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Abstract of the dissertation entitled A parental education program for the management of atopic dermatitis in children Submitted by Kong Wing Yin For the Degree of Master of Nursing at The University of Hong Kong in August 2015 In the pediatric ward of a major public hospital in Hong Kong, around 5% of patients admitted were due to eczema. Among them, 30% had poor disease control with repeated admissions. Some studies showed that nurse-led parental education in eczema can lead to better disease management, but it has not been considered in the local setting. Despite a systematic review was conducted, there has been subsequently new evidence that urges for an updated evaluation. Therefore, this dissertation aims to systematically review the up-to-date evidence on the effectiveness of parental education program in reducing the severity of eczema, develop an evidence-based guideline for the program, assess the implementation potential, and plan for a pilot and an evaluation of the program. A systematic search of British Nursing Index, PubMed, CINHAL and PsyInfo

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Abstract of the dissertation entitled

A parental education program for the management

of atopic dermatitis in children

Submitted by

Kong Wing Yin

For the Degree of Master of Nursing

at The University of Hong Kong

in August 2015

In the pediatric ward of a major public hospital in Hong Kong, around 5% of

patients admitted were due to eczema. Among them, 30% had poor disease control

with repeated admissions. Some studies showed that nurse-led parental education in

eczema can lead to better disease management, but it has not been considered in the

local setting. Despite a systematic review was conducted, there has been subsequently

new evidence that urges for an updated evaluation. Therefore, this dissertation aims to

systematically review the up-to-date evidence on the effectiveness of parental

education program in reducing the severity of eczema, develop an evidence-based

guideline for the program, assess the implementation potential, and plan for a pilot

and an evaluation of the program.

A systematic search of British Nursing Index, PubMed, CINHAL and PsyInfo

   

identified 5 randomized controlled trials (RCTs) that assessed the effectiveness of

parental program in reducing severity of eczema in children. Using the Scottish

Intercollegiate Guidelines Network (SIGN) checklist, three of them had high

methodological quality, and two had acceptable quality. Four studies reported

parental education reduced severity of eczema. Thus, it was considered as sufficient

evidence that supported the implementation of parental education program in

reducing severity of eczema. An evidence-based guideline for parental education was

then developed. The local setting shared similar characteristics with the selected

studies in terms of the eligible participants and settings. It also had the staff

supportive to the change with available resources. Moreover, there would be an

annual cost saving of around HK$650,000. Hence, the proposed education program is

feasible and transferable to the local setting.

Training of staff will be made in one month before embarking on a 3-month pilot

study on ten eczematous patients. Then, a 5-month evaluation study on eczematous

patients would be commenced. The primary outcome is the severity of eczema, while

the secondary outcomes are patient’s satisfaction, frontline staff workload and morale,

   

admission rate and attendance rate at specialty outpatient clinic, and the cost of

innovation. Finally, the primary and secondary outcomes would be evaluated in order

to identify the effectiveness of the program.

   

A parental education program for the management

of atopic dermatitis in children

by

Kong Wing Yin

B.Nurs. H.K.U.

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

August 2015

  i  

 

Declaration

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

acknowledge is made, and that it had 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 ______________________________________

Kong Wing Yin

  ii  

Acknowledgements

I would like to express my sincere gratitude to my supervisor, Dr. Daniel Yee-Tak

Fong, Associate Professor, for his generous guidance, enlightenment and patience in

directing me to the right track throughout the dissertation process.

I would also like to thank the staff of the School of Nursing for their assistance and

teaching in my master study.

Finally, I must express my immense gratitude and appreciation to my dear family,

classmates, friends and colleagues for their love, support and encouragement

throughout my study.

 

  iii  

Table of Contents

Declaration ................................................................................................................................ i  

Acknowledgements .................................................................................................................. ii  

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

List of Appendices....................................................................................................................iv

Chapter 1. Introduction .......................................................................................................... 1  

1.1  Background   1  

1.2  Affirming  needs   2  

1.3  Dissertation  Objectives   7  

Chapter 2. Critical Appraisal ................................................................................................. 9  

2.1  Search  and  appraisal  strategies   9  

2.1.1  Identification  of  Study  ...........................................................................................................................  9  

2.1.2  Criteria  for  selecting  studies  for  review  .....................................................................................  10  

2.1.3  Data  Extraction  .....................................................................................................................................  11  

2.1.4  Appraisal  strategy  ................................................................................................................................  11  

2.2  Results   13  

2.2.1  Search  Results  ........................................................................................................................................  13  

2.2.2  Characteristics  of  the  Studies  ..........................................................................................................  13  

2.2.2.1  Study  Types  ..........................................................................................................................................  13  

2.2.2.2  Sample  Characteristics  ...................................................................................................................  14  

2.2.2.3  Interventions  .......................................................................................................................................  14  

2.2.2.4  Length  of  follow-­‐up  ..........................................................................................................................  15  

2.2.2.5  Outcome  measures  ...........................................................................................................................  16  

2.2.3  Quality  assessment  of  Studies  .........................................................................................................  16  

2.3  Summary  and  Synthesis  of  Data   19  

2.3.1  Summary  ..................................................................................................................................................  19  

2.3.2  Synthesis  of  data  ...................................................................................................................................  21  

Chapter 3. Translation and Application .............................................................................. 25  

3.1  Implementation  Potential   25  

3.1.1Target  Setting  .........................................................................................................................................  25  

3.1.2  Target  audience  ....................................................................................................................................  25  

 

  iii  

3.2  Transferability  of  the  Findings   25  

3.2.1  Comparison  of  Setting  and  Audience  ...........................................................................................  25  

3.2.2  Philosophy  of  Care  ...............................................................................................................................  27  

3.2.3Number  of  clients  benefit  from  the  Innovation  ........................................................................  27  

3.2.4  Time  for  Implementation  and  Evaluation  .................................................................................  27  

3.3  Feasibility   28  

3.3.1  Freedom  on  implementation  ...........................................................................................................  28  

3.3.2  Interference  of  Staff  Functions  .......................................................................................................  29  

3.3.3  Administrative  Support  .....................................................................................................................  30  

3.3.4  Consensus  among  the  Staff  and  Administrators  .....................................................................  31  

3.3.5  Risk  of  Friction  .......................................................................................................................................  32  

3.3.6  Skills  of  Adopting  the  Innovation  ..................................................................................................  32  

3.3.7  Equipment  and  Facilities  ..................................................................................................................  33  

3.3.8  Staff  Training  .........................................................................................................................................  33  

3.3.9  Measuring  tool  for  evaluation  ........................................................................................................  33  

3.4  Cost-­‐benefit  Ratio  of  the  Innovation   34  

3.4.1  Potential  Risks  .......................................................................................................................................  34  

3.4.2  Potential  Benefits  .................................................................................................................................  34  

3.4.3  Risks  of  Maintaining  Current  Practice  ........................................................................................  35  

3.4.4Material  Cost  of  Implementing  the  Innovation  ........................................................................  35  

3.4.5  Material  Cost  for  not  implementing  the  Innovation  .............................................................  36  

3.4.6  Potential  Non-­‐material  Cost  of  implementing  the  Innovation  .........................................  36  

3.4.7  Potential  Non-­‐material  Benefits  of  Implementing  the  Innovation  .................................  37  

3.5  Evidence-­‐based  Guideline   37  

Chapter 4. Implementation Plan .......................................................................................... 39  

4.1  Communication  Plan   39  

4.1.1  Identification  of  Stakeholders  .........................................................................................................  39  

4.1.2  Initiation  stage  ......................................................................................................................................  39  

4.1.3  Facilitation  Stage  .................................................................................................................................  41  

4.1.4  Communication  Strategies  to  Sustain  Change  Process  .......................................................  41  

4.2  Pilot  Study  Plan   42  

4.2.1  Objectives  of  Pilot  Study  Plan  ..........................................................................................................  42  

 

  iii  

4.2.2  Preparation  of  the  Pilot  Study  ........................................................................................................  43  

4.2.3  Subject  Recruitment  Strategies  ......................................................................................................  44  

4.2.4  Data  Collection  ......................................................................................................................................  45  

4.2.5  Data  Evaluation  ....................................................................................................................................  45  

4.3  Evaluation  Plan   46  

4.3.1  Objectives  of  Evaluation  Plan  .........................................................................................................  46  

4.3.2  Outcomes  ..................................................................................................................................................  46  

4.3.2.1  Patient  Outcomes  ..............................................................................................................................  46  

4.3.2.2  Healthcare  Provider  Outcomes  ...................................................................................................  48  

4.3.2.3  System  Outcomes  ..............................................................................................................................  48  

4.3.3  Nature  and  Number  of  Clients  to  be  involved  ..........................................................................  49  

4.3.4  Timing  and  Frequency  of  Data  Collection  .................................................................................  50  

4.3.5  Data  Analysis  ..........................................................................................................................................  51  

4.3.6  Basis  for  Recommendation  of  Nurse-­‐led  Education  Program  to  Eczematous    

Pediatric  Patients  ............................................................................................................................................  52  

References………………………………………………………………………………………………………………  55  

Appendices.....……………………………………………………………………………………………….…………  57  

 

iv    

List  of  appendices  

Appendix  1a:  Systemic  Search  Strategies  &  Results   57  

Appendix1b:  PRISMA  Flowhchart                                                                                         58  

Appendix  2:  Table  of  Evidence   59  

Appendix  3:  Quality  Assessment  of  Selected  Studies   65  

Appendix  4:     Estimated  Set-­‐Up  Cost  of  the  Parental  Education  Program  of    

Management  of  Eczema  (1st  –  2nd  Year)   75  

Appendix  5  :  Estimated  Operation  Cost  of  the  Parental  Education  Program  of  

Management  of  Eczema  (3rd  year  onward)   76  

Appendix  6:     Evidence-­‐based  Guideline  of  Parental  Education  Program  for    

Eczematous  Children   77  

Appendix  7:     Level  of  Evidence  Developed  by  the  SIGN   86  

Appendix  8:     Grading  of  Recommendations  Developed  by  the  SIGN   87  

Appendix  9:     Recommendation  Synthesis  Process   88  

Appendix  10:     Gantt  Chart  of  The  Education  Program  for  The  Eczematous  Pediatric  

Patients   90  

Appendix  11:     Scoring  of  Atopic  Dermatitis  Assessment  Form   91  

Appendix  12:     Evaluation  Questionnaire  of  the  Education  Program  for  Pediatric  

Eczematous  Patients   92  

Appendix  13:     Evaluation  Questionnaire  for  the  Nursing  and  Medical  Staff  of  Pediatric  

and  Adolescent  Medicine  Department   93  

 

  1  

Chapter 1

Introduction

1.1 Background

Atopic Dermatitis is also known as atopic eczema. It is an itchy inflammatory

chronically relapsing skin disease (Williams 2005). Such skin disorder can be acute

with symptoms such as redness, oozing and vesicles. It can also be chronic with skin

thickening or skin pigmentation.

Atopic eczema is one of the most common inflammatory skin diseases in

childhood, affecting a huge number of children worldwide (Asher 2006). Indeed, the

prevalence of atopic eczema has increased by two to three-fold over 30 years (Schram,

2010). Based on the International Study of Asthma and Allergies in Childhood

questionnaire, the three most frequently reported allergic conditions or symptoms in

children aged 14 and below were allergic rhinitis (24.5%), sneezing, a runny or

blocked nose without a cold or flu (14.5%) and eczema (12.4%). The Child Health

Survey conducted by the Surveillance and Epidemiology Branch Centre for Health

Protection of the Department of Health in Hong Kong reported that eczema (25%)

was among the five most frequently reported conditions in children aged 14 or below.

 

  2  

In Hong Kong, eczema is one of the most common chronic diseases in children.

Deficient knowledge of disease management and the lack of confidence may

lead to suboptimal management of atopic eczema. In atopic eczema management,

nurses play a vital role in disease management because they can provide

comprehensive education to the parents of the children with atopic eczema. By

providing education with knowledge of disease management, nurses can play a

prophylactic role in preventing the exacerbation of atopic eczema, resulting in a

decrease in both the admission rate at pediatric ward and the follow up frequency in

hospital due to eczema.

1.2 Affirming needs

I considered a pediatric ward setting in the public hospital of the Hong Kong

Hospital Authority, where pediatric patients suffering from eczema with acute skin

inflammation were admitted. About 5% of pediatric patients were admitted with

eczema as current diagnosis at my pediatric ward. 30% of children admitted with

asthma also had past medical history of eczema. Eczema was one of the common

chief complaints of children admitted in my pediatric ward. During the hospital stay

 

  3  

in pediatric ward unit, nurses were only allowed to spend very little time on eczema

patients. In local setting, one single nurse had to take care of a team of around 8

patients in one shift. Usually there were 5 or more patients admitted for acute

diagnosis in one team and eczema was considered as less acute diagnosis. Therefore,

nurses spent more time on the urgent treatments for the other patients with acute

diseases in one shift. Thus, less time can be spent on eczematous children and nurses

can only contact the eczematous children’s parents during medication prescription. It

was just around a few minutes and nurses instructed them how to apply the topical

medication on the skin surface. Therefore, when the patient’s skin condition

recovered, they would be discharged without receiving any education on disease

management. Thus, these eczematous children would be frequently re-admitted after a

few months. Almost 30% of the children repeated admissions for the second time or

more for eczema.

For the children with eczema who have regular follow up after discharge from

public setting, their waiting time takes more than a few months. The regular medical

follow up time would be around 10 minutes. Physicians mainly focus on assessment

 

  4  

and prescription of medication. Therefore parents and their children with atopic

dermatitis have to manage the disease by themselves with little knowledge of eczema.

Consequently, some of the patients were found to have poor control and compliance

from time to time. Many of them needed to be re-admitted at the pediatric ward for

managing the inflamed poor skin condition. Therefore, a nurse-led parental education

program is needed which can allow more time for nurses to educate patients with

better disease management and control.

Education interventions aim at targeting the children and their caregivers. They

are designed to teach the techniques which are related to prevention and management.

Strategies include instructional lectures, role-playing, printed pamphlets and personal

experience sharing, etc. Education interventions focus on the process how the

caregiver acquires new knowledge and gets better preparation in understanding the

children’s medical’s condition, therefore effective disease management can be

provided. The objective of education programs is to motivate patients and primary

care-givers in solving the problems associated with chronic disease. Meta-analysis of

results has highlighted the need for standardized method so the improvement in

 

  5  

self-management of chronic disease can be more precisely assessed (Warsi , 2004 ).

Management of atopic dermatitis should involve symptoms relief treatment,

maintenance of skin integrity, prevention of secondary infection and enhancement of

the quality of life (Ayliffe, 2009). Identifying the predisposing factors, appropriate

skin care and adoption of correct treatments are crucial for desirable outcomes

(Ayliffe, 2009).

The cause of atopic eczema is not clear. It is likely to be environmental factors

and genetic factors. Nevertheless, parents with good compliance can lead to a better

control of the disease management (McHenry, Williams, & Bingham, 1995).

Inadequate knowledge and poor compliance are the main reasons for poor disease

management. Patient education, adequate time for explanation and discussion, and

demonstration of treatments are important for successful management of atopic

eczema (Mc Henry et al., 1995). However, in local context it cannot be met by only

the medical follow-up due to time restraint. Some studies have shown that the benefit

of nurse-intervention is that clinical outcomes can be improved by giving patient

specific education about the etiology and management of eczema (Cork et al., 2005).

 

  6  

The nurse-led parental education program in atopic eczema management by

giving specific education on etiology and management is in great demand because of

its potential capability to reduce the admission rate and follow up frequency due to

eczema, and hence a better clinical outcome is expected. Since new evidence emerged

after the systematic review had been done. Hence, there is a need for gathering new

evidence for an updated evaluation.

 

  7  

1.3 Dissertation Objectives

This dissertation aims

1.To systematically evaluate the evidence of the effectiveness of parental education

program in atopic dermatitis management for children.

2. To develop clinical guidelines of the parental education program for the

management of atopic dermatitis in local hospitals.

3. To assess the feasibility and implementation potential of the parental education

program for children with atopic dermatitis.

4. To develop evaluation plans to evaluate the parental education program.

The primary care of atopic eczema focuses on the provision of an education

program for the caregivers in disease management. With better control of disease

management, the severity of eczema can be reduced and the affected parents and

children can have a better quality of life. It can also serve as a prophylactic,

cost-effective measure to reduce the admission rate and follow-up frequency due to

 

  8  

eczema, so that the workload of healthcare providers in pediatric department can be

relieved.

 

  9  

Chapter 2

Critical Appraisal

2.1 Search and appraisal strategies

2.1.1 Identification of Study

Three groups of keywords were used in the search. The first group consisted of

“educational” or “educating” or “education”. The second group consisted of “ atopic

dermatitis” or “eczema”. The third group consisted of “child” or “childhood” or

“children” or “paediatric” or “pediatric”. The above keywords were used in the

search through the electronic resources at The University of Hong Kong Library. A

comprehensive literature search was performed from 17 August 2014 to 13 September

2014 in four databases via The University of Hong Kong Library electronic search

engine to identify studies; which were relevant.

The four databases were:

1. British Nursing Index

2. PubMed

3. CINHAL

4. PsyInfo

 

  10  

Details of the search terms and results are shown in Appendix1a. Titles and

abstracts of the resulting citations were first screened according to the selection

criteria. Potential studies were retrieved and the full papers were screened to confirm

their eligibility. In addition, a manual search of reference lists from those five selected

eligible studies was performed to avoid missing any relevant studies. The process is

shown in the PRIMSA flowchart in Appendix 1b.

2.1.2 Criteria for selecting studies for review

Inclusion criteria

1. Randomized controlled trials;

2. Studies involving 0 to 18 years old children with eczema and their parents

3. Studies that evaluated a parental education program for the management of

eczema

4. Studies that included the following outcome measure:

-­‐ Severity of eczema in Scoring of Atopic Dermatitis (SCORAD) Index

 

  11  

Exclusion criteria

1. Single nurse consultation session

2. Assessment of a web-based program

3. Only medical decision

4. Ongoing studies

2.1.3 Data Extraction

All eligible studies were carefully read and the data were extracted. The details

extracted were presented in terms of study type, level of evidence, subject

characteristics, sample size, interventions, control, outcome measures, length of

follow up and effect size. They are formulated in the table of evidence as shown in

Appendix 2.

2.1.4 Appraisal strategy

Quality assessment was done with reference to the methodology checklist for RCTs

from the Scottish Intercollegiate Guidelines Network (SIGN) (2012 version2.0). The

 

  12  

checklists for critical appraisal of the five reviewed studies were performed as shown

in Appendix 3. The internal validity of the studies was evaluated according to the ten

aspects of the design as shown in the following:

-­‐ Appropriate and clearly focused question

-­‐ Randomization

-­‐ Concealment method

-­‐ Blinding

-­‐ Similarities of participants

-­‐ Treatment under investigation

-­‐ Standard validity and reliability of all outcomes

-­‐ Dropout rate

-­‐ Intention to treat analysis

-­‐ Comparability of the results at different sites

Each component was rated as Yes, No, or Can’t Say. The details of rating the overall

methodological quality of the study is also shown in the checklist. They were graded

as High Quality (++),Acceptable (+) and Low quality (0).

 

  13  

2.2 Results

2.2.1 Search Results

A systematic search was done from 15th August 2014 to 13th September 2014 in

four databases via the electronic resources search engine at Hong Kong University

Library to find all relevant studies regardless of language. A total of 907 citations

were retrieved. After screening the titles, 30 citations were found potentially relevant.

By screening the abstracts, 6 results were relevant and 1 was written in German. The

English version of the study written in German was not found. So, the citation written

in German cannot be included in the systematic review. Finally, five eligible studies

were identified in which the population, interventions and outcomes corresponded to

my study. After reading the reference lists of all five selected studies, no additional

relevant citation can be extracted for systematic review.

2.2.2 Characteristics of the Studies

2.2.2.1 Study Types

 

  14  

All of the selected studies were RCTs. All the participants were randomly assigned

to different groups.

2.2.2.2 Sample Characteristics

In the five selected studies, all participants involved were under the age of 18. The

number of participants recruited varied from one another. Two of the studies

(Futamura et al., 2013, Grillo et al., 2006) recruited around 60, while Moore et al.,

2009 and Staab et al., 2002 recruited around 200 participants. One of the studies

(Staab et al., 2006) recruited 1010 participants.

Four of the selected studies (Futamura et al., 2013, Grillo et al., 2006, Moore et al.,

2009, and Staab et al., 2002) designed an education program for eczematous children

of all ages, while another study (Staab, et al., 2006) divided 1010 participants into

three groups according to their age i.e. 3 months to 7 years old, 8 to 12 years old, 13

to18 years old. The baseline mean total SCORAD index of each selected study was

around 40 to 50.

2.2.2.3 Interventions

 

  15  

The interventions in Futamura et al., 2013, Grillo et al., 2006, Staab et al., 2002 and

Staab et al., 2006 involved lectures of eczema etiology and disease management,

practical sessions and group experience sharing. In Moore et al., 2009, it involved a

90 minutes nurse-led workshop including education session and an individualized

management plan written according to the eczema clinical practice guidelines but no

group experience sharing.

The duration of each study design varied from 2 to 120 hours. In Staab et al., 2006,

the intervention was three separate education sessions according to the age group, and

the content was specially tailored to their needs. In four of the studies (Futamura et al.,

2013, Grillo et al., 2006, Staab et al., 2002 and Staab et al., 2006), the control groups

received no education while the control group of Moore, et al., 2009 took part in a

dermatologist- led workshop spending an average of 40 minutes with the doctor.

2.2.2.4 Length of follow-up

The length of follow-up among the five selected studies ranged from 3 months to

12 months.

 

  16  

2.2.2.5 Outcome measures

All of the selected studies used SCORAD index as one of the measurement tools

for the severity of eczema. For the effect size, four out of five selected studies showed

there was a significant difference in the SCORAD indices between the intervention

and control groups. The mean difference ranged from -4 to -19.93.

2.2.3 Quality assessment of Studies

In general, all selected studies addressed an appropriate and clearly focused

question. Randomization reduces confounding by equalizing independent variables

that have not been accounted for in the experimental design. Blinding is necessary for

minimizing bias from a subjective assessment of outcome measures. Effective

strategies of randomization and blinding are vital for assessing the quality of an RCT

(Pilot & Beck, 2008). Allocation concealment ensures researchers and subjects do not

know the target grouping before the subjects enter the study in order to minimize the

risk of allocation bias.

 

  17  

Four of the studies (Futamura et al., 2013, Grillo et al., 2006, Moore et al., 2009

and Staab et al., 2006) mentioned the details of randomization method. While one of

them (Staab et al., 2002) did not report the method of randomization.

Two of the studies (Grillo et al., 2006, Staab et al., 2002) did not state the

concealment method. For blinding, all participants in the five selected studies cannot

be blinded as they noticed that they were receiving education and it was also

impossible for the trainers to be blinded in all studies. The assessors responsible for

scoring the atopic dermatitis scale in three of the studies (Futumura et al., 2013, Grillo

et al., 2006, Staab, et al., 2006) were blinded, as they were not actively involved as

trainers.

The similarities and differences between the intervention and control groups

were well covered in all selected studies, four of them (Futamura et al., 2013, Moore

et al., 2009, Staab et al., 2002 and Staab et al., 2006) showed that there was no

significant difference between the treatment and control groups as they were similar

at the start of the trial. One of the studies (Grillo et al., 2006) did not mention the

differences of demographic data between the intervention and control groups. In

 

  18  

addition, the only difference between the two groups was the treatment under

investigation in all studies.

All relevant outcomes were measured in a standard, valid and reliable way among

all selected studies.

RCTs studies were conducted over a period of time prospectively. A dropout rate

of 20% or less is considered as acceptable but it also depends on the study duration

(Polit et al., 2008). Among all five selected studies, one of them (Staab et al., 2002)

showed 72 out of 93 participants (77%) in intervention group were followed up while

73 out of 111 participants (66%) in control group were followed up. The dropout rate

in the study (Staab et al., 2002) was more than 20%. The reason for the dropout

participants was not mentioned in the study. All of the other four selected studies

showed a dropout rate of less than 20%. They are therefore considered acceptable.

In Grillo et al., 2006, the method of intention-to-treat analysis was implemented.

All other four selected studies did not mention the use of intention-to-treat analysis.

Two of the studies (Moore et al., 2009 and Staab et al., 2006) were carried out at more

than one site. In Moore et al., 2009, results were not comparable as participants

 

  19  

received different interventions with nurse-led workshop and dermatologist-led

workshop. In Staab et al., 2006, the results were comparable, as all trainers from

multi-disciplinary team had undergone the same 40-hour training program to qualify

as trainers.

In general, among five selected studies, four of them including Futamura et al.,

2013, Moore et al., 2009 and Grillo et al., 2006 and Staab et al., 2006 reported

randomization, method of blinding and concealment process in details. With low risk

of bias in reporting outcome measures, the internal validity can be ensured and

evidence of high quality can be provided.

Four (Futamura et al., 2013, Grillo et al., 2006, Moore et al., 2009, Staab et al.,

2006) out of five selected studies, which measured severity of eczema in terms of

SCORAD index, showed a significant difference between intervention and control

groups. For overall quality assessment, the methodological evidence of Futamura et

al., 2013, Moore et al., 2009, Staab et al., 2006 was rated as high quality.

2.3 Summary and Synthesis of Data

2.3.1 Summary

 

  20  

All of the five selected studies applied parental education program in children with

eczema. The Severity Scoring of Atopic Dermatitis (SCORAD) ranged from 0 to 103

was used to measure the severity of eczema including both the subjective and

objective scores. Total score of SCORAD includes several components: the subjective

score is comprised of the extent of affected sites by calculating the rule of 9 with a

maximum score of 20 and the intensity with a maximum score of 63 while the

maximum objective score is 20. The Overall effect of the parental education to reduce

severity of atopic dermatitis among four (Futamura et al., 2013, Grillo et al., 2006,

Moore et al., 2009, Staab et al., 2006) out of five studies were statistically significant.

It provides adequate evidence that parental education program is effective.

Among all studies, four of them (Futamura et al., 2013, Grillo et al., 2006,

Moore et al., 2009, Staab et al., 2002) provided participants of all ages with one

education program, while one (Staab et al., 2006) of the studies divided the

participants in three different age groups. The study (Staab et al., 2006) provided

three education programs that were tailored to their needs.

 

  21  

Regarding the intervention components in all five studies, four of them (Futamura

et al., 2013, Grillo et al., 2006, Staab et al., 2002, Staabl et al., 2006) comprised of

lectures on basic information about eczema and practical sessions. All studies except

Moore et al., 2009 involved sharing sessions. Moore et al., 2009 offered a single

nurse-led consultation session.

For the length of follow-up, it should be adjusted to 3 months and six months.

Among all selected studies, only one study (Staab et al., 2002) showed a dropout rate

of more than 20% as the participants in the study were followed a year after while the

control group received no intervention before the one-year follow-up.

The quality of methodological evidence is high enough to support the

effectiveness of nurse-led parental education program in reducing the severity of

eczema.

2.3.2 Synthesis of data

The target group can be children aged from 0 to 18 years old and it is not

necessary to divide them into three different groups. The SCORAD index did not

show a big difference between age specific and non-age specific education program.

 

  22  

Therefore, in order to increase the cost-effectiveness, the education program will not

be designed for different age groups. Since it is a parental program, the main target

audience of the education program is the parents instead of the eczematous children.

It is expensive to run a single nurse consultation workshop currently in a pediatric

ward setting in the public sector. The parental education program should allow

parents to share their own experience and practice the treatment prescribed by

physicians in eczema management. Its cost effectiveness is higher than that of the

nurse consultation session due to the limited resource in my unit. Due to limited

manpower and heavy workload in my unit, it does not allow nurses to provide

sufficient time for face-to-face interview with each patient. Due to limited authority of

nurses in Hong Kong, nurses are not allowed to prescribe medication for patients or to

make any referral. So, providing a nurse-led education on knowledge about eczema

management together with a practical session and a group sharing session with all

parents of eczematous children on personal disease management experience is a trial

in moving forward on education in eczema.

 

  23  

Motivation and intention to change are essential factors in educational interventions,

and it is well known that intention to change does not certainly lead to behavioral

change (Webb 2006). Therefore, a plan including follow-ups is important and the

length of follow-up needs to be fixed wisely. Both the intervention and control group

should have the follow-up within a suitable period. In between the follow-ups,

participants should receive neither education nor conventional treatment.

Scoring of Atopic Dermatitis (SCORAD) index should be chosen as the

measurement tool for the outcome measure.

In local context, the credibility of a nurse-led workshop is less sufficient than a

dermatologist-led one. Nurses are not allowed to prescribe medicine or make referral

to patients. Regarding the social acceptance in Hong Kong, patients usually prefer

treatments prescribed by physicians rather than nurses. According to the workshops

provided by nurses in the study of Moore et al., 2009, nurses were competent to do so.

The result in the study showed that the participants who attended the nurse-led

workshop ended up with lower severity of eczema than the control group who

attended dermatologist-led workshop. Therefore, it has been proven that the program

 

  24  

can be solely run by nurses.

A nurse-led parental education program for atopic dermatitis is suggested to be

held in the activity room in the Specialty Out-patient Department monthly. It will take

a further forward step in disease management education program of atopic eczema.

An evidence-based guideline is needed in order to ensure the quality of evidence

based parental education program for the children with eczema.

 

25  

Chapter 3

Translation and Application

3.1 Implementation Potential

3.1.1Target Setting

The proposed education will be implemented in an outpatient setting instead of

an in-patient one because of inadequate space and time. The proposed parental

education program will include a lecture session and a practical session. The proposed

program can be held in an activity room at the specialty outpatient clinic. The

proposer as the program leader and four Registered Nurses who are qualified for the

pediatric specialty training will be responsible for the proposed program.

3.1.2 Target audience

From my observation, around 5% of patients admitted for eczema as chief

complaint at Pediatric and Adolescent Medicine (PAM) wards. The target audience

will be aged from 0 to 18 years old, with history of eczema referred by doctors or

nurses in the PAM wards and outpatient department.

3.2 Transferability of the Findings

3.2.1 Comparison of Setting and Audience

 

26  

All education programs in the reviewed studies were conducted on outpatient

basis. The target setting of the proposed program is at a specialty outpatient clinic.

Since the education programs in the reviewed studies were conducted in an outpatient

clinic, thus it can be adjusted to fit into the proposed site.

The characteristics of the target audience match greatly with most of the

reviewed studies. They were aged between 0 to 18 years old and were diagnosed with

eczema in the last admission or with a history of eczema.

The participants in the reviewed studies were predominantly Europeans and one

of the reviewed studies targeted at the Japanese patients. As the results obtained from

this study also achieved significantly positive outcomes, therefore cultural difference

may not be one of the main concerns.

In the reviewed studies, some of the eczema workshops were carried out by

pediatricians, psychologists, dietitians and nurses. The eczema workshops in two of

the selected studies were carried out solely by nurses. And these two studies also

obtained significantly positive outcomes. It proves that nurses are capable of

providing eczema education to parents with eczematous children. Therefore, the

 

27  

proposed program can be solely run by nurses.

3.2.2 Philosophy of Care

The philosophy of care in the reviewed studies and the proposed program share

the same objective as they were all devoted to help parents with eczematous children

to reduce the severity and improve their quality of life. Skin condition will be

promoted by educating knowledge of eczema, and a lower symptom score will be

achieved by learning the dermatological management through practical session so as

to promote a better quality of life.

3.2.3Number of clients benefit from the Innovation

At the Pediatric and Adolescent Medicine wards, a total of 300 patients were

admitted and around 5% i.e. 15 of these patients were diagnosed with chief complaint

of eczema monthly. These patients would be referred to outpatient clinic for attending

the nurse-led proposed program. The number of clients who could benefit from this

proposed program should be sufficiently large.

3.2.4 Time for Implementation and Evaluation

 

28  

We will conduct a pilot program to estimate and draft the schedule for

implementation and evaluation. In the preparation phase, it will take 4 months for

designing and planning the program structure, briefing and training the nurses,

printing the reading materials, venue arrangement and the promotion of the eligibility

criteria of referring the patients to the proposed program through internal e-mail and

circulars to doctors and nurses within the department. It will take two months for

seeking approval, four moths for preparation and three months for pilot study. In total,

it will take 9 months for the entire pilot study. Evaluation will be made after that. The

actual implementation will also be carried out for another six months, and it will take

around nine months for the evaluation of the program. In total, it is estimated that the

implementation of the proposed program will take 2 years.

3.3 Feasibility

3.3.1 Freedom on implementation

In the Pediatric department, nurses can have the freedom to introduce an

innovation only if it shows significantly positive outcome on an evidence-based basis.

The proposed program can be implemented after the approval from the administrative

 

29  

level. Nurses in the pediatric specialty outpatient department are encouraged to take

part in the proposed program. Clients have the right to terminate the program when

they think it is undesirable and can give precious feedback for the proposed program

to make particular improvement.

Patient education on eczema is one of the major issues in the pediatric outpatient

clinic. Based on my observation in the local clinical setting, an increasing number of

children are diagnosed as eczema with mild to high severity and about 70% of the

parents with eczematous children do not understand the eczema management plan to

reduce its severity. For this particular group of parents, they have to understand the

importance of the proposed program that can offer them with an evidence-based

management plan.

3.3.2 Interference of Staff Functions

The proposed program will not interfere with the staff functions. Nurses who are

assigned to hold the program will be arranged to receive a training program of 3

two-hour sessions. It is planned to set up in 2016. The training session will be held in

the afternoon when nurses are originally assigned to hold appointments with clients.

 

30  

They will be free from the clients’ appointments. The time-slot available for the

clients to meet nurses will be reduced on those three training days and the preparation

meetings during the preparation phase. No extra working hours are needed. There will

be 4 months of time for staff to prepare all the materials and receive training before

the pilot program. Sufficient manpower will be available for providing the service.

The estimated number of participants served annually will be around 150. It will

take a maximum of 15 hours a week for a nurse to spend on the proposed program

during implementation phase. Over half of the eczematous patients will be

re-admitted due to eczema as chief diagnosis. It will take more working time on the

hospitalized patient care than that on the eczema education. It takes around 2 days of

hospital stay and at least an hour of education to one single patient with limited

knowledge on applying the treatment only during one shift. It takes around 64 hours

for around 4 patients admitted weekly, which is far more than the 15 hours spent on

the proposed program per week.

3.3.3 Administrative Support

Support from the department head and the hospital is needed to put the proposed

 

31  

program into practice. The Chief of Service (COS) and Department Operation

Manager (DOM) encourage the implementation of the evidence-based innovations.

The hospital is conducive to research utilization in obtaining better care outcomes.

The evidence-based protocol of distraction therapy during venipuncture has been

successfully established in the pediatric department.

3.3.4 Consensus among the Staff and Administrators

Both nursing staff and administrators understand the importance of providing

education to parents on different issues so as to provide better patient outcomes. And

both of them have consensus that eczema is a growing and common problem that

many children are suffering from this disease. The affected group will benefit from

the proposed program and the program can reduce the workload of staff ultimately.

The major pockets of resistance are the motivation of the parents of the eczematous

children to attend the nurse-led workshop and the dropout rate due to the control

group that receive no education. The results of evaluation will be unreliable if the

dropout rate is high. In order to reduce the dropout rate in the proposed program, the

length of follow-up cannot be too long. Therefore, the importance of the program

 

32  

information should be emphasized before referring patients to the program. We

should also keep contact with those who are absent from the program. A primary

nurse should be assigned for each individual for follow-up.

3.3.5 Risk of Friction

The implementation of the proposed program may include some potential risks

for the clients. Medical officers and psychiatrist can also be invited to be the

supporters who are available for medical assessments and psychological

consultations.

3.3.6 Skills of Adopting the Innovation

Experienced nurses who are involved in the proposed program are capable of

performing the physical assessment and education, as they are all qualified from

specialty training in the pediatric department. All nurses involved in the proposed

program are qualified to provide comprehensive education on the management of

eczema. No extra special skills are needed to be trained. By receiving the training

workshop, they will be capable of holding the program smoothly and effectively with

enhanced knowledge and communication skills.

 

33  

3.3.7 Equipment and Facilities

The venue will be the activity room in the outpatient clinic. The education

pamphlets, notes and PowerPoint slides will be printed for distribution. Some

souvenirs, food and drinks are needed to be prepared as the incentives to attend the

workshop.

3.3.8 Staff Training

Nurses who are going to hold the program have already understood and learnt

about the epidemiology and management of eczema in their specialty training in the

pediatric department. Three two-hour briefing sessions during their duties will be held

for learning more about the proposed program structure and enhancing

communication skills. Some regular evaluation sessions will be held at a 3-month

interval for evaluating the proposed program.

3.3.9 Measuring tool for evaluation

Scoring System of Atopic Dermatitis (SCORAD) is used to measure the severity

of eczema. There are some existing printed forms in the ward. The score can be

 

34  

calculated by the in-charge nurse.

3.4 Cost-benefit Ratio of the Innovation

3.4.1 Potential Risks

There is no potential risk in this proposed program. All selected studies did not

show negative outcome in the severity of eczema or skills of management.

3.4.2 Potential Benefits

At the client’s level, the proposed program will provide an opportunity to

increase the affected parents’ ability and confidence to improve and maintain their

children’s health, increase physical and psychological well-being, improve quality of

life, increase the compliance and reduce the severity of eczema.

At the staff’s level, the nurses can make decisions from the best education regime

by an evidence-based guideline so as to reduce the inconsistency of eczema

management, gain appreciation from clients so as to increase job satisfaction. The

re-admission rate and follow-up frequency due to eczema can be reduced, thus the

workload of staff will also decrease.

At the organization’s level, it will reduce the healthcare cost on eczematous

 

35  

clients, have better utilization of resources, raise the reputation for client’s

relationship, and create an image of showing respect and encouragement to

implement evidence-based practice to provide the most updated care. It also shows

that the hospital is always striving for the best quality of patient outcomes.

3.4.3 Risks of Maintaining Current Practice

If the current practice is maintained, the parents of eczematous children cannot

obtain much knowledge on eczema and the misconception of prescriptions from

pediatricians cannot be clarified. If the proposed program is not implemented, the

re-admission rate of eczema and the follow-up frequency will remain high, and clients

will keep relapsing in a scratching cycle and the severity can never be improved.

3.4.4Material Cost of Implementing the Innovation

Set-up cost

The budget will be spent mainly on the wages of nurses who are conducting the

proposed program, which is HKD 234 per hour. The annual personnel expenses will

cover the meeting, staff training, program design, operation and evaluation. The direct

cost of the proposed program includes the printed materials e.g. the PowerPoint notes,

 

36  

assessment forms and questionnaires. The total set up cost of the proposed program

would be HKD 273,140 as shown in Appendix 4.

Operational Cost

The majority of operational cost is still the personnel expenses. The personnel

expenses are based on the number of hours of staff spent on running the proposed

program, follow-up sessions with clients and regular evaluation meetings. It is

estimated that from the third year onwards, the cost of the proposed program would

be HKD 143,400 per year as shown in Appendix 5.

3.4.5 Material Cost for not implementing the Innovation

The estimated acute health care cost for patients with eczema admitted to

hospital will be HKD4580 per day and the estimated follow-up cost for one patient

would be HKD 1000 per visit. It is estimated that the medical cost spent on pediatric

eczema will be HKD 927,000 annually. Thus, the material cost for not implementing

the innovation will be the cost spent on repeated admissions and follow-ups, and the

workload of the frontline staff will also increase.

3.4.6 Potential Non-material Cost of implementing the Innovation

 

37  

Staff may have increased stress of adapting the changes when conducting the

proposed program. Staff morale may alter. Nurses may have to put extra effort in

preparing the assessment and evaluation forms, education materials, monitoring the

clients’ progress and evaluation meetings.

3.4.7 Potential Non-material Benefits of Implementing the Innovation

The non-material benefits of implementing the innovation include improved staff

morale due to reduced workload, appreciations from clients by building up a rapport

between nurses and clients, higher quality of life for both the children and parents.

Ultimately it may also increase job satisfaction of nurses and reduce the turnover rate.

3.5 Evidence-based Guideline

An evidence-based guideline was developed for the proposed program to reduce

the severity of eczema in children and is presented in Appendix 6. The evidence

levels of the selected studies were based on Scottish Intercollegiate Guideline

Network (SIGN) as shown in Appendix 7. The recommendations were extracted from

the five selected studies, two (Moore et al., 2009; Stabb et al., 2006) were graded as

1++, and the other three (Futumura et al.,2013; Grillo et al., 2006; Stabb et al., 2002)

 

38  

were graded as 1+. For the grading of the proposed recommendations, they were

determined by the evidence level of each identified studies. These recommendations

were then graded according to Grades of Recommendation (SIGN, 2012a) as shown

in Appendix 8. Tables illustrating the recommendation synthesis process are shown in

Appendix 9.    

 

39  

Chapter 4

Implementation Plan

4.1 Communication Plan

4.1.1 Identification of Stakeholders

The stakeholders are the people who may be affected by the proposed program.

In the education program for the eczematous children, stakeholders at the

administrative level are COS, GMN, DOM and the ward managers of wards and

Specialty Out-patient Department (SOPD) who are responsible for allocating

resources and managing manpower for the proposed program. At the frontline level in

Pediatric and Adolescent Medicine wards and outpatient clinic, 30 Medical Officers,

18 Advanced Practice Nurses and 80 Registered Nurses are responsible for providing

health assessments and referring clients. Nurses at Specialty Outpatient Department

are responsible for conducting the education program. The parents of the eczematous

patients aged from 0 to 18 who are admitted to the wards are also part of the key

stakeholders.

4.1.2 Initiation stage

In order to gain support from the administrative level, the proposer of the

 

40  

program will arrange a 1-hour meeting with the ward managers of in-ward and SOPD.

In the meeting, the proposer will report the prevalence of eczema in children, the

effectiveness of the parental education program supported by research evidence and

the protocol of the proposed program that can be held at the Specialty Out-patient

Department. By holding the meeting with a comprehensive written proposal, it helps

to raise the concern of high re-admission rate and frequent follow-ups so that the

managers will understand the needs for change. After getting the agreement from the

ward managers, a formal presentation will be arranged in a monthly departmental

meeting with the DOM. The affirming needs of a nurse-led parental education

program to pediatric eczematous patients will be disseminated in the meeting. The

new proposed program guideline with its transferability and feasibility will also be

presented and written in the proposal. To ease their concern on the impacts that

brought by the proposed program, the cost-benefit ratio will be shown clearly that

benefits from the program can outweigh the costs of implementation. The proposed

program can also alleviate the burden of the workload of the frontline staff. The

initiation stage will take one month.

 

41  

4.1.3 Facilitation Stage

In order to gain a better understanding of the proposed program, a meeting will

be arranged for the frontline staff to understand the needs for change and what are

needed to be accomplished. Five nurses will be selected into the program team. To

avoid interference with routine clinic operations, program team members will be free

from the routine work for the meeting time. The facilitation stage will last for one

month. Full-text articles about the education program will be sent to all frontline staff

in the Pediatric Department via e-mail. Posters including the outline of the program

will be posted in the clinic and the pediatric wards. They can help to raise the staff’s

awareness of the program and can help to encourage them to refer eligible clients.

Posters will also be posted in the eye-catching areas in the Pediatric and Adolescent

Medicine wards so as to draw the attention and raise the parents’ interest to the

program. The communication period will last for one month according to the Gantt

chart in Appendix 10. It will also be used to illustrate the time frame of the program

schedule.

4.1.4 Communication Strategies to Sustain Change Process

 

42  

In order to sustain the change process, nurses’ compliance with the guideline of

the proposed program will be assessed. Monthly on-site audits will be done by the

proposer and the SOPD ward manager. The review reports and the reminders will be

sent to the involved program team members monthly. The records of progress will be

kept and reviewed annually. The SOPD ward manager and the proposer should

maintain a two-way communication with the frontline staff. They have to discuss the

difficulties encountered by the frontline staff in implementing the program and collect

the feedbacks during the monthly review. Amendments should be made to the new

guidelines if necessary according to the opinions collected. Nurses should also keep

monitoring the progress of patient outcomes and share the successful cases of

eczematous children with reduced SCORAD index to encourage their colleagues and

keep the staff morale.

4.2 Pilot Study Plan

4.2.1 Objectives of Pilot Study Plan

A pilot study plan will be conducted prior to the full-scale program evaluation. It

can help to determine the feasibility of the proposed program and can avoid the

 

43  

unexpected difficulties. It can also help to evaluate the proposed program and can

solve the possible problems before its implementation. Training workshops for the

staff and the preparation of materials for presentation will take 4 months. The actual

pilot study will take three months. Another five months will be spent on evaluation of

the pilot study and amendments will be made accordingly before its implementation.

In total, the pilot study plan takes one year before the actual implementation

commenced.

4.2.2 Preparation of the Pilot Study

It will take six months for the preparation of the pilot study. The work meetings

will be held monthly for the program team to plan and follow the progress. The

proposer will be selected as the program leader and communicate with team members

through email regarding the agenda of the meeting. The program team members will

have to attend three two-hour training workshops. The topic of the first session will

mainly focus on epidemiology of eczema. It will also teach the method of topical

application and stress management. The second session will introduce the

evidence-based guideline to standardize the teaching in the proposed program and the

 

44  

use of Scoring Atopic Dermatitis (SCORAD) Index. The use of SCORAD system will

be demonstrated and discussed so that it can help to standardize the scoring of each

program team member. The third session will focus on presentation skills and

consultation skills. The atmosphere of holding an education program is very

important and directly affects the outcome measures. After the training, all the

program team members will be capable of providing evidence-based education and

effective communication. During the promotion period, a 1-hour session to nurses and

medical staff will be held for introducing the proposed program. It will also highlight

the inclusion criteria of eligible participants and their roles in referring cases. A

hotline will be provided for them to contact the program leader for any enquiries.

4.2.3 Subject Recruitment Strategies

The recruitment of eligible subjects will mainly rely on the referrals from the

Pediatric and Adolescent Medicine wards and outpatient clinic. Under the pilot study,

it will recruit 10 eczematous pediatric patients who meet the inclusion criteria of the

proposed program. The nurses and medical officers in Pediatric and Adolescent

Department will also be responsible for accessing the readiness of the parents of the

 

45  

eligible subjects in joining the pilot study. Nurses and pediatricians will be allowed to

refer the eligible subjects to the pilot study with signed consents. The recruitment

period will last for one month before the pilot study.

4.2.4 Data Collection

The severity of eczema will be assessed by the SCORAD index as baseline data.

The demographic data and the treatments that doctors prescribed will also be

recorded.

4.2.5 Data Evaluation

After collecting the data, evaluation has to be done and the period will last for

five months. The program team will hold a debriefing session with the frontline staff.

All possible problems that may happen will be discussed in the debriefing meeting.

After reviewing all the problems, amendments may have to be made according to the

logistics, the program guidelines and the outcome measurements. The confidence

level of using the guideline to carry out the program is also needed to be discussed

during the evaluation period. A 15-minutes group meeting right after the program

with ten participants who have taken part in the pilot study will be held to get the

 

46  

feedbacks on the content, duration and practicability of the program. After collecting

comments from the frontline staff and participants, the guidelines will be discussed

and revised according to their comments.

4.3 Evaluation Plan

4.3.1 Objectives of Evaluation Plan

The aim of evaluation plan is to assess the effectiveness and the clinical benefits

of the proposed program.

4.3.2 Outcomes

4.3.2.1 Patient Outcomes

One of the clinical benefits of the education program is directly reflected by the

severity of eczema. It is determined by the SCORAD Index (Appendix 11) and

assessed by the program team members. The SCORAD index is determined on the

basis of several criteria concerning the extent, intensity as well as subjective signs.

For the extent criteria, the rule of nine is used. It is advised to draw lesion spread

directly on the evaluation sheet and then perform calculation. The marks of total area

 

47  

extent will be regarded as component A (0 to 100) in the formula of calculation. For

the intensity criteria, it will be graded according to the following aspect: erythema,

oedema or papulation, oozing or crust, excoriation, lichenification and dryness. Each

intensity item will be graded from 0 to 3 and the total marks will be regarded as

component B (0 to18) in the formula of calculation. For the subjective symptoms, it

will be measured in the following two aspects: pruritis and sleeplessness for the

average of last 3 days or nights. It will be graded by a 10 cm visual analog scale and

regarded as component C (0 to 20) in the formula of calculation. The total score will

be calculated by the following formula: A/5 + 7B/2 + C. The range of total SCORAD

Index is 0 to103. The severity of the total score that is less than 25 is regarded as mild,

25 to 50 is regarded as moderate, and higher than 50 is regarded as severe.

Another outcome would be patients’ satisfaction. Parents will have to fill a

questionnaire (Appendix 12). It is used to evaluate the patients’ satisfaction to the

program content and to gather the overall comment. There are five questions that

focus on knowledge and management skills of eczema and the program structure. The

last question will be an open-ended question for collecting any other comment.

 

48  

4.3.2.2 Healthcare Provider Outcomes

The comments collected by the involved staff are very important to the proposed

program. The involved staff members are the ones who can directly reflect the

effectiveness and staff morale after running the program. The comments about the

workload of nurses and pediatricians after running the program have to be collected.

There are five questions in the structured questionnaire (Appendix 13). Three of them

will be Yes / No questions. The fourth question is to assess the staff’s satisfaction to

the program. The last question will be an open-ended question for collecting any other

comment.

4.3.2.3 System Outcomes

System outcomes can help to measure the system effectiveness. The admission rate

of the pediatric ward, the attendance rate of pediatric outpatient clinic and the cost of

innovation are the system outcomes.

By receiving a comprehensive education on eczema, the severity can then be

reduced. The admission rate due to eczema and the follow-up frequency of the

eczematous patients should be lowered after attending the proposed program. The

 

49  

number of admissions and follow-ups will be collected and reviewed at baseline, 3

months, 6 months and 1 year.

For the cost of innovation, it should be compensated by the medical cost of the

admissions due to eczema at wards and the follow-up visits at specialty outpatient

clinic. The workload of the staff should be reduced by the program. The medical cost

for the admissions and follow-up visits will be calculated and should be reduced at 3

months, 6 months and 1 year. The cost of innovation will also be calculated at 3

months, 6 months and 1 year.

4.3.3 Nature and Number of Clients to be involved

The nature of the eligible participants should be based on the identified studies. The

inclusion criteria are as follow:

1. Aged between 0 – 18 years old

2. Diagnosed as eczema or with a history of eczema who are under the care of PAM

department

3. One of the parents is available to join the program

The exclusion criteria are:

 

50  

1. The eczematous patient is currently attending a study related to eczema

2. The parents and the patients cannot communicate well in Cantonese.

A convenient sampling method will be used to recruit participants. The sample size

will be determined by the Java Applets For Power and Sample Size. As the SCORAD

index will be analyzed by a paired t-test, with significant effect size of 5 and power as

80%, alpha as 0.05 and the standard deviation as 20, the total sample size of

participants needs to be more than 128. Based on the selected studies, the drop-out

rate in four of them were not more than 20%. If the dropout rate is taken into account,

it has to recruit at least 154 participants for the study.

4.3.4 Timing and Frequency of Data Collection

Before the recruitment period, an approval has to be obtained from the ethics

committee of the Hospital Authority. After getting the approval, nurses and

pediatricians in PAM Department will refer the eligible participants to the study. The

program team members will introduce the proposed program to the potential

participants. If they agree to join, written consents will be obtained before data

collection. Baseline information will then be collected before the program

 

51  

implementation. The 3-hour workshop will also be introduced. Participants will have

to fill a questionnaire about their satisfaction to the program before they leave the

workshop. Follow-ups will be arranged at 3 months, 6 months and 1 year by

interviews. The actual implementation period will last for 9 months. The patient

outcomes will also be assessed by the SCORAD index and patient’s satisfaction will

also be assessed at baseline, 3 months and 6 months and 1 year.

For the staff outcomes, the workload of nurses and pediatricians and all other

comments will be collected and reviewed at baseline, 6 months and one year.

For the system outcomes, the admission rate and the follow-up frequency of the

participants will be documented at baseline, 3months, 6 months and 1 year. The cost

of innovation will be calculated and recorded at baseline, 3 months, 6 months and 1

year for comparison.

4.3.5 Data Analysis

For the demographic data and the types of treatments received by the participants,

descriptive statistics will be used.

For the patient outcome, the severity of eczema will be assessed by the

 

52  

SCORAD index. The score ranges from 0 to 103 and will be assessed at baseline, 3

months, 6 months and 1 year. At each follow-up time, paired t-test will be used to

assess the severity of eczema. For the patient’s satisfaction to the program, it will be

evaluated by the questionnaire and the score of each question will be calculated. It

will use 95% confidence interval to determine the patient’s satisfaction level. For the

open-ended question, all comments will be collected, discussed and analyzed.

For the system outcomes, the admission rate of pediatric ward, the attendance

rate of pediatric outpatient clinic and the cost of innovation will be examined and

evaluated. The admission rate of pediatric ward and the attendance rate due to eczema

of each participant will be recorded within a year after the program implementation.

The differences at 3 months, 6 months and 1 year will also be calculated, compared

and paired t-test will be used for analysis. The cost of innovation will be calculated

and compared to the medical cost at baseline, 3 month, 6 month and 1 year.

4.3.6 Basis for Recommendation of Nurse-led Education Program to Eczematous

Pediatric Patients

The primary objective of the proposed program is to reduce the severity of eczema

 

53  

of pediatric patients. According to the reviewed studies, the changes in the score of

SCORAD index which showed significant difference ranged from -5.2 (Stabb et al.,

2006) to -19.93 (Grillo et al., 2006). The education program will be considered as

clinically effective with a change in SCORAD Index more than -5 at 6 months after

attending the proposed program. This estimation is based on the revised studies as

well as the experience of the proposer. By equipping themselves with better

knowledge and management skills after attending the program, parents of patients

will have better control in managing the disease and thus the severity can be reduced.

For the staff outcome, if over 60% of staff agree that the workload is reduced,

the program will then be considered as effective.

For the system outcomes, the main objective is to reduce the expenditure of the

hospital. There are about 70 admissions to ward and 1200 outpatient clinic visits due

to eczema every year. Each admission lasts for about 5 days. According to the study

shown by the Hospital Authority in 2014, the average inpatient cost per patient per

day was $4580. $687,000 will be saved if the admission rate decreases by 40%. The

average cost of each outpatient attendance is $1000. (Hospital Authority, 2014) It will

 

54  

save $240,000 if the number of visits decreases by 20%. It may save $ 927,000

annually. The estimated budget for the set-up cost would be $273,140. Thus, around

$653,860 will be saved annually. If the expenditure can be reduced, the program is

considered as effective.

 

55  

References

Asher, M. Innes, et al. "Worldwide time trends in the prevalence of symptoms of

asthma, allergic rhinoconjunctivitis, and eczema in childhood: ISAAC Phases One

and Three repeat multicountry cross-sectional surveys." The Lancet368.9537 (2006):

733-743.

Ayliffe, Vicki. "Clinical features and management of atopic eczema in

children."Paediatric Care 21.9 (2009): 35-40.

Cork, M., et al. "Predisposition to sensitive skin and atopic eczema."Community

practitioner 78.12 (2005): 440

European Task Force on Atopic Dermatitis. (1993). Severity scoring of atopic

dermatitis: the SCORAD index. Consensus Report of the European Task Force on

Atopic Dermatitis. Dermatology, 186(1), 23-31

Futamura, Masaki, et al. "Effects of a Short-Term Parental Education Program on Childhood Atopic Dermatitis: A Randomized Controlled Trial." Pediatric

dermatology 30.4 (2013): 438-443.

Grillo, Marianne, et al. "Pediatric atopic eczema: the impact of an educational

intervention." Pediatric dermatology 23.5 (2006): 428-436.

Hospital Authority, Careers (2014). Retrieved December 15, 2014 from

http://www.ha.org.hk/visitor/ha_visitor_index.asp?Content_ID=2010&Lang=ENG&

Dimension=100&Ver=HTML

Lenth, R. V. (2006-9). Java Applets for Power and Sample Size. Retrieved May 18,

2014, from http://www.stat.uiowa.edu/~rlenth/Power.

McHenry, P. M., H. C. Williams, and E. A. Bingham. "Management of atopic eczema.

Joint Workshop of the British Association of Dermatologists and the Research Unit of

 

56  

the Royal College of Physicians of London." BMJ: British Medical Journal 310.6983

(1995): 843.

Moore, Elizabeth J., et al. "Eczema workshops reduce severity of childhood atopic

eczema." Australasian journal of dermatology 50.2 (2009): 100-106.

Schram, M. E., et al. "Is there a rural/urban gradient in the prevalence of eczema? A

systematic review." British journal of dermatology 162.5 (2010): 964-973.

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

developer’s handbook ANNEX B: key to evidence statements and grades of

recommendations. Retrieved Dec 25, 2015, from

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

Staab, Doris, et al. "Evaluation of a parental training program for the management of

childhood atopic dermatitis." Pediatric allergy and immunology13.2 (2002): 84-90.

Staab, Doris, et al. "Age related, structured educational programmes for the

management of atopic dermatitis in children and adolescents: multicentre, randomised

controlled trial." Bmj 332.7547 (2006): 933-938.

Warsi, Asra, et al. "Self-management education programs in chronic disease: a

systematic review and methodological critique of the literature." Archives of Internal

Medicine 164.15 (2004): 1641-1649.

Webb, Thomas L., and Paschal Sheeran. "Does changing behavioral intentions

engender behavior change? A meta-analysis of the experimental

evidence."Psychological bulletin 132.2 (2006): 249.

Williams, Hywel C. "Atopic dermatitis." New England Journal of Medicine352.22

(2005): 2314-2324.

 

57  

Appendices

Appendix 1a: Systemic Search Strategies & Results

  British  Nursing  

Index  

CIHNAL   PubMed   PsyInfo  

Search  Data   15/8/2014   15/8/2014   15/8/2014   15/8/2014  

“educational  or  educating  or  education”  

and  “atopic  dermatitis  or  eczema”  and  

“Child  or  childhood  or  children  or  

pediatric  or  pediatric”.  

37   26   651   32  

Search  by  titles   3   0   71   4  

Search  by  abstract   1   0   17   0  

Manually  Remove  duplicated  &  final  

number  selected  

5  

 

58  

Appendix 1b: PRIMSA Flowchart

 

59  

Appendix 2: Table of Evidence

      Bibliographic  citation/Study  design  

Patient  characteristics   Intervention(s)   Comparison   Length  of  follow  up  

Outcome  measures   Effect  Size  (Intervention  vs  control)  

M.Futamua  et  al.  2013  /  RCT    

59  children  age  6months  -­‐  6years  with  moderate  to  severe  AD  and  their  mothers      19  Male  (IG)  22  Male  (CG)  10Female(IG)  8  Female  (CG)    Mean  age:    2.2  years  (IG)  2.6  years  (CG)  (Range:0.5  –  5.7)    Mean  total  eczema  score  40.2(IG)  42.0  (CG)  

2-­‐day  parental  education  program  (PEP)  comprising  3  lectures  (1PA  +2NP)+  practical  sessions  +  a  group  discussion    Continued  conventional  treatment  for  6  months  (n=29)  

Booklet  +  conventional  treatment  (n=30)  

3  months      6  months  

Primary  outcome:  (1) Evaluation  of  severity  of  eczema  

using  SCORAD  at  6  months  (Range:  0  –  103)    

(2)  1. Change  in  symptoms  scores  

(Range  0-­‐10)    

2. Amount  (Grams)  of  corticosteroid  used          

3. Parental  QoL  by  DFI  questionnaires  (range  0  –  30)  

4. Change  in  parental  anxiety  regarding  the  use  of  corticosteroids  in  children  (Score1=No  Anxiety  -­‐  score  5=Very  anxious)  

 

 (1) -­‐10  (p=0.012)  

 (2)  

1. -­‐1.3  (p=0.056)  2. No  significant  

difference  3. -­‐2.1  (p=0.111)  4. 3months:  

p=0.02  6months:p=0.02  

 

60  

M.  Griollo,  et  al,  2006/  Longitudinal  RCT  

61  pediatric  patients  (0  -­‐16  years)  diagnosed  with  Atopic  eczema  from  the  metropolitan  area  of  Adelaide  (1)  35  boys  &  26  girls      (2)  Mean  age=  4.3  years  (Range:  4months  to  13  years)    (3)  Mean  SCORAD=  50.97  (IG)  47.7  (CG)      (4)  Baseline  mean  DFI=    11.09  (IG)  10.86  (CG)    (5)  Mean  CDLQI=    8.1  (IG)  9.69  (CG)    (6)  Mean  IDQOL=    11  (IG)  8.63  (CG)  

2-­‐hour  education  workshop    -­‐Basic  Information  of  eczema    -­‐Practical  session    -­‐Sharing  session    Normal  management  regimen  (n=32)  

Routine  education  medical  consultation  and  management  (n=29)  

Week  4  Week  12  

(1) SCORAD  (Range:  0  –  103)  (2) DFI  (Range:  0  -­‐30)  (3) CDLQI  for  5-­‐16years  

(Range:  0-­‐30)  (4) IDQOL  for  <5  years  

(Range:  0-­‐30)  

(1) Wk4:  -­‐18.93  (p<0.005)  Wk12:  -­‐19.93  (p<0.05)  

(2) No  significant  difference  

(3) Wk  4:  No  sig  difference  Wk  12:  -­‐3.74  (p=0.004)  

(4)  No  significant  difference  

 

61  

E.  Moore  et  al.,2009/  RCT  ++  

182  patients  new  referral  for  the  management  of  eczema  at  Royal  children’s  Hospital  in  Melbourne    (1)  30  boys  (IG)  24  boys  (CG)       19  girls  (IG)  26  girls  (CG)    (2)  Mean  age=  3.3  years  2.8  years  (IG)    3.75  years  (CG)    (Range:  0-­‐16)    (3)  Baseline  mean  SCORAD=    38  (IG)  42  (CG)      

Nurse-­‐led  eczema  workshop  (n=80)  -­‐Referral  to  dermatologist  -­‐Eczema  booklets  +  cards  -­‐  Practical  session  on  application  -­‐Written  management  plan  

Dermatologist-­‐led  clinic  (n=85)  -­‐Prescription  -­‐Eczema  booklets  +cards  -­‐Educational  video  Management  plan  

4  week  Follow-­‐up  

Primary  outcome:  (1) Severity  of  eczema  as  

determined  by  scores  of  SCORAD    (Range:  0  –  103)    

 (1) -­‐9.93  (P<0.001)  

     

Kupfer  et  al.,  2010  /RCT  

185  aged  8  -­‐12  years  and  their  parents    

6  weekly  2  hours  group  session  (n=102)  

Control  group    Same  education  program  received  at  1  year  follow  up  (n=83)  

1  year  follow-­‐up  

(1) Differences  between  training  group  and  control  group  in  coping  behavior  of  children  (COPEKI)  and  parental  disease  management  (FEN)  

(2) Changes  in  training  group  and  control  group  concerning  the  psychological  variables  not  due  to  changes  in  somatic  severity  

(1) COPEKI1:  -­‐3.6(p=0.007)  COPEKI2:  -­‐2.3  (p=0.016)  

(2) FEN1:  -­‐2.4  (p=0.002)  FEN2:  -­‐0.8  (p=0.3)  FEN3:  -­‐1.5  (p=0.002)  FEN4:  1.2  (p=0.003)  

 

62  

(3) JUCKKI1:  castrophizing  (p<0.01)  JUCKKI2:  Coping  (P<0.05)  

D  Stabb  et  al,  ,  2002/  Prospective  RCT  

204(  5  months  -­‐12  years)  suffered  from  moderate  to  severe  AD  (SCORAD  >  20  points)at  least  4  months    

(1) Mean  age:  2.7(IG)  3.4  years(CG)  

(2) SCORAD  index=44(IG)  42(CG)  

(3) Duration  of  disease  2.1(IG)  2.4(CG)  

Intervention  group  parental  training  6  group  session  of  2hour  each  -­‐Presentation  of  information  -­‐Experience  sharing  -­‐Practical  session    (n=93)  

Control  Group  no  training  (n=111)  

1  year  follow-­‐up  

(1) Severity  of  eczema  (SCORAD)    (Range  0  –  103)  

(2) Treatments  costs    

(3) QoL  (4) Coping  strategies  

(1) -­‐4  (p=0.43)    

(2) 92  vs  54  -­‐38  (p=0.043)    

(3) p=0.016  alpha  level  set  as  0.01  after  correction  for  the  number  of  scales  

(4) p=0.013  alpha  level  set  as  0.01  after  correction  for  the  number  of  scales  

 

63  

D.  Stabb  et  al.,  2006  /  Multi-­‐centered,  RCT  

Parents  of  children  with  AD    3months-­‐18years  (1) 3months  –  7  years  

143Male  (IG)  127  Male  (CG)  131Female  (IG)  117  Female  (CG)    8-­‐12  years  41  Male  (IG)  40  Male  (CG)  61  Female(IG)43Female  (CG)    13-­‐18  years  29  Male  (IG)18  Male  (CG)  41Female  (IG)  32Female  (CG)    (2  )     Mean  age:  3months  –  7  years  2.4  (IG)  2.4(CG)    8-­‐12  years  9.5(IG)  9.5(CG)    13-­‐18  years  14.9(IG)  14.8(CG)    (3)Total  severity  score    

Group  session  of  standardized  intervention  program  for  AD  once  weekly  for  6  weeks  2hrs  each    3months  –  7  years  receive  education+  sessions  based  ib  previously  reported  work  8-­‐12  years  separate  educational  session  13-­‐18  years  educational  sessions  tailored  to  their  needs    Personal  experience  sharing    Practical  session  (n=496)  

no  education    (n=  496)  

12  months   (1) Severity  of  eczema:  By  scoring  of  atopic  dermatitis  scale  (SCORAD)  (0-­‐103)    

(2) Subjective  severity:  QoL  for  parents  of  affected  children<  13  years  old  (Range  :0-­‐20)    

(3) QoL  5  subscales:  1. Psychosomatic  wellbeing    2. Effects  on  social  life  3. Confidence  in  medical  

treatment  4. Emotional  coping  5. Acceptance  of  disease      

(1) 3Months  –  7  Years:  -­‐5.2  (p=0.0002)  8  –  12  Years:  -­‐8.2  (p=0.003)  13-­‐18  years:  -­‐14.5  (p<0.0001)  

(2) 3Months  –  7  Years:  -­‐1.1  (p<0.001)  8  –  12  Years:  -­‐2.1  (p<0.001)  13-­‐18  years:  -­‐2.1  (p<0.0022)  

(3) 3months  -­‐  7  years:  All  5  QoL  subscales  Significant  better  8-­‐12  years:  3/5  subscales  shown  significant  better  improvement  

 

64  

 

(SCORAD)    3months  –  7  years:  41.1(IG)  40.6(CG)  8  -­‐12  years:    41.8  (IG)  40.4(CG)  13  –  18  years:  43.1  (IG)  40.4  (CG)    

 

65  

Appendix 3: Quality Assessment of Selected Studies

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

M Futamura et al. (2013) Effects of a Short-Term Parental Education Program on Childhood Atopic

Dermatitis: A Randomized Controlled Trial, Pediatric Dermatology Vol. 30 no.438-443

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question

Yes R

Can’t say £

No £

1.2 The assignment of subjects to treatment groups is randomised. -Use of computer-generated randomisation list with a block size of eight.

Yes R

Can’t say £

No £

1.3 An adequate concealment method is used.

-Adequate concealment method is used by each patient is picking up a

paper from a total of eight pieces of paper, half of which were labeled

parental education program and half control in a sealed box

Yes R

Can’t say £

No £

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation. Analyses performed before un-blinding of treatment

allocation

-uses digital photographs as they could conceal group allocation and time

of assessment from the objective scorer.

Yes R

Can’t say £

No £

1.5 The treatment and control groups are similar at the start of the trial.

-Well match and shown in table 2 but no p-value was shown.

Yes R

Can’t say □

No £

1.6 The only difference between groups is the treatment under

investigation.

Yes R

Can’t say £

No £

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes R

Can’t say £

No £

 

66  

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

1 in IG lost follow up 2 in CG lost to follow up

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes £

Can’t say £

No £

Does not apply

R

1.10 Where the study is carried out at more than one site, results are

comparable for all sites

Yes £

Can’t say £

No £

Does not apply

R

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows.

High quality (++)R

Acceptable (+)£

Unacceptable – reject 0 £

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

 

67  

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Grillo,2006, Pediatric atopic eczema : The impact of an Educational Intervention Pediatric Dermatology,

2006, Vol.23(5), pp.428-436

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes R

Can’t say £

No £

1.2 The assignment of subjects to treatment groups is randomised. -A random number generator was used to place the participants into either the intervention group or control group.

Yes R

Can’t say £

No £

1.3 An adequate concealment method is used.

-Insufficient detail in concealment allocation was provided.

Yes £

Can’t say R

No £

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

- They are receiving the education program, they cannot be blinded.

- Blinding is unclear for the assessor.

Yes R

Can’t say £

No £

1.5 The treatment and control groups are similar at the start of the trial. Yes £

Can’t say P

No £

1.6 The only difference between groups is the treatment under

investigation.

Yes R

Can’t say £

No £

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes R

Can’t say £

No £

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

>80% follow-up 3 lost contact

 

68  

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes £

Can’t say *

No £

Does not apply

R

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes £

Can’t say £

No £

Does not apply

R

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++)£

Acceptable (+) R

Unacceptable – reject 0 £

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

 

69  

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Moore et al.(2009) Eczema workshops reduce severity of childhood atopic eczema, Australasian Journal of

Dermatology, 2009, Vol.50(2), pp.100-106

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes R

Can’t say £

No £

1.2 The assignment of subjects to treatment groups is randomised. -They are randomised in block of 10 using (Stata Crop)statistical software.

Yes R

Can’t say £

No £

1.3 An adequate concealment method is used.

-Sequentially numbered sealed opaque envelopes used.

Yes R

Can’t say £

No £

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

-Complete blinding cant be made, minimized by 10 blinded assessment

and assessors. Inter-rater reliability established using Lin concor-dance.

Yes R

Can’t say £

No £

1.5 The treatment and control groups are similar at the start of the trial.

Yes R

Can’t say □

No £

1.6 The only difference between groups is the treatment under

investigation.

Yes R

Can’t say £

No £

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

-All outcome listed

Yes R

Can’t say £

No £

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

13 patiemts lost to follow up >80% follow up

 

70  

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes £

Can’t say R

No £

Does not apply

£

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes R

Can’t say R

No £

Does not apply

£

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++)R

Acceptable (+)£

Unacceptable – reject 0 £

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

yes

 

71  

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

D. Staab et al., (2002) Evaluation of a parental training program for the management of childhood atopic

dermatitis. Pediatric Allergy and Immunology, 2002, Vol.13(2), pp.84-90

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes R

Can’t say £

No £

1.2 The assignment of subjects to treatment groups is randomised. Not stated

Yes £

Can’t say R

No £

1.3 An adequate concealment method is used.

Not stated

Yes £

Can’t say R

No £

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

-Cant be blinded as the questionnaires answered by the parents which they

know which group they were in

Yes £

Can’t say £

No R

1.5 The treatment and control groups are similar at the start of the trial.

-No significant difference in any of socio-economic parameters

Yes R

Can’t say □

No £

1.6 The only difference between groups is the treatment under

investigation.

Yes R

Can’t say £

No £

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes R

Can’t say £

No £

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

77% follow-up IG 66% follow-up CG

 

72  

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes £

Can’t say

No R

Does not apply

£

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes £

Can’t say £

No £

Does not apply

R

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++)£

Acceptable (+)R

Unacceptable – reject 0 £

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the statistical

power of the study are you certain that the overall

effect is due to the study intervention?

Yes

2.3 Are the results of this study directly applicable to the

patient group targeted by this guideline?

Yes

 

73  

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

D.Staab, (2006),Age related, structured educational programmes for the management of atopic dermatitis in

children and adolescents: multicentre, randomised controlled trial. Apr 22;332(7547):933-8

Section 1: Internal validity

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

YesR No £

1.2 The assignment of subjects to treatment groups is randomised. - Randomization was carried out by an independent study centre by computer-generated numbers.

Yes R

Can’t say £

No £

1.3 An adequate concealment method is used.

-The randomization code was concealed in closed envelopes.

Yes R

Can’t say £

No £

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

-Blinding is impossible for the participants who provide most of the

outcome measure by answering questionnaires. Trainers cannot be

blinded.

-The scoring of the AD severity assessors are not involved in the

intervention.

Yes £

Can’t say £

No R

1.5 The treatment and control groups are similar at the start of the trial.

well covered

Yes R

Can’t say □

No £

1.6 The only difference between groups is the treatment under

investigation.

Yes R

Can’t say £

No £

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes R

Can’t say £

No £

1.8 What percentage of the individuals or clusters recruited into each Overall follow up rate is 83%

 

74  

treatment arm of the study dropped out before the study was

completed?

The dropout rate was 17% (10% in intervention group, 24% in control group)

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes £

Can’t say R

No £

Does not apply

£

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes R

Can’t say £

No £

Does not apply

£

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++) R

Acceptable (+)£

Unacceptable – reject 0 £

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

 

75  

Appendix 4: Estimated Set-Up Cost of the Parental Education Program of Management of Eczema (1st – 2nd Year) Items     Cost  

Personal  Cost  

Program  Team  Members   Preparation  of  presenting  materials  and  booklet  Work  meeting    Introductory  session  Program  Session    Follow  Up    Data  analysis  Nursing  Staff  training  $234  (max  RN  pay)  x  500  hours  

$117,000  

Medical  Introductory  Training  30  Medical  Officer  x  1  hour  $464  x  30  hours  

$13,920  

Nursing  Introductory  Training  

80  Registered  Nurse  x  1  hour  $234  x  80  hours  

$18,720  

Compensatory  Nursing  Staff  for  Program  Team  Members  

$  234  x  500  hours     $117,000  

 

Direct  Program  Cost    

Printing  &  Photocopying  

  $5000  

Stationery     $500  

Promotion     $1000  

Total  Set  Up  Cost   $273,140  

 

76  

Appendix 5 : Estimated Operation Cost of the Parental Education Program of

Management of Eczema (3rd year onward)

Items     Cost  

Personal  Cost    

Program  Team  Leader   Meetings    

Introductory  session  

Data  Analysis    

Writing  Reports  

$234  x  50  hours  

$11,700  

Program  Team  Members   Meetings  

Introductory  sessions  

Running  program  

Follow-­‐up  session  

$234  x  250  hours  

$58,500  

Compensatory  Nursing  

Staff  

$234  x  300  hours   $70,200  

Direct  Program  Cost        

Printing  &  photocopying       $2500  

Stationery     $500  

Total  Running  Cost     $143,400  

 

77  

Appendix 6: Evidence-based Guideline of Parental Education Program for

Eczematous Children

 

 

 

 

An  Evidence-­‐Based  Guideline  of  Parental  Education  Program  

for  Eczematous  Children  

June  2015

 

78  

Introduction:  

It  is  an  evidence-­‐based  eczema  education  program  for  reducing  the  severity  of  

eczema  in  children.  The  purpose  of  this  guideline  is  to  develop  an  organized  

education  program  in  helping  parents  of  eczematous  children  to  obtained  the  

knowledge  and  acquire  the  skills  in  managing  eczema.  It  is  developed  based  on  

the  evidence  on  the  reviewed  studies  which  was  graded  by  the  Level  of  

evidence(  SIGN,  2012a)  and  the  recommendations  provided  in  this  guideline  are  

developed  from  the  selected  studies  and  graded  according  to  the  Grades  of  

Recommendation  (SIGN  ,  2012).  The  in-­‐charge  nurses  should  stop  this  program  

if  any  adverse  events  occur  and  should  document  clearly  with  the  reason.    

Rationale  of  the  Guideline  

1. To  maintain  the  consistency  of  nurses  in  holding  the  education  program  on  

management  of  eczema  in  children  

2. To  increase  nurses’  confidence  in  holding  the  parental  education  program    

Objectives  of  the  Parental  Education  Program  

1. To  improve  confidence  and  to  enhance  the  skills  of  parents  of  eczematous  

children  in  management  of  eczema  

 

79  

2. To  improve  the  severity  of  skin  condition  of  eczematous  children  

3. To  decrease  the  admission  rate  and  follow-­‐up  frequency  

Target  Group  

    The  targeted  participants  are  parent  of  children  diagnosed  as  eczema  or  with  a  

history  of  eczema  aged  between  0  –  18  years  old  children.    

Content  of  the  Program  

    The  education  program  is  organized  by  five  registered  nurses  who  have  more  

than  5  years  experience  in  pediatric.  

    Pediatricians  and  nurses  in  Pediatric  and  Adolescent  Medicine  will  refer  the  

eligible  participants  and  their  parents  to  the  parental  education  program.    

    The  education  program  lasts  for  three  hours.  Follow  up  will  be  one  month,  

three  month,  six  month  and  one  year.  The  basic  information  about  eczema  will  

be  given  in  presentation  in  the  first  45  minutes.  The  remaining  time  will  be  run  

in  form  of  a  group  discussion.

 

80  

The  schedule  of  the  program    

Time   Content   Aims  

30  minutes   Presentation  

Ø Introduction of the education

program

Ø Basic epidemiology of atopic eczema

Ø Signs and symptoms of atopic eczema

Ø Triggering factors

Ø Basic skin care

- To  understand  the  basic  

knowledge  of  atopic  

eczema  

90  minutes   Group  Discussion  

Ø Self  introduction  

Ø Sharing  of  own  experience  (e.g.  

when  and  how  was  it  found?  

Treatment  undertaking?  Allergens?  

Technique  of  dealing  with  itching  

behavior?  )  

- To  develop  a  supportive  

and  friendly  atmosphere  

- To  learn  the  different  

approaches  in  tackling  

eczema  from  each  others    

 

81  

60  minutes   Demonstration  on  treatment  application  

Return  Demonstration  

- To  develop  and  strengthen  

the  skills  of  wet  wrapping  

- To  learn  the  common  

mistakes  in  wet  wrapping  

skills  from  each  others    

 

82  

Recommendations  

Recommendation  1.0  Recruitment    

1.1  The  target  population  would  be  pediatric  diagnosed  with  atopic  eczema  

and  their  parents.  The  patient  should  aged  from  0-­‐18  years  old  that  

includes  in-­‐patients  and  outpatients.  (Grade  A)  

    All  the  participants  in  the  selected  studies  were  under  18  years  old  and  their  

parents.  Both  parents  and  some  children  who  are  capable  in  self-­‐management  

are  also  encouraged  to  join  the  program.  (Futamura  et  al.,  2013;  Grillo  et  al.,  

2006;  Moore  et  al.,  2009;  Stabb  et  al.,  2002;  Stabb  et  al.,  2006).(1+,  1+,  1++,  1+,  

1++)  

Recommendation  2.0  Implementation  of  the  management  of  eczema  

education  program    

2.1  The  education  should  be  conducted  in  the  outpatient  clinic.  (Grade  A)  

    The  program  should  conduct  in  the  outpatient  clinic  so  as  to  facilitate  the  

interdisciplinary  communication  and  can  provide  a  spacious  activity  room  and  

staffs  at  outpatient  clinic  are  experienced  in  giving  primary  health  education  

 

83  

program.(Futamura  et  al.,  2013;  Grillo  et  al.,2006;  Moore  et  al.,2009).  (1+,  

1+,1++)  

2.2  The  eczema  workshop  is  suggested  to  be  carried  out  in  a  group  basis.  

(Grade  A)  

    All  education  program  in  all  selected  studies  include  group  session.  (Futamura  

et  al.,  2013;  Grillo  et  al.,  2006;  Moore  et  al.,  2009;  Stabb  et  al.,  2002;  Stabb  et  al.,  

2006).  (1+,  1+,  1++,  1+,  1++).  It  allows  them  to  share  their  personal  experience  

and  understand  more  about  the  obstacles  when  managing  eczema.  Therefore,  it  

is  desirable  to  carry  out  the  sharing  session  in  a  group  basis.  

2.3  Practical  session  on  wet  wrapping  and  cream  application  skills  should  

be  included  in  the  program.  (Grade  A)    

    Application  of  treatment  such  as  cream  or  wet  wrapping  is  demonstrated  and  

re-­‐turn  demonstration  on  trying  out  the  newly  learned  skills  is  also  encouraged  

under  a  nurse  supervision  so  as  to  improve  the  treatment  outcome  (Futamura  et  

al.,  2013;  Grillo  et  al.,  2006;  Moore  et  al.,  2009;  Stabb  et  al.,  2002;  Stabb  et  al.,  

2006).(1+,  1+,  1++,  1+,  1++).  

 

84  

Recommendation  3.0  Evaluation  and  Follow-­‐up  

3.1  It  is  suggested  to  evaluate  the  program  by  measuring  SCORAD  of  the  

clients  at  baseline  before  the  program  and  after  the  program  in  order  to  

evaluate  the  change  in  SCORAD.  (Grade  A)  

    All  the  studies  measure  the  baseline  SCORAD  at  follow-­‐up  session  and  

calculate  the  change  in  severity  after  the  program  so  as  to  evaluate  the  efficacy  of  

the  proporsed  program.  (Futamura  et  al.,  2013;  Grillo  et  al.,  2006;  Moore  et  al.,  

2009;  Stabb  et  al.,  2002;  Stabb  et  al.,  2006).(1+,  1+,  1++,  1+,  1++).  

3.2  The  length  of  follow-­‐up  is  set  to  be  one  month  and  3  month  and  one  

year.  (Grade  A)      

    The  length  of  follow  up  cannot  be  too  long  because  the  dropout  rate  is  high  

especially  if  the  participants  are  in  the  control  group  which  are  having  no  

intervention.  Among  all  selected  studies,  only  one  (Stabb  et  al.,  2002)  shown  

more  than  20%  of  dropout  rate  as  the  first  follow-­‐up  is  conducted  at  one  year  

after  the  education  program.

 

85  

References

Futamura, Masaki, et al. "Effects of a Short-Term Parental Education Program on Childhood Atopic Dermatitis: A Randomized Controlled Trial." Pediatric

dermatology 30.4 (2013): 438-443.

Moore, Elizabeth J., et al. "Eczema workshops reduce severity of childhood atopic

eczema." Australasian journal of dermatology 50.2 (2009): 100-106.

Grillo, Marianne, et al. "Pediatric atopic eczema: the impact of an educational

intervention." Pediatric dermatology 23.5 (2006): 428-436.

Staab, Doris, et al. "Evaluation of a parental training program for the management of

childhood atopic dermatitis." Pediatric allergy and immunology13.2 (2002): 84-90.

Staab, Doris, et al. "Age related, structured educational programmes for the

management of atopic dermatitis in children and adolescents: multicentre, randomised

controlled trial." Bmj 332.7547 (2006): 933-938.

 

86  

Appendix 7: Level of Evidence Developed by the SIGN

1++  High-­‐quality  meta-­‐analyses,  systematic  reviews  of  RCTs*,  or  RCTs  with  very  low  risk  of  bias  

1+  Well-­‐conducted  meta-­‐analyses,  systemic  reviews  of  RCTs,  or  RCTs  with  low  risk  of  bias.  

1-­‐  Meta  analyses,  systematic  reviews  of  RCTs,  or  RCTs  with  a  high  risk  of  bias.  

2++  High  quality  systematic  reviews  of  case-­‐control  or  cohort  studies.  

High  quality  case-­‐control  or  cohort  studies  with  a  very  low  risk  of  confounding,  bias,  or  

chance  and  a  high  probability  that  the  relationship  is  causal  

2+  Well-­‐conducted  case  control  or  cohort  studies  with  a  low  risk  of  confounding,  bias,  or  chance  

and  a  moderate  probability  that  the  relationship  is  causal.  

2-­‐  Case  control  or  cohort  studies  with  a  high  risk  of  confounding,  bias,  or  chance  and  a  

significant  risk  that  the  relationship  is  not  causal.  

3  Non-­‐analytic  studies,  e.g.  case  reports,  case  series  

4    Expert  opinion  

RCT:  randomized,  controlled  trial  

 

87  

Appendix 8: Grading of Recommendations Developed by the SIGN

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

as  1++,  and  directly  applicable  to  the  target  population;  or  

A  systematic  review  of  RCTs  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  

 

88  

Appendix 9: Recommendation Synthesis Process

Recommendation  1.0  Who  are  the  target  population?  

 

  0-­‐7  years  old     8  –  12  years  old     13-­‐18  years  old  

Futamura  et  al.,2013  (1+)   ✓      

Grillo  et  al.,  2006  (1+)   ✓   ✓   ✓  

Moore  et  al.,  2009  (1++)   ✓   ✓   ✓  

Staab  et  al.,  2002  (1+)   ✓   ✓    

Staab  et  al.,2006  (1++)   ✓   ✓   ✓  

 

Recommendation  2.1  Should  the  education  conducted  in  the  outpatient  

clinic?  

  Out-­‐patient  clinic  

Futamura  et  al.,2013  (1+)   ✓  

Grillo  et  al.,  2006  (1+)   ✓  

Moore  et  al.,  2009  (1++)   ✓  

Staab  et  al.,  2002  (1+)    

Staab  et  al.,2006  (1++)    

 

Recommendation  2.2  Should  the  eczema  workshop  be  carried  out  in  a  group  

basis  or  individual  session?  

  Group   Individual  

Futamura  et  al.,2013  (1+)   ✓    

Grillo  et  al.,  2006  (1+)   ✓    

Moore  et  al.,  2009  (1++)   ✓    

Staab  et  al.,  2002  (1+)   ✓    

Staab  et  al.,2006  (1++)   ✓    

 

 

 

 

 

89  

 

Recommendation  2.3  Practical  sessions  on  wet  wrapping  and  cream  

application  skills  should  be  included  in  the  program?  

  Practical  session  

Futamura  et  al.,2013  (1+)   ✓  

Grillo  et  al.,  2006  (1+)   ✓  

Moore  et  al.,  2009  (1++)   ✓  

Staab  et  al.,  2002  (1+)   ✓  

Staab  et  al.,2006  (1++)   ✓  

 

Recommendation  3.1  Should  the  program  evaluated  by  SCORAD?    

  Evaluated  by  SCORAD  

Futamura  et  al.,2013  (1+)   ✓  

Grillo  et  al.,  2006  (1+)   ✓  

Moore  et  al.,  2009  (1++)   ✓  

Staab  et  al.,  2002  (1+)   ✓  

Staab  et  al.,2006  (1++)   ✓  

 

Recommendation  3.2  What  is  the  length  of  follow-­‐up?  

    4  week   12  week     24  week     52  week  

Futamura  et  al.,2013  (1+)     ✓   ✓    

Grillo  et  al.,  2006  (1+)   ✓   ✓      

Moore  et  al.,  2009  (1++)   ✓        

Staab  et  al.,  2002  (1+)         ✓  

Staab  et  al.,2006  (1++)         ✓  

 

90  

Appendix 10: Gantt Chart of The Education Program for The Eczematous Pediatric Patients

Month

Description

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Preparation of the

proposal and guideline

Approval seeking

Training session to

program team

Promotion +

Introductory Session to

pediatrician and nurses +

Participants Recruitment

Pilot Study

Evaluation of Pilot Study

Actual Implementation

Evaluation

 

91  

Appendix 11: Scoring of Atopic Dermatitis Assessment Form

 

92  

Appendix 12: Evaluation Questionnaire of the Education Program for

Pediatric Eczematous Patients

兒童濕疹護理課程問卷調查

非常不同意

不同意

無意見

同意 非

常同意

此課程可增加你對兒童濕疹的認識 此課程可增加你對兒童濕疹的護理 此課程可減少因兒童濕疹住院或覆診 課程長度適中 你滿意此課程 其他意見

*請在適當位置✔

 

93  

Appendix 13: Evaluation Questionnaire for the Nursing and Medical Staff of

Pediatric and Adolescent Medicine Department

Education Program for Eczematous Pediatric Patients

Evaluation Questionnaire for the Nursing and Medical Staff of Pediatric and Adolescent Medicine

1. Do you think the workload at

your workplace is reduced after

the implementation of the

education program?

Yes No

Please specify:__________

2. Do you think the referral made

is appropriate?

Yes No

Please specify:__________

3. Do you support to continue the

education Program?

Yes No

Please specify:__________

4. What is the overall comment to

the education program?

Extremely

not

Satisfied

Not

Satisfied

Neutral Satisfied Extremely

Satisfied

5. Other Comments:

*Please  circle  the  appropriate