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

i

Declaration

I declare that this thesis represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualifications.

Signed……………………………………………………….

Tai Siu King, Rosetti

ii

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.

iii

Contents

Declaration…………………………………………………………………. i

Acknowledgements………………………………………......................... ii

Table of Contents…………………………………………………………... iii

List of Appendices………………………………………………………….. v

Abbreviations…………………………………………….......................... vi

Chapter 1: Introduction……………………………………….. 1

1.1 Background………………………………………………… 2

1.1.1 Diagnostic Criteria for Constipation in Adults......................... 2

1.1.2 Causes and Complications………………………………... 2

1.1.3 Treatment………………………………………………. 3

1.1.4 Epidemiology…………………………………………… 4

1.2 Affirming the Need………………………………………… 5

1.2.1 Clinical Setting………………………………………….. 5

1.2.2 Current Practice and Problems……………………………. 6

1.2.3 Potential Innovation……………………………………… 8

1.3 Research Questions………………………………………… 9

1.4 Objectives of the Proposal……………………………......... 9

1.5 Significance of the Proposal………………………….......... 10

Chapter 2: Critical Appraisal.................................................... 11

2.1 Search and Appraisal Strategies…………………………… 11

2.1.1 Search Strategy………………………………………….. 11

2.1.2 Data Extraction………………………………………….. 13

2.1.3 Appraisal Strategy……………………………………….. 13

2.2 Results……………………………………………………... 14

2.2.1 Overview of Study Characteristics………………………… 14

2.2.2 Summary of Quality Assessment.......................................... 15

2.3 Summary and Synthesis……………………………………. 18

2.3.1 Data Summary…………………………………………... 19

2.3.2 Synthesis of Data………………………………………... 23

iv

Chapter 3: Translation and Application…………………… 26

3.1 Implementation Potential……………………………........... 26

3.1.1 Target Setting…………………………………………… 26

3.1.2 Target Audience…………………………………………. 26

3.1.3 Transferability of the Findings……………………………. 27

3.1.4 Feasibility………………………………………………. 29

3.1.5 Cost-benefit Ratio……………………………………….. 32

3.2 Evidence-based Dietary Fiber Enrichment Programme for

Relieving Constipation in Elderly Orthopaedic

Patients.........................................................................................

36

3.2.1 Objectives………………………………………………. 36

3.2.2 Target Users…………………………………………….. 36

3.2.3 Target Patient Population………………………………… 36

3.2.4 Rating Scheme for the Strength of the Recommendation…….. 36

3.2.5 Recommendations……………………………………….. 37

Chapter 4: Implementation Plan…………………………….. 42

4.1 Communication Plan…………………………………......... 42

4.1.1 Communication Plan with Stakeholders……………………. 43

4.2 Pilot Study Plan………………………………………......... 47

4.2.1 Objectives………………………………………………. 47

4.2.2 Target Setting and Target Audience……………………….. 47

4.2.3 Sampling Plan…………………………………………... 47

4.2.4 Ethical Consideration…………………………………….. 48

4.2.5 Evaluation of the Pilot Study……………………………… 48

Chapter 5: Evaluation Plan……………………………............ 50

5.1 Outcome Measures………………………………………… 50

5.1.1 Patient Outcome…………………………………………. 50

5.1.2 Healthcare Provider Outcome……………………………... 51

5.1.3 System Outcome………………………………………… 51

5.2 Nature and Number of Clients to be Involved……………... 52

5.3 Data Collection and Analysis……………………………… 53

5.4 Criteria for Effective Change………………………………. 55

Chapter 6: Conclusion…………………………………………. 57

Appendices………………………………………………………….. 59

References…………………………………………………………… 90

v

List of Appendices

Appendix 1 Search Strategies………………………………….. 59

Appendix 2 Table of Evidence………………………………… 60

Appendix 3 Overall Summary of Quality Assessment………… 67

Appendix 4 Methodology Checklists of Selected

Studies……………………………………..............

68

Appendix 5 Key to Evidence Statements……………................ 75

Appendix 6 Study Results with P-value‹0.05………………….. 76

Appendix 7 Bristol Stool Chart………………………............... 77

Appendix 8 Visual Analogue Scale……………………………. 78

Appendix 9 Comparison of Participant’s Characteristics............ 79

Appendix 10 Timeline of the Programme Development………... 80

Appendix 11 Constipation Assessment Form…………………... 81

Appendix 12 Comparison of Staffing Cost & Cost of Staff

Training……………………………........................

83

Appendix 13 Grades of Recommendations……………………... 84

Appendix 14 Logistics of Evidence-based Dietary Fiber

Enrichment Programme…………………………...

85

Appendix 15 Nursing Procedure Audit Form…………………… 86

Appendix 16 Questionnaire of Nurse Satisfaction Survey……… 87

Appendix 17 Questionnaire of Patient Satisfaction Survey…….. 88

Appendix 18 Table of Outcome Measurement………………….. 89

vi

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

1

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.

2

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

3

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.

4

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.

5

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,

6

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.

7

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

8

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 the power of

non-pharmacological strategy in relieving constipation.

9

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

10

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

11

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)

12

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

13

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

14

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

15

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.

16

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

17

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,

18

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:

19

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

20

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

21

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).

22

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

23

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

24

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

25

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.

26

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,

27

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.

28

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

29

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

30

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

31

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

practicing nurse (APN)

Registered nurse (RN)

(10)

Enrolled nurse (EN)

(6)

Programme Introduction 20 minutes

Question and Answer 15 minutes

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,

32

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

33

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

34

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

35

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.

36

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

37

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

institutionalized elderly (Pitkala et al., 2007; Sturtzel et al., 2010).

� Constipation is especially prevalent in older people (Philippe et al.,

2011; Zennure & Magfiret, 2007).

� Constipation impairs the functional status and quality of life in older

adults (Aase & Torbjorn, 2005).

1+, 1-

1+, 2++

1+

Recommendation 2.0

a. Patient’s risk of constipation should be assessed through the following

aspects:

� medical background, medication history, mobility status, nutritional

38

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

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

which cause constipation as side-effect (Sairanen et al., 2007).

� Changes in taste perception and dental condition might interfere

with the intake of dietary fiber in elderly (Philippe et al., 2011).

� Patient is constipated if having less than 3 bowel movements per

week or complaining difficulty in defecation ((Aase & Torbjorn,

2005; Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al.,

2011).

1+, 2++

1+

1+

1+

Recommendation 3.0

The programme is not advised to patients with the following conditions:

39

� 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

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,

kidney 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

taking antibiotics during the 2 months before the study were

excluded (Philippe et al., 2011).

1+

2++, 1-

1+

Intervention

Recommendation 4.0

Written informed consent should be obtained before implementation.

Available evidence:

40

� All the subjects were informed and gave their written consent

before beginning the study (Aase & Torbjorn, 2005; Sairanen et al.,

2007; Pitkala et al., 2007; Philippe et al., 2011).

1+

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

3 three times per week (Aase & Torbjorn, 2005).

� Fermented yoghurt with high fiber content was given to patients

during breakfast and dinner (Sairanen et al., 2007; Philippe et al.,

2011).

� Patient received 200ml fermented oat drink with bifidobacteria

daily (Pitkala et al., 2007).

1+

1+

1+

Recommendation 6.0

Laxatives should still be administered if necessary or patient has no defecation for

2 consecutive days.

Available evidence:

41

� Subjects were given pharmacological interventions when needed

(Aase & Torbjorn, 2005).

� Laxatives were taken on the third day if no bowel movement for 2

whole days (Sairanen et al., 2007).

1+

1+

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,

consistency of stool, use of laxatives and self-estimated discomfort

(Sairanen et al., 2007; Pitkala et al., 2007; Philippe et al., 2011).

1+

42

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

43

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

44

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.

45

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

46

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.

47

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

48

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

49

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.

50

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

51

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

52

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.

53

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

54

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.

55

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

56

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.

57

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.

58

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.

59

Appendix 1 Search Strategies

Database

Keywords

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

12.

Limited to aged 65+ years

or above and clinical trial

or randomized controlled

trial

75 2 71 4

13.

Studies retrieved from

related citation or

reference list

1 0 0 0

14. Filtered by inclusion and

exclusion criteria 7

4 (All

duplicated with

PubMed)

4 (All duplicated

with PubMed)

1(Duplicated

with PubMed)

15. Total number of studies

recruited 7

60

Appendix 2 Table of Evidence

Citation

(1) Study Type Patient Characteristics

Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up Outcome Measures Effect Size

Lois et

al., 2000

Randomized

controlled

study

� 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

� 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)

Received usual

ward diet

(n=6)

16 weeks 1. Mean bowel

movements per

week

2. Mean IG /CG

difference in

reduction of

laxative use per

week

3. Laxative use per

week (%)

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

61

Citation

(2) Study Type Patient Characteristics

Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up Outcome Measures Effect Size

Aase et

al., 2005

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

IG CG

Sex Male: 6

Female: 4

Male: 4

Female: 6

Mean age 74.9 78.4

Immobilized 4 2

Use of one

drug with

constipation

as a

side-effect

5 5

Use of two

or more

drugs with

constipation

as a

side-effect

2 2

� 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)

Served

standard

breakfast

(n=10)

14 days 1. Number of days

with defecation

without laxatives

2. Number of days

with defecation

and

osmotic/stimulant

laxatives

3. Number of days

without defecation

4. Perceived

well-being

(10-degree visual

analogue scale)

5. Costs for laxatives

(%)

1. 10.7/14 in

IG vs 3.2/14

in CG

(p=0.003)

2. 0.8/14 in IG

vs 5.2/14 in

CG

(p=0.009)

3. 2.5/14 in IG

vs 5.6/14 in

CG (p=0.06)

4. 2.5 in IG vs

6.5 in CG

(p=0.008)

5. 93% lower

in IG

62

Citation

(3) Study Type Patient Characteristics

Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up Outcome Measures Effect Size

Sairanen

et al.,

2007

Randomized

controlled,

two-period

cross-over study

� 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

� 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)

10 weeks 1. Frequency of

defecation

(times/week)

2. Difficulty in

defecation (points)

3. Hardness of feces

(points)

4. Overall

gastrointestinal

symptoms

(abdominal pain,

distension and

flatulence) (points)

5. Abdominal pain

(points)

6. Use of laxatives

7. Patient’s satisfaction

on effectiveness of

yoghurt in relieving

constipation

(median scores)

1. 8.0±0.6 in IG

vs 7.1±0.5 in

CG (p‹0.011)

2. 1.3 in IG vs 1.5

in CG

(p‹0.01)

3. 2.1 in IG vs 2.2

in CG

(p‹0.059)

4. 2.2 in IG vs 2.2

in CG

(p‹0.967)

5. 0.1 in IG vs 0.3

in CG

(p‹0.031)

6. Remained

constant

7. 2.0 in IG vs 1.5

in CG

(p‹0.005)

63

Citation

(4) Study Type Patient Characteristics

Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up Outcome Measures Effect Size

Pitkala et

al., 2007

Randomized

controlled

study

� Patients institutionalized in two

nursing homes IG CG

Mean age

(range)

84.7

(65-102)

84.7 (61-99)

Sex (%) Male: 11.5

Female:

88.5

Male: 25.8

Female: 74.2

Nutritional

status (%)

Malnutrition

At risk

Well-nourishe

d

34.6

59.6

5.8

41.9

58.1

0

Mean body

mass index

(BMI) (SD)

(kg/m2)

22.4 (4.4) 22.7 (4.7)

Impaired

mobility (%)

25.9 20.3

Impaired

cognition (%)

50.0 45.3

Constipation

during the

previous 3

months (%)

27.5 20.2

Diarrhoea

during the

previous 3

months (%)

20.4 22.0

Use of

laxatives

77.4% 77.1%

Received 200ml

fermented oat

drink with

bifidobacteria

daily

(n=56)

Received

200ml

pasteurized

fermented oat

drink

(n=67)

217 days 1. Compliance in

consuming the

study product

(% of participants)

2. Mean frequency

of defecation

( % of days)

3. Mean frequency

of normal bowel

movements

( % of days)

4. Mean frequency

of diarrhoea or

loose stool

(% of days)

5. Use of laxatives

(% of participants)

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)

64

Citation

(5) Study Type Patient Characteristics

Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up Outcome Measures Effect Size

Zennure

et al.,

2007

Quasi-experi

mental study

� Patients undergoing

Orthopaedic surgery

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)

Provided

routine

nursing care

(fluid diet at

1st

postop

D1, then

normal diet,

laxative

agents and

gradual

exercise)

(n=30)

5 days

1. Time of defecation (No. of persons)

Not defecation

Defecation

2. Number of defecation (No. of persons)

0

1

3. Duration of defecation (No. of persons)

Not defecation

Normal

Long

4. 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

IG CG p-value

9 15 0.032

IG CG 21 15

Sex Male: 15

Female: 15

Male: 18

Female: 12

9 15 0.142

Mean

age 69.05 69.29

21 15

9 15

0.03 18 7

3

8

9 15

0.001 1 3

18 3

2 9

9 15

0.206 1 1

16 8

4 6

9 15

0.016

1 8

16 5

4 2

65

Citation

(6)

Study Type Patient Characteristics Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up

Outcome Measures Effect Size

Sturtzel et

al., 2010

Randomized

controlled

study

� 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

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

1. Reduced by 59%

in IG

(p‹0.001)

Increased by 8%

in CG

(p›0.05)

2. Decreased in CG

(p‹0.05) only

3. Remained

constant in two

groups

66

Citation

(7) Study Type Patient Characteristics

Intervention(s)

(IG)

Comparison

(CG)

Length of

Follow-up Outcome Measures Effect Size

Philippe

et al.,

2011

Randomized

controlled

study

IG CG

Sex Male: 2

Female:

23

Male:4

Female:

21

Age 55.6 (±

5.4)

57.1 (±

4.8)

Body

mass

index

(BMI)

(kg/m2)

26.35 (±

4.77)

24.89 (±

5.18)

� Patients suffering from

constipation according to

Rome III criteria

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 1. Bowel symptoms

and quality of life

(Visual analogue

scale)

a. Flatulence

b. Borborygmi

c. Bloating

d. Satisfaction of

digestion

2. 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)

1. 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

2. Bowel motor

function

parameters

e. No

significant

difference

f. Increased

in IG

(p‹0.01)

g. Decreased

in IG

(p‹0.001)

67

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

I n a w e l l c o n d u c t e d R C T s t u d y … . 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

Drop-out rate

Treatment group:

1/25

Control group: 5/25

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

Section 2: Overall assessment of the study

2.1

How well was the study done to minimise bias?

Code ++, +, or − 1- 1+ 1+ 1+ 2++ 1- 1+

68

Appendix 4 Methodology Checklists of Selected Studies

Citation 1 Lois, Diane & Deborah, 2000

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. The objectives and hypothesis are

clearly stated.

1.2 The assignment of subjects to treatment groups

is randomised

Adequately addressed. Patients were paired up and

one member of each pair was randomized to receive

treatment.

1.3 An adequate concealment method is used Not reported.

1.4 Subjects and investigators are kept ‘blind’ about

treatment allocation

Not reported.

1.5 The treatment and control groups are similar at

the start of the trial

Poorly addressed. Members of control group use more

bowel medications which was statistically borderline

significant.

1.6 The only difference between groups is the

treatment under investigation

Poorly addressed. 3 out 6 in control group and 4 out of

6 in intervention group were on high fibre diet.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Well covered. Measurements shown were standard,

valid and reliable.

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.

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. No drop out and all subjects were

analysed in their original groups.

1.10 Where the study is carried out at more than 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 −

1-

69

Citation 2 Aase & Torbjorn, 2005

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. The objectives and hypothesis are

clearly stated.

1.2 The assignment of subjects to treatment

groups is randomised

Adequately addressed. Patients were randomized

into two groups with same amount in each.

1.3 An adequate concealment method is used

Well covered. Patients were allocated by drawing an

opaque and sealed envelope with respective group

stated.

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation

Not applicable. Both subjects and investigators were

unable to blind due to the food delivering mode.

1.5 The treatment and control groups are similar at

the start of the trial

Well covered. No significant differences between

groups were found.

1.6 The only difference between groups is the

treatment under investigation

Well covered.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Well covered. Measurements shown were standard,

valid and reliable.

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.

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. No drop out and all subjects were

analysed in their original groups.

1.10 Where the study is carried out at more than

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 −

1+

70

Citation 3 Sairanen et al., 2007

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. The objectives and hypothesis are

clearly stated.

1.2 The assignment of subjects to treatment

groups is randomised

Well covered. Subjects were randomized in blocks and

randomization was stratified.

1.3 An adequate concealment method is used Not reported.

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation

Well covered. Both subjects and investigators were

blinded.

1.5 The treatment and control groups are similar at

the start of the trial

Poorly addressed. Only overall baseline characteristics

of both groups were reported.

1.6 The only difference between groups is the

treatment under investigation

Well covered.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Well covered. Measurements shown were standard,

valid and reliable.

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.

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. No drop out and all subjects were

analysed in their original group.

1.10 Where the study is carried out at more than

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 −

1+

71

Citation 4 Pitkala et al., 2007

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. The objectives and hypothesis are

clearly stated.

1.2 The assignment of subjects to treatment

groups is randomised

Well covered. Randomization was performed by

means of computer-generated random numbers

1.3 An adequate concealment method is used

Well covered. Subjects received corresponding

numbers and assignment from a randomization staff

not familiar with them.

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation

Well covered. Both subjects and investigators were

blinded.

1.5 The treatment and control groups are similar at

the start of the trial

Well covered. No significant differences between

groups were found.

1.6 The only difference between groups is the

treatment under investigation

Well covered.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Well covered. Measurements shown were standard,

valid and reliable.

1.8

What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Drop-out rate:

Treatment group: 10/56

Control group: 6/67

1.9

All the subjects are analysed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis)

Well covered. Intention-to-treat analysis was

adopted.

1.10 Where the study is carried out at more than

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 −

1+

72

Citation 5 Zennure & Magfiret, 2007

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. The objectives and hypothesis are

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 Not applicable. It was a quasi-experimental study.

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation

Not applicable. It was a quasi-experimental study.

1.5 The treatment and control groups are similar at

the start of the trial

Poorly addressed. Significant difference was found in

the marital status of study participants.

1.6 The only difference between groups is the

treatment under investigation

Well covered.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Poorly addressed. Instruments used were designed

specifically for the study by researcher.

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.

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. No drop out and all subjects were

analysed in their original group.

1.10 Where the study is carried out at more than

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 −

2++

73

Citation 6 Sturtzel et al., 2010

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. The objectives and hypothesis are

clearly stated.

1.2 The assignment of subjects to treatment

groups is randomised

Poorly addressed. Details of randomization were not

mentioned.

1.3 An adequate concealment method is used Not reported.

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation

Not applicable. It was impossible to blind both due

the working procedures of nursing staff.

1.5 The treatment and control groups are similar

at the start of the trial

Poorly addressed. Only overall baseline

characteristics of both groups were reported beside

age.

1.6 The only difference between groups is the

treatment under investigation

Well covered.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Well covered. Measurements shown were standard,

valid and reliable.

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.

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. No drop out and all subjects were

analysed in their original group.

1.10 Where the study is carried out at more than

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 −

1-

74

Citation 7 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. The objectives and hypothesis are

clearly stated.

1.2 The assignment of subjects to treatment

groups is randomised

Poorly addressed. Details of randomization were not

mentioned.

1.3 An adequate concealment method is used Not reported.

1.4 Subjects and investigators are kept ‘blind’

about treatment allocation

Well covered. Both subjects and investigators were

blinded.

1.5 The treatment and control groups are similar at

the start of the trial

Well covered. No significant differences between

groups were found.

1.6 The only difference between groups is the

treatment under investigation

Well covered.

1.7 All relevant outcomes are measured in a

standard, valid and reliable way

Well covered. Measurements shown were standard,

valid and reliable.

1.8

What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Drop-out rate:

Treatment group: 1/25

Control group: 5/25

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. Intention-to-treat analysis was

adopted.

1.10 Where the study is carried out at more than

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 −

1+

75

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

76

Appendix 6

Table 1. Study results with p-value‹0.05

Remarks: BO = Bowel movement

Name of RCT

& Intervention

Positive Outcome & Significance

Lois, Diane &

Deborah, 2000

Aase & Torbjorn

, 2005

Sairanen et al., 2007

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

Normal frequency of bowel movement (at least 3times / week + without laxatives)

× P=0.003 p‹0.011 P=0.042 × p‹0.01

Reduction in number of days without defecation / with difficulty in defecation

× × p‹0.01 P=0.003 × p‹0.001

Positive well-being (VA Scale)

× P=0.008 p‹0.031 (↓abdomina

l pain)

× × p‹0.01 (flatulence)

Normal stool consistency (BS Scale)

Reduction in laxative use

↓80%

P=0.03

P=0.009 × × ↓59%

P‹0.001

×

Reduction in cost for laxatives

↓93% in

cost

× × × ×

Level of evidence 1- 1+ 1+ 1+ 1- 1+

77

Appendix 7

(Nursing Times, 2006)

78

Appendix 8

(Fibro Action, 2012)

79

Appendix 9

Comparison of participant’s characteristics

Characteristics of

participants

Reviewed

Studies

(n=7)

Target Setting

Age 62 – 86 (7) 65 or above

Sex Male and Female

(6)

Only male (1)

Male and Female

Medical background With chronic

illness and/or

operation done (6)

With chronic

illness and/ or

operation done

Mobility status Impaired (6) Impaired

Level of dependency Moderate to high

(6)

Moderate to high

Nutritional Status At risk (2) At risk

Symptom of

constipation

Yes (7) Yes

Use of laxatives Yes (6) Yes

80

Appendix 10 Timeline of the Programme Development

Communication with

WM, NC, DOM & COS

(4 weeks)

Programme revision

(1 week)

Communication with

frontline nurses, O&T doctors & Dietitian

(4 weeks)

Briefing session for

frontline nurses and doctors

(1 week)

Pilot study in two wards

(4 weeks)

Evaluation of the pilot

study

(4 weeks)

Full implementation

(12 weeks)

Final programme

evaluation

(8 weeks)

Total Duration:

38 weeks

81

Appendix 11

Dietary Fiber Enrichment

Programme

Constipation Assessment Form

Patient’s Gum Label

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

2. �With assistance +/- aids �Without assistance +/- aids

Nutritional Status

1 Meal: �Breakfast �Lunch �Dinner

2 Fluid Intake: _________ml / day

Dental Condition

False teeth: ����Yes, Upper (Fixed / Detachable), Lower (Fixed / Detachable) ����No

Risk of constipation

����Yes ����No

82

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:___________________ Rank: _____________

Date:______________________________

83

Appendix 12

Table 2. Comparison of staffing cost

Table 3. Cost of staff training

Items

Current Practice Innovation Net Balance

($ saved)

Calculation

(monthly salary/no.

of days per month

/no. of working hours

per day /no. of

minutes per hour

*no. of minutes

spent)

Total

($/patient)

Calculation

(monthly salary/no.

of days per month

/no. of working

hours per day /no. of

minutes per hour

*no. of minutes

spent)

Total

($/patient)

Calculation

(current

practice –

innovation)

Registered

nurse $35,290/30/8/60*40 $98 $35,290/30/8/60*10 $25

$98 - $25 =

$73

Enrolled

nurse $22,005/30/8/60*40 $61 $22,005/30/8/60*10 $15

$61 - $15 =

$46

Items

Calculation

(monthly salary/no. of days per month /no.

of working hours per day /no. of minutes per

hour *no. of minutes spent* no. of

participants)

Subtotal

($)

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

84

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

85

Appendix 14

Logistics of Evidence-based Dietary Fiber

Enrichment Programme

NO YES

Elderly aged 65 or above

Dietary fiber enrichment

programme

1. Fruit and fiber-rich porridge for breakfast 3

times / week

2. Fermented yoghurt with high fiber content

during breakfast and dinner

3. Fermented oat drink with high fiber content

200ml / day

*(Choose one among the three options)

Assess risk of constipation

According to medical background, medication history,

mobility status, nutritional intake, bowel pattern, use of

laxatives and dental condition

Excluded

� Impaired

cognition

� Expressing and

swallowing

difficulties

� GI diseases or

surgeries

� Endocrine

disorders

� Long-term drug

therapy,

� Constipation from

organic reasons

� Poor prognosis.

� Refuse

Evaluate patient’s response daily

Frequency and consistency of feces, laxative use

and self-estimated discomfort

At risk

� Age-related illness or

surgery done

� Immobilization +

Dependence in ADL

� Inadequate nutritional

intake

� Symptom of

constipation +/- Use of

laxatives

Give laxatives

� PRN

� No bowel movement

for 2 consecutive

days

Ward

habitual

diet

Terminate

� Adverse reaction

� Withdrawal

� Discharge or

transfer out

86

Appendix 15

Nursing Procedure Audit Form

for Evidence-based Dietary Fiber Enrichment

Programme

*Please circle the appropriate source of information and tick as appropriate

Standard criteria Source of

information Yes No N/A Remarks

Patient recruitment

1

Assess risk of constipation for every

newly admitted elderly with the

dedicated assessment form on

admission.

AN/AF/O/CR

2 Complete all the items in the

assessment form accurately. AN/AF/O/CR

3 Include patients fulfilling the

recruitment criteria only. AN/AF/O/CR

4 Provide programme introduction to

every eligible case AN/AF/O/CR

5 Obtain written informed consent

before implementation. AN/AF/O/CR

Intervention

6 Serve the selected food product

according to the instruction. AN/AF/O/CR

7 Administer laxatives whenever

necessary. AN/AF/O/CR

Evaluation

8 Record all relevant data timely,

accurately and appropriately. AN/AF/O/CR

Remarks: AN: ask nurse AF: ask family O: observation CR: check record N/A: not applicable

Ward: Percentage of compliance: / 8 = % Name & Signature of auditor: Date:

87

Appendix 16

Nurse Satisfaction Survey for Evidence-based Dietary Fiber Enrichment

Porgramme

Questionnaire

Date: Name & Rank (Optional):

*Please circle the appropriate rating for the following aspects of this programme:

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?

Item No.

Description

Str

on

gly

Dis

ag

ree

Dis

ag

ree

Slig

htl

y

Ag

ree

Ag

ree

Str

on

gly

Ag

ree

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

6 You are satisfied with the programme as a whole.

1 2 3 4 5

88

Appendix 17

Patient Satisfaction Survey for Evidence-based Dietary Fiber Enrichment

Programme

Questionnaire

Date: Name (Optional):

*Please circle the appropriate rating for the following aspects of this programme:

Item No.

Description S

tro

ng

ly

Dis

ag

ree

Dis

ag

ree

Slig

htl

y

Ag

ree

Ag

ree

Str

on

gly

Ag

ree

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

89

Appendix 18

Dietary Fiber Enrichment Programme

Table of Outcome Measurement

*Please fill in the following blanks and delete as appropriate.

Patient’s Gum Label

Date

Patient Outcome

Number of defecation

Consistency of stool

Self-estimated comfort level

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

Amount consumed

Use of laxatives

Date of discontinuation: / / 2013 Reason: ����Discharge ����Withdrawal ����Completion of the programme

Keys

Consistency of stool

(Bristol Stool Scale)

Self-estimated comfort level

(Visual Analogue Scale) Amount consumed Use of

laxatives

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

0 5 10

CC = Consumed completely CA = Consumed almost completely HC = Half of the product consumed LC = A little consumed NC = None consumed

Y = Yes N = No

Not at all A lot Few

90

References

Alison, C. (2005). A model for successful change management.

Nursing Standard, 19(25), 40-42.

Andrew, C. L., Lori, L. D., & Helena, C. K. (2011). The role and

interpretation of pilot studies in clinical research. Journal of

Psychiatric Research, 45(5), 626-629.

Andrew, R. (2000). Barriers to using research evidence in nursing

practice. Journal of Advanced Nursing, 31(3), 599-606.

Asae, W., & Torbjorn, M. (2005). Fruit and fibre (Pajala porridge) in

the prevention of constipation. Nordic College of Caring

Science, 19, 71-76.

Chan, O.O. (2009). Chronic constipation. Medical Bulletin, 14(11),

11-14.

Claire, W. (2006). Change management and quality. Nursing

Management, 13(5), 23-25.

Fibro Action. (2012). Visual Analogue Scale. Retrieved September

20, 2012 from

http://www.fibroaction.org/Articles/Scales-and-Assessments

-for-Measuring-and-Recording-Pain.aspx

91

Gibson, C. J., Opalka, P. C., Moore, C. A., & Brady, R. S. (1995).

Effectiveness of bran supplement on the bowel management

of elderly rehabilitation patients. Journal of Gerontological

Nursing, 21(10), 21-30.

Hinrichs, M., & Huseboe, J. (2001). Research-based protocol:

management of constipation. Journal of Gerontololgical

Nursing, 27(2), 17-28.

Khaja, M., Thakur, C. S., Bharathan, T., Baccash, E., & Goldenberg, G.

(2005). Fiber 7 supplement as an alternative to laxatives in a

nursing home. Gerodontology, 22, 106-108.

Kristina, L., Lars, L., Birgitta, E & Catrine, J. (2010). Abdominal

massage for people with constipation: a cost utility analysis.

Journal of Advanced Nursing, 66(8), 1719-1729.

Lenth, R. V. (2006-9). Java Applets for Power and Sample Size

[Computer software]. Retrieved May 15, 2013 from

http://www.cs.uiowa.edu/~rlenth/Power/

Lois, V. H., Diane, W., & Deborah, J. O. (2000). Chronic constipation

management for institutionalized older adults. Geriatric

Nursing, 21(2), 78-119.

92

Marc, D. B. (2011). Constipation. Medscape Reference. Retrieved

May 23, 2012 from

http://emdicine.medscape.com/article/184704-overview

Marilee, S. (1990). Effectiveness of wheat bran in preventing

constipation of hospitalized Orthopaedic surgery patients.

Orthopaedic Nursing, 9(6), 55-59.

Martha, H., & Sarah, K. (2012). Quality matters using

patient-reported outcomes to improve health care quality.

The Commonwealth Fund. Retrieved May 23, 2013 from

http://www.commonwealthfund.org/Newsletters/2011/Dec

ember-January-2012/In-Focus.aspx

Nursing times. (2006). Bristol Stool Form Scale. Retrieved

September 20, 2012 from

http://www.nursingtimes.net/Binaries/0-4-1/4-1646160.pdf

Philippe, M., Heidi, J., Murielle, C., Cathy, S., Jean, M. P., & Beatrice,

H. (2011). Effects of chicory inulin in constipated elderly

people: a double-blind controlled trial. International Journal

of Food Sciences and Nutrition, 62(2), 164-170.

93

Pitkala, K. H., Strandberg, T. E., Finne-Soveri, U. H., Ouwehand, A. C.,

Poussa, T., & Salminen, S. (2007). Fermented cereal with

specific bifidobacteria normalizes bowel movements in

elderly nursing home residents: a randomized controlled trial.

The Journal of Nutrition, Health & Aging, 11(4), 305-311.

Polit, D.F., & Beck, C.T. (2008). Nursing research: principles and

methods (7th

ed.): Lippincott Willam & Wilikins: Philadelphia.

Robert, J. C. (2008). Change management in health care. The

Health Care Manager, 27(1), 23-39.

Robyn, E. S., Maureen, S. T., Judith, C., Jennene, G., & John, H.

(2001). Managing constipation in elderly Orthopaedic

patients using either pear juice or a high fibre supplement.

Australian Journal of Nutrition and Dietetics, 58(3), 181-185.

Sairanen, U., Piirainen, L., Nevala, R., & Korpela, R. (2007). Yoghurt

containing galacto-oligosaccharides, prunes and linseed

reduces the severity of mild constipation in elderly subjects.

European Journal of Clinical Nutrition, 61, 1423-1428.

Statistics by Country for Constipation. (2012). Extrapolation of

prevalence rate of constipation to countries and regions.

94

Retrieved July 19, 2012 from

http://www.rightdiagnosis.com/c/constipation/stats-country.

html

Scottish Intercollegiate Guidelines Network. (2012). Methodology

Checklist 2: Randomized Controlled Trials. Retrieved July 30,

2012 from

http://www.sign.ac.uk/guidelines/fulltext/50/checklist2.html

Scottish Intercollegiate Guidelines Network. (2012). SIGN 50: A

guideline developer’s handbook ANNEX B: key to evidence

statements and grades of recommendations. Retrieved

September 19, 2012 from

http://www.sign.ac.uk/guidelines/fulltext/50/annexb.html

Spinzi, G., Amato, A., Imperiali, G., Lenocci, N., Mandelli G., Paggi,

S., Radaelli, F., Terreni, N., & Terruzzi, V. (2009). Constipation

in the elderly: management strategies. Drugs Aging, 26(6),

469-74.

Sturtzel, B., Mikulits, C., Gisinger, C., & Elmadfa, I. (2009). Use of

fiber instead of laxative treatment in a geriatric hospital to

improve the wellbeing of seniors. The Journal of Nutrition,

95

Health & Aging, 13(2), 136-139.

Sturtzel, B., Dietrich, A., Wagner, K. H., Gisinger, C., & Elmadfa, I.

(2010). The status of vitamins B6, B12, Folate and of

homocysteine in geriatric home residents receiving laxatives

or dietary fiber. The Journal of Nutrition, Health & Aging,

14(3), 219-233.

Titler, M. G., Kl;eiber, C., Steelmen, Y., Rakel, B., Budreau, G.,

Everett, L. Q., Buckwalter, K. C., Tripp-Reimer, T., & Goode, C.

(2001). The IOWA Model of evidence-based practice to

promote quality care. Critical Care Nursing Clinics of North

America, 13(4), 497-509.

Zaharoni, H., Rimon, E., Vardi, H., Friger, M., Bolotin, A., & Shahar, D.

R.(2011). Probiotics improve bowel movements in

hospitalized elderly patients – the PROAGE study. The

Journal of Nutrition, Health & Aging, 15(3), 215-220.

Zennure, K., & Magfiret, K. (2007). Effectiveness of bran

supplement in older orthopaedic patients with constipation.

Journal of Clinical Nursing, 16, 928-936.