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MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN

Abstract of the dissertation entitled

An Evidence-based Guideline of using Multidisciplinary Primary Care Program

in Patients with Chronic Low Back Pain

Submitted by

Sham Lai Mei

for the degree of Master of Nursing

at The University of Hong Kong

in July 2015

We consider the local setting of five Family Medicine clinics under primary care

in Hong Kong, where chronic low back pain (LBP) accounted over a thousand of

consultations every year. Patients with chronic LBP are only prescribed with anti-pain

oral medication, brief health education and sometimes referral for physiotherapy, but

they lack comprehensive and consistent health care intervention. There has been

growing evidence that shows multidisciplinary primary care program may help to

reduce the level of chronic LBP in adult patients, but there was no systematic review.

Therefore, this dissertation aims to develop an evidence-based clinical guideline on

multidisciplinary primary care program in patients with chronic LBP.

Four electronic databases: Cochrane Library, CINAHL Plus, PubMed, and

Medline were searched for randomized controlled trials (RCTs) on multidisciplinary

program for patients with chronic LBP. After reading full texts, eight studies

remained. Quality appraisal was performed by the Scottish Intercollegiate Guidelines

Network (SIGN) checklist for RCTs. Four of the eight RCTs had moderate to good

methodological quality. They indicated that multidisciplinary primary care program

has a significant effect on reducing pain among patients with chronic LBP and

improving quality of life. There was adequate evidence in support of using

multidisciplinary program in primary care.

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN

An evidence-based guideline on multidisciplinary primary care program for

patients with chronic LBP was subsequently developed to guide nurses for the

effective implementation of the program. The SIGN grading system was chosen to

grade the recommendations in the guideline. In our program, patients with chronic

LBP are required to attend theory classes and practice exercises in local clinics for 5

weeks in instructive phase and for 12 months in reinforcement phase. The

evidence-based guideline was considered to be feasible and transferable in the local

clinical setting. There would be a potential saving of HK$ 0.5 million per year with

minimal associated risks to the patients and stakeholders.

The stakeholders are the Consultant of Family Medicine, Medical Officer and the

nurses of the Quality Assurance Team. A working group will conduct regular

meetings to facilitate the implementation of the new guideline. Before full

implementation of the guideline, a 10-month pilot study on chronic LBP patients will

be conducted to assess the feasibility of the guideline. The primary outcome of pain

will be assessed by Visual Analogue Scale (VAS). Secondary outcome measurements

comprise health outcomes, healthcare provider outcomes and system outcomes.

Evaluation study will take approximately 30 months. Patients with chronic LBP will

be assessed before the program, at the end of 5-week instructive phase, followed with

the third, sixth, ninth and 12th

month after the end of instructive phase. After the

13-month program, patients with chronic LBP will be evaluated every three months

over a 12-month follow up period. Finally, the results of innovation will be evaluated

over three months to decide whether the innovation should be continued. The

effectiveness of the guideline will be determined by its ability in reduced pain

intensity, improved nursing acceptance, increased nursing compliance, good

utilization rate and reduced incremental cost of the program.

Running head: MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN

An Evidence-based Guideline of using Multidisciplinary Primary

Care Program in Patients with Chronic Low Back Pain

by

Sham Lai Mei

PcPsy, BSc(N), MSocSc(BH), RN

A dissertation submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

July 2015

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN i

Declaration

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

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

dissertation or report submitted to this university or to any other institution for a degree,

diploma or other qualifications.

Signed………………………………………………………………………………

Sham Lai Mei

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN ii

Acknowledgements

It has been my immense honor to be a dissertation student of Dr. Daniel Fong. I

would like to extend my sincerest gratitude to my supervisor for his support and

encouragement in this dissertation. I am in tremendous appreciation for all his

valuable, countless hours and patience devoted to guide my work.

I would like to extend my heartfelt gratitude to my father and mother whose love

and support have nurtured me constantly throughout my life and my entire learning

endeavor. Thanks so very much for their unconditional positive regards accepting me

as who I am.

I am also grateful to all my friends for their understanding and support during my

graduate study. May I take this opportunity to praise the God for his unending love

embracing me and my family members.

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN iii

Contents

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

Acknowledgements………………………………………………………………………… ii

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

List of Tables……………………………………………………………………………….. vi

List of Appendices…………………………………………………………………………. vii

List of Abbreviations………………………………………………………………………. viii

Chapter 1: Introduction

1.1 Background………………………………………………………………. 1

1.2 Affirming Needs………………………………………………………….. 3

1.3 Objectives and Significance……………………………………………… 5

Chapter 2: Critical Appraisal

2.1 Search and Appraisal Strategies

2.1.1 Search strategies………………………………………………….. 6

2.1.2 Study selection criteria…………………………………………… 6

2.1.3 Data extraction…………………………………………………… 7

2.1.4 Critical appraisal and rating scheme……………………………... 7

2.2 Results

2.2.1 Search results…………………………………………………….. 8

2.2.2 Overview of selected articles and study population……………... 8

2.2.3 Methodological quality…………………………………………... 12

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN iv

2.3 Summary and Synthesis

2.3.1 Summary of the reviewed studies………………………………... 13

2.3.2 Synthesis and recommendations…………………………………. 15

Chapter 3: Translation and Application

3.1 Implementation Potential

3.1.1 Target audience and setting………………………………………. 18

3.1.2 Transferability of findings………………………………………... 18

3.1.3 Feasibility………………………………………………………… 22

3.1.4 Cost-benefit ratio of the innovation……………………………… 25

3.2 Evidence-based Protocol…………………………………………………. 27

Chapter 4: Implementation Plan

4.1 Communication Plan

4.1.1Identifying stakeholders………………….……………………….. 28

4.1.2 Communication process………………………………………….. 29

4.2 Pilot Testing Plan

4.2.1 Timeline of pilot test……………………………………………... 31

4.2.2 Training workshop……………………………………………….. 31

4.2.3 Measurement of pilot test………………………………………… 31

4.2.4 Patient recruitment……………………………………………….. 32

4.2.5 Intervention………………………………………………………. 32

4.2.6 Evaluation of pilot test……………………………………………

33

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN v

4.3 Evaluation Plan

4.3.1 The objectives of evaluation……………………………………... 34

4.3.2 Identifying outcomes…………………………………………….. 35

4.3.3 Plan of measurements……………………………………………. 36

4.3.4 Nature and number of clients…………………………………….. 36

4.3.5 Data analysis……………………………………………………... 37

4.3.6 Basis for concluding the effectiveness of the guideline………….. 38

Appendices………………………………………………………………………… 40

References…………………………………………………………………………. 78

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN vi

List of Tables

Table 1

Table of Evidence………………………………………………………………..10

Table 2

Comparison of Baseline Demographic Characteristics of Patients between

Families Clinics and the Four Included Studies…………………………………19

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN vii

List of Appendices

Appendix A

Result of the Search for Studies on Multidisciplinary Primary Care Program

for Patients with Chronic Low Back Pain…………………………………….

40

Appendix B

PRISMA Flowchart…………………………………………………………...

41

Appendix C

Quality Assessment…………………………………………………………...

42

Appendix D

Estimated Cost of Multidisciplinary Chronic LBP Program in 2015 (1 Year

Period)……………………………………………………………...…………

50

Appendix E

Cost Gain after Implementation of the One Year Program………...…………

51

Appendix F

SIGN 50: A Guideline Developer’s Handbook---Level of Evidence and

Grade of Recommendations…………………………………………………..

52

Appendix G

An Evidence-based Guideline of using Multidisciplinary Primary Care

Program in Patients with Chronic Low Back Pain……………………………

53

Appendix H

An Organizational Structure of the Quality Assurance Service……...……….

68

Appendix I

A Proposed Planning Timeline for Multidisciplinary Chronic LBP program...

69

Appendix J

Assessment Form of Multidisciplinary Primary Care Program in Patients

with Chronic Low Back Pain………………………..………………………..

71

Appendix K

Progress Sheet of Multidisciplinary Primary Care Program in Patients with

Chronic Low Back Pain……………………………………………..………..

75

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN viii

Abbreviations

DALY Disability Adjusted Life Year

FU Follow Up

HA Hospital Authority

LBP Low Back Pain

MO Medical Officer

N Sample Size

NRS Numerical Rating Scale

NO Nursing Officer

ODI Oswestry Disability Index

PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses

QA Quality Assurance

QoL Quality of Life

QDS Quebec Disability Score

RCT Randomized Controlled Trial

RMDQ Roland Morris Disability Questionnaire Scale

SMO Senior Medical Officer

SNO Senior Nursing Officer

SF-36 Medical Outcomes Study Short Form- 36 Health Survey

SIGN Scottish Intercollegiate Guideline Network

VAS Visual Analog Scale

MULTIDISCIPINARY PRIMARY CARE IN CHRONIC LOW BACK PAIN 1

Chapter 1

Introduction

1.1 Background

Chronic low back pain (LBP) is a prevailing health problem worldwide. This

constellation of symptoms becomes a major cause of disability affecting general

well-being. Nowadays, many individuals suffered from LBP due to prolonged

incorrect sitting posture, degenerative disc, over weight and lack of stretching exercise

(CHEU, 2012). Though several risk factors of LBP have been identified, the specific

underlying causes of chronic LBP remain unknown on the whole (WHO, 2014).

Chronic pain is defined as pain over muscle of lumbar spine continuously

persisted for more than three months (Ehrlich et al., 2013). Chronic LBP affects

people of all ages and patients require frequent medical consultations. As a result,

chronic LBP is estimated as one of the top 10 diseases accounting for the highest

number of Disability Adjusted Life Years (DALYs) all over the world (WHO, 2014).

Meanwhile, the lifetime prevalence of chronic LBP is estimated to be 60% to 70%

with the peak of 35-55 year old and the highest prevalence occurs among female

individual aged 40-80 (WHO, 2014 & Hoy et al., 2012). Chronic LBP is prevalent in

Hong Kong that overall 34.9% of the population reported to suffer from LBP for more

than three months (Wong & Fielding, 2011). If chronic LBP is not well cured, the risk

of sciatic and disabilities will be increased.

Chronic LBP bears substantial costs to the society imposing a hugh economic

burden on the society in terms of healthcare expenditure and reduced work

productivity. Currently, chronic LBP is alleviated primarily by oral analgesics while

physical therapy and spinal manipulation can be the alternative treatments (WHO,

2014). Although spinal fusion and disc surgery remains the last option, these surgeries


still fail to provide permanent relief of LBP and recurrence of chronic LBP often

follow (Ehrlich, 2003 & WHO, 2014). Treatment for chronic LBP is spectacularly

challenging and no intervention has yet been universally endorsed.

Traditional care services no longer adequately serve the needs of the patients with

chronic LBP. As such a more integrated, multidisciplinary, primary care approach in

the management of chronic LBP is required to reduce the rate of progression and the

incidence of complications in the community level.

1.2 Affirming Needs

In the local setting, patient would have their consultation of chronic LBP in the

Family Medicine clinics under primary care. Currently, only prescription of anti-pain

oral medication, provision of health education on LBP and sometimes use of

physiotherapy referred to out-patient clinics of hospital will be entailed as usual

practice. In terms of health education, usually the pamphlets only mention the postural

hygiene, heavy work load prevention and description of back muscle strengthening

exercise without providing practical sessions for the patients. Patients are required to

carry out the exercise at home by themselves. Obviously, patients having LBP lack

comprehensive and consistent health care intervention in the current situation. They

cannot receive appropriate preventive and follow-up care.

The impact of chronic LBP is vulnerable. Degeneration of lumbar disc is an

irreversible health problem that management of LBP in the daily living is crucial.

Chronic LBP bringing socioeconomic burden to Hong Kong has become an

increasingly important public health concern. The utilization of medical services and

the loss of productivity of patients result in direct and indirect cost. Chronic LBP

adversely affects physical and social activities to the Hong Kong Chinese population.


Moreover, strong psychological overlay such as distress, anxiety, depression or work

dissatisfaction (Erhlich et al., 2013 & Abbasi, et al., 2012) often put a large impact on

the daily life of chronic LBP patient.

The clinical issue of chronic LBP concerns the recurrence of LBP after certain

period of time. The cause and its physiology remains unknown. Recurrent chronic

LBP may happen periodically or continuously. The current practice for LBP

intervention is not effective that chronic LBP cannot be treated in the primary care.

More prevention on the recurrence of LBP is thus necessary that there is a need to

change the exiting practice in primary care. The involved clinics are required to

provide more focused care to serve the needs of the patients with chronic LBP.

Multidisciplinary primary care program can be a potential innovation for patients

with chronic LBP. Johnson (2007) concluded that active exercise is able to reduce the

pain intensity and disability of patients suffered from LBP. Educational interventions

for musculoskeletal pain should include pathophysiology of pain and various pain

management techniques which strongly influence the trajectory of chronic LBP. On

the other hand, fear of movement and avoidance behavior leads to hesitation of active

exercise and therefore more severe pain. A vicious cycle between increased pain and

poor quality of life is resulted. Therefore, an integrated health care program which can

be implemented in the primary care is necessary to change the cognitive thinking and

reduce avoidance behavior of patients suffered from LBP for better quality of life.

Multidisciplinary is defined as involving several fields of professional specialist in

an approach to a complex problem (Oxford University Press, 2014). There are already

lots of recommended exercises suitable for LBP to reduce pain intensity and disability.

However, the essential point is to modify the cognitive thinking and health behavior

of the individuals. Therefore, with the help of multidisciplinary program, patients are


able to receive educational health information, psychological training in pain coping

skills, behavioral reinforcement and managing pain at home. Some multidisciplinary

components are therefore required to meet the challenges of chronic LBP.

Currently, there has not been any systematic review of the efficacy of

multidisciplinary primary care program for patients in chronic LBP. Therefore, there

is a need to review the relevant evidence for the sake of developing clinical guidelines

for the patients in the community.

1.3 Objectives and Significance

Chronic LBP significantly degrades quality of life and substantially raises the

medical costs for individuals with chronic LBP. Local primary care nurses should

change their practice by translating the best available evidence into local clinical

practice. Effective and standardized health care program for chronic LBP can be

beneficial to both patients and the health care system. An evidence-based guideline

would be able to alleviate the pain of the LBP patient, eliminate recurrence, prevent

complications and enhance their quality of life. On the other hand, efficacious

intervention would lower the health care expenditure by reducing the frequency of

clinic attendance and hospitalization owing to the complications of chronic LBP.


In view of the above, the objectives of this dissertation are:

1. to evaluate current evidence on the effectiveness of using multidisciplinary

primary care program compared with usual care in patients with chronic LBP,

2. to develop an evidence-based nurse-led clinical guideline on multidisciplinary

primary care program in patients with chronic LBP,

3. to assess the transferability and feasibility of implementing a nurse-led

multidisciplinary primary care program in patients with chronic LBP in Hong

Kong,

4. to develop implementation strategies and evaluation plan for the use of

multidisciplinary primary care program in patients with chronic LBP.


Chapter 2

Critical Appraisal

2.1 Search and Appraisal Strategies

2.1.1 Search strategies

Four electronic searching engines were used to search for the relevant studies.

These databases were the Cochrane Library (earliest to Apr 2014), PubMed (earliest

to Apr 2014), CINAHL Plus (earliest to Apr 2014) and MEDLINE (earliest to Apr

2014). Both electronic and manual search strategies were conducted from 1st March

2014 to 27th

Apr 2014. Keywords used in electronic database searching were’ Low

back pain’, ‘multidisciplinary’ and ‘quality of life’. The search was restricted to

randomized controlled trial (RCTs). There was no restriction on the language in order

to avoid language bias. From the resulting citations, titles and abstracts were screened

carefully. Only papers relevant to the review topic with full text were retrieved. The

relevant articles were carefully read and the citation lists of the relevant articles were

examined for titles and abstracts for further relevant studies. Those relevant studies

were further selected manually by inclusion and exclusion criteria. The result of the

search for relevant studies is presented in Appendix A and Preferred Reporting Items

for Systematic Reviews and Meta-Analyses (PRISMA) Flowchart is presented in

Appendix B.

2.1.2. Study selection criteria

Selecting the relevant studies, a number of inclusion and exclusion criteria were

set. The inclusion criteria were studies that 1) involved patients aged 18- 65 year old;

2) involved patients with chronic LBP persistently 12 weeks or more; 3) assessed a

multidisciplinary approach, education or cognitive therapy; 4) had the intervention


conducted in a primary care setting, health center or clinic; 5) were randomized

controlled trials (RCTs); and 6) measured outcomes including quality of life.

The exclusion criteria were studies that 1) had patients involved were under

spinal operation or spinal injection; 2) involved patients having acute LBP only; 3)

had patients diagnosed of spinal stenosis, malignancy, fracture, kyphosis or scoliosis;

and 4) had the intervention conducted in a hospital setting.

2.1.3 Data extraction

Scottish Intercollegiate Guidelines Network (2014) ‘SIGN 50: A guideline

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

recommendations’ was used as the reference to extract and translate data from the

selected studies into table of evidence. The data extracted in this integrated review

include study design, level of evidence, participant characteristics, sample size,

content of the intervention and control arms, length of follow up, outcome measures

and their statistical analysis. Extracting data from the relevant studies in the form of a

Table of Evidence (Table 1) was presented in the Session 2.2.2 Overview of selected

articles and study population.

2.1.4 Appraisal and rating scheme

Scottish Intercollegiate Guidelines Network (SIGN) (2014) was used as the

critical appraisal tool interpreting and evaluating the quality of the selected studies.

Methodology Checklist 2: Randomized controlled trial was used in the quality

assessment based on 13 guiding questions. In addition, corresponding quality was

rated in terms of Level of evidence according to the SIGN grading system. The

checklist is presented in Appendix C.


2.2 Results

2.2.1 Search results

A total of 168 citations were identified by the pre-defined keyword search

strategy conducted from 1st March 2014 to 27

th Apr 2014. After screening the titles

and abstracts, a total of 51 citations from database search were found to be potentially

relevant after randomized controlled trial (RCT) restriction criterion applied. By

manual selection, a total of 9 RCTs fulfilled all the inclusion criteria. Other studies

were excluded by exclusion criteria. However, only 8 RCTs left after screening full

text. Seven studies searched in PubMed were duplicated with Cochrane Library

search that those studies were discarded. No relevant studies were yielded after the

review of reference lists of identified RCTs by manual search. At the end, a total of

eight relevant studies were included for subsequent review and quality assessment.

2.2.2 Overview of selected articles and study population

The characteristics of eight RCTs were formulated in the Table of evidence in

Table 1. An overview of selected articles and study population is described as below.

The eight RCTs were published from 2006 to 2013. Four studies were conducted

in Europe (Finland, Italy and Denmark) and four studies were conducted in Middle

East (United Arab Emirates and Iran). All eight RCTs were conducted in single-center

design that studies were conducted in health care centers or clinics. The sample sizes

were ranged from 33 to 197. In the aspect of interventions, all studies described the

use of multidisciplinary program but the content and field of specialist involved were

varied in method and number. Sources of funding were not disclosed in most studies.


All eight RCT studies stated clearly the focused research questions. In these

seven studies, study population, intervention and outcome measures were specified in

the methodology. Moreover, Tavafian et al. (2013) is the extend study of Tavafian et al.

(2011) in that Tavafian et al. (2013) extended the period of intervention and follow up

from 6 month to 12 month. On the other hand, one single study stated intervention as

spouse assisted multidisciplinary pain management program (SA-MPMP). However,

in this study, patient-oriented multidisciplinary pain management program (P-MPMP)

is presented as one of the three intervention arms that it was still recruited as relevant

article. P-MPMP is compared with standard medical care in the process of data

extraction making the table of evidence.

Most of the selected studies focused on the effect of the multidisciplinary

program on the pain intensity by Visual Analog Scale (VAS) on patients having

chronic LBP as the primary outcome. Some of the studies focused on the quality of

life by Medical Outcomes Study Short Form- 36 Health Survey (SF-36) and disability

by Roland Morris Disability Questionnaire Scale (RMDQ) as outcome measure. Most

of the studies achieved significant results in pain reduction, disability reduction and

improved quality of life after implementing education and exercise in various

multidisciplinary programs. All the relevant results were consistent with other studies.

The sample sizes of each group varied from 11 to 143. While some of the studies

did not lose follow up participants, one study showed a high dropout rate. The reasons

of dropping out include illness, surgery, fall and worsening of pain or for unknown

reasons (Dufour et al., 2010). Moreover, there was no significant difference in

demographic characteristics baseline outcome measures between the intervention and

control groups. The demographic characteristics include age, gender, body weight or

Body Mass Index, employment status, duration of LBP and smoking status.


Table 1. Table of Evidence Bibliographic

citation/

study design Participant characteristics Intervention Comparison Length of FU Outcome measures Intervention vs control

Kaapa et

al. (2006) / RCT

(1+)

N= 120

Mean age=46.0-46.5 Back pain=28-34 (month)

BMI: 25-26.5

Smoker: 28-34% Blue-collar workers: 45-49%

N= 59

6-8 people/group -360 min/day x 5 day x1wk

-2 week home training

-240 min x 2/week x 5wk (Total 70 hrs) 1.CB stress mx and relaxation

2. back school education

3. physical ex

N= 61

60 min X 10 session in 6-8wk Each session

1. 30-40 min passive pain tx

2. 15-20 min light active ex 3. light home ex

24 month

(1) LBP intensity (0-10) (2)Sciatic pain intensity (0-10)

(3) ODI (0-100)

(4) General well-being (0-32)

Mean (SD) @ 24 mon FU

(1) 3.5 (2.6) vs 4.0 (2.9) (p=0.71) (2) 2.1 (2.8) vs 2.7 (2.9) (p=0.39)

(3) 19.7(14.3) vs19.3(13.1) (p=0.71)

(4) after rehabilitation

7.74 (5.45) vs 9.83 (5.4) (p=0.02)

Dufour et

al. (2010)/

RCT

(1++)

N=286

Mean age=40.6-41.2 Male/ Female=

43.4/56.6 vs 44.1/55.9

back pain=18 month Radiation=48.1-54.6

BMI: 26.0-26.8

Smoker: 25.9-34.9 Employed: 55.2-56.6

N=129

120 min x triple/wk x 12 wk 6 people/gp

1.set tx goal

2.stretching ex 3. aerobic &strengthening

4.combined ex

5. education 6. pain mx

N=143

60 min x twice/wk x 12 wk

1.body & leg lifting

24 month (1)VAS (0-100mm)

(2)RMDQ) (0-24)

(3)SF36

a. physical functioning

b. physical component


(1)14.8(27.1) vs 12.1(2.2) (p=0.081)

(2) 3.2(6.4) vs 1.4 (5.4) (p=0.003)

(3)

a.11.2 (23.3) vs 1.6 (20.4) (p=0.000)

b. 5.0 (8.2) vs 1.7 (7.8) (p=0.001)

Morone

et al.

(2011)/ RCT (1-)

N=70

Mean age= 58.6-61.2

Sex Male/female= 17/24 vs 8/21

Back/Leg pain = 18-26month

Weight: 65.2-69.9kg Employed: 32-34%

Smoking: 31-39%

Italian

N=41

10 session

4-5 people/gp 1. general anatomical knowledge, brief

edu. Info. Pain concepts, psy aspects,

stress mx 2.exercise

3.ergonmic use of spine, self-correction,

cope with spine stress

N=29

1.medical /pharmacological

assistance

(usual care)

6 month

(1) SF 36 (0-100)

(2) WI (0-10)

(3) ODI (0-100)

(4) VAS (0-10)

Mean (SD)@ 6month FU

(1)45.0(8.2)vs 42.6(8.4)

Group *time difference

<0.001 (p<0.025)

(2)2.0(1.8)vs 2.9(1.7) (p<0.001)

Group diff = 0.009 (p<0.025)

(3)16.8(14.2)vs 26.0(16.1) (p<0.001)

Group diff=0.011 (p<0.025)

(4) 4.4 (2.5) vs 6.5(1.9) ((p<0.001)

Group diff= 0.000 (p<0.025)

Abbasi et

al.(2012)/ RCT (1-)

N=23

Mean age= 45 Pain duration= 6-276 month

N=12

120 min x 1/wk x 7 wk 6ppl/gp

1. aetiology & tx, self mx: relaxation,

imagery, activity pacing, education, cognitive restricting, goal setting

2. orthopeadic surgeon,

3.physiotherapist 4. psychiatrist 30-60 min

N=11

1. routine treatment based on ordinary medical care

12 month

(1)RMDQ (0-24)

(2)VAS(0-10)

(3)Tampa Scale of

Kinesiophobia


(1) 8.8(5.9)vs10.4 (6.2)

F-value (df) 5.50(2,22), p=0.01

Effect size= 0.33

(2) 3.7 (2.5) vs 4.3(1.4)

F-value (df) 4.05 (2,22), p=0.032

Effect size= 0.27

(3) 25.1 (6.9) vs 29.7 (9.6)

F-value (df) 4.94 (2,22), p=0.01

Effect size = 0.31


Bibliographic

citation/study

design

Participant characteristics Intervention Comparison Length of

FU

Outcome measures Intervention vs control

Monticone et al.

(2013)/

RCT (1++)

N=90 Mean age= 48.96-49.71

Sex M/F=18/27 vs 20/25

Pain duration=25.15-26.33 Pain limb

involvement=19/26-16/29

Italian

N=45 60 min x once/wk x 5 wk60 min monthly

1. modify fear of movement belief

2. catastrophizing thinking 3. negative feelings

4. gradual reactions

5. correct relearning and cognitive reconducting

6. stretching muscle

7. Postural control

8. Manual therapy

N=45 60 min x twice/wk x5wk

(10session)

1. stretching &strengthening muscle

2. postural control

3. manual therapy

4. ergonomic advice

12 month (1) RMDQ(0-24)

(2) TSK (0-100)

(3) NRS (0-11)

(4) SF 36 (0-100) a. physical functioning

b. physical role

c. physical pain

d. general health

e. vitality

f. social functioning

g. emotional role

h. mental health

Mean (SD) @ 12 mon FU (1)1.40(1.19)vs11.07(2.22), interaction effect 126.6 (p<0.001)

(2)17.67(1.62) vs 40.96(5.17), interaction effect 327.2(p,0.001)

(3)1.47(1.10)vs6.24(0.85), interaction effect 92.7(p<0.001)

(4)

a.87.56(18.35)vs65.00(17.74), interaction effect 5.3(p=0.02)

b. 88.00(17.97)vs62.67(17.3), interaction effect 4.2(p=0.007)

c. 80.42(13.2)vs61.78(13.93), interaction effect 15.8(p<0.001)

d. 86.33(13.24)vs63.11(15.01), interaction effect 19.9(p<0.001)

e. 91.33(10.35)vs56.22(10.50), interaction effect 29.7(p<0.001)

f. 92.33(9.20)vs 52.50(10.18), interaction effect 33.2(p<0.001)

g.93.11(13.45)vs60.74(12.88), interaction effect 6.2(p=0.01)

h.91.02(11.28)vs58.84(11.80), interaction effect 44.6(p<0.001)

Nazzal et al. (2013)/

RCT (1+)

N=100 Mean age= 49.4-49.8

Sex M/F= 17/33 vs 18/32

weight= 64.4-65.2 Arabia nationality

N=50 1.Continuous USG x 10 min

2.TENS x 30 min

3.aerobic 4.resistive

5.stretching

6.flexibility 7.postual ex

8. massage

9.education

10.occupational therapy

N=50 120 min/day x 5 day/wk

x 6 wk

1.intensive therapist assisted back muscle

strengthening exercise

6 month (24 week)

(1)VAS (0-10cm)

(2)McGill (0-78)

(3)ODI (0-100)

(4)extension

(5)Flexion

(6)Rt lateral bending

(7) Lt later bending

(8) ability to work


(1) 4.5(1.2) vs 5.6(1.5) (p=0.0001)

(2)25.2 (11) vs 36(12.2) (p=0.0001)

(3)20(11.5) vs 31(12.8) (p=0.0001)

(4) 3.9(0.6) vs 3.5(0.3) (p=0.0001)

(5)15.2(1.2 )vs 14.1(0.9) (p=0.0001)

(6) 45.2(3.7) vs 47.9(3.0) (p=0.0001)

(7) 45(4.6) vs 48.2(3.4) (p=0.0001)

(8) 30(60) vs 17(34) (p=0.04)

Tavafian et

al. (2011)/ RCT (1+)

N=197

Mean age=44.6-45.9 M/F= 71/26 vs 83/17

Weight=71.9-72.8kg

Smoking: 4-7.2% Duration of CLBP:

75.9-88.5month

Sciatica: 83-86% Iranian

N=97

120 min x 5 class in a week

1.medication as needed

2.theoretical physio class

3.practical physio 4.rheumatology class

5.psychology class

6.health edu class 7. monthly booster class: motivational consultation

8.monthly telephone counseling

N=100

1.medication as needed 2.Analgesics,NSAID,

muscle relaxants,

anti-depressant drugs

6 month

(1)SF 36 (0-100)

(2)QDS (0-100)

(3)RDQ (0-24)

Mean (SD) @ 6month FU

(1) (Not significant)

(2) 18.65(16.14)vs27.19(17.85) (p<0.05)

Group x Time Difference <0.0001

(3) 7.03(5.49) vs 8.80(5.68) (p>0.05) Group x Time difference =0.01

Tavafian et

al. (2013)/

RCT (1+)

N=178

Mean age=44.6-46.2

M/F= 65/22 vs 75/16

Weight=71.8-72.3kg

Smoking: 4-5% Duration of CLBP:

70.4-97.08month

Sciatica: 74-77% Iranian

N=87 (120 min x 5/week)


2.theoretical physio class

3.practical physio

4.rheumatology class 5.psychology class

6.health edu class

7. monthly booster class: motivational consultation 8.monthly telephone counseling

N=91


2.Analgesics,NSAID,

muscle relaxants,

anti-depressant drugs

12 month (1) SF 36 (0-100)

a. physical functioning

b. physical role

c. physical pain

d. general health

e. vitality

f. social functioning

g. emotional role

h. mental health

(2)QDS (0-100)

(3)RMDQ (0-24)

Mean (SD) @12 month FU *(p<0.05)

(1) a.80.3(18.6) vs64.6(22.8)* Gp*Time Diff=0.02

b. 72.4(37.3) vs56.04(38.4)*

c.69.5(18.3) vs56.2(21.3)*

d.69.6(21.7) vs59.9(24.3)*

e.70.3(22.5) vs63.1(22.5)*

f.81.6(19.3) vs70.05(27.4)*

g.72.4(42.3) vs53.1(46.6)*

h.71.8(20.2) vs58.9(24.9)*

(2)17.4(16.4)vs24.4(18.3)*

(3)6.01(5.8) vs8.9(6.6)*


2.2.3 Methodological quality

Six RCTs were methodologically strong, with two studies graded as 1++ in level

of evidence while four studies graded as 1+. The remaining two RCTs were graded as

1- because of small sample size. In all the selected studies, the research purposes were

clearly stated.

All the eight RCTs performed randomization that three studies used block of 12

or 20 patients while four studies used number list or chart for randomization. One

study (Morone et al., 2011) just randomly assigned the participants to intervention and

control group on 3:2 ratio. Seven RCTs reported allocation concealment by either

opaque sealed envelope (Kaapa et al., 2006), an separate secretary (Dufour et al.,

2010 & Nazzal et al., 2013), blinded treatment codes (Abbasi et al., 2012 &

Monticone et al., 2013) or concealed to the physicians by patients not disclosing their

group assignment (Tavafian et al., 2011 & Tavafian et al., 2013). All studies reported

that the comparison groups were treated equally except the interventions. Most of the

studies blinded the patient while two studies (Tavafian et al., 2011 & Tavafian et al.,

2012) reported that full blinding of patients was impractical due to the nature of the

intervention.

All the relevant outcomes were measured in a standardized, valid and reliable

way in the eight RCTs. Most of the studies reported acceptable dropout rate from 0%

to 17% while one study (Kaapa et al., 2006) reported overall 21% dropout rate. Some

studies (Kaapa et al., 2006, Abbasi et al., 2012, Tavafian et al., 2011 & 2013) showed

no intention-to-treat analysis because the number of participants dropping out was not

significant. All the eight RCTs demonstrated to be statistically powerful that the

overall effect was due to the interventions of the studies.


As of the above quality assessment, two of the eight RCTs were further excluded

from the synthesis process owing to poor quality in methodological assessment. They

have small sample sizes (Morone et al., 2011 & Abbasi et al., 2012) and uneven 3:2

ratio randomization and group allocation in comparison groups (Morone et al., 2011).

Overall, the six remaining RCTs were demonstrating moderate (1+) to good (1++)

quality. The quality assessment of the individual study is formulated in Appendix C.

2.3 Summary and Synthesis

2.3.1 Summary of the reviewed studies

The integrated review of the six reviewed studies suggested that there was

sufficient evidence to support the use of multidisciplinary primary care program in

patients with chronic LBP. In the final six reviewed studies, the patient populations

were generally homogenous in Europe and Middle East population. They represented

a spectrum of chronic LBP patients resembling in Hong Kong local clinical setting.

The demographic characteristics such as age and the severity of illness across studies

were similar. The mean age ranged from 40 - 50 years and the duration of LBP ranged

from 18- 97 month.

The content of the multidisciplinary primary care program in patients with

chronic LBP was based in the combination of different inventions including education,

medication (Tavafian et al., 2011 & 2013) physical and psychological intervention.

Education included anatomy and physiology of LBP, theoretical physiotherapy and

rheumatology class and health education (Kaapa et al., 2006, Dufour et al., 2010,

Nazzal et al., 2013, Tavafian 2011 & 2013). Physical interventions included postural

control, manual therapy, use of ultrasound and TENS, massage, physical exercise

(stretching, aerobic, strengthening, resistive exercise) and occupational therapy


(Dufour et al., 2010, Nazzal et al., 2013, Tavafian et al., 2011 & 2013). Psychological

interventions included goal setting, cognitive-behavioral stress management,

relaxation, modifying fear of movement belief, management of catastrophizing

thinking and negative feelings, gradual reactions, correct relearning and cognitive

reconducting (Kaapa et al., 2006 & Monticon et al., 2013). All the multidisciplinary

programs were conducted by trained specialist including physicians (rehabilitation

medicine, orthopedic surgeon or rheumatologist), physiotherapist, occupational

therapists, psychologist and health education specialist. There was no major adverse

event reported in the reviewed studies.

The number of participants per group in each multidisciplinary program was

generally six to eight people. The programs were conducted over various time periods,

from an intensive schedule of 5 days per week plus two times per week for 5 weeks

(Kaapa et la., 2006), twice for 5 weeks (Monticon et al., 2013), 5 day per week for 6

weeks (Nazzal et al., 2013), 3 days per week for 12 weeks (Dufour et al., 2010) to 5

classes in one week followed with monthly booster class for 6 or 12 months (Tavafian

et al., 2011 & 2013). The duration of follow up ranged from 6 to 24 months after

completion of the intervention. In the control group, participants received usual care

or standard medical care such as pain medical consultation, medication, light and

passive exercise.

The venues of the multidisciplinary programs were located in outpatient setting,

healthcare center or research center. Subsequently, participants were encouraged to

continue exercise two to three times per week during home training period for 2

weeks (Kaapa et al., 2006).


Several different tools were used to assess the level of LBP, disability and quality

of life of the participants. Some reported large effect size in some part of the outcome

than the others. Five of the six studies used SF-36 or General Well-being Scale to

measure quality of life which showed significant effect in four studies. Four of the six

studies used LBP intensity or Visual Analog Scale (VAS) or Numerical Rating Scale

(NRS) or McGill to measure pain intensity which showed significant improvement in

two studies. Five of the six studies used Roland Morris Disability Questionnaire

(RMDQ) or Oswestry Disability Index (ODI) or Quebec Disability Scale (QDS) to

measure the disability which showed significant effect in all five studies.

2.3.2 Synthesis and recommendations

In view of the evidence-based recommendations, the multidisciplinary program

consisted of different combination of program content, field of specialists, duration of

intervention and time intervals to follow up. Up to this juncture, there has been no

review article identifying any protocol of multidisciplinary primary care program in

patients with chronic LBP. Therefore, a new innovated multidisciplinary program

design is formulated by comparing the effect size of each outcome measures to obtain

optimal result. The result of the reviewed studies can be generalized into local setting

by the involvement of different fields of specialty.

In view of all the studies, Monticone et al. (2013) and Tavafian et al. (2013)

reported higher effect size of the outcome measures, including quality of life (SF-36)

and disability (RMDQ) than two other studies (Kappa et al., 2006 & Dufour et al.,

2010). Also, Nazzal et al. (2013) and Monticone et al. (2013) reported higher effect

size of pain intensity (NRS and VAS) than these two studies (Kappa et al., 2006 &

Dufour et al., 2010). Therefore, the content and schedule of the multidisciplinary


program can be summarized from Monticon et al. (2013), Nazzal et al. (2013) and

Tavafian et al. (2013) in order to obtain optimal effect of the outcome for the

innovated multidisciplinary program.

The multidisciplinary program should be conducted in the rehabilitation center or

clinic (Monticone et al., 2013 & Tavafian et al., 2013) The multidisciplinary program

should be most beneficial to the group of population aged between 44-50 years old

with chronic LBP for 25-97 month (Monticone et al., 2013, Nazzal et al., 2013 &

Tavafian et al., 2013).

The number of participants per each group was suggested to be six to eight

(Kaapa et al., 2006 & Dufour et al., 2010). As Monticone et al. (2013) reported higher

effect size than Tavafian et al. (2013) in terms of quality of life and disability, the

multidisciplinary program is suggested to be conducted 60 min per session, once per

week for 5 weeks then followed by 60 min monthly booster class (Monticone et al,

2013). Monthly booster class is also reported to be essential as shown in Tavafian et

al., (2013).

The multidisciplinary program is suggested to include the following intervention

components. Psychological interventions include modifying fear of movement belief,

catastrophizing thinking, negative feelings, and gradual reactions, correct relearning

and cognitive reconducting (Monticon et al., 2013), in conjunction with motivational

consultation and telephone counseling (Tavafian et al., 2013). Physical exercise

interventions include postural control, manual therapy (Monticon et al., 2013),

exercise (aerobic, resistive, stretching, flexibility, postural), ultrasound, TENS and

massage (Nazzal et al., 2013). Occupational therapy includes on back care and lifting

techniques (Nazzal et al., 2013). Medical interventions include physician consultation

and prescription of anti-pain medication (Tavafian et al., 2013).


Education components include theoretical physiotherapy knowledge, anatomy

and physiology of LBP, stress management and cognitive behavioral interventions for

LBP (Tavafian et al.2013). The education is conducted as 5 initial classes finished

during the first week. Each class is suggested to be a two hour session concerning

physiotherapist, rheumatologist, psychologist and health education specialist.

By comparing the original study (Tavafian et al., 2011) with the extended study

(Tavafian et al., 2013), the former, which had only a 6-month follow up only reported

significant effect on the improvement of Quebec Disability Score (QDS). However,

the extended study (Tavafian et al., 2013) with 12-month follow up reported

significant effect on the improvement of Quality of life (SF-36) and disability (QDS

and RMDQ). Therefore, the multidisciplinary program should be at least 12 months

long. Moreover, Dufour et al. (2010), which conducted the multidisciplinary program

up to 24 months of follow up, reported there was also significant effect in the

improvement of physical functioning and physical component of SF-36 at 12-month

follow up. Therefore, it was suggested that the duration of the multidisciplinary

program should be up to 12 months.

In conclusion, all reviewed studies demonstrated that multidisciplinary program

was able to improve quality of life, significantly reduce pain intensity and disability in

patients with chronic LBP in primary care. Thus, the proposed guideline of using

multidisciplinary primary care program in patients with chronic LBP can be assessed

in the local setting.


Chapter 3

Translation and Application

3.1 Implementation Potential

3.1.1 Target audience and setting

The target setting comprises five Family Medicine clinics of a governmental unit

in Hong Kong, which serves a population of around 0.6 million target population. The

clinics provide quality primary care services including physician consultations, nurse

assessments, health education, dietitian consultations, pharmaceutical services and

collaboration referral to and from other departments such as orthopedics, clinical

psychologist and physiotherapy.

Every month, there are around 18 new chronic LBP patients aged 18 or above in

a clinic. In total of five clinics, there are around 90 new chronic LBP patients every

month and up to 1200 new patients every year. The existing findings showed that

multidisciplinary chronic LBP program may improve quality of life and decrease pain

intensity of the patients (Dufour 2010, Morone 2011). All included studies conducted

in foreign countries shared a common feature that chronic LBP patient care

(Monticone 2013, Nazzal 2013& Tavafian 2013) was performed by physicians,

physiotherapist, psychologist and health educators. Currently in Hong Kong, such

multidisciplinary approach for chronic LBP patient care has not been widely adopted

in local families clinics. Furthermore, no guideline is available for nurse-led

multidisciplinary primary care program for patients with chronic LBP in local clinics.

3.1.2 Transferability of findings

The target population in both the local setting and the included trials with high

similarity in terms of the basic demographic characteristics are presented in Table 2.


Table 2

Comparison of baseline demographic characteristics of patients between Families

clinics and the four included studies

Demographics Families

Clinics *

Monticone et al.

(2013)

Nazzal et al.

(2013)

Tavafian et al.

(2011)

Tavafian et

al. (2013)

Total population considered (N) 90 90 100 197 178

Gender Male (n (%)) 40 42.2 35 21.9 21.45

Female (n (%)) 60 57.8 65 78.1 78.55

Age (years)(mean) 47.5 48.9-49.7 49.4-49.8 44.6-45.9 44.6-46.2

Married 80 66.7 -- 82.0-86.6 83.5-86.2

Employed 80 85.6 -- -- --

Physical activity 30 43.3 -- -- --

Education (high school or above) 80 44.4 -- 50 50

Weight (kg) (mean) 70 -- 64.4-65.2 71.9-72.8 71.8-72.3

Pain duration (month) 25-27 25.2-26.3 -- 75.9-88.5 70.4-94.08

Pain limb involvement (%) 30 38.9 -- 85.6-86.9 85.1-85.6

VAS (0-10) 7.5 7.02 6.0-6.1 -- --

Tampa Scale for

Kinesiophobia (0-100)

-- 41.67- 41.78 -- -- --

Roland Morris Disability

Questionnaire (0-24)

-- 15.27-15.00 -- 9.80-10.04 5.09-5.3

McGill Pain Scale (0-78) -- 44-44.1 -- --

Oswestry disability (0-100) -- 39.1-39.2 -- --

SF-36 (0-100)

Physical functioning

Physical role

Physical pain

General health

Vitality

Social functioning

Emotional role

Mental health

--

47.22-48.33

29.44-31.11

38.24-41.36

34.00-36.67

52.00-52.56

50.83-51.56

39.26-39.26

50.13-52.09

--

54.53-54.61

30.70-32.81

43.27-47.45

49.92-50.41

53.58-53.95

62.22-63.02

38.04-49.65

44.00-47.43

22.7-23.8

36.4-43.1

22.2-23.7

19.7-19.7

19.2-20.3

23.9-29.06

19.7-39.7

13.2-13.5

No. of sick leave (Day) 5 -- 10 -- --

Physiotherapy referral

(per month)

20 -- -- -- --

Orthopedics referral

(per month)

1 -- -- -- --

Lumber Spine X-ray

(per month)

20 -- -- -- --

Health Education

(per month)

10 -- -- -- --

*Data extracted from five families clinics for chronic LBP patients from January 2014

to December 2014.


In people with chronic LBP, female patients slightly outnumbered male patients

in the local setting. The gender distribution in the included studies and local setting

are similar. Moreover, the local setting had individuals aged 45-55 years with chronic

LBP which are again similar to those considered in the included studies. In addition,

the average pain duration in both groups was 25-27 month with weight 64-73kg. The

above information shows the homogeneity of patient between the included studies and

the local setting.

The only difference between the local setting and the included studies is their

ethnicities. The target population in this guideline only focuses on Chinese, whereas

the population of the included studies was composed of Italian and Sandi Arabian.

However, there is still no proven evidence suggesting that multidisciplinary program

works differently in individuals of different race or ethnicity.

The quality of life and disability of the patients in the local setting are not

measured that those parameters are not comparable with the included studies. In view

of pain intensity, the patients with chronic LBP in the local setting appears to have

slightly higher pain level by VAS score than those considered in the included studies

(Monticone 2013, Nazzal 2013, Tavafian 2011 & Tavafian 2013).

In considering the philosophy of care, the underlying principles delivered in this

innovation is basically the same as that in the local setting which aims to provide

quality assured personal health services in primary health care (PDQA, 2004). The

physicians and nurses are delivering patient health education, referring physiotherapy

and prescribing pain killer medication to alleviate the physical complications of

chronic LBP. The prevailing philosophy of both groups is entrenched by shortening

the treatment waiting time and providing quality care for better patient outcome

treating chronic LBP in the primary care.


The size of population gaining benefit from this guideline-led multidisciplinary

program will be large. In the local setting, LBP syndrome accounts for 1648

consultations in 2005. The incidence of chronic LBP varies significantly among

clinics that the prevalence of chronic LBP consultation for patients aged 18-65 years

old ranges from 0.9 to 2.4% in 2009 (Cheng, 2011). Based on the data from the local

setting, the number of patients who will benefit from the proposed change in all five

clinics is nearly 1200 per annum.

Most of the patients are referred to Hospital Authority (HA) for physiotherapy

and X-ray assessment on lumber spine. Nearly none of them were referred to

Special-outpatient clinic of orthopedics department or hospital for advanced tertiary

care. Most of the chronic LBP cases are indicated to be managed under primary care

instead. Therefore, the multidisciplinary program would benefit sufficient number of

chronic LBP patients in appropriate level of care with high cost-effectiveness.

Multidisciplinary program uses bio-psychosocial approaches which include 5

hours of cognitive behavioral intervention, 17 hours of supervised physical exercise

sessions, 12 hours of monthly motivational consultation and additional 12 monthly

sessions of 15-minute individual telephone counseling. The innovation takes about

five weeks in instructive phase and 12 months in reinforcement phase. The monthly

booster class aims to sustain the effectiveness in improved quality of life and reduced

pain intensity. Moreover, telephone counseling motivates the patients with chronic

LBP to adapt healthy behaviors and to comply with individual home exercise. The

effect of multidisciplinary program on patients with chronic LBP is usually long after

completion of the intervention (immediate to 12 months follow up period). As such,

the follow up period of the new program will be carried out till one year after

implementation. The total time before the full implementation of the guideline will be


16 months including 6-month communication process and 10-month pilot study. In

summary, the patients in the clinics and included studies shared similar characteristics.

This guideline-led program can be successfully translated into the local primary care

setting and benefit reasonably large number of target population.

3.1.3 Feasibility

The feasibility of implementing multidisciplinary program in the target clinics

concerns about the potential of the proposed innovation in the area of staffing,

environment, and program evaluation. Nurses in the clinics services have the freedom

to carry out the innovation provided that strong evidence-based guidelines are

submitted for Consultant and Senior Nursing Officer to consider change of practice.

Strong administrative support plays a strong role to grant for clinical projects

implemented in the clinic. Since 2002, the local setting has already shown

collaboration with other services (PDQA, 2014). Continuous support from senior

management helps in the implementation of evidence-based clinical guidelines.

The consensus of the implementation of the program can be reached through

discussion among stakeholders such as consultant, medical officers, nursing officers

and registered nurses. Especially, consensus should be obtained from the Consultant

who delegate the physiotherapist and psychologist of other accredited organizations as

the trainer of this program. Previously, implementation of evidence based clinical

guidelines in local setting was a success. A dietitian was delegated from an

organization to provide training for the nurses in Family Medicine Service. It showed

that the senior management is willing to provide and support advanced training as for

staff development and service needs. The consensus among stakeholders can therefore

be easily reached.


In view of staff level in the target clinic, there are seven registered nurses and

one nursing officer. Three nurses are experienced and have worked in clinic for more

than 10 years and one have completed public health specialty training. Although none

is excellently qualified with the knowledge and skills of multidisciplinary program

such as physiotherapy or psychology, most of them are experienced in managing

patients using health education and simple back exercise demonstration.

Currently, the nurses are required to conduct smoking cessation program and

support groups for the patients with hypertension, diabetic mellitus and obesity. With

support from the service department in terms of training fund and full-pay study day,

all nurses are able to attend the training of the proposed program. The staff is

benefited from career development and in-service training in this new innovation.

Moreover, nurses are able to minimize their work-load of daily, repeated health

education interview for each of the chronic LBP patients. It is very likely that the

establishment of multidisciplinary program will be appreciated by the nurses.

On the other hand, some nurses may feel stressful because of inadequate

professional knowledge on physiotherapy and psychology. Any inappropriate use of

guideline may lead to legal actions due to breach of duty or negligence. With proper

training and supervision from respective specialist, the expected risk can be

minimized. Support from the physician is also important because the proposed

guideline involves a multifaceted care model. Furthermore, the staff may complain of

increased workload. Manpower allocation would need to be considered by senior

management for duty arrangement and staff development.

Identifying nurses having training with the implementation of this new

innovation in the local setting is totally feasible. Each nurse would be responsible for

specialized field of knowledge and skills. Job division will facilitate efficient running


of the program. In order to maximize the number of chronic LBP patients benefited

from the program, all five clinics are required to conduct the program in parallel. The

implementation of the innovation may cause friction among clinics. With the authority

dedicated by the senior management, the other clinics are strongly motivated to follow

and support the guideline. Moreover, open communication, consistent resource

persons and staged training are the effective strategies in ensuring a successful

guideline-led multidisciplinary program (Tavafian et al., 2011).

In terms of the environment, there is lack of equipment for carrying out

physiotherapy in the clinics. The support of purchase additional physiotherapy

equipment in this program is granted from the Consultant. A large activity room

should be available for the exercise to ensure patient safety.

The program retains high potential to perform evaluation. The efficacy of the

new innovation can be evaluated by measuring pain intensity, quality of life and

disability by assessing tools such as VAS, SF-36 and RMDQ. Pre-program

assessments will be performed and further evaluations will be carried out at the end of

instructive phase and followed with the third, sixth, ninth and 12th

month after the end

of instructive phase. The assessments will be arranged on the same day as a patient

engaged in reinforcement phase (1st month to 12

th month). According to the included

studies (Tavafian, 2011 & Tavafian, 2013), the most suitable time to conduct

evaluation is between the sixth to the twelfth months after program intervention.

Therefore, the long term benefit of the program cannot be accurately measured and

evaluated until after the twelfth month.


3.1.4 Cost-benefit ratio of the innovation

The costs and benefits associated with the multidisciplinary program can be

analyzed in several levels: individual (patient and nurses), institution (clinic) and

community (Hong Kong health care system).

The potential risks of maintaining the current practices are prolonged waiting

time before receiving physiotherapy in HA. Also, the brief health education materials

provided to the nurses are outdated and it can only be delivered by simple verbal

education. Indeed, the patients need a practical session on physical exercises and a

holistic care plan for chronic LBP with multidisciplinary components.

From the perspective of the patients, the main cost of the patient is the time spent

for the intensive multidisciplinary session. However, the most obvious benefit for the

patients is the reduction in LBP intensity and enhanced quality of life by safe and

effective interventions of the multidisciplinary program. The studies of Nazzal et al.

(2013) had showed that pain intensity was reduced by 25% in VAS average pain score

and 49% in McGill average pain score at the end of treatment period. Monticone et al.

(2013) reported a significant reduction in fear avoidance by 24 points in Tampa Scale

for Kinesiophobia (0-100) after treatment. Furthermore, patients with chronic LBP

increased the ability to work from 20% to 50% at the end of 6 weeks treatment and

maintained to 60% at 24 weeks follow up (Nazzal et al., 2013).

The potential non-material costs of implementing this innovation are

absenteeism and lower morale of staff. The staff may reject the program because of

increased the workload of others. On the other hand, the non-material benefits may

include improved patient care by quality service enhancing clinic reputation and staff

development in a long run.


From the clinic perspective, the associated costs in implementing guideline-led

multidisciplinary primary care program can be divided into two parts: set up costs and

operational cost. The set up costs include training costs, equipment, trainer salary and

making of power point. The costs for setting up the program is HKD $ 86,827. The

operational costs includes nursing salary, progress notes paper and education materials.

The annual operational cost for running the program is HKD $ 87,465. The total cost

of the program for a one year program is estimated as HKD $ 174,292 (Appendix D).

On the other hand, the cost benefit is that the number of physician consultation

will be decreased and saving HKD $13,500/ year in five clinics. The use of anti-pain

medication will be reduced and resulting in saving HKD $10,800/ year in five clinics.

On the other hand, the local setting is benefited by paying less for the physiotherapy

service under HA. Since less patients are referred for out-service physiotherapy, the

local setting is saving the largest sum of money up to HKD $ 711,600 per year.

Overall, the gain is much more than the cost in the implementation of the proposed

intervention. The total cost gain after implementation of the one year program will be

HKD $ 537,308 per year (Appendix E).

In view of the Hong Kong health care system, the main benefit is the reduction

of health care cost in specialist orthopedics consultation, X-ray assessment for lumbar

spine and prolonged waiting time in physiotherapy. Furthermore, a number of patients

may be able to lessen sick leaves and return-to work, which will enhance the

productivity and economic performance of the society.

In conclusion, the benefits of this innovation can outweigh its costs. With the

implementation of a systematic plan, this guideline-led multidisciplinary program has

great potential to be implemented in the clinics.


3.2 Evidence-based Protocol

The guideline development process was based on the Scottish Intercollegiate

Guidelines Network (SIGN) (SIGN, 2014). Details on the development process were

discussed in Chapter Two. In this evidence-based guideline, Scottish Intercollegiate

Guidelines Network [SIGN] (SIGN, 2014) presented in Appendix F was adopted to

illustrate the level of evidence and grade of recommendation of each evidence-based

recommendation. An Evidence-based Guideline of using Multidisciplinary Primary

Care Program in Patients with Chronic Low Back Pain is presented in Appendix G.


Chapter 4

Implementation Plan

4.1 Communication Plan

4.1.1 Identifying stakeholders

The organizational structure of the Quality Assurance (QA) Service is shown in

Appendix H. The following stakeholders are identified:

1. The Consultant and Senior Nursing Officer (SNO) are the administrators who are

responsible for the clinic operation, resources allocation and manpower

deployment.

2. A Medical Officer (MO) of the QA Service Planning Committee is the opinion

leader who has strong influence on clinical practice.

3. A Nursing Officer (NO) of the QA Service Planning Committee is responsible to

allies all the nurses among the five clinics for implementation of the innovation.

4. A Registered Nurse (RN) of the QA Service Planning Committee who draws up

evidence-based guideline for multidisciplinary program. She is responsible to

initiate and guide the practice change in the implementation of new guideline.

5. A NO of each clinic (in total of 5 NOs) acts as the clinic coordinator who is the

supervisor of implementing the program in clinic level.

6. Two QA nurses of each clinic (in total of 10 RNs) act as the program providers

who implement the program for patients with chronic LBP in clinic level.

7. All the clinic clerical staff who are responsible to prepare the progress sheet and

assessment forms for the program.

8. All the clinic workmen who are responsible to set-up and clean-up of the

equipment.


4.1.2 Communication process

In the first month, a working group which involves a MO, a NO and a RN from

the QA Service Planning Committee will be formed. The RN acting as the chairman

of the working group will also be the Project Coordinator. With the support of the

working group, the Project Coordinator will propose a meeting for the QA Service

Planning Committee. In the meeting, the Project Coordinator will initiate the change

of practice in managing patients with chronic LBP to the SNO and the Consultant.

The evidence-based guideline will be submitted to the Committee for consideration.

Also, the working group will convince the administrators about the feasibility, cost

benefit of the guideline and timetable of implementation. At the end of the meeting, it

is expected that both the Consultant and the SNO will approve the change of practice

and adapt the new clinical guideline.

In the second month, the working group will purpose the draft guideline, present

the relevant evidences and start to convince all the stakeholders in a clinic meeting.

The clinical guideline will be well consulted among the stakeholders within one

month after the meeting. The working group will collect all the comments from the

stakeholders and revises the draft guideline.

In the third month, the working group will approach SNO for preliminary

consultation on the feasibility of the revised guideline in a month. Administrative

support such as funding, training and job allocation will be discussed.

In the forth month, the revised guideline will be submitted to the Consultant for

comment in a month. The working group will further convince the Consultant about

the cost-effectiveness of the guideline, positive impact of the program and safety of

the innovation. Then, the guideline will be revised and finalized before endorsement.

Moreover, the working group will seek support from the Consultant and SNO to solve


the feasibility issues identified such as seeking manpower deployment in increased

nursing workload, seeking support in staff education fund for arranging practical

training to develop staff competence in implementing the guideline, purchasing

additional equipment and granting an exercise room for the program.

In the fifth month, once endorsement of guideline is obtained from the

Consultant, the working group will publish the finalized guideline and guide the

practice change. Promotion of the new innovation will be performed and resource

manual will be circulated among the stakeholders in a month.

In the sixth month, the working group will conduct a clinic meeting and

announce the implementation of guidelines to all the stakeholders. In clinic level, each

clinic will involve one clinic coordinator (NO), two QA Nurses (Program provider),

clerks and workman who are going to implement the guideline. The aims of the

meeting are to deliver the implementation plan of the guideline and to delegate roles

and responsibilities of each party. All the queries will be collected and responded by

the working group simultaneously in the clinic meeting.

Communication takes 6 months before the pilot study commences. Then, the

working group will conduct weekly meeting with the program providers to facilitate

the implementation of new guideline in pilot test. The total time for pilot study will be

10 months before the full implementation of the innovation. Once the program is fully

implemented, the working group will continuously conduct in-service communication

with all the stakeholders every month. Problems encountered during the

implementation will be discussed among the stakeholders and the working group. In

order to ensure the sustainability of the program, regular evaluations of the program

will be performed and discussed in the monthly clinic meeting. A proposed planning

timeline for multidisciplinary chronic LBP program is shown in Appendix I.


4.2 Pilot Testing Plan

4.2.1 Timeline of pilot test

A pilot test will be conducted in a pilot clinic to evaluate the feasibility of the

guideline with a smaller group of patients in local setting. The pilot study will start

from the 1-month preparation of pilot program in which nurse training and

preparation of the material will be included. Then 18 pilot patients will be recruited in

a month. The pilot program will take seven months in which five weeks for instructive

phase and 6 months for reinforcement phase will be conducted. Outcome

measurement of pilot program will be conducted at baseline, end of instructive phase

and every three months in reinforcement phase. Evaluation of pilot will take one

month after the end of pilot program that data analysis and discussion of the pilot

results with the working group will be conducted. Possible refinement of the

guidelines will be made. As such, the whole pilot study will take approximately 10

months before full implementation of the guideline.

4.2.2 Training workshop

One month before the pilot program, the working group will arrange a two day

training workshop for the program providers. In total, 10 QA nurses (RN) and five

clinic coordinators (NO) will be trained on the knowledge and skills required in the

implementation of LBP program. Orthopedic surgeon, psychologist, physiotherapist

and nurse specialist will be invited to provide training on physiology of LBP,

psychological coping skills, theory and practicum of exercise, nursing care on LBP

and health promotion skills respectively. The training will require two full days with

each professional conducting a half day workshop. Group discussion and individual

performance feedback will be included.


4.2.3 Measurements of pilot test

The pilot test will determine the feasibility of implementing the new innovation

in the local setting. The clinic coordinator (NO) will assess the compliance of the

nurses in the pilot test, the degree of nursing workload, the acceptance of the patients

towards the program and the logistic issues of implementing the program.

4.2.4 Patient recruitment

Eighteen eligible patients will be recruited in a month in a clinic to participate in

the pilot test. Based on the selection criteria set out in the evidence based guideline,

the case physicians are responsible to refer the potential chronic LBP patients to

participate in the program. The Project Coordinator will approach these patients to

explain the details of the program. Informed consent will be obtained.

4.2.5 Intervention

Two QA nurses will provide the program for 18 patients who are divided into

two groups with nine patients in each group and one clinic coordinator (NO) will act

as the supervisor. Multidisciplinary primary care program will be delivered in the

clinic activity room of the pilot clinic for 13 months. A multidisciplinary program of

ten sessions in instructive phase and twelve monthly booster classes in reinforcement

phase will be conducted. In the pilot test, the working group and the clinic coordinator

(NO) will supervise the QA nurses in each session to ensure the delivery of the pilot

test with high quality. Any discrepancy among nurses in the decision making will be

documented for further investigation. If there is any violation of the guideline

jeopardizing the safety of patients, the program will be ceased immediately by the

working group.


At the beginning of the first session, the two QA nurses will take the baseline

assessment of the patient by questionnaires. Then, further assessment will be

conducted in monthly booster class. The QA nurses will complete the progress note of

individual patient after each session (Appendix K). Before the termination of the pilot

test, the case physician will be informed of the results of respective patients.

4.2.6 Evaluation of pilot test

During the pilot test, the Project Coordinator will conduct weekly evaluation

meeting with the stakeholders of the pilot clinic to collect comments on the various

situations they encountered and the feedback from the patients. This will allow early

identification and provide adequate time for the working group and program providers

to assimilate transition of the new program.

On the completion of the pilot program, evaluation of the pilot test will take one

month that it aims to address the feasibility of implementing innovation in the local

setting. The working group will conduct an evaluation meeting with all the

stakeholders in the pilot clinic. In view of logistics, any factors affecting the

implementation of the program will be identified. Staff acceptance and workload will

be discussed and the data of patient health outcomes will be assessed and discussed.

The acceptance of patients will be evaluated by the dropout rate and data from group

qualitative interview. Furthermore, the working group will then present the results of

pilot test to all the stakeholders in a clinic meeting. Necessary change of the

implementation plan and guideline will be made after evaluation. In total, the pilot

study including preparation, training, recruitment, pilot program, discussion of the

pilot results with the working group will take approximately 10 months before full

implementation of the guideline.


4.3 Evaluation Plan

4.3.1 The objectives of evaluation

Evaluation of the program which focuses on both the process and outcomes of

the innovation will aim to determine the effectiveness of the new innovation, to

provide evidence quantifying the accountability of the stakeholders, to ensure the

sustainability of the program in the local setting, to ensure appropriate use of

resources for better patient outcome and to enhance the modification of the guideline.

4.3.2 Identifying outcomes

First, patient outcome is the benchmark for assessing the clinical benefits of the

innovation. Pain intensity is the primary outcome measure for the effectiveness of this

program. Pain intensity would be measured by Visual Analog Scale (VAS) (Gift,

1989). VAS score ranged from 0 to 10 with a higher score indicates a more severe

pain. As in secondary outcome, the quality of life is assessed by self-reported Medical

Outcomes Study short form- 36 (SF-36) questionnaire with score ranged from 0-100

(Ware, 1988). The degree of disability would be measured by Roland Morris

Disability Questionnaire (RMDQ) (Roland & Morris, 1983). RMDQ score ranged

from 0-24 with higher score indicates a higher degree of disability. All the

questionnaires will be put together into a pile of assessment forms (Appendix K). In

addition, each patient would be assessed for any complications related to the program

and the data will be documented in the progress notes. Patient acceptance towards the

program is assessed by group qualitative interview.

Second, healthcare provider outcomes include the acceptance level to the

program and the compliance level to the guideline. In view of nursing acceptance

level, change in satisfaction and confidence level of the nurses will be evaluated by


group qualitative interviews. On the other hand, nursing audit will be conducted for

evaluating nursing compliance to the guideline. The skill and knowledge of the nurses

will be measured by auditing against guideline standard and criteria. Patient progress

documentation and class observation will also be audited by the working group. Data

related to the noncompliance of the nurses will be collected by the working group.

Third, the system outcomes will be used to evaluate the effectiveness in the

utilization of the innovation and the incremental costs of the program. The total

number of the patients cared by this program annually will be recorded. The analysis

of cost-effectiveness estimates the outcomes benefited to the patients and healthcare

system on a yearly basis. The benefits of the program will include the decreased

number of chronic LBP patient, shorter period of consultation, the decreased specialty

and physiotherapy referral and decreased manpower on individual health education.

Meanwhile, the cost of the program will include operational cost such as salary and

material costs such as stationary consumables and exercise equipment.

4.3.3 Plan of measurements

For the patient outcome, the baseline assessment on the health outcomes will be

performed at the beginning of the first session. Outcome measure will be assessed at

the end of the instructive phase measuring short effect. The intermediate effect will be

assessed every three months in the reinforcement phase. The long term effect will be

measured every three months in the 12-month follow up period after the program

(Tavafian 2011 & Tavafian 2013). Evaluation of the guideline will be carried out

every three months (3rd

, 6th

, 9th

, 12th

month). On the other hand, patient acceptance

toward the program will be evaluated by group qualitative interview at the end of the

instructive phase and at the end of reinforcement phase.


For the health care provider outcome, the nursing compliance will be assessed

weekly in instructive phase for 5 weeks and monthly in reinforcement phase for 12

months by nursing audit. Class observation will be done in every class in a total of 10

times over 5 weeks. Progress notes will be examined weekly in instructive phase and

monthly in reinforcement phase for 12 months. It is necessary to conduct nursing

audit in between instructive phase and reinforcement phase to ensure adherence of

guideline. Regarding the nursing acceptance toward the program, group qualitative

interview will be held at the end of instructive phase and at the end of reinforcement

phase, in a total of two times.

For the system outcomes, the total number of patients treated annually and the

annual running costs of the program will be evaluated at the end of the program in a

year base. The operational costs required in implementation of the program will be

analyzed by the working group in a yearly basis. The assessment of the utilization of

the program will be calculated at the end of the program.

4.3.4 Nature and number of the clients

The nature of the clients involved is consistent to the eligibility criteria of the

clinical guidelines. The sample size calculation was based on a two-tailed paired t-test

at a maximum of 5% chance of committing a false positive error and 80% power to

detect a difference of at least 0.3 as the effect size. Using G*Power 3.1.9.2 (Heinrich,

2013), the required sample size was 82 in each collection time point. Accounting 10%

drop out rate, the sample size is taken as 90 for the five clinics in the full scale

implementation.


4.3.5 Data analysis

In data analysis, 5% nominal level of significance will be used in all significance

tests, and 95% confidence intervals will be provided where appropriate.

As the VAS, RMDQ and SF-36 will be used to measure pain, disability and

quality of life at different points in time, repeated measures analysis of variance will

be performed to assess the change of scores over time. The method of analysis for all

the above outcomes will be performed by a two-tailed paired t-test for each follow up

visit. SPSS version 21 statistical software program will be used to perform the

statistical analyses. Independent samples t-test will be used to assess the mean

differences between groups. Regarding patient acceptance towards multidisciplinary

program, valuable comments will be collected by a group qualitative interview. The

main theme will be the satisfaction of the patients toward the new program.

For health care worker, the data of nursing compliance will be collected by

nursing audit to sustain the change of practice. The evaluation objectives are to

determine if the knowledge and skills of the nurse meet the standard and criteria of the

guideline. All the audit criteria of the guideline must be met. The audit will run in a

cycle including first data collection, comparison of performance with criteria and

standards, implementation of change, and a second data collection within a year of the

program. On the other hand, the healthcare provider outcomes will evaluate the

change in self-perceived skill and confidence level of nurses in conducting

multidisciplinary program by group qualitative interview. The main theme is the

satisfaction and confidence of the nurses toward the new program.

In the system outcome, the data of cost effectiveness will be collected by

calculating the incremental cost of the program at the end of the program. The

evaluation objectives are to determine if incremental cost is reduced. On the other


hand, the data of utilization of the innovation will be collected by measuring the

number of patient participated in the program in each session.

4.3.6 Basis for concluding the effectiveness of the guideline

The evaluation of program aims at ensuring the sustainability of implementing

this new innovation in the local setting. As such, the efficacy of multidisciplinary

primary care program comparing usual care in patients with chronic LBP is addressed.

The effectiveness of the guideline will be shown by decreased pain intensity by

decreased VAS, improved quality of life as in scores increased in SF-36 and decreased

disability by decreased scores in RMDQ. The objective is to achieve 25 % reduction

of pain intensity by VAS average pain score. The program will be considered effective

if the paired t-test on mean percentage change in quality of life and pain intensity

before and after program showed a p-value of less than 0.05.

For the health care worker, the effectiveness of the guideline will be based on the

improved nursing acceptance towards the program and increased nursing compliance

to the guideline. For the staff acceptance level, the effectiveness of the guideline will

be based on the increased level of staff acceptance with satisfaction and confidence on

the use of the guideline.

For the system outcomes, the cost effectiveness of the guideline will be based on

the achievement of good utilization rate with near 80% of participation rate. In the

five clinics, there will be in total 90 patients in a month. In a one year of time, there

will be 1080 clients benefited from the new guidelines. The guideline will be

considered as effective if the incremental cost is lowered by 30% significantly after

one year of the program and the operational cost will be expected to be kept below

HK$100,000 per annum.


At the end of the program, the working group will conduct a meeting with the

administrators and present the outcomes of the program. The effectiveness of the

guideline will be concluded by considering the above indicators. The Consultant of

the service will make the final decision of whether the innovation will be

implemented in the local setting.


Appendix A

Result of the Search for Studies on Multidisciplinary Primary Care Program for

Patients with Chronic Low Back Pain

Databases Searched

Search Terms Cochrane

Library

PubMed CINAHL

Plus

MEDLINE

1) Low Back Pain 4878 25477 2033 2550

2) Multidisciplinary 8660 60701 6655 5982

3) Quality of Life

44048 229086 17604 34387

Combined item

1 AND 2 AND 3

57 89 7 15

Limit (Randomized

Controlled Trial)

30 21 0 0

Manual Exclusion by

inclusion & exclusion

criteria

8 7 0 0

Discard Duplicate Paper

0 *7

0 0

Manual Search for

citation selected paper

0 0 0 0

Final number of

Literature can be used 8

*7 PubMed Papers were duplicated with Cochrane library data search


Appendix B

PRISMA Flowchart

Iden

tification

Eligib

ility Screen

ing

Inclu

ded

168 number of records

identified through database

Zero number of additional records

identified through other sources

79 number of records after duplicates removed

79 number of

records screened

49 number of

records excluded

30 number of full-text

articles assessed for

eligibility

22 number of full-text

articles excluded, with

reasons

8 number of studies included

in qualitative synthesis


Appendix C

Quality Assessment

Study identification: Kaapa, E.H., Frantsi, K.,

Sarna, S., & Malmivaara, A. (2006) No. 1

Study Type: RCT

Section1: Internal Validity

1.1 The study addresses an appropriate and clearly

focused question.

Yes. Patient, intervention,

comparison and outcome

measure are specified.

1.2 The assignment of subjects to treatment groups

is randomized.

Yes. The randomization list was

generated by an independent

biostatistician using a table of

random numbers. Blocks of 20

patients

1.3 An adequate concealment method is used. Yes. Randomized each patient

into one of the two groups by

opening an opaque sealed

envelope. Results were kept in

sealed envelopes, one for each

patient

1.4 Subjects and investigators are kept blind about

treatment allocation.

Yes. The physiotherapist was

not aware of the block size

1.5 The treatment and control groups are similar at

the start of the trial.

Yes. Pt gps look reasonably

similar.

1.6 The only difference between groups is the

treatment under investigation.

Yes. 2 groups are treated

equally except intervention

1.7 All relevant outcomes are measured in a

standard, valid and reliable way.

Yes. All outcome measures

were accounted in the analysis

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Intervention: 10/59=17%

Control: 15/61 = 25%

Overall: 25/120= 21%

1.9 All the subjects are analyzed in the groups to

which they were randomly allocated (often

referred to as intention to treat analysis).

Yes. The results according to

intention to treat did not differ

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply. Only one site

Section 2: Overall Assessment of the Study

2.1 How well was the study done to minimize bias? High quality (++)

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study

intervention?

No statistically significant

differences between the two

treatment gps after

rehabilitation, 6, 12 and 24

month FU in outcome measure

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Only general well being

after rehabilitation

2.4 Level of evidence 1+


Study identification: Dufour, N., Thamsborg, G.,

Oefeldt, A., Lundsgaard, C. & Stender, S. (2010)

No.2

Study Type: RCT



focused question.




1.2 The assignment of subjects to treatment

groups is randomized.

Yes. According to random

number chart for each

subgroup

1.3 An adequate concealment method is used. Yes. Allocated by an separate

secretary



Yes. Physician was blinded

1.5 The treatment and control groups are similar

at the start of the trial.

Yes. P value >0.05 (not sig).

Pt gps look reasonably

similar.












11 pts in each group: Gp A 9%

& Gp B 8% dropped out

during treatment period




Yes. Data were analyzed using

ITT principle.

1.10 Where the study is carried out at more than

one site, results are comparable for all sites.

Does not apply


2.1 How well was the study done to minimize

bias?

High quality (++)

Because of ITT applied

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. Chi square testes, student

paired and unpaired t tests.

ANOVA

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes. Result of SF 36 &

RMDQ are applicable. VAS

no significant different

2.4 Level of evidence 1++


Study identification: Morone, G., Paolucci, T.,

Alcuri, M.R., Vulpiani, M.C., Matano, A. et al. (2011)

No. 3

Study Type: RCT


1.1 The study addresses an appropriate and

clearly focused question.






Yes. Pts were randomly inserted

in BSG and CG in a ratio of

3:2.

1.3 An adequate concealment method is used. Can’t say. Extraction each time

on a group of 15 pts. 5 pts were

allocated in a tx gp, other 4 pts

in similar treated gp and the last

6 in the control gp.

1.4 Subjects and investigators are kept blind

about treatment allocation.

Yes. single-blind study (patient)



Yes. P value >0.05 (not sig). Pt

gps look reasonably similar.



Yes. Back School program and

control group








3/73 x 100% = 4.1%




No. the drop out pt is not

included in the data analysis.



Does not apply


2.1 How well was the study done to minimize bias? Low quality (1-). Because of

3:2 ratio & no ITT



the statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes. One way ANOVA &

Mann Whitney u-test



Result of SF-36, VAS &

ODI are applicable

2.4 Level of evidence 1-


Study identification: Abbasi, M., Dehghani, M.,

Keefe, F.J., Jafari, H., Behtash, H., Shams, J. (2012)

No. 4

Study Type: RCT



focused question.

Yes. Patient-oriented

multidisciplinary pain mx program

vs stand medical care was extracted

to answer question



Yes. randomized to the three groups

in blocks of 12 using a

software-generated randomization

plan.

1.3 An adequate concealment method is used. Yes. Patients were coded

consecutively



Yes. Participants were blinded to

their random assignment, but

investigators and treatment staff

were not blinded to the

randomization.



Yes. Pt gps look reasonably

similar.



Yes. SA-MPMP vs P-MPMP

vs standard medical care








4/33= 12.1%




No. no intention to treat and

the sample size is very small



Does not apply


2.1 How well was the study done to minimize

bias?

Acceptable (+)



the statistical power of the study, are you

certain that the overall effect is due to the

study intervention?

Yes. But the sample size is

rather low.



Yes. Only RQD, Tampa scale

of Kinesiophobia and VAS

2.4 Level of evidence 1-


Study identification: Monticone, M., Ferrante, S.,

Rocca, B., Baiardi, P., Farra, F.D. & Foti, C. (2013)

No. 5

Study Type: RCT



focused question.




1.2 The assignment of subjects to treatment groups

is randomized.

Yes. PI randomizes the pts to

one of the 2 programs using a

list generated by statistician.

1.3 An adequate concealment method is used. Yes. Randomization with

blinded treatment codes.



Yes. Patients and PI and

statisticians are blinded.

Physiotherapies could not be

blinded.

1.5 The treatment and control groups are similar at

the start of the trial.

Yes. Yes. P value is not sig. Pt

gps look reasonably similar.












0%




Does not apply. No patient is

switched to another group.

1.10 Where the study is carried out at more than one

site, results are comparable for all sites.

Does not apply. Only one

study site.



Because of low bias


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. Linear mixed model

analyses and Mann-Whitney

test are used with significant

result.

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Result of RMDQ & SF 36

are applicable.

2.4 Level of evidence 1++


Study identification: Nazzal, M.E., Saadah, M.A., Saadah, L.M.,

Al-Omari, M.A., Al-Oudat, Z.A., Nazzal, M.S. El-Bashari, M.Y.,

Al-Zaabi, A. A., Alnuaimi, Y.I. (2013)

No. 6

Study Type: RCT



focused question.

Yes. Management options

include multidisciplinary

rehabilitation.


groups is randomized. Yes. according to a random

number chart

1.3 An adequate concealment method is used. Yes. allocated by a separate

secretary



Yes. Single blinded





similar.












0%




Does not apply



Does not apply





the statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes. Fisher’s exact

test to generate p-values for

categorical data



some. only VAS, McGill

pain, Oswestry disability.



Study identification: Tavafian, S.S., Jamshidi, A.R.,

Mohammad, K. (2011)

No. 7

Study Type: RCT



focused question.





groups is randomized. Yes. Through random

permutation blocking of every

6 participants.

1.3 An adequate concealment method is used. Yes. The sequence of allocation

was concealed to the physcians

by pt saying nothing about the gp

assignment



Yes. Due to the nature of the

intervention, full blinding of patients

was impractical. The physician and

statistical analyst were blinded to

the group assignment





similar.












9/197=4.56%




No. As there were not a

considerable number of participants

who did not fulfill the protocol of

the study, no intention-to-treat

analysis was performed



Does not apply


2.1 How well was the study done to minimize bias? Acceptable (+)

Patient not fully blind


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. Fisher exact test,

independent t test

2.3 Are the results of this study directly applicable to the

patient group targeted by this guideline?

Yes. Only QDS is

significant



Study identification: Tavafian, S.S., Jamshidi, A.R.,

Mohammad, K. (2014)

No. 8

Study Type: RCT



focused question.





groups is randomized. Yes. through random

permutation blocking of every

6 participants.

1.3 An adequate concealment method is used. Yes. The sequence of allocation

was concealed to the physcians

by pt saying nothing about the gp

assignment



Yes. Due to the nature of the

intervention, full blinding of patients

was impractical. The physician and

statistical analyst were blinded to

the group assignment





similar.












Ix gp: 10/97= 10.3%

Control: 9/100= 9%




Yes. Intention to treat was

performed.



Does not apply


2.1 How well was the study done to minimize bias? Acceptable (+)

Patient not fully blind


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. 12 month

intervention & FU is

more effective than 6

month Ix & FU

2.3 Are the results of this study directly applicable to the

patient group targeted by this guideline?

Yes. SF36, QDS,

RDQ

2.4 Level of evidence 1+ (intention to tx)


Appendix D

Estimated Cost of Multidisciplinary Chronic LBP Program in 2015 (1 Year Period)

Set Up Cost for Multidisciplinary Chronic LBP Program

Item Description Cost (HK$)

Salary in training Registered Nurse Mid-Point Salary (Point 20)

[$177/hr X 10 hr + $177/hr X 6hr] x 10 persons

28,320

Nursing Officer Mid-point Salary (Point 30)

[$281/hr X 10 hr+ $281 x 6 hr]x 5 persons

22,720

Physiotherapist II Mid-point Salary (Point 18)

[$160/hr X (2+6) hr]x 1 person

1,280

Clinical Psychologist Mid-point Salary (Point 33)

[$323/hr X (2+6) hr]x 1 person

2,584

Medical and Health Officer Mid-point Salary (Point 36)

[$349/hr X 2 hr] x 1 person

698

Salary in Power Point Registered Nurse Mid-Point Salary (Point 20)


19,470

Buying Equipment Resistance Exercise Band

($112 +$118+$128+$150+$158+$215+$270) x 5 Sets

5,755

Yoga Mat (173 x 61 x 6mm PVC)

$120/each X 50 set

6,000

Total set up cost 86,827

Operational Cost (for 1 Year Program)

Item Description Cost (HK$)

Salary in Room

preparation

Workman II Mid-Point Salary (Point 4)

[$70/hr X 5 hr + $70/hr X 12hr] x 5 person

5,950

Salary in Conduct Program Registered Nurse Mid-Point Salary (Point 20)


30,090

Team Leader Salary in

Evaluation

Registered Nurse Mid-Point Salary (Point 20)

[$177/hr X 5hr + $177/hr X 12hr] x 5 person

15,045

Salary in Supervision Nursing Officer Mid-Point Salary (Point 30)


18,530

Salary in equipment

cleaning

Workman II Mid-Point Salary (Point 4)


11,900

Salary in booking & filing

progress record

Clerical Assistant Mid-Point Salary (Point 5)

[$78/hr X 5 hr + $78/hr X 12 hr] x 5 person

5,950

Total operational cost in a year 87,465

Total cost of the program (set up cost + operational cost) 174,292


Appendix E

Cost Gain after Implementation of the One Year Program

Items Description Cost (HK$)

Family Medicine

Consultation fee

(Medication excluded)

$150/each x 90 patients in 5 clinics 13,500/Year

Medication

(Analgesics &

Famotidine)

$ 120/ each x 90 patients in 5 clinics 10,800/ Year

Physiotherapy

(Lumbar spine) by

physiotherapy in HA

$380/hr x (5+12) hrs x 90 patients in 5

clinics 581,400/ Year

X Ray Lumbar Spine

in HA

$610/case x 90 patients in 5 clinics 54,900/ Year

Nurse Salary on

Referral

Registered Nurse Mid-Point Salary

(Point 20)

[$177/hr X 40 hr] x 5 persons

35,400/ Year

Shoff Salary on

booking consultation

& filing

Clerical Assistant Mid-Point Salary

(Point 5)

[$78/hr X 40 hr] x 5 persons

15,600/ Year

Total gain after implementation of the program in a year 711,600

Total cost – Total gain

Balance

711,600-174,292

537,308


Appendix F

SIGN 50: A Guideline Developer’s Handbook---

Level of Evidence and Grade of Recommendations

SIGN Grading System 1999-2012

LEVELS OF EVIDENCE

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a

very low risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk

of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

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

High quality case control or cohort studies with a very low risk of

confounding or bias and a high probability that the relationship is causal

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

confounding or bias and a moderate probability that the relationship is

causal

2- Case control or cohort studies with a high risk of confounding or bias and a

significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

GRADES OF RECOMMENDATIONS

A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or

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

C A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+


Appendix G

An Evidence-based Guideline of using Multidisciplinary Primary Care Program in

Patients with Chronic Low Back Pain

Public Health Nursing Division Documentation No. xxxx-xxxxxx-001-xx

Issue Date 1st July 2015

An Evidence-based Guideline of using Multidisciplinary

Primary Care Program in Patients with Chronic Low

Back Pain

Review Date 1st July 2016

Page 1 of 10

An Evidence-based Guideline of using Multidisciplinary Primary

Care Program in Patients with Chronic Low Back Pain

Version Effective Date

1 1st July 2015

Document Number xxxx-xxxxxx-001-xx

Author SHAM Lai-mei, Phoebe

Registered Nurse

Custodian Public Health Nursing Division

Approved by Consultant &

Principal Nursing Officer

Approval Date 31st July 2015


Background

Chronic low back pain (Chronic LBP) is estimated as the top 10 diseases or

injuries that account for the highest number of Disability Adjusted Life Years (DALYs)

worldwide (WHO, 2014). The lifetime prevalence of non-specific LBP is estimated at

60% to 70% and the peak of prevalence reaches between the ages of 35 and 55 (WHO,

2014). Chronic LBP has the highest prevalence among female individual aged 40-80

(Hoy et al., 2012). In Hong Kong, overall 34.9% of the population reported chronic

LBP lasting more than 3 months (Wong & Fielding, 2011).

Chronic LBP bears substantial costs to society through healthcare expenditure and

reduced work productivity that imposes a high economic burden on the individuals

and communities. At present, chronic LBP is treated mainly by oral analgesics (WHO,

2014). Alternative treatments include physical therapy, rehabilitation and spinal

manipulation. Disc surgery remains the last option when all other strategies have

failed (WHO, 2014). Treatment for chronic LBP remains notoriously difficult and

none of the interventions are universally endorsed.

In order to reduce the rate of chronic LBP in the target population, several

components would integrate as a comprehensive multidisciplinary primary care

program for the prevention and treatment of chronic LBP in the community level. A

set of intervention using biopsychosocial approaches which consists of physical,

mental and social aspects of the patients is developed and administered by specialists

from different backgrounds (Tavafian, et al., 2014). It has been shown to be effective

and safe in improving quality of life and reducing pain intensity in patients with

chronic LBP when combined with usual care such as anti-pain medication and brief

health education (Kamper, 2014 & Monticone, 2013).


Since the development of Family Medicine services in the local setting, the

guidelines on health education for chronic LBP only focus on individual counseling

with pamphlet given. The content of the health education information is mainly

postural hygiene and general back exercise. There is a need to develop guidelines

directed by primary care nurses, physicians, physiotherapist, occupational therapist

and psychologist. The guideline will allow specialists within the local setting to

contribute their professional roles into the multidisciplinary care program according to

the established service protocols. This is very different from the traditional

physician-directed chronic LBP intervention, which only involved referral from

physicians to out-service physiotherapist and pharmaceutical regime.

Multidisciplinary primary care program is proven as safe and effective as

physician-directed intervention (Tavafian, et al., 2014), Furthermore, it also can

improve quality of life and decrease pain in patients with chronic LBP (Nazzal et al.,

2013). This innovation can be translated into the local setting as a nurse-led

evidence-based guideline in clinical practice.

Aim & Objectives of the Guideline

The aim of this guideline is to provide evidence-based guidance on the

management of patients with chronic LBP using a multidisciplinary primary care

program in a local clinic. The objectives of the guideline are to:

i. Summarize and formulate clinical evidences for the interventions of patients with

chronic LBP based on the best evidence available

ii. Streamline and standardize the interventions of patients with chronic LBP in

Families clinics of a government unit

iii. Standardize the management of patients with chronic LBP


Target Population

The target population is the patients presented with chronic LBP attending

Families Clinics of a government unit. The inclusion criteria are 1) aged 18 or above,

2) having LBP for more than 3 months, and 4) Patients who are eligible to have

medical treatment under Families clinics of a government unit. They are civil servant,

dependent of civil servant, retired civil servants and dependents of retired civil servant.

The exclusion criteria are 1) having received or planned to have spine operation, 2)

having diagnosis as spinal stenosis, malignancy, fracture, kyphosis or scoliosis, and 3)

pregnant women.

Keys to Level of Evidence and Grade of Recommendation

In this evidence-based guideline on nurse-led multidisciplinary primary care

program in patients with chronic LBP , Scottish Intercollegiate Guidelines Network

(SIGN, 2014) was used to indicate the level of evidence and grade of recommendation

in each evidence based recommendation.


Evidence Supporting the Recommendations

I. Assessment of Chronic LBP

Recommendation 1

Assess physical and psychosocial factors of chronic LBP using Visual Analog Scale

(0-10cm), Short Form-36 and Roland Morris Disability Questionnaire to measure pain

intensity, disability and quality of life of patients with chronic LBP. (Grade of

Recommendation: B)

Available Evidence:

Multidisciplinary program significantly improved VAS score showing reduced

pain and enhanced mobility. McGill pain score and Oswestry disability index

demonstrated significant differences (Nazzal, et al., 2013).

Disability was assessed by specific tools such as RMDQ and SF-36 scale

(Tavafian, et al., 2011).

II. Patient Recruitment of Multidisciplinary Primary Care Program

Recommendation 2

Group based multidisciplinary program is consisted of a group with 6-9 patients with

chronic LBP. (Grade of Recommendation: A)

Available Evidence:

Group-based treatment of 6-8 patients provided an opportunity for peer group

support (Monticone, et al., 2013).


Recommendation 3

Treat patients with chronic LBP using multidisciplinary primary care program plus

usual care (medication). (Grade of Recommendation: B)

Available Evidence:

This program was complimented of physical components and pharmacologic

management of chronic LBP (Nazzal, et al., 2013).

Addition of a multidisciplinary program to usual care with oral medications for

patients with chronic LBP (Tavafian, et al., 2011).

III. Delivery of Multidisciplinary Chronic LBP Primary Care Program

Recommendation 4

Provide five sessions of chronic LBP treatment in instructive phase, two hours per day,

two days per week to a total of five weeks. (Grade of Recommendation: A)

Available Evidence:

The main changes occurred during the first five weeks (Monticone, et al., 2013).

The program was implemented for 120min per week to a total of five weeks



Recommendation 5

Provide 12 sessions of chronic LBP monthly booster class in reinforcement phase.

Two hours per day over one day per week in once per month, to a total of 12 months.

(Grade of Recommendation: A)

Available Evidence:

Patients had improvement in disability due to monthly meetings for a year

(Monticone et al., 2013).

Initial classes were followed by monthly booster class: monthly motivational

consultation and monthly telephone counseling (Tavafian et al., 2014).

Recommendation 6

Use motivational telephone counseling to motivate patients performing home exercise

in reinforcement phase and using stress management techniques in daily life. Exercise

as 60 minutes per day over twice per week in one month to a total of 12 months.

(Grade of Recommendation: A)

Available Evidence:

The monthly telephone reminders established a controlled situation during

reinforcement phase (Monticone, et al., 2013).

Monthly motivational telephone counseling, following initial classes in instructive

phase, encouraged patients to use stress management techniques in their daily life



IV. Content of Multidisciplinary Chronic LBP Primary Care Program

Recommendation 7

Multidisciplinary program should involve a team of specialists such as nurse,

physician, psychologist and physiotherapist. (Grade of Recommendation: A)

Available Evidence:

A well-integrated multidisciplinary team was consisted of physicians,

psychologist and physiotherapists (Monticone, et al., 2013).

The program involved a team of local specialists such as clinical psychologist,

physiotherapists and physicians (Tavafian, et al., 2014).

Recommendation 8

Multidisciplinary program should use comprehensive biopsychosocial approaches

which focused on physical, mental and social aspects of the patients with chronic LBP.

It includes cognitive-behavioral therapy, stress management, physical exercise and

health education. (Grade of Recommendation: B)

Available Evidence:

Biopsychosocial program focused on physical dimensions of chronic LBP as well

as mental and social aspects of the patients. Providing information to patients with

chronic LBP could have positive impact (Tavafian, et al., 2014).

Long tasting multidisciplinary program included cognitive behavioral therapy

(Monticone, et al., 2013).


Recommendation 9

Multidisciplinary program should have a strong psychological component included

stress management, active coping strategies and problem solving which is based on

model of change and linking fear avoidance to disability. The program discussed and

practiced avoidance of movement and ways to overcome fear. (Grade of

Recommendation: A)

Available Evidence:

Multidisciplinary program has a strong psychological component based on

developing a precise model of change, and linking fear avoidance to disability

(Monticone, et al., 2013).

Psychological coping strategies included stress management, active coping

strategies and problem solving. Avoidance of movement and the ways to

overcome this fear were discussed and practiced (Tavafian, et al., 2011).

Recommendation 10

Physical activity (exercise) in both instructive and reinforcement phase include

education component, joint mobilization, strengthening and stretching exercise,

aerobic exercise, resistive and endurance exercise, relaxation and complying with

correct vertebra position. (Grade of Recommendation: A)

Available Evidence:

Subcategory included education and joint mobilization, stretching, aerobic, and

resistive and endurance exercise (Nazzal, et al., 2013).

The program includes relaxation, strengthening and stretching exercises and

complying correct vertebra position (Tavafian, et al., 2011).


Recommendation 11

Individual motivational nurse consultation targets on the specific needs of each patient.

The consultation includes cognitive reconditioning, re-learning and exchanging

information between patient and the nurse. (Grade of Recommendation: A)

Available Evidence:

Individual session target treatment goals to the specific needs of each patient,

ensuring cognitive reconditioning and re-learning, and exchanging information

between patient and specialist of multidisciplinary team (Monticone, et al., 2013).

Booster classes reviewed all learned behaviors and skills (Tavafian, et al., 2014).

V. Patient Follow Up

Recommendation 12

Provide follow up for 12 months after completion of multidisciplinary chronic LBP

primary care program. (Grade of Recommendation: A)

Available Evidence:

A further improvement in disability was observed and maintained until the end of

the 1 year follow up (Monticone, et al., 2013).

Addition of a multidisciplinary program to usual care with oral medications for

chronic LBP improved quality of life and disability in the 12-month period of

follow up (Tavafian, et al., 2014).


Operational Protocol

Setting: Health Education Room of Families Clinics

1. Referral and Assessment

i. Patients with chronic LBP can be referred to multidisciplinary primary care

program by physicians or nurses by completing the program referral from.

ii. Patients shall be assessed by physicians to exclude any evidence of other

pathology.

iii. Multidisciplinary program nurses should confirm that the patient fulfills all

the eligibility criteria

iv. At the first multidisciplinary session, patients will be asked to fill in

questionnaires on quality of life and condition of LBP (Short-Form (36)

Health Survey, Visual Analog Scale and Roland Morris Disability

Questionnaire).

2. Intervention

i. In instructive phase, patient education and exercise will be given in the first

to fifth session which last for two hours.

ii. In reinforcement phase, the patient will be phone contacted by nurse for

motivation on exercise practiced (twice a week) at home.

iii. In reinforcement phase, monthly booster class will be carried out once per

month to a total of 12 months.

iv. After each session, the program nurse will complete the progress note for

each patient.


3. Termination of Treatment

i. Treatment shall be terminated when a total of 5 weeks and 12 months

program have been completed.

ii. Treatment shall be withheld when a patient develop discomfort. The patient

shall be assessed and the treatment may be resumed or discontinued on the

recommendation of the physician.

iii. When signs and symptoms of spine or limb injury developed during the

physical activity, the program shall be terminated for that patient and whom

shall be referred to a physician for further management.

4. Follow-up and Evaluation

Patients shall be followed up at third months, sixth months, ninth months and one

year after the program. Evaluation on pain intensity, disability and quality of life will

be repeated at the end of instructive phase, at the end of the program and every three

months during the 12-month follow up period.


Combined Summary of Proposed Multidisciplinary Chronic LBP program---Instructive Phase

Session Time Content Remarks

1stwk Gp A: Mon & Thu

2:30-3:30

Gp B: Tue & Fri

2:30-3:30

Physiotherapy Theory Class

Explain the anatomy and physiology of the spine, lifestyle factors that can moderate the chronic LBP

process, and the preventive back injury techniques. Patients will understand how correct posture of the

vertebra can protect the vertebral column from injury.

9 patients/

group in

Clinic

Activity

Room

Instructive

Phase

(Total 5

session)

Gp A: Mon & Thu

3:30-4:30

Gp B: Tue & Fri

3:30-4:30

Exercise

1. Passive mobilization of spine (Manual Therapy): The passive mobilization involves manual therapy

for accessory and physiological movements to improve the range of motion.

2. Stretching muscle: The stretching is segmentary and involve the groups of lower limb and back

muscles.

3. Strengthening muscle: Basic exercises are gradually introduced to improve spinal deep muscle

awareness, and the patients learn a specific strengthening technique for the same muscles.

4. Postural control: Postural control is developed by means of exercises aimed at developing motor

control of the spine and pelvis.

5. Ergonomic advice: Ergonomic advice is provided by means of a booklet given to the patients during

the first session to facilitate the modification of daily living activities.

6. Complete an ongoing treatment diary for each session

2nd

wk

Gp A: Mon & Thu

2:30-3:30

Gp B: Tue & Fri

2:30-3:30

Physiotherapy Guided Practice Class

Same nurse evaluate the patients’ skills regarding protecting correct biomechanical posture of the spine

as well as performing stretching, strengthening, and relaxing exercises for the muscles of back, abdomen,

and thigh. Educate patients to maintain correct posture of the vertebral column while walking, sitting,

standing, sleeping, and bending. Instruct the patients to practice specific exercises for back pain.

Gp A: Mon & Thu

3:30-4:30

Gp B: Tue & Fri

3:30-4:30

Exercise

Passive mobilization of spine, stretching muscle, strengthening muscle, postural control, treatment diary


Combined Summary of Proposed Multidisciplinary Chronic LBP program---Instructive Phase (Cont’d)

Session Time Contents Remarks

3rd

wk Group A: Mon & Thu 2:30-3:30

Group B: Tue & Fri 2:30-3:30

Rheumatology Class

Explain the process of developing chronic LBP, the characteristics of LBP, and the effect of risk factors

on pain severity. Different methods of diagnosis and treatments of chronic LBP will be explained

9 patients/

group in

Clinic

Activity

Room

Instructive

Phase

(Total 5

session)

Group A: Mon & Thu

3:30-4:30

Group B: Tue & Fri

3:30-4:30

Exercise

Passive mobilization of spine, stretching muscle, strengthening muscle, postural control, treatment

diary

4th

wk Group A: Mon & Thu

2:30-3:30

Group B: Tue & Fri

2:30-3:30

Psychology Class

Facilitate the focus of patients on individual understanding of stress and coping, perception of different

stressors or threatening events, perception of one’s ability to control stressors or change the situation,

and managing emotional reactions leading to successful adaptation. Explain the strategies for problem

management and focused on problem solving or changing stressful situations. Emotional regulation

strategies aimed at changing the way one thought or felt about stressors as well as relaxation techniques

will be described and practiced in this class.

Group A: Mon & Thu

3:30-4:30

Group B: Tue & Fri

3:30-4:30

Exercise


diary

5th

wk Group A: Mon & Thu

2:30-3:30

Group B: Tue & Fri

2:30-3:30

Health Education Class (CBT)

Focus on cognitive-behavioral interventions for chronic LBP. Aimed to conceptualize the beliefs of

participants regarding LBP, replace maladaptive thinking patterns with adaptive patterns, and replace

maladaptive behavior patterns with functional alternatives such as exercise participation, relaxation

skills, and fear avoidance of movements that were critical to adjust with pain and injury.

Group A: Mon & Thu

3:30-4:30

Group B: Tue & Fri

3:30-4:30

Exercise


diary


Combined Summary of Proposed Multidisciplinary Chronic LBP program---Monthly Booster Class

Session Time Contents Remarks

1st

month

-

12th

month

Wednesday, 1st week of

each month

Group A: 08:30 - 09:30

Group B: 14:00-15:00

Monthly booster class

1. Exercise:

Passive mobilization of spine, stretching muscle, strengthening muscle, postural control, tx

diary

9 patients per

group in Clinic

Activity Room

Wednesday, 1st week of

each month

Group A: 09:30 -10:30

Group B: 15:00-16:00

2. Motivational consultation:

Aim to be aware knowledge, perception, beliefs, and motivations of the patients concerning

their understanding of LBP, the contributions of their non- healthy behaviors in developing

LBP, and their applied approaches to changing these unhealthy behaviors. Motivate the

patients to adapt healthy behaviors and to comply with specific exercises for LBP. Encourage

the patients to cope with the stressors actively. Encourage the patients to manage their stress

and anger as they had learned in the psychological Class. CBT: Verify growing ability to

manage chronic pain and reinforce self-management of dysfunctional thoughts and wrong

belief related to the fear of movement.

9 patients per

group

In Clinic

Activity Room

Reinforcement

phase

(Total 12

session)

Wednesday, 3rd

week

of each month

Group A: 09:30 -12:00

For 9 patients

15 min/patients

Group B: 15:00-17:30

For 9 patients

15 min/patients

Monthly telephone counseling (Individual)

Patients will receive telephone reminders from nurse aimed at strengthening their adhesion to

individual home exercise two sessions per week, 60 min per session. The patients are

encouraged to maintain improved behaviors. All learned behaviors and skill will be reviewed.

Individual at

home

Home exercise:

Two session/

week

60 min/session

0, 3rd

,

6th

, 9th

,

12th

Month

Wednesday, once of

three month, 12 min

consultation

Group A: 10:30-12:30

Group B: 16:00-18:00

Family Medicine physician consultation (Individual)

See the same Family Medicine Physician every 3 months. Medications such as analgesics,

nonsteroidal anti-inflammatory drugs, muscle relaxants, and antidepressant drugs were

prescribed as needed. Medications prescribed were based only on the clinical findings. Patients

were encouraged to take their medications as prescribed by their physician.

Individual

physician

consultation


Appendix H

An Organizational Structure of the Quality Assurance Service

Consultant (Adminstrator)

Senior Nursing Officer (Adminstrator) Medical Officer (Clinical Practice)

Nursing Officer

Project Coordinator (RN)

Clinic A

Clinic Coordinator (NO)

2 QA Nurse (Program Provider)

Clerks + Workman

Clinic B



Clerks + Workman

Clinic C



Clerks + Workman

Clinic D



Clerks + Workman

Clinic E



Clerks + Workman


Appendix I

A Proposed Planning Timeline for Multidisciplinary Chronic LBP program

Tasks Month

1-4 5-6 7 8 9 - 15 16 17-18 19-31 32-43 44-46

Presentation to stakeholders and seek comments & Consultant endorsement

4m

Circulation of guideline & clinic meeting with stakeholders

2m

Training workshop and preparation of program material

1

m

Patient recruitment 1

m

Pilot program 7m

Evaluation of pilot result, refinement of guideline

1m

Preparation for program 2m

Full implementation 13m

Patient Follow Up 12m

Discussion of whether the innovation should be continued

3m


Appendix I (Cont’d)

Description of the Proposed Planning Timeline for Multidisciplinary Chronic LBP program

1st – 4

th Month A working group is formed. The Project Coordinator initiates Project to QA Service Planning Committee and submits the

evidence-based guideline. Purposes draft guideline to the stakeholders in a clinic meeting. Comments are collected and the

draft guideline is revised. SNO is approached for preliminary consultation on the feasibility of the revised guideline.

Consultant revises guideline before endorsement and seeks support to solve the feasibility issues identified.

5th

- 6th

Month

Publish and circulate finalized guideline among the stakeholders. The working group delivers the implementation plan of

guidelines to all the stakeholders. Queries will be collected and responded in the clinic meeting.

7th

Month Conduct Two day practical training for program providers and prepare the educational materials for the program.

8th

Month Recruit 18 pilot patients in a pilot clinic

9th

– 15th

Month Conduct a pilot program in a pilot clinic for 18 patients in 7 months. Assess patient health outcome monthly.

16th

Month Data analysis and discussion of pilot result. Necessary change of the implementation plan and guideline will be made.

17th

-18th

Month Preparation of the program. Staff training and patient recruitment will be conducted.

19th

-31st Month Implement the new innovation in full scale in 5 clinics. Conduct 5 weeks instructive phase and 12 months reinforcement

phase of multidisciplinary program for chronic LBP patients.

19th

-31st Month Conduct baseline assessment before the start of the program. Conduct evaluation at the end of 5-week instructive phase.

Assess patient health outcome, patient acceptance and health care provider outcome.

32nd

– 43rd

Month Conduct 12-month patient Follow up.

34th

Month Conduct 3rd

month evaluation in reinforcement phase. Assess patient outcome.

37th

Month Conduct 6th

Month evaluation in reinforcement phase. Assess patient outcome, health care provider outcome.

40th

Month Conduct 9th

Month evaluation in reinforcement phase. Assess patient outcome.

43rd

Month Conduct 12th

Month evaluation. Assess patient outcome, health care provider outcome and system outcome.

44th

- 46th

Month Discussion of whether the innovation should be continued under evaluation study.


Appendix J

Assessment Form of Multidisciplinary Primary Care Program in Patients with

Chronic Low Back Pain

Date: ________________Patient Name: ____________ HKID No.:______________

Phase: Pilot Baseline/ Pilot end of instructive phase/ Pilot reinforcement phase: 3 6 month/ Baseline/

End of instructive Phase/ Reinforcement Phase: 3 6 9 12 month / Follow up: 3 6 9 12 month

I. Visual Analogue Scale (Score 0-10)

II. The Roland-Morris Disability Questionnaire (Score 0-24)

When you read a sentence that describes you today, put a tick against it. If the

sentence does not describe you, then leave the space blank and go on to the next one.

1. I stay at home most of the time because of my back.

2. I change position frequently to try and get my back comfortable.

3. I walk more slowly than usual because of my back. 4. Because of my back I am not doing any of the jobs that I usually do around the house.

5. Because of my back, I use a handrail to get upstairs.

6. Because of my back, I lie down to rest more often.

7. Because of my back, I have to hold on to something to get out of an easy chair.

8. Because of my back, I try to get other people to do things for me.

9. I get dressed more slowly then usual because of my back.

10. I only stand for short periods of time because of my back.

11. Because of my back, I try not to bend or kneel down.

12. I find it difficult to get out of a chair because of my back.

13. My back is painful almost all the time.

14. I find it difficult to turn over in bed because of my back.

15. My appetite is not very good because of my back pain.

16. I have trouble putting on my socks (or stockings) because of the pain in my back.

17. I only walk short distances because of my back.

18. I sleep less well because of my back.

19. Because of my back pain, I get dressed with help from someone else.

20. I sit down for most of the day because of my back.

21. I avoid heavy jobs around the house because of my back. 22. Because of my back pain, I am more irritable and bad tempered with people than usual.

23. Because of my back, I go upstairs more slowly than usual.

24. I stay in bed most of the time because of my back.


II. SF-36 Questionnaire (Score 0-100)

This survey asks for your views about your health. This information will help keep

track of how you feel and how well you are able to do your usual activities. For each

of the following questions, please mark an in the one box that best describes your

answer.

Q1. In general, would you say your health is:

Excellent Very Good Fair Poor

Q2. Compared to one year ago, how would you rate your health in general now?

Much better

now than one

year ago

Somewhat

better now

than one year

ago

About the

same

Somewhat

worse now

than one year

ago

Much worse

than one year

ago

Q3. The following items are about activities you might do during a typical day.

Does your health now limit you in these activities? If so, how much?

Q3a. Vigorous activities, such as running, lifting heavy objects, participating in

strenuous sports.

Yes, Limited a lot Yes, Limited a Little No, Not Limited at all

Q3b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling,

or playing golf


Q3c. Lifting or carrying groceries


Q3d. Climbing several flights of stairs


Q3e. Climbing one flight of stairs


Q3f. Bending, kneeling, or stooping


Q3g. Walking more than a mile


Q3h. Walking several blocks


Q3i. Walking one block


Q3j. Bathing or dressing yourself



Q4. During the past 4 weeks, have you had any of the following problems with

your work or other regular daily activities as a result of your physical health?

Q4a. Cut down the amount of time you spent on work or other activities

Yes No

Q4b. Accomplished less than you would like

Yes No

Q4c. Were limited in the kind of work or other activities

Yes No

Q4d. Had difficulty performing the work or other activities (for example, it took extra

effort)

Yes No

Q5. During the past 4 weeks, have you had any of the following problems with

your work or other regular daily activities as a result of any emotional problems

(such as feeling depressed or anxious)?

Q5a. Cut down the amount of time you spent on work or other activities

Yes No

Q5b. Accomplished less than you would like

Yes No

Q5c. Didn't do work or other activities as carefully as usual

Yes No

Q6. Emotional problems interfered with your normal social activities with family,

friends, neighbors, or groups?

Not at all Slightly Moderately Severe Very Severe

Q7. How much bodily pain have you had during the past 4 weeks?

None Very Mild Mild

Moderate

Severe Very Severe

Q8. During the past 4 weeks, how much did pain interfere with your normal

work (including both work outside the home and housework)?

Not at all A little bit Moderately Quite a bit Extremely

Q9. These questions are about how you feel and how things have been with you

during the last 4 weeks. For each question, please give the answer that comes

closest to the way you have been feeling.

Q9a. Did you feel full of pep?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9b. Have you been a very nervous person?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time


Q9c. Have you felt so down in the dumps that nothing could cheer you up?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9d. Have you felt calm and peaceful?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9e. Did you have a lot of energy?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9f. Have you felt downhearted and blue?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9g. Did you feel worn out?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9h. Have you been a happy person?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q9i. Did you feel tired?

All of the

time

Most of the

time

A good Bit

of the Time

Some of the

time

A little bit

of the time

None of the

Time

Q10. During the past 4 weeks, how much of the time has your physical health or

emotional problems interfered with your social activities (like visiting with

friends, relatives, etc.)?

All of the

time

Most of the

time

Some of the

time

A little bit

of the time

None of the Time

Q11. How true or false is each of the following statements for you?

Q11a. I seem to get sick a little easier than other people

Definitely true Mostly true Don't know Mostly false Definitely false

Q11b. I am as healthy as anybody I know


Q11c. I expect my health to get worse


Q11d. My health is excellent



Appendix K

Progress Sheet of Multidisciplinary Primary Care Program in Patients with Chronic Low Back Pain

Patient Name: _______________________________________ HKID No.:________________________

Progress Sheet (Instructive Phase)

Date VAS (0-10) RMDQ (0-24) SF-36 (0-100) Complaints & Physical Findings Management

Before

Program

(Baseline)

Week 1

Week 2

Week 3

Week 4

Week 5

End of

instructive

phase


Appendix K (Cont’d)



Progress Sheet (Reinforcement Phase)


Month 1

Month 2

Month 3

Month 4

Month 5

Month 6

Month 7

Month 8

Month 9

Month 10

Month 11

Month 12


Appendix K (Cont’d)



Progress Sheet (Follow Up Period)


Month 3

Month 6

Month 9

Month 12


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