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Abstract of thesis entitled
“An Evidence-based Dietary Fiber Enrichment
Programme for Relieving Constipation in Elderly
Orthopaedic Patients”
Submitted by
Tai Siu King, Rosetti
for the degree of Master of Nursing
at The University of Hong Kong
in July 2013
Constipation is a multifactorial digestive disorder highly prevailing among
the hospitalized elderly Orthopaedic patients. Unlike Western countries, laxative
therapy is used to be the first line remedy for constipation in many hospitals of
Hong Kong although fiber-rich diet has been proven by numerous studies as the
best alternative with low cost and less complications.
This dissertation is a translational nursing research which aims at
formulating a programme of using fiber-rich food products for relieving
constipation in elderly Orthopaedic patients, based on the best available research
evidences.
It was started with an integrated and systematic review of papers studying
the dietary interventions for relieving constipation and reducing laxative
consumption in elderly with ADL dependency. Seven relevant studies were
identified and critically appraised using the methodology checklist for RCTs
designed by Scottish Intercollegiate Guidelines Network (SIGN). After
summarizing and synthesizing the data, three dietary interventions with 1+ level
of evidence were concluded as the most effective strategies for eradicating the
clinical issue.
Following assessment of the implementation potential of the proposed
innovation in designated clinical setting in terms of transferability, feasibility and
cost-benefit ratio, an evidence-based dietary fiber enrichment programme was
developed with recommendations for patient recruitment, intervention and
evaluation. Furthermore, to assure a smooth change of practice and to determine
the effectiveness of the programme, comprehensive plans of communication with
different stakeholders, pilot study and evaluation were also subsequently
established.
With this evidence-based programme, the prevalence of functional
constipation and laxative consumption are hoped to be reduced in elderly
Orthopaedic patients.
An Evidence-based Dietary Fiber Enrichment
Programme for Relieving Constipation in Elderly
Orthopaedic Patients
by
Tai Siu King, Rosetti
Bachelor of Nursing (La Trobe University)
A thesis submitted in partial fulfillment of the requirements for
the Degree of Master of Nursing
at The University of Hong Kong.
July 2013
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……………………………………………………….
Tai Siu King, Rosetti
i
Acknowledgements
Apart from the efforts of myself, the completion of this dissertation depends
largely on the encouragement and support of many others. Foremost, I would like
to express my sincere gratitude to my supervisor, Dr. Felix Yuen, for his insightful
comments and unfailing support throughout the learning process of this master
dissertation. Without his encouragement and guidance, this dissertation would not
have materialized. Furthermore, I am indebted to Dr. Elizabeth Hui for giving me
invaluable comments during the presentation session and to all staff from the
School of Nursing of the University of Hong Kong for their teaching and
on-going help.
I would also like to acknowledge my fellow classmates, Carey, Ka Lai, Hidy
and Raymond for providing tremendous invaluable suggestions to my work.
Last but not the least, I am deeply grateful to my family, especially my
husband Thomas and my kids Hugo and Tracy, for their constant support,
understanding, encouragement and unwavering love during the past two years.
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Contents
Declaration………………………………………………………………….
Acknowledgements……………………………………….........................
Table of Contents…………………………………………………………...
List of Appendices…………………………………………………………..
Abbreviations……………………………………………..........................
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Chapter 1: Introduction………………………………………..
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1.1 Background…………………………………………………
1.1.1 Diagnostic Criteria for Constipation in Adults.........................
1.1.2 Causes and Complications………………………………...
1.1.3 Treatment……………………………………………….
1.1.4 Epidemiology……………………………………………
1.2 Affirming the Need…………………………………………
1.2.1 Clinical Setting…………………………………………..
1.2.2 Current Practice and Problems…………………………….
1.2.3 Potential Innovation………………………………………
1.3 Research Questions…………………………………………
1.4 Objectives of the Proposal…………………………….........
1.5 Significance of the Proposal…………………………..........
Chapter 2: Critical Appraisal....................................................
2.1 Search and Appraisal Strategies……………………………
2.1.1 Search Strategy…………………………………………..
2.1.2 Data Extraction…………………………………………..
2.1.3 Appraisal Strategy………………………………………..
2.2 Results……………………………………………………...
2.2.1 Overview of Study Characteristics…………………………
2.2.2 Summary of Quality Assessment..........................................
2.3 Summary and Synthesis…………………………………….
2.3.1 Data Summary…………………………………………...
2.3.2 Synthesis of Data………………………………………...
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Chapter 3: Translation and Application……………………
3.1 Implementation Potential……………………………...........
3.1.1 Target Setting……………………………………………
3.1.2 Target Audience………………………………………….
3.1.3 Transferability of the Findings…………………………….
3.1.4 Feasibility……………………………………………….
3.1.5 Cost-benefit Ratio………………………………………..
3.2 Evidence-based Dietary Fiber Enrichment Programme for
Relieving
Constipation
in
Elderly
Orthopaedic
Patients.........................................................................................
3.2.1 Objectives……………………………………………….
3.2.2 Target Users……………………………………………..
3.2.3 Target Patient Population…………………………………
3.2.4 Rating Scheme for the Strength of the Recommendation……..
3.2.5 Recommendations………………………………………..
Chapter 4: Implementation Plan……………………………..
4.1 Communication Plan………………………………….........
4.1.1 Communication Plan with Stakeholders…………………….
4.2 Pilot Study Plan……………………………………….........
4.2.1 Objectives……………………………………………….
4.2.2 Target Setting and Target Audience………………………..
4.2.3 Sampling Plan…………………………………………...
4.2.4 Ethical Consideration……………………………………..
4.2.5 Evaluation of the Pilot Study………………………………
Chapter 5: Evaluation Plan……………………………............
5.1 Outcome Measures…………………………………………
5.1.1 Patient Outcome………………………………………….
5.1.2 Healthcare Provider Outcome……………………………...
5.1.3 System Outcome…………………………………………
5.2 Nature and Number of Clients to be Involved……………...
5.3 Data Collection and Analysis………………………………
5.4 Criteria for Effective Change……………………………….
Chapter 6: Conclusion………………………………………….
Appendices…………………………………………………………..
References……………………………………………………………
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List of Appendices
Appendix 1
Search Strategies…………………………………..
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Appendix 2
Table of Evidence…………………………………
60
Appendix 3
Overall Summary of Quality Assessment…………
67
Appendix 4
Methodology
Checklists
of
Selected
Studies……………………………………..............
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Appendix 5
Key to Evidence Statements……………................
75
Appendix 6
Study Results with P-value‹0.05…………………..
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Appendix 7
Bristol Stool Chart………………………...............
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Appendix 8
Visual Analogue Scale…………………………….
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Appendix 9
Comparison of Participant’s Characteristics............
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Appendix 10
Timeline of the Programme Development………...
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Appendix 11
Constipation Assessment Form…………………...
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Appendix 12
Comparison of Staffing Cost & Cost of Staff
Training……………………………........................
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Appendix 13
Grades of Recommendations……………………...
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Appendix 14
Logistics
of
Evidence-based
Dietary
Fiber
Enrichment Programme…………………………...
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Appendix 15
Nursing Procedure Audit Form……………………
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Appendix 16
Questionnaire of Nurse Satisfaction Survey………
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Appendix 17
Questionnaire of Patient Satisfaction Survey……..
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Appendix 18
Table of Outcome Measurement…………………..
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Abbreviations
ACHS
Australian Council on Healthcare Standard
ADL
Activity of daily living
BSS
Bristol Stool Scale
CQI
Continuous quality improvement
DOM
Departmental Operational Manager
EBP
Evidence-based practice
EN
Enrolled nurse
GI
Gastrointestinal
HA
Hospital Authority
IBS
Irritable Bowel Syndrome
I&O
Input and output
IT
Information technology
LOS
Length of stay
NC
Nurse Consultant
O&T
Orthopaedic & Traumatology
Q&A
Question & Answer
RCT
Randomized controlled trial
RN
Registered nurse
SIGN
Scottish Intercollegiate Guidelines Network
SPSS
Statistical Package for Social Science
VAS
Visual Analogue Scale
WM
Ward Manager
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CHAPTER 1: INTRODUCTION
Constipation is a bothersome and multifactorial gastrointestinal disorder which
imposes numerous negative impacts on people’s physical health and social life. It
also brings along with heavy economic burden to both patients and public health
services per annum (Spinzi, Amato, Imperiali, Lenocci, Mandelli, Paggi, Radaelli,
Terreni & Terruzzi, 2009; Kristina, Lars, Birgitta, & Catrine, 2010). For the health
care professionals, constipation is regarded as one of the major clinical problems to
be addressed and prevented effectively and proactively.
In Hong Kong, laxative treatment are normally adopted as the conventional or
even long term therapy for constipated individuals in many clinical settings
irrespective of its unpleasant side-effects and increasing cost. However, based on the
results of several clinical studies, it is in fact revealed that the clinical outcomes of
non-pharmacological measures have been proven as effective and persuasive as
pharmacological ones in relieving constipation. Both patients and health care system
are also economically more benefited.
In this chapter, the background information of concerned clinical issue,
affirming needs for practice change in designated clinical setting, objectives and
significance of this dissertation will be discussed.
1
1.1 Background
1.1.1 Diagnostic Criteria for Constipation in Adults
People are considered constipated if presenting two or more of the following
symptoms for at least 25% of defecation in the preceding 12 months under the Rome
III criteria for functional gastrointestinal disorders in adults (Annie, 2009; Marc,
2011):
Straining
Lumpy or hard stool
Sensation of incomplete evacuation
Sensation of anorectal obstruction / blockage
Manual manoeuvres required to facilitate, e.g. digital evacuation
Fewer than 3 bowel movements per week
Moreover, loose stools are rarely found without use of laxatives and criteria for
the diagnosis of Irritable Bowel Syndrome (IBS) are not enough.
1.1.2 Causes and Complications
Constipation is generally precipitated by two groups of physiological factor:
intestinal and anorectal causes or extraintestinal causes. For the intestinal causes, it
can be subdivided into functional or organic disorders. Functional disorders are
2
related to IBS or slow colonic transit resulting from inadequate fluid and dietary
fiber intake, immobility, lack of exercise and adverse drug reaction which is the most
common type of constipation occurring in older adults. Neoplasm, stricture, rectal
prolapse, anal stenosis rectocele or Hirschsprung’s disease are the identified organic
disorders leading to constipation. For extraintestinal causes, endocrine, neurologic,
metabolic, psychological, rheumatologic and medication reasons are all involved
(Zennure, 2005; Annie, 2009).
Without timely, effective and sustained management for constipation, patients
could definitely end up with a number of dreadful consequences like fecal impaction,
intestinal obstruction or perforation, exacerbation of postoperative ileus, acute
retention of urine, rectal prolapse, haemorrhoids, associated gastrointestinal
disorders (e.g. loss of appetite), mental tension and laxatives abuse. In other words,
patient’s recovery, rehabilitation and discharge from hospital might be ultimately
strangled with these complications and health care cost is substantially escalated
(Marilee, 1990; Spinzi et al., 2009). So treating and preventing constipation are
surely the key clinical concerns to health care providers in view of the above
possible negative outcomes.
3
1.1.3 Treatment
Treatment of constipation is basically divided into two categories:
pharmacological or non-pharmacological. Reviewing research literatures and clinical
guidelines, the pharmacological interventions are composed of five types of laxative
treatment, involving bulk-forming laxatives, stool softeners, osmotic laxatives,
stimulants and suppositories. It is suggested that serving laxatives as first line
treatment or long-term therapy for constipation is widely not advocated because of
heavy economic burden and multiple adverse effects like oesophageal blockage,
abdominal pain, electrolyte imbalance, diarrhoea, fecal incontinence and lower
bowel dysmotility. Contrary to pharmacological treatment, non-pharmacological
strategies like adequate fluid and dietary fiber intake, increased exercise and toilet
regime are highly recommended as the initial measures for functional constipation in
adults regarding their features: low cost and less harmfulness. Laxatives are advised
to use only if patients have no defecation for 3 consecutive days (Gibson, Opalka,
Moore & Brady, 1995; Lois, Diane & Deborah, 2000; Hinrichs & Huseboe, 2001;
Aase & Torbjorn, 2005; Zennure & Magfiret, 2007; Sturtzel, Mikulits, Gisinger &
Elmadfa, 2010). However, in reality, our current practice is totally in opposite.
4
1.1.4 Epidemiology
Constipation afflicts up to 20% of general population, 26% of men and 34% of
women older than 65 years every year worldwide. In Western countries, the
prevalence of constipation is reported as high as 24% in elderly. It accounts for over
2.5 million physician visits each year and almost half of patients older than 65 years
have routine use of laxatives which costs approximately $400 million annually in US
(Hinrichs & Huseboe, 2001; Khaja, Thakur, Bharathan, Baccash & Goldenberg,
2005; Annie, 2009; Spinzi et al., 2009; Kristina et al., 2010).
In Hong Kong, 110,891 out of 6,855,125 people were diagnosed of
constipation according to 2012 Statistics by Country for Constipation and the
prevalence rate in elderly population also reached up to 14% based on the
epidemiological survey conducted in 2009 (Annie, 2009). Overall speaking,
constipation is a highly prevalent and costly digestive disorder among “elderly and
women” groups in the light of captioned epidemiological data.
1.2 Affirming the Need
1.2.1 Clinical Setting
The target place for the proposed innovation is an adult Orthopaedic &
Traumatology (O&T) rehabilitation unit. The proportion of patient is 25% male,
5
75% female and more than 90% aged above 65 years old. Patients are mostly
admitted for rehabilitation after surgeries or stabilization of musculoskeletal diseases
and their levels of dependency in daily living activities vary from moderate to high.
As indicated in many research studies, about 50% to 80% of elderly and 40%
of immobilized Orthopaedic patients will develop constipation within hospitalization
or institutionalization because of prolonged bed confinement, decreased motility
due to immobility, lack of privacy for defecation or postponement of defecation by
unavailable health care assistance, in addition to the causes mentioned previously
(Marilee, 1990; Robyn, Maureen, Judith, Jennene & John, 2001; Zennure &
Magfiret, 2007; Sturtzel et al., 2009; Zaharoni, Rimon, Vardi, Friger, Bolotin &
Shahar, 2011). Also 50% to 75% of these patients are reported to use laxatives
(Khaja et al., 2005). Therefore, the issue of constipation is specifically crucial to the
said hospital setting with fairly large proportion of elderly, female and immobilized
patients.
1.2.2 Current Practice and Problems
Besides the above traits, the following problematic practices in dealing with
constipation further highlight the clinical significance of the issue and needs for
practice change in the target clinical setting.
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1. High Dependency on Pharmacological Interventions
Pharmacological interventions are implemented as first line management for
constipation in the mentioned rehabilitation unit. Laxatives are used to be prescribed
if patients having no defecation for 3 days or by request of patient/ nursing staff
without trial of all alternate non-pharmacological measures initially. In fact,
one-third of these patients are not truly constipated according to the diagnostic
criteria. Consequently, such practice constitutes a number of unfavourable outcomes,
such as laxatives abuse by patients or medical/nursing staff, heavy medication cost
and increased nursing workload. Referring to the survey of laxative consumption in
O&T rehab unit conducted by local pharmacy in 2009, about 75% of the total
number of patients was found to use laxatives during hospitalization. Their mean
demand of rectal suppository or enema was once per week and their average length
of stay (LOS) was 4 weeks. So the expense of purchasing laxatives was an average
of HK$120 per head. The figure is actually alarming and derangement instead of
improvement of the issue is obviously seen with laxative treatment.
2. Lack of Immediate Medical Management
Owing to lack of 24-hour medical support and prohibition of phone-ordering
of laxatives, those constipated patients usually have to wait until the next day if their
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complaints are raised after doctor’s morning round. Patients’ emotion becomes
agitated and frustrated with the symptoms of constipation all along the waiting
period. And some even tend to consume fewer meals and refuse to undertake any
rehabilitation exercises. Furthermore, this practice also comes along with certain
negative clinical outcomes. Retrieving data from 2009-2010 O&T patient statistics, 8
cases were reported to be transferred back to acute setting for constipation-related
complications and their average LOS was delayed for 5-20 days.
To tackle these problematic practices, reduction of dependency on laxative
treatment and early prevention of constipation through non-pharmacological
strategies are deemed as the answers to Orthopaedic nurses.
1.2.3 Potential Innovation
Among all the non-pharmacological interventions recommended by research
studies, exercise regime by allied health care professionals and toilet training
programme have been implementing for a period of time in the said clinical setting.
But no apparent improvement is seen in the prevalence of constipation and laxative
consumption. Thus, there is an urge for the unit to develop an evidence-based dietary
fiber
enrichment
programme
for
further
strengthening
non-pharmacological strategy in relieving constipation.
8
the
power
of
1.3 Research Questions
Clinical question of the proposed innovation is formulated in terms of PICO
format after affirming the clinical significance of concerned issue and needs for
practice change.
"In elderly Orthopaedic patients, how effective is a dietary fiber enrichment
programme as compares with laxative treatment in relieving constipation?"
Patient - elderly Orthopaedic patients
Intervention - dietary fiber enrichment programme
Comparison – laxative treatment
Outcome - relieving constipation
1.4 Objectives of the Proposal
Based on the IOWA model of evidence-based practice to promote quality care
(Titler, Kl;eiber, Steelmen, Rakel, Budreau, Everett, Buckwalter, Tripp-Reimer &
Goode, 2001), the objectives of this proposal are developed as below:
1
To assemble relevant research evidences on the effectiveness of dietary
interventions for resolving constipation in elderly
2
To appraise, summarize and synthesize the findings extracted from the selected
research studies
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3
To formulate an evidenced-based dietary fiber enrichment programme for
relieving constipation in elderly Orthopaedic patients
4
To assess the implementation potential of the proposed innovation in designated
clinical setting
5
To develop an implementation and evaluation plan for the proposed programme
1.5. Significance of the Proposal
1
Reduce the prevalence of functional constipation and reliance on laxatives in
elderly Orthopaedic patients
2
Cut down health care cost
3
Eliminate nursing workload and improve staff morale
4
Build up best evidence-based nursing practice in managing constipation
10
CHAPTER 2: CRITICAL APPRAISAL
Assembling relevant research evidences, summarizing and synthesizing the
best findings from selected studies are the coming steps for developing an
evidence-based practice according to IOWA model. So the search and appraisal
strategies, results, summary and synthesis of the research findings will be gone
through one by one in this chapter.
2.1 Search and Appraisal Strategies
2.1.1 Search Strategy
A. Electronic Databases, Search Keywords and History
A comprehensive and systematic literature search focusing on the dietary
interventions for relieving constipation and reducing laxatives consumption in
elderly with moderate to high level of dependency in activity of daily living (ADL)
was conducted within the period of April 2012 to August 2012 through four
electronic databases, including PubMed, CINAHL Plus (EBSCOhost 1991-2012),
Medline (Ovid 1946-August week 3 2012) and British Nursing Index. The searching
step was started with individual search of the following keywords:
1) constipation,
2) infrequent fecal evacuation, 3) difficult fecal evacuation, 4) diet, 5) dietary, 6)
11
dietetic, 7) dietary fiber, 8) dietary therapy and 9) dietary programme. The keywords
were then categorized into two groups: 1, 2, 3 and 4, 5, 6, 7, 8, 9. Individual search
results were combined within the same group for another search by using the word
“or”. Afterwards, to narrow down the scope, the results of two groups were further
combined with another word “and” and limitation stipulating as “aged 65+ years or
above” and “clinical trial or randomized controlled trial” for final search. A total of
152 relevant articles in English were eventually yielded from the four electronic
databases. Assessing their related citations and reference lists, 1 additional article
was identified to be relevant in title and abstract. A total of 7 eligible articles were
assembled after manual selection by screening the title, abstract and text content
sequentially with the inclusion and exclusion criteria and removal of those
duplicated. The logistics of whole literature search is attached in Appendix 1.
B. Inclusion and Exclusion Criteria
Controlled trial or randomized controlled trial (RCT) study in English or
Chinese, comparing specific dietary intervention with normal diet or laxatives in
resolving constipation was included for review. Study participants were patients of
both genders, aged 65 years or above, suffering from functional constipation
together with moderate to high ADL dependency regardless of the clinical settings
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they came from. Intervention adopted was either natural food product or oral fluid.
Outcome measurements on quality of defecation and use of laxatives were
performed.
Study with participants suffering from constipation by IBS, organic or
extraintestinal disorders, having parental/enteral feeding, undergoing bowel surgery
or taking strong opioids like Morphine was excluded. Furthermore, study with
comparison to herbal medications was also ignored.
2.1.2 Data Extraction
Findings from the reviewed studies were extracted and recorded into a table of
evidence in terms of patient characteristics, study intervention and comparison,
length of follow-up, outcome measures and results. Table of evidence for each study
is enclosed in Appendix 2.
2.1.3 Appraisal Strategy
The Methodology Checklist for Controlled Trials designed by the Scottish
Intercollegiate Guidelines Network (SIGN) was used for quality assessment as all
the selected studies were controlled trials with or without randomization. The
checklist is composed of two sections: 1) internal validity, 2) overall assessment of
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the study. In section 1, ten questions regarding research hypothesis, sample
randomization, concealment method, blinding, study measurement, drop-out rate and
data analysis are asked for examining the validity of selected studies. In section 2,
the quality of selected studies is rated in terms of level of evidence according to
“SIGN 50: A guideline developer’s handbook Annex B” (Appendix 5), in which 1++
is the highest score and 4 is the lowest one. The codes ++, + and – indicate how well
the study has done in minimizing research bias. The overall results of quality
assessment are tabulated and shown in Appendix 3. And details of individual
assessment are also attached in Appendix 4.
2.2 Results
2.2.1 Overview of Study Characteristics
The 7 reviewed studies included 6 RCTs (Lois, Diane & Deborah, 2000; Aase
& Torbjorn, 2005; Sairanen, Piirainen, Nevala & Korpela, 2007; Pitkala, Strandberg,
Finne-Soveri, Ouwehand, Poussa & Salminen, 2007; Sturtzel et al., 2010; Philippe,
Heidi, Murielle, Cathy, Jean & Beatrice, 2011) and 1 quasi-experimental study
(Zennure & Magfiret, 2007). All the studies were conducted in Western countries.
Both community and hospitalized or institutionalized setting were involved. The
study participants were all elderly and mostly female who were generally ADL
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dependent, sufferers of functional constipation and had history of using laxatives.
The sample size ranged from 12 to 123. Soluble or insoluble dietary fibers were
employed as main ingredient of the dietary interventions being tested in the 7 studies.
Frequency and quality of defecation were measured in all the studies while
measurements on laxatives use and cost were only performed in 5 studies (Lois,
Diane & Deborah, 2000; Aase & Torbjorn, 2005; Sairanen et al., 2007; Pitkala et al.,
2007; Sturtzel et al., 2010). Participant’s perceived well-being with the dietary
intervention was reported in 3 studies (Aase & Torbjorn, 2005; Sairanen et al., 2007;
Philippe et al., 2011).
2.2.2 Summary of Quality Assessment
In the 6 RCTs, only 4 studies scored 1+ (Aase & Torbjorn, 2005; Sairanen et
al., 2007; Pitkala et al., 2007; Philippe et al., 2011) whereas the rest were rated as 1(Lois, Diane & Deborah, 2000; Sturtzel et al., 2010). The quasi-experimental study
got only 2++ for no randomization between the experimental and control groups and
invalid outcome measurement (Zennure & Magfiret, 2007). The study population,
intervention and outcomes were explicitly stated in all the studies. So they all had
got clearly focused questions.
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A. Randomized controlled trials
For randomization, only 2 studies provided thorough information on the
method
used
which
included
block
and
stratified
randomization
and
computer-generated randomization (Pitkala et al., 2007; Sairanen et al., 2007). The
remaining just had brief or even no description on the randomization process (Lois,
Diane & Deborah, 2000; Aase & Torbjorn, 2005; Sturtzel et al., 2010; Philippe et al.,
2011). The majorities had demonstrated equilibrium in the randomization between
the treatment and control groups except 1 study owing to the diverse size of the
subjects and the differing proportions of people consenting to the trial (Pitkala et al.,
2007).
No details were found in 4 out of the 6 trials regarding the concealment
method (Lois, Diane & Deborah, 2000; Sairanen et al., 2007; Sturtzel et al., 2010;
Philippe et al., 2011). For the rest, drawing an opaque and sealed envelope and
arranging a randomization staff member not familiar with the subjects to undertake
the job of computer code generation and group assignment were applied for
concealment (Aase & Torbjorn, 2005; Pitkala et al., 2007).
Only 1 study had clearly described the method of blinding (Pitkala et al., 2007)
and 3 studies had inadequate or even no information in this connection (Lois, Diane
& Deborah, 2000; Sairanen et al., 2007; Philippe et al., 2011). Although blinding is
16
highly recommended in RCT for preventing bias, it is sometimes infeasible to
implant especially for those food studies. 2 studies mentioned difficulty in blinding
due to the food delivering mode and working procedures of the investigators (Aase
& Torbjorn, 2005; Sturtzel et al., 2010). In fact, to study the effectiveness of dietary
intervention for relieving constipation and reducing laxative consumption, blinding
is deemed not a big deal as the intervention effect could be objectively reflected
from daily bowel movement and medication records which are normally hard to be
fabricated in most cases.
3 studies demonstrated insignificant difference in confounders between groups
(Aase & Torbjorn, 2005; Pitkala et al., 2007; Philippe et al., 2011) and only 2 studies
reported the overall baseline characteristics of two groups (Sairanen et al., 2007;
Sturtzel et al., 2010). 1 study presented with borderline significant difference in the
bowel medication use between groups (p‹0.052) and revealed that 1/2 to 3/4 of
participants in both groups was already on high fiber diet before the trial which
might induce confounding treatment effect (Lois, Diane & Deborah, 2000).
The outcome measurements were illustrated with p-values in all the studies.
Valid and reliable instruments were utilized: Bristol Stool Scale (BSS) for
monitoring stool consistency (Sairanen et al., 2007; Philippe et al., 2011) and Visual
Analogue Scale (VAS) for measuring participant’s comfort level (Aase & Torbjorn,
17
2005; Philippe et al., 2011). Only the studies of Pitkala et al (2007) and Philippe et al
(2011) reported drop-out owing to withdrawal, death, missing or poor compliance
and the rate ranged from 4-20%. Intention-to-treat analysis was also implemented in
both studies only while the remaining was unclear because of lack of information.
B. Quasi-experimental study
Randomization, concealment and blinding were all inapplicable in this study.
Significant difference in the marital status between groups was illustrated, but it
carried not much confounding effect on the study issue. Outcome measurement was
not valid and reliable as the instrument was designed specifically for the study by the
researcher. No drop-out was noted.
Among the 7 studies, only 2 studies were carried out at more than one site but
no comparable results were available (Aase & Torbjorn, 2005; Pitkala et al., 2007).
2.3 Summary and Synthesis
After critical appraisal of all the assembled studies, summary of the extracted
data and synthesis of the evidences will be elaborated in the followings:
18
2.3.1 Data Summary
Study Population
All the studies were conducted in Western countries including USA (Lois,
Diane & Deborah, 2000), Austria (Sturtzel et al., 2010), France (Philippe et al.,
2011), Finland (Sairanen et al., 2007; Pitkala et al., 2007), Sweden (Aase & Torbjorn,
2005) and Turkey (Zennure & Magfiret, 2007). So there might be potential problems
of transferability and feasibility if applying the interventions to Asian population as
Hong Kong Chinese.
Patient Characteristics
All the subjects were older adults of both sex with mean age ranged from
62-86 years old and diagnosed of constipation according to Rome III criteria. Female
dominance was shown in 3 studies (Sairanen et al., 2007; Pitkala et al., 2007;
Philippe et al., 2011). 6 out of the 7 studies included hospitalized or institutionalized
elderly with age-related chronic illnesses, surgery done, insufficient nutritional
intake, routine use of laxatives, impaired physical mobility or medium to high level
of dependency in daily living activities (Lois, Diane & Deborah, 2000; Aase &
Torbjorn, 2005; Sairanen et al., 2007; Pitkala et al., 2007; Zennure & Magfiret, 2007;
Sturtzel et al., 2010). Only 1 study recruited community-based patients without
19
specific illness, physical impairment or regular use of bowel medications (Philippe
et al., 2011).
Sample Size
The sample size of 7 studies varied from 12 to 123 participants. 6 studies got
relative small sample size of 12 (Lois, Diane & Deborah, 2000), 20 (Aase &
Torbjorn, 2005), 30 (Sturtzel et al., 2010), 43 (Sairanen et al., 2007), 50 (Philippe et
al., 2011) and 60 (Zennure & Magfiret, 2007). The remaining had more than 120
participants (Pitkala et al., 2007). There were a total of 338 participants involved in
the 7 studies. Small sample size actually indicates potential problem of
generalizability.
Intervention
Adding various kinds of dietary fiber into patient’s normal diet / snack or
serving dietary fiber as supplement was the major strategy implemented in all 7
studies. 1 study provided 3-6 tablespoons of bran mixture 2 times per day together
with 1.5L fluid intake (Lois, Diane & Deborah, 2000) and another study served
fruit-rich porridge with 7.5g of fiber content as breakfast for 3 times per week (Aase
& Torbjorn, 2005). Giving fermented yoghourt containing 6-7.5g of high fiber
20
content twice daily was used in 2 studies (Sairanen et al., 2007; Philippe et al., 2011)
while supplying 200ml of fermented oat drink with bifidobacteria daily was taken in
another study (Pitkala et al., 2007). For the rest, providing bran supplement together
with 1.5L fluid intake/day and blending 8.3g of insoluble fermentable fiber and 9.7g
of insoluble non-fermentable fiber into common daily meal were applied (Zennure &
Magfiret, 2007; Sturtzel et al., 2010).
Comparison
Habitual ward diet was served as comparison group in 4 studies (Lois, Diane
& Deborah, 2000; Aase & Torbjorn, 2005; Zennure & Magfiret, 2007; Sturtzel et al.,
2010) while 2 studies took same type of product without addition of dietary fiber for
comparison (Sairanen et al., 2007; Pitkala et al., 2007). There was also one study
comparing the intervention with food additive (Philippe et al., 2011).
Length of Follow-up
The length of follow-up varied from 5-217 days. 5 studies just had follow-up
period under 100 days (Aase & Torbjorn, 2005; Sairanen et al., 2007; Zennure &
Magfiret, 2007; Sturtzel et al., 2010; Philippe et al., 2011) whereas 2 studies had
over 112 days (Lois, Diane & Deborah, 2000; Pitkala et al., 2007).
21
Outcome Measures
To measure frequency of defecation with or without laxatives, bowel
movement and medication records were used in 5 studies (Lois, Diane & Deborah,
2000; Aase & Torbjorn, 2005; Sairanen et al., 2007; Pitkala et al., 2007; Philippe et
al., 2011). VAS (point 1-10) was adopted for evaluating patient’s perceived
well-being towards the intervention in 3 studies (Aase & Torbjorn, 2005; Sairanen et
al., 2007; Philippe et al., 2011) while BSS was implanted for monitoring patient’s
stool consistency in 2 studies (Sairanen et al., 2007; Philippe et al., 2011). 5 studies
also reviewed the use and cost of laxatives in terms of % (Lois, Diane & Deborah,
2000; Aase & Torbjorn, 2005; Sairanen et al., 2007; Pitkala et al., 2007; Sturtzel et
al., 2010). In the quasi-experimental study, self-designed instrument was applied for
measuring the time, number, duration and intensity of defecation at early
post-operative period in terms of person (Zennure & Magfiret, 2007).
Results
Overviewing the data recorded in the table 1 (Appendix 6), 4 studies exhibited
exciting results in achieving normal frequency of bowel movement without laxatives
(Aase & Torbjorn, 2005; Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al.,
2011) and 3 of them also showed significant outcomes in patient’s well-being
22
towards the intervention (Aase & Torbjorn, 2005; Sairanen et al., 2007; Philippe et
al., 2011). Besides, there are 3 studies getting significant results in reducing laxative
consumption (Lois, Diane & Deborah, 2000; Aase & Torbjorn, 2005; Sturtzel et al.,
2010).
The quasi-experimental study presented with significant results in the time
(p=0.032), duration (p=0.03) and intensity (p=0.001) of defecation. But its level
of evidence only scored 2++.
2.3.2 Synthesis of Data
Assessment
To have early and appropriate identification of patient with propensity to
develop constipation, assessment of age, medical background, medication history,
nutritional intake, mobility status, bowel habit and use of laxatives, is regarded as
the very first and fundamental step to be undertaken according to the selected studies
(Sairanen et al., 2007; Zennure & Magfiret, 2007; Sturtzel et al., 2010; Philippe et al.,
2011). In addition, to attain better patient compliance, assessment of dental condition
should also be embraced (Aase & Torbjorn, 2005; Philippe et al., 2011). As per the
captioned items, a constipation assessment form will be designed and used for
assessing every elderly patient aged 65 or above on admission. Patient will be
23
recruited to the proposed programme if risk of constipation is affirmed through the
assessment which will be further discussed in the next chapter.
Intervention
Fruit and fiber-rich porridge, fermented yoghurt with high fiber content and
fermented oat drink with bifidobacteria are appraised as the most effective dietary
strategies for relieving constipation and reducing laxative consumption in elderly
without much negative impact on patient’s physiological comfort (Aase &
Torbjorn, 2005; Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al., 2011). In
order to accommodate the taste of different patients and to provide more relevant
choices, the three interventions will be incorporated in the proposed programme
simultaneously. Also, laxatives will still be given if patient has no defecation for 2
consecutive days with the dietary intervention as suggested by the selected studies
(Lois, Diane & Deborah, 2000; Aase & Torbjorn, 2005; Sairanen et al., 2007).
Outcome Measures
Daily input and output (I&O) chart and medication administration record will
be used for evaluating the effectiveness of the dietary intervention on faecal
frequency and laxatives use. But defecation frequency alone might not adequately
24
reflect the real constipated situation a patient is bearing as told by all the selected
studies. Thus, BSS will be also adopted for measuring stool consistency in which
early sign of constipation will be detected if a patient presents with Type I or II stool
form as shown in Appendix 7. For assessing patient’s gastrointestinal (GI) symptoms,
VAS will be utilized (Appendix 8).
Based on the above discussion, it is concluded that an evidence-based dietary
fiber enrichment programme is an effective tactics for relieving functional
constipation and reducing laxative consumption in older adults with physiological
illness and physical impairment. And to facilitate the effectiveness of the programme,
patient assessment is always the key element to be included.
25
CHAPTER 3: TRANSLATION AND APPLICATION
Polit & Beck (2008) stated that the implementation potential in the target
setting should be evaluated after research evidences being synthesized. So prior to
develop
an
evidence-based
dietary
fiber
enrichment
programme,
the
implementation potential of the proposed innovation will be examined in terms of
transferability of the findings, feasibility and cost-benefit ratio initially in this
chapter.
3.1 Implementation Potential
3.1.1 Target Setting
The target setting is an adult O&T rehabilitation unit located at a public
hospital under Hospital Authority (HA). There are three female wards and one
male ward with 52 beds in total and the nurse-patient ratio is 1:13. Patients are
generally admitted for rehabilitation after surgeries or stabilization of
musculoskeletal diseases.
3.1.2 Target Audience
Based on the traits of the subjects involving in most of the reviewed papers,
26
the proposed innovation is decided to recruit O&T patients aged 65 or above of
both sex and having one of the following conditions:
age-related illness or surgery done
impaired physical mobility together with moderate or high level of
dependency in daily living activities
inadequate nutritional intake
symptom of constipation +/- use of laxatives
3.1.3 Transferability of the Findings
Target Setting and Audience
Among the 7 reviewed studies, apart from one being conducted in the
community (Philippe et al., 2011), all the rest were under hospital or
institutional-based setting which is similar to the target unit. In comparison,
similarities are also seen between the reviewed studies and the target setting in
terms of participant’s age, sex, medical background, mobility status, level of
dependency, nutritional status, symptom of constipation and laxative use
(Appendix 9). Although all the studies were done in Western countries, exclusion
of Chinese subjects was never stated.
27
Underlying Philosophy of Care
“Helping people stay healthy” is the mission stressed by HA in the annual
plan 2011-2012. The innovation is well-suited to this core value as it can bring
about positive outcomes to patient like laxatives, but produce less adverse effects
and improve patient’s quality of life (Aase & Torbjorn, 2005; Sairanen et al., 2007;
Pitkala et al., 2007; Philippe et al., 2011).
Number of Clients Being Benefited
The target audience accounts for approximately 90% of the total number of
admission at any period of time and there is an average of 750 patients admitted to
the target unit each year. By estimation, 675 patients will be benefited from the
innovation accordingly which is sufficiently large.
Timeline of Implementation and Evaluation
Firstly, 10-week time will be scheduled for communication, programme
revision and staff training. As per the length of follow-up adopted by most of the
reviewed studies, 4-week pilot study will be initiated in two wards in which
patients will receive the intervention after assessment on admission and their
outcomes will be evaluated regularly until discharge. The programme will be fully
28
implemented for 3 months, following 4-week evaluation period of the pilot study.
Lastly, 8 weeks will be spent for final programme evaluation. So the total duration
is 38 weeks (Appendix 10).
3.1.4 Feasibility
Organizational Climate and Administrative Support
The vital element in implementing change is a smooth transition from an old
system to a new one (Claire, 2006) in which organizational climate and
administrative support always play pivotal roles. To prepare for the upcoming
hospital accreditation conducted by Australian Council on Healthcare Standard
(ACHS), the development of evidence-based practice (EBP) and launching of
continuous quality improvement (CQI) project are highly advocated and
supported by the top managers of the target setting in the recent years. Besides
organizing workshops and sponsoring staff for training, a cluster-based EBP
development committee is also established. In the target unit, evidence-based
multidisciplinary geriatric hip fracture programme and nursing guideline of using
negative pressure wound therapy have been successively developed and are
awarded prize in the HA Convention and cluster CQI conference respectively.
Thence the organizational and administrative climate is conducive to the
29
implementation of evidence-based nursing initiatives.
Moreover, with the promulgation of the local survey of laxative
consumption and O&T patient statistics, the stakeholders of the programme
including the Consultant of O&T Rehab Unit, Departmental Operational Manager
(DOM), Nurse Consultant (NC), Ward Manager (WM), O&T doctors and nurses
have clearly recognized the negative impacts provoked by the current practice and
the consensus for practice change has been reached among them. Therefore, it is
confident that approval for the implementation of the innovation will be gained
without too much friction or resistance within the department if having a detailed
prior communication with those stakeholders.
Staff’s Acceptability
Instead of interfering with current staff function, the innovation will help in
reducing workload and saving time. As mentioned before, nurses currently spend
much time on administering laxatives and tackling cases with the complications of
constipation in the target setting. But patients will have less laxatives usage and
achieve optimal bowel functions with the innovation according to the research
findings. Also, no specific skill or additional manpower is demanded. The
additional works needed are just performing a 5-minute constipation assessment
30
on admission by using a newly designed form (Appendix 11) and giving a
5-minute programme introduction to patients and/or relatives. Thus, the workload
is reasonable.
Staff might feel insecure, incompetent and stressed with the initiative if
without adequate understanding (Claire, 2006). To ease their stress and clarify
misconceptions, prior communication via different channels including routine
nursing sharing session, case conference or journal club is indispensable. For
further enhancement of knowledge and competency, two identical 45-minute
briefing sessions will be arranged to all frontline nurses before implementation.
Details are as the following table.
Briefing session
Items
Duration
Speaker
Target Participant
(n)
Literature Review
10 minutes
Investigator - Advanced
Registered
Programme Introduction
20 minutes
practicing nurse (APN)
(10)
Question and Answer
15 minutes
nurse
(RN)
Enrolled nurse (EN)
(6)
Patient’s Acceptability
Elderly’s oral tolerance to dietary fiber is usually poor because of its taste,
dryness and difficulty for chewing (Marilee, 1990). To address the issue, the three
interventions with 1+ level of evidence in patient’s satisfaction (Aase & Torbjorn,
31
2005; Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al., 2011), will be
applied in the programme simultaneously. Patients are free to opt in accordance
with their own preference. In addition, detailed programme introduction will be
provided by nurses together with information sheet to patients and/or relatives
beforehand for consolidation of knowledge and clarification. To ensure patient’s
comfort and safety, laxatives will still be given if needed or no defecation for a
recommended period of time. The intervention will be also ceased once adverse
reaction is detected or patient eventually decide to withdrawal.
Availability of Resources
Resources including accommodation and information technology (IT) for
staff training, designated fiber-rich food products, measuring tools and
photocopier are all readily available in the target setting. For the assessment and
evaluation forms and patient information sheet, they could be printed out and then
multi-photocopied by ward clerks without charges.
3.1.5 Cost-benefit Ratio
Potential Benefits
Apart from inducing patient’s physical discomfort and delaying their
32
rehabilitation journey, constipation imposes heavy costs accounting for bowel
management on the healthcare system as well.
The innovation can significantly help patient normalize bowel movement
to 3-5 times weekly, reduce dependence on laxatives by 59-80% and improve
physical well-being. Unlike laxatives, it seldom induces side-effects after
ingestion (Lois, Diane & Deborah, 2000; Aase & Torbjorn, 2005; Sairanen et al.,
2007; Pitkala et al., 2007; Sturtzel et al., 2010; Philippe et al., 2011). Hence,
patient’s quality of life and rehabilitation progress are highly promoted.
By calculation, each constipated case consumes average 40-minute nursing
time in administering suppository or enema within hospitalization based on the
local survey. Without requirement of additional manpower, the programme just
takes nurses 10 minutes for accomplishment. But the outcomes are as effective as
laxatives. As the nursing time for bowel management are drastically reduced by
75%, nurses could have better job satisfaction and improved morale with
decreased workload and working pressure consequently.
The target unit has to spend approximately HK$67,500 in purchasing
laxatives each year in the light of the local survey. With the innovation, the cost
for laxatives can be maximally decreased by 93% (Aase & Torbjorn, 2005). The
amount saved is around HK$62,775. Staffing cost for managing one constipated
33
patient could be also saved about $73 and $46 for registered nurse (RN) and
enrolled nurse (EN) respectively (Appendix 12). Having better utilization of
human resource and mass reduction of healthcare cost, the organization could
have less staff turnover and gain high reputation in the hospital accreditation.
In opposite, the organization has to bear increasing prevalence of
constipation and heavier economic burden if maintaining current practice as the
aging population and medication cost are projected to increase over time
(Hinrichs & Huseboe, 2001).
Potential Material and Non-material Costs
As all the essential hardware is available, the material cost will be only
limited to one-off staff training which costs about HK$1,781 (Appendix 12). The
expenditure is cost-effective.
The possible non-material costs are nursing resistance and patient’s
non-adherence to the progamme. Nurses might be frustrated and uneasy with the
change at the initial stage which could end up with low compliance or even
absenteeism. To overcome the situation, supportive and respective attitude and
on-going appreciation to staff will help much besides prior communication. For
patients, their eligibilities and willingness to join the programme should be
34
accurately assessed and confirmed by obtaining written informed consent
beforehand.
Potential Risks
Dietary fiber might evoke few undesirable side-effects, like flatulence,
bloating, abdominal cramping / rumbling or diarrhea (Sairanen et al., 2007;
Philippe et al., 2011). The occurrence and intensity of these symptoms vary
among individuals and are generally dose-related. The fiber dosages of the chosen
food products are within the recommended intake of 25 – 35g/day (Aase &
Torbjorn, 2005). The participants taking the products also have significantly less
GI discomforts according to the reviewed studies. So the products are reasonably
safe to be adopted.
In conclusion, the proposed innovation is highly transferrable, feasible and
cost-effective to be implemented in the target setting in view of the above
discussion. Then the next step will be proceeded to develop an evidence-based
dietary fiber enrichment programme for the target audience.
35
3.2 Evidence-based Dietary Fiber Enrichment Programme for
Relieving Constipation in Elderly Orthopaedic Patients
3.2.1 Objectives:
To provide an evidence-based clinical pathway of handling patient with
functional constipation
To normalize elderly patient’s bowel movement without laxatives
To reduce morbidity resulting from constipation-related complications or
long-term laxative therapy
To cut down health care cost
3.2.2 Target Users
Nurses working in the target O&T rehabilitation unit
3.2.3 Target Patient Population
The target audience described in 3.12
3.2.4 Rating Scheme for the Strength of the Recommendations
With the determined levels of evidence of the reviewed studies, a grade is
given to each recommendation according to the “SIGN 50: A guideline
36
developer’s handbook Annex B” (Appendix 13) in which “A” is regarded as the
highest grade whilst “D” is the lowest one (SIGN, 2012).
3.2.5 Recommendations
Recruitment
Recommendation 1.0
Assessment of constipation should be conducted for every hospitalized elderly.
Available evidence:
Constipation is a common gastro-motility disorder among the 1+, 1institutionalized elderly (Pitkala et al., 2007; Sturtzel et al., 2010).
Constipation is especially prevalent in older people (Philippe et al., 1+, 2++
2011; Zennure & Magfiret, 2007).
Constipation impairs the functional status and quality of life in older 1+
adults (Aase & Torbjorn, 2005).
Recommendation 2.0
a.
Patient’s risk of constipation should be assessed through the following
aspects:
medical background, medication history, mobility status, nutritional
37
intake, bowel pattern, use of laxatives and dental condition
b.
Patient should be recruited if risk factor is identified in one of the above
areas.
Available evidence:
Constipation is commonly related to chronic illness, inadequate 1+, 2++
intake of dietary fibers or fluid, immobilization, irregular bowel
habit, laxative abuse or adverse medications reactions (Aase &
Torbjorn, 2005; Zennure & Magfiret, 2007).
Elderly people often have to use a wide range of medicines, some of 1+
which cause constipation as side-effect (Sairanen et al., 2007).
Changes in taste perception and dental condition might interfere 1+
with the intake of dietary fiber in elderly (Philippe et al., 2011).
Patient is constipated if having less than 3 bowel movements per 1+
week or complaining difficulty in defecation ((Aase & Torbjorn,
2005; Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al.,
2011).
Recommendation 3.0
The programme is not advised to patients with the following conditions:
38
Impaired cognition, expressing and swallowing difficulties, GI diseases or
surgeries, endocrine disorders, long-term drug therapy, constipation from
organic reasons or limited prognosis.
Available evidence:
Patients were excluded for aphasia / dementia (unable to use Visual 1+
Analogue Scale), dysphagia, poor prognosis or having long-term
drug therapy (Aase & Torbjorn, 2005; Pitkala et al., 2007).
Patients having chronic diseases like diabetes, hypothyroidism, 2++, 1kidney insufficiency, heart and vessels diseases or GI disorders /
surgeries were not involved (Zennure & Magfiret, 2007; Sturtzel et
al., 2010).
Participants suffering from constipation from organic causes or 1+
taking antibiotics during the 2 months before the study were
excluded (Philippe et al., 2011).
Intervention
Recommendation 4.0
Written informed consent should be obtained before implementation.
Available evidence:
39
All the subjects were informed and gave their written consent 1+
before beginning the study (Aase & Torbjorn, 2005; Sairanen et al.,
2007; Pitkala et al., 2007; Philippe et al., 2011).
Recommendation 5.0
The fiber-rich food products should be provided to patients on a regular basis.
Available evidence:
Patients were served with fruit and fiber-rich porridge for breakfast 1+
3 three times per week (Aase & Torbjorn, 2005).
Fermented yoghurt with high fiber content was given to patients 1+
during breakfast and dinner (Sairanen et al., 2007; Philippe et al.,
2011).
Patient received 200ml fermented oat drink with bifidobacteria 1+
daily (Pitkala et al., 2007).
Recommendation 6.0
Laxatives should still be administered if necessary or patient has no defecation for
2 consecutive days.
Available evidence:
40
Subjects were given pharmacological interventions when needed 1+
(Aase & Torbjorn, 2005).
Laxatives were taken on the third day if no bowel movement for 2 1+
whole days (Sairanen et al., 2007).
Evaluation
Recommendation 7.0
A list of parameters regarding patient’s response to the intervention should be
evaluated daily.
Available evidence:
The subjects filled in daily a questionnaire concerning faecal frequency, 1+
consistency of stool, use of laxatives and self-estimated discomfort
(Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al., 2011).
41
CHAPTER 4: IMPLEMENTATION PLAN
To refrain from barriers impeding implementation of an innovation and to
have a smooth transition, some preparatory works are needed to be undertaken
(Alison, 2005 & Claire, 2006). With establishment of the proposed
evidence-based programme, the next move will thus be developing an
implementation plan involving strategic plan for communication and pilot testing.
4.1Communication Plan
For successful change, it should be agreed by all participants
“democratically” and acted on “collectively” (Claire, 2006). In order to do so, a
set of proactive communication strategies will significantly help. Formulating a
communication plan, the first step is to identify who you are going to dialogue –
the stakeholders who are influencing or being influenced by the proposed change
(Polit & Beck, 2008).
The key stakeholders identified for the proposed programme and the
sequence for communication are as below:
1
Management level: Consultant of O&T Rehab Unit, DOM, NC and WM
2
Frontline nurses
3
Orthopaedic surgeons
42
4
Dietitian
5
Clerical staff
6
Patients and their caregivers
4.1.1Communication Plan with Stakeholders
Communication with stakeholders will be carried out in a “top-to-down
approach as success could be hardly achieved if top managers are not acquainted
with the innovation and incorrectly exercise their power during the change
process (Claire, 2006 & Robert, 2008). And the strategies used will be different,
depending on the interests of different stakeholders. Totally 8-week time will be
spent for communication with all hospital stakeholders.
1. Management Level
As one of the key policy-makers and liaison person with the top
management level in the target unit, WM will be selected as the first person to be
contacted. Together with the local survey of laxative consumption and O&T
patient statistics, a brief summary of the research evidences and the details of the
proposed programme including objectives, implementation and evaluation plans,
cost-benefit analysis, barriers and solutions and timeline of implementation will
be presented to WM. To enhance the feasibility of the programme, ongoing
43
refinement will be done according to the perspectives of WM.
Presentation to the Consultant of O&T Rehab Unit, DOM and NC will be
performed in the monthly top managers meeting soon after approval is gained
from WM. In the presentation, besides the information mentioned earlier, a
detailed budget plan will be shown as well. Programme will be revised if
additional comment is received from the top managers.
2. Frontline Nurses
Nursing involvement is particularly significant in the patient recruitment
and outcome measurement of the progrramme. To win nurses’ acceptance and
cooperation, they should be motivated to create a “vision” on the urgency for
change and benefit of the proposed change (Claire, 2006 & Robert, 2008). The
proposed innovation will be promulgated to frontline nurses by means of case
conference and nursing sharing session, in which an interactive discussion
regarding the issue will be held. Evaluation form will be distributed after the
activities for collecting further positive and negative feedbacks. To clarify
misconceptions and elucidate skepticism identified from previous activities, two
identical briefing sessions involving literature review, programme introduction
and Q&A will be subsequently organized.
44
3. Orthopaedic Surgeons
Orthopaedic surgeons are mainly responsible for medication prescription in
the programme. Poor medical support is anticipated as the differential power
relations between doctors and nurses still remain a problem despite attempts by
the nursing profession to change them (Andrew, 2000). To eliminate the resistance,
the implementation plan will be firstly conveyed by the Consultant of O&T Rehab
Unit in the monthly cluster O&T doctors’ meeting. Afterwards, all surgeons will
be invited to attend a briefing session held after the weekly patient grand round by
email. The content of the briefing session will alike the one given to nurses,
except more time will be reserved for explaining surgeons’ roles and
responsibilities in the programme. Lastly, electronic notice will be released to
nurses and doctors before launching.
4. Dietitian
Dietitian’s support is indispensable as the focus of the proposed programme
is dietary intervention. To gain support and promote the nurse-dietitian partnership
throughout the implementation period, the idea of the proposed programme is
unfolded to the responsible dietitian at the stage of confirming the feasibility of
the programme and her expert opinion is incorporated in the design of the
45
programme also. The finalized logistics will be presented to the dietitian once
approval for implementation is attained.
5. Clerical Staff
Clerical assistance is required for document arrangement and procedures of
diet ordering, data collection and evaluation. To facilitate the workflow, a briefing
will be arranged to ward clerks ahead of formal implementation.
6. Patients and Their Caregivers
Background information of constipation and programme outline will be
posted up at the education board outside the patient receiving room of the target
hospital, giving a snapshot to patients and relatives first. After the initial nursing
assessment on admission, together with a well-illustrated information sheet
written in Chinese or English, a detailed programme introduction will be provided
to those eligible cases by ward nurses. Written informed consent will then be
obtained if acceptance is confirmed.
46
4.2 Pilot Study Plan
To boost the probability of success in a full-scale implementation, it is
essential to have a mini preliminary test which is so-called “pilot study” for
examining the feasibility the programme and identifying areas to be modified
(Andrew, Lori & Helena, 2010).
4.2.1 Objectives
test the feasibility of the programme design including patient recruitment and
workflow
assess patients’ adherence and nurses’ compliance to the programme
assess patient and nurse satisfaction with the programme
reveal unexpected impediments for actual implementation
4.2.2 Target Setting and Target Audience
These are identical to that of the proposed programme described in the
chapter 3.
4.2.3 Sampling Plan
A 4-week pilot study will be launched in one female ward and one male
47
ward respectively following completion of the briefing sessions. Subjects will be
recruited by purposive sampling. The inclusion and exclusion criteria and
workflow constituted for the actual study in the previous chapter will be applied
in the pilot test. Reviewing the patient admission record in 2012, about 3 to 4
eligible cases were admitted to each ward weekly. With the highest dropout rate as
20% (Philippe et al., 2011), 26 samples will be expected to be recruited within the
period.
4.2.4 Ethical Consideration
To safeguard patient’s rights and privacy, ethical approval will be obtained
from the Hospital Clinical Research Ethic Committee. Like the target audience of
the proposed programme, participants of the pilot study will also receive
programme introduction conducted by ward nurses after initial nursing assessment
on admission and have to sign an informed consent before joining the programme.
4.2.5 Evaluation of the Pilot Study
Evaluation will be initiated after the first week of the pilot trial. To evaluate
programme structure and nursing compliance, data will be collected through
bi-weekly compliance check with use of a “self-designed audit form” (Appendix
48
15) and a semi-structured focus group interview for nurses working at the pilot
wards. Upon accomplishment of the pilot trial, staff satisfaction survey will be
conducted in the form of self-administrated questionnaire (Appendix 16).
Patients’ adherence to the study will be assessed weekly by reviewing their
daily I&O charts. To determine patient satisfaction, few questions in 5-point
Likert Scale will be asked on discharge (Appendix 17).
All data captured from the captioned assessments will be transcribed in a
written report with recommendation for modification of the programme within the
4-week evaluation period. This formative evaluation report will be subsequently
disseminated to frontline nurses and surgeons by email and presented in the top
managers meeting for final approval of full-scale implementation.
49
CHAPTER 5: EVALUATION PLAN
To measure the effectiveness of the programme, quantify the effort of
stakeholders and look for continuous improvement, a systematic summative
evaluation plan with clear depiction of outcomes to be achieved, nature and
number of clients to be involved, data collection and analysis and criteria for
effective change has to be established beforehand.
5.1 Outcome Measures
The outcome measures will be categorized into three groups in terms of
patient, healthcare provider and system. Among them, patient outcome weighs
heavily in the evaluation as it is a critical component of assessing whether the
programme is effectively improving the health of patients (Martha & Sara, 2012).
5.1.1 Patient Outcome
The ultimate goal of the programme is to help hospitalized Ortho-geriatric
patients prevent constipation and reduce dependence on laxatives. For
determining the effectiveness of the programme, the bowel motor function
parameters (stool frequency and consistency) and use of laxatives are the primary
outcomes to be assessed according to the reviewed papers. For measurement, I&O
50
chart, Bristol Stool Scale (BSS) and patient medication record will be utilized.
Patient’s adherence to the given food product will be monitored by I&O
chart because the primary outcomes correlate closely with patient’s consumption
as told by the reviewed studies.
With the possibility of developing certain GI discomforts after ingestion of
the food products (Sairanen et al., 2007; Philippe et al., 2011), the intensity of
each symptom will be rated on a Visual Analogue Scale (VAS), encoded from 0
(not at all) to 10 (a lot).
To reveal the reasons of poor compliance or withdrawal, patient satisfaction
will be measured with the questionnaire in 5-point Likert Scale.
5.1.2 Healthcare Provider Outcome
Nursing compliance will be checked by using the self-designed audit form
for ascertaining the fidelity of the programme intervention and outcome
measurement (Polite & Beck, 2008). To decide the acceptability of the innovation,
nurse satisfaction will be assessed with the self-administrated questionnaire.
5.1.3 System Outcome
As preventing prolonged hospitalization resulted from constipation-related
51
complications and reducing laxative consumption are the system goals of the
programme, number of cases being transferred back to acute setting for that
particular reason and cost for laxatives will be evaluated with the monthly patient
statistics and medication consumption report of the local pharmacy.
5.2 Nature and Number of clients to be involved
Patients fulfilling the inclusion criteria described in the proposed
programme will be recruited during the 12-week study period.
The sample size of the study is calculated based on the study design,
primary outcomes and method of analysis. The actual implementation is an
after-only quasi-experimental study design with patient records of the preceding
three months as non-equivalent control group. To determine the change in
patient’s bowel motor function parameters and use of laxatives, a two-tailed z-test
for testing one proportion will be used as method of analysis. Taking 5% level of
significance and 80% power, the calculated sample size is 88 (Lenth, 2013). With
20% dropout rate (Philippe et al., 2011), 110 samples are required which will take
8-week time for accomplishment.
52
5.3 Data Collection and Analysis
Within the 8-week final evaluation period, statistical analysis will be done
by the Statistical Package for Social Science (SPSS) under the intention-to-treat
principle.
To compare the baseline characteristics of both groups, Chi-square test will
be adopted to analyze the categorical variables including age, sex, body mass
index, medical background, Early Mobility Score, Modified Barthel Index,
symptom of constipation and use of laxatives which will be assembled through
reviewing the hospital records. The result will be expressed as “mean” and
“standard deviation”.
Patient Outcome
The stool frequency and consistency, use of laxatives, amount consumed
and self-estimated comfort level will be all registered at a “table of outcome
measurement” (Appendix 18) by ward nurses daily as a summary and reviewed by
the investigator monthly until patients discharge, withdraw or completion of the
programme.
A two-tailed z-test for testing one proportion will be used to evaluate the
proportion changed in the bowel motor function parameters and use of laxatives.
Percentage will be calculated for different categories of patient’s
53
consumption (consumed completely or almost completely / about half of the
product consumed / a little or none consumed) and patient developing GI
symptoms. Mean score of each symptom will be also obtained. No comparison
could be made for these two outcomes as both are not measured in current
practice.
Patients will be invited to answer the questionnaire by trained ward clerks
on discharge. Mean value will be calculated for each question.
Healthcare Provider Outcome
The investigator will conduct nurse compliance audit in the middle and at
the end of the study. Two wards will be involved each time. For calculating the
compliance percentage, the number of items completed will be divided by the
total number of items in the audit form.
The self-administrated questionnaire will be distributed to nurses after
accomplishment of the programme. Besides getting a mean score for each item in
the questionnaire, descriptive statistical method will be also utilized for analyzing
textual data.
54
System Outcome
The total number of cases being transferred back for constipation-related
complications and total cost for laxatives within the study period will be
compared with the figures of last three months using a two-tailed independent
t-test.
5.4 Criteria for Effective Change
Among the three outcomes, patient outcome is regarded as the most crucial
element for deciding the effectiveness of the programme as mentioned earlier.
According to the high level studies (Aase & Torbjorn, 2005; Sairanen et al., 2007;
Pitkala et al., 2007; Philippe et al., 2011), to consider the programme as effective,
the main criteria for patient outcome are as follows:
participants having normal stool frequency and consistency without laxatives
in 70% of the study days
above 60% decrease in the use of laxatives
each GI symptom getting mean score of 3 or lower on the 10-degreeVAS
over 80% of the participants showing good compliance in consuming the
food product
For patient satisfaction, mean value for each question should be 3 or above
55
on the 5-point Likert Scale.
A minimum of 85% compliance rate which is the normal standard for
nursing audit in the target setting and mean score of 3 or higher out of 5 points for
each item in the self-administrated questionnaire should be acquired for the
healthcare provider outcome.
For the system outcome, there should be no rise in the total number of cases
being transferred back for constipation-related complications and above 80%
reduction on the cost for laxatives (Aase & Torbjorn, 2005) during the study
period.
56
CHAPTER 6: CONCLUSION
Constipation is a gastrointestinal disorder highly prevailing among the
hospitalized elderly Orthopaedic patients. Without much help on the prevalence of
constipation, laxative therapy is conventionally taken as the first line treatment in
the hospitals of Hong Kong. It brings about substantial economic burden to the
health care system and numerous complications to patients. In fact, many research
studies have proven that fiber-rich diet can be as effective as laxatives in helping
patients prevent and relieve constipation but with less cost and side-effects. A
translational research is initiated in this dissertation as a result of the above
reasons.
First of all, an integrated and systematic review of papers studying dietary
interventions for resolving constipation and reducing laxatives consumption in
elderly with ADL dependency is performed. Seven relevant studies are selected
and assessed on the quality and internal validity in which 4 out of the 7 studies are
rated with 1+ level of evidence. Following synthesis of data and assessment of the
transferability of the research findings, feasibility and cost-benefit ratio of the
innovation, an evidence-based dietary fiber enrichment program is developed with
high grade recommendations for patient recruitment, intervention and evaluation.
57
To ensure a smooth change of practice, a comprehensive implementation plan
involving communication plan with different stakeholders and pilot study plan is
also established. Finally, for determining the effectiveness of the programme, a
thorough evaluation plan is set up with clear delineation of outcome measures,
nature and number of participants to be involved, data collection and analysis and
basis for an effective change.
With this innovation, it is expected that the problems of functional
constipation and heavy reliance on laxatives could be ultimately resolved in the
elderly Orthopaedic patients. In addition, such practice change is hoped to be
further rolled out to other institutional settings like nursing home in the future.
58
Appendix 1
Search Strategies
Database
PubMed
CINAHL PLUS
(EBSCOhost)
(1991-2012)
Medline (Ovid)
(1946-August
week 3 2012)
British
Nursing
Index
(1932-2012)
Constipation
17,419
708
16,500
432
1.
Infrequent fecal
evacuation
7
13
9,739
0
2.
Difficult fecal evacuation
26
0
9,739
0
3.
1 or 2 or 3
17,430
713
16,500
432
4.
Diet
331,104
15,020
266,645
3,422
5.
Dietary
440,080
15,446
228,396
839
6.
Dietetic
12,760
347
7,687
35
7.
Dietary fiber
16,108
1,214
12,738
52
8.
Dietary therapy
173,756
53
10,026
130
9.
Dietary program
14,219
45
56
51
10.
5 or 6 or 7 or 8 or 9 or 10
447,195
24.241
387,795
3,749
11.
4 and 11
1,882
123
1,676
897
75
2
71
4
1
0
0
0
7
4 (All
duplicated with
PubMed)
4 (All duplicated
with PubMed)
1(Duplicated
with PubMed)
Keywords
12.
13.
Limited to aged 65+ years
or above and clinical trial
or randomized controlled
trial
Studies retrieved from
related
citation
or
reference list
14.
Filtered by inclusion and
exclusion criteria
15.
Total number of studies
recruited
7
59
Appendix 2
Table of Evidence
Citation
(1)
Lois et
al., 2000
Study Type
Randomized
controlled
study
Patient Characteristics
Institutionalized older
adults suffering from
dementia,
CVA,
degenerative
joint
disease, hypertension,
heart
disease
or
Parkinson’s disease
Only male, age ranged
from 61-80
Mean age: 72.6 (IG),
73.8 (CG)
Average daily fluid
intake of at least
1500ml
Taking 2 or 3 bowel
medications
Have 2.39-2.72 bowel
movements per week
4 subjects in IG and 3
subjects in CG already
on high fiber diet
before the study
Intervention(s)
(IG)
Received 3-6
tablespoons of
bran mixture
with ingredient
of
unsweetened
applesauce,
unprocessed
coarse wheat
bran &
unsweetened
prune juice
before
breakfast and
before supper
daily
Minimum fluid
intake:
1.5L/day
Give laxatives if
no defecation
for 3 days
(n=6)
Comparison
(CG)
Length of
Follow-up
Received usual
ward diet
(n=6)
16 weeks
Outcome Measures
1.
2.
3.
60
Mean bowel
movements per
week
Mean IG /CG
difference in
reduction of
laxative use per
week
Laxative use per
week (%)
Effect Size
1. 2.28 in IG vs 2.67 in
CG (P=0.875)
2. 5.72 (p=0.03)
3. Decreased by 80% in
IG
Citation
(2)
Aase et
al., 2005
Study Type
Patient Characteristics
Randomized
controlled
study
Patients undergoing surgery
or having stroke,
degenerative joint disease /
Parkinson’s disease
Hospitalized in geriatric ward
of two small hospitals
No use of laxatives before
hospitalization
Sex
Mean age
Immobilized
Use of one
drug with
constipation
as a
side-effect
Use of two
or more
drugs with
constipation
as a
side-effect
IG
Male: 6
Female: 4
74.9
CG
Male: 4
Female: 6
78.4
4
2
5
5
2
2
Intervention(s)
(IG)
Served
fruit-rich
(flaxseed,
raisins,
apricots &
prunes)
porridge
with fiber
content
7.5g for
breakfast 3
times per
week
Give
laxatives
when
needed
(n=10)
61
Comparison
(CG)
Served
standard
breakfast
(n=10)
Length of
Follow-up
14 days
Outcome Measures
1.
2.
3.
4.
5.
Number of days
with
defecation
without laxatives
Number of days
with
defecation
and
osmotic/stimulant
laxatives
Number of days
without defecation
Perceived
well-being
(10-degree visual
analogue scale)
Costs for laxatives
(%)
Effect Size
1.
2.
3.
4.
5.
10.7/14 in
IG vs 3.2/14
in
CG
(p=0.003)
0.8/14 in IG
vs 5.2/14 in
CG
(p=0.009)
2.5/14 in IG
vs 5.6/14 in
CG (p=0.06)
2.5 in IG vs
6.5 in CG
(p=0.008)
93% lower
in IG
Citation
(3)
Sairanen
et al.,
2007
Study Type
Randomized
controlled,
two-period
cross-over study
Patient Characteristics
Institutionalized or
home-bounded elderly
suffering from mild
constipation and various
age-related chronic diseases
and taking a wide range of
medicines
Both gender (11 male and 32
female) with mean age 76
years, ranged from 61-92
years
Mean daily fiber intake
22.3g/day, ranged from
8.9-43.9g/day
Use of laxatives
Daily or weekly: 15
persons
Less than weekly: 4
persons
Not use: 24 persons
Period of constipation
Over 20 years: 14
persons
3-20 years: 15 persons
Less than 3 years:14
persons
Level of exercise
Daily: 32 persons
Sometimes: 7 persons
None or minimal: 4
Intervention(s)
(IG)
Comparison
(CG)
Ingested
130g of
fermented
yoghurt
containing
soluble fiber:
galacto-oligos
accharides
(GOS) 6g,
prunes 6g
and linseed
3g twice daily
( in the
morning and
in the
evening)
Give laxatives
if no
defecation
for 2 days
(n=43)
Ingested 130g of
fermented
yoghurt twice
daily ( in the
morning and in
the evening)
(n=43)
62
Length of
Follow-up
10 weeks
Outcome Measures
1.
2.
3.
4.
5.
6.
7.
Frequency
of
defecation
(times/week)
Difficulty
in
defecation (points)
Hardness of feces
(points)
Overall
gastrointestinal
symptoms
(abdominal
pain,
distension
and
flatulence) (points)
Abdominal
pain
(points)
Use of laxatives
Patient’s satisfaction
on effectiveness of
yoghurt in relieving
constipation
(median scores)
Effect Size
1.
2.
3.
4.
5.
6.
7.
8.0±0.6 in IG
vs 7.1±0.5 in
CG (p‹0.011)
1.3 in IG vs 1.5
in CG
(p‹0.01)
2.1 in IG vs 2.2
in CG
(p‹0.059)
2.2 in IG vs 2.2
in CG
(p‹0.967)
0.1 in IG vs 0.3
in CG
(p‹0.031)
Remained
constant
2.0 in IG vs 1.5
in CG
(p‹0.005)
Citation
(4)
Pitkala et
al., 2007
Study Type
Patient Characteristics
Randomized
controlled
study
Patients institutionalized in two
nursing homes
Mean age
(range)
Sex (%)
Nutritional
status (%)
Malnutrition
At risk
Well-nourishe
d
Mean body
mass index
(BMI) (SD)
(kg/m2)
Impaired
mobility (%)
Impaired
cognition (%)
Constipation
during the
previous 3
months (%)
Diarrhoea
during the
previous 3
months (%)
Use of
laxatives
IG
84.7
(65-102)
Male: 11.5
Female:
88.5
CG
84.7 (61-99)
Male: 25.8
Female: 74.2
Intervention(s)
(IG)
Comparison
(CG)
Length of
Follow-up
Received 200ml
fermented oat
drink with
bifidobacteria
daily
(n=56)
Received
200ml
pasteurized
fermented oat
drink
(n=67)
217 days
Outcome Measures
1.
2.
3.
34.6
59.6
5.8
41.9
58.1
0
22.4 (4.4)
22.7 (4.7)
25.9
20.3
50.0
45.3
27.5
20.2
20.4
22.0
77.4%
77.1%
4.
5.
63
Compliance
in
consuming
the
study product
(% of participants)
Mean frequency
of defecation
( % of days)
Mean frequency
of normal bowel
movements
( % of days)
Mean frequency
of diarrhoea or
loose stool
(% of days)
Use of laxatives
(% of participants)
Effect Size
1.
84% in IG
vs 78% in
CG
(p=0.003)
2.
38.8 in IG
vs 30.6 in
CG
(p=0.042)
3.
28.5 in IG
vs 20.0 in
CG
(p=0.003)
4.
5.4 in IG
vs 6.5 in
CG
(p=0.585)
5.
76.8% in
IG
vs
77.6% in
CG
(no difference)
Citation
(5)
Zennure
et al.,
2007
Study Type
Patient Characteristics
Quasi-experi
mental study
Patients undergoing
Orthopaedic surgery
Sex
Mean
age
IG
Male: 15
Female: 15
69.05
CG
Male: 18
Female: 12
69.29
Intervention(s)
(IG)
Provided diet
consisting of bran
supplement
together with
planned nursing
interventions
including
preliminary
nursing
assessment,
toilet training,
fluid intake
1.5L/day and
daily physical
activity
(n=30)
Comparison
(CG)
Provided
routine
nursing care
(fluid diet at
st
1 postop
D1, then
normal diet,
laxative
agents and
gradual
exercise)
(n=30)
Length of
Follow-up
5 days
Outcome Measures
1.
Time of defecation (No. of persons)
Not defecation
2.
Defecation
Number of defecation (No. of persons)
0
3.
1
Duration of defecation (No. of persons)
Not defecation
Normal
Long
4.
Effect Size
IG
CG
9
15
21
15
p-value
0.032
9
15
21
15
0.142
9
15
18
3
7
8
9
1
18
2
15
3
3
9
0.001
9
1
16
4
15
1
8
6
0.206
9
15
1
8
0.03
Intensity of feces (No. of persons)
Not defecation
Watery
Normal
Hard
5.
Colour of feces (No. of persons)
Not defecation
Open colour
Normal
Dark open
6.
Amount of feces (No. of persons)
Not defecation
Small
Normal
Much
64
16
5
4
2
0.016
Citation
(6)
Study Type
Sturtzel et
al., 2010
Randomized
controlled
study
Patient Characteristics
Geriatric hospital
residents with multiple
chronic diseases and
requiring assistance in
their daily life activities
Either sex, with mean
age 86 years in IG and
84.6 years in CG
Mean body weight (BW)
59.5kg
Mean height 1.63m
Use laxatives routinely
Intervention(s)
(IG)
Comparison
(CG)
Length of
Follow-up
Outcome Measures
Blended
oat-bran product
containing 8.3g
insoluble
fermentable
fiber and 9.7g of
insoluble
non-fermentable
fiber into
common daily
meal
(n=15)
Served ward’s
habitual diet
(n=15)
12 weeks
Primary outcome
Use of laxative (% of
individuals))
Secondary outcomes
Plasma B12
Plasma B6 & folate
Effect Size
1.
2.
3.
65
Reduced by 59%
in IG
(p‹0.001)
Increased by 8%
in CG
(p›0.05)
Decreased in CG
(p‹0.05) only
Remained
constant in two
groups
Citation
(7)
Study Type
Philippe
et al.,
2011
Randomized
controlled
study
Patient Characteristics
Patients suffering from
constipation according to
Rome III criteria
Sex
Age
Body
mass
index
(BMI)
2
(kg/m )
IG
Male: 2
Female:
23
55.6 (±
5.4)
26.35 (±
4.77)
CG
Male:4
Female:
21
57.1 (±
4.8)
24.89 (±
5.18)
Intervention(s)
(IG)
Comparison
(CG)
Length of
Follow-up
Consumed
7.5g native
dietary fiber
(inulin) mixing
with yoghurt
or stewed
fruits twice
daily (during
breakfast and
dinner)
(n=25)
Consumed
placebo (7.5g
maltodextrin/sach
et)
(n=25)
28 days
Outcome Measures
1.
2.
66
Bowel symptoms
and quality of life
(Visual analogue
scale)
a.
Flatulence
b.
Borborygmi
c.
Bloating
d.
Satisfaction of
digestion
Bowel motor
function parameters
(% of people)
e.
Stool
frequency and
consistency
(by periods of 5 days)
f.
More than one
bowel
movement per
day
(by periods of 5 days)
g.
Difficulties in
defecation
(by periods of 5 days)
Effect Size
1.
2.
Bowel symptoms
and quality of
life
a.
5.64±3.21
in IG vs
2.91±2.74
in CG
(p‹0.01)
b.
Not
significant
c.
Not
significant
d.
No
significant
difference
Bowel motor
function
parameters
e.
No
significant
difference
f.
Increased
in IG
(p‹0.01)
g.
Decreased
in IG
(p‹0.001)
Appendix 3
Overall Summary of Quality Assessment
Methodology Checklist: Controlled Trials (SIGN, 2012)
Citations
Lois et al., 2000
Aase & Torbjorn,
2005
Sairanen et al.,
2007
Pitkala et al., 2007
Zennure &
Magfiret, 2007
Sturtzel et al., 2010
Philippe et al., 2011
Section 1: Internal validity
In a well conducted RCT study….
In this study this criterion is:
1.1
The study addresses an appropriate and
clearly focused question.
Well covered
Well covered
Well covered
Well covered
Well covered
Well covered
Well covered
1.2
The assignment of subjects to treatment
groups is randomised
Adequately
addressed
Adequately
addressed
Well covered
Well covered
Not applicable
Poorly addressed
Poorly addressed
1.3
An adequate concealment method is used
Not reported
Well covered
Not reported
Well covered
Not applicable
Not reported
Not reported
1.4
Subjects and investigators are kept ‘blind’
about treatment allocation
Not reported
Not applicable
Well covered
Well covered
Not applicable
Not applicable
Well covered
1.5
The treatment and control groups are similar at
the start of the trial
Poorly addressed
Well covered
Poorly addressed
Well covered
Poorly addressed
Poorly addressed
Well covered
1.6
The only difference between groups is the
treatment under investigation
Poorly addressed
Well covered
Well covered
Well covered
Well covered
Well covered
Well covered
1.7
All relevant outcomes are measured in a
standard, valid and reliable way
Well covered
Well covered
Well covered
Well covered
Poorly addressed
Well covered
Well covered
1.8
What percentage of the individuals or clusters
recruited into each treatment arm of the study
dropped out before the study was completed?
No drop out
No drop out
No drop out
Drop-out rate
Treatment group:
46/56
Control
group:
61/67
No drop out
No drop out
1.9
All the subjects are analysed in the groups to
which they were randomly allocated (often
referred to as intention to treat analysis)
Well covered
Well covered
Well covered
Well covered
Well covered
Well covered
Well covered
1.10
Where the study is carried out at more than one
site, results are comparable for all sites
Not addressed
Adequately
addressed
Not reported
Adequately
addressed
Not addressed
Not addressed
Not reported
1-
1+
1+
1+
2++
1-
1+
Drop-out rate
Treatment group:
1/25
Control group: 5/25
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
67
Appendix 4
Methodology Checklists of Selected Studies
Citation 1
Lois, Diane & Deborah, 2000
Section 1: Internal validity
In a well conducted RCT study……
1.1
In this study this criterion is:
The study addresses an appropriate and clearly
Well covered. The objectives and hypothesis are
focused question.
clearly stated.
Adequately addressed. Patients were paired up and
1.2
The assignment of subjects to treatment groups
is randomised
one member of each pair was randomized to receive
treatment.
1.3
Not reported.
An adequate concealment method is used
Subjects and investigators are kept ‘blind’ about
Not reported.
1.4
treatment allocation
Poorly addressed. Members of control group use more
The treatment and control groups are similar at
1.5
bowel medications which was statistically borderline
the start of the trial
significant.
The only difference between groups is the
1.6
6 in intervention group were on high fibre diet.
treatment under investigation
All relevant outcomes are measured in a
1.7
Well covered. Measurements shown were standard,
valid and reliable.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Poorly addressed. 3 out 6 in control group and 4 out of
No drop out.
recruited into each treatment arm of the study
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. No drop out and all subjects were
analysed in their original groups.
referred to as intention to treat analysis)
Where the study is carried out at more than one
1.10
Not addressed. The study was carried out at only one
medical centre.
site, results are comparable for all sites
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
68
1-
Citation 2
Aase & Torbjorn, 2005
Section 1: Internal validity
In a well conducted RCT study……
1.1
1.2
In this study this criterion is:
The study addresses an appropriate and
Well covered. The objectives and hypothesis are
clearly focused question.
clearly stated.
The assignment of subjects to treatment
groups is randomised
Adequately addressed. Patients were randomized
into two groups with same amount in each.
Well covered. Patients were allocated by drawing an
1.3
opaque and sealed envelope with respective group
An adequate concealment method is used
stated.
Subjects and investigators are kept ‘blind’
1.4
Not applicable. Both subjects and investigators were
unable to blind due to the food delivering mode.
about treatment allocation
The treatment and control groups are similar at
1.5
Well covered. No significant differences between
groups were found.
the start of the trial
The only difference between groups is the
Well covered.
1.6
treatment under investigation
All relevant outcomes are measured in a
1.7
valid and reliable.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Well covered. Measurements shown were standard,
No drop out.
recruited into each treatment arm of the study
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. No drop out and all subjects were
analysed in their original groups.
referred to as intention to treat analysis)
Where the study is carried out at more than
1.10
one site, results are comparable for all sites
Adequately addressed. Study was carried out at two
small hospitals.
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
69
1+
Citation 3
Sairanen et al., 2007
Section 1: Internal validity
In a well conducted RCT study……
1.1
1.2
1.3
In this study this criterion is:
The study addresses an appropriate and
Well covered. The objectives and hypothesis are
clearly focused question.
clearly stated.
The assignment of subjects to treatment
groups is randomised
Well covered. Subjects were randomized in blocks and
randomization was stratified.
Not reported.
An adequate concealment method is used
Subjects and investigators are kept ‘blind’
1.4
Well covered. Both subjects and investigators were
blinded.
about treatment allocation
The treatment and control groups are similar at
1.5
Poorly addressed. Only overall baseline characteristics
of both groups were reported.
the start of the trial
The only difference between groups is the
Well covered.
1.6
treatment under investigation
All relevant outcomes are measured in a
1.7
valid and reliable.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Well covered. Measurements shown were standard,
No drop out.
recruited into each treatment arm of the study
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. No drop out and all subjects were
analysed in their original group.
referred to as intention to treat analysis)
Where the study is carried out at more than
1.10
one site, results are comparable for all sites
Not reported. Only mentioned the subjects were
recruited from community or nursing homes.
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
70
1+
Citation 4
Pitkala et al., 2007
Section 1: Internal validity
In a well conducted RCT study……
1.1
1.2
In this study this criterion is:
The study addresses an appropriate and
Well covered. The objectives and hypothesis are
clearly focused question.
clearly stated.
The assignment of subjects to treatment
groups is randomised
Well covered. Randomization was performed by
means of computer-generated random numbers
Well covered. Subjects received corresponding
1.3
numbers and assignment from a randomization staff
An adequate concealment method is used
not familiar with them.
Subjects and investigators are kept ‘blind’
1.4
Well covered. Both subjects and investigators were
blinded.
about treatment allocation
The treatment and control groups are similar at
1.5
Well covered. No significant differences between
groups were found.
the start of the trial
The only difference between groups is the
Well covered.
1.6
treatment under investigation
All relevant outcomes are measured in a
1.7
valid and reliable.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Well covered. Measurements shown were standard,
recruited into each treatment arm of the study
Drop-out rate:
Treatment group: 10/56
Control group: 6/67
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. Intention-to-treat analysis was
adopted.
referred to as intention to treat analysis)
Where the study is carried out at more than
1.10
one site, results are comparable for all sites
Adequately addressed. Study was carried out at 12
wards of 2 nursing homes.
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
71
1+
Citation 5
Zennure & Magfiret, 2007
Section 1: Internal validity
In a well conducted RCT study……
In this study this criterion is:
The study addresses an appropriate and
Well covered. The objectives and hypothesis are
clearly focused question.
clearly stated.
1.2
The assignment of subjects to treatment
groups is randomised
Not applicable. It was a quasi-experimental study.
1.3
An adequate concealment method is used
1.1
Not applicable. It was a quasi-experimental study.
Subjects and investigators are kept ‘blind’
Not applicable. It was a quasi-experimental study.
1.4
about treatment allocation
The treatment and control groups are similar at
1.5
Poorly addressed. Significant difference was found in
the marital status of study participants.
the start of the trial
The only difference between groups is the
Well covered.
1.6
treatment under investigation
All relevant outcomes are measured in a
1.7
specifically for the study by researcher.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Poorly addressed. Instruments used were designed
No drop out.
recruited into each treatment arm of the study
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. No drop out and all subjects were
analysed in their original group.
referred to as intention to treat analysis)
Where the study is carried out at more than
1.10
Not addressed. The study was carried out at only one
medical centre.
one site, results are comparable for all sites
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
72
2++
Citation 6
Sturtzel et al., 2010
Section 1: Internal validity
In a well conducted RCT study……
1.1
1.2
1.3
In this study this criterion is:
The study addresses an appropriate and
Well covered. The objectives and hypothesis are
clearly focused question.
clearly stated.
The assignment of subjects to treatment
groups is randomised
Poorly addressed. Details of randomization were not
mentioned.
Not reported.
An adequate concealment method is used
Subjects and investigators are kept ‘blind’
1.4
Not applicable. It was impossible to blind both due
the working procedures of nursing staff.
about treatment allocation
Poorly addressed. Only overall baseline
The treatment and control groups are similar
1.5
characteristics of both groups were reported beside
at the start of the trial
age.
The only difference between groups is the
Well covered.
1.6
treatment under investigation
All relevant outcomes are measured in a
1.7
valid and reliable.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Well covered. Measurements shown were standard,
No drop out.
recruited into each treatment arm of the study
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. No drop out and all subjects were
analysed in their original group.
referred to as intention to treat analysis)
Where the study is carried out at more than
1.10
one site, results are comparable for all sites
Not addressed. The study was carried out at only one
medical centre.
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
73
1-
Citation 7
Philippe et al., 2011
Section 1: Internal validity
In a well conducted RCT study……
1.1
1.2
1.3
In this study this criterion is:
The study addresses an appropriate and
Well covered. The objectives and hypothesis are
clearly focused question.
clearly stated.
The assignment of subjects to treatment
groups is randomised
Poorly addressed. Details of randomization were not
mentioned.
Not reported.
An adequate concealment method is used
Subjects and investigators are kept ‘blind’
1.4
Well covered. Both subjects and investigators were
blinded.
about treatment allocation
The treatment and control groups are similar at
1.5
Well covered. No significant differences between
groups were found.
the start of the trial
The only difference between groups is the
Well covered.
1.6
treatment under investigation
All relevant outcomes are measured in a
1.7
valid and reliable.
standard, valid and reliable way
What percentage of the individuals or clusters
1.8
Well covered. Measurements shown were standard,
recruited into each treatment arm of the study
Drop-out rate:
Treatment group: 1/25
Control group: 5/25
dropped out before the study was completed?
All the subjects are analysed in the groups to
1.9
which they were randomly allocated (often
Well covered. Intention-to-treat analysis was
adopted.
referred to as intention to treat analysis)
Where the study is carried out at more than
1.10
one site, results are comparable for all sites
Not reported. Only mentioned the trial was
conducted in France.
Section 2: Overall assessment of the study
2.1
How well was the study done to minimise bias?
Code ++, +, or −
74
1+
Appendix 5
Key to Evidence Statements (SIGN, 2012)
LEVELS 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 or 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 confounding 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
75
Appendix 6
Table 1. Study results with p-value‹0.05
Name of RCT
&
Intervention
Positive Outcome
& Significance
Normal frequency
of
bowel
movement
(at least 3times /
week + without
laxatives)
Reduction
in
number of days
without defecation
/ with difficulty in
defecation
Positive well-being
(VA Scale)
Normal
consistency
(BS Scale)
Reduction
laxative use
Aase & Sairanen
Lois,
et al.,
Diane & Torbjorn
2007
Deborah, , 2005
2000
Pitkala
et al.,
2007
Sturtzel
et al.,
2010
Philippe
et al.,
2011
3-6
tablespoons
of Bran
mixture +
1.5L Fluid +
Laxative if no
BO for 3 days
Fiber-rich
porridge +
7.5g of Fiber
content +
Laxatives if
needed
Fermented
yoghurt + 6g
of High fiber
content +
Laxatives if
no BO for 2
days
200ml of
Fermented
oat drink
with
bifidobacteri
a
8.3g of
Insoluble
fermentable
fiber + 9.7g
of Insoluble
non-ferment
able fiber +
common diet
Fermented
yoghurt +
7.5g of High
fiber content
×
P=0.003
p‹0.011
P=0.042
×
p‹0.01
×
×
p‹0.01
P=0.003
×
p‹0.001
×
P=0.008
p‹0.031
×
×
(↓abdomina
l pain)
p‹0.01
(flatulence)
stool
in
↓80%
P=0.03
Reduction in cost
for laxatives
Level of evidence
1-
×
×
↓59%
P‹0.001
×
1+
1-
1+
P=0.009
×
×
↓93% in
cost
×
1+
1+
Remarks: BO = Bowel movement
76
×
Appendix 7
(Nursing Times, 2006)
77
Appendix 8
(Fibro Action, 2012)
78
Appendix 9
Comparison of participant’s characteristics
Characteristics of
Reviewed
participants
Studies
Target Setting
(n=7)
Age
62 – 86 (7)
65 or above
Sex
Male and Female
Male and Female
(6)
Only male (1)
Medical background
With chronic
With chronic
illness and/or
illness and/ or
operation done (6)
operation done
Mobility status
Impaired (6)
Impaired
Level of dependency
Moderate to high Moderate to high
(6)
Nutritional Status
Symptom
At risk (2)
At risk
of Yes (7)
Yes
Yes (6)
Yes
constipation
Use of laxatives
79
Appendix 10
Timeline of the Programme Development
Communication with
WM, NC, DOM & COS
Evaluation of the pilot
study
(4 weeks)
(4 weeks)
Programme revision
Pilot study in two
wards
Final programme
evaluation
(4 weeks)
(8 weeks)
Communication with
frontline nurses, O&T
doctors & Dietitian
Briefing session for
frontline nurses and
doctors
Total Duration:
(4 weeks)
(1 week)
(1 week)
80
Full implementation
(12 weeks)
38 weeks
Appendix 11
Dietary Fiber Enrichment
Programme
Patient’s Gum Label
Constipation Assessment Form
Medical Background
Reason(s) of Admission:_____________________________
Past History:_____________________________________________________________________
________________________________________________________________________________
Current Medication(s):____________________________________________________________
________________________________________________________________________________
Mobility Status
1.
Bed-bounded
Chair-bounded
NWB
PWB
TDW
FWB
Walking as tolerated
With assistance +/- aids
2.
Without assistance +/- aids
Nutritional Status
1
Meal:
Breakfast
2
Fluid Intake: _________ml / day
Lunch
Dinner
Dental Condition
False teeth:
Yes, Upper (Fixed / Detachable), Lower (Fixed / Detachable)
Risk of constipation
Yes
No
81
No
Eligible for the “Dietary Fiber Enrichment Programme”
Yes
No, specify reason(s)_______________________________________________
Selected food product
Fruit and fiber-rich porridge for breakfast 3 times / week
Fermented yoghurt with high fiber content during breakfast and dinner
Fermented oat drink with high fiber content 200ml / day
Performed by:
Name& Signature:___________________
Date:______________________________
82
Rank: _____________
Appendix 12
Table 2. Comparison of staffing cost
Net Balance
Current Practice
Innovation
($ saved)
Calculation
Items
Calculation
Calculation
(monthly salary/no.
(monthly salary/no.
(current
of days per month
of days per month
practice –
/no. of working hours
per day /no. of
/no. of working
Total
($/patient)
hours per day /no. of
minutes per hour
minutes per hour
*no. of minutes
*no. of minutes
spent)
spent)
Total
innovation)
($/patient)
$98 - $25 =
Registered
$35,290/30/8/60*40
$98
$35,290/30/8/60*10
$25
$73
nurse
$61 - $15 =
Enrolled
$22,005/30/8/60*40
$61
$22,005/30/8/60*10
$15
$46
nurse
Table 3. Cost of staff training
Calculation
(monthly salary/no. of days per month /no.
Items
of working hours per day /no. of minutes per
hour *no. of minutes spent* no. of
Subtotal
($)
participants)
Investigator
$42,410/30/8/60*90
$265
Registered nurses (10)
$35,290/30/8/60*45*10
$1,103
Enrolled nurses (6)
$22,005/30/8/60*45*6
$413
Accommodation
Free
IT equipment
Free
Stationery
Free
Total of training cost
$1,781
83
Appendix 13
GRADES OF RECOMMENDATIONS
(SIGN, 2012)
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
A body of evidence including studies rated as 2++, directly
applicable to the target population, and demonstrating overall
consistency of results; or
Extrapolated evidence from studies rated as 1++ or 1+
A body of evidence including studies rated as 2+, directly applicable
to the target population and demonstrating overall consistency of
results; or
Extrapolated evidence from studies rated as 2++
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
84
Appendix 14
Logistics of Evidence-based Dietary Fiber
Enrichment Programme
Excluded
Elderly aged 65 or above
Impaired
cognition
Expressing and
swallowing
Assess risk of constipation
difficulties
According to medical background, medication history,
GI diseases or
mobility status, nutritional intake, bowel pattern, use of
surgeries
laxatives and dental condition
Endocrine
disorders
Long-term drug
therapy,
NO
At risk
YES
Age-related illness or
Constipation from
organic reasons
surgery done
Poor prognosis.
Immobilization +
Refuse
Dependence in ADL
Inadequate nutritional
intake
Symptom of
Ward
habitual
diet
Dietary fiber enrichment
programme
constipation +/- Use of
laxatives
1.
Fruit and fiber-rich porridge for breakfast 3
times / week
Give laxatives
2.
PRN
Fermented yoghurt with high fiber content
during breakfast and dinner
No bowel movement
3.
for 2 consecutive
Fermented oat drink with high fiber content
200ml / day
days
*(Choose one among the three options)
Terminate
Adverse reaction
Evaluate patient’s response daily
Withdrawal
Frequency and consistency of feces, laxative use
Discharge or
and self-estimated discomfort
transfer out
85
Appendix 15
Nursing Procedure Audit Form
for Evidence-based Dietary Fiber Enrichment
Programme
*Please circle the appropriate source of information and tick as appropriate
Source of
information
Standard criteria
Yes
No
N/A Remarks
Patient recruitment
Assess risk of constipation for every
1
newly admitted elderly with the
dedicated
assessment
form
on
AN/AF/O/CR
admission.
2
3
4
5
Complete all the items in the
assessment form accurately.
Include
patients
fulfilling
the
recruitment criteria only.
Provide programme introduction to
every eligible case
Obtain written informed consent
before implementation.
AN/AF/O/CR
AN/AF/O/CR
AN/AF/O/CR
AN/AF/O/CR
Intervention
6
7
Serve the selected food product
according to the instruction.
Administer
laxatives
whenever
necessary.
AN/AF/O/CR
AN/AF/O/CR
Evaluation
8
Record all relevant data timely,
accurately and appropriately.
Remarks: AN: ask nurse
AN/AF/O/CR
AF: ask family O: observation
Ward:
Percentage of compliance:
/8=
%
Name & Signature of auditor:
Date:
86
CR: check record
N/A: not applicable
Appendix 16
Nurse Satisfaction Survey
for Evidence-based Dietary Fiber Enrichment
Porgramme
Questionnaire
Disagree
Slightly
Agree
Agree
Strongly
Agree
Name & Rank (Optional):
Strongly
Disagree
Date:
1
The programme has achieved its
stated objectives.
1
2
3
4
5
2
The information provided in the briefing
session is clear, adequate and useful.
1
2
3
4
5
3
The tools for patient assessment and
outcome
measurement
are
understandable and easy to use.
1
2
3
4
5
4
The workflow of the programme is
reasonable and acceptable.
1
2
3
4
5
5
The programme can effectively cut
down nursing workload in dealing
patients with constipation.
1
2
3
4
5
4
5
Item
No.
Description
You are satisfied with the programme
1
2
3
as a whole.
*Please circle the appropriate rating for the following aspects of this programme:
6
7. Which part of the programme is most difficult to be carried out? Why?
8. What additional patient information you would like to be included in the programme?
9. Which area of the programme could be further improved in the future? Any
suggestions?
87
Appendix 17
Patient Satisfaction Survey
for Evidence-based Dietary Fiber Enrichment
Programme
Questionnaire
Disagree
Slightly
Agree
Agree
Strongly
Agree
Name (Optional):
Strongly
Disagree
Date:
1
The programme is useful for
preventing and relieving
constipation.
1
2
3
4
5
2
The programme can help you
reduce reliance on laxatives.
1
2
3
4
5
3
The food product is tasty and
acceptable.
1
2
3
4
5
4
The side-effects of dietary fiber are
minimal and tolerable.
1
2
3
4
5
5
You will continue same diet at
home after discharge.
1
2
3
4
5
6
You will recommend the diet to
other people.
1
2
3
4
5
7
You are satisfied with the
programme as a whole.
1
2
3
4
5
Item
No.
Description
*Please circle the appropriate rating for the following aspects of this programme:
88
Appendix 18
Dietary Fiber Enrichment Programme
Table of Outcome Measurement
Patient’s Gum Label
*Please fill in the following blanks and delete as appropriate.
Date
Patient Outcome
Number of defecation
Consistency of stool
Abdominal pain
/10
/10
/10
/10
/10
/10
/10
Diarrhoea
/10
/10
/10
/10
/10
/10
/10
Flatulence
/10
/10
/10
/10
/10
/10
/10
Bloating
/10
/10
/10
/10
/10
/10
/10
Self-estimated comfort level
Amount consumed
Use of laxatives
Date of discontinuation:
/
/ 2013
Reason:
Discharge
Consistency of stool
(Bristol Stool Scale)
Keys
I = Hard stool
II = Sausage-shaped but
lumpy stool
III = Sausage-shaped stool
with cracks on its surface
IV = Sausage-shape smooth
and soft stool
V = Soft stool with clear-cut
edges
VI = Mushy stool
VII = Watery stool
Withdrawal
Completion of the programme
Self-estimated comfort level
(Visual Analogue Scale)
0
5
Not at all
Few
89
Amount consumed
10
A lot
CC = Consumed completely
CA = Consumed almost completely
HC = Half of the product consumed
LC = A little consumed
NC = None consumed
Use of
laxatives
Y = Yes
N = No
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