Abstract of dissertation on entitled

“An evidence-based protocol on integrating cut down to quit intervention and nicotine

replacement therapy in helping smokers quit smoking."

Submitted by

SUNG Wing-ting

for the degree of Master of Nursing

at The University of Hong Kong

in August 2015

According to Tobacco Control Office (2012), smoking is the most preventable cause of

death in Hong Kong and in many other countries. 10.7% of the population was smokers in

Hong Kong (Tobacco Control Office, 2012). Smoking is definitely harmful to the health of

everybody on the earth and the natural environment. It is a major cause of death and illness,

including cancers, heart diseases and stroke. Treating those tobacco-related diseases imposed

about HK$5.3 billion economic and medical burden on our society yearly (Tobacco Control

Office, 2012). And those tobacco-related disease and death could affect the smokers’ working

lives, productivity and incomes. It resulted in the lost in the families, businesses and

governments (World Health Organization, 2014). The existing standard smoking cessation is

only to stop smoking abruptly starting from the quit day. The effectiveness of stop smoking

abruptly with nicotine replacement therapy is well supported by the past studies and it

worked for many years in Hong Kong. But there are still many smokers do not want to quit

smoking and cannot quit smoking successfully, especially those heavy smokers. There is a

need to explore a new smoking cessation intervention to help the smokers in Hong Kong.

Objective

The objective of the translational nursing research is to develop evidence-based

protocols for smokers to quit successfully by using the cut down to quit intervention with

nicotine replacement therapy.

Methods

A systematic search of literature was done in four electronic databases including

PubMed (1845 – Aug 2014), ISI web of knowledge (1956- Aug 2014), The PsycINFO

(1980-Aug 2014), Cochrane Library (1950- Aug 2014) and Cumulative Index to Nursing and

Allied Health Literature (CINAHL) Plus. Five studies were selected and identified as suitable

for contributing the development of the new protocols. The finding of these 5 studies were

summarized and showed in the tables of evidences. These five studies were also done with

critical appraisal by The Scottish Intercollegiate Guidelines Network (SIGN) checklists.

Those findings from these selected studies indicate that the cut down to quit intervention with

nicotine replacement therapy has significant effects in successful smoking cessation. A pilot

test will be implemented before starting the full-scale program. The evaluation plan is

developed for assessing the effectiveness of the intervention.

Conclusion

Based on the five selected studies, total 11 recommendations are made for the new

protocol. According to the “Grades of Recommendation” of SIGN, the 11 recommendations

for the protocol are graded as “A”. The flow of the intervention was included. This new

intervention is implemented in a family’s clinic and targeted at the adult smokers. This new

intervention will incorporate with the current smoking cessation services. The programme

will last for three months and telephone follow-up will be arranged in month 6 and 12. With

the evidences from the selected studies, the feasibility, the cost-effectiveness and

transferability, the proposed intervention are worthy to promote the use of cut down to quit

intervention with nicotine replacement therapy in Hong Kong.

An evidence-based protocol on integrating cut down to quit intervention and nicotine

replacement therapy in helping smokers quit smoking.

by

SUNG Wing-ting

Bachelor of Nursing (Hons) H.K.U.

A thesis submitted in partial fulfillment of the requirements

for the Degree of Master of Nursing

at The University of Hong Kong

August 2015

Contents

Tables of contents

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

Acknowledgments ..................................................................................................................... ii

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

1.1 Explain its significance ................................................................................................. 1

1.2 Background ................................................................................................................... 2

1.3 Identify the affirming needs ......................................................................................... 3

1.4 Objectives of the translational nursing research ........................................................... 5

1.5 Translational Nursing Research question ..................................................................... 6

Chapter 2: Critical Appraisal ..................................................................................................... 7

2.1 Search and Appraisal strategies .................................................................................... 7

2.2 Data extraction .............................................................................................................. 8

2.3 Critical Appraisal .......................................................................................................... 8

2.4 Summary of the results ................................................................................................. 8

2.5 Quality of the studies .................................................................................................. 10

2.6 Summary of the data ................................................................................................... 14

2.7 Summary of the synthesis ........................................................................................... 16

Chapter 3: Implementation Potential ....................................................................................... 19

3.1 Target setting .............................................................................................................. 19

3.2 Proposed venue ........................................................................................................... 20

3.3 Target participants ...................................................................................................... 20

3.4 Feasibility of the program in the local setting ............................................................ 20

3.5 Transferability of the findings .................................................................................... 22

3.6 Cost-benefit ration of the innovation .......................................................................... 23

3.6.1 Costs of the innovation ........................................................................... 23

3.6.2. Potential risks and benefits .................................................................... 24

3.7 Evidence-Based Practice Guideline/Protocol ............................................................. 25

3.7.1 Title of the Protocol ................................................................................ 25

3.7.2 Aim .......................................................................................................... 25

3.7.3 Objective ................................................................................................. 25

3.7.4 Intended users ......................................................................................... 26

3.7.5 Target Group ........................................................................................... 26

3.7.6 Grades of Recommendation .................................................................... 26

3.7.7 Recommendations ................................................................................... 26

Chapter 4: Implementation Plan .............................................................................................. 28

4.1 Communication plan................................................................................................... 28

4.2 Communication Process ............................................................................................. 28

4.3 Pilot Test ..................................................................................................................... 31

4.4 Pilot Test Evaluation .................................................................................................. 33

Chapter 5: Evaluation Plan ...................................................................................................... 34

5.1 Objectives ................................................................................................................... 34

5.2 Characteristics and numbers of patients involved ...................................................... 34

5.3 Identify the outcomes ................................................................................................. 35

5.4 Data analysis ............................................................................................................... 36

5.5 Basis of an Effective Change of Practice ................................................................... 36

Chapter 6: Conclusion ............................................................................................................. 38

References ................................................................................................................................ 39

Appendix .................................................................................................................................. 42

Appendix A- Searching Strategies and Results ................................................................ 42

Appendix B- Tables of evidences ..................................................................................... 43

Appendix C- Critical appraisal checklists ........................................................................ 48

Appendix D- Budget Plan for the Proposed Program ...................................................... 60

Appendix E- Grade of Recommendation ......................................................................... 61

Appendix F: Recommendations ....................................................................................... 62

Appendix G- pilot test evaluation Questionnaire for the nurses, doctors and dispensers 66

Appendix H- pilot test evaluation Questionnaire for participants .................................... 67

Appendix I- evaluation questionnaire for participants ..................................................... 68

Appendix J- evaluation questionnaire for the nurses, doctors and dispensers ................. 69

Appendix K- The flow of the intervention ....................................................................... 70

Appendix L- PRISMA 2009 Flow Diagram..................................................................... 71

i

Declaration

I declare that this thesis represents my own work, except where due acknowledgment 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 diploma, degree or other qualifications.

Signed ______________________________

SUNG Wing-ting

ii

Acknowledgments

Firstly, I would like to express my sincerest gratitude to my dissertation supervisor, Dr.

William Li, Associate Professor for his kindness, unfailing support, encouragement,

understanding, valuable advices and guidance throughout the past two years. Thanks for

guiding me back to the right tract when I was getting lost along the path of dissertation. With

his support and assistance, it made my idea and finally the dissertation possible.

I would also like to thank my family, daddy, mammy, little brother TinTin, friends,

father and mother in law. I prepared my wedding and did the dissertation at the same time in

the last year. It was not easy to handle both issues at the same period. Thanks for their love

help, caring and understanding.

Last but not least, I would like to thank you my husband, Henry Yu, for your love,

support, encouragement, caring, sharing my worries and fears throughout these two years.

And I have to thank him for doing all the housework; pushing me to focus on my dissertation

(when I was distracted) and taking care our beloved Fishball (our pet).

1

Chapter 1: Introduction

1.1 Explain its significance

According to World Health Organization (2014), 22% of the world population was

smokers. Smoking killed one smoker in every 6 seconds. Smoking could kill up to half of the

smokers. There were 5.7 million people killed by smoking every year in the world. World

Health Organization estimated that the number of smoking related death might be over 8

million people in year 2030.The cost in treating tobacco-related diseases including cancer

and heart disease were expensive. And those tobacco-related disease and death could affect

the smokers’ working lives, productivity and incomes. It resulted in costs for families,

businesses and governments (World Health Organization, 2014).

According to the Tobacco Control Office (2012), 10.7% of the population was smokers

in Hong Kong. Many people knew the disadvantages of smoking. The cigarettes smoke had

many harmful substances, including nicotine tar, carbon monoxide, more than seven

thousand types of chemicals and more than sixty types of carcinogens (Tobacco Control

Office, 2013). They could cause many fatal diseases to the smokers, for example, cancers,

cardiovascular disease, respiratory disease… (Tobacco Control Office, 2013). People around

and the smokers themselves could also be affected by the second-hand and third –hand

smoke. It was always not too late to quit. Smoking imposed about HK$5.3 billion to the

economic and medical burden of our society annually (Tobacco Control Office, 2012).

Whenever people started to quit, it would bring positive effect to the quitters’ health

(Chan et al., 2011). Nicotine was the main substance causing smoking to be so addictive.

Although most of the smokers knew all the above facts of smoking, there were still some

smokers were unwilling and unmotivated to quit. In Hong Kong, there were 62% of current

Chinese smokers did not ever try to quit smoking (Census and Statistics Department, 2013).

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Smoking cessation involved both physical and psychological modification to induce this

behavior changes. Although we did have nicotine replacement therapy to help smokers to

deal with those physical nicotine withdrawal symptoms, the study find that many smokers

did not adhere to the suggested regimen (Lam et al., 2005). Smokers’ motivation, willingness

and readiness to change were always important to the success of smoking cessation.

What health care professionals could do to help them getting through this process upon

the current interventions? There were still rooms to find more effective ways helping

different smokers to quit. Our current smoking interventions mainly focused on abrupt

attempt to stop smoking (Taskila et al., 2012). According to Taskila et al. (2012), they

suggested that the gradual reduction with nicotine replacement therapy could bring benefit to

the public health especially for those who were highly depend on smoking, not confidence or

ready to stop smoking abruptly. According to Chan et al. (2011), they suggested the smoking

reduction intervention could increase the smokers’ sense of control over their smoking habits

and it could motivate them to quit. And the reduction to quit intervention could act as a

precursor or an intermediate step towards the successful of quitting finally (Taskila et al.,

2012, Lam et al., 2012). In Hong Kong, there was no jurisdiction in using the gradual

reduction of tobacco intervention in clinic. An evidence-based guideline would be needed to

set up in order to facilitate the implementation of the reduction to quit intervention.

1.2 Background

Smoking cessation is always the concern of public health. Smoking cessation

interventions in our clinic included pharmacotherapy, nicotine replacement therapy (NRT)

and counseling. In current smoking cessation practice, we have protocol to guide the

smoking cessation interventions. Our clinic doctors assessed each client’s smoking status in

consultations. After the doctors referring the clients to quit smoking, registered nurses would

then perform the assessment for them. The smoking history, reasons for quitting, nicotine

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dependence level, level of confidence and readiness to quit would all be assessed and

documented. The next follow up date would be the agreed date to start quitting by the clients.

Before the next follow up, nurses would ask the clients to prepare themselves physically and

psychological well, for example, not to buy any cigarettes and throw away the ashtray.

According to the training and current practice, clients would be advised stop smoking

abruptly from the quit day. Although the quitter might experience different levels of

withdrawal symptoms because of the drop of nicotine level inside the quitters’ body, there

was nicotine replacement therapy including nicotine gum, patch, and inhaler to help them

relieving those symptoms. For those smokers who were not the first time joining our

smoking cessation intervention, we would ask them to review and learn from their past

quitting experiences.

Some clients would give up to quit because they did not have confidence to stop

smoking totally at once. Through the counseling with the quitters, we found that some of

them continued smoking with the reduction of cigarettes smoked after the use of nicotine

replacement therapy. It was easy to check by using carbon monoxide monitors to find out

that they still smoked. As they thought the nurses and doctors would not agree them to do so,

so they did not tell the health care professionals. We did come across some smokers

requested to cut down the number of cigarettes and quit smoking gradually with nicotine

replacement therapy. But some nurses were doubt about this quitting method as they were

afraid it would weaken the cessation by lowering the smokers’ motivation to change from

reduced smoking status to complete cessation and the concurrent use of nicotine replacement

therapy with smoking might bring adverse reaction (Chan et al., 2011).

1.3 Identify the affirming needs

The effectiveness of nicotine replacement therapy in smoking cessation was well

supported by many studies (Bolliger et al., 2000). According to Bolliger et al. (2000),

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nicotine replacement therapy could double the rate of successful in smoking cessation. But

the successful rate was usually got from the low to moderate nicotine dependence smokers.

Those smokers with highly nicotine dependence level had the highest rate in relapse. This

group of relapse smokers was usually highly nicotine dependence which meant they were

mostly heavy smoker. They would have the highest risk in developing those smoking-related

diseases. In knowing that there were still many people did not quit smoking and many

smokers needed few attempts of quitting before successful, there was a clear need for new

smoking intervention and approaches (Bolliger et al., 2000).

The total stop of smoking was always the ultimate goal for every smoking cessation

interventions. In Hong Kong, the standard way to stop smoking was to stop abruptly on the

quit day (Lindson et al., 2009). Our department did not have any guideline in helping

smokers to quit by reducing the number of smoking cigarettes gradually with nicotine

replacement therapy. Nurses did not know the effectiveness and impact of quitting in this way.

Some nurses thought it could be possible to quit gradually with reducing cigarettes smoked.

We should not just blindly follow the usual guidelines without consider the realities and the

needs of the quitters. We should learn from the smokers’ real experiences and look for

alternative intervention in order to help different smokers with different needs and situations.

Many smokers thought the reduction of smoking gradually was more natural and easy

accepted for them (Lindson et al., 2009). If reduction of smoking could be incorporated into

our current smoking cessation practice, quit smoking might become more attractive to them

and more smokers might be willing to approach the health care professional and take up the

treatment (Shiffman, Ferguson & Strahs, 2009). And if more smokers became assessable,

health care professional could help them to quit.

According to Bolliger et al. (2000), smoking should not be viewed as a

dichotomous process which only involved the status of complete cessation or not. It was a

5

continuum with different stages. These were empirical evidences showing the reduction to

quit as a therapeutic choice for those unmotivated and unable to quit (Bolliger et al., 2000).

But as cited in Shiffman, Ferguson & Strahs (2009), only reduction of cigarettes smoke might

increase smokers’ experience on withdrawal symptoms and the successful rate of stopping to

smoke without any aid was only 3%. Bolliger et al. (2000) suggested that it was safe to use

the combination of nicotine replacement inhaler with reduced smoking. They found that a

long term reduction in smoking could be maintained and it made reduction of smoking as a

step towards better health and completely smoke-free (Bolliger et al., 2000).

The combination of nicotine replacement therapy and gradual reduction could

reduce craving, withdrawal symptoms and in turn promote the successful of smoking

cessation (Shiffman, Ferguson & Strahs, 2009). It could double the rate of the long-term

smoking abstinence (Asfar et al., 2011). According to Chan et al. (2011), the combination of

smoking reduction intervention and nicotine replacement therapy would increase the

successful of smoking cessation rate for at least 6 months. And there was no evidence to

show the reduction of cigarettes smoking would reduce the smokers’ motivation towards

complete cessation. It was believed that appropriate assistances in reducing cigarettes smoked

would attract more unwilling and unmotivated smokers. However, the use of nicotine

replacement therapy was restricted to abrupt stop smoking in our current practice. So there

was a need to explore the possibilities of incorporating smoking reduction intervention into

current smoking cessation interventions. More updated evidences were needed to gather in

planning a guideline for the combination of nicotine replacement therapy and gradual

smoking reduction in helping the smokers to quit.

1.4 Objectives of the translational nursing research

- To search the data from the database related to the reduction to quit with nicotine

replacement therapy in helping the adult smokers to quit

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- To summarize & critique the quality of the papers found

- To summarize & synthesis all the findings and planning for the implementation guidelines

- To develop an evaluation plan for the proposed reduction to quit with nicotine replacement

therapy smoking cessation programme for adult smokers

1.5 Translational Nursing Research question

The searchable and answerable questions would be how effective is the combination of

gradual smoking reduction with nicotine replacement therapy in helping the smokers to quit

and towards complete cessation?

The PICO question is identified as follows:

P (Population): Adult smokers

I (Intervention): Reduction to quit with nicotine replacement therapy

C (Control): Routine smoking cessation (stop smoking abruptly with health education or

placebo) or no treatment

O (Outcome): complete smoking cessation

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Chapter 2: Critical Appraisal

2.1 Search and Appraisal strategies

After affirming the needs and significant of the reduction to quit intervention with

nicotine replacement therapy for smokers to quit smoking, the systematic reviews of the

related studies were done to develop an evidence-based protocol about that. The strategies in

identifying the relevant studies in different databases and the details of critical appraisal were

discussed as follow.

Identification of studies

A systematic search for potential studies was done from 15th

July 2014 to 18th

August

2014. Five electronic databases were used to identify the relevant studies. They included

PubMed (1845 – Aug 2014), ISI web of knowledge (1956- Aug 2014), The PsycINFO

(1980-Aug 2014), Cochrane Library (1950- Aug 2014) and Cumulative Index to Nursing and

Allied Health Literature (CINAHL) Plus. The details of the systematic search strategies and

results were shown in appendix A and it was also illustrated by the PRISMA flow diagram in

appendix L ( Moher, Tetzlaff, Liberati & Altman, 2009).

Inclusion and exclusion criteria were set in order to search the potential studies.

The inclusion criteria were:

- Studies that included the reduction to quit with nicotine replacement therapy;

- Studies that included adult smokers;

- Outcome measures included the successful smoking cessation rate

The exclusion criteria were:

- If the target participants were pregnant women;

- If the target participants with mental disorders and

- If the target participants were normotensive clients

Keywords used

8

The keywords were used to search the relevant studies including “gradual smoking

reduction”, “ cut down to quit”, “Smoking reduction intervention”, “nicotine replacement

therapy”, “nicotine gum”, “nicotine inhaler” and “nicotine patch”.

2.2 Data extraction

After searching with the keywords through those electronic databases, narrowing down

the topic with the inclusion and exclusion criteria, screening those papers’ topics, abstract,

content and the reference lists, the potential relevant studies were find as show in appendix A.

Five studies were selected (Wennike et al., 2003; Rennard et al., 2006; Shiffman, Ferguson &

Strahs, 2009; Lam et al., 2012). They were conducted from 2003 to 2011. The data from

these five studies were extracted and listed in the table of evidence which was developed by

Scottish Intercollegiate Guidance Network (SIGN, 2014). The table of evidence included the

study types, patient characteristics, interventions, comparison, length of follow up, interested

outcome measures and the effect sizes. The interested outcomes measures were mainly about

the rate of reduction of 50% number of cigarettes and the complete abstinence rate. The table

of evidence was shown in Appendix B.

2.3 Critical Appraisal

The critical appraisal checklist by Scottish Intercollegiate Guidance Network (SIGN,

2014) was used to assess the quality of the five studies. As five of the studies were all

randomized controlled trail, so checklist for randomized controlled trail was used and they

were shown in Appendix C.

2.4 Summary of the results

Studies’ characteristics

By searching the five electronic databases, 615 related studies were identified. The titles,

9

abstracts and citations of these studies were first reviewed. 10 potential studies which were

related to our interested topics were identified. The full texts of these potential studies were

then further reviewed and the duplicated studies were checked. Five studies, which could

meet our inclusion and exclusion criteria, were identified finally. All the five studies were

randomized controlled trial and they were done within the last 11 years.

Participants’ characteristics

The five studies involved total 5710 participants. They ranged from involving 411 to

3297 participants in each study. The participants were all smokers. They included both sex.

The participants were all above 18 years old. Participants of the studies were ranged from

light (2 cigarettes/day) to heavy smokers. All the participants were interested in reducing their

smoking but no intention to quit completely during the recruitment. All of them also failed in

one serious quit attempt before. None of the participants used of nicotine replacement therapy,

participated in any smoking cessation or reduction programme currently. Subjects with

known heart related diseases, psychological problems or pregnant were excluded. The five

studies were conducted in different cities and countries including United State, Denmark and

Hong Kong.

Intervention used

All of the five studies also involved the smoking reduction intervention. Three out of

five studies used smoking reduction with nicotine replacement therapy as the intervention and

smoking reduction with placebo as comparison (Wennike et al., 2003; Rennard et al., 2006;

Shiffman, Ferguson & Strahs, 2009). One study involved smoking reduction with nicotine

replacement therapy as intervention while simple advice on smoking cessation with a

self-help pamphlets as a control group (Lam et al., 2012). And one study showed the

comparison between the reduction to quit intervention with nicotine replacement therapy and

the no-treatment group (Carpenter et al., 2004). All studies also defined successful smoking

10

reduction as reduction in daily cigarettes consumption equal or more than 50%. Participants

were asked to reduce their cigarettes consumption as much as possible in different ways

including increase the interval between cigarettes or selectively eliminating cigarette

throughout the day. The types of nicotine replacement therapy used in the five studies

included the nicotine patch, inhaler and gum.

Length of follow up

The lengths of follow up among five studies were varied from 6 months to 2 years. The

frequencies of follow up were different. It ranged from four to nine follow-up among the five

studies.

Outcome measures

Self-report 7-day point prevalence abstinence in different time intervals was the

common outcome measures in all five studies. Four studies’ abstinence rate were biomedical

validated with exhaled carbon monoxide level (Wennike et al., 2003; Rennard et al 2006;

Shiffman, Ferguson & Strahs, 2009; Lam et al., 2012). Biomedical validated self-reported

7-day point prevalence reduction of 50% cigarettes consumption in different time interval

was also the outcome measure in four studies (Wennike et al., 2003; Rennard et al., 2006;

Shiffman, Ferguson & Strahs, 2009; Lam et al., 2012).

2.5 Quality of the studies

Clearly stated question

All the five studies had a clearly stated research questions and objectives with populations,

interventions, comparisons and outcomes. It provided us the direct information to judge

whether these studies met our guideline’s topic and objectives.

Appropriate study design

The five studies were randomized controlled trial. The randomized control setting could

provide a good quality of evidence in theory. Three studies were double-blind (Wennike et al.,

11

2003; Rennard et al., 2006; Shiffman, Ferguson & Strahs, 2009) while one study was

single-blind study (Lam et al., 2012). Three studies were aimed at comparing the reduction to

quit with nicotine replacement therapy and placebo (Wennike et al., 2003; Rennard et al.,

2006; Shiffman, Ferguson & Strahs, 2009) while the study of Lam et al. (2012) compared the

reduction to quit with nicotine replacement therapy and simple advice and the study of

Carpenter et al. (2004) compared with no-treatment.

Allocation of the participants

All the five studies also stated that their participants were allocated randomly to the

intervention and comparison or control groups. But the details of randomization methods and

allocation concealment were not described in all the five studies.

Blinding

Three out of five studies were double-blind (Wennike et al., 2003; Rennard et al., 2006;

Shiffman, Ferguson & Strahs, 2009) and one study by Lam et al. (2012) was single-blind

study while one study by Carpenter et al. (2004) did not use blinding. The intervention group

of the Lam et al. (2012) study involved the reduction to quit and nicotine replacement therapy

while the comparison group involved the brief advice only. Only single-blinded could be

applied in this study as the participants might aware they were in the intervention or control

groups. Those three studies with double-blinded were comparing the intervention group with

nicotine replacement therapy and the controlled group with placebo. So the double-blinding

method could be applied in order to reduce the risk of bias. The control group in the study of

Carpenter et al. (2004) did not receive any treatment on smoking cessation so it might make

blinding impossible.

Conclusion accounted from all participants

The dropout rates were relative high in two studies (Wennike et al., 2003; Rennard et al.,

2006). The dropout rate for the study of Wennike et al. (2003) was 41% among the first year

12

attendance rate and it was even higher in the second year. The dropout rate for the study of

Rennard et al. (2006) was 58.6%. Rennard et al. (2006) explained the high dropout rates

could be quite common among smoking cessation and reduction studies. The entire drops out

subjects in the five studies were assumed as failure of the corresponding treatments. So they

were also accounted for the conclusion. Four out of five studies used the intention to treat in

making their conclusion (Wennike et al., 2003; Carpenter et al., 2004; Rennard et al., 2006;

Lam et al., 2012).

Follow up for participants

The data of participants were collected through phone-calls, study site visits or clinic

visits. The lengths of follow up were varied from 6 months to 2 years. The frequencies of

follow up for each study were different. It ranged from four to nine follow up. Different

studies collected the data from the participants at different time intervals. Both the

intervention and comparison groups’ data were collected in the five studies. Missing data and

intention-to-treat were mentioned.

Power analysis

There was three studies mention the power calculation (Wennike et al., 2003; Rennard et

al., 2006; Lam et al., 2012) while the other two did not mention about that . Lam et al. (2012)

stated that the required sample size was calculated based on primary outcome measures to

provide at least 90% power with a significance level of 5 %. Rennard et al. (2006) stated that

the required sample size was calculated based on previous results of other smoking reduction

studies. By using this assumption, they recruited 197 subjects for each group in order to

provide a power of 80% with a significance level of 0.05. Wennike et al. (2003) also based on

the results of previous smoking reduction studies, 200 subjects in each group were needed for

80% of power with a two-tailed significant level of 0.05.

Main result

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The related outcomes were presented in the forms of percentage with p-value, standard

deviation and odd ratio. The main outcome measure was the 7-day point prevalence tobacco

abstinence. Three studies collected the main outcome measures of abstinence rate at 6 months

(Carpenter et al., 2004; Shiffman, Ferguson & Strahs, 2009; Lam et al., 2012) and two studies

at 12 month (Wennike et al., 2003; Shiffman, Ferguson & Strahs, 2009).

Precision of the data

Three studies presented the results with p-values (Carpenter et al., 2004; Rennard et al.,

2006; Lam et al., 2012) and two studies presented the results with 95% confidence intervals

(Wennike et al., 2003; Shiffman, Ferguson & Strahs, 2009). All the five studies also showed

that the intervention groups of reduction to quit with nicotine replacement therapy achieved

higher percentage of time- point prevalence cessation rates than placebo and control groups.

Three studies showed statistically significant higher prevalence cessation rates in intervention

groups at 6 month (Carpenter et al., 2004; Shiffman, Ferguson & Strahs, 2009; Lam et al.,

2012). Lam et al. (2012) presented the finding with p-value (p=0.012) while Carpenter et al.

(2004) and Shiffman, Ferguson & Strahs (2009) presented them with 95% confidence

intervals. These data implied that there were statistically significant differences between the

intervention and control groups. The other two studies with longer period of follow up

showed statistically significant higher prevalence self-report cessation rates in intervention

groups at 12 month (p=0.014) (Wennike et al., 2003; Shiffman, Ferguson & Strahs, 2009).

Applicable of the data

The result of those outcome measures could apply to my guideline topic. The population

and intervention of the five studies met my interested targets- the adult smokers. The settings

of the five studies were varied. Two studies involved the clinic setting (Wennike et al., 2003;

Rennard et al., 2006) , one was done in study site (Shiffman, Ferguson & Strahs, 2009) and

two studies were done mainly by telephone calls (Carpenter et al., 2004; Lam et al., 2012).

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The setting was similar to my clinical situation as our smoking cessation services could carry

out in clinical and telephone call bases.

Level of evidence

The five studies were rated according to the critical appraisal checklists of Scottish

Intercollegiate Guidance Network (SIGN, 2014). Two studies were rated as 1- (Carpenter et

al., 2004; Shiffman, Ferguson & Strahs, 2009) and three were rated as 1+ (Wennike et al.,

2003, Rennard et al., 2006; Lam et al., 2012). According to Melnyk & Fineout-Overholt

(2005), it belonged to level II in the Level of evidence as there was evidence from at least one

well-designed RCT.

2.6 Summary of the data

There were total 5710 participants were recruited in these five studies. The number of

participants in each study was ranged from 411 to 3297. The five studies were conducted in

developed countries including the United State, Denmark and Hong Kong. All the

participants were adult including both female and male from different countries. They were

recruited through media advertisement (Wennike et al., 2003; Rennard et al., 2006; Shiffman,

Ferguson & Strahs, 2009; Lam et al., 2012) or proactive telephone calls through the

assistance of a marketing firm (Carpenter et al., 2004). The studies included light to heavy

smokers. They were all willing to cut down their smoking cigarette but unwilling to quit in

the beginning of the studies. All the five studies were investigated the effectiveness of the

reduction to quit with nicotine replacement therapy in smoking cessation. The time-point

prevalence tobacco abstinence was the common main outcome measures among the five

studies. All the outcome measures were presented in percentage with p-value or 95%

confidence intervals. The abstinence rate in these five studies depended on the self-report

method and four studies were validated by the biochemical parameter with exhaled carbon

monoxide level not more than 10 p.p.m. (Wennike et al., 2003; Rennard et al., 2006;

15

Shiffman, Ferguson & Strahs, 2009; Lam et al., 2012). Five studies showed the point

prevalence tobacco abstinence in different time intervals (6 months, 12 months, 15 months

and 24 months) with statistically significant results. Three studies about the comparison

between reduction to quit with and without nicotine placement therapy showed the

statistically significant higher percentage of abstinence rate in intervention groups than the

placebo groups (Wennike et al., 2003; Rennard et al., 2006; Shiffman, Ferguson & Strahs,

2009). The study of Lam et al (2011) showed statistically significant higher percentage

abstinence rate in groups of reduction to quit with nicotine replacement therapy than the

control with simple advice and a self-help pamphlet (p=0.012). Carpenter et al. (2004)

showed the intervention group of reduction to quit with NRT was statistically significant

higher percentage abstinence rate in comparing with the no treatment group.

Four studies also showed the successful reduction rate (≥ 50%) of cigarette consumption

in different time-point (Wennike et al., 2003; Rennard et al., 2006; Shiffman, Ferguson &

Strahs, 2009; Lam et al., 2012). All the results were depended on self-report and three studies

involved biomedical validated of carbon monoxide level (Wennike et al., 2003; Rennard et al.,

2006; Shiffman, Ferguson & Strahs, 2009). All the finding showed the intervention groups of

reduction to quit with NRT were statistically significant higher percentage of success in at

least 50% smoking cigarettes reduction than the control groups.

The data of the adverse reaction in using the nicotine replacement therapy during

reduction to quit intervention was collected in three studies (Wennike et al., 2003; Carpenter

et al., 2004; Shiffman, Ferguson & Strahs, 2009). But only the study of Shiffman, Ferguson &

Strahs (2009) performed the statistical testing on it. Shiffman, Ferguson & Strahs (2009)

find that the intervention groups reported statistically significant higher percentage adverse

reaction rate than the placebo group (p<0.001).

Moreover, one study investigated the sense of control among the participants of the

16

intervention and controls groups (Rennard et al., 2006). It showed statistically significant

improvement in the sense of control among the participants who could reduce at least 50% of

their cigarettes smoking at 4 and 15 month.

The outcome measures of all the studies matched the interested of my translational

research. All the outcomes measures were statistically significant. They all showed that the

reduction to quit intervention with nicotine replacement therapy could help smokers to quit

smoking. It could help smokers with light to high dependence level on cigarettes smoking to

quit, even they were not willing to quit in the beginning of the studies.

2.7 Summary of the synthesis

All the five selected studies concluded that the reduction to quit with nicotine

replacement therapy could help the adult smokers in smoking cessation. This intervention

could help those hard core smokers who could not quit by the current interventions. The

interventions in the studies were done by trained smoking cessation counselor or research

assistances. Participants were advised to reduce their cigarettes consumption as much as

possible. There were two strategies including the hierarchical reduction and scheduled

reduction. The participants could selectively eliminate cigarette throughout that day or

increase the time interval between cigarettes. The type of nicotine replacement therapy

included nicotine inhaler, patch and inhaler.

Nicotine replacement therapy was proofed to be used safely for many years. Nicotine

replacement therapy was used to be assist smokers to quit abruptly. The safety in using the

nicotine replacement therapy during reduction to quit could be the concern of the health care

professional. Although the participants were more likely to experience the adverse reaction

than the participants in placebo group( p< 0.001), all the reported adverse reaction were the

mild common side effects in using nicotine gum and it was just consistent with those find in

people using nicotine gum to quit abruptly (Shiffman, Ferguson & Strahs, 2009). Wennike et

17

al. (2003) and Rennard et al. (2006) suggested those reported adverse reactions were not

related to the study interventions.

According to the five studies, the smokers could be advised to reduce their smoking as

much as possible by increasing the time between each smoke step by step , for example, the

clients could delay the smoking for one hour and then add one more hour in the other day or

using the nicotine replacement therapy to replace the smoking. The recommendations are

listed as followed:

(1) The whole treatment would take at least 6 months and the participants should be followed

up. In each follow-up, the clients’ smoking status, number of cigarettes smoking per day

and the use of nicotine replacement therapy should be assessed. The smoking status

would be validated by measuring the exhaled carbon monoxide level.

(2) The trained health care professional could act as a smoking cessation counselor to provide

counseling in each follow up.

(3) The pamphlets about the reduction to quit and the proper use of the nicotine replacement

therapy should provide to the clients.

(4) The studies suggested different nicotine replacement therapy including the nicotine patch,

inhaler and gum could work well with the reduction to quit intervention (Wennike et al.,

2003; Rennard et al., 2006; Shiffman, Ferguson & Strahs, 2009; Lam et al., 2012).

(5) The review of the five studies summarized with evidences that the smoking reduction

counseling with adherence intervention and free nicotine replacement therapy with the

reduction to quit intervention could help the smokers quit smoking in practice.

(6) During each follow up, any adverse events in using the nicotine replacement therapy

should be assessed. The participants should be reminded to report if they find any

discomfort.

(7) The proper use of nicotine replacement therapy should be reinforced and the side effects

18

were needed to explain before prescription.

The used of nicotine replacement therapy was proofed to be effective in helping the

reduction of at least 50% smoking cigarette (Wennike et al., 2003; Rennard et al., 2006;

Shiffman, Ferguson & Strahs, 2009; Lam et al., 2012). And the five studies also showed the

effectiveness of the reduction to quit with nicotine replacement therapy to the smoking

cessation. According to Rennard et al. (2006), the success in at least 50% reduction of

cigarettes smoking could increase the sense of control in the participants. It could be an

option for those who were lack of confidence to quit. It would be worth to implement this

new intervention. This would provide the smokers with more choice in smoking cessation. It

could act as a feasible first step towards complete smoking cessation for smokers who were

unable or unwilling to quit smoking abruptly (Bolliger et al., 2000). It would not only

improve their health but also the non-smokers’ health and the environment.

As a public health nurse, smoking cessation was always our concerns. Complete

smoking cessation should be our ultimate goal. Complete smoking cessation would be the

only way to eliminate those bad effects of smoking to the smokers, non-smokers and the

society totally. But stop smoking abruptly might frighten some smokers to quit. It would be

an unrealistic big step for some smokers to complete smoking cessation. Nurses could

introduce this new evidence-based reduction to quit intervention with nicotine replacement

therapy to our smokers, especially those who were unwilling to quit smoking abruptly.

19

Chapter 3: Implementation Potential

There were many studies proofed that smoking could lead to lots of health

problems and even death. In my clinical setting, the current management of smoking

cessation included nicotine replacement therapy, pharmacological and counseling. The clients

were asked to stop smoking abruptly. As a front line nurse in providing smoking cessation

services, clients who requested to quit gradually could be come across. However, there was

no standard protocol for nurses to help the smokers quitting gradually with or without

nicotine replacement therapy. The benefits of helping the smokers to quit gradually with

nicotine replacement therapy were well showed in the previous chapter, including for those

who did not decide to quit originally or failed in previous quit attempt.

The implementation potential should be examine carefully before translated the evidence to

the practice. So the implementation of reduction to quit with nicotine replacement therapy to

the quitters in my current clinical setting would be discussed as followed. It included the

transferability of the findings, the feasibility, the potentials risks, the benefits and the cost of

the implementation.

3.1 Target setting

The reduction to quit with nicotine replacement therapy intervention would be

proposed to use in families clinic of the Department of Health. Families’ clinics are under the

services unit of the Professional Development and Quality Assurance (PDQA). Their mission

is to provide good quality health care services, support the professional development and

quality assurance in the Department of Health and primary health care services (PDQA,

2012). Their objectives include implementing the evidence–based clinical protocols and

developing protocols to practice evidence-based health care. The clients of the families’

clinics are only civil servants, pensioners and their family members. The consultation and

20

smoking cessation services are free to provide to the clients. They could join our smoking

cessation programme through the referral from the doctors in our clinics or recruiting through

the hotlines of Tobacco Control Office.

3.2 Proposed venue

The proposed venue of implementing the reduction to quit intervention with

nicotine replacement therapy would be the families’ clinics. The counseling session and the

telephone follow-up could be done in the multi-function room of the families’ clinic. The

room was about 400 square feet and it was well equipped with a projector, screen, computer

system and telephone.

3.3 Target participants

The target participants of the reduction to quit intervention with nicotine

replacement therapy will be the smokers who are adult, want to reduce the number of

smoking cigarettes, have one fail quit attempt before and no contraindication in using

nicotine replacement therapy. They should be referred by the clinics’ doctor or Tobacco

Control Office. Smokers with mental disorders will be excluded.

3.4 Feasibility of the program in the local setting

Administrative support

The vision of the Department of Health is to build a healthy Hong Kong. As a

government’s health adviser and agency, the mission of the Department of Health is to

execute health policies. It aims as safeguard the health of the people of Hong Kong through

different services including health promotion and preventive services (Department of Health,

2013).

There are evidences showing that smoking cessation could improve the health of

21

the smokers. The smoke free environment could also benefit to the health of the non-smokers

and the quality of the air. As a public health nurse in the Department of Health, we should

play multiple roles including a care provider, health promoter, health educator, counselor,

client advocate, case finder, case manager, coordinator and collaborator, change agent and

researcher in the delivery of public health nursing services (PDQA, 2011). One of the

objectives of the Public Health Nursing Services in the Department of Health is participating

in and contributing to the development of evidence-based public health nursing practice. It

aims at providing quality service to the public in Hong Kong (PDQA, 2011). One of the

visions of our department about the smoking cessation is to promote a smoke-free culture in

Hong Kong so as to safeguard the health of the community. So our department supports the

development of evidence–based smoking cessation nursing practices.

Interference of the normal function of the clinic

Registered nurses mainly provided counseling in our current smoking cessation

programme. The quitters were asked to stop smoking abruptly starting from their quit date.

The quitters were strongly advised not to smoke when they started the use of nicotine

replacement therapy. However, not all quitters wanted to quit abruptly. It seemed that there

was no option for the smokers who wanted to quit progressively.

We could still continue our usual practice on smoking cessation. If the clients agree

to quit abruptly with nicotine replacement therapy, the clients then just follow the current

practice. If the clients are not willing to quit but only agree to cut down the number of

smoking cigarettes or they prefer to quit progressively, they may then be suggested

considering the cut down to quit intervention. So the proposed intervention is just

incorporated to our current practice as one of the smoking cessation option for the smokers.

In our clinics, we have registered nurses to hold the smoking cessation programme on every

Wednesday and Friday afternoon sessions. Extra manpower for adding this new option for

22

our clients is not required. But it may need time for the nurses to set up, receive training and

familiar with this new intervention.

3.5 Transferability of the findings

According to the five randomized controlled studies of the cut down to quit

intervention with the nicotine replacement therapy, they also suggested this intervention for

the smokers. This new intervention was proofed to help the smokers to quit, especially who

preferred to quit progressively and those who did not want to quit but only cut down the

number of smoking cigarettes. The implementation of this intervention would depend on the

possibility in transferring it to our own clinic setting.

Similarity of the target setting

The settings of the five selected studies were varied. Two studies involved the

clinic setting (Wennike et al., 2003; Rennard et al., 2006) , one was done in study site

(Shiffman, Ferguson & Strahs, 2009) and two studies were done mainly by telephone calls

(Carpenter et al., 2004; Lam et al., 2012). The setting was similar to my clinical situation as

our smoking cessation services could carry out in clinical and telephone call bases. One of the

selected randomized controlled studies was conducted in Hong Kong. The results of the local

study are similar to those conducted in the west. There is no cultural implication on the

effectiveness of such intervention and so the intervention can be applied in Hong Kong

context.

Similarity of the target participants

All the five selected studies concluded that the reduction to quit with nicotine

replacement therapy could help the adult smokers in smoking cessation. This intervention

could better help those interested in reducing their smoking. The target participants of the

studies were ranged from light (2 cigarettes/day) to heavy smokers. It could fit for our clients

as they could have wide range of smoking dependence level.

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3.6 Cost-benefit ration of the innovation

3.6.1 Costs of the innovation

Staff training and materials cost

This new intervention could be incorporated into our current smoking cessation

programme. The clients participate this new intervention can also receive the assessment,

counseling sessions with introducing the disadvantages of smoking, the benefit of smoking

cessation, the use of nicotine replacement therapy and the way to deal with the withdraw

syndromes. The different of the practice may need to brief the registered nurses. The

intervention given by the nurses includes the advice to smokers on cutting down the number

of smoking instead of stop smoking abruptly and the use of nicotine replacement therapy. The

introduction of this new programme will be discussed in our monthly journal club meeting. It

takes only an hour during the lunch time. The senior medical officers will introduce the

reduction to quit with nicotine replacement therapy to the doctors, nurses and the dispensers.

The nursing officers will then brief the work flow of having clients to participate the new

intervention. This can make sure every involving party knowing what they had to do and

what others would do. After that, nursing officers, senior medical officers and senior

dispensers will brief their corresponding staff in details respectively. Nursing staff will focus

on the assessment and counseling part. Doctors will focus on referring and prescribing the

nicotine replacement therapy. The dispensers will need to estimate the need of the nicotine

replacement therapy in order to make sure the stock would be enough for the new

intervention. When the programme is in progress, the nursing officers will follow any

comments and questions about this new intervention from the nursing staff. She will then

bring those questions and comments to the senior medical officers every week.

As this new intervention will incorporate into our current smoking cessation

programme, the power point content of the programme will be needed to update. One of the

24

senior registered nurses will appoint as the in-charge nurse of the smoking cessation

programme. She/ He will make the draft and confirm by the nursing officers and the seniors

medical officers. Related pamphlets would also be needed for promoting and educating the

clients about this new intervention. The in-charge nurse can discuss with Tobacco Control

Office of the Department of Health about the printing materials on this updated smoking

cessation intervention. The budget plan for the proposed intervention is shown in the

appendix D.

3.6.2. Potential risks and benefits

According to the five selected randomized controlled studies, the reduction to quit

with nicotine replacement therapy intervention was supported with evidence-based. The flow

of the intervention including the frequency of follow up and the way of reducing the number

of smoking cigarettes, would base on the evidences and the benefit of the smokers.

Potential risks and benefits should be assessed before the implementation of this

new intervention. There is no evidence showing that the new intervention could bring any

risks to the smokers. The safety of using the nicotine replacement therapy during the

reduction to quit could be the concern of the health care professional. Nevertheless, Shiffman,

Ferguson & Strahs (2009) suggested that those reported adverse reactions were only the mild

common side effects in using nicotine gum and it was just consistent with those find in

people using nicotine gum to quit abruptly. Participants should be educated the proper use of

the nicotine replacement therapy and they should be advised to inform nurses or doctors as

soon as possible if they find any discomfort in using the nicotine replacement therapy.

The participants in the five selected studies also had unsuccessful quit smoking

experiences before. And they find the reduction to quit intervention with nicotine replacement

therapy could really help them to quit. This could provide an alternate choice for smokers

who want to quit gradually and attract the smokers who might scare by stop smoking abruptly.

25

This could make our smoking cessation to attract more smokers including this group of

smokers. As more smokers quit smoking successfully, more clients could become healthier

and less harmful effect from second-hand or third-hand smoke to the public.

3.7 Evidence-Based Practice Guideline/Protocol

An evidence-based practice protocol of the reduction to quit intervention with

nicotine replacement therapy will be developed in order to guide the health care professionals

in the families’ clinics of the Department of Health in providing such services to the smokers

in a safe, effective and evidence-based way.

3.7.1 Title of the Protocol

The title of the protocol is “An evidence-based protocol on integrating reduction to

quit intervention and nicotine replacement therapy in helping adult smokers to quit smoking”.

3.7.2 Aim

The aim of the protocol is to provide evidence-based practice guidelines for the

health care professionals to advocate the method of using reduction to quit intervention with

nicotine replacement therapy for the smokers.

3.7.3 Objective

The objectives of the protocol were:

1. To provide evidence-based information and guidelines for the health care professionals in

providing reduction to quit intervention with nicotine replacement therapy to the smokers.

2. To help those smokers who had failed at least one quit attempt by using our current

smoking cessation intervention.

3. To attract smokers joining the smoking cessation programme, including those only wanted

to cut down the number of smoking cigarettes.

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3.7.4 Intended users

The intended users of this protocol will be the health care professionals in the

families’ clinics, including the senior medical officers, medical officers, nursing officers,

registered nurses, senior dispensers and the dispensers. One medical officer and two

registered nurses will be appointed as the in-charge of the smoking cessation programme.

Doctors are responsible in referring interested smokers to the smoking cessation programme.

Nurses are responsible in carrying out the smoking cessation programme. As the dispensers

will be involved in ordering and dispensing the nicotine replacement therapy and educating

the smokers about the use of nicotine replacement therapy, so they are also the intended user

of the protocol.

3.7.5 Target Group

The inclusion criteria for the target group of this protocol will be the adult smokers

who smoked at least two cigarettes per day. The smokers show interested in reducing their

smoking but not necessary having intention to quit completely during the recruitment.

Smokers failed in one serious quit attempt before would be our target groups. The quitters

should not use any nicotine replacement therapy, participated in any smoking cessation or

reduction programme currently. The exclusion criteria are smokers with known heart related

diseases, psychological problems, pregnant or having medical problems which have

contraindication in using nicotine replacement therapy.

3.7.6 Grades of Recommendation

SIGN’s “Grades of Recommendation was used to assess the level of the evidences

in the following recommendations of the protocol (SIGN, 2012).

3.7.7 Recommendations

Eleven recommendations are made and elaborated basing on the five selected

27

studies. The details of the grading reference for the recommendation are shown in appendix E.

The eleven recommendations include modes of delivering the reduction to quit with nicotine

replacement therapy intervention, length of the programme, frequency of follow-up, duration

of each reduction to quit with nicotine replacement therapy intervention session, the choice of

nicotine replacement therapy in the reduction to quit intervention, ways to cut down the

number of cigarettes, defining the successful smoking reduction, the method in validating the

smoking status, ways to check the use of nicotine replacement therapy by the quitters,

instructor of the programme and the provision of free nicotine replacement therapy. Details of

these recommendations were shown in appendix F. A flow of the intervention is summarized

as shown in appendix K.

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Chapter 4: Implementation Plan

After setting the evidence –based protocol, developing the implementation plan will be

the next step. The implementation plan includes three parts, the communication plan, the pilot

test and the evaluation of the program.

4.1 Communication plan

A communication between all the stakeholders is important to facilitate the

implementation of the program. A good communication plan is needed to foster a better

communication between the stakeholders and it could help to conduct the messages to all the

stakeholders effectively. They could then understand more about the program and lead to a

successful implementation. Our communication team will be formed by two nursing officers,

two trained registered nurses, senior medical officer and senior dispenser.

Identify and analyze the stakeholders

The stakeholders are the group of people who would influence and be affected by

the proposed protocol. The involvement of all the stakeholders and good communication

between them could contribute positively to the planning of the implementation. The

stakeholders of the proposed protocol included the senior medical officers, medical officers,

senior nursing officer, nursing officers, registered nurses and dispensers of the families’ clinic.

The smokers and the quitters are also the stakeholders of the proposed protocol.

4.2 Communication Process

All of the stakeholders should take part in the communication process. Their

involvement could contribute to the successful of the proposed program. Nursing officers

are at the good position to be the coordinator and facilitator of implementing the proposed

program. They are familiar with launching the new health-related program or protocol. Their

experiences and the administrative skills could help to facilitate the communication process.

29

The introduction and details of the whole proposed program will be presented to the nursing

officers first. The content of the presentation will include the current situation, comments

from quitters, smokers and nurses’ towards the current smoking cessation service of our clinic.

Moreover, the significance, objective, content, flow, expected outcomes, impacts and

cost-benefit ratio of the proposed program will also be presented. The possible difficulties

and problems can be discussed with the nursing officers. Their comments, advices and

suggestions will be gathered. Changes and amendments on the proposed program will then be

made.

After the nursing officers agree with the amended one, nursing officers will then

bring this proposed program to the regular meeting with senior nursing officers. The

registered nurses who in-charge this proposed program will also participate in this meeting.

The amended proposed program will be presented to the senior nursing officers by the

nursing officer. The seniors nursing officer’s feedbacks, recommendations will be used for

further amendments. The seniors nursing officers and nursing officers will have a senior

meeting with the senior medical officers and senior dispenser of the clinic. Their comments

and suggestions will be used for adjusting the proposed program. After making all the

amendments, the approval of disseminating and implementing the proposed program will be

obtained from the senior medical officers, senior nursing officer and the nursing officers.

A clinical meeting will be held for introducing this proposed smoking cessation

intervention to all the involved parties, including the registered nurses, medical officers and

the dispensers. As we have all on duty doctors, nurses and dispensers to join the journal club

meeting regularly on the third Wednesday of every month, the proposed program will be

introduced to them in our coming journal club meeting. It is important for them to have a full

picture of the program because they all take part in it. The meeting will take about one hour.

It included briefing the new reduction to quit intervention, discussing the flow of the program

30

and collecting the comments from different parties towards this proposed program. Doctors

will recruit and refer the smokers to join our reduction to quit intervention program. Nurses

will be responsible in providing the counseling and follow-up to the participants. Dispensers

will give the nicotine replacement therapy according to the protocol and doctor’s prescription.

A file of the proposed protocol including the information, flow and forms will be distributed

to each doctor. This file will also be kept one in the clinical protocol cabinet. A softcopy

will be sent to each medical officer’s email and it will be saved in the computer at nursing

treatment room. Nurses are welcomed to print or photocopy one for reference and study.

These above measures can facilitate all parties to familiar with the new proposed protocol.

Two of the registered nurses who finished the three full days of smoking cessation counseling

course which organized by the Department of Health and the Mayo Clinic in United State,

will be chosen as the responsible nurses for the proposed program. They will work with the

nursing officers to act as a coordinator between different involved parties. The responsible

nurses should be familiar with the proposed program. They will demonstrate the counseling

of the reduction to quit intervention to other nurses. The nursing officers and the responsible

nurses will observe all other nurses in performing the counseling of reduction to quit

intervention. Comments and suggestions would be given to the nurses. Whenever other

nurses have any problems or suggestions in carrying out the proposed program, they can

discuss with the responsible nurses first. The responsible nurses will gather and direct these

feedbacks to the nursing officers. Nursing officers will bring these issues to discuss with the

senior medical officers and senior dispenser in their senior meeting every two weeks. The

flow and details of the program will be refined. Moreover, the responsible nurses will work

with other nurses of the Tobacco Control Office to make pamphlets and a broad to introduce

this new program to our clients.

Our doctors must assess every new client’s or review the old client’s smoking status

31

in each consultation. When they come across the smoking clients who met our program

inclusion criteria, doctors will ask them to quit smoking and refer them to join our smoking

cessation program. Doctors will then briefly introduce our current smoking cessation

intervention and the new reduction to quit intervention to them. The clients are free to choose

joining the new intervention or not. Those who join the new intervention are then referred to

the nurses for details assessment and providing more information about the smoking

cessation program. In the last follow-up of the program, the participants will be asked to fill

in a questionnaire about the reduction to quit with nicotine replacement therapy intervention

for the evaluation.

As our proposed program is evidence based, so the program will be adjusted

according to the updated evidences. The filled questionnaire from the participants will be

reviewed regularly. The suggestions from all the stakeholders will be collected and discussed

in bi-monthly communication team meeting. The updated information and refinement of the

program will be delivered to all involved parties in monthly clinical meeting.

4.3 Pilot Test

A pilot test will be run before implementing the full-scale program and

incorporating to our current smoking cessation services. Through the pilot test, the feasibility,

time, cost, resources needed and potential problems will be evaluated in order to make the

full implementation of the proposed program smoother. The pilot test will take three months.

The participants will be recruited within the first month. They will be recruited according to

our inclusion criteria. The program will take two months. And the evaluation of the proposed

program will be done in the last month.

The objectives of the pilot test are:

1. To gain experience in implementing the innovation

2. To evaluate the feasibility of the proposed reduction to quit intervention with nicotine

32

replacement therapy

3. To gather all the stockholders’ feedbacks and acceptability towards the new proposed

protocols

4. To identify difficulties and potential problems in implementing the proposed program and

incorporating it into our current smoking cessation services

5. To make an improvement on the proposed protocol

Participants of the pilot test

The doctors are responsible in recruiting the eligible smokers to join our new

reduction to quit program. The smoking cessation in-charge nurses will be responsible for the

three-month reduction to quit intervention program. She will assess the eligibility of each

smokers referring from our doctors. She will do the counseling, follow-up and arrange the

follow-up for each participant.

Clients’ recruitment

Six to eight participants will be recruited for the pilot test of the reduction to quit

intervention within one month. The doctors will refer the eligible smokers to join the program.

The nurses will make sure they fully meet the inclusion criteria and do not against the

exclusion criteria which were mentioned in the previous chapter. The responsible nurses for

this reduction to quit intervention will perform the assessment for the smokers. If they are

willing to participate in our new program, an inform consent will be obtained from them. And

the follow-up dates will be arranged.

Baseline assessment

Nurses will obtain and record some basic information of the smokers during the

assessment. It included asking their smoking history, habit, and medical background, number

of attempt in trying to quit smoking, ways to quit before, the reasons of failure, the reasons of

choosing reduction to quit, their confidence level, readiness towards the reduction to quit and

33

the preference of nicotine replacement therapy. All these information will be recorded on the

clients’ medical file in our clinic and their own log book of smoking cessation.

Intervention

After the assessment, the participants will be followed up at week 1, 4 and 8. In

each follow up, the nurses will review the smoking status; the number of cigarette reduced

every day and the use of nicotine replacement therapy. These are depended on the

participants’ self-report and validated by the exhaled carbon monoxide level. Each session

takes about 15-30 minutes.

4.4 Pilot Test Evaluation

All stakeholders will be involved in the evaluation. Nurses and doctors can express

their comments, difficulties and suggestions of the protocol on the self-developed

questionnaire (Appendix G). The smoking cessation service in-charge nurses, nursing officers

or the senior medical officers will collect all the questionnaires. Those comments, difficulties

and suggestions will then be grouped up and discussed in the monthly clinical meeting.

The smoking cessation in-charge nurses and the nursing officers will responsible in

collecting the participants’ opinions towards the reduction to quit smoking intervention. Each

participant will be given a questionnaire in their last follow-up at week 8. The content of the

questionnaire will focus on asking about their feeling, comments, suggestions for

improvement, satisfaction and acceptance level towards the new intervention (Appendix H).

Comments and suggestion from all stakeholders will be accounted for improving

our program. The outcome of the pilot test and the confirmed changes on the program will

notify the doctors, nurses and the dispensers. The refined protocol will be printed out and sent

to the involved parties. A full-scale of the program is then ready to be implemented.

34

Chapter 5: Evaluation Plan

The aim of the evaluation plan is to assess the implementation potential of the

newly introduced intervention into our smoking cessation services. All the stakeholders,

including the participants, the doctors, the nurses and dispensers are included in our

evaluation plan. The evaluation of the program will first be done at month 8 after the full

implementation of the program.

5.1 Objectives

The objectives of the evaluation plan are

- To identify the outcome of implementation the protocol

- To assess the effectiveness of the protocol

- To assess all the stakeholders’ acceptability to the protocol

5.2 Characteristics and numbers of patients involved

The numbers of smokers for evaluation depend on the primary outcome of our

proposed program. The primary outcome of our program is the smoking abstinence rate. The

effectiveness of the program will be found out through comparing the smoking abstinence

rate between week 0 and month 6. Our power and sample size is find out through statistic

power analysis by the G*power (Faul, Erdfelder, Buchner & Lang, 2009). According to the

reviewed studies, we take 0.5 as the level of significance and 0.8 as the power. We take the

effect size as 0.27 by calculating from the selected studies and excluding the extreme finding

from one study. 110 samples are needed for the program. According to our monthly statistic

of smoking cessation new cases, it is not practical to recruit 110 smokers to join this new

program in two months. It will be much realistic if we expect to recruit about 15-20 smokers

in a month because the monthly newly recruited smokers in our current smoking services was

ranged from 15 to 20.

35

5.3 Identify the outcomes

The successful of the reduction to quit smoking intervention will be affected by

different parties’ outcomes including the clients’ outcomes, health care providers’ outcomes

and the clinical system outcome.

Client’s outcomes

The aim of our proposed program is helping smokers to cut down their smoking

cigarettes and then to complete smoking cessation. According to the review studies, the

reduction to quit intervention with nicotine replacement therapy can help smokers to quit.

The participants will be asked to report their smoking status and validated by the exhaled

carbon monoxide level. Based on the review studies, the participants are expected to report

no smoking and the exhaled carbon monoxide is less than 10 ppm. The clients’ satisfaction,

acceptability and feedbacks towards the program are also our concerns. The clients’ outcomes

will be measured by using the self-developed questionnaire (Appendix I).

Healthcare provider outcomes

The attitude of the health care professional to the reduction to quit smoking intervention

will be evaluated. Their attitude and thinking towards the program will be first collected

through the self-developed questionnaires (Appendix J). They will be collected by the

nursing officers and seniors medical officers. They will group up the comments and results

and bring them to the clinical meeting for discussion. The questionnaire will be focused on

asking the health care professional about the workload changes, the workflow of the program

and the effectiveness of the reduction to quit intervention on smoking cessation. This

evaluation will be held at 6-month after the implementation of the program. The expected

result is nearly 95% of our health care professionals satisfied the program and it will not over

load our staff.

System outcomes

36

The expenses for setting up and running this program will be marked and

calculated. If the total expenses using on this program in half year is match with our budget

plan, which is less than $80000 yearly, it will be considered as effective. In long-term, if

more smokers can quit smoking successfully through our smoking cessation services, the

expenses spending on treating our clients’ smoking–related disease may be reduced.

5.4 Data analysis

The collected data, including the number of cigarettes smoking per day, the exhaled

carbon monoxide level, will be inputted to the Statistical Package for Social Science (SPSS)

version 19 for statistically analysis. The one-sample paired t-test will be used in the statistical

analysis to calculate the mean smoking abstinence rate in comparing the result at week 0 and

month 6 after the start of the reduction to quit intervention. For those questions with choices

on the clients’ and health care professionals’ feedback and satisfaction questionnaires, the

result will be analyzed by measuring the percentage of each item. For those open questions,

the comments will be collected and categorized by the responsible nurses.

5.5 Basis of an Effective Change of Practice

The successful smoking cessation rate can be the indicator of the effectiveness of

the reduction to quit intervention. By comparing with the smoking cessation rate of the

participants joining the smoking cessation services before, it can be regarded as effective if

the smoking cessation rate of the new intervention’s clients are higher or nearly the same. But

even the smoking cessation rate is much less than clients joining the past smoking cessation

program, it did not necessary mean the new intervention is not effective. It is because we are

not trying to find which smoking cessation intervention is better. We want to find an alternate

way attracting the smokers to quit smoking. So the basis of the effective change of practice

should be included the increasing of smokers joining the smoking cessation services and the

37

increasing successful smoking cessation rate.

38

Chapter 6: Conclusion

Smoking control is one of the prioritized topics of public health in Hong Kong.

Smoking cessation services in Hong Kong should be reinforced to help more smokers to quit.

Abruptly smoking cessation is the main proofed way to quit smoking in Hong Kong before.

After reviewing those related and selected studies, the reduction to quit intervention with

nicotine replacement therapy is effective to help smokers quitting, especially those have high

dependence level on nicotine and did not have confidence to quit abruptly (Taskila et al.,

2012). So we expected incorporating the new intervention to our current smoking cessation

services can increase the successful smoking cessation rate. It can promote the smoke-free

Hong Kong. It can be beneficial to all peoples’ health in Hong Kong.

A pilot test will be carried out before the full implementation of the new

intervention. Through the pilot study, the feasibility of the intervention will be assessed. An

evaluation plan is developed to find out the effectiveness of the intervention. After the

comprehensive evaluation, an evidence-based protocol on cut down to quit intervention with

nicotine replacement therapy is developed. This intervention can provide health care

professional with alternate choices to help the smokers quitting. It also gives the smokers

more choices to quit. With the successful implementation of the reduction to quit intervention

in our clinic, we will promote this new intervention to other families’ clinics and clinics under

the Department of Health with smoking cessation services.

39

References

Asfar, T., Ebbert, J. O., Klesges, R. C., & Relyea, G. E. (2011). Do smoking reduction

interventions promote cessation in smokers not ready to quit? Addict Behav, 36(7),

764-768.

Bolliger, C. T., Zellweger, J. P., Danielsson, T., van Biljon, X., Robidou, A., Westin, A.,

Perruchoud, A.P., & Sawe, U. (2000). Smoking reduction with oral nicotine

inhalers: double blind, randomised clinical trial of efficacy and safety. BMJ,

321(7257), 329-333.

Carpenter, M. J., Hughes, J. R., Solomon, L. J., & Callas P. W. (2004). Both smoking

reduction with nicotine replacement therapy and motivational advice increase

future cessation among smokers unmotivated to quit. Journal of Consulting and

Clinical Psychology. 72(3), 371-381.

Census and statistics department. (2013). Thematic household survey. Report No.53: Pattern

of smoking. Hong Kong

Chan, S. S., Leung, D. Y., Abdullah, A. S., Wong, V. T., Hedley, A. J., & Lam, T. H. (2011). A

randomized controlled trial of a smoking reduction plus nicotine replacement

therapy intervention for smokers not willing to quit smoking. Addiction, 106(6).

Department of Health (2013). Retrieved November 27 2014, from

http://www.dh.gov.hk/english/aboutus/aboutus_mv/aboutus_mv.html

Faul, F., Erdfelder, E., Buchner, A., & Lang, A.-G. (2009). Statistical power analyses using

G*Power 3.1: Tests for correlation and regression analyses. Behavior Research

Methods, 41, 1149-1160.

Lam, T. H., Abdullah, A. S., Chan, S. S., Hedley, A. J., Hong Kong Council on, S., & Health

Smoking Cessation Health Centre Steering, G. (2005). Adherence to nicotine

replacement therapy versus quitting smoking among Chinese smokers: a

preliminary investigation. Psychopharmacology (Berl), 177(4), 400-408.

Lam, T. H., Chan, S. S., Abdullah, A. S., Wong, V. T., Chan, A. Y., & Hedley, A. J. (2012).

Smoking reduction intervention for smokers not willing to quit smoking: a

randomised controlled trial. Hong Kong Med J, 18 Suppl 3, 4-8.

Lindson, N., Aveyard, P., Ingram, J. T., Inglis, J., Beach, J., West, R., & Michie, S. (2009).

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a

randomised controlled non-inferiority trial. Trials, 10, 69.

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Melnyk, B.M. & Fineout-Overholt, E. (2005). Evidence-based practice in nursing &

healthcare. A guide to best practice. Philadelphia: Lippincott Williams & Wikins.

Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting

Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement.

PLoS Med 6(6)

Professional Development and Quality Assurance (2012). Retrieved August 18, 2014, from.

vhttp://www.pdqa.gov.hk/english/aboutus/about_us.php

Professional Development and Quality Assurance (2011). Public Health Nursing Services.

Retrieved August 18, 2014, from

http://www.pdqa.gov.hk/english/primarycare/phns/pc_phns_roles.php

Rennard, S. I., Glover, E. D., Leischow, S., Daughton, D. M., Glover, P. N., Muramoto,

M., . . . Westin, A. (2006). Efficacy of the nicotine inhaler in smoking reduction:

A double-blind, randomized trial. Nicotine Tob Res, 8(4), 555-564.

Scottish Intercollegiate Guidelines Network. (2012). Key to evidence statements and grades

of recommendations. Retrieved 18th December, 2014, from

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

Scottish Intercollegiate Guidelines Network (SIGN) (2014). Sign grading system 1999-2012.

August 18, 2014, from http://www.sign.ac.uk/guidelines/fulltext/50/annexoldb.html

Scottish Intercollegiate Guidelines Network (SIGN) (2014). Notes and checklists. Retrieved

August 18, 2014, from http://www.sign.ac.uk/methodology/checklists.html

Shiffman, S., Ferguson, S. G., & Strahs, K. R. (2009). Quitting by gradual smoking

reduction using nicotine gum: a randomized controlled trial. Am J Prev Med, 36(2),

96-104.

Taskila, T., Macaskill, S., Coleman, T., Etter, J. F., Patel, M., Clarke, S., Bridson, R., &

Aveyard, P. (2012). A randomised trial of nicotine assisted reduction to stop in

pharmacies - the RedPharm study. BMC Public Health, 12, 182.

41

Tobacco Control Office (2013). Quitting Smoking. Retrieved August 18, 2014, from

http://www.tco.gov.hk/english/quitting/quitting_ycqs.html

Tobacco Control Office ( 2012). eLearning ABC- Help your clients to quit. Retrieved July 28,

2015, from http://www.tco.gov.hk/english/quitting/elearning_abc.html

Tobacco Control Office ( 2011) . Smoking rate hits 30-year low. Retrieved August 18, 2014,

from

http://www.tco.gov.hk/english/whatsnew/smoking_rate_hits_30_year_low.html

Wennike, P., Danielsson, T., Landfeldt, B., Westin, A., & Tonnesen, P. (2003). Smoking

reduction promotes smoking cessation: results from a double blind, randomized,

placebo-controlled trial of nicotine gum with 2-year follow-up. Addiction, 98(10),

1395-1402

World Health Organization (2014). WHO calls for higher tobacco taxes to save more lives.

Retrieved August 18, 2014, from

http://www.who.int/mediacentre/news/releases/2014/no-tobacco-day/en/

42

Appendix

Appendix A- Searching Strategies and Results

Electronic Databases

Searching items PubMed ISI web of knowledge CINAHL The PsycINFO Cochrane Library

1) Gradual smoking reduction 94 92 66 58 101

2) Cut down to quit 82 87 9 56 52

3) Smoking reduction

intervention

1492 2375 5 816 1981

4) Nicotine replacement

therapy

2217 2343 358 1067 791

5) Nicotine gum 2568 1290 47 536 637

6) Nicotine inhaler 233 221 8 83 118

7) Nicotine patch 3081 2319 122 834 884

8) (1) OR (2) OR (3) 1650 2528 80 912 2011

9) (4) OR (5) OR (6) OR (7) 5450 4792 451 2019 1783

10) (8) AND (9) 136 196 4 88 191

11) Screening by reading the

topics, citations & abstract

10 10 1 7 1

12) Screening by reading the full

text

3 3 1 3 0

13) Exclude the duplication 5

43

Appendix B- Tables of evidences

Title: Smoking reduction promotes smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with

2-year follow-up

Bibliographic

citation

Study type Patient characteristics Intervention(s) Comparison Length of

follow up

Interested Outcome

measures

Effect size

Wennike et

al., 2003

Double-blind,

randomized,

placebo-

controlled

trial

- Healthy smokers

- Interested in

reducing their

smoking but no

intention to quit

smoking within

the next month

- Smoke at least 15

cigs/day, for 3

years

- Fail in last quit

attempt within 24

months

Gradual

smoking

reduction with

nicotine gum

(n=205)

Gradual

smoking

reduction

with

placebo

( n=206)

24 months Primary outcome

(Biochemical validated

with CO reduction at least

1 ppm )

Self-reported 7-day point

prevalence reduction of at

least 50% of cigarettes

(1) 12-month

(2) 24-month

Secondary outcome

(Biochemical validated

with Co measurement less

than 10 ppm))

Self-reported 7-day point

prevalence abstinence

(3) 12-month

(4) 24-month

(1) Intervention: 21%

Control: 13.1%

(p=0.0036)

(2) Intervention: 14.6%

Control: 9.7%

( p= 0.13)

(3) Intervention: 11.2%

Control: 3.9%

(p=0.005)

(4) Intervention: 9.3%

Control: 3.4%

( p= 0.015)

44

Appendix B- Tables of evidences

Title: Both smoking reduction with nicotine replacement therapy and motivational advice increase future cessation among smokers unmotivated

to quit

Bibliographic

citation

Study type Patient characteristics Intervention(s) Comparis

on

Length of

follow up

Interested Outcome

measures

Effect size

Carpenter et

al., 2004

randomized,

controlled

trial

- Recruited via

proactive telephone

calls through national

marketing firm

- Willing to reduce

their smoking but

unable or unwilling

to stop immediately

Smoking

reduction with

nicotine

replacement

therapy

(nicotine gum,

7mg, 14 mg or

21mg nicotine

patch)

(n=212)

No

treatment

( n=207)

6 months Primary outcome:

Self-reported 7-day point

prevalence abstinence

(1) Week 6

(2) Week 24

(1) Intervention: 1.0%

Control: 1.0%

OR: +0.40

(95%CI= 0.20,8.80)

(2) Intervention: 18.0%

Control: 4.0%

OR: +4.50

(95%CI= 2.10,9.60)

45

Appendix B- Tables of evidences

Title: Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial

Bibliographic

citation

Study type Patient characteristics Intervention(s) Comparison Length of

follow up

Interested Outcome

measures

Effect size

Rennard., et

al 2006

Double-blind,

multi-center,

randomized

controlled

trial

- Healthy smokers

- Smoke at least 20

cigs per day

- Want to reduce

their cigarette

consumption but

not to plan stopping

smoking within the

next 4 weeks

Gradual

smoking

reduction with

nicotine

inhaler

(n=215)

Gradual

smoking

reduction

with

placebo

( n=214)

15 months Primary outcome

(Biochemical validated

with decrease in expired

CO of at least 1 ppm)

(1) Self-reported

reduction of 50%

number of cigarettes at

4-month

Secondary outcome

(Biochemical validated by

CO less than 10 ppm)

(2) 12-month abstinence

(3) 15-month abstinence

(1) Intervention:18%

Control: 8%

(p= 0.004)

(2) Intervention: 7.9%

Control: 2.3%

(p=0.014)

(3) Intervention: 7.9%

Control: 1.4%

( p= 0.002)

46

Appendix B- Tables of evidences

Title: Quitting by Gradual smoking reduction using nicotine gum

Bibliographic

citation

Study type Patient characteristics Intervention(s) Comparison Length of

follow up

Interested Outcome

measures

Effect size

Shiffman,

Ferguson &

Strahs., 2009

Multi-center,

placebo-controlled,

double-blind

randomised

controlled trial

- Recruited using

print and radio

advertisements

- Interested in

quitting by gradual

reduction within 30

days

- Self-selected

nicotine gum

dosage according to

label instructions

- Not working during

the night hours

Gradual

smoking

reduction with

nicotine gum

(n=1649)

Gradual

smoking

reduction

with

placebo

( n=1648)

6 months Primary outcome

(Biochemical

validated)

(1) Successful

reduction (≥ 50%

in smoking level

and 25% in CO

level) at week 2

(2) 6-month

abstinence

( average of 2 CO

reading <= 10

ppm)

Secondary outcome

(3) Adverse events

report

(1) Intervention: 18.6%

Control: 11.2%

OR: +1.81

(95%CI= 1.49,2.21)

(2) Intervention: 5.9%

Control: 2.1%

OR:+2.86

(95% CI= 1.93,

4.24)

(3) Intervention: 48.2%

Control: 36.6%

(p<0.001)

47

Appendix B- Tables of evidences

Title: Smoking reduction intervention for smokers not willing to quit smoking: a randomized controlled trial

Bibliographic

citation

Study type Patient

characteristics

Intervention(s) Comparison Length of

follow up

Interested Outcome

measures

Effect size

Lam et al.,

2012

Single-blind

Randomized

controlled

trial

- Chinese in

Hong Kong

- Smoke at least

2 cigarettes

daily

- No intention to

quit in the near

future/ fail in

previous quit

attempts with

NRT

- Intent to reduce

smoking within

next 7 days

using NRT

-Reduction and

adherence group

( 15 mins

smoking

reduction

counselling + 3

mins adherence

counselling + free

NRT)(n=479)

-Reduction

intervention

group ( received

smoking

reduction

counselling + free

NRT

only)(n=449)

Controlled

group

(receive

simple advice

on smoking

cessation and

a self-help

pamphlet

only)

(n=226)

6 months Primary outcome

(1) Self-reported 7-day

point prevalence

tobacco abstinence at

month 6 between

combined intervention

and control groups

(2) Self-reported reduction

rate (≥ 50%) of

cigarette consumption

at month 6 between

combined intervention

and control group

Secondary outcome

(3) Biochemical validated

quit rate at month 6

(1) Intervention: 17%

Control: 10.2%

OR: +1.81

(p= 0.012)

(2) Intervention: 50.9%

Control: 25.7 %

OR:+3.0

( p < 0.001)

(3) Intervention: 8%

Control: 4.4%

OR:+1.87

(p=0.066)

48

48

Appendix C- Critical appraisal checklists

S I G N

Methodology Checklist 2: Controlled Trials

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

Wennike, P., Danielsson, T., Landfeldt, B., Westin, A., & Tonnesen, P. (2003). Smoking reduction promotes

smoking cessation: results from a double blind, randomized, placebo-controlled trial of nicotine gum with

2-year follow-up. Addiction, 98(10), 1395-1402.

Guideline topic: An evidence-based protocol on integrating

cut down to quit intervention and nicotine replacement

therapy in helping smokers quit smoking

Key Question No: Reviewer:

Sung Wing Ting

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

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

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used. Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.

Yes

Can’t say

No

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

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation.

Yes

Can’t say

No

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

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

41% dropout rate among

1-year attendance rate

Dropout rate in 2-year study:

intervention group: 60%

49

49

Control group: 65.5 %

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

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

comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

Using double-blind randomized placebo-

controlled trial could avoid systematic bias. The

authors aimed at recruiting 400 subjects. It was

based on the results of previous smoking reduction

studies. They stated 200 subjects in each group

were needed for 80% of power with a two-tailed

significant level of 0.05. But the recruitment

method of subjects, concealment and site specific

data were not given in the study. They brought

some uncertainties into the study.

The primary analysis included all participants who

were randomized and receive treatment. There was

an intention-to –treat analysis. Abstainers were

also included in the primary analysis. All

statistical methods used were two-tailed test with

significant level of 0.05. P-value of each test was

presented for relevant interpretation while

confidence intervals were calculated in appropriate

situation.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The authors concluded that this study implied smokers who were not ready to quit smoking could be

offered nicotine gum in reducing smoking. This reduction to quit with nicotine gum approach could

promote smoking cessation on those smokers as well. The effect of the nicotine gum on smoking

reduction and cessation could be maintain and achieved over the period of twelve months. This study

was relative long study in comparing with other studies about the effectiveness of smoking reduction

with nicotine replacement therapy. It could give 2-year effect of this approach on smoking cessation.

This study could answer my question. This two-year, double-blind, randomized placebo-controlled

setting could provide a good quality of evidence in theory. The inclusion and exclusion criteria of

subjects were clearly stated and the consolidated standards of reporting trials flow chart of the study

were shown. Those related outcome measures were all significant findings which supporting the

50

50

effectiveness of smoking reduction interventions with nicotine replacement therapy, except for point

prevalence reduction at 24 months. The data was collected through self-reported and it was

biochemically validated through carbon monoxide measurement, blood sample for serum cotinine and

thiocyanate.

The authors did mention the potential limitation of this study. It was the high premature dropout rate

(41% in 1 –year attendance rate). But the authors explained that by using the intention-to-treat for

outcome analysis, there was no significant difference between the dropout subjects in the intervention

and control groups, for example, the nicotine dependence level and age. So, they believed the high

dropout rate would not affect much on the outcomes. The authors even performed the second analysis

in order to check the robustness of the conclusions from the primary analysis. The second analysis

was done by replacing those missing data by estimated value from a linear regression model. The

result of the second analysis was just similar to the primary analysis.

Although the authors reported that this study was a randomized controlled study but the recruitment

and randomization methods were not given in detail throughout the study. It brought the uncertainties

to the generalizability of the finding. Moreover, the uncertainties included the unsure of any

concealment method. The nicotine replacement therapies were free to provide in this study. It might

favor people to adhere to the nicotine replacement therapy and increase the successful rate of smoking

cessation by the combination of smoking reduction interventions and the nicotine replacement therapy

in this study.

S I G N

Methodology Checklist 2: Controlled Trials

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

Carpenter, M. J., Hughes, J. R., Solomon, L.J.,& Callas, P.W. (2004). Both smoking reduction with nicotine

replacement therapy and motivational advice increase future cessation among smokers unmotivated to quit.

Guideline topic: An evidence-based protocol on integrating cut

down to quit intervention and nicotine replacement therapy in

helping smokers quit smoking

Key Question No: Reviewer:

Sung Wing

Ting

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

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

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

51

51

1.2 The assignment of subjects to treatment groups is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say

No

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

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes

Can’t say

No

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

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

Only mention 6% data

missing in the study

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

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

comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

The authors did do a pilot study before this

study. The limitation of the pilot was

improved. The participants were recruited by

marketing firm and “behavior filter” which

could exclude those smokers who were more

motivated to quit. Using randomization

controlled trial could avoid systematic bias

and it could help to conclude the effectiveness

of the intervention. But the recruitment

database of participants from the marketing

firm was unclear, the details of randomization,

concealment and blinding were not given in

the study. They brought some uncertainties

into the study.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes.

52

52

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The authors concluded that this study provided evidence for the effectiveness of smoking reduction

intervention with nicotine replacement therapy for smoking cessation in comparing no treatment.

They agreed that smoking reduction intervention with NRT would not undermine the cessation but

rather increase the likelihood of quitting similar to motivational interview. So smoking reduction with

NRT might work when other current cessation methods failed. The authors also pointed out that the

smoking reduction strategies reflected visible behavioral change, it might be a more concrete method

for the smokers who were frustrated by the relative abstract motivational interventions. Health care

professional could suggest this intervention to smokers who were unmotivated to quit.

This study could answer my question. The randomized control setting could provide a good quality of

evidence in theory. The inclusion and exclusion criteria of subjects were clearly stated and the

consolidated recruitment flowchart were shown. But the standards of reporting trials flow chart of the

study were not clearly shown. Those related outcome measures were all significant findings which

supporting the effectiveness of smoking reduction interventions with nicotine replacement therapy in

comparing with no treatment.

The authors did mentioned the limitations of this study. The free offer of NRT might led to more quit

attempts and abstinence in the intervention groups. The recruitment and randomization methods were

unclear and not given throughout the study. It brought the uncertainties to the generalizability of the

finding. Moreover, the uncertainties included the unsure of any concealment and blinding method

might induce bias to the study. The data was all collected through phone calls by self-report. It did not

involve any biochemical verification of quit attempts or abstinence. The authors explained that it was

because the biochemical verification was not feasible for their telephone-based setting throughout the

nation. And the authors find that some researchers suggested that biochemical verification was not

necessary for this kind of population-based minimal intervention. The generalizability of this studies’

results might be limited as the participants were predominantly female (71%) and Caucasian (89%).

And the study only followed up the subjects for 6 months. It might not provide the long-term effects

of the interventions.

S I G N

Methodology Checklist 2: Controlled Trials

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

Rennard, S. I., Glover, E. D., Leischow, S., Daughton, D. M., Glover, P. N., Muramoto, M., . . . Westin, A.

(2006). Efficacy of the nicotine inhaler in smoking reduction: A double-blind, randomized trial. Nicotine Tob

Res, 8(4), 555-564.

Guideline topic: An evidence-based protocol on integrating cut

down to quit intervention and nicotine replacement therapy in

helping smokers quit smoking

Key Question No: Reviewer:

Sung Wing

Ting

53

53

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

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

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes

Can’t say

No

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

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation. Yes

Can’t say

No

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

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

During the study ,the

dropout rate of : 58.6%

intervention group: 69.6%

Control group: 14.9 %

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

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

comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your Using double-blind randomization controlled

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54

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?

trial could avoid systematic bias. The authors

did state that the required sample size was

calculated based on previous results of other

smoking reduction studies. By using this

assumption, they recruited 197 subjects for

each group in order to provide a power of 80%

with a significance level of 0.05.But the

recruitment method of subjects, concealment

and site specific data were not given in the

study. They brought some uncertainties into the

study.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The authors concluded that this study showed the use of nicotine inhaler could led to sustained

smoking reduction in daily cigarette consumption for 15 months and promoted the smoking cessation.

This study confirmed that the smoking reduction concept could facilitate the smoking cessation

including smokers who were not willing to quit currently. It demonstrated a statistically significant

effect of active inhaler in achieving reduction. The authors agreed that smoking reduction facilitated

the quit attempts rather than compromised them.

This study could answer my question. This double-blinded randomized control setting could provide a

good quality of evidence in theory. The inclusion and exclusion criteria of subjects were clearly stated.

But the consolidated standards of reporting trials flow chart of the study were not shown. Those

outcome measures, which related to our guideline topic, were all significant findings. They supported

the effectiveness of smoking reduction interventions with nicotine inhalers. The data was collected

through self-reported and it was biochemically validated through carbon monoxide measurement,

blood sample for serum cotinine and thiocyanate.

The authors did not mention any limitation of this study. But they did discuss the dropout rates of the

participants were quite high (total 64%). They explained that it was the common problems of many

smoking cessation and reduction studies. The authors though the lack of behavioral counseling

component might contribute to the dropout rate. All those dropout participants were assumed to be

failed cases in this study. This approach might then increase the likelihood of Type II error in the

intention-to-treat analysis. It might cause the result wrongly concluding that the intervention did not

bring the effect. The high dropout rate might then confound the interpretation as well. So, the

conclusions made in this study were only based on available data. Moreover, the recruitment and

randomization methods were not given throughout the study. It brought the uncertainties to the

generalizability of the finding. The study was followed up the participants for 15 months. It might not

provide the long-term effects of the interventions.

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55

S I G N

Methodology Checklist 2: Controlled Trials

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

Shiffman, S., Ferguson, S. G., & Strahs, K. R. (2009). Quitting by gradual smoking reduction using nicotine

gum: a randomized controlled trial. Am J Prev Med, 36(2), 96-104.

Guideline topic: An evidence-based protocol on integrating cut down

to quit intervention and nicotine replacement therapy in helping

smokers quit smoking

Key Question No: Reviewer:

Sung

Wing Ting

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

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

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.

Yes

Can’t say

No

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

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation.

Yes

Can’t say

No

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

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

At 6months, dropout

rate of :

Combined

intervention group:

1.3%

Control group: 0.3%

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56

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

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

comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

Using multi-center, placebo-controlled,

double-blind randomization controlled

trial could avoid systematic bias. The

authors did not state the power analysis

and the required sample size. But it

included a very large and diverse sample.

And the study was done in a real-world

environment. The blinding and

concealment were not given in the study.

They still brought some uncertainties into

the study.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes. `

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The authors concluded that this study provided evidence for the efficacy and safety of using

nicotine gum to help smoking cessation by gradual smoking reduction. The study suggested

that gradual smoking reduction with nicotine gum could offer a very substantial advantage,

more likely to substantially reduce smoking, maintain abstinence in the short term and up to

6 months. The study also showed that using nicotine gum while smoking carried little to no

risk. By using the NRT in such a new way could enhance the reach of the NRT and increase

the success. It could bring positive public health impact to the community.

This study could answer my question. This multi-center, placebo-controlled, double-blind

randomization controlled setting could provide a good quality of evidence in theory. The

inclusion and exclusion criteria of subjects were clearly stated and the consolidated standards

of reporting trials flow chart of the study was shown. Those related outcome measures were

all significant findings which supporting the efficacy and safety of smoking reduction

interventions with nicotine replacement therapy. The data on cigarette smoked and nicotine

gum used were shown in details. And the smoker exposures were biochemically validated

through carbon monoxide measurement and blood sample for serum thiocyanate.

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57

S I G N

Methodology Checklist 2: Controlled Trials

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

Lam, T. H., Chan, S. S., Abdullah, A. S., Wong, V. T., Chan, A. Y., & Hedley, A. J. (2012). Smoking reduction

intervention for smokers not willing to quit smoking: a randomised controlled trial. Hong Kong

Med J, 18 Suppl 3, 4-8.

Guideline topic: An evidence-based protocol on integrating

cut down to quit intervention and nicotine replacement

therapy in helping smokers quit smoking

Key Question No: Reviewer:

Sung Wing Ting

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

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

1.1 The study addresses an appropriate and clearly focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation.

Yes

Can’t say

No

The authors only mention the main limitation of this study. There was lack of detailed data

about how the participants using the nicotine gum. There was no detailed information about

those subjects who were screened out in participation. The randomization, blinding and

concealment methods were not given throughout the study. It brought the uncertainties to the

generalizability of the finding. As smokers with heart diseases were excluded from this

study, they could have higher risk of adverse effects in using NRT while smoking. So, it

made the result might not generalized to all smokers. And the study only followed up the

subjects for 6 months. It might not provide the long-term effects of the interventions.

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58

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

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation.

Yes

Can’t say

No

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

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

At 6months, dropout rate of :

Combined intervention group:

10.3%

Control group: 4.4 %

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are comparable for all sites.

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows.

High quality (++)

Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

Using single-blind randomization controlled trial

could avoid systematic bias. The authors did state

that the required sample size was calculated based

on primary outcome measures to provide at least

90% power with a significance level of 5 %.But

the recruitment method of subjects, concealment

and site specific data were not given in the study.

They brought some uncertainties into the study.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

The authors concluded that this study provided evidence for the effectiveness of smoking reduction

intervention in smoking cessation. They agreed that smoking reduction intervention could be

important for planning smoking cessation services. They also concluded free nicotine replacement

therapy with smoking reduction counseling was a feasible and cost-effective approach to help

unmotivated smokers to reduce and quit smoking. It could attract smokers who were not willing or

ready to quit.

This study could answer my question. This randomized control setting could provide a good quality of

evidence in theory. The inclusion and exclusion criteria of subjects were clearly stated and the

consolidated standards of reporting trials flow chart of the study were shown. Those related outcome

measures were all significant findings which supporting the effectiveness of smoking reduction

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59

interventions with nicotine replacement therapy. This study was carried out in Hong Kong and the

subjects were Chinese which were same as the target group of my clinical protocol. It could eliminate

the possible of culture different in using this study’s finding for my clinical protocol.

The authors only mention the main limitation of this study. It was the difficulty in recruiting

participants. The recruitment and randomization methods were not given throughout the study. It

brought the uncertainties to the generalizability of the finding. Moreover, the uncertainties included

the unsure of any concealment method and the study was single-blind only which might induce bias to

the study. The nicotine replacement therapies were free to provide in this study. It might favor people

to adhere to the nicotine replacement therapy and increase the successful rate of smoking cessation by

the combination of smoking reduction interventions and the nicotine replacement therapy in this

study. And the study only followed up the subjects for 6 months. It might not provide the long-term

effects of the interventions.

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60

Appendix D- Budget Plan for the Proposed Program

Items Estimated Cost

Manpower cost No Extra manpower was needed

Venue for the programme Clinic provision

Computer, projector system Clinic provision

Carbon monoxide analyzer Clinic provision

Health education pamphlets x 150 $2/ one pamphlet x 150 = $300

Nicotine replacement therapy x 50 * $1500 x50= $75000

Total cost $75300

*The senior dispensers would order the amount of nicotine replacement therapy depending on

the use of them.

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Appendix E- Grade of Recommendation

SIGN grading system: Grade of Recommendation

(Scottish Intercollegiate Guidelines Network, 2012)

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+

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Appendix F: Recommendations

Recommendation 1: Modes of delivering the reduction to quit with nicotine replacement

therapy intervention. (Grade A)

The programme would be delivered by clinic visit in the first assessment session and five

follow up. The two follow up at month 6 and 12 would be done by telephone calls 〔Rennard

et al., 2006 (+1); Shiffman, Ferguson & Strahs, 2009 (+1); Lam et al., 2012 (++1) 〕.

Recommendation 2: Length of the programme. (Grade A)

The intensive follow up would be arranged in the first 3 month ( total 5 follow up ) and there

would be a telephone follow up at month 6 and 12 to see the extensive effects. If the quitters

was find relapsing , they would be invited to join the smoking cessation programme again

〔Rennard et al., 2006 (+1); Shiffman, Ferguson & Strahs, 2009 (+1); Lam et al., 2012

(++1) 〕.

Recommendation 3: Frequency of follow-up. (Grade A)

According to the selected studies, the frequency of follow up was ranged from four to nine

clinic visit in between. As this new intervention would incorporate into our current smoking

cessation programme, so there would be also assessment session, week 0,1,4,8,12 clinic visit

follow up and telephone follow up at month 6, 12 〔Wennike et al., 2003 (++1); Carpenter et al.,

2004 (+1); Rennard et al., 2006 (+1); Shiffman, Ferguson & Strahs, 2009 (+1); Lam et al., 2012

(++1) 〕.

Recommendation 4: Duration of each reduction to quit with nicotine replacement therapy

intervention session. (Grade A)

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The duration of each reduction to quit with nicotine replacement therapy intervention session

should take about 15 to 30 minutes 〔Wennike et al., 2003 (++1); Carpenter et al., 2004 (+1). 〕

Recommendation 5: The choice of nicotine replacement therapy in the reduction to quit

intervention. (Grade A)

Nicotine replacement therapy including nicotine gum, patch, inhaler could be the choice for the

smokers of the reduction to quit intervention 〔Wennike et al., 2003 (++1); Carpenter et al.,

2004 (+1); Rennard et al., 2006 (+1); Shiffman, Ferguson & Strahs, 2009 (+1) 〕.

Recommendation 6: Ways to cut down the number of cigarettes. (Grade A)

The smokers should be advised to reduce their daily number of smoking as much as possible

and increase the nicotine replacement therapy use progressively. There was two types of

reduction, hierarchical reduction (selectively eliminating cigarettes throughout the day), or

scheduled reduction (increasing the time interval between cigarettes). 〔Wennike et al., 2003

(++1); Carpenter et al., 2004 (+1); Rennard et al., 2006 (+1); Shiffman, Ferguson & Strahs,

2009 (+1) 〕.

Recommendation 7: Defining the successful smoking reduction. (Grade A)

The successful of smoking reduction would be defined as 50% reduction of the original daily

number of smoking. 〔Wennike et al., 2003 (++1); Carpenter et al., 2004 (+1); Rennard et al.,

2006 (+1); Shiffman, Ferguson & Strahs, 2009 (+1); Lam et al., 2012 (++1) 〕.

Recommendation 8: The method in validating the smoking status. (Grade A)

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64

The smoking status of the smokers should be collected by self –report method in all the

follow-up including the clinic visit and telephone follow up. During each clinic visit at week 0,

1, 4,8,12 should be validated by biomedical measurement, the exhaled carbon monoxide by

using a Carbon monoxide analyzer. The reduction of smoking should be biochemical validated

with CO reduction at least 1 ppm while the cessation should be showed CO measurement less

than 10 ppm 〔Wennike et al., 2003 (++1); Carpenter et al., 2004 (+1); Rennard et al., 2006

(+1); Shiffman, Ferguson & Strahs, 2009 (+1); Lam et al., 2012 (++1) 〕.

Recommendation 9: Ways to check the use of nicotine replacement therapy by the quitters.

(Grade A)

The use of nicotine replacement therapy by the smokers could be assessed by asking their daily

consumption of the nicotine replacement therapy and counting the amount of nicotine

replacement therapy left 〔Wennike et al., 2003 (++1); Lam et al., 2012 (++1) 〕.

Recommendation 10: Instructor of the programme. (Grade A)

The reduction to quit intervention should be provided by the trained smoking cessation

counselor. It was suggested to delivery by the health care professional. Trained registered

nurses would act as counselor to delivery this new programme to the smokers in our clinics.

The nurses should elicit a reduction goal, discuses the advantages of using nicotine

replacement therapy to reduce and any possible side effects. The nurses could provide

motivational advice and counseling with strict adherence to the prescribed dosage of nicotine

replacement therapy. The nurses should assess any adverse effect reported in each follow up

〔Carpenter et al., 2004 (+1); Lam et al., 2012 (++1) 〕.

Recommendation 11: The provision of free nicotine replacement therapy. (Grade A)

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Families clinics would continue to provide free nicotine replacement therapy to the participants

and it was proofed that it would lead to more quit attempts and abstinence 〔Wennike et al.,

2003 (++1); Carpenter et al., 2004 (+1); Lam et al., 2012 (++1) 〕.

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Appendix G- pilot test evaluation Questionnaire for the nurses, doctors and dispensers

Department of Health

Professional Development & Quality Assurance

Families Clinic

Cut down to quit intervention with nicotine replacement therapy pilot test evaluation

Questionnaire for the nurses, doctors and dispensers

(Please write down your comments)

1. What are the difficulties, barriers or problems that you encountered in recruiting the

smokers to the program? ( For doctors only)

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

2. What are the difficulties, barriers and problems that you encountered in carrying out the

program to the participants?

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

3. How do you think the participants acceptability to the intervention?

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

4. What other comments or suggestions do you have for the program?

________________________________________________________________

________________________________________________________________

________________________________________________________________

________________________________________________________________

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Appendix H- pilot test evaluation Questionnaire for participants

Date: _______________________

Department of Health

Professional Development & Quality Assurance

Families Clinic

Cut down to quit intervention with nicotine replacement therapy pilot test evaluation

Questionnaire for participants

Please circle only one answer for each question.

1. Program content

How would you rate the reduction to quit with nicotine replacement therapy intervention?

Excellent Good Fair Poor

Do you think this is useful for helping you towards smoking cessation?

Yes No

How you think the frequency of the follow-up?

Too frequent Just right Not enough

How you think the duration of each follow-up?

Too long Just right Not enough

Do you satisfy with the counseling which was provided by the nurses?

Yes No

Do you satisfied with the pamphlets and information provided?

Yes No

2. Administration

Do you satisfy with the flow of the program?

Yes No

If you answer “No”, please explain: _____________________________________________

__________________________________________________________________________

__________________________________________________________________________

Do you satisfy with the environment of the counseling room?

Yes No

3. General Comments

Please write down your comments and suggestions to the program.

__________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________

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Appendix I- evaluation questionnaire for participants

Date: __________________

Department of Health

Professional Development & Quality Assurance

Families Clinic

Full- scaled implementation of the cut down to quit intervention with nicotine replacement

therapy evaluation questionnaire for participants

Please circle only one answer for each question.

Smoking status

1. Did you smoke in the last seven days?

Yes No

Exhaled Carbon Monoxide level: _____________ (filled by the nurses)

2. Program content

How would you rate the reduction to quit with nicotine replacement therapy intervention?

Excellent Good Fair Poor

Do you think this is useful for helping you towards smoking cessation?

Yes No

How you think the frequency of the follow-up?

Too frequent Just right Not enough

How you think the duration of each follow-up?

Too long Just right Not enough

Do you satisfy with the counseling which was provided by the nurses?

Yes No

Do you satisfied with the pamphlets and information provided?

Yes No

2. Administration

Do you satisfy with the flow of the program?

Yes No

If you answer “No”, please explain: _____________________________________________

__________________________________________________________________________

__________________________________________________________________________

Do you satisfy with the environment of the counseling room?

Yes No

3. General Comments

Please write down your comments and suggestions to the program.

__________________________________________________________________________

__________________________________________________________________________

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Appendix J- evaluation questionnaire for the nurses, doctors and dispensers

Department of Health

Professional Development & Quality Assurance

Full- scaled implementation of the cut down to quit intervention with nicotine replacement

therapy evaluation questionnaire for the nurses, doctors and dispensers.

Please circle only one answer for each question.

1. How would you rate the flow of the program?

Very satisfied Satisfied Neutral Dissatisfied

2. How would you rate the workload of the program?

Not at all Just right Too heavy

3. How satisfied were you with protocol for you to implement the program to the clients?

Very satisfied Satisfied Neutral Dissatisfied

4. Do you think the support enough for you to implement this new intervention?

Yes No

5. What other suggestions or comments do you have for the improvement of the program?

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

__________________________________________________________________

Name/ Rank (optional): ______________________ Date: _______________

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Appendix K- The flow of the intervention

The flow of the intervention

The smokers, who interested to quit by the cut down to quit intervention with nicotine

replacement therapy, recruited by the doctors during consultation

↓

The nurse will perform the assessment for the smokers

↓

Follow-up at week 0

Nurse counseling +

decide the use of nicotine replacement therapy (nicotine gum, inhaler, patch)

↓

Follow up at week 1,4,8 and 12.

Each follow-up lasts 15-30 minutes

Nursing counseling + prescribe nicotine replacement therapy+

Smoking status validation: (1) self- report + (2) counting the nicotine replacement therapy

left+ (3) measuring the exhaled carbon monoxide level by carbon monoxide analyzer ( ↓ at

least 1ppm for reduction or ↓ 10 ppm for cessation)

↓

Telephone follow-up by nurses at month 6 and 12

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Appendix L- PRISMA 2009 Flow Diagram

PRISMA 2009 Flow Diagram ( Moher, et al., 2009)

Records identified through

database searching

(n = 615 )

Records screened by reading the

topics, citations & abstract

(n = 29)

Records excluded

(n = 586)

Full-text articles

assessed for eligibility

(n = 10)

Full-text articles

excluded, with reasons

(n = 19)

Studies retained for data

extraction

(n = 10)

Records after duplicates

removed

(n = 5)

Studies included in final

narrative synthesis

(n =5)