Abstract of thesis entitled

An evidence-based patient education programme for reduction of peritoneal

dialysis-related infection

Submitted by

Lau Sai Kuk

For the Degree of Master of Nursing

At The University of Hong Kong

in July, 2013

Background:

End Stage Renal Disease (ESRD) is one of the commonest diseases in Hong

Kong. Patient with ESRD needs to start dialysis for life maintenance. Peritoneal

dialysis (PD) is the predominant dialysis modality for home dialysis patients. More

than 80% of dialysis patients in Hong Kong receive PD. However, it also brings out

some PD-related infectious complication such as tenckhoff exit-site infection,

tenckhoff tunnel infection and PD peritonitis. These complications markedly

contribute to treatment failure in PD patients. Especially PD peritonitis, it remains a

leading complication of PD. Also it is a main cause of patients switch to

haemodialysis (HD)and discontinue PD. Nevertheless, if the primary prevention of

PD education do better, research evidences have shown that peritonitis infection rate

of PD patients can be effectively reduced. It can be achieve by the utilization of

2

effective education strategies and advanced training skills to enhance patients ’

knowledge and skills of peritoneal dialysis.

Purpose:

This written proposal aims to identify the best evidence of PD education and to

develop a guideline for this health education programme. The goal of the programme

is to reduce the rate of PD-related infection for patients who started PD treatment at

home after first CAPD training and education.

Method:

A total of 12 studies which focused on PD education and strategies for reducing

PD-related infections were searched from electronic databases. Data extraction and

critical appraisal were performed on these 12 studies. After the integrative review, the

implementation potential was assessed. The results shown that the transferability of

finding is high and it is feasible to conduct the proposed innovation. Then, the

evidence-based guideline for PD education programme were developed and based on

the high and medium level of evidence with grades of recommendation stated.

Before implementing the proposed innovation, a communication plan

was developed and targeted the various stakeholders (the administrators,

nurses, patients and their relatives). The proposer would initiate the change

and the programme leading group would guide and sustain the proposed

innovation.

The next process was planning a pilot study to examine the feasibility of the

3

proposed innovation before implementation.

Finally, different outcomes of the programme has been identified and evaluated

in the evaluation plan. The methods for data analysis were formulated.

Conclusion:

The proposed peritoneal dialysis education programme with best evidences

support is worthy to be adopted in the clinical setting for the beneficial of PD patients

to reduce their PD-related infectious complications.

4

An evidence-based patient education programme for reduction of peritoneal

dialysis-related infection

by

Lau Sai Kuk

A thesis submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

July, 2013

5

Declaration

I declare that the thesis and the research work there of represents my own work,

except where due an acknowledgement is made, and that 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............................................................................

Lau Sai Kuk

6

Acknowledgements

I would like to express my gratitude to my supervisor Professor Agnes Tiwari

for her expertise suggestions and guidance throughout the preparation of this thesis. I

also want to express my thanks to Dr. William Li, Dr. Daniel Fong and all staffs of

HKU School of Nursing for their helping and teaching during my master study.

Lastly, I must offer my heartfelt thanks to all my classmates of the programme:

Master of Nursing for their support in my project.

7

Table of Contents

Declarations................................................................................................................ 5

Acknowledgements.....................................................................................................6

Table of Contents........................................................................................................7

Appendixs................................................................................................................... 8

Abbreviations..............................................................................................................9

CHAPTER 1 Introduction......................................................................................10

1.1 Background......................................................................................................11

1.2 Affirming the Needs....................................................................................... 11

1.3 Question, Objectives and Significance........................................................... 15

CHAPTER 2 Critical Appraisal.............................................................................17

2.1 Searching and Appraisal Strategies................................................................ 17

2.2 Result.............................................................................................................. 20

2.3 Summary of Findings......................................................................................25

2.4 Synthesis of Findings......................................................................................27

2.4.1 Evidence-based recommendations.........................................................28

CHAPTER 3 Implementation potential

3.1 Target Setting..................................................................................................30

3.2 Target Audience..............................................................................................30

3.3 Transferability of the proposed programme................................................... 31

3.4 Feasibility........................................................................................................34

3.5 Cost Benefit ratio of the innovation................................................................36

CHAPTER 4 Evidence-based Practice guideline.................................................. 37

4.1 Guideline Title................................................................................................ 37

4.2 Aims of establishing the guideline..................................................................37

8

4.3 Intended Users................................................................................................ 37

4.4 Target Patients................................................................................................ 38

4.5 Primary outcome consideration...................................................................... 38

4.6 Recommendations...........................................................................................38

CHAPTER 5 Implementation plan........................................................................43

5.1 Communication plan.......................................................................................43

5.2 Pilot testing plan............................................................................................. 47

CHAPTER 6 Evaluation plan................................................................................ 49

6.1 Nature and number of clients to be involved..................................................49

6.2 When and how often to take measurements................................................... 50

6.3 Data analysis...................................................................................................50

6.4 Effectiveness of the guideline.........................................................................55

CHAPTER 7 Summary..........................................................................................55

Appendices

Appendix 1 Table of evidence.....................................................................58

Appendix 2 Quality assessment of studies...................................................63

Appendix 3 Search result in databases.........................................................87

Appendix 4 Level of evidence.....................................................................88

Appendix 5 Comparison of demographic data............................................ 89

Appendix 6 Estimated cost.......................................................................... 90

Appendix 7 Coding system of level of evidence......................................... 91

Appendix 8 Grades of recommendation...................................................... 92

References.................................................................................................................93

9

Abbreviations used in the study

APD Automated Peritoneal Dialysis

CAPD Continuous Ambulatory Peritoneal Dialysis

ESRD End-Stage Renal Disease

ESRF End-Stage Renal Failure

HA Hospital Authority of Hong Kong

HD Haemodialysis

K/DOQI Kidney Disease Outcomes Quality Initiative

PD Peritoneal dialysis

SIGN Scottish Intercollegiate Guidelines Network

RCTs Randomized Controlled trial

RRT Renal Replacement Therapy

10

CHAPTER 1

Introduction

Renal failure is a continued deterioration of renal function in which too low to

sustain normal life. These people will receive Renal Replacement Therapy (RRT) in

the form of renal transplantation or dialysis in developed countries. Patient with

End-Stage Renal Disease (ESRD) needs to start dialysis for life maintenance.

Peritoneal dialysis (PD) is the predominant dialysis modality for home dialysis

patients. It is the most widely used treatment for End-Stage Renal Failure (ESRF)

patients in Hong Kong. Continuous Ambulatory Peritoneal Dialysis (CAPD) is a

well-established mode of dialysis (Lo, 1998). But, it also brings out some PD related

infectious complication such as tenckhoff exit-site infection, tenckhoff tunnel

infection and PD peritonitis. These complications markedly contribute to treatment

failure in PD patients. (Gertrude, 2009) Especially PD peritonitis, it remains a leading

complication of PD. Also it is a main cause of patients switch to haemodialysis

(HD)and discontinue PD. Therefore, the PD expert continues to focus attention on

treatment and prevention of PD-related infectious complications. The ongoing rates of

infectious complications of home PD patients are also the key performance index of a

11

PD education programme. This study focus on CAPD which is the majority of PD

modality (92%) in Hong Kong and purposes to summarize various modern strategies

of patient education for CAPD patients, so as to gather the best evidence to enrich the

patient education programme which aims to reduce the local rate of CAPD related

infections.

1.1 Background:

ESRD is an incurable, life-threatening chronic disease. The prevalence rate of

ESRD in Hong Kong 2009 was 1078.8 patients per million populations (pmp) (HK

renal registry report 2010). Nearly 93% of the RRT are provided by the Hospital

Authority of Hong Kong (HA). All new patients need RRT begin with CAPD unless

there are contraindications to do so. The PD came first policy of Hong Kong results a

large portion (81.5%) of dialysis patients managed by PD. The remaining (18.5%)

patients receive HD treatment at HA renal centers. Among PD patients, a majority of

92% by CAPD. The remaining 8% PD patients by Automated Peritoneal Dialysis

(APD) which PD is achieved by the operation of a programmed PD machine (Lui et al.

2005). More than 80% of RRT patients with reports on rehabilitation were active and

had normal activities (Hong Kong J Nephrol, 2010)

1.2 Affirming the Needs:

12

CAPD training is an important element of a peritoneal dialysis programme to

prepare patients or their helpers to perform home CAPD. CAPD was achieved by

means of twin bags disconnect systems (Baster Healthcare) with lactate buffered

dextrose containing dialysate solutions. Home CAPD training is provided by renal

nurse whom was being trained as a trainer. No selection of patient by nurse can be

made since the allocation of patient to trainer is by rotation. CAPD training started

about 4 weeks after the implantation of a tenckhoff PD catheter. The location of PD

training is at the renal dialysis clinic. Usually last for 5 hours a day on average. The

total time spend for training depends on the learner. The trainer should determine the

learners have achieved the minimum objectives set by the programme. If a patient is

incompetent of self-care and cannot perform CAPD, a member from his/her family

will be needed for assistance. This helper must understand the procedures and be

ready to help voluntarily, whose assistance must not be stopped abruptly or taken over

by another person. In the present time, none of any standards were issued to guide the

educational process. The current routine home CAPD training programmes in Hong

Kong were very briefly train the patients or their assistant helper (or both) the

procedures of CAPD bag exchange. Nurses first explain the theory and demonstrated

the bag exchange technique. Patient can practice several times using a dummy as a

13

teaching aid. Emphasis put on the non-touch technique involved and successful return

demonstration of bag exchange procedures. Usual education program also included

knowledge of end stage renal disease, different modality of treatment, principle of

CAPD, nutrition and dietary advice, signs and symptoms of complication, infection

control at home and common troubleshooting solution. An individual one to one

dietary counselling session will also offer to patient. Video CD and reading materials

were free to provide to patients or their caregivers. In Hong Kong, the ratio of training

nurse to patient is from 1:1 to 1:2 depends on manpower of staffing. Although

different learners have different learning abilities, memory, and motor skills, they

might not finish PD training at the same time. Actually, training is tailored for each

patient or helper as in 1:1 teaching model, the one with slower would be coached

individually after the first one finished training. A home visit will arrange after the

first month of training but further home visit is not a routine. The needs of retraining

are identified by physicians or by nurse specialists for suspected improper PD

exchange technique as a result causing PD peritonitis.

The overall CAPD peritonitis rate in Hong Kong was 31.8 patient-months per episode

in 2009 ( i.e. the average time taken for all CAPD patients in Hong Kong to get one

episode of PD peritonitis is 31.8 months). The most common type of PD peritonitis is

14

Gram-positive peritonitis. It is usually caused by contamination of the disconnect

system which is a technique related factor. In short term, during the incident of

peritonitis, patients will experience excessive pain and may require hospitalization. In

a six-year retrospective study involving 101 incident patients on PD in which patients

were hospitalized for peritonitis, 65% were hospitalized, with a mean length of stay of

8.7±7 days (Lecame, 2006). Mortality from peritonitis is 7% to 10%, and

approximately 40% to 45% of patients transfer to hemodialysis as a result of

peritonitis (Vargemezis & Thodis, 2001). Peritonitis is a major contributor to

technique failure along with psychosocial factors, catheter-related problems, and

difficulties with clearance and ultrafiltration (National Kidney Foundation, 2006).

Technique failure occurs when patients discontinue PD for reasons other than death or

transplantation. Although sclerosing peritonitis is rare and is associated with

long-term PD, the mortality rate has been reported to be as high as 37.5% (Kawanishi,

2004). Repeated episodes of peritonitis can cause damage to the peritoneal membrane

by increasing membrane permeability and reducing ultrafiltration. These effects on

membrane transport can persist for years. Peritonitis has been shown to be an

important predisposing factor (Brown, 2005). The peritonitis rate is a suggested

domain for ongoing monitoring (National Kidney Foundation, 2006) Updated Kidney

15

Disease Outcomes Quality Initiative (K/DOQI) clinical practice guidelines for PD

state that home-training providers should establish a quality improvement program

with the goal of improving patient outcomes..

1.3 Questions, Objectives and Significance

Questions

(1) What is the evidence that CAPD patient education can improve patients’ PD

knowledge and technique so as to reduce the rate of PD-related infections?

(2) How effective of a structured CAPD training programme in reducing the rates of

PD-related infection?

Objectives:

1. To evaluate and search the modern research findings on CAPD training or

education programme.

2. To investigate and incorporate the most effective evidence based interventions.

3. To summarize data from studies and create evidence tables and carry out quality

assessment.

4. To synthesize the summarized data.

Significance:

Home CAPD patients are perform PD bag exchange and tenckhoff catheter care

16

by patients themselves or their helpers. PD peritonitis is the main cause of technique

failure, hospitalization and even mortality in PD patients. It remains the most common

complication in PD patients’ society. If left untreated, peritonitis can result in sepsis

and death. Research data show that 15% of deaths in PD patients can be primarily

attributed to peritonitis. Exit-site infection and tunnel infections are also considered

serious infections and independently predispose patients to PD peritonitis and its

consequences. Published peritonitis rates vary from 16 to 30 patient-months per

episode. Due to an increase in the proportion of unusual and complex infections over

the past decade, up to two third of PD patients with peritonitis need hospitalization.

The major cause of PD peritonitis is being contamination during a PD bag exchange.

Given that peritonitis can be prevented by strengthening training in connection

techniques and exit-site care. Training patients to manage PD safety is thus crucial for

the success of treatment modality. A structured training programme can also facilitate

the job of nursing staff, help them to conduct programme efficiently, consequently

enhanced staff morale.

17

CHAPTER 2

Critical Appraisal

2.1 Searching and Appraisal Strategies:

2.1.1 Electronic databases and search keywords

Based on the clinical questions identified above, a systematic review is

conducted and targeted to answer the above clinical questions. The primary outcome

of interest was focus on PD peritonitis. The secondary outcomes included: exit-site

infection, tunnel infection, PD exchange technique and infection control. The

following computer databases were used to identify studies for this systematic search:

CINAHL (1982 to May 2012), MEDLINE (1950 to May 2012), PsycINFO (1806 to

May 2012), PubMed (1901 to May 2012) and British Nursing Index (1994 to May

2012). The citation lists and reference lists of those high quality studies are manually

screened to identify more relevant studies that meet the inclusion criteria. The

inclusion and exclusion criteria were checked against with those abstracts to obtain

suitable English references. The methodological quality and the results of the

reviewed studies are then analyzed to obtain the best evidence on which types of

educational intervention have most effect on reduce CAPD related infectious

18

complications for local Chinese patients.

Keywords and medical subject heading use included: ‘peritoneal dialysis’,

‘program’, ‘training’, ‘education’, ‘CAPD’, ‘intervention’, ‘peritonitis’, ‘exit-site

infection’, ‘complication’, ‘infection prevention’, ‘tunnel infection’, ‘technique’,

‘mortality’ and ‘assessment’. There is no restriction of the language used by any

journal.

All these keywords used are interchangeably or used alone. A huge number of

papers obtained when searched by using the major keywords. But it has been lessened

when confined to CAPD peritonitis, CAPD patients, exit-site infection and tenckhoff

tunnel infection.

2.1.2 Inclusion and exclusion criteria:

Type of studies: Abstract indicated that the article appears to inform one or more of

the search questions. The search for best evidence on clinical outcomes was originally

focused on systematic reviews and randomized clinical trials (Melnyk and

Fineout-Overholt 2005). However, there are limited such papers on the effectiveness

on reducing PD related infectious complications. Therefore, case-control studies,

cohort studies were also included to fulfill some particular area of the education

programme. But conference proceedings, dissertation theses, unpublished studies or

19

descriptive studies of lower levels of evidence are excluded. Finally, papers which are

not written in English are also excluded because of difficulties in comparing the result

in different languages.

Type of participants: Patients already undergoing home CAPD or prepare to home

CAPD are included to enhance the generalizability of the interventions. Patients

performing home APD which using automated PD machine were excluded because

they involve different kind of training programme.

Type of interventions: Any set of training or educational activities designed to reduce

patients’ risk of PD related infectious complications as a nursing intervention are

included. Those interventions can be compared with conventional PD training

programme.

Type of outcome measure: The outcome measure of the clinical question is reducing

PD related infectious complications. Studies which outcomes other than improvement

of PD related infectious complications were excluded.

2.1.3 Quality Assessments of the Studies:

The evaluated grading of the level of evidence for interventions included in

those studies are performed (See appendix 4). The level of evidence was categorized

into 7 levels. Level I is the highest, level IV is the median and level VII is the lowest

20

by Melnyk and Fineout-Overholt (2005). They represent the quality of evidence ready

for select outcomes in the definite populations of interest. Among the twelve studies,

two were at level II, nine were at level III and one was at level IV of evidence.

The quality of the studies was assessed with the aid of a set of appraisal checklists

offered by Scottish Intercollegiate Guidelines Network 2012 (SIGN). Various

methodology checklists provided by SIGN to assess different methodological research

approach, such as systematic reviews and meta-analyses, randomized controlled trials,

cohort studies, case-control studies and diagnostic studies. The quality of a research

study can be justified by answering the questions set in the particular checklist. The

checklist also mentioned some critical criteria that a study should be met; otherwise

the study should be rejected.

Details of quality assessment content of this study were tabulated in appendix 2.

2.2 Results

The initial clinical evidence search was carried out on May 2012 to August

2012.

Keywords of peritoneal dialysis, program, training, education, CAPD, intervention,

peritonitis, exit-site infection, complication, infection prevention, tunnel infection,

technique, mortality and assessment were input into the database of CINAHL,

21

MEDLINE, PsycINFO, PubMed and British Nursing Index. It created a huge numbers

of search results in each of the database. When linked up all the main keywords, there

are totally 700 papers with full text available in all five databases. When limited to

inclusion criteria and absence of exclusion criteria, there are totally twenty-three

papers left and among eleven papers were duplicated. (Appendix 3)

Total twelve studies were selected after the systematic search. Data of each study

were extracted to form respective tables of evidence.

(See appendix 1)

All twelve studies had a sample size ranged from 30 to 620.

The length of follow-up ranged from 12 to 48 months.

2.2.1 Participants’ characteristics

All adult male and female patients of no mental disabilities are included. They

all got ESRD and underwent PD (CAPD or APD) or new patient whom prepared to

receive PD treatment. No matter self care or need assistant.

2.2.2 Interventions Used in the Reviewed Studies

Hall, (2004) suggested the use of adult learning theory-based curriculum for PD

training. Casey, (2000) suggested the routine daily application of mupirocin cream

which is a prophylactic antibiotic ointment to reduce tenckhoff catheter related

22

infections. Figueiredo, (2000) studied the effectiveness of PD peritonitis prevention

by put on a face mask during PD exchange procedure. Bernardini, (2005) suggested

the application of gentamicin cream which is more powerful than mupirocin cream as

a routine daily prophylactic agent. Gadola, (2012) introduced an Objective Structured

Assessment tool to test patients’ post CAPD training skills which can identify the

patient who are at higher risk of getting PD peritonitis. Moreover, Gadola, (2012) also

introduced a new multidisciplinary peritoneal dialysis education program (PDEP)

which can further lowering peritonitis rates. Chen, (2008) introduced a post PD

training test which helps to evaluate the learning process and provides immediate

feedback to the learner. Prasad, (2006) addressed the importance to maintain a good

nutritional status of CAPD patients against PD peritonitis. Dong, (2010) emphasized

the bag exchange procedure on risk of PD peritonitis. Mawar, (2011) emphasized the

importance of CAPD procedure compliance with increase risk of PD peritonitis. Xu,

(2011) raised PD training to patient or helper is of similar PD related infectious

outcomes. Therefore assisted PD is a good option for patients with poor self care

ability. Barone, (2011) concluded that patients with higher educational level will have

lower risk of PD peritonitis. Despite patients with lower educational level receive

longer training time. Chow, (2007) raised the importance of active continue learning

23

of PD nurses him/herself and apply adult learning principles to enhance CAPD

training.

2.2.3 Outcome Measures Used in the Reviewed Studies

Six studies were used peritonitis rates as the primary outcome measure. (Hall,

2004 ; Casey, 2000 ; Bernardini, 2005 ; Gadola, 2012 ; Chen, 2008 ; Barone, 2011).

Three studies were used peritonitis free period as the primary outcome measure.

(Figueiredo, 2000 ; Prasad, 2006 ; Xu, 2011). Two studies were used harzard ratio of

PD peritonitis as the primary outcome measure. (Dong, 2010; Chow, 2007) One study

was used the association with peritonitis and association with frequency of peritonitis

as the outcome measures (Mawar, 2011). Three studies were used exit-site infection

rate as the secondary outcome. (Hall, 2004 ; Casey, 2000 ; Chen, 2008). One study

was used tunnel infection rate as the secondary outcome (Chen, 2008). One study was

used mortality rate and survival time as the secondary outcome (Xu, 2011).

2.2.4 Randomization

Two studies reported patients were randomized (Figueiredo, 2000; Bernardini,

2005). Only one study specifies the randomization process. A randomization list was

generated by using a computer random-number generator (Bernardini, 2005).

Randomization eliminates the source of bias in treatments assignment; facilitates

24

blinding the type of treatments to investigator, participants and evaluators (M.

Saghaei, 2004). In this study, a few papers were randomized. Since four papers were

retrospective studies (Gadola, 2012; Chen, 2008; Barone, 2011; Chow, 2007) and one

paper was cohort study (Xu, 2011), randomization seems to be impossible. Three

papers of their participants have some specified characteristics such as malnutrition or

PD treatment more one and a half years (Mawar, 2011; Prasad, 2006; Dong, 2010).

Two papers had not specified the allocation of participants (Hall, 2004; Casey, 2000).

2.2.5 Blinding

Double blinded was used in the study Bernardini, (2005). Four other studies

were reported to use single blind that patients did not know to which group they

belong (Hall, 2004; Gadola, 2012; Prasad, 2006; Mawar, 2011).

2.2.6 Intention to Treat Analysis

Ten studies reported that data was analysis with the utilization of intention to

treat (Hall, 2004; Casey, 2000; Bernardini, 2005; Gadola, 2012; Chen, 2008; Prasad,

2006; Dong, 2010; Mawar, 2011; Barone, 2011; Chow, 2007). The high dropout rates

of some studies were being taken into consideration for data analysis.

2.2.7 Setting

Eleven studies were carried out at renal clinics or centers. Only 1 study was

25

carried out at different patients’ home during home visit (Mawar, 2011). Among the

eleven studies, two were carried in multi-centers (Hall, 2004; Bernardini, 2005); Nine

were carried out in a single center (Casey, 2000; Figueiredo, 2000; Gadola, 2012;

Chen, 2008; Prasad, 2006; Dong, 2010; Xu, 2011; Barone, 2011; Chow, 2007).

2.3 Summary of findings:

Twelve studies which published from 2000 to 2012 were selected. There are

two randomised control trials (Figueiredo, 2000; Bernardini, 2005). One longitudinal

quasi-experimental design study (Hall, 2004). One prospective historically controlled

study (Casey, 2000). Three prospective observational study (Prasad, 2006; Dong,

2010; Mawar, 2011). Two retrospective observational studies (Chen, 2008; Chow,

2007). Two retrospective analysis studies (Gadola, 2012; Barone, 2011). One

prospective cohort study (Xu , 2011).

Among those twelve studies, three of them carried out in USA (Hall, 2004;

Casey, 2000; Bernardini, 2005). Two were conducted in India (Prasad, 2006; Mawar,

2011). Other two were conducted in Republic of China (Dong, 2010; Xu, 2011). The

remaining were came from Brazil (Figueiredo, 2000), Taiwan (Chen, 2008), Uruguay

(Gadola, 2012), Argentina (Barone, 2011) and Hong Kong SAR (Chow, 2007)

respectively.

26

Related to the details of training programme, two studies emphasis the structure

of the programme is more important than the experience of training nurses (Hall, 2004;

Chow, 2007).

Short of description of the study’s methodology presented in few studies, for

instance, blinding was not tackled, only few with allocation concealment mentioned.

However double blinding is not an easy job as being assigned into a training

programme is obvious.

Two retrospective observational study and three prospective observational

study were regarded as relatively low level of evidence (Prasad, 2006; Dong, 2010;

Mawar, 2011; Chen, 2008; Chow, 2007); with higher risk of bias. The lack of

randomization can make selection bias; and do not use the strategy of intention to

treat for data analysis. On the whole, most of appraised studies achieved an

appropriate p-value (<0.05) except Chen, (2008). Therefore most results were

statistically significant. All high quality studies supported to initiate programme at

outpatient centers, which in accordance with the nature of CAPD clients as they are

not in-patient. Eight studies supported one to one, nurse to learner training programme

(Hall, 2004; Gadola, 2012; Chen, 2008; Dong, 2010; Mawar, 2011; Xu, 2011; Barone,

2011; Chow, 2007). Although Chow, (2007) supported one to one PD training, their

27

center still running one to two training practice owing to staffing limit at their center.

The duration of training session ranged from 4 to 5 hours. The total training

time vary from 22.6 to 40.0 hours depend on the learner’s ability (Hall, 2004; Chow,

2007; Chen, 2008). Barone, (2011) study the number of PD training lessons received

by patients in relation to peritonitis rates. But the time duration of each lesson was not

specified.

Long follow-up period >4 years was not recommended, moderate follow-up

around 18 months is advised. All PD programme in studies consisted of similar

components such as lessons, video show, booklets and video CD delivery.

Figueiredo, (2000) found out from their study that wear a facial mask during PD bag

exchange procedure was no significant different in peritonitis incident rate with no

mask while Dong, (2010) stated that the hazard ratio of peritonitis if not wearing a

mask was 7.26 (P<0.001). The main different may be due to all patients in Figueiredo,

(2000) study were well prepared to do the bag exchange except not wearing a mask.

But patients in Dong, (2010) study were being assessed various bag exchange

procedures including put on mask, hand washing, steps to connect and disconnect the

bag etc. That may lead to confound the outcome of the study.

2.4 Synthesis of findings

28

Preventing peritonitis through training is an effective approach. It is critical for

patients to adhere the proper technique of PD bag exchange procedure to prevent

peritonitis when utilizing CAPD. Demonstration and return demonstration are good

practice of CAPD training. The adult learning teaching strategies is a successful way

to implement education and training programme. Learning direction has been changed

nowadays. It should be focus on what the learner needed to learn rather than on what

the teacher needed to teach (Hall, 2004). Other approach, such as retraining, skill

updating, written tests, post training assessment or direct observation of patients’

technique are worthy to incorporate in the PD training programme. Renal nurses

training, support providing, individual patient monitoring and continuing connection

are directly contributed to the success of an education programme.

2.4.1 Evidence-based recommendations

After the first month of post CAPD training, weekly clinic follow-up should be

arrange to assess the patients’ performance of bag exchange technique until the whole

procedure is performed smoothly. Home visit is suggested within the first month of

post CAPD training. This is to prevent patients to develop any shortcut of bag

exchange procedure since this time interval is most likely for patients to do so. More

detailed and frequent peritonitis reviews decrease the overall peritonitis rates.

29

Semi-annual patient reviews are also important since patient is time for change a new

transfer set (transfer set of tenckhoff catheter should be change by renal nurse every

six months). Assessment of PD exchange sequence, technique reinforcement and

written test can be done during the peritonitis review. Details of the written test

should assess the patient’s cognitive response to some common CAPD problems that

will encountered at home.

The routine daily application of prophylactic antibiotic cream at tenckhoff

exit-site is an effective way to reduce catheter related infections.

It should be emphasize in the CAPD self-care education session. Especially for those

patients with diabetes mellitus, malnutrition or frequent PD peritonitis whom are

higher risk for PD infection.

An objective structured assessment tool should be introduced to guide the post

CAPD training assessment process (Gadola, 2012). It was specially designed to

evaluate only practical skills but not knowledge demonstrated by patient. The

evaluated result directly reflected the learner’s skill of bag exchange and

troubleshooting behavior. The step by step assessment can facilitate nurses to identify

the learner’s week points promptly and give immediate feedback.

30

CHAPTER 3

Implementation potential

3.1 Target Setting

The programme will be implemented in a public hospital situated at New

Territories of Hong Kong. It is an acute hospital with a designed capacity of 1,915

beds. The programme will be carried out in the renal unit of the hospital. The unit

consists of one renal subspecialty ward and one integrated renal centre which both

occupied ~10000 square feet area respectively. The renal subspecialty ward offers

50-60 hospitalization beds for renal disease patients and the integrated renal centre

offers Monday to Saturday day services for daily ~50 haemodialysis patients; 2

automated peritoneal dialysis patients; 2-4 patients receive peritoneal dialysis

education and training; renal nurse-led clinic; pre-dialysis renal assessment; and fast

track clinic for renal patients.

3.2 Target Audience

The target audience included the patients over 18 years old and was confirmed

to be suitable for home CAPD after pre-dialysis renal assessment and their related

home helper if any. Those patients who frequently got PD related infectious disease

31

and need retraining are also included.

3.3 Transferability of the proposed programme

Transferability refers to the degree to which the results of the selected studies

can be generalized or transferred to a new target context or setting. The study

situation must first compare with the specifics of the environment or situation which

we are familiar. If there are enough similarities between those study situations, it will

be able to infer that the results of those studies can be transfer to our context. To do

this effectively, these is a need to consider the similarities of the patients’

demographic data, clinical settings, amount of audiences and cultural differences. The

table of comparison on the similarities between the research studies and the target

population is shown in appendix 5. The disease nature of both target and study

populations are the same. Their demographic data such as the mean age and gender

ratio are similar. Those are adult patients with end stage renal disease that need

peritoneal dialysis. Most studies carried out in renal centre setting which match to the

proposed programme except one study that evaluates patients’ PD exchange technique

in patients’ home during home visit. But the same evaluation procedure can also be

done in a renal centre setting. However, the main difference would be the cultural

factor. Six out of twelve studies were carried out in Western countries like USA;

32

Brazil and Argentina. But, the remaining six studies were initiated in Asian areas such

as Taiwan and Republic of China. One study was a local one. This may greatly help to

strengthen the transferability of study findings to our local setting.

Moreover, the research studies share similar philosophy of care with our

hospital. Those researchers aim at improving and providing high quality and standard

of care by utilization of evidence-based findings to maintain clients’ health while our

hospital provided not only the best-possible services to cure our patients, so they will

not have to be readmitted, and secondly enable outpatients to enjoy the best-possible

health and quality of life. Its mission is to empower patients to regain their health and

stay healthy by offering support in the forms of medication, information, training,

education, encouragement and motivation. As well as continuously service quality

and safety improvement and build up a people-first culture.

Besides, the aim of the proposed programme shared the same objective of all

twelve research studies. That is: ‘to reduce the chance of peritoneal dialysis-related

infection of PD patients through an evidence-based education programme’ (Hall,

2004; Casey, 2000; Figueiredo, 2000; Bernardini, 2005; Gadola, 2012; Chen, 2008;

Prasad, 2006; Dong, 2010; Mawar, 2011; Xu, 2011; Barone, 2011; Chow, 2007).

Concerning the number of clients who could benefit from the programme, there

33

are 85; 92; 105 and 113 newly diagnosis ESRD patients in 2007; 2008; 2009 and

2010 year respectively of received PD education in our hospital. About 16% of total

Hong Kong newly started PD treatment patients every year, and the trend is

increasing. In addition to about 650 CAPD patients currently follow-up in our hospital,

among one thirteenth of that patients need CAPD retraining. Therefore, a significant

number of patients could benefit from the proposed programme.

Before the implementation of the programme, a 60-minute orientation training

session must be given to every renal nurse who response to educate and train patients.

We have 21 renal nurses in total who are eligible to conduct patient education. But

every week our unit only assigns 2 renal nurses responsible only for the task of CAPD

education and training. Therefore, the programme can start after the 2 renal nurses

have been trained. The remaining nurses can be orientated at any time when they are

not very busy during duty hours. The programme also takes place in the education

room of the integrated renal centre as mentioned before. It doesn’t need to make any

change. But a new guideline, new education contents and new assessment form must

be prepared prior to implementing the proposed programme. The evaluation process

may take up to one year because it takes time to follow-up all patients who have

undergone the programme to see if they have any undesirable PD related infectious

34

complications.

3.4 Feasibility

To assess the feasibility of the proposed project, some major concern must be

considered. For example, the support of administration team, the freedom of nurses to

carry out the innovation and the view point of patients and their care givers. Other

aspects such as available of resources, sufficient of manpower, resistance or friction

arises, readiness of necessary equipment and facilities, consensus among staff and

likely interfere with the current functions of staff need to be taken into account too

and are likely to be easier to overcome and resolve.

For the administration team of the hospital, they usually delegate the

management to the head of each department. For the renal team, the head of our unit

is a consultant physician. He usually welcomes any innovation which can improve the

quality of services of the unit provided that the proposed programme does not violate

the mission of the hospital. Our unit also preserves a certain amount of the budget

every financial year for initiation of various kinds of programme to improve our

services, such as specialty nurses home visit programme, phone follow-up programme

and physical exercise to improve renal patients’ quality of life programme, etc.

For the nurses, they have the autonomy to carry out the innovation or not. Even

35

though the proposed programme may be approved by the team head and unit

manager, nurses still have the freedom to decide whether or not to carry out the

innovation using their own professional judgment. Moreover, the proposed

programme is carried out entirely by nursing staff and does not involve any other

allied health care profession. Therefore, there are no collaborative problems with

other disciplines.

For the patients, CAPD training and education is a compulsory process. Patients

or their care givers must pass the necessary training before they are allowed to start

CAPD treatment at home. Since there is no existing evidence-based education and

training guideline in our hospital, a structured evidence-based guideline will certainly

facilitate their learning. Clients should be able to undertake the training because it is

flexible in terms of the hours of training. It vary from 22.6 to 40.0 hours depends on

learning ability of each client (Hall, 2004; Chow, 2007; Chen, 2008). According to

some feedback of former CAPD learners, they were more concern about the final

successful learning rather than the time spent to learn. They know that there is a long

way for them to wait for renal transplant and the most imminence matter is to learn

home CAPD to sustain their life. Therefore, most clients were very appreciating and

willing to try any innovative teaching strategies that offer by renal nurses. This is also

36

the consequence of the trustworthiness relation between renal nurses and renal

patients.

3.5 Cost Benefit ratio of the innovation

Before the implementation of the innovation, a cost-benefit analysis should be

performed. The following questions should be considered: What is the minimal cost

to achieve the programme? Will benefits outweigh cost? How soon will the benefits

accrue?

Consider the tangible costs and benefits to implement the innovation, the total

expenditure to carry out the programme is HKD $10,222. (Appendix 6) All the

expend is one-time budget, no recurring cost. Furthermore, the ongoing expenditure

was just same as the current one. All nursing staff, setting, training room, facilities

remain the same. Even the evaluation process has no change. It is to statistically

analysis all PD patients who follow-up in our hospital of their yearly PD related

infectious complications rates in terms of ‘patient-month per episode’. According to

the rationale of translational research, the evidence-based intervention is also effective

after being transferred to another similar situation. If the incident rate lowered for 1

patient-month per episode, it will reduce 42.4 hospitalization days in our hospital.

Assume that the peritonitis rate of our hospital (2010) was 38.4 patient-months per

37

episode, total PD patients (2010) were 634. If the non-subsidy charge of daily

hospitalization fee is $3,300 per day, then the hospital will save

$3,300x42.4=$139,920 per year. The overall peritonitis rate of CAPD patients in

Hong Kong (2009) was 31.8 patient-months per episode (HK renal registry report

2010) which is largely greater than our hospital.

CHAPTER 4

Evidence-based Practice guideline

4.1 Guideline Title

A nurse-delivered education programme for reduction of peritoneal

dialysis-related infection.

4.2 Aims of establishing the guideline

1. To summarize research evidence on CAPD training and education programme.

2. To formulate and incorporate the best evidence in a nurse-delivered education

programme in order to reduce peritoneal dialysis-related infection for PD patients.

3. To standardize the process of delivering the nurse-led CAPD training and education

to prepare patient for home CAPD treatment.

4.3 Intended Users

38

This guideline is intended for use by all trained renal nurses who are

responsible for CAPD patients’ training and education.

4.4 Target Patients

Adult patients of age 18 or above with end stage renal disease and plan to

receive home CAPD treatment.

4.5 Primary outcome consideration

The major outcome is the rate of reduction of PD-related infectious

complications for the target patients after the implementation of the proposed

programme.

4.6 Recommendations

The levels of evidence and grades of recommendations of this guideline follow

that of SIGN (Scottish Intercollegiate Guidelines Network, 2011) which is shown in

Appendix 7 and 8 respectively.

Recommended interventions

1. Adult learning theory such as (Speck, 1996) should be incorporated into the

curriculum of CAPD training and education programme. (A).

Available evidences:

Use of the adult learning theory-based training method curriculum was

39

positively associated with improved patient outcomes in the PD population (Hall,

2004). (1+)

The finding of negative association between the trainers’ length of time in

practice and peritonitis incidence reminds us that active continued learning and

applying principles of adult learning might be the answer for the nurses to teach the

patients (Chow, 2007). (1+)

Education programs with a theoretical basis, using cognitive framing and

motivational interviewing principles, are associated with improved outcomes (Gadola,

2012). (1+)

2. Teach patients the proper application of mupirocin cream which is a prophylactic

antibiotic ointment routinely prescribed by physicians for PD patients. (A)

Available evidences:

Our study contributes to the growing body of evidence that daily local

application of mupirocin cream at the PD catheter exit-site significantly reduces

episodes of peritonitis and exit-site infection. Widespread use of an antibiotic can lead

to the development of resistance. However, in a recently reported follow-up of the

(Thodis, 1998) study; there was no mupirocin resistance 1 year after institution of

local mupirocin at the PD catheter exit-site to prevent exit-site infection (Casey, 2000).

40

(1++)

Mupirocin applied to the exit site has proved to be very effective in reducing S.

aureus infections in PD patients. S. aureus exit-site infections are associated with

considerable morbidity, including peritonitis, catheter removal, and transfer to

haemodialysis. Therefore, maneuvers to decrease S. aureus infections are an

important part of improvement of outcomes in PD (Bernardini, 2005). (1++)

Mupirocin cream is recommended to be applied to the skin around the exit site

after daily cleansing with antiseptics (Dong, 2010). (1+)

3. An objective structured assessment should be used to test the patient’s or helper’s

post training PD skill and technique in the revised CAPD training programme. It is

specially designed to evaluate only practical skills but not knowledge demonstrated

by patient. (A)

Available evidences:

The training of PD patients is extremely important and may affect technique

success and clinical outcomes. Therapeutic education has been considered a key

factor in PD outcomes. The objective structured assessment is a reliable tool for

assessing patients’ skills, and it correlates with peritonitis rates (Gadola, 2012). (1++)

4. An integrated post PD training test should be introduced to assess the PD related

41

knowledge of PD learners. (A)

Available evidences:

The post-training test helps to evaluate the learning process and provides

immediate feedback to the learner. With repeated and sufficiently long training, even

patients with a minimum educational background can perform PD techniques

precisely (Chen, 2008). (1++)

5. Patients should be reminded to wear mask when performing PD bag exchange

procedure and doing every minor steps during PD exchange such as hang the new PD

bag to the drip-pod; remove the protective ring of PD bag; break the frangible stopper

of PD bag. (A)

Available evidences:

Among bag exchange items, only failure to wear a face mask and cap was a

significant predictor of peritonitis in the univariate regression model (Dong, 2010).

(1+)

Follow-up is suggested within the first month of post CAPD training. This is to

prevent patients to develop any shortcut of bag exchange procedure since this time

interval is most likely for patients to do so. Due to the chronic nature of CAPD,

patients tend to progressively alter CAPD procedure by skipping mandatory steps

42

thereby decreasing their attention to hygiene (Mawar, 2011). (1+)

6. Training of PD patients’ helpers (usually their family members) should be

considered for patient with poor self-care ability. (A)

Available evidences:

Although peritoneal dialysis has many advantages, such as ease of training and

accommodation, simple facilities, and good mobility, the procedure is difficult for

patients who are physically disabled or noncompliant. Accordingly, assisted PD

provides a good alternative in Europe. In China, assisted PD by well-trained and

compliant assistants can be as good as self-care PD with regard to peritonitis (Xu,

2011). (1+)

Summary

The PD come first policy of public hospitals in Hong Kong makes ESRD patients

with no choice of initial renal replacement therapy. Patients need to attend PD

education and training course before they can start PD treatment. Develop of a

structured evidence-based guideline not only facilitate the teaching process that make

the course more streamline but also enhance the learning outcomes of patients. The

success of a PD programme is dependent upon specialized nurses with appropriate

skills in assessing and training patients for PD, monitoring of treatment and with

43

sufficient resources to provide continued care in the community.

CHAPTER 5

Implementation Plan

To ensure smooth and successful carry out of the evidence-based innovation, a

well-organized communication plan is essential. It must make certain that all

stakeholders are fully informed of when, how and why communication will take place.

As a matter of fact that communication is always a very effective method to deal with

risks, to solve problems and ensure that projects are completed on time.

5.1 Communication plan

Stakeholder analysis

Stakeholders are those people who have influence and interest in the project. For the

implementation of the proposed innovation, it is required to gain the support from a

variety of stakeholders. Therefore, those stakeholders of the project innovation in

evidence-based PD education programme for patients with End Stage Renal Disease

(ESRD) should be identified. They included the unit manager of the renal ward and

the integrated renal centre, physicians (nephrologists) of the renal team, nursing staff

44

including registered nurses, enrolled nurses and renal nurse consultant; patients with

ESRD who follow-up in renal clinic and their carers; Department Operations Manager

(DOM) and General Manager of nursing services (GMN).

A good communication process between the proposer and stakeholders is an essential

component to achieve success of the programme innovation. At the beginning, a

senior staff of renal unit who is interested in the proposed innovation will act as a

proposer and initiate changes on existing practice. The proposer should identify what

improvement should be performing to replace the existing. Later on, the proposer will

search for any information and decide what should be included in the programme

innovation, for example; how the programme innovation will be implemented, for

whom, by whom, and where and when will it be took place. Furthermore, proposer

should identify what requires to be prepared in order to implement the proposed

innovation. For example, posters, training session, resource manual, information

board and who will be involved in the training. Next, the proposer should access a

peer group of colleague and inspire them to see the need for change. Having gained

the support of colleagues, the proposer needs to prepare a clear proposal to persuade

the stakeholders as identified above in terms of the need for changes. With the support

of the senior executives DOM and renal consultant, the proposer will start to

45

implement the change including a survey to assess support or potential obstacles. A

pilot study further revision of the proposed guideline as required before implementing

the project. Special attention will be given to the needs of the patients and their carers

to ensure they understand the changed practice will better address their needs and

provide support as required.

How to Sustain and Guide the Change

A programme leading group should be set up to sustain and guide the change in the

programme innovation. The proposer will be the leader of the group and responsible

for identify the needs of staff and introduce training. Other members included the unit

manager and a frontline nurse who act as a helper from the renal unit. They will meet

frequently and regularly at the beginning. In order to discuss, plan, and respond to any

queries related prior to the innovation. Other group members will prepare and provide

resources and equipment such as teaching aids and materials such as pamphlets,

stationery and audio-visual aids that will be used during the training programme. Staff

training will be provided for those nurse participants. A one-hour-training session is

offered to all 22 renal nurses. In the staff training sessions, specific new teaching

strategies to enhance patients’ learning of PD knowledge and skill are introduced.

46

Aims to improve patients’ self-care and their alertness of factors related to PD

infection. Assessment of nurse participants for their teaching skill and knowledge is

done by the proposer through a pre and post short test.

The proposer is also responsible for answering any questions rise by nursing staff if

they encounter any difficulties or problems during the implementation of the

innovation. The programme leading team should continue to promote the innovation,

continuous update of the latest PD information and maintain effective communication

throughout the programme. Furthermore all renal nurses are ensured to have the soft

copy of the education programme guideline through their hospital e-mail box and can

be downloading from hospital’s intranet for references. For any up-to-date

information on related topics such as research papers and journals, it should be

posting on the unit’s notice boards for staff to read.

A database which includes research articles related to ESRD, innovation in use and

the survey results related to the costs and benefits of the innovation will be set up in

hospital website for references too. Lastly, one of the elements in sustaining the

change process will be assessing the effectiveness of the innovation.

5.2 Pilot Study Plan

47

Purpose of conducting a pilot study

The pilot study is a small scale preliminary test which attempts to assess process and

outcome of the designed innovation. The process of testing included the availability

of resources for the innovation; the acceptability of the proposed innovation by ESRD

patients; and the costs of implementation. For the outcome testing, it includes the

study measure testing, and the satisfaction of users (Polit & Beck, 2010). The purpose

of conducting a pilot study is to evaluate and test the feasibility of the proposed

innovation in a small scale, which is more economical to determine if the innovation

can result in lengthen the time of first onset of PD related infection and enhance the

PD related knowledge of ESRD patients (Polit & Beck, 2010). Another purpose of the

pilot study is used to help identify design issues and allow programme to make

corrective changes or adjustments before the actual innovation implemented with the

target participants.

Participants, Duration, and Location of the Pilot Study

The pilot study of the innovation will be carried out by the proposer of the programme

innovation, who is the member of programme leading group and lead the programme

innovation. The duration of the pilot study is about 6 months. Participants will be

48

nurses in renal unit and ESRD patients who follow-up in Renal Replacement Therapy

(RRT) Clinic of the hospital. Location of the pilot study will be take place in

integrated renal centre of the hospital which is the same location of the coming

innovation.

Inclusion Criteria for the Pilot Testing

The proposed sample size of the pilot study is 10 patients. Convenience sampling is

used to choose sample population. The inclusion criteria are the same as the final

programme innovation. Firstly, patients should over 18 years of age and diagnosed

with ESRD. Secondly, they should be first time training and then following-up in

RRT clinic of the hospital where the proposed innovation will carry out. It is very

important that the inclusion criteria must be similar to those in final programme

innovation and thus can truly reflecting the feasibility of programme innovation.

Summary

By identifying stakeholders who will be affected by the proposal, conducting effective

communication with the stakeholder and testing the feasibility of the proposal using a

pilot study, it is intended that the proposed guideline will be better prepared and

49

accepted prior to its full-scale implementation.

CHAPTER 6

Evaluation Plan

The purpose of evaluation plan is to assess the clinical benefits of the innovation by

identifying those outcomes to be achieved. The evaluation can be done in three

dimensions and includes patient outcomes, staff outcomes and system outcomes.

These will be elaborated as below.

6.1 Nature and Number of Clients to Be Involved

There are three criteria for those patients to be included in the evaluation plan. Firstly,

they should be adult over 18 years old. Secondly, they are diagnosed with ESRD.

Thirdly, they are first time trained by renal nurse and follow-up in RRT clinic of the

hospital between 1 June, 2013 and 31 May, 2014. For the sample size of evaluation

plan, the number of clients to be involved in the evaluation plan is 115. This is

calculated by making use of the sample size calculator of Raosoft (2011). The margin

of error is set at 5% and the response distribution is 50%. However, with assuming

that the anticipated population proportion is to be 50%, so extra 50% of patients

50

should be recruited to account for potential sample loss due to refusal of participation

or loss of follow-up. Thus the final number of patients required for the evaluation is

165. With reference to the patients’ statistics of the hospital, there are around 203 new

cases of ESRD prepare for PD within a year. Therefore, it is possible to achieve the

number of people to be involved in evaluation.

6.2 When and How Often to Take Measurements

The time duration of the innovation is 18 months for each patient. The total duration

of the innovative project is 2.5 years. Measurement will be taken by the proposer

depending on when (if any) PD peritonitis occurs. The overall PD peritonitis rate of

all participants within the 18 months and patient satisfaction score will be measured at

the end of 2.5 years. The proposer who is the leader of the programme is responsible

to collect data for evaluation.

6.3 Data analysis

Patient outcomes

The objective of the innovation in PD education programme for ESRD patients is to

extend the time of PD related infection occurring by using the best evidence-based

51

guideline.

The primary patient outcome is

1.) Time for the first onset of PD peritonitis for first trained PD patients and their long

term mean PD peritonitis rate in patient-month per episode.

The secondary outcomes are

1.) Time for onset of other form of PD related infections (e.g. tenckhoff catheter

tunnel infection, tenckhoff catheter exit-site infection) of newly started PD patients.

2.) Patients satisfaction on the innovation.

When evaluating the patient outcomes, the proposer will compare the data of two

groups of patients. The group of patients who receive innovated education programme

will be used to compare with the previous statistical patients’ data of the hospital

retrospectively.

Primary outcome—PD peritonitis

The time for first onset of PD peritonitis (if any) will be assessed at the end of 18

months, which is the end of programme innovation. Proposer will measure the time

intervals between the first day of intervention and the first day of PD peritonitis. Next,

the proposer will calculate the mean average time for the first PD peritonitis in

52

innovation groups and compare with the previous patients’ statistical data of last year

who received usual education. The effectiveness of the innovation is indicated by

extend in average time to onset of first PD peritonitis of ESRD patients and their rate

of occurrence within 18 months in the innovation group.

Secondary outcome--client satisfaction

The level of client satisfaction will be determined for knowing whether patients

accept and satisfy with the new education programme or not. It is useful for further

improvement in conducting the same programme innovation. At the end of the

programme innovation, proposer will carry out various focus group discussions and

inviting some of the ESRD participants to join randomly. Questions based on the

topics of satisfactory level of education program, inclusion of all important points,

detailed elaboration, and whether the information is tailor-made for patients or not

will be asked to patients. Also, questions focused on the performance of nurses will be

asked, such as familiarity on latest ESRD knowledge and treatments, courtesy of

nurses, ability to concern patients’ needs and the competence of nurses. The results

will reported as percentage of positive comments. The effectiveness of the innovation

is indicated by the percentage of positive comments. At the 5% significance level,

53

more than 50 % of comments are positive will the innovation being regarded as

effective.

Staff outcomes

When evaluating the staff outcomes, the proposer will focus on evaluating the

satisfaction level of staff while implementing the programme, and their knowledge

and skill level and their confidence in them while providing education programme.

Thus, the two staff outcomes will mainly be the improvement in staff satisfaction and

the knowledge enhancement of staff after innovation.

Staff outcomes--Improvements in staff satisfaction

The level of staff satisfaction will be considered by asking or ascertaining of the

nursing staff appreciates with the new education programme or not. It is useful for

further improvement for conducting the same programme innovation in the future. At

the end of the programme innovation, proposer will carry out various focus group

discussions and inviting all the nursing staff in renal unit to participate. Questions

based on the topics of effectiveness of new health education programme, and whether

the innovation helps fellow colleagues to perform a better for patient education and

54

helps gaining professional knowledge will be asked. Moreover, comments on the

satisfaction of training provided before implementing the innovation and the

enhancement in confidence level of nurses in problem solving will be concerned too.

The results will reported as percentage of positive comments. The effectiveness of the

innovation is indicated by the percentage of positive comments. At 5% significance

level if more than 50 % of the comments are positive then the innovation will be

regarded as effective.

Staff outcomes-- Knowledge enhancement of staff after innovation

The knowledge enhancement of staff means the staff will be tested by experts on PD

related knowledge after they received training. A quiz designed by external experts,

but not the proposer, will be held for all nursing staff before and after the innovation.

It is used to compare the increase in knowledge score of staff. The results will be

reported as mean score of the test. Knowledge enhancement is indicated by the

increase in mean scores of the quiz test.

System outcomes

Cost of implementing the innovation

55

The cost of innovation will be calculated by Microsoft Excel software after the

innovation. It will be done by recording the expenditure of all materials and

non-materials cost during the innovation programme. However, this outcome will not

be considered for effectiveness. Proposer will compare it with the estimated material

cost and non-material cost of implementing the health education programme for 100

patients with ESRD.

6.4 Effectiveness of the Guideline

The guideline will be considered as effective if the primary outcome is proved as

effective, which is the time of onset of PD peritonitis. When the outcomes other than

the item mentioned above are not achieved, the proposer will not stop the innovation.

However, proposer will make use of these minor outcomes as a hint to get further

improvement of the programme in the future.

CHAPTER 7

Summary

Summarizing the best evidences, they supported that PD patient education

programme were effective in improving patients’ disease-related knowledge and

56

decrease the rate PD-related infectious complications. The evidence suggested that

incorporation of adult learning theory into the curriculum and the introduction of an

objective structured assessment to test the patients’ or helpers’ post training PD skills

are effective interventions to reinforce learners’ outcomes. In the written proposal, it

also discussed the transferability, feasibility and cost-benefit ratio of the programme

and found that it is possible to carry out in local setting. To enhance the effectiveness

of PD education, a structured programme should be implemented with a

comprehensive communication plan with potential users through appropriate

strategies, development of evidence-based guidelines and suitable educational

materials, as well as pilot study to assess the proposed plan and guideline. A

comprehensive evaluation plan assessing the patients and staff outcomes of the

programme is essential to assure it is effective in improving knowledge and outcomes

of ESRD patients and to ensure that the programme is also supported by patients and

staff.

The major complication of PD is PD peritonitis. It is the major contributor to

technique failure and lead patients shift to haemodialysis. As a result increased the

burden of limited service from HA haemodialysis centres. Patients themselves also

will suffer from pain and greatly lowering their quality of life. However, if the

57

primary prevention of PD education do better, research evidences have shown that

peritonitis infection rate of PD patients can be effectively reduced. It can be achieve

by the utilization of effective education strategies and advanced training skills to

enhance patients’ knowledge and skills of peritoneal dialysis. Therefore, a structured

PD education programme with best evidences support is worthy to establish for the

beneficial of PD patients nowadays and in the future.

58

Table of evidence Appendix 1

Citation/Date/Country of

Origin

Evidence

level

Design, Setting, Sample Size

and Population

Intervention(s) Control Outcome measures/

Length of follow up

Effect size

1 Hall G, Bogan A, Dreis S,

Duffy A, Greene S, Kelley K,

Lizak H, Nabut J, Schinker V,

Schwartz N: New directions in

peritoneal dialysis patient

training. Nephrol Nurs J 31:

149 –154, 159 –163, (2004)

USA.

Ⅲ Design:

Setting:

Sample:

Population:

Longitudinal

Quasi-experimental

Controlled Study

32 Gambro

healthcare PD clinic.

CAPD adult patients

620 PD patients

Enrolled.

PD technique and

diet training using

theory-based

curriculum.

(n=246)

Using non-

standardized

conventional

PD training

programs.

(n=374)

(1) Peritonitis rates.

(2) Exit-site infections rates.

(ESI)

(3) Drop out from PD to

Haemodialysis secondary

to infection.

2 years

(1) 28.8 cases per 1000

patient-months (intervention)

vs 36.7 cases per 1000

patient-months (control)

(P=0.09783)

(2) 18.5 vs 31.8 (P=0.00349)

(3) 1.6% vs 5.6% (P=0.0069)

2 Casey M, Taylor J, Clinard P

et al. Application of

mupirocin cream at the

catheter exit site reduces

exit-site infections and

peritonitis in peritoneal

dialysis patients. Perit

Dial Int 2000; 20: 566.

USA

Ⅲ Design:

Setting:

Sample:

Population:

Prospective

historically

controlled study

Single home PD

training center

Adult PD patients

291 PD patients

Application of

2% mupirocin

cream daily to

exit-site.

(n=143))

Use older

practice of

liquid

antibacterial

soap and water

and gauze

dressing.

(n=148)

(1) Peritonitis rates.

(2) Exit-site infections rates.

(ESI)

12 months

(1) 0.42 episode per

patient-year (intervention)

vs 0.61 episode per

patient-year (control)

(P=0.003)

(2) 0.19 ESI per patient-year

(intervention) vs 0.39 ESI per

patient-year (control)

(P<0.001)

3 Figueiredo AE, Poli de

Figueiredo CE, d'Avila DO,

Peritonitis prevention in

CAPD: to mask or not?

Perit Dial Int. 2000

May -Jun;20(3):354-8.

Brazil.

Ⅱ Design:

Setting:

Sample:

Population:

Randomized

controlled trials

Single renal unit at a

university hospital

CAPD adult patients

64 PD patients

Patient perform

PD exchange

with a face mask.

(n=24)

Patient perform

PD exchange

without a face

mask.

(n=40)

Occurrence of first episode

of peritonitis and total number

of episode.

12 months

Only patients holding university

degrees shown evidence of

protection, relative risk 0.52,

(CI) 95%, 0.23-1.18. (P=0.109)

Incidence of peritonitis was not

significantly different between

groups.

59

Citation/Date/Country of

Origin

Evidence

level Design, Setting, Sample Size

and Population

Intervention(s) Control Outcome measures/

Length of follow up

Effect size

4 Bernardini J, Bender F, Florio

T, Sloand J, Palmmontalbano

L, Fried L,Piraino B.

Randomized, double-blind

trial of antibiotic exit site

cream for prevention of exit

site infection in peritoneal

dialysis patients. J Am

SocNephrol.

2005 Feb;16(2):539-45. Epub

2004 Dec 29. USA

Ⅱ Design:

Setting:

Sample:

Population:

Ramdomised

controlled trials

3 renal centers

Adult CAPD patients

133 PD patients

Application of

gentamicin cream

daily to exit-site

(n=67 )

Application of

mupirocin

cream daily to

exit-site

(n=66 )

(1) Peritonitis rates.

(2) Cathether infection rates.

12 months

(1) 0.34 episode per patient-year

(intervention) vs 0.52 episode

per patient-year (control)

(P=0.03)

(2) 0.23 episode per patient-year

(intervention) vs 0.54 episode

per patient-year (control)

(P=0.005)

5 Gadola L, Poggi C, Poggio M,

Sáez L, Ferrari A, Romero J,

Fumero S, Ghelfi G, Chifflet L,

Larre Borges P. Using a

multidisciplinary training

program to reduce peritonitis

in peritoneal dialysis patients.

Perit Dial Int. 2012 Jul 1.

Uruguay

Ⅲ Design:

Setting:

Sample:

Population:

Retrospective

analysis study

A single renal center

Adult CAPD

patients, at least 1

month on treatment

56 PD patients

Phase 1:

Apply assessment

tool of Objective

Structured

Assessment(OSA)

(n= 25)

Phase 2:

Implementation

of a new

multidisciplinary

peritoneal dialysis

education program

(PDEP)

(n=31)

Phase 1:

Correlated with

the prior year’s

peritonitis rate.

(n=25 )

Phase 2:

Correlated with

the prior year’s

peritonitis rate.

(n=31)

Peritonitis rates

12 months

Phase 1:

0.24 episode per patient-year

(OSA with an acceptable score)

vs 0.67 episode per patient-year

(OSA with an unacceptable

score) (P<0.05)

Phase 2:

0.28 episode per patient-year

(intervention) vs 0.55 episode

per patient-year (control)

(P<0.05)

60

Citation/Date/Country of

Origin

Evidence

level Design, Setting, Sample Size

and Population

Intervention(s) Comparison Outcome measures/

Length of follow up

Result

6 Chen TW, Li SY, Chen JY,

Yang WC. Training of

peritoneal dialysis

patients--Taiwan's experiences.

Perit Dial Int. 2008 Jun;28

Suppl 3:S72-5.

Taiwan

Ⅲ Design:

Setting:

Sample:

Population:

Retrospective

observational study

Single renal center

Adult new start

CAPD or APD

patients

100 PD patients

Implementation

of a post training

test for patients

(n=100).

Compare the

Post-training

score correlated

with peritonitis

rates, exit-site

infection rates

and tunnel

infection rates.

(n= 100).

(1) peritonitis rates

(2) exit-site infection rates

(3) tunnel infection rates

12 months

(1) not significantly different

from score for patients without

infection complications (P=0.8).

(2) higher score got higher

infection rates (P=0.036).

(3) higher score got higher

infection rates (P=0.043).

7 Prasad N, Gupta A, Sharma

RK, Sinha A, Kumar R.

Impact of nutritional status on

peritonitis in CAPD patients.

Perit Dial Int. 2007

Jan-Feb;27(1):42-7.

India

Ⅲ Design:

Setting:

Sample:

Population:

Prospective

observational study

Single renal center

Adult CAPD patients

56 CAPD patients

Patients divided

malnutrition and

normal nutrition

group by

Subjective Global

Assessment(SGA)

And then assess

correlation with

peritonitis

(n=56 )

Compare the

malnutrition

and normal

nutrition group

in terms of the

outcome

measure

(n=56 )

Peritonitis-free survival

period

4 years

42 months (normal nutrition

group) vs 21 months

(malnutrition group) (P=0.003)

8 Dong J, Chen Y. Impact of the

bag exchange procedure on

risk of peritonitis. Perit Dial Int.

2010 Jul-Aug;30(4):440-7.

RP China

Ⅲ Design:

Setting:

Sample:

Population:

Prospective

observational study

Single renal center

Newly started adult

CAPD patients

130 CAPD patients

Offer standard

initial training

program and

evaluation at

the 6th

month of

PD treatment.

(n=130 )

Compare 8

evaluation items

in relation with

peritonitis

(n=130 )

Hazard ratio of PD peritonitis

14 months

(1) Hazard ratio 7.26 (Not

wearing a face mask and cap)

(P<0.001)

(2) Hazard ratio 0.96

(anaemia) (P=0.005)

61

Citation/Date/Country of

Origin

Evidence

level Design, Setting, Sample Size

and Population

Intervention(s) Comparison Outcome measures/

Length of follow up

Result

9 Mawar S, Gupta S, Mahajan S.

Non-compliance to the

continuous ambulatory

peritoneal dialysis procedure

increases the risk of peritonitis.

Int Urol Nephrol. 2012

Aug;44(4):1243-9.

India

Ⅲ Design:

Setting:

Sample:

Population:

Prospective

observational study

Patients’ home

during home visit

Adult CAPD patients

at least 1.5 years of

treatment.

30 CAPD patients

Observe CAPD

exchange

technique during

home visit using a

structured

checklist and

determine the

compliance of

patient.

(n= 30)

Compare the

compliance of

CAPD

procedure

associated with

PD peritonitis.

(n=30 )

(1) Association with

peritonitis

(2) Association with

frequency of peritonitis

12 months

(1) significant association of

compliance with peritonitis

occurrence. (P<0.02)

(2) significant association of

compliance with higher

frequency of peritonitis.

(P<0.03)

10 Xu R, Zhuo M, Yang Z, Dong

J. Experiences with assisted

peritoneal dialysis in China.

Perit Dial Int. 2012 Jan-Feb;

32(1):94-101.

RP China

IV Design:

Setting:

Sample:

Population:

Prospective cohort

study

Single renal center

Adult CAPD patients

313 PD patients

Cohort study is

divided the

patients into

assisted and self

care groups.

Assisted group

(n=122 )

Self-care group

(N=191)

To compare the

outcome

variables of first

episode of

peritonitis and

all causes of

mortality

between the

two groups.

(n= 313)

(1) Peritonitis-free interval.

(2) Mortality rate

(3) Survival time

4 years

(1) 23.5±2.5 months (assisted

CAPD patients) vs 23.4±2.0

months (self-care patients)

(P=0.93)

(2) 69.7% (assisted CAPD

patients) vs 26.2% (self-care

patients) (P<0.0001)

(3) 43.8±2.3 months (assisted

CAPD patients) vs 69.8±2.1

months (self-care patients)

(P<0.0001)

62

Citation/Date/Country of

Origin

Evidence

level Design, Setting, Sample Size

and Population

Intervention(s) Comparison Outcome measures/

Length of follow up

Result

11 Barone RJ, Campora MI,

Gimenez NS, Ramirez L,

Santopietro M, Panese SA.

The importance of the Patient's

training in chronic peritoneal

dialysis and peritonitis. Adv

Perit Dial. 2011;27:97-100.

Argentina

Ⅲ Design:

Setting:

Sample:

Population:

Retrospective

analysis study

Single renal center

Adult APD or CAPD

patients. At least

undergone 3 months of

of treatment.

90 PD patients

Retrospective

analysis of

patients in 3

different length of

training groups

(n= 90)

Compare

peritonitis rates

of 3 different

groups with

group A (up to

8 lessons),

group B

(9-13 lessons),

group C (14 or

more lessons)

(n=90 )

Peritonitis rates

12 months

0.31 in group A (up to 8

lessons)

0.37 in group B (9-13 lessons)

0.47 in group C (14 or more

lessons)

(P<0.05)

12 Chow KM, Szeto CC, Law MC,

Fun Fung JS, Li PKT.

Influence of peritoneal dialysis

training nurses’ experience on

peritonitis rates. Clin J Am

Soc Nephrol 2007;2:647–52.

Hong Kong SAR

Ⅲ Design:

Setting:

Sample:

Population:

Retrospective

observational study

Single renal center

Newly started adult

APD or CAPD

patients.

200 PD patients

A standard PD

training is given

to patients by

three different

group of nurses

with different

lengths of training

experience

(n= 200)

Compare the

relationship

between PD

peritonitis

occurrence

in terms of

length of PD

training nurses’

experience.

(n=200 )

Hazard ratio of PD peritonitis.

3 years

1 for lower tertile (reference)

1.94 for intermediate tertile

(P=0.037)

2.13 for highest tertile

(P=0.022)

63

Quality Assessment Appendix 2

1 Hall G, Bogan A, Dreis S, Duffy A, Greene S, Kelley K, Lizak H, Nabut J, Schinker V,

Schwartz N: New directions in peritoneal dialysis patient training. Nephrol Nurs J 31:

149 –154, 159 –163, 2004.

Study type: Longitudinal quasi-experimental Controlled Study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

1.2 The assignment of subjects to

treatment groups is randomised

Adequately addressed. Number of

patients excluded from study was not

reported. No randomization was made.

1.3 An adequate concealment

method is used

Not addressed. Concealment was not

reported.

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation

Not addressed. Blinding was not used

due to the study nature, blinding to

participants is difficult as they received

lessons. Issue on blinding was not

discussed.

1.5 The treatment and control

groups are similar at the start

of the trial

Well covered. Demographic data

between groups were similar

statistically.

1.6 The only difference between

groups is the treatment under

investigation

Well covered. No additional treatment was

introduced other than the study

interventions.

1.7 All relevant outcomes are

measured in a standard, valid

and reliable way

Adequately addressed. All outcome

measures were accounted for in the

analysis.

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

Intervention group: 0

Control group: 0

1.9 All the subjects are analyzed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis)

Well covered. The subjects were

analyzed under the principle of

intention to treat.

64

1.10 Where the study is carried out

at more than one site, results

are comparable for all sites

Adequately addressed. Results were

comparable with similar baseline

characteristic.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

No, no power calculation was made.

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study. However, the

generalization of results was not addressed.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The use of adult learning theory-based training method

was positively improve patient outcomes.

65

2 Casey M, Taylor J, Clinard P et al. Application of mupirocin cream at the catheter

exit site reduces exit-site infections and peritonitis in peritoneal dialysis patients.

Perit Dial Int 2000; 20: 566.

Study type: Prospective historically controlled study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

1.2 The assignment of subjects to

treatment groups is randomised

Well covered

1.3 An adequate concealment

method is used

Not addressed

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation

Not addressed

1.5 The treatment and control

groups are similar at the start

of the trial

Well covered

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

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

Intervention group: 0

Control group: 0

1.9 All the subjects are analyzed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis)

Adequately addressed

1.10 Where the study is carried out

at more than one site, results

are comparable for all sites

Well covered

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

66

2.1 How well was the study done to

minimise bias? Code ++, +, or -

-

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The application of mupirocin cream is an effective way

to reduce PD catheter related infectious complication.

67

3 Figueiredo AE, Poli de Figueiredo CE, d'Avila DO, Peritonitis prevention in CAPD:

to mask or not? Perit Dial Int. 2000 May-Jun;20(3):354-8.

Study type: Randomised controlled trials

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

1.2 The assignment of subjects to

treatment groups is randomised

Well covered

1.3 An adequate concealment

method is used

Not addressed

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation

Not addressed

1.5 The treatment and control

groups are similar at the start

of the trial

Well covered. Demographic data

between groups were similar.

1.6 The only difference between

groups is the treatment under

investigation

Well covered. No additional treatment was

introduced other than the study

interventions.

1.7 All relevant outcomes are

measured in a standard, valid

and reliable way

Adequately addressed

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

Intervention group: 0

Control group: 0

1.9 All the subjects are analyzed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis)

Well covered. The subjects were

analyzed under the principle of

intention to treat.

1.10 Where the study is carried out

at more than one site, results

are comparable for all sites

Adequately addressed. Results were

comparable with similar baseline

characteristic.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

68

2.1 How well was the study done to

minimise bias? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

No. There are also many factors affect the result. For

example: hand wash technique, bag exchange

technique etc.

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The author concluded that the routine use of a facial

mask may not necessary during CAPD bag exchange.

But this is a risk factor of being contamination during

the procedure. It is not worth to eliminate just for

reduce costs of CAPD.

69

4 Bernardini J, Bender F, Florio T, Sloand J, Palmmontalbano L, Fried L, Piraino B.

Randomized, double-blind trial of antibiotic exit site cream for prevention of exit

site infection in peritoneal dialysis patients. J Am Soc Nephrol. 2005

Feb;16(2):539-45. Epub 2004 Dec 29.

Study type: Randomised controlled trials

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

1.2 The assignment of subjects to

treatment groups is randomised

Well covered.

1.3 An adequate concealment

method is used

Well covered.

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation

Well covered.

1.5 The treatment and control

groups are similar at the start

of the trial

Well covered. Demographic data

between groups were similar.

1.6 The only difference between

groups is the treatment under

investigation

Well covered. No additional treatment was

introduced other than the study

interventions.

1.7 All relevant outcomes are

measured in a standard, valid

and reliable way

Adequately addressed. All outcome

measures were accounted for in the

analysis.

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

Intervention group: 0

Control group: 0

1.9 All the subjects are analyzed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis)

Well covered. The subjects were

analyzed under the principle of

intention to treat.

1.10 Where the study is carried out

at more than one site, results

are comparable for all sites

Adequately addressed. Results were

comparable with similar baseline

characteristic.

70

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes, the study was well controlled. There was no

different in groups by gender, age, race or previous

time on dialysi treatment.

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The application of antibiotics cream on exit-site is an

effective way to reduce PD catheter related infectious

complication.

71

5 Gadola L, Poggi C, Poggio M, Sáez L, Ferrari A, Romero J, Fumero S, Ghelfi G,

Chifflet L, Larre Borges P. Using a multidisciplinary training program to reduce

peritonitis in peritoneal dialysis patients. Perit Dial Int. 2012 Jul 1.

Study type: Retrospective analysis study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

1.2 The assignment of subjects to

treatment groups is randomised

Adequately addressed. Number of

patients excluded from study was not

reported.

1.3 An adequate concealment

method is used

Not addressed. Concealment was not

reported.

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation

Not addressed. Blinding was not used

due to the study nature, blinding to

participants is difficult as they received

lessons.

1.5 The treatment and control

groups are similar at the start

of the trial

Well covered. Demographic data

between groups were similar.

1.6 The only difference between

groups is the treatment under

investigation

Well covered. No additional treatment was

introduced other than the study

interventions.

1.7 All relevant outcomes are

measured in a standard, valid

and reliable way

Adequately addressed. All outcome

measures were accounted for in the

analysis.

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

Intervention group: 0

Control group: 0

1.9 All the subjects are analyzed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis)

Well covered. All subjects recruited were

being analyzed under the principle of

intention to treat.

1.10 Where the study is carried out

at more than one site, results

are comparable for all sites

Adequately addressed. Results were

comparable with similar baseline

characteristic.

72

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study. However, the

generalization of results was not addressed.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The author concluded that the Objective Structured

Assessment is a reliable tool for assess patients’ skills.

The multidisciplinary PD education programm further

improve peritonitis rates.

73

6 Chen TW, Li SY, Chen JY, Yang WC. Training of peritoneal dialysis

patients--Taiwan's experiences. Perit Dial Int. 2008 Jun;28 Suppl 3:S72-5.

Study type: Retrospective observational study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The cases and controls are taken from

comparable populations

Adequately addressed.

1.3 The same exclusion criteria are used for

both cases and controls

Well covered

1.4 What percentage of each group (cases

and controls) participated in the study?

Cases: 100%

Control: 100%

1.5 Comparison is made between

participants and non-participants to

establish their similarities or

differences

Adequately addressed.

1.6 Cases are clearly defined and

differentiated from controls

Well covered.

1.7 It is clearly established that controls are

non-cases

Well covered.

ASSESSMENT

1.8 Measures will have been taken to

prevent knowledge of primary exposure

influencing case ascertainment

Adequately addressed

1.9 Exposure status is measured in a

standard, valid and reliable way

Well covered

CONFOUNDING

1.10 The main potential confounders are

identified and taken into account in the

design and analysis

Not addressed

STATISTICAL ANALYSIS

1.11 Confidence intervals are provided No

74

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding? Code ++, +, or -

-

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes.

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

There are many factors that can induce PD peritonitis.

The total scores of post training test only reflect the

learning abilities of individual patients.

75

7 Prasad N, Gupta A, Sharma RK, Sinha A, Kumar R. Impact of nutritional status on

peritonitis in CAPD patients. Perit Dial Int. 2007 Jan-Feb;27(1):42-7.

Study type: Prospective observational study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The cases and controls are taken from

comparable populations

Well covered.

1.3 The same exclusion criteria are used for

both cases and controls

Well covered.

1.4 What percentage of each group (cases

and controls) participated in the study?

Cases: 100%

Controls: 100%

1.5 Comparison is made between

participants and non-participants to

establish their similarities or

differences

Well covered.

1.6 Cases are clearly defined and

differentiated from controls

Well covered.

1.7 It is clearly established that controls are

non-cases

Adequately addressed.

ASSESSMENT

1.8 Measures will have been taken to

prevent knowledge of primary exposure

influencing case ascertainment

Adequately addressed

1.9 Exposure status is measured in a

standard, valid and reliable way

Well covered.

CONFOUNDING

1.10 The main potential confounders are

identified and taken into account in the

design and analysis

Not addressed.

STATISTICAL ANALYSIS

1.11 Confidence intervals are provided Yes.

76

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes.

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The peritonitis rate is relatively high in malnutrition

patients. The authors concluded that the malnutrition

indices is the predictor of CAPD patients with

peritonitis.

77

8 Dong J, Chen Y. Impact of the bag exchange procedure on risk of peritonitis. Perit

Dial Int. 2010 Jul-Aug;30(4):440-7

Study type: Prospective observational study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The cases and controls are taken from

comparable populations

Well covered.

1.3 The same exclusion criteria are used for

both cases and controls

Well covered.

1.4 What percentage of each group (cases

and controls) participated in the study?

Cases: 100%

Controls: 100%

1.5 Comparison is made between

participants and non-participants to

establish their similarities or

differences

Well covered.

1.6 Cases are clearly defined and

differentiated from controls

Well covered.

1.7 It is clearly established that controls are

non-cases

Adequately addressed.

ASSESSMENT

1.8 Measures will have been taken to

prevent knowledge of primary exposure

influencing case ascertainment

Adequately addressed.

1.9 Exposure status is measured in a

standard, valid and reliable way

Well addressed.

CONFOUNDING

1.10 The main potential confounders are

identified and taken into account in the

design and analysis

Not addressed.

STATISTICAL ANALYSIS

1.11 Confidence intervals are provided Yes

78

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding? Code ++, +, or -

-

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

2 out of 8 items were identified as independent risk

factors for peritonitis.

79

9 Mawar S, Gupta S, Mahajan S. Non-compliance to the continuous ambulatory

peritoneal dialysis procedure increases the risk of peritonitis. Int Urol Nephrol. 2012

Aug;44(4):1243-9.

Study type: Prospective observational study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The cases and controls are taken from

comparable populations

Adequately addressed.

1.3 The same exclusion criteria are used for

both cases and controls

Well covered.

1.4 What percentage of each group (cases

and controls) participated in the study?

Cases: 100%

Controls: 100%

1.5 Comparison is made between

participants and non-participants to

establish their similarities or

differences

Not reported.

1.6 Cases are clearly defined and

differentiated from controls

Well covered.

1.7 It is clearly established that controls are

non-cases

Adequately addressed.

ASSESSMENT

1.8 Measures will have been taken to

prevent knowledge of primary exposure

influencing case ascertainment

Well covered.

1.9 Exposure status is measured in a

standard, valid and reliable way

Well covered.

CONFOUNDING

1.10 The main potential confounders are

identified and taken into account in the

design and analysis

Not reported.

STATISTICAL ANALYSIS

1.11 Confidence intervals are provided Yes

80

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The study shown significant association of frequency

of peritonitis with non-compliance. Non-compliance

can be improved by retraining, it is a correctable rick

factor.

81

10 Xu R, Zhuo M, Yang Z, Dong J. Experiences with assisted peritoneal dialysis in

China. Perit Dial Int. 2012 Jan-Feb; 32(1): 94-101.

Study type: Prospective cohort study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The two groups being studied are

selected from source populations that

are comparable in all respects other

than the factor under investigation.

Well covered.

1.3 The study indicates how many of the

people asked to take part did so, in each

of the groups being studied.

Not addressed.

1.4 The likelihood that some eligible

subjects might have the outcome at the

time of enrolment is assessed and taken

into account in the analysis.

Well covered.

1.5 What percentage of individuals or

clusters recruited into each arm of the

study dropped out before the study was

completed.

Assisted group: 17.2%

Self care group: 10.9%

1.6 Comparison is made between full

participants and those lost to follow up,

by exposure status.

Well covered.

ASSESSMENT

1.7 The outcomes are clearly defined. Well covered.

1.8 The assessment of outcome is made

blind to exposure status.

Well covered.

1.9 Where blinding was not possible, there

is some recognition that knowledge of

exposure status could have influenced

the assessment of outcome.

Well covered.

82

1.10 The measure of assessment of exposure

is reliable.

Well covered.

1.11 Evidence from other sources is used to

demonstrate that the method of

outcome assessment is valid and

reliable.

Well covered.

1.12 Exposure level or prognostic factor is

assessed more than once.

Adequately addressed.

CONFOUNDING

1.13 The main potential confounders are

identified and taken into account in the

design and analysis

Well covered.

STATISTICAL ANALYSIS

1.14 Have confidence intervals been

provided?

Yes

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding, and to establish a causal

relationship between exposure and

effect? Code ++, +, or -

-

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The authors concluded that assisted PD is a good

option for patients with poor self-care ability.

83

11 Barone RJ, Campora MI, Gimenez NS, Ramirez L, Santopietro M, Panese SA. The

importance of the Patient's training in chronic peritoneal dialysis and peritonitis.

Adv Perit Dial. 2011;27:97-100.

Study type: Retrospective analysis study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The cases and controls are taken from

comparable populations

Well covered.

1.3 The same exclusion criteria are used for

both cases and controls

Well covered.

1.4 What percentage of each group (cases

and controls) participated in the study?

Cases: 100%

Controls: 100%

1.5 Comparison is made between

participants and non-participants to

establish their similarities or

differences

Well covered. Demographic data

between groups were similar.

1.6 Cases are clearly defined and

differentiated from controls

Well covered.

1.7 It is clearly established that controls are

non-cases

Not applicable.

ASSESSMENT

1.8 Measures will have been taken to

prevent knowledge of primary exposure

influencing case ascertainment

Well covered.

1.9 Exposure status is measured in a

standard, valid and reliable way

Well covered.

CONFOUNDING

1.10 The main potential confounders are

identified and taken into account in the

design and analysis

Not adddressed.

STATISTICAL ANALYSIS

1.11 Confidence intervals are provided No

84

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

No, it is because the demographic data (education

level) between groups are different.

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

The result of the study shown that the lengths of CAPD

training received by patients is not associated with the

PD peritonitis rate. It only determinined that some

patients need more time of training is due to the present

of learning difficulties.

85

12 Chow KM, Szeto CC, Law MC, Fun Fung JS, Li PKT. Influence of peritoneal

dialysis training nurses’ experience on peritonitis rates. Clin J Am Soc Nephrol

2007;2:647–52.

Study type: Retrospective observational study

SECTION 1: INTERNAL VALIDITY

In this study this criterion is:

1.1 The study addresses an

appropriate and clearly focused

question.

Well covered. A clear and well defined

question is specified in the study.

SELECTION OF SUBJECTS

1.2 The cases and controls are taken from

comparable populations

Well covered.

1.3 The same exclusion criteria are used for

both cases and controls

Well covered.

1.4 What percentage of each group (cases

and controls) participated in the study?

Cases: 100%

Controls: 100%

1.5 Comparison is made between

participants and non-participants to

establish their similarities or

differences

Well covered. Demographic data

between groups were similar.

1.6 Cases are clearly defined and

differentiated from controls

Well covered.

1.7 It is clearly established that controls are

non-cases

Not applicable.

ASSESSMENT

1.8 Measures will have been taken to

prevent knowledge of primary exposure

influencing case ascertainment

Well covered.

1.9 Exposure status is measured in a

standard, valid and reliable way

Well covered.

CONFOUNDING

1.10 The main potential confounders are

identified and taken into account in the

design and analysis

Well covered.

STATISTICAL ANALYSIS

1.11 Confidence intervals are provided Yes

86

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise the risk of bias or

confounding? Code ++, +, or -

+

2.2 Taking into account clinical

considerations, your evaluation of

the methodology used, and the

statistical power of the study, are

you certain that the overall effect is

due to the study intervention?

Yes

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes. The patient population of my

proposed guideline was similar to those

in the study.

2.4 Summarise the authors conclusions.

Add any comments on your own

assessment of the study, and the extent

to which it answers your question.

Negative association between nurses’ experience as a

trainer and peritonitis rate implied that active continued

education for nurses are very important for them to

train the patients.

87

Appendix 3 Search result in databases

MEDLINE

( 3-5-2012)

CINAHL

(3-5-2012)

British

Nursing

Index

(3-5-2012)

PsycINFO

(3-5-2012)

PubMed

(3-5-2012)

(1)program*OR training*OR

intervention*OR education* OR

assessment*

(Limit to English and

year=2000-2012)

264615

157945

47915

1175531

2003329

(2) peritoneal dialysis*OR CAPD*

(Limit to English and

year=2000-2012)

2252

472

142

375

26757

(3) complication* OR infection*

OR peritonitis*OR exit-site

infection* OR tunnel infection*

(Limit to English and

year=2000-2012)

285753

80149

11785

78324

3407907

(4) infection prevention* OR

technique* OR mortality*

(Limit to English and

year=2000-2012)

191638

42257

4912

186851

2202802

(5) #1 AND #2 AND #3 AND #4 63 77 13 23 524

(6) Limit #5 to inclusion criteria

and absence of exclusion criteria

4 4 2 5 8

(7) Final number of studies chosen 12

88

Appendix 4 Level of evidence

Bibliographic citation Study type Level of

evidence

1 Hall G, et al., 2004 Longitudinal quasi-experimental design

study

Ⅲ

2 Casey M, et al, 2000 Prospective historically controlled

study

Ⅲ

3 Figueiredo E, et al., 2000

Randomized controlled trials (RCTs) Ⅱ

4 Bernardini J, et al., 2005

Randomized controlled trials (RCTs) Ⅱ

5 Gadola L, et al., 2012

Retrospective analysis study Ⅲ

6 Chen T W, et al., 2008

Retrospective observational study Ⅲ

7 Prasad N, et al., 2006

Prospective observational study Ⅲ

8 Dong J, et al., 2010

Prospective observational study Ⅲ

9 Mawar S, et al., 2011

Prospective observational study Ⅲ

10 Xu R, et al., 2011

Prospective cohort study IV

11 Barone RJ, et al, 2011

Retrospective analysis study Ⅲ

12 Chow K M, et al., 2007

Retrospective observational study Ⅲ

89

Appendix 5

Comparison of demographics characteristics between the target population of 12

studies and the target population in the local setting.

Target population in local

Setting (Data from our

hospital starting from

January 2009 to December

2010)

Target population in the

studies (Data represent the

summary of all 12 studies)

Nature of

population

Patients preparing for

home CAPD

Patients preparing for

home CAPD

Number of

audiences

113 Average 174

Age

(Mean)

59.9 years 58.5 years

Gender

(Male)

61.4% Average 64.7%

Countries

(Geographical)

Hong Kong (Asia) USA x 3, Brazil, Uruguay,

Taiwan (Asia), India x 2

(Asia), China x 2 (Asia),

Argentina, Hong Kong

(Asia)

Setting Integrated renal center Renal center x 11,

patients’ home x 1

90

Appendix 6

Estimated extra cost to implement the proposed programme

Personnel:

21 Training time for staff 1 hour/each $230/hr $4,830

1 Working time for trainer

(Train 2 nurses each time)

11 hours $230/hr $2,530

1 Working time to prepare written

material, training material

10 hours $230/hr $2,300

Expenses:

Education rooms Available in hospital -----

Teaching aids Available in hospital -----

Training material (handouts) Paper, files $250

Miscellaneous e.g. stationery Pens, files, staplers, clips, etc $300

Pre & post questionnaires $0.3 / sheet x2 x21 $12.6

91

Appendix 7

The Coding System of the Level of Evidence from Scottish Intercollegiate

Guidelines Network (Scottish Intercollegiate Guidelines Network, 2010)

Level of

Evidence

Evidence Statements

1++ High quality meta-analyses, systematic reviews of

randomized controlled trials (RCTs), or RCTs with a

very low risk of bias

1+ Well conducted meta-analyses, systematic reviews of

RCTs, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews of RCTs, or RCTs

with high risk of bias

2++ High quality systematic reviews of case control or cohort

studies High quality case control or cohort studies with a

very low risk of confounding or bias and a high

probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low

risk of confounding or bias and a moderate probability

that the relationship is causal

2- Case control or cohort studies with 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

92

Appendix 8

The Grades of Recommendation from Scottish Intercollegiate Guidelines

Network (Scottish Intercollegiate Guidelines Network, 2010)

Grade Explanation

A At least one meta-analysis, systematic review, or RCT

rated as 1++, and directly applicable to the target

population; or

A body of evidence consisting principally of studies

rated as 1+, directly applicable to the target population,

and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++,

directly applicable to the target population, and

demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+,

directly applicable to the target population and

demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

(Good Practice

Points)

Recommended best practice based on the clinical

experience of the guideline development group

93

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