial intestinal
obstruction, tumor, spinal cord compression and metabolic effects (Lai et al., 2011)
while iatrogenically induced constipation is caused by pharmacological intervention
(Lai et al., 2011). The side effects of medications related to constipation, including
anti-cholinergic, anti-emetics, analgesics and chemotherapy, were commonly occurred
4
in medical patients (Lai et al., 2011).
1.2.2 Poor evidence support in current practice
Increasing physical activity, fiber and fluid intake are recognized as a first choice of
non-pharmacological intervention to prevent constipation. It proposed that increasing
mobility and ensuring adequate fiber and fluid intake can pass bulky and soft stool
easily. However, few scientific evidences supported the stand (Kristina et al., 2009).
Medications to relieve constipation is the commonest treatment given by the physicians
in medical ward when constipation is diagnosed. However, according to ACG (2005),
only two kinds of medications are proved to be effective on treating constipation. One
is Tegaserod, which enhances the peristaltic reflex and fosters colonic motility and the
other one is osmotic laxatives, for instance, lactulose. Surprisingly, insufficient
evidence showed bulking agent psyllium provides relief and lack of evidence proved
the effectiveness of using other bulking agents, stimulant laxatives, such as dulcolax
and stool softeners (ACG, 2005). By own observation in medical ward in Hong Kong
hospital, majority of patients still suffered from constipation despite of using at least
two or more kinds of medications to treat constipation.
1.2.3 Innovation
Concerning the side effects and lacks of evidence support on the medications (Lamas
et al., 2011; ACG, 2005), other non-pharmacological intervention, abdominal massage
is recommended to facilitate defecation, which does not have any negative impact on
patients (Ayas et al., 2006). Abdominal massage has been used in management of
constipation since 1870 (Doreen et al., 2011). Between the late 19th and early 20th
century, it was adopted to use. However, possibly due to the insufficient evidence to
5
support, the practice of such intervention declined in 1950s. From 1950s till now,
there are several reliable randomization controlled trials (RCTs) done on abdominal
massage to prove the effectiveness on relieving constipation symptoms (Doreen et al.,
2011; Kristina et al., 2009; Emly et al., 1998). Therefore, abdominal massage are now
revival. Although there was a systematic review of abdominal massage therapy for
chronic constipation by Ernst (1999), it only included four controlled clinical trials to
support the therapy, which were consisted of methodological flaws. No further
comprehensive systematic review after several RCTs done.
Trials proposed abdominal massage is an alternative intervention for constipation
management, which is effective in alleviation of constipation symptoms (Doreen et al.,
2011, Kristina et al., 2009; Ayas et al., 2006; Emly et al., 1998). Abdominal massage
is recommended to implement in management of constipation.
In theory, according to Doreen et al. (2011) and Marybetts (2010), the mechanisms of
abdominal massage are to increase intra-abdominal pressure during massage so as to
enhance rectal loading. In some cases, massage can release rectal waves, which elicit
the bowel sensation and somato-autonomic reflex on the gut to encourage peristalsis.
The movement of the gut is then encouraged and the strength of the propulsive and
contraction force is increased. On the other hand, the function of gastrointestinal tract
is affected by stimulation in the parasympathetic division of the autonomic nervous
system. During abdominal massage, sensory stimulation is produced in the
parasympathetic division of the gastrointestinal tract, causing increase in mobility to
the muscle of the gut and the amount of digestive secretions and relaxation of the
sphincter in the gastrointestinal tract.
6
1.3 Research Question, Objectives and Significance
1.3.1 Research Question
The research question is “How efficient abdominal massage is in alleviation of
constipation symptoms among medical patients?”
1.3.2 Significance
For medical patients
Physically, abdominal massage significantly relieves the symptoms from constipation,
for instance, reducing faecal incontinence and abdominal distension, shorter transit time,
increasing bowel movements, which helps patients to return to normal bowel function
(Kristina et al., 2009). Innovating abdominal massage to manage constipation
provides another alternative for patients to choose, which had positively improvement
on constipation symptoms and unlike laxatives with any negative adverse effects
reported (Kristina et al., 2009; Kendra & Esther, 2006). Although it is unavoidable to
use laxatives to treat constipation, abdominal massage can act as a non-pharmacological
method to alleviate constipation symptoms with the combination of encouraging
activity and maximizing the consumption of fiber and fluid intake (Lai et al., 2011).
By educating abdominal massage skills to patients and relatives, they can perform it at
home and maintain a good bowel habits (Lai et al., 2011; Michelle et al., 2014).
Psychologically, abdominal massage facilities the delivery of oxygen and nutrients to
cells and tissue (Lai et al., 2011). By increasing the release of endorphins, patients
feel complete relaxed, wholeness and calmness (Lai et al., 2011). It eases comfort and
enhances sleep quality (Lai et al., 2011). Hence, quality of lives among patients is
improved (Lai et al., 2011; Kristina et al., 2011).
7
For nurses
Being a profession, nurses have responsibility to provide care to manage constipation,
including monitoring bowel habits, providing nursing care and administrating
prescribed laxatives. However, based on Kristina et al. (2009), it was difficult for
nurses to manage constipation due to different bowel habits, inconsistent definition of
constipation and different of abdominal massage skills. An evidence-based protocol
can help nurses to manage the situation in a scientific way.
Besides, by giving abdominal massage to relieve constipation, patients feel respect as
their suffering is being taken seriously. Nurses’ caring and supportive attitude can be
passed to patients through positive physical contact during massage. It facilitates to
build a trustful relationship between nurses and patients (Kristina et al., 2009; Michelle
et al., 2014).
1.3.3 Objectives
Based on the above significance, the objectives of this thesis are:
1. To review existing evidence on using abdominal massage in alleviation of
constipation symptoms.
2. To establish an evidence-based practice protocol for using abdominal massage for
constipation management.
3. To assess the transferability and feasibility of implementing a nurse-led abdominal
massage protocol in a public hospital in Hong Kong.
4. To develop a plan for implementation and evaluation of the protocol.
8
Chapter2
Critical Appraisal
After affirming the needs and stating the significance of using abdominal massage on
management of constipation in the previous chapter, the search strategies, appraisal
strategies and summary of findings will be discussed in this chapter in order to provide
evidence support to the innovation.
2.1 Search and Appraisal Strategies
2.1.1 Selection criteria
Inclusion criteria
Research articles were included if:
Type of studies: Randomized controlled trials (RCTs) and cohort studies
Type of target groups: Medical patients with constipation
Type of interventions: Abdominal massage given by trained staffs, patients or their
relatives
Type of outcomes: Constipation symptoms and the numbers of bowel movement
Exclusion criteria
Research articles were excluded if:
1. Their target groups were pediatric population
2. The interventions involved were not studied abdominal massage only
2.1.2 Search strategies
From 15 August 2016 to 15 December 2016, potential studies were searched by the
9
four selected electronic databases, including PubMed, CINAHL PLUS, Cochrane
Library and British Nursing Index. Two keywords “abdominal massage” and
“constipation” were used during searching. During searching, RCT was not set as a
criteria to ensure all of the potential studies screened. Moreover, language was also
not set as a filter so that language bias was avoided. After removing the duplication
of studies, titles and abstracts of the studies were then extracted. Full-text relevant
studies were assessed and carefully selected based on the inclusion and exclusion
criteria.
2.1.3 Data Extraction
Data were extracted including study design, level of evidence, target group
characteristics, sample size, the content of intervention and control groups, outcome
measures and effect size. Two outcome measures, constipation symptoms and the
numbers of bowel movement, were extracted.
2.1.4 Appraisal Strategies
The quality of each included study was assessed by the methodology checklist designed
by the Scottish Intercollegiate Guidelines Network (SIGN, 2014). Different
methodology checklists were used for their corresponding study designs. Both of
them have section 1 “internal validity” and section 2 “overall assessment of the study”.
For section 1 “internal validity”, it evaluated ten criteria. They were the clarity of
focused question, randomized allocation, adequate concealment, double “blind”
treatment allocation, similarity between groups, treatment as the only difference, and
the valid measurement of outcomes, drop-out rate, intention-to-treat analysis and
comparable results at all sites.
10
For section 2 “overall assessment of the study”, it evaluated four areas. They were
coding the quality of study, commenting the overall effect of the intervention according
to the methodology and statistical power, justifying the applicability of the target group
on this guideline and providing conclusion and uncertainty of the study.
2.2 Results
2.2.1 Search Results
66 studies in total were then generated after being searched by combination of keywords.
A PRISMA 2009 flow diagram (PRISMA, 2015) was used to illustrate the search
strategies (see Appendix 1). After 27 duplicates were removed, 39 titles and abstracts
were then extracted. 16 studies were confirmed relevant to the topic and full-text
articles assessed. Based on the inclusion and exclusion criteria, four studies were
excluded due to unsuitable target groups while five studies were excluded due to
unsuitable interventions. Finally, four RCTs and an uncontrolled clinical study were
used to review, which were all published in English.
2.2.2 Study characteristics
Five studies were selected in this review with different study designs. Four of them
were RCTs (Doreen et al., 2011; Emly et al., 1998; Kristina et al., 2009; Lai et al., 2011)
while one was uncontrolled clinical study (Ayas et al., 2006). The characteristic of
the studies were shown by using the table of evidence (see Appendix 2). They were
conducted in different countries, including one in Sweden (Kristina et al., 2009), one in
Turkey (Ayas et al., 2006), two in United Kingdom (Northern Ireland and Taunton)
(Doreen et al., 2011; Emly et al., 1998), and one local study (Lai et al., 2011). Their
research settings included a rehabilitation program at a center in University (Ayas et al.,
11
2006), recruitment through media (Doreen et al., 2011), a hospital (Lai et al., 2011), a
nursing home (Kristina et al., 2009) and a residential care institution (Emly et al., 1998).
Most of the studies included female more than male. The sample size ranged from 24
to 60 people. All of the studies mentioned the course, duration and the procedure of
the abdominal massage, but they varied. The intervention group received abdominal
massage 15 minutes for 1-4 weeks in two studies (Ayas et al., 2006; Doreen et al., 2011)
or 15-20 minutes in 5 days per week for 1-8weeks in the other three studies (Emly et
al., 1998; Kristina et al., 2009; Lai et al., 2011). Three of them had their control group
between groups (Doreen et al., 2011; Kristina et al., 2009; Lai et al., 2011) while two
of them had their control group within groups (Ayas et al., 2006; Emly et al., 1998).
The control group in five studies received standard care (Emly et al., 1998; Kristina et
al., 2009; Lai et al., 2011), advice on bowel management (Doreen et al., 2011), standard
bowel program (Ayas et al., 2006). Two of them were allowed to perform abdominal
massage by trained carers (Doreen et al., 2011; Emly et al., 1998) while three of them
were performed by trained staffs only (Ayas et al., 2006; Kristina et al., 2009; Lai et al.,
2011). In term of outcomes, four of them included constipation symptoms despite
different assessment tools were used (Ayas et al., 2006; Doreen et al., 2011; Kristina et
al., 2009; Lai et al., 2011) when one was not (Emly et al., 1998). All of five studies
included the numbers of bowel movement in their outcomes. None of the studies were
multi-center design. Four out of five studies were obtained ethical approval (Ayas et
al., 2006; Doreen et al., 2011; Emly et al., 1998; Lai et al., 2011) and two of them
mentioned source of funding (Doreen et al., 2011; Kristina et al., 2009).
2.2.3 Overview of the selected studies
Four methodology checklists for RCTs and a methodology checklist for cohort study
12
designed by SIGN (SIGN, 2014) were done and shown (see Appendix 3-7). A table
for comparison of assessment results between studies was demonstrated (see Appendix
8).
Three out of four RCTs (Doreen et al., 2011; Kristina et al., 2009; Lai et al., 2011)
demonstrated relatively good methodological quality, which fulfilled half of the criteria
in internal validity while one of the RCTs (Emly et al., 1998) and the uncontrolled trial
(Ayas et al., 2006) were not. Comparing with criteria in internal validity, several areas
were performed well.
2.2.4 The strengths criteria in internal validity
Clear focused question & randomization
First of all, all of the studies demonstrated clear focused question with Patient or
Population, Intervention, Comparison, Outcome (PICO) components. Second, four
out of five studies mentioned randomized allocation although one of them (Emly et al.,
1998) did not mention the randomization allocation method in detail. They were
reliable, including web-based system, block randomization and random number
generator, which can minimize the sampling bias (SIGN, 2014).
Similarity between groups
Third, the similarity between groups were satisficing. The characteristics of the
population in majority of the studies looked reasonably similar and only one of the
study (Kristina et al., 2009) showed difference at constipation syndrome at baseline.
All studies agreed the treatment under investigation was the only difference between
groups.
Missing data
13
Fourth, the drop-out rate was relatively low, within 0 to 13.33% in four studies with
reasonable explanation. Only one of the study (Lai et al., 2011) had a higher drop-out
rate, which was 36.67%. 63.6% of withdrawn patients were due to increased use of
laxatives in both groups, 18.2% of them were due to discharge home in control group
and 9.1% of them were due to both increased shortness of breath and increased fatigue
in massage group.
Intention to treat analysis
Finally, intention to treat analysis was used in two studies (Emly et al., 1998; Kristina
et al., 2009) and one study was not applicable due to 0% drop out rate (Ayas et al.,
2006). Despite of not using intention to treat analysis in two studies (Doreen et al.,
2011; Lai et al., 2011), explanation of drop-out rate was given.
2.2.5 The weakness criteria in internal validity
Concealment & Blinding process
There were also a few of weakness on the methodological quality among studies. First,
if the adequate concealment is non-compliance, it may increase the risk of allocation
bias (SIGN, 2014). However, only one of the studies confirmed using codes to
conceal (Doreen et al., 2011). Second, the double “Blind” treatment allocation was
poor. One of them (Doreen et al., 2011) had single blinded for phone questionnaire
assessors, but majority of them did not blind the statisticians even though they could.
It might increase the risk of subjective bias (SIGN, 2014).
Measurement tools & Generalizability
Third, the valid of measurement tools were suspected. Two of RCTs (Doreen et al.,
2011; Lai et al., 2011) had good validity and reliability tools to demonstrate the
14
constipation symptoms, including the constipation scoring system (CSS) and
constipation assessment scale (CAS), but the gastrointestinal symptoms rating scale
(GSRS) in a RCT (Kristina et al., 2009) had not been valid. Furthermore, the objective
measurement data used was unclear in two studies (Lai et al., 2011; Ayas et al., 2006).
Fourth, none of studies carried out at more than one site, the generalizability of the
studies may not be confirmed (SIGN, 2014).
2.2.6 Summary of quality appraisal
Comparing with overall quality assessment, four studies done to minimize bias were all
coded as acceptable (+) as half of the area in internal validity were achieved. In
exception of Ayas et al. (2006), less than half of the area in internal validity were not
met despite of using methodology checklist of cohort study. Therefore, only four
studies had good quality to go through summary and synthesis process as well as their
result are believed to directly applicable to target groups (see Appendix 9).
2.3 Summary and Synthesis
2.3.1 Comparison between the selected studies
Comparison between intervention and standard care
Comparing the outcomes, the constipation symptoms among studies, two out of four
studies were found significantly in reduction of the constipation symptoms in
intervention groups. Also, in one of the studies, the intervention group relieved the
constipation symptoms, but it did not reach the significant level (Lai et al., 2011).
However, no measurement on constipation symptoms was done in the residual study
(Emly et al., 1998).
Referring another outcomes, the number of bowel movement among studies, all of the
15
studies were shown significantly increased in the numbers of bowel movement in the
intervention groups.
Comparison between the content of the intervention
The duration of abdominal massage per each session was similar ranged from 15-20
minutes among studies while the course of abdominal massage was heterogeneous
ranging from daily last for five days to eight weeks. The study adopting the
intervention daily for 5 days, was the one that reported insignificantly reduction on the
constipation symptoms (Lai et al., 2011). Either abdominal massage performed by
trained staffs or carer had shown significant results in the studies according to the
number of bowel movement and decrease in constipation symptoms (Doreen et al.,
2011; Emly et al., 1998).
2.3.2 Summary of data
Constipation symptoms
Four RCTs were included in the summary and synthesis eventually. In view of
constipation symptoms, three of them mentioned this measure outcomes. Both of
them were using different measurement tools to assess the constipation symptoms and
using mean of the score and p-value to illustrate the effect size. Two out of three
studies had significantly decreased in different period of the intervention while one
study did not. The constipation symptoms in Doreen et al. (2011) was relieved in
week 0-4, but the effect of abdominal massage did not last till week 8. The
constipation symptoms in Kristina et al. (2009) was reduced in week 0-8 and week 4-
8, but not in week 0-4. The p-value in this significant results were all 0.003.
However, there was no significant decreased in constipation symptoms in a study, Lai
et al. (2011) that abdominal massage was only provided by five consecutive days and
16
its p-value was 0.718.
The numbers of bowel movement
In view of the numbers of bowel movement, all studies reported this measure outcomes
and both reported significantly increased. Two of them (Doreen et al., 2011, Emly et
al., 1998) used the unit of bowel movement per week while the other two used the unit
of bowel movement per 5 days (Kristina et al., 2009; Lai et al., 2011). Three of them
used mean of the number of bowel movement and p-value to illustrate the effect size
while one of them only provided the p-value. The numbers of bowel movement
showed increased in Doreen et al. (2011) at week 0-4, but the data of week 0-8 were
missed due to poorly completed in the study. The number of bowel movement was
increased in Kristina et al. (2009) in week 0-8 only, but not in week 0-4 and week 4-8.
The one (Lai et al., 2011), which providing only five day abdominal massage, also
mentioned increase in the numbers of bowel movement. RCT (Emly et al., 1998),
which was compared within groups, had the same result with the other studies. It
illustrated significantly increase in the numbers of bowel movement (p=0.07) in week
0-18. The study (Doreen et al., 2011) stated the highest mean score of the numbers of
bowel movement, which was -2.2 in week 0-4 and its p-value was 0.003.
2.3.3 Synthesis of data
The effectiveness of using abdominal massage in constipation management among
medical patients, was supported by the review based on the strong evidence from four
RCTs.
Analysis on subject characteristics
The medical problem with constipation among subject population in four studies were
17
similar to patients in local medical ward setting despite of the recruitment being not in
a hospital setting. In term of subject characteristics, the mean age was similar, but the
gender proportion was not. Excluding Lai et al. (2011) study due to lack of illustration
of gender proportion, 86 female and 34 male were included in total, which was
consistent to the higher prevalence rate among female than male mentioned in Higgins
& Johanson (2004). In term of inclusion criteria on definition of constipation, two of
four studies (Doreen et al., 2011; Lai et al., 2011) used the Rome II criteria (see
Appendix 10), one (Kristina et al., 2009) used CAS and one (Emly et al., 1998)
depended on the duration of the use of laxatives/enemas before the study. The
definition of constipation chosen in the studies was influential as it might affect the
recruitment of the subjects. Rome II criteria was established by experts and widely
used for diagnosis functional constipation (Thompson et al., 1999), which was matched
with the subject population in this review. Although part of the criteria in Rome II
criteria was covered in CAS, such as “rectal fullness or pressure” and “less frequent
bowel movement”, the diagnostic criteria in Rome II criteria was more specific and
valid (Thompson et al., 1999). Emly et al. (1998) study used the duration of the use
of laxatives/enemas to determine patients having constipation seemed inappropriate.
Analysis on intervention
Duration and course of the abdominal massage played a crucial role to design whether
the intervention succeeded or not. The duration of the abdominal massage for each
session among four studies was around 15-20 min, which was similar. However, the
course of the abdominal massage varied. The course of the abdominal massage daily
for four weeks in a study (Doreen et al., 2011) was shown significant result on reduction
in constipation symptoms (p=0.003) and increase in the numbers of bowel movement
(p=0.001). The effect of abdominal massage was then decreased to insignificant level
18
(p=0.112) for eight weeks in study (Doreen et al., 2011) despite of still having further
beneficial effect. On the other hand, the course of the abdominal massage daily in five
days per week for four weeks in a study (Kristina et al., 2009) was shown insignificant
result on reduction in constipation symptoms (p=0.140) and increase in the numbers of
bowel movement (p=0.377). However, the significant results (Kristina et al., 2009)
were achieved in week 0-8 and week 4-8, which p-value on decrease in constipation
symptoms were both 0.003. Although both of the two studies lasted for eight weeks,
two abdominal massage sessions less per week were performed in Kristina et al. (2009)
study than Doreen et al. (2011) study. This might give a reasonable explanation why
the effect of abdominal massage was present in Doreen et al. (2011) study while absent
in Kristina et al. (2009) study at week 4. Not surprisingly, the course of abdominal
massage daily for five days in Lai et al. (2011) study reported insignificant level on
relieving constipation symptoms (p=0.718). To synthesize, the studies suggested that
the course of abdominal massage daily per week for at least four weeks would
demonstrate the most effective reduction on constipation symptoms. For reviewing
four RCTs in total, the numbers of bowel movement was increased in most of the result
no matter the course of the abdominal massage varied. It indicated that abdominal
massage could facilitate defecation in certain extent. Besides, it also implied that the
numbers of bowel movement may not be a good indicator for assessing the
effectiveness of the abdominal massage.
Regarding to the methods of providing abdominal massage, three out of four studies
mentioned the steps of abdominal massage (Doreen et al., 2011, Kristina et al., 2009,
Emly et al., 1998), which yielded significant result on management of constipation.
Furthermore, one of them produced a teaching DVD to demonstrate the skills (Doreen
et al., 2011) to maintain the standard of abdominal massage. One of them provided
19
supportive environment, such as classical music, private room and blankets to enhance
patients’ relaxation. Two of studies (Doreen et al., 2011; Lai et al., 2011) illustrated
four basic stokes provided including stroking, kneading, effleurage and vibration while
two of studies (Kristina et al., 2009; Emly et al., 1998) recommended to massage in the
direction of the colon. All these methods of providing abdominal massage could give
crucial elements in the protocol design. However, the methods of providing
abdominal massage in a study (Lai et al., 2011), which failed to reach significant level
on management of constipation, were not provided in detail. It projected that the
methods of providing abdominal massage were critical on the effectiveness of the
intervention.
Concerning the personal to perform the abdominal massage, the abdominal massage
was performed by either trained staffs or carers in two studies (Doreen et al., 2011;
Emly et al., 1998) while the rest of the studies were only allowed by trained staffs
(Kristina et al., 2009; Lai et al., 2011). The abdominal massage provided by trained
carers also reported significant results on managing constipation symptoms. It gave a
cue that trained carers to provide abdominal massage to patients was feasible in the
protocol.
Using abdominal massage as a complement to laxative use or applied solely was
important concern in this protocol. Two studies (Kristina et al., 2009; Lai et al., 2011)
confirmed that patients continued to take laxative in their previous prescription during
intervention. One studies (Doreen et al., 2011) might allow patients to continue their
prescribed laxative as the study did not mention obviously and could only be found in
the description of the paper. Only one of the study (Emly et al., 1998) investigated
the comparison of the effectiveness between laxative and massage group. The
20
conclusion of that result claimed any different effectiveness between laxative and
massage groups. However, the quality of that study was poor than the other studies.
Therefore, the conclusion of that result was questioned. Hence, using abdominal
massage as a complement to laxative use was recommended with strong evidence.
By using abdominal massage as a non-pharmacological method to treat constipation,
the necessity of assessment by physicians is concerned. Two studies (Lai et al., 2011;
Emly et al., 1998) were requested the assessment done by physicians before the
intervention began so as to assess any undiagnosed bowel disease and suitability
condition of the patients. However, two studies (Doreen et al., 2011, Kristina et al.,
2009) were assessed by trained nurses. None of the intervention in four studies
showed adverse effects of the intervention among medical patients. To synthesize, the
assessment by physicians might not be needed before the start of the intervention.
However, it was more appropriate to inform physicians to implement the abdominal
massage when the criteria of constipation was met, which can enhance the
communication and facility cooperation between physicians and nurses.
2.3.4 Implications for practice
The available evidence from RCTs proved that using abdominal massage as a
complement to laxative use was effective in constipation management among medical
patients. Two studies (Doreen et al., 2011, Kristina et al., 2009) with level of evidence
(see Appendix 11) rated 1+ indicated reduction in constipation symptoms significantly.
In addition, all of the studies with level of evidence rated from 1- to 1+ showed increase
in the numbers of bowel movement. Using abdominal massage appeared to be an
alternative method for medical patients to solve their constipation symptoms, which
was regarded as a safe and beneficial intervention. Nurses played an important role
21
in helping them to alleviate constipation by using this complementary therapy.
However, during establishing the protocol, the duration, the course, the methods and
the skills of trained personal of the abdominal massage were needed to be concerned
and standardized. There was an urge to establish an evidence-based protocol on
abdominal massage in order to provide a good quality of services.
22
Chapter 3
Implementation Potential and
Clinical Guideline
Implementation Potential
In Chapter Two, the comprehensive critical appraisal provided strong evidence to
support abdominal massage in management of constipation. It is a potential nursing
care to be implemented in a medical ward at hospital so as to enhance the quality of
nursing care. To determine whether the innovation can be applied from evidence into
local practice, it is necessary to assess the implementation potentials including
transferability, feasibility, cost-benefit ratio (Polit & Beck, 2012), and thus to establish
an evidence-based practice protocol before implementation. A careful consideration
can help to examine the effectiveness of the innovation as well as the protocol can
maintain a standard quality of nursing care.
3.1 Target Audience
Patients aged from 50 to 70 years old who are fulfilled Rome II criteria for constipation,
without having medical history of Crohn’s disease, diverticular disease, colon cancer,
rectal bleeding or recent change in bowel function. They are able to read and listen
Cantonese or English.
3.2 Target Setting
The innovation will be held in a medical ward at a hospital under Hospital Authority
(HA). The services provided by the target medical ward are medical care and
23
rehabilitation. There are total 19 staffs, including 2 SMOs (Senior medical officer), 1
MO (Medical officer), 2 APNs (Advanced practice nurse), 11 RNs (Registered nurse)
and 3ENs (Enrolled nurse), who run the target medical ward. By my observation,
around 60 patients per month are newly admitted in the medical ward and
approximately one fourth patients were diagnosed as constipation. In the current
practice, laxatives are prescribed by MO to treat constipation patients without any other
alternatives for them to choose. No abdominal massage is provided in management
of constipation now.
3.3 Transferability of the Findings
In order to examine the appropriateness of implementing the innovation in the target
medical ward at the hospital, the patients’ demographic data, philosophy of care and the
severity of constipation among patients were compared. By my observation, data was
collected in the target medical ward to demonstrate the transferability.
3.3.1 Demographic data
Regarding the sources of the patients, overwhelming majority of patients (~95%) in this
medical ward were medical patients transferred from medical wards in acute hospitals,
except minority of patients (~5%) were transferred from home care teams or outpatient
clinics. Although not all the target settings in the selected studies were at hospitals,
those patients in the studies all had medical problems which were similar to the target
local setting.
By comparing the age of the patients, the age in all studies ranged from 40 to 70 years
old while that in target medical ward ranged from 50 to 70 years old, which was similar
to each other.
24
Concerning the gender of the patients, the number of female patients was more than
that of male patients in one study (Kristina et al., 2009) while gender population was
evenly distributed in two studies (Doreen et al., 2011; Emly et al., 1998). And one study
did not mention gender proportion (Lai et al., 2011). However, since the target local
setting is a male ward, all of the patients are male. Although women are prone to have
constipation as mentioned in Chapter One (Higgins & Johanson, 2004), the recruitment
of male patients with constipation in the target medical ward will not be a problem
based on my observation. Moreover, four of studies showed positive outcomes
despite of difference gender population, which was not a key factor to affect the
transferability.
Hence, the demographic data, including sources, age and gender of the patients, is able
to translate from evidence into local practice successfully.
3.3.2 Philosophy of care
Moreover, the consistency of philosophy of care between the innovation and the target
local setting is also a crucial element to affect the successfulness of the transferability
of the findings. The philosophy of care of the innovation aims to relieve the symptoms
from constipation significantly and pass caring and supportive attitude to patients
through abdominal massage. It is consistently with that in the target hospital. The
target hospital is under HA with organizational background. The organization
provides Christian services and their aim is “… to provide holistic care services with a
caring, professional and progressive attitude …” (Haven of Hope Christian Service,
2016). On the other side, HA aims to provide professional services that is “…
increase one’s knowledge continuously by staying abreast of the latest developments in
25
one's profession, taking action to improve one's skills…” (Hospital Authority, 2016).
Both of the philosophy of care between the innovation, the target hospital and the HA
are similar, which aim to provide an updated and evidence-based holistic care to
patients. Hence, conflicts can be minimized during implementation.
3.3.3 The severity of constipation patients
Furthermore, the size of patient population benefit from the innovation is another
significant factor for the transfer of research findings. By my observation in the target
setting, the average number of patients who fulfilled Rome II criteria for constipation,
was nearly 15 per month, which were 25 percent of the total monthly admission.
Besides, the average number of patients who were taking one kind of laxatives was 15
per month while that taking two or more than two kinds of laxatives was 12 per month.
They occupied nearly half of the total monthly admission. The data showed that an
influential proportion of patients were suffered from constipation and the innovation
will then change the situation.
3.3.4 Time to implement and evaluate
To strive for transferring of the findings successfully, the time to implement the
innovation and the evaluation also needed to be considered. The abdominal massage
will be performed by either trained nurses or trained patients or their relatives, which
will take 15 mins daily. Trained nurses will act as an educator to supervise patients or
their relatives to return demonstration of the massage skills while patients or their
relatives will mainly perform the massage during visiting hours. In order to evaluate
the effect of the innovation, 8-item tool, CAS (Lai et al., 2011) (see Appendix 12) and
the number of daily bowel movement will be recorded before the start of innovation
and after four weeks implementation to evaluate the constipation symptoms and the
26
bowel habits respectively. They are estimated to take totally 10 mins to be completed
per patient for each evaluation. The length of implementation and evaluation is
similar to the selected evidence.
Summarizing the above considerations of the transferability of the findings, the target
population and the philosophy of care between the innovation and the target medical
ward, are high degree of resemblance. It implies that implementing abdominal
massage has high possibility to transfer in medical ward setting.
3.4 Feasibility
To investigate the feasibility of the innovation in the local practice, some critical
elements needed to be considered, including support from administration, nurses and
other departments, any resistance to implement as well as equipment needed.
3.4.1 Administration support
Concerning support from administration, target hospital endeavored to increase nursing
autonomy on innovative nurse-led program as evidenced by establishing groups to draft
protocols, including wean Foley protocols as well as hypoglycemia management
guidelines. Also, ward manager (WM) in the target medical ward encouraged nurses
to submit abstract on clinical innovations to HA convention. All these showed that
the organization climate provided nurses autonomy to conduct clinical research to
advance the quality of nursing care. In fact, constipation symptoms among medical
patients were worse in the past few years, the prevalence rate was 14% (Chan, 2009).
The innovation with low cost and risk satisfied the needs of those patients to relieve
their symptoms (Myra et al., 2008). It has high possibility to gain support from the
administration.
27
3.4.2 Nurse support
For the support from nurses, over half of nurses in the target medical ward are
university-graduated. They support and are familiar with evidence-based protocols to
implement. Nurses have autonomy to carry out and terminate the innovation anytime
if the patients are not physically fit. In addition, the innovation suggests that trained
patients or relatives will be the main abdominal massage performers while nurses act
as educators. Time spent by nurses on the innovation and the interference on normal
routine nursing work will be minimized in despite of the implementation of the
innovation. It is more feasible to implement the innovation, which gain support from
nurses.
3.4.3 Resistance to implement
Despite of support from administration and nurses, major pockets of resistance needed
to be identified before implementation. From the perspective of the physicians, since
abdominal massage is only a complement therapy to laxatives in constipation
management and does not have an obvious effect in short term, they may devalue the
innovation. Hence, it is essential to explain the effectiveness of abdominal massage
with evidence-based support to the physicians in order to gain their support.
Besides, nurses’ competence and compliance are also important factors to influence the
success of the innovation. Competence in mastering abdominal massage skills may
not be a barrier as abdominal massage only included four simple steps, which are easy
to master via a training session. Also, the training session will be held during working
hours, no extra time will be needed for nurses to spend. However, extra workload will
be predicted for nurses to supervise relatives to return demonstration of abdominal
28
massage skills. Also, if relatives are not available to perform abdominal massage on
that day, nurses may need to perform instead. Therefore, fully understand of the
effectiveness of abdominal massage, open communication and resource allocation are
key strategies to ensure the success.
3.4.4 Equipment needed
Referring to the equipment and facilities needed for the innovation, no additional
material is needed to purchase. Although cushions are needed to put under shoulder
and head to increase the comfort of the patients during abdominal massage, small
pillows in ward can be replaced. Hence, the materials needed to prepare will be the
production of DVDs and the pamphlets of abdominal massage skills for patients and
relatives, evaluation form including CAS and bowel habit charts. CAS was chosen
since it was well developed and already used in Hong Kong for measuring constipation
symptoms. It had a good reliability (0.86) and validity (0.83) (Lai et al., 2011).
3.5 Cost-Benefit Ratio of the innovation
In order to provide the innovation to patients with the maximum benefit at the lowest
risk and cost (Kristina et al., 2010), cost-benefit ratio of the innovation will be analyzed.
3.5.1 Potential risks and benefits of the innovation
In term of benefit of the innovation, patients are the most beneficial party. The main
benefit is to reduce the constipation symptoms among medical patients in long term.
Implementing the innovation by an evidence-based protocol can provide a standard
nursing care to patients so as to control the practice variation and ensure the
effectiveness of the innovation. Besides, for nurses, it may increase nurses’ images
and working satisfaction due to increase capability to manage constipation. For
29
organization, it may establish an image of endeavor in providing quality of services and
thus enhance reputation in the community. On the other hand, in term of risk of the
innovation, there is any risks to be reported during abdominal massage based on the
previous studies (Doreen et al., 2011; Emly et al., 1998; Kristina et al., 2009; Lai et al.,
2011).
3.5.2 Potential risks of maintaining current practices
However, if the innovation does not be introduced, patients may continue to suffer from
constipation symptoms and organization need to support the huge healthcare cost on
management of constipation. For patients, a qualitative research (Kock and Hudson,
2000) showed that patients experienced unpleasant physical symptoms, for instance,
nausea, cramps and bloating due to the use of laxatives. Another study (Friedrichsen
& Erichsen, 2004) pointed out that constipation affected the whole body of cancer
patients, causing them distress. For organization, based on the data in the USA in
2001 (Joyce, 2002), there were 5.7 millions of people seeking ambulatory for help due
to constipation, which costed US$235 million for a year. It is time to face squarely on
the management of constipation and implement evidence-based innovation. Although
abdominal massage may not have an immediate effect, it was proved to improve
patients’ constipation symptoms in long term.
3.5.3 Potential material costs
For material costs, concerning healthcare cost spent on the innovation, they can be
divided into two categories of expenses, personnel expenses and material expenses (see
Appendix 13). Personnel expenses included frontline staffs’ working hours used
during the innovation, for example, having a training session, supervising relatives’
return-demonstration skills and performing abdominal massage by nurses. To run the
30
innovation, two APNs act as supervisors, which is estimated to use 108 hours per year.
Two RN act as coordinators to prepare materials, including producing DVDs of
abdominal massage skills and pamphlets for patients and relatives & holding a training
session to frontline staffs, which is estimated to use 104 hours per year. 11 RNs, 3
ENs and 1 MO will attend a 1 hour one-off training session before implementing the
innovation. The extra time needed for nurses to perform abdominal skills and
supervise return-demonstration by patients or relatives, is estimated to use two hours
for each new patient. Therefore, the total time spent to perform the innovation is 270
hours per year. To sum up, the overall time spent by all nursing staffs and a MO will
be 588.5 hours, which is estimated $103,647 per year. By adding up the material costs
including printing of evaluation forms, abdominal massage guidelines, pamphlets and
program progress report, which is estimated $2000, the total expenditure of the
innovation is estimated $ 105,647 annually. In long run, the total expenditure will be
reduced to $ 69,500 while the total time spent will be reduced to 378 hours per year.
3.5.4 Potential non-material costs
It is difficult to measure non-material costs, but it cannot be underestimated as it may
act as resistance force on the innovation. Non-material costs includes disruption in
routine work and nurses reluctant to change. They may lower the staff morale, which
affect nurses working performance and thus reduce in service quality. Periodic
evaluation of the innovation is needed to address the problem and modify the practice.
To conclude, the benefit of abdominal massage outweigh its risks and the costs,
abdominal massage has a high chance to be implemented in the target medical ward
successfully. Through understanding the transferability and feasibility of the
innovation, abdominal massage has a great potential to become an evidence-based
31
nursing care.
3.6 Evidence-based protocol
After discussing the implementation potential, an evidence-based protocol will then be
developed with graded evidence-based recommendations.
3.6.1 Background
Constipation was one of the most common complaints in hospitals, which occupied one
of the top three most distressing symptoms and thus affected the well-being of the
patients. It affected over a half of patients in hospitals. The traditional constipation
management was mainly provision of laxatives regularly. However, several RCTs
already proved that abdominal massage can significantly reduce the symptoms of
constipation and increase daily bowel open.
In Hong Kong, there is any abdominal massage provided to medical patients to reduce
their constipation symptoms. After reviewing the transferability, feasibility and cost-
benefit ratio of the abdominal massage from the studies into clinical practice, an
evidence-based protocol is then established.
Based on the Scottish Intercollegiate Guidelines Network (SIGN) (Harbour, 2008), the
level of evidence of each study will be given and seven recommendations for this
protocol will be graded (see Appendix 11).
3.6.2 Title of the Evidence-based Practice Protocol
An Evidence-based protocol on using abdominal massage in management of
constipation among medical patients.
32
3.6.3 Target Population
Medical patients in hospital with the following inclusion criteria:
-Aged 50 to 70 years old
-Fulfilled Rome II criteria for constipation (see Appendix 10)
-No medical history of Crohn’s disease, diverticular disease, colon cancer, rectal
bleeding or recent change in bowel function
-Able to read and listen Cantonese or English
3.6.4 Target Users of the Protocol
The target users are nurses working in medical ward in hospital.
3.6.5 Aim of the Protocol
To provide proper abdominal massage skills to constipation patients in medical ward
so as to maintain the quality of care and enhance the innovation outcome.
3.6.6 Objectives of the Protocol
1. To standardize the abdominal massage skills to constipation patients with evidence-
based support
2. To educate constipation patients and their relatives about proper abdominal massage
skills
3. To reduce the constipation symptoms of the patients
4. To increase daily bowel open of constipation patients
5. To enhance patients’ satisfaction on service provided
3.6.7 Practice Recommendations
33
Recommendation 1 (A)
The duration of abdominal massage per each session should be at least 15 minutes.
Evidence:
Two RCTs showed that the abdominal massage performed at least 15 minutes
demonstrated significantly reduction in constipation symptoms and increase in daily
bowel open. (Doreen et al., 2011, Kristina et al., 2009; 1+, 1+)
Recommendation 2 (A)
The abdominal massage should be performed daily for at least 4 consecutive weeks.
Evidence:
Abdominal massage do not have an immediate effect, so a study had abdominal
massage in consecutive 5 days showed an increase in daily bowel open only (Lai et al.,
2011; 1+). However, a RCT showed that abdominal massage was performed in
consecutive 4 weeks showed both reduction in constipation symptoms and increase in
daily bowel open (Doreen et al., 2011; 1+). In addition, another RCT also showed
positive outcomes when abdominal massage was performed in consecutive 8 weeks.
Thus, it illustrated that abdominal massage should be performed in long term. (Kristina
et al., 2009; 1+)
Recommendation 3 (A)
The patient should be positioned supine with shoulder and head supported.
Evidence:
A comfortable environment was given to the patients in order to enhance their
relaxation. (Doreen et al., 2011, Emly et al., 1998, Kristina et al., 2009; 1+, 1-, 1+)
Recommendation 4 (A)
34
The abdominal massage should include four basic stokes, including stoking, effleurage,
kneading and vibration.
Evidence:
A standardized series of stimulating strokes could be performed on large intestine to
propel the faecal matter along the gut to the rectum and break up faecal matter.
Besides, a standardized series of relaxing strokes could be performed over the
abdominal wall to relieve flatus. (Doreen et al., 2011, Emly et al., 1998, Kristina et al.,
2009; 1+, 1-, 1+)
Recommendation 5 (A)
Either trained nurses, patients or relatives can perform the abdominal massage.
Evidence:
A RCT allowed both trained nurses, patients and relatives to perform abdominal
massage. It showed significantly reduction in constipation symptoms and increase in
daily bowel open (Doreen et al., 2011; 1+) while the other RCT also showed
significantly increase in daily bowel open (Emly et al., 1998; 1-).
Recommendation 6 (B)
The patients and their relatives should be educated the abdominal massage skills by
trained nurses and return demonstration should be provided to them.
Evidence:
Since there is a rapport between nurses and patients and their relatives, nurses can act
as an educator to teach them the abdominal massage skills. Patients and relatives are
more willing to learn and ask questions if they do not understand. Also, return
demonstration by patients and relatives can make sure their proper skills. (Doreen et al.,
2011, 1+)
35
Recommendation 7 (B)
A teaching DVD which demonstrated the proper abdominal massage skills should be
provided to the patients and their relatives for learning and revision.
Evidence:
A teaching DVD can teach and remind patients and their relatives the steps of the
abdominal massage skills, which can reduce the extra time that nurses needed to re-
educate them. (Doreen et al., 2011, 1+)
36
Chapter 4
Implementation Plan
In the previous chapter, the implementation potential of the innovation was confirmed
and the evidence-based protocol for using abdominal massage in management of
constipation among medical patients was established. To ensure the implementation
of the innovation effectively and smoothly into the current practice, a comprehensive
implementation plan will be discussed in this chapter, including a detail communication
plan with all stakeholders, a pilot study plan to evaluate its feasibility and the evaluation
plan to evaluate the innovation.
4.1 Communication Plan
4.1.1 Identifying the stakeholders
To strive the success of the innovation, it is crucial to identify all the potential
stakeholders, understand their interests and expectation in order to get their engagement
and avoid conflicts. All the potential stakeholders can be grouped into three major
categories, including the administrators, the frontline staffs and the patients.
The administrators such as the Chief of Service (COS), the Department Operation
Manager (DOM) and the WM are the influential stakeholders. Since they need to
monitor the safety and the cost-effectiveness of the service, it is necessary to get their
approval and support before implementation of the innovation. Besides, by getting
their support, resources and manpower can be allocated easily to enhance the success
of the innovation. Furthermore, COS can act as a bridge to communicate with the MO
to cooperate in the innovation and give feedback afterward.
37
Another key stakeholders are frontline staffs including the MO, 2 APNs, 11 RNs and 3
ENs. The MO can provide professional advice and feedback on abdominal massage
protocol. 2 APNs are responsible to conduct audits clinically to maintain the quality
of the innovation. 11 RNs and 3 ENs are responsible to assess the constipation
patients, perform abdominal massage and teach the skills to patients and relatives.
Their active participation and standardized performance are main factors to affect the
outcomes of the innovation.
Finally, the patients are also one of our stakeholders. Since they are the consumers of
the service, letting them understand the benefit and the risk of the innovation, is a way
to encourage them to participate into the innovation and evaluate the innovation.
4.1.2 The process of communication plan
To implement the innovation, good communication to all the stakeholders are important.
Communicating with different parties step by step are needed to plan in order to strive
for the implementation of the innovation smoothly (see Appendix 14).
At first, informal meetings can be held within frontline nurses during tea or lunch time.
During the informal meeting, the innovation and protocol are introduced briefly with
evidence-based, benefit and risk of the innovation are explained, the amount of extra
workload and difficulties are predicted & training and resource are allocated. This
informal meeting not only to gain their support and feedback of the innovation, but also
understand their concerns and worry. Besides, it can help to search and invite RNs
who are interested in the innovation as a working group member.
38
After getting feedback and support from frontline nurses, it is time to gain approval
from administrators before implementing the innovation. The first administrator to
communicate is WM. An e-mail with a full proposal is sent. The contents of the e-
mail include introducing the innovation and protocol in detail, supporting with
evidence-based, providing potential benefit with low risk and cost & explaining the
transferability and feasibility of the innovation. A formal presentation can be given
to answer WM’s enquires and elaborate the innovation in detail. It aims to gain her
support, feedback and approval and help to allocate resource. Also, WM can act as a
bridge to introduce the innovation to COS and coordinate with nurses.
When WM accepts the idea of the innovation, the next step is to gain support, feedback
and approval from COS as he is the ultimate decision maker on the implementation of
this innovation. An e-mail and a formal presentation are given to him via WM. The
content is the same as that to WM. If COS accepts the idea, he can help to coordinate
with the MO and allocate resources. Hence, the implementation of the innovation can
be started to progress.
After getting the approval from the administrators, it is right time to convey the concrete
implementation of the innovation to the frontline staffs, including the MO and nurses.
For communicating with the MO, e-mail can be sent and 30mins presentation can be
given by a Working Group (WG) in the staff meeting held by COS. Both the contents
of the e-mail and presentation are related to the innovation and protocol with evidence-
based, benefit and risk of the innovation and emphasizing on no extra workload for the
MO needed. Thus, cooperation and support may be gained.
At the same time, for communicating with 11 RNs and 3 ENs, e-mails can be sent and
39
30mins presentation can be given by a WG in the staff meeting held by WM. Both
the contents of the e-mail and presentation are related to explain the flow and contents
of the protocol, provide the time frame to implement the innovation & arrange training
session so that they are able to perform the innovation coherently.
4.1.3 Initiating, guiding and sustaining the change
A WG consists of 2APNs and 2RNs, is formed. Within a month, WG is responsible
to prepare the materials needed during the implementation, such as the contents of
training session, a DVD of abdominal massage skills, pamphlets to relatives and
patients & evaluation materials. After that, the WG holds a training session and staffs
need to perform return-demonstration to committees, which can ensure staffs to
perform standard abdominal massage skills.
After approximately three months on communication with different parties and
preparation of the materials needed, two months pilot study is then started. Pamphlets
can be used to communicate with both relatives and patients to introduce the innovation.
The WG holds monthly meeting to monitor progress within the planned time frame, on-
going evaluating the innovation, removing any obstacles, refining innovation and
regular reporting to WM. When two months pilot study is finished, data will be
collected and the outcomes of the innovation will be evaluated for a month.
4.2 Pilot Study Plan
A pilot study should be planned and started after establishing the complete
communication plan. It is essential to have a trial run before the full scale
implementation of the innovation to test the feasibility of the innovation.
40
4.2.1 Objectives
1) To identify any unexpected difficulties by receiving stakeholders’ feedback
2) To understand the stakeholders’ readiness to change by receiving their feedback
3) To evaluate the outcomes of the innovation by using evaluation forms
4) To evaluate and refine the protocol
5) To calculate the sample size in full scale implementation of the innovation by
obtaining information
4.2.2 Target population
The pilot study is held in a medical ward and the sample size is approximately 30 by
using convenience sampling. The inclusion criteria is as follow, which is the same as
that mentioned in Chapter 3.
The inclusion criteria of target population:
-Medical patients
-Aged 50 to 70 years old
-Fulfilled Rome II criteria for constipation (see Appendix 10)
-No medical history of Crohn’s disease, diverticular disease, colon cancer, rectal
bleeding or recent change in bowel function
-Able to read and listen Cantonese or English
4.2.3 Time frame
Before the pilot study, the WG should have a month to prepare the material needed,
including the contents of training session, a DVD of abdominal massage skills,
pamphlets to relatives and patients & evaluation materials. The WG should hold a
training session and ensure nurses to perform return-demonstration in the following two
41
weeks. The pilot study will then be started and last for two months. The number of
target patients will be estimated as 15 per month, which was mentioned in Chapter 3.
Therefore, 30 patients should be recruited in first two months, who will then receive
abdominal massage therapy at least 4 consecutive weeks.
4.2.4 Method
The pilot study will follow the protocol as mentioned in Chapter 3. The target patients
will be invited to participate in the innovation by team nurses with pamphlets provided.
The pamphlets will mention the innovation provided, risks and benefits of the
innovation and the simple steps of self-abdominal massage skills. Before the
implementation of the innovation, verbal consents will be obtained from patients and
CAS, Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979) (see Appendix
15) and bowel habit charts will be done as pre-test.
A DVD of abdominal massage skills will be played to recruited patients or their
relatives, which shows the abdominal massage skills step by step. They are stoking,
effleurage, kneading and vibration. The whole abdominal massage will be taken for
about 15 minutes. After that, re-demonstration done by either patients or relatives will
be evaluated by each team nurses to ensure their abdominal massage skills reach the
standard. Patients or relatives are responsible to perform abdominal massage daily for
4 consecutive weeks. The same sets of questionnaire will be done at week 4 as post-
test.
4.2.5 Pilot study evaluation
In the pilot study, the feasibility of the innovation, the stakeholders’ acceptance and the
nursing competence in mastering abdominal massage and the study outcomes should
42
be reviewed to refine the clinical protocol.
The feasibility of the innovation can be reviewed by analyzing the difficulties
encountered, for instance, the insufficiency of manpower and resources or the
inappropriateness of time management. Besides, to evaluate the stakeholders’
acceptance, feedback should be got from different parties in order to refine the
innovation. Moreover, nursing competence in mastering abdominal massage should
be audited by the WG to determine whether the training is sufficient or not. For
reviewing study outcomes, it is necessary to show how significance the result is. After
the pilot study evaluation, a formal report with suggestions will be handed in to the
administrators to get the approval for further full-scale implementation of the
innovation.
4.3 Evaluation Plan
It is crucial to prove the effectiveness of abdominal massage on constipation
management among medical patients from evidence-based research into current
practice. The goal is to gain the majority of stakeholders’ support to sustain the
innovation. Therefore, evaluation plan will be developed to assess the proper sample
size calculation, the evaluation designs, the data collected and analysis, the outcomes
to be achieved and the criteria to be a successful innovation.
4.3.1 Outcomes to be achieved
In Chapter three, the objectives of the protocol were mentioned. They are to
standardize the abdominal massage skills to constipation patients with evidence-based
support, educate constipation patients and their relatives about proper abdominal
massage skills, reduce the constipation symptoms of the patients and increase daily
43
bowel open of constipation patients. Patient outcomes, healthcare provider outcomes
and system outcomes will be discussed according to the above objectives.
Patient outcomes
The primary outcome is to reduce the constipation symptoms among medical patients,
which is assessed by using CAS before and after the innovation. It is an 8-item tool
and the score ranges from 0-16 (see Appendix 12). The higher the score, the severity
of the constipation symptoms. CAS had a good reliability and validity and already be
used in measuring constipation symptoms in Hong Kong (Lai et al., 2011).
Healthcare provider outcomes
Since nurses are the main conductors of the protocol, their acceptance on the protocol
and competence in using the protocol will be measured. Their acceptance on the
protocol can be evaluated by sharing their experience and difficulties during regular
ward meeting while the nurses’ competence can be assessed by return-demonstration
and regular audit by the WG.
System outcomes
The patients’ satisfaction to the service is a vital factor to affect the reputation and the
image of the hospital, so it can be assessed by CSQ-8 before and after the innovation.
The CSQ-8 is an 8-item tool and the score ranges from 8-32 (see Appendix 15). CSQ-
8 had a good reliability and validity in measuring satisfaction with a wide range of
services (Larsen et al., 1979). The higher the score, the greater the patients’
satisfaction to the innovation. Thus, the better reputation and the image of the hospital
may be implied.
44
Other than patients’ satisfaction on services, the accessibility and utilization of the
innovation can also be the criteria to evaluate the system outcomes. For accessibility
of the innovation, the average time from learning abdominal massage skills to starting
the abdominal massage therapy can be evaluated. For utilization of the innovation,
the percentage of the target patients choosing abdominal massage therapy as their way
to manage constipation can be evaluated.
4.3.2 Evaluation Design
Both of the patient outcomes and system outcomes will be measured by pre and post-
test design while the healthcare provider outcomes will be assessed by group sharing.
4.3.3 Nature and number of patients involved
The inclusion criteria
Medical patients are aged 50 to 70 years old and fulfilled Rome II criteria for
constipation. They do not have any medical history of Crohn’s disease, diverticular
disease, colon cancer, rectal bleeding or recent change in bowel function, who are able
to read and listen Cantonese or English
Sample size calculation
The sample size is calculated based on the primary outcome, which is patients’ severity
of constipation symptoms in terms of CAS. It can be analyzed by paired t-test by
using a statistical software called Java Applets for Power and Sample Size (Lenth,
2006). Based on the previous study (Lai et al., 2011), the meaningful difference in
CAS is 4.16 among Hong Kong populations. By putting 15 as the sigma, 4.16 as the
true mean difference, 0.8 as the power and 0.05 as the alpha into the software, the
sample size estimated is 104. It is anticipated that 20% as the potential dropout rate,
45
a sample size will then be 130.
4.3.4 Data collection
Before the innovation, demographic data, CAS, the bowel habits chart and CSQ-8 score
will be collected from the target patients. At week 4 from the first date of the
implementing the innovation, CAS, the bowel habits chart and CSQ-8 score will be
done again. Each data collection is estimated to take 15 minutes by nurses at ward.
4.3.5 Data analysis
The Statistical Package for The Social Sciences (SPSS) version 21.0 will be used for
data analysis. For demographic data and the bowel habits chart from patients will be
presented by descriptive statistics. For quantitative data from patients, such as CAS
and CSQ-8 score, a two-tailed paired t-test will be used to compare the difference
between pre and post-test. The result is used to prove the significance of abdominal
massage on reducing constipation symptoms. For qualitative data from frontline
staffs, the feedback will be summarized and analyzed.
4.3.6 Basis for implementation
Patient Outcomes
The basis to determine the effectiveness of the innovation based on the primary
outcome with support by established data. Hence, if there is a significant reduction in
CAS for constipation symptoms, the innovation will be regard as effective. Among
the selected studies, Lai et al. (2011) showed that a decrease in mean 4.16 CAS score
can be considered as clinically significant improvement.
Other Outcomes
46
Healthcare provider outcomes and system outcomes are secondary outcomes to support
the effectiveness of the innovation. For healthcare provider outcomes, if a positive
feedback from frontline staffs is concluded, the innovation will be suggested as
effective. For system outcomes, if there is a significant increase in client service
satisfaction in terms of CSQ-8 score, the effectiveness of the innovation will be
supported.
If the above primary outcome and secondary outcomes are fulfilled, the higher chance
the innovation will be fully implemented to the medical ward in the whole hospital.
47
Chapter 5
Conclusion
Although there are different kinds of medications to treat constipation nowadays,
constipation is still a major complaint in hospitals among medical patients. Medical
patients having constipation, have already suffered a lot on both their physical and
psychosocial aspects. Researches have proved that abdominal massage is an effective
method to alleviate constipation symptoms. However, there is any evidence-based
protocol to guide nurses to perform accountable care in local setting.
Through critical appraisal of four high quality studies, abdominal massage is proved to
alleviate constipation symptoms among medical patients. By assessing
implementation potential of the innovation, the transferability, the feasibility and
cost/benefit ratio of the abdominal massage into local practice are confirmed. After
that, an evidence-based protocol is established.
In order to communicate with all the stakeholders and gain approval and support from
them, communication plan was done. Pilot study is then run to test the feasibility of
the innovation in a real situation and modifications of the innovation are made before
the full scale implementation. Finally, an evaluation plan is developed to evaluate the
effectiveness of the innovation. In the future, the innovation aims to become a usual
nursing care to relieve constipation symptoms among medical patients in all medical
wards locally.
48
Appendix 1.
PRISMA 2009 Flow Diagram Keywords: Abdominal massage and Constipation
Records identified
through database
searching
(n = 19 )(PubMed)
Scre
enin
g In
clu
ded
El
igib
ility
Id
enti
fica
tio
n
Records after duplicates removed
(n = 39 )
Records screened
(n = 39 )
Records excluded
(n = 23 )
njhj
Full-text articles assessed
for eligibility
(n = 16 )
Full-text articles excluded,
with reasons
(n = 11 )
3 studies population
included children
1 study population
included pediatric patients
1 study focus on the use of
both abdominal muscle
training, breathing
exercises and abdominal
massage
4 studies focus on the use
of meridian massage or
aromatherapy massage
Studies included in
qualitative synthesis
(n = 5 )
Records identified
through database
searching
(n = 6 )
(CINAHL PLUS)
Records identified
through database
searching
(n =25 )
(Cochrane Library)
Records identified
through database
searching
(n = 16 )
(British Nursing Index)
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.
49
Appendix 2. Table of Evidence
Topic: An Evidence-based protocol on using abdominal massage in management of constipation among medical patients.
Research questions: How efficient abdominal massage is in alleviation of constipation symptoms among medical patients?
Citation/Design Patient characteristics Intervention Control Outcomes Effect Size
(Intervention-Control)
Doreen et al.
(2011)/ RCT
(1+)
1. Mean age= 55years (SD=
13)
2. 12 male and 18 female
3. 30 patients with Multiple
sclerosis and constipation
1. Advice on bowel
management was provided.
2. Abdominal massage was
taught to and performed by
participant and carer.
3. Abdominal massage was
performed 15mins daily for 4
weeks
(n=15)
1. Advice on bowel
management was provided
only.
(n=14)
1. Constipation symptoms
-CSS (0-30)
-0,4,8 weeks
2. Bowel habits
-A bowel diary
-the number of bowel
movement (no./week)
Week 0 - 4:
1. Mean= -5.0 (95% CI-8.1 to -1.8),
p= 0.003
2. Mean= -2.2 (95%-0.98 to -0.97),
p= 0.001
Week 0 - 8:
1. Mean= =1.6 (95% CI-5.6 to 0.6),
p= 0.112
2. N/A (poorly completed)
Kristina et al.
(2009)/ RCT
(1+)
1. Mean age=63.7 years
(SD= 10.5)
2. 8 male and 50 female
3. 60 people with
constipation
1. An earlier prescribed laxative
was continued to use.
2. Abdominal massage was
performed by author and
experienced assistants 15
mins daily in 5 days per week
1. An earlier prescribed laxative
was continued to use
2. Decrease laxative use was not
instructed when
gastrointestinal function
improved
1. Gastrointestinal function
-GSRS (15-105)
-0, 4, 8 weeks
2. Bowel habits
-A bowel protocol
-the number of bowel
Week 0 - 4:
1. Mean= -0.03 (p= 0.140)
2. Mean=0.55 (p=0.377)
Week 0 - 8:
1. Mean= -0.20 (p=0.003)
50
for 8 weeks.
3. Decrease laxative use was
instructed when
gastrointestinal function
improved.
(n=26)
(n=26) movement
(no./5 days)
2. Mean=1.19 (p=0.016)
Week 4 to Week 8:
1. Mean= -0.20 (p= 0.003)
2. Mean=1.19 (p=0.096)
Lai et al.
(2011)/RCT
(1+)
1. Mean age=60.3 years
2. Gender proportion was
not mentioned
3. 30 patients with
advanced cancer and
constipation
1. An earlier prescribed laxative
was continued to use.
2. Abdominal massage was
performed by author and
trained nurses 15-20 mins
daily for 5 consecutive days.
(n=11)
1. An earlier prescribed laxative
was continued to use.
2. No massage session given
(n=8)
1. Constipation symptoms
-CAS (0-16)
-Day1 & 5
2. Bowel habits
-the number of bowel
movement (no./ 5 days)
Within groups:
(Day 5 – Day 1)
1. Intervention group:
Mean=-2.64, p= 0.718
Control group:
Mean=+1, p= 0.348
2. Mean=-1.10 (p<0.05)
Ayas et al.
(2006)/
uncontrolled
clinical study
(2-)
1. Mean age=39.8 years
2. Gender proportion was
not mentioned
3. 24 patients with spinal
cord injury and
constipation
Phase 2:
1. All patients continued on a
standard bowel program
2. Abdominal massage was
performed at least 15 mins
daily for 1 weeks
Phase1:
1. All patients on a standard
bowel program lasted for 2
weeks (Standard diet used
and all laxative discontinued)
1. Gastrointestinal symptoms
a) Difficult intestinal
evacuation
b) Fecal incontinence
c) Abdominal distention
d) Abdominal pain
2. Bowel habits
Within groups:
(Phase2 - Phase1)
1. a) -20.8% (p=0.063)
b) -25% (p=0.031)
c) -33.3% (p=0.008)
d) -20.8% (p=0.063)
51
–the number of bowel
movement
(no./week)
2. Mean=0.82 (p=0.006)
Emly et al.
(1998)/
Randomized
cross-over
design (1-)
1. Mean age=42.9 years
2. 14 male and 18 female
3. 32 patients with severe
learning disability and
constipation
1. A 16-day baseline
measurement phase without
any treatment
2. Phase 1:
Abdominal massage was
performed by trained PT,
nurses or carers 20 mins in 5
times per week for 7 weeks
3. 1 week washout period
4. Phase 2:
7 weeks of patients’ pervious
laxative regimen
(n=15)
1. A 16-day baseline
measurement phase without
any treatment
2. Phase1:
7 weeks of patients’ previous
laxative regimen
3. 1 week washout period
4. Phase 2:
Abdominal massage was
performed by trained PT,
nurses or careers 20 mins in 5
times per week for 7 weeks
(n=16)
1. Total colonic transit time
(hours)
2. Bowel habits
-the number of bowel
movement
(no./week)
Massage group first (Phase 1+2)-
laxatives group first (Phase 1+2)
1. Median=+96 (p=0.74)
2. Mean not mentioned (p=0.07)
1: Level of evidence as defined by (Scottish Intercollegiate Guidelines Network, 2014)
2: CSS= The constipation Scoring System; CI= Confidence interval; RCT= Randomized controlled trial; SD= Standard deviation, GSRS= Gastrointestinal Symptoms Rating
Scale, CAS= Constipation Assessment Scale, PT= physiotherapist
52
Appendix 3. SIGN Controlled Trials checklist for Doreen, M., Suzanne, H., Stanley,
H. & Andrea, L. S. (2011).
S I G N Methodology Checklist 2: Controlled
Trials
Study identification (Include author, title, year of publication, journal title, pages)
Doreen, M., Suzanne, H., Stanley, H. & Andrea, L. S., (2011). Abdominal massage for the alleviation of
constipation symptoms in people with multiple sclerosis: a randomized controlled feasibility study. Multiple
Sclerosis Journal, 17 (2), 223-233.
Guideline topic: How efficient abdominal massage is in
alleviation of constipation symptoms among medical
patients?
Key Question No: Reviewer:
Chow Sze Ming
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study
design algorithm available from SIGN and make sure you have the correct checklist. If it is a
controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated
higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
Section 1: Internal validity
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Note: P: Multiple Sclerosis, I: Abdominal massage, C: No
abdominal massage, O: CSS, NBDS & frequency of defaecation
Yes
Can’t say
No
53
1.2 The assignment of subjects to treatment groups is randomised.
Note: Participants were randomly allocated by the therapist using a
web-based system
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Note: Group allocation concealed using codes
Yes
Can’t say
No
1.4 The design keeps subjects and investigators ‘blind’ about treatment
allocation.
Note: The questionnaires were administered to participants via
telephone by an outcome assessor blinded to group allocation.
However, the statistician can also be blinded, but it did not blind.
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.
Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under
investigation.
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was
completed?
3.33%
Intervention: 0%
Control: 6.7%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
54
2.1
How well was the study done to minimise bias?
Code as follows:
Note: small sample size
High quality (++)
Acceptable (+)
Low quality (-)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the
statistical power of the study, are you certain
that the overall effect is due to the study
intervention?
Yes
30 participants were recommended by
consultation with a statistician in order to provide
a robust estimate of the intervention effect size to
inform sample size calculations for a definitive
randomized controlled trial.
2.3 Are the results of this study directly applicable
to the patient group targeted by this guideline?
Yes.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question and mention any areas of uncertainty raised above.
Conclusion: Abdominal massage has a positive effect on the symptoms of constipation and support
the feasibility of a substantive trial of abdominal massage. .
Comments: The statistician was not be blinded, chance of subjective bias was present. Single-center
study was used, generalizability was decreased. Small sample size was used, chance of false
positive and negative error rates were increased.
55
Appendix 4. SIGN Controlled Trials checklist for Kristina, L., Lars, L., Hans, S.,
Birgitta, E. & Catrine, J. (2009).
S I G N Methodology Checklist 2: Controlled
Trials
Study identification (Include author, title, year of publication, journal title, pages)
Kristina, L., Lars, L., Hans, S., Birgitta, E. & Catrine, J., (2009). Effects of abdominal massage in
management of constipation-A randomized controlled trial. International Journal of Nursing Studies, 46 759-
767.
Guideline topic: How efficient abdominal massage
is in alleviation of constipation symptoms among
medical patients?
Key Question No: Reviewer:
Chow Sze Ming
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study
design algorithm available from SIGN and make sure you have the correct checklist. If it is a
controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated
higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
Section 1: Internal validity
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Note: P: people with constipation, I: abdominal massage, C: No
abdominal massage, O: Decrease severity of gastrointestinal
symptoms
Yes
Can’t say
No
56
1.2 The assignment of subjects to treatment groups is randomised.
Note: By block randomization
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Note: No concealment method is reported
Yes
Can’t say
No
1.4 The design keeps subjects and investigators ‘blind’ about treatment
allocation.
Note: The statisticians can be blinded
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.
Note: A significant difference at baseline between groups regarding
constipation syndrome assessed with GSRS. No significant
differences were found regarding GSRS total score.
Yes
Can’t say □
No
1.6 The only difference between groups is the treatment under
investigation.
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.
GSRS has not been validated but has been used earlier in relation to
constipation.
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was
completed?
13.33%
Intervention:13.33%
Control: 13.33%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
57
2.1
How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Low quality (-)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the
statistical power of the study, are you certain
that the overall effect is due to the study
intervention?
Yes.
Power calculation and statistical procedure were
clearly stated.
2.3 Are the results of this study directly applicable
to the patient group targeted by this guideline?
Yes.
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question and mention any areas of uncertainty raised above.
Conclusion: Abdominal massage decreases severity of gastrointestinal symptoms associated with
constipation and abdominal pain syndrome and increase number of bowel movements.
Abdominal massage did not lead to a decrease in laxative intake.
Comment: No concealment was reported, chance of performance bias was present. The statistician
was not be blinded, chance of subjective bias was present. Single-center study was used,
generalizability of the result may decrease. GSRS had not been validated, chance of measurement
bias was present. Difference at baseline characteristic of groups, the result may be invalid.
58
Appendix 5. SIGN Controlled Trials checklist for Lai, T. K. T, Cheung, M. C., Lo, C.
K., Ng, K. L., Fung, Y. H., Tong, M. & Yau, C.C. (2011).
S I G N Methodology Checklist 2: Controlled
Trials
Study identification (Include author, title, year of publication, journal title, pages)
Lai, T. K. T, Cheung, M. C., Lo, C. K., Ng, K. L., Fung, Y. H., Tong, M. & Yau, C.C., (2011). Effectiveness
of aroma massage on advanced cancer patients with constipation: A pilot study. Complementary Therapies in
Clinical Practice, 17 37-43.
Guideline topic: How efficient abdominal massage is in
alleviation of constipation symptoms among medical
patients?
Key Question No: Reviewer:
Chow Sze Ming
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study
design algorithm available from SIGN and make sure you have the correct checklist. If it is a
controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated
higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
Section 1: Internal validity
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Note: P: Advanced cancer, I: Aroma massage & plain massage, C:
No abdominal massage, O: CAS, MQOL-HK & frequency of bowel
Yes
Can’t say
No
59
opens
1.2 The assignment of subjects to treatment groups is randomised.
Note: Eligible subjects were randomly selected into relevant groups
using a random number generator
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Yes
Can’t say
No
1.4 The design keeps subjects and investigators ‘blind’ about treatment
allocation.
Note: Statisticians can be blinded, but not blinded in this research.
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial.
Yes
Can’t say
No
1.6 The only difference between groups is the treatment under
investigation.
Note: No data addressing the use of opioids and laxatives, but any
adjusting dosage of opioids and laxatives, data was removed from
the study in order to avoid contamination of the data.
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.
Note: the severity level of constipation is measured by constipation
assessment scale
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was
completed?
36.67%
Intervention group:
26.67%
Control group: 46.67%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.
Note: there is only one site.
Yes
Can’t say
No
Does not apply
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
60
2.1
How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Low quality (-)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the
statistical power of the study, are you certain
that the overall effect is due to the study
intervention?
No
No sample size calculation and statistical power
were mentioned.
2.3 Are the results of this study directly applicable
to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question and mention any areas of uncertainty raised above.
Conclusion: Abdominal massage did not have significantly improvement on constipation in patients
with advanced cancer, but only increase the number of bowel movement.
Comments: No concealment was reported, chance of allocation bias was present. The statistician
was not be blinded, chance of subjective bias was present. Single-center study was used,
generalizability may decrease. Small sample size was used, chance of false positive and negative
error rates increased. The dropout rate was relatively high and the massage period is too short.
61
Appendix 6. SIGN Cohort studies checklist for Ayas, S., Leblebici, B., Sozay, S.,
Bayramoglu, M. & Niron, EA. (2006).
S I G N Methodology Checklist 3: Cohort studies
Study identification (Include author, title, year of publication, journal title, pages)
Ayas, S., Leblebici, B., Sozay, S., Bayramoglu, M. & Niron, EA., (2006). The effect of abdominal massage on
bowel function in patients with spinal cord injury. American Journal of Physical Medicine & Rehabilitation,
85 951-955.
Guideline topic: How efficient abdominal massage is in alleviation
of constipation symptoms among medical patients?
Key Question No: Reviewer:
Chow Sze
Ming
Before completing this checklist, consider:
1. Is the paper really a cohort study? If in doubt, check the study design algorithm available from SIGN
and make sure you have the correct checklist.
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist..
Reason for rejection: 1. Paper not relevant to key question □ 2. Other reason □ (please specify):
Please note that a retrospective study (ie a database or chart study) cannot be rated higher than +.
Section 1: Internal validity
In a well conducted cohort study: Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.i
P: Spinal Cord Injury, I: abdominal massage, C: a standard bowel program,
O: bowel dysfunction and colonic transit time
Yes
Can’t say □
No □
SELECTION OF SUBJECTS
62
1.2 The two groups being studied are selected from source populations that are
comparable in all respects other than the factor under investigation.ii
Notes: The study was conducted within group.
Yes □
Can’t say
No □
Does not
apply
1.3 The study indicates how many of the people asked to take part did so, in each
of the groups being studied.iii
Yes
No
Does not
apply □
1.4 The likelihood that some eligible subjects might have the outcome at the
time of enrolment is assessed and taken into account in the analysis.iv
Patients in phase1 act as a baseline of initial bowel dysfunction and colonic
transit time.
Yes
Can’t say □
No □
Does not
apply □
1.5 What percentage of individuals or clusters recruited into each arm of the
study dropped out before the study was completed.v
0%
1.6 Comparison is made between full participants and those lost to follow up, by
exposure status.vi
Notes: drop-out rate is 0%.
Yes □
Can’t say □
No □
Does not
apply
ASSESSMENT
1.7 The outcomes are clearly defined.vii Yes
Can’t say □
No □
1.8 The assessment of outcome is made blind to exposure status. If the study is
retrospective this may not be applicable.viii
Notes: There is only one group.
Yes □
Can’t say □
No □
Does not
apply
1.9 Where blinding was not possible, there is some recognition that knowledge
of exposure status could have influenced the assessment of outcome.ix Yes
Can’t say □
No
□
63
1.10 The method of assessment of exposure is reliable.x
Note: The measures used are clearly defined, but the degree of accuracy was
unknown.
Yes
Can’t say
No □
1.11 Evidence from other sources is used to demonstrate that the method of
outcome assessment is valid and reliable.xi
Note: The measures used are completely objective, but not mention clearly
Yes □
Can’t say
No □
Does not
apply
1.12 Exposure level or prognostic factor is assessed more than once.xii
Note: no indication of exposure was measured
Yes □
Can’t say
No □
Does not
apply
CONFOUNDING
1.13 The main potential confounders are identified and taken into account in the
design and analysis.xiii
Note: A standard diet and all laxatives, suppositories and enemas are
controlled in the study
Yes
Can’t say □
No □
STATISTICAL ANALYSIS
1.14 Have confidence intervals been provided?xiv Yes □ No
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1 How well was the study done to minimise the risk of bias or confounding?xv
High quality (++) □
Acceptable (+)
Unacceptable – reject
2.2 Taking into account clinical considerations, your evaluation of the
methodology used, and the statistical power of the study, do you think there
is clear evidence of an association between exposure and outcome?
Note: uncontrolled clinical study may cause sampling bias
Yes
Can’t say
No
2.3 Are the results of this study directly applicable to the patient group targeted
in this guideline? Yes No
64
2.4 Notes. Summarise the authors conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question and mention any areas of uncertainty raised above.
Conclusion: Abdominal massage has positive effects on some clinical aspects of neurogenic bowel
dysfunction in patients with spinal cord injury.
Comment: No concealment was reported, chance of allocation bias was present. No randomization
was used, chance of overestimation of the result was present. The statistician was not be blinded,
chance of subjective bias was present. Single-center study was used, generalizability may decreased.
Small sample size was used, chance of false positive and negative error rates increased. The validity
and reliability of objective data was not confirmed, chance of measurement bias was present.
65
Appendix 7. SIGN Controlled Trials checklist for Emly, M., Cooper, S. & Vail (1998)
S I G N Methodology Checklist 2: Controlled
Trials
Study identification (Include author, title, year of publication, journal title, pages)
Emly, M., Cooper, S. & Vail (1998). Colonic Motility in Profoundly Disabled People: A comparison of
massage and laxative therapy in the management of constipation. Physiotherpay, 84 (4), 178-183.
Guideline topic: How efficient abdominal massage is in
alleviation of constipation symptoms among medical
patients?
Key Question No: Reviewer:
Chow Sze Ming
Before completing this checklist, consider:
1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study
design algorithm available from SIGN and make sure you have the correct checklist. If it is a
controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated
higher than 1+
2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention
Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.
Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):
Section 1: Internal validity
In a well conducted RCT study…
Does this study do it?
1.1 The study addresses an appropriate and clearly focused question.
Note: P: severity learning disability patients with constipation, I:
abdominal first in Phase 1 and vice versa with control group in
Phase 2, C:laxative first in Phase 1 and vice versa with intervention
group in Phase 2, O: total colonic transit times and no. of bowel
movement per week
Yes
Can’t say
No
66
1.2 The assignment of subjects to treatment groups is randomised.
Note: Randomisation is mentioned but method not specified
Yes
Can’t say
No
1.3 An adequate concealment method is used.
Note: No concealment was mentioned
Yes
Can’t say
No
1.4 The design keeps subjects and investigators ‘blind’ about treatment
allocation.
Note: the two treatment regimens were evaluated solely in relation
to each other, no attempt was made to evaluate either treatment in
absolute terms
Yes
Can’t say
No
1.5 The treatment and control groups are similar at the start of the trial. Yes
Can’t say
No
1.6 The only difference between groups is the treatment under
investigation.
Note: A standardized series of abdominal massage was established
and the subjects had no change in their regular daily lives regarding
diet, levels of fluid intake, the use or non-use of toilet facilities and
leisure and social activities.
Yes
Can’t say
No
1.7 All relevant outcomes are measured in a standard, valid and reliable
way.
Note: the source of outcome measures were mentioned without
stating the validity and reliability
Yes
Can’t say
No
1.8 What percentage of the individuals or clusters recruited into each
treatment arm of the study dropped out before the study was
completed?
3.33%
Massage group
first:6.67%
Laxative group first: 0%
1.9 All the subjects are analysed in the groups to which they were
randomly allocated (often referred to as intention to treat analysis).
Yes
Can’t say
No
Does not apply
1.10 Where the study is carried out at more than one site, results are
comparable for all sites.
Yes
Can’t say
No
Does not apply
67
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1
How well was the study done to minimise bias?
Code as follows:
High quality (++)
Acceptable (+)
Low quality (-)
Unacceptable – reject 0
2.2 Taking into account clinical considerations, your
evaluation of the methodology used, and the
statistical power of the study, are you certain
that the overall effect is due to the study
intervention?
No
More than 80% statistical power was used.
However, no sample size calculation was done.
2.3 Are the results of this study directly applicable
to the patient group targeted by this guideline?
Yes
2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study,
and the extent to which it answers your question and mention any areas of uncertainty raised above.
Conclusion: The effects of laxative and massage therapy within this environment were not
demonstrably different.
Comment: No concealment was reported, chance of allocation bias was present. Unclear
randomization was mentioned, chance of overestimation of the result was present. Unclear blinding
level was mentioned, chance of subjective bias was present. Single center study was used,
generalizability may be decreased. Small sample size was used, chance of false positive and
negative error rates increased. The validity and reliability of objective data was not confirmed,
chance of measurement bias was present.
68
Appendix 8. Tables of SIGN comparison
Section1: Internal validity
Paper Clarity of
Focused
Question
Randomized
Allocation
Adequate
Concealment
Double “Blind”
Treatment
Allocation
Similarity
between
groups
Treatment
as the only
difference
Valid
Measurement
of Outcomes
Dropped
out rate
Intention
to treat
analysis
Comparable
results at all
sites
Doreen
et al.
(2011)
Yes Yes
Web-based
system
Yes
Concealed
using codes
No
Phone
questionnaire by
an outcome
assessor blinded,
but the statistician
can be blinded.
Yes Yes Yes 3.33%
I: 0%
C: 6.67%
No No
Kristina
et al.
(2009)
Yes Yes
Block
randomization
No
Not reported
No
The statisticians
can be blinded
No
Difference
at
constipation
syndrome at
baseline
Yes No
GSRS has not
been validated
13.33%
I: 13.33%
C: 13.33%
Yes No
Lai et al.
(2011)
Yes Yes
Random
number
generator
No
Not reported
No
The statisticians
can be blinded
Yes Yes Yes
CAS has
Reliability
(0.86)
36.67%
I: 26.67%
C:46.67%
No No
69
Validity (0.83)
Ayas et
al.
(2006)
Yes No No No Can’t say
The study
conducted
within
groups
Yes Can’t say
Objective
measurement
data
0% NA No
Emly et
al.
(1998)
Yes Can’t say
Randomization
method not
specified
No Can’t say
Not mentioned in
detail
Yes Yes Can’t say
Objective
measurement
data
3.33%
Massage
group
first:6.67%
Laxative
group first:
0%
Yes No
70
Section2: Overall assessment of the study
Paper Quality
rating
Effect due to
Intervention
Result
directly
applicable to
target group
Conclusion Any bias
Doreen et
al. (2011)
+ Yes Yes Abdominal massage has a positive effect
on the symptoms of constipation and
support the feasibility of a substantive
trial of abdominal massage.
1. The statistician not be blinded, chance of subjective
bias.
2. Single center study, decrease in generalizability.
3. Small sample size, chance of false positive and
negative error rates increased.
Kristina et
al. (2009)
+ Yes Yes Abdominal massage decreases severity of
gastrointestinal symptoms associated
with constipation and abdominal pain
syndrome and increase number of bowel
movements.
Abdominal massage did not lead to a
decrease in laxative intake.
1. No concealment was reported, chance of allocation
bias.
2. The statistician not be blinded, chance of subjective
bias.
3. Single center study, decrease in generalizability.
4. GSRS has not been validated, chance of measurement
bias.
5. Difference at baseline characteristic of groups, the
result may invalid.
Lai et al.
(2011)
+ No
No sample
size
Yes Abdominal massage did not have
significantly improvement on
constipation in patients with advanced
1. No concealment was reported, chance of allocation
bias.
2. The statistician not be blinded, chance of subjective
71
calculation
and
statistical
power
mentioned
cancer, but only increase the number of
bowel movement.
bias.
3. Single center study, decrease in generalizability.
4. Small sample size, chance of false positive and
negative error rates increased.
5. The dropout rate is relatively high and the massage
period is too short.
Ayas et al.
(2006)
- Can’t say
Uncontrolled
clinical
study
No Abdominal massage has positive effects
on some clinical aspects of neurogenic
bowel dysfunction in patients with spinal
cord injury.
1. No concealment was reported, chance of allocation
bias.
2. No randomization used, chance of overestimation of
the result.
3. The statistician not be blinded, chance of subjective
bias.
4. Single center study, decrease in generalizability.
5. Small sample size, chance of false positive and
negative error rates increased.
6. The validity and reliability of objective data was not
confirmed, chance of measurement bias.
Emly et al.
(1998)
+ No
No sample
size
calculation,
but 80%
Yes The effects of laxative and massage
therapy within this environment were not
demonstrably different.
1. No concealment was reported, chance of allocation
bias.
2. Unclear randomization, chance of overestimation of
the result.
3. Unclear blinding level was mentioned, chance of
72
statistical
power was
used
subjective bias.
4. Single center study, decrease in generalizability.
5. Small sample size, chance of false positive and
negative error rates increased.
6. The validity and reliability of objective data was not
confirmed, chance of measurement bias.
I: intervention group; C: control group; GSRS= Gastrointestinal Symptoms Rating Scale
73
Appendix 9. Reference of four selected studies
Studies Design
Doreen, M., Suzanne, H., Stanley, H. & Andrea, L. S., (2011). Abdominal
massage for the alleviation of constipation symptoms in people with multiple
sclerosis: a randomized controlled feasibility study. Multiple Sclerosis
Journal, 17 (2), 223-233.
RCT
Emly, M., Cooper, S. & Vail (1998). Colonic Motility in Profoundly Disabled
People: A comparison of massage and laxative therapy in the management of
constipation. Physiotherpay, 84 (4), 178-183.
RCT
Kristina, L., Lars, L., Hans, S., Birgitta, E. & Catrine, J., (2009). Effects of
abdominal massage in management of constipation-A randomized controlled
trial. International Journal of Nursing Studies, 46 759-767.
RCT
Lai, T. K. T, Cheung, M. C., Lo, C. K., Ng, K. L., Fung, Y. H., Tong, M. &
Yau, C.C., (2011). Effectiveness of aroma massage on advanced cancer
patients with constipation: A pilot study. Complementary Therapies in
Clinical Practice, 17 37-43.
RCT
74
Appendix 10. Rome II Diagnostic Criteria for Functional Constipation
Diagnostic criteria*
1. Must include two or more of the following:
a. Straining during at least 25% of
defecations
b. Lumpy or hard stools in at least 25% of
defecations
c. Sensation of incomplete evacuation for
at least 25% of defecations
d. Sensation of anorectal obstruction/
blockage for at least 25% of defecations
e. Manual maneuvers to facilitate at
least 25% of defecations (e.g., digital
evacuation, support of the pelvic floor)
f. Fewer than three defecations per week
2. Loose stools are rarely present without the
use of laxatives
3. Insufficient criteria for irritable bowel
Syndrome
* Criteria fulfilled for the last 3 months with
symptom onset at least 6 months prior to
diagnosis
Cited from Doreen, M., Suzanne, H., Stanley, H. & Andrea, L. S., (2011). Abdominal massage
for the alleviation of constipation symptoms in people with multiple sclerosis: a randomized
controlled feasibility study. Multiple Sclerosis Journal, 17 (2), 223-233.
75
Appendix 11. Key to evidence statements and grades of recommendations
Level of evidence
1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a
very low risk of bias
1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk
of bias
1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias
2++ High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a very low risk of
confounding or bias and a high probability that the relationship is causal
2+ Well conducted case control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relationship is
causal
2- Case control or cohort studies with a high risk of con founding or bias and
a significant risk that the relationship is not causal
3 Non-analytic studies, e.g. case reports, case series
4 Expert opinion
Grades of recommendation
A At least one meta-analysis, systematic review, or RCT rated as 1++, and
directly applicable to the target population; or
A body of evidence consisting principally of studies rated as 1+, directly
applicable to the target population, and demonstrating overall consistency
of results
B A body of evidence including studies rated as 2++, directly applicable to
the target population, and demonstration overall consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
C A body of evidence including studies rated as 2+,
directly applicable to the target population and demonstration overall
consistency of results; or Extrapolated evidence from studies rated as 2++
D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+
Good practice points
Recommended best practice based on the clinical experience of the guideline development group
76
Appendix 12. Constipation Assessment Scale (CAS)
Cited from Lai, T. K. T, Cheung, M. C., Lo, C. K., Ng, K. L., Fung, Y. H., Tong, M. & Yau, C.C.,
(2011). Effectiveness of aroma massage on advanced cancer patients with constipation: A pilot
study. Complementary Therapies in Clinical Practice, 17 37-43.
77
Appendix 13. Estimated costs for the abdominal massage protocol (Annually)
Items Time (Hour) No. of people
participate
Total time spent
(Hour)
Cost (HK$)
Personnel cost
Preparation of the
program
-Evaluation materials
- Producing DVDs and
pamphlets of
abdominal massage
skills
- Holding a training
session
-16
-16
-20
2 RNs 104 17,680
Performing abdominal
massage and supervise
return-demonstration
by patients or relatives
2 hour/patient 135 patients
(15 newly
constipation
patients/month x
9 months)
270 45,900
Staff training session 1 hour/nurse or MO 11 RNs and 3
ENs and 1 MO
15 2,552
Monitoring 1.5 hours/week
(9 months)
2 APNs 108 21,600
Evaluation of the
program
-Data entry and
analysis
-Meetings
-0.5/patient
-1 hour/meetings
(6 meetings in total)
-135 patients
-2 RNs and 2
APNs
-67.5
-24
-11,475
-4,440
Subtotal 588.5 103,647
Material cost
Printing and
photocopying
/ / / 2000
Cushions / / / Ward assets
Venue to hold
meetings and training
session
/ / / Hospital
assets
Software for analysis
data
/ / / Hospital
assets
Total 105,647
78
Appendix 14. Time frame for Communication Plan & Pilot Study Plan (6 months)
Period Event Content & purpose of the event
Week 1 Communicating with
2APNs, 11RNs and
3ENs
Informal meeting
Content:
-The innovation & protocol introduced briefly with evidence-based
-Explaining benefit & Risk of the innovation
-The amount of extra workload and difficulties predicted
-Training & resource allocated
Purpose:
-Gaining their support & feedback
-Understanding their concerns and worry
-Searching RNs interested in this innovation as a working group member
Week2-3 Communicating with
WM
E-mail & formal presentation
Content:
-The innovation and protocol introduced in detail
-Supporting the innovation with evidence-based
-Providing potential benefit with low risk and cost
-Explaining the transferability and feasibility of the innovation
Purpose:
-Gaining her support, feedback & approval
-Helping to introduce the innovation to COS
-Helping to coordinate with frontline staffs
-Allocating resource
Week4-5 Communicating with
COS
E-mail & formal presentation
Content:
-The innovation and protocol introduced in detail
-Supporting the innovation with evidence-based
-Providing potential benefit with low risk and cost
-Explaining transferability and feasibility of the innovation
Purpose:
-Gaining his support, feedback & approval
-Helping to coordinate with a MO
-Allocating resource
Week6 Forming a Working
Group (WG)
WG consist of 2APNs & 2RNs
79
Week6-7 Communicating with
the MO
E-mail & staff meeting held by COS
Content:
- The innovation and protocol introduced briefly with evidence-based
-Explaining benefit & risk of the innovation
-Providing the time frame to implement the innovation
-No extra workload needed
Purpose:
-Gaining cooperation & support
Week6-7 Communicating with
11 RNs and 3ENs
E-mail & staff meeting held by WM
Content:
- Explaining the flow & content of the protocol
-Providing the time frame to implement the innovation
-Arranging training session
Purpose:
-Frontline staffs able to perform the innovation coherently
Week 6-9 Preparing the
material needed
E.g. the content of training session, a DVD of abdominal massage skills,
pamphlets to relatives & patients, evaluation materials
Week10-
11
Holding a training
session &
performing return-
demonstration
A training session
Purpose:
-Learning and standardizing the abdominal massage skills
Return-demonstration
Purpose:
-Ensuring to perform standard abdominal massage skills
Week12 Starting the pilot
study
Communicating with
targeted patients
Recruit targeted patients
Week12-
19
Monthly WG
meetings
Purpose:
Monitoring progress within the planned time frame, evaluating the
innovation, removing any obstacles, refining the innovation and regular
reporting to WM
Week20-
23
Evaluating the pilot
study
Purpose:
Collecting data & evaluating the outcomes of the innovation
80
Appendix 15. Client Satisfaction Questionnaire (CSQ-8)
81
Cited from Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D. (1979). Assessment of
client/patient satisfaction: Development of a general scale. Evaluation and Program Planning, 2 197-207.
82
Reference
American College of Gastroenterology (2005). An Evidence-Based Approach to the
Management of Chronic Constipation in North America. American Journal of
Gastroenterology, 100 (S1-4).
Ayas, S., Leblebici, B. & Bayramoglu, M. (2006). The effect of Abdominal Massage
on Bowel Function in Patients with Spinal Cord Injury. American Journal of Physical
Medicine & Rehabilitation, 85 (12), 951-955.
Chan, O. O. (2009). Chronic Constipation. Medical Bulletin, 14 (11), 11-14.
Doreen, M., Suzanne, H., Stanley, H. & Andrea, L. S. (2011). Abdominal massage for
the alleviation of constipation symptoms in people with multiple sclerosis: a
randomized controlled feasibility study. Multiple Sclerosis Journal, 17 (2), 223-233.
Emly, M., Cooper, S. & Vail (1998). Colonic Motility in Profoundly Disabled People:
A comparison of massage and laxative therapy in the management of constipation.
Physiotherpay, 84 (4), 178-183.
Ernst, E. (1999). Abdominal Massage Therapy for Chronic Constipation: A Systematic
Review of Controlled Clinical Trials. Forsch Komplementarmed, 6 149-151.
Friedrichsen, M. & Erichsen, E. (2004). The lived experience of constipation in cancer
patients in palliative hospital-based home care. International Journal of Palliative
Nursing, 10 (7), 321-325.
Harbour, R.T. (2008). SIGN 50: A Guideline Developer’s Handbook, Edinburgh. 96
Scottish Intercollegiate Guidelines Network.
Harrington, K. L. & Haskvitz, E. M. (2006). Managing a patient's constipation with
Physical Therapy. Physical Therapy, 86 (11), 1511-1519.
Haven of Hope Christian Service (2016). Retrieved February 1, 2016 from Haven of
Hope, Web site: http://www.hohcs.org.hk/mission_en.php
Higgins, P. D. & Johanson, J. F. (2004). Epidemiology of constipation in North America:
a systematic review. American Journal of Gastroenterology, 99 (4), 750-759.
83
Hospital Authority (2016). Retrieved February 1, 2016 from Hospital Authority, Web
site:
http://www.ha.org.hk/visitor/ha_visitor_index.asp?Content_ID=10009&Lang=ENG&
Dimension=100&Parent_ID=10004&Ver=HTML
Joyce, P. (2002). Introducing abdominal massage in palliative care for the relief of
constipation. Complementary Therapies in Nursing & Midwifery, 8 101-105.
Kendra, L. H. & Esther, M. H. (2006). Managing a Patient's Constipation With Physical
Therapy. Physical Therapy, 86 (11), 1511-1519.
Kock, T. & Hudson, S. (2000). Older people and laxative use: literature review and pilot
study report. Journal of Clinical Nursing, 9 516-525.
Kristina, L., Lars, L. & Birgitta, E. (2010). Abdominal massage for people with
constipation: a cost utility analysis. Journal of advanced nursing, 66 (8), 1719-1729.
Kristina, L., Lars, L., Hans, S., Birgitta, E. & Catrine, J. (2009). Effects of abdominal
massage in management of constipation-A randomized controlled trial. International
Journal of Nursing Studies, 46 759-767.
Kristina, L., Ulla, H. G. & Catrine, J. (2011). Experiences of abdominal massage for
constipation. Journal of Clinical Nursing, 21 , 757-765.
Lai, T. K. T, Cheung, M. C., Lo, C. K., Ng, K. L., Fung, Y. H., Tong, M. & Yau, C.C.
(2011). Effectiveness of aroma massage on advanced cancer patients with constipation:
A pilot study. Complementary Therapies in Clinical Practice, 17 37-43.
Lamas, K., Graneheim, U. H. & Jacobasson, C. (2011). Experiences of abdominal
massage for constipation. Journal of Clinical Nursing, 21 757-765.
Larsen, D.L., Attkisson, C.C., Hargreaves, W.A. & Nguyen, T.D. (1979). Assessment
of client/patient satisfaction: Development of a general scale. Evaluation and Program
Planning, 2 197-207.
Lenth, R. V. (2006). Java Applets for Power and Sample Size [Computer software].
Retrieved month day, year, from http://www.stat.uiowa.edu/~rlenth/Power.
84
Martin, B. C., Barghout, V. & Cerulli, A. (2006). Direct medical costs of constipation
in the United States. Managed Care Interface, 19 (12), 43-49.
Marybetts, S. (2010). The use of abdominal massage to treat chronic constipation.
Journal of Bodywork & Movement Therapies, 15 436-445.
Michelle, C., Catherine, H., Alison, L. & John, A. (2014). Using abdominal massage in
bowel management. Nursing Standard, 28 (45), 37-42.
Myra, W., Annette, B., Hannah, F. L., Lindsay, G., Mary, Y., Stephanie, F. & Susan, C.
M. (2008). Evidence-Based Interventions for the Prevention and Management of
Constipation in Patients With Cancer. Clinical Journal of Oncology Nursing, 12(2),
317-337.
Polit, D.F. & Beck, C.T. (2012). Nursing research: Generating and assessing evidence
for nursing practice (9thed.). Philadelphia: Lippincott.
PRISMA (2015). Retrieved November 18, 2015 from Health care Improvement
Scotland, Web site: http://www.prisma-
statement.org/PRISMAStatement/FlowDiagram.aspx
Scottish Intercollegiate Guidelines Network (2014). SIGN 50: A guideline developer's
handbook. Retrieved September 9, 2015 from Health care Improvement Scotland, Web
site: http://www.sign.ac.uk/pdf/sign50.pdf
Thompson, W. G., Longstreth, G. F., Drossman, D. A., Heaton, K. W., Irvine, E. J. &
Muller-Lissner, S. A. (1999). Functional bowel disorders and functional abdominal pain.
Gut, 45(Supp II), II43-7.
85