The effectiveness of a nurse led intensive community. based smoking cessation protocol in quitting smoking. in women smokers.

Transcription

1 1 The effectiveness of a nurse led intensive community based smoking cessation protocol in quitting smoking in women smokers by Chau Kwan Yu B.Nurs. H. K. U. A thesis submitted of the requirements for the Degree of Master of Nursing at The University of Hong Kong. July 2012

2 2 Abstract of thesis entitled The effectiveness of a nurse led intensive community based smoking cessation protocol in quitting smoking in women smokers Submitted by Chau Kwan Yu for the Degree of Master of Nursing at The University of Hong Kong in July 2012 Background: Women smoking is a critical world health concern. Women are special risk group of smoking because approximately 1 million women died from tobacco-induced diseases worldwide each year and this number was increasing rapidly (Wesley and Sternbach, 2008). Besides, smoking increased the prevalence of menstrual irregularity, intermenstrual bleeding, varied length of menstrual cycle, pain and discomfort during menstruation of women (McEwen, 2006). Moreover, smoking will not just affect women but their children. Smoking is related to miscarriage, bleeding, premature rupture of the membranes, premature birth, growth retard baby, still birth, birth defects (The University of Hong Kong, 2007). Researches proved that combining telephone counseling and nicotine replacement therapy (NRT) are needed

3 3 to help quitting smoking in women (Palmer, 2000). Quitting smoking can greatly reduce the chance of smoking associated diseases. Risk of lung cancer will be reduced by one-half to two-thirds after 10 years of abstinence and the risk of cardiovascular diseases (CVD) will be reduced by half within 1-2 years (Lewis, 2010). Nurses are the largest group of health professionals who work with people of all ages and community settings, so they should have enormous potential in helping people to quit smoking. As a result, it is important for nurses to understand more about this combined approach for quitting smoking in women smokers and translate the research evidence to real world practice in Hong Kong. Purpose: The aims of this paper are to investigate the barriers to quit of women smokers in Hong Kong and their needs, to find out the gap between current and proposed smoking cessation services, to explore the relevant studies about smoking cessation in women smokers, to perform the quality assessment of selected studies, to summarize and synthesis the extracted data, to translate the existing data into a practice guideline that can be used in community setting for women smokers, to assess the implementation potential of the proposed guideline and to formulate an implementation and evaluation plan for the proposed guideline. Methods: A total of 7 studies focusing on quitting smoking of women smokers located in Medline (1950- ), EMBASE (EMBASE Classic + EMBASE ) and

4 4 Pubmed (1950- ) were selected. Thirty-day point prevalence quit rates at 12-month follow-up was used as the major outcome indicators. After quality assessment and extracting data from the related literatures, a practice guideline will be synthesized and the implementation potential will be assessed. The guideline will be graded according to the Scottish Intercollegiate Guidelines Network system. The implementation potential of the guideline will be assessed according to: (1) the transferability of the guideline, (2) the feasibility of implementing the guideline, and (3) cost-benefit ratio of the innovation. Then, the nurse led intensive community based smoking cessation program will be developed. An effective communication with all stakeholders is important in developing a positive relationship and to gain their support throughout the implementation of the proposed innovation. Pilot test will be conducted to test the satisfaction level of the innovation among women smokers in the real world setting, to test the feasibility of the innovation in the real world setting and to measure the actual material cost and non-material cost of the innovation. Am improvement plan will be drawn after evaluating the pilot test. After implementing the innovation, three outcomes evaluations will be used to evaluate this nurse led intensive community based smoking cessation program which include patient outcome, staff outcome and system outcome. The above results will be reported within one month after the innovation. The report can act as a useful

5 5 guide for running similar smoking cessation programme in the future. Conclusion: The proposed programme is recommended in the community setting to assist women smokers to quit smoking which is an important public health issue.

6 6 Declaration I declare that this dissertation represents my own work, except where due acknowledgement is made, and that it has not been previously included in a thesis, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications. Signed

7 7 Acknowledgements I would like to express my heartfelt gratitude to Professor Sophia Chan for her guidance and assistance throughout my study. Her stimulating suggestions, continuous support and encouragement in this two year help me a lot. Her professional advice deeply inspires my mind and thoughts. I would also like to thanks Professor Sharron Leung and Professor Daniel Fong for their fruitful tutorials about this dissertation. Their explanation and advice had shed light on my exploration and understanding over this meaningful and challenging dissertation. Finally, I would like to express my deep sincere thanks to my family. Their continuous and unlimited love, care and support made the successful completion of the dissertation become possible.

8 8 Table of Contents Abstract 2 Declaration 6 Acknowledgements 7 Table of contents 8 Chapter 1 Introduction Background Affirming the Needs and Significance Objectives 21 Chapter 2 Critical Appraisal Search Strategies Study selection criteria Searching engines Keywords Extracting the Data and Summary from Table of Evidence Bibliographic citation Study type, sample size and level of evidence Patient characteristics and recruitment sites Setting Control groups Intervention Outcome measures Results Follow up 29

9 Abstinence rate with long term measurement Appraisal Strategies Critical appraisals and quality assessments of studies Rating scheme for quality assessment Assessing the Quality of the Reviewed Studies The level of evidence Synthesis of Findings from the Reviewed Studies Multiple interventions Telephone counseling Contents Schedule of telephone counseling Counselors Number of telephone counseling sessions and duration of 37 each session Pharmacological Self-help materials Smoking cessation program and women smokers Frequency of follow up calls or booster sessions 39 Chapter 3 Implementation Potential 3.1 Target Population and Clinical Setting Transferability Philosophy of care Number of clients Time for implementation Characteristics of participants 44

10 Feasibility Freedom to run the program Consensus among the staff and administrators Friction Establishment of a development team Required equipment and facilities Availability of measurement tools Recruitment potential Cost-benefit Ratio of the Program Benefit of the program Set up costs Running costs Nonmaterial costs Comparing the total cost of our program and the estimate costs of diseases caused by active and passive smoking in female smokers Chapter 4: EBP Guideline Aims and Objectives of the Guideline Users and Setting Target Population Levels of Evidence and Grades of Recommendation Details of the EBP Guideline 58 Recommendation 1 58 Recommendation 2 60 Recommendation 3 61

11 11 Recommendation 4 62 Recommendation 5 63 Recommendation 6 64 Recommendation 7 65 Recommendation 8 66 Recommendation 9 67 Chapter 5: Implementation Plan Communication Plan Identifying the stakeholders Communication process Pilot Testing To test the effectiveness of the training sessions To test the satisfaction level of the innovation among women smokers in the real world setting To test the feasibility of the innovation in the real world 80 setting To measure the actual material cost and non-material cost 80 Chapter 6: Evaluation Plan Patient Outcome Evaluation Primary outcome: smoking cessation in women smokers Secondary outcomes: satisfaction level of the women smokers towards the nurse led intensive Staff Outcome Evaluation Knowledge, skills of the trained counselors in the smoking cessation counseling Satisfaction level towards the programme System Outcome Evaluation 87

12 Utilization of the services provided by innovation Costs of the innovation 88 References 90 APPENDIX 1 The searching profiles of each data base 96 APPENDIX 2-8 Table of evidence 100 APPENDIX 9 CASP Appraisal tool for RCTs 107 APPENDIX 10 Quality coding system and level of evidence 110 APPENDIX11-17 Table of Critical Appraisal 111 APPENDIX18 Time schedule for implementation of the innovation 130 APPENDIX19 The set up costs of the innovation in Hong Kong 132 Dollar APPENDIX20 The running costs of the innovation in Hong Kong 133 Dollar APPENDIX21 Grades of recommendation 134 APPENDIX22 Motivational interviewing 135 APPENDIX23 Use of nicotine gum, patches and inhalers 139 APPENDIX24 Fagerstrom Test of Nicotine Dependence 146 APPENDIX25 Questionnaire for data collection regarding knowledge, attitude and practice on cessation counseling 147

13 13 Chapter 1: Introduction 1.1 Background Cigarette smoking endangers women s health physically and mentally and causes great economic and medical burden. However, tobacco companies continue trying their best to recruit more new customers worldwide especially women and girls (Bellenir, 2004). The World Health Organization estimated that tobacco attributed to more than 4 million deaths every year (Landow, 2008). The tobacco-related mortality will increase to 8.3 million deaths annually by 2020 (Landow, 2008). In Hong Kong, the percentage of male smokers decreased from 28.5 percent in 1990 to 19.9 percent in 2010 but the percentage of female smokers increased from 2.6 percent in 1990 to 3 percent in 2010 (The Department of Health., 2011). So, it is a cause for alarm. Smoking increases the risk for many cancers including lung, breast and cervix. There are seventy carcinogens in tobacco smoke (Bellenir, 2004). Tobacco is related to more than one third of all cancer deaths (Wesley and Sternbach, 2008). The chance of lung cancer for a cigarette smoker is 15 times greater than that of a non-smoker, the chance accumulates overtime (McEwen, 2006). Smoking shortens the life span of smokers. Long term regular smoking reduced an average of 14.5 years of life (Dodgen, 2005). Smoking increases the environment tobacco smoke (ETS). Non-smokers are

14 14 exposing to ETS in various places such as street and home. Nowadays, more than 40% of children worldwide are exposed to passive smoking at home (Wesley and Sternbach, 2008). ETS causes plenty of health problems in non-smokers. It increases the risk of cancer, cardiac and respiratory disease (Landow, 2008). It kills approximately lives of non-smokers annually (Bellenir, 2004). Non-smokers expose to environment tobacco smoke will have a 25% increase in the risk of heart diseases (Dodgen, 2005). Women are a special risk group. Approximately 1 million women die from tobacco-induced diseases worldwide each year and this number is increasing rapidly (Wesley and Sternbach, 2008). It is estimated that between 1950 and 2000, 10 million women have died from smoking (Lewis, 2010). The percentage of female died from smoking is now approaching the percentage of male (Landow, 2008). In developed countries, it is estimated that female who smoke regularly throughout their adult lives will cause at least half of all deaths in middle age (Munafò, 2003). So, there will be a large increase in female mortality in the near future. Smoking increases risk of cancer, cardiovascular and respiratory diseases in female. More than 90% of women die from lung cancer are due to smoking (Wesley and Sternbach, 2008). The risk of developing lung cancer in female smokers is about 13 times higher than those of non-smokers (McEwen, 2006). There will be a two to six-fold increased risk for myocardial

15 15 infarction, three fold increased risk of incident angina, six to thirty fold increased risk of peripheral vascular disease and 2 to 3 fold increased risk of stroke in female smokers (Dodgen, 2005). For women, about 90% of chronic obstructive pulmonary disease (COPD) is caused by tobacco use (Landow, 2008). So, women smokers have high chance of death cause by smoking. Cigarette smoking is related to abnormal menstrual function, infertility and hip fracture. Researches had shown that smoking increase the prevalence of menstrual irregularity, intermenstrual bleeding, varied length of menstrual cycle, pain and discomfort during menstruation (McEwen, 2006). The fertility of smoking women was just 72% that of non-smokers (Bellenir, 2004). Smoking will reduce the chance of getting pregnant per cycle up to 40 % (Lewis, 2010). Smoking reduces bone density which is related to hip fracture. Smoking will increase the risk of osteoporosis by 50 % (Landow, 2008). Smoking will not just affect women but their children. Smoking is related to miscarriage, bleeding, premature rupture of the membranes, premature birth, growth retard baby, still birth, birth defects (The University of Hong Kong, 2007). Also, smoking during pregnancy will increase the chance of asthma in young children by 2.8 times (Munafò, 2003). Children exposing to smoke will have higher chance to become smokers in the future. Youth s addition to nicotine is very rapid even at a very

16 16 small dose (Landow, 2008). Moreover, cigarette smoking affects women s mental health. Smoking induces dependence, suicidal behavior, depression and anxiety especially in women (McEwen, 2006). To conclude, smoking kills many lives and is associated with many health problems of women. Smoking cessation is the most rapid way to decrease morbidity and mortality caused by cigarette smoking. So, finding effective and cost effective smoking cessation programs among women is an important world-wide public health issue. 1.2 Affirming the Needs and Significance In Hong Kong, the percentage of male smokers decreased from 28.5 percent in 1990 to 19.9 percent in 2010 but the percentage of female smokers increased from 2.6 percent in 1990 to 3 percent in 2010 (The Department of Health., 2011). 9% deaths among all women are related to active smoking which involved approximately 1167 lives a year (The University of Hong Kong, 2005). The estimate costs of disease caused by active and passive smoking was 5.3 billion each year (The University of Hong Kong, 2007). However, the 5.3 billion did not include the cost of health cares for children and young adults, the cost of family members caring for a sick smoker or sick passive smoker, the impact of pain and suffering due to disease or death of a family member and the value of lives lost (The University of Hong Kong, 2007).

17 17 Quitting smoke can greatly reduce the chance of smoking associated diseases. Risk of lung cancer will be reduced by one-half to two-thirds after 10 years of abstinence and the risk of cardiovascular diseases (CVD) will be reduced by half within 1-2 years (Lewis, 2010). The risk of stroke will be the similar to those of non-smokers by 5 to 15 years after quitting (McEwen, 2006). Risk of sudden death will decrease within 24 hour after quitting (Munafò, 2003). Nowadays, the Hong Kong government has increased cigarette taxes and established the clean indoor air laws. It is predicted that the demand for quitting will increase. Although most smokers would like to quit, less than 10% succeed in a given year (Bellenir, 2004). Lack of support and withdrawal symptoms are some of the factors related to the poor outcome in female smokers (Bellenir, 2004). In Hong Kong, 98.5% of women smokers had never tried the existing smoking cessation service and only 20% of attendees of the Smoking Cessation Health Centre (SCHC) were women smokers (The University of Hong Kong, 2007). Among those who have utilized the existing smoking cessation services, female smokers experience more difficulties and had lower confidence in quitting than male smokers (The University of Hong Kong, 2007). So, there is a need for a gender specific smoking cessation program for women smokers in Hong Kong. The University of Hong Kong established the Women Against Tobacco

18 18 Taskforce (WATT). The WATT is the first smoking cessation counseling service tailor-made for women smokers in Hong Kong (The University of Hong Kong, 2007). It is also the only organization providing telephone counseling in Hong Kong. The Department of Health is a major organization in Hong Kong providing smoking cessation service, but it only provides face to face counseling service. Nurses are the largest group of health professionals who work with people of all ages and community settings, so they should have enormous potential in helping people to quit smoking in order to reduce smoking-related diseases. In fact, every nurse has the responsibility helping smokers to quit, reinforcing a nonsmoker to stay smoke-free and helping people with smoking associated diseases to live a better life (Lewis, 2010). However, many nurses do not recognize they role in quitting smoking or they just too busy and unable to carry out the role. Researches proved that combining pharmacological and non-pharmacological intervention is needed to help quitting smoking in women (Palmer, 2000). Non-pharmacological intervention includes relapse prevention and smoking cessation counseling. Pharmacological intervention includes various type of nicotine replacement therapy (NRT). We also need to identify and remove barriers preventing women from utilizing treatment. There are various types of counseling including telephone counseling, face

19 19 to face counseling and group counseling. The reasons of choosing telephone counseling for this dissertation are explained as following. Telephone counseling had proved to be effective for smoking cessation (McEwen, 2006). In Hong Kong, 98.5% of women smokers had never tried the existing smoking cessation service (The University of Hong Kong, 2007). So, we need to identify and remove the barriers preventing women from utilizing treatment. In Hong Kong, female workers with regular employment account for more than 90 percent of the female labour force and female workforce participation is comparable to men with 76.6 women for every 100 men in the workforce (The Hong Kong Liaison Office of the international trade union movement, 2006). However, many of them still need to do housework after work because women are expected to be responsible for the housework in the traditional Chinese culture. So, many women in Hong Kong need to work and take care of family. Telephone counseling is more user-friendly because smokers can save a lot of time and money traveling to and from the smoking cessation clinics for the counseling sessions. Moreover, telephone counseling is cost effective and wide reaching (Lewis, 2010). Telephone counseling service is able to gain access to a large number of smokers. Besides, there are researches showed that smokers would prefer telephone counseling over face-to-face counseling (McEwen, 2006). Smokers are four times as likely to use quitline as face-to-face counseling (Zhu, Anderson, Tedeschi, Rosbrook,

20 20 Johnson, Byrd and Gutierrez-Terrell, 2002). According to the US Preventive Services Task Force, smoking cessation delivered through telephone counseling is rated as the highest priority category with the lowest delivery rate (Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). Since 1992, the California Department of Health has launched the first statewide telephone counseling service to help smokers to quit (North American Quitline Consortium, 2006). However, the Department of Health, which is the main public organization in Hong Kong providing the smoking cessation services, has no telephone smoking cessation counseling services at this moment and they only provides face to face counseling. Many researches showed that smoking cessation counseling should combine with NRT to maximize quit rate (Lewis, 2010). NRT is the first-line pharmacological intervention for smoking cessation (Landow, 2008). NRT is available over-the-counter in Hong Kong. The Department of Health offers free nicotine patches, gum and inhaler. NRT aims at relieving the nicotine withdrawal syndromes such as cravings by replacing the nicotine which is normally taken in during smoking. NRT is safe. NRT delivers much smaller amount of nicotine, which smokers would always receive from cigarette smoking, in a slower rate than cigarette smoking (Dodgen, 2005). The smoking related diseases and deaths are caused by substance such as tar and carbon monoxide but not nicotine (Dodgen, 2005). NRT are more relevant for women than

21 21 men. Nicotine withdrawal syndromes are more significant for women than for men (Munafò, 2003). However, smokers are recommended to assess for any contraindications for using NRT such as unstable diseases or any acute events in the past four weeks (Lewis, 2010). 1.3 Objectives To understand the characteristics of woman smokers, To investigate the barriers to quit of women smokers in Hong Kong and their needs, To find out the current smoking cessation services available in Hong Kong, To propose the smoking cessation services targeting at the barriers to quit, To find out the gap between current and proposed smoking cessation services, To search for related studies, To extract data from selected studies in the form of a table of evidence, To perform the quality assessment of selected studies, To summarize and synthesis the extracted data, To assess the possibility of whether the smoking cessation intervention used on the general population can be transferred to women smokers in Hong Kong, To translate the existing data into a practice guideline that can be used in community setting for women smokers, To assess the implementation potential of the proposed guideline,

22 To formulate an implementation and evaluation plan for the proposed guideline. 22

23 23 Chapter 2: Critical Appraisal 2.1 Search Strategies Study selection criteria Inclusion criteria: 1. Patient types: Smokers 2. Interventions: Telephone counseling + nicotine replacement therapy for smoking cessation 3. Outcome measures: Abstinence rate 4. Article types: Randomized controlled trial (RCT) 5. Languages: English or Chinese Exclusion criteria: 1. Studies only targeting at children or teenagers Searching engines A systematic search of the evidence has been conducted from 3 August, 2011 to 10 August, 2011, by means of three electronic searching engines and manual search. Three electronic searching engines included Medline (1950- ), EMBASE (EMBASE Classic + EMBASE ) and Pubmed (1950- ). The following keywords were used. Different combinations of the 3 groups of keywords using explode and MeSH headings yielded many relevant studies. Finally, the reference

24 24 lists of the selected articles were screened for related articles. Details of the searching strategies are provided in the Appendix 1. According to the selection criteria, abstracts and full texts were reviewed and assessed for relevance. Finally, 7 studies were selected Keywords Three sets of keywords used for searching were listed in the following: 1. Smoking cessation: smoking, smoking cessation, tobacco use disorder, tobacco, tobacco smoke pollution, tobacco, smokeless 2. Telephone counseling: telephone, hotline, hotlines, telecommunications, telemedicine 3. Nicotine replacement therapy (NRT): Nicotinic Agonists, Nicotine

25 Extracting the Data and Summary from Table of Evidence Findings of the 7 selected studies were presented in form of tables of evidence in the Appendix 2-8 and summarized as the followings according to the SIGN 50: A guideline developer s handbook Annex D (Scottish Intercollegiate Guidelines Network, 2008a, 2008c) Bibliographic citation All the studies were published between 2002 and They were extracted from various journals include: preventive medicine, nicotine & tobacco research, tobacco control, medical journal of Australia, journal of consulting & clinical psychology, new England journal of medicine Study type, sample size and level of evidence All studies were quantitative and randomized controlled trials. The range of sample size is large. It ranged from 275 participants (McClure, Westbrook, Curry and Wetter, 2005) to 6322 participants (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). The level of evidence ranged from 1+ (n=4) to 1++ (n=3) Patient characteristics and recruitment sites The baseline characteristics were described and compared in all the studies. Only two studies recruited only women smokers. The remaining studies (n=5) recruited participants of both gender. Within the remaining studies, 3 studies involved

26 26 similar number of female smokers and male smokers and other 2 studies involved greater number of female smokers than male smokers. The mean age of participants ranges from 33 to 44 year old. The mean cigarettes consumption per day ranges from 14 to 24. Most studies (n=5) recruited participants who intended to quit smoking. All studies involved mainly the white, percentage of the white ranging from 60% to 93%. 2 studies mainly involved the low income group. Some studies have mentioned the education level of participants (n=4), two of them mainly involved participants having more than high school education, the remaining studies (n=2) mainly involved participants having high school education or less. Some studies mentioned the quit attempts of participants in the past 1 year (n=5), the average quit attempt arranged from 1-3 times. 2 studies had mentioned the rate of depression of participants. The depression rates reported by both studies were 40% Setting 3 studies recruited participants through quitline. 1 study recruited participants in community centers. The other studies (n=3) recruited participants through mass media, advertisements flyers or referrals Control groups All studies (n=7) involved a control group. Most studies (n=4) involved only 1 pair of comparison group. 1 study involved a control group and 3 intervention

27 27 groups. 1 study involved a control group and 5 intervention groups. 1 study involved a control group and 6 intervention groups Intervention All studies (n=7) included multiple interventions involving telephone counseling in the intervention groups. 2 studies combining telephone counseling with NRT for the intervention groups and NRT alone for the control group. 1 study involved participants assigning to one of six interventions which varied in number and duration of telephone counseling sessions with or without free NRT patches. 2 studies combining telephone counseling with self-help materials for the intervention groups and self-help materials alone for the control group. 1 study involved participants assigning to one of seven interventions for comparing five-session abbreviated counseling, three-session counseling and five full length sessions with or without booster sessions. 1 study compared telephone counseling with different content (basic content and enhanced content) following a group program. The details of content of the studies are described in the appendix in form of tables of evidence Outcome measures All studies (n=7) measured the quit rate. 2 studies also measured relapse rate. Another study (n=1) also measured cost effectiveness, participant s satisfaction and feeling of interventions. 1 study also measured the effects of gender, ethnicity,

28 28 education and history of depression in quit rate. Quit rate, relapse rate, cost effectiveness, participant s satisfaction rate and rate of feeling of receiving right amount of contact were all collected by self-report though telephone questionnaires. Some studies (n=3) also use biochemical confirmation including the level of expired air carbon monoxide and saliva cotinine for quit rate and relapse rate Results All studies made use of percentage with p-value with or without 95% CI and odd ratio to present quit rate, relapse rate, participant s satisfaction rate, rate of feeling of receiving right amount of contact and effects of gender, ethnicity, education and history of depression on quit rate. The cost effectiveness was present as incremental costs per additional quit in 2004 dollars which were based on what was actually provided to each individual including training costs and the differential delivery costs for each intervention (Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007). Within the studies (n=3) involving telephone counseling and NRT, 1 study showed that this combination had short-term effect in quitting (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005); the remaining studies (n=2) proved that this combination had a significant long-term and short-term effect in quitting (Macleod, Charles, Arnaldi and Adams, 2003; Hollis, McAfee, Fellows, Zbikowski, Stark and

29 29 Riedlinger, 2007). For the 2 studies combining telephone counseling and self-help materials, both of them showed a significant long-term and short-term effect in quitting (McClure, Westbrook, Curry and Wetter, 2005; Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). 1 study involving telephone counseling with different content showed that women with telephone counseling emphasized supportive, positive reinforcement and general encouragement for progress and efforts toward quitting or maintaining abstinence produced better abstinence rates and men with telephone counseling tailored to the stage of cessation and individuals characteristics produced better abstinence rates (Mermelstein, Hedeker and Wong, 2003). The remaining study (n=1) involved telephone counseling alone reported that five sessions abbreviated telephone counseling with two boosters was more cost effective (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). The details of content of the studies are described in the appendix in form of tables of evidence Follow up 3 studies followed up participants for 6 months and assessment was performed at 3 and 6 months. Another three studies followed up participants for 1 year and assessment was performed at 3, 6 and 12 months. The other one study followed up participants for around 2 year at 3, 6, 9, 12, 15 months. All data collectors

30 30 were not telephone counseling staff and they collected data through telephone questionnaires. Most studies (n=6) used point prevalent abstinence to measure quit rate such as 7-day, 30-day and 12 months abstinence depending on the length of follow up. Only 1 study used 28-day and 90-day continuous abstinence (Macleod, Charles, Arnaldi and Adams, 2003) Abstinence rate with long term measurement Eventually, most of the studies (n=6) had the effect size decreased over time but the effect size remained significant within the length of follow up.

31 Appraisal Strategies Critical appraisals and quality assessments of studies Critical Appraisal Skills Programme (CASP) appraisal tools for randomized controlled trial attached in the appendix 9 were used to assess the quality of the seven selected studies (Public Health Resources Unit, National Health Service, 2007). The percentage of CASP criteria fulfilled was showed at the end of the critical appraisal table. The seven tables of critical appraisal were attached in Appendix Rating scheme for quality assessment After assessing the quality of the seven selected studies, each study was rated according to the SIGN coding system (Scottish Intercollegiate Guidelines Network, 2008a, 2008d). Together with the study type, the levels of evidence of studies were given after referring to SIGN 50: A guideline developer s handbook Annex B (Scottish Intercollegiate Guidelines Network, 2008a, 2008b). The level of evidence was listed in the tables of critical appraisal. According to the CASP assessment tool, there was no clear cut scoring to determine the level of evidence, if the studies fulfilled 85% or above of the criteria, the level of evidence was regarded as high; if the studies fulfilled 70% or above of the criteria, the level of evidence was regarded as medium; if the studies fulfilled less than 70 % of the criteria, the level of evidence was regarded as low (Scottish

32 32 Intercollegiate Guidelines Network, 2004). 2.4 Assessing the Quality of the Reviewed Studies The level of evidence All studies (n=7) were classified as high level of evidence as they fulfilled all or most of the criteria. The level of evidence ranged from 1+ to 1++. All studies were RCT with randomization. However, only some studies (n=3) had clearly stated the methods of randomization including using computer algorithm, shuffling of folders and computer generated random number sequence (Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007; Macleod, Charles, Arnaldi and Adams, 2003; Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). All studies had data collectors blinded to participants randomization status and separated from the smoking cessation counselors. Most studies (n=6) did not mention the blinding of counselors and participants. All studies (n=7) had no significant different in demographic characteristics among groups. All studies (n=7) had result presented in form of percentage and p-value with or without 95% confidence interval and odd ratio for categorical variables; mean with standard deviation was used for continuous variables. The sample size was large for all the reviewed studies ranging from 275 to 6322 participants. Most studies (n=4) had mention the power sample size, three of them had power up to 0.8 and the remaining study (n=1) had the power 0.4. Large power of

33 33 sample size permitted the usual normal approximation to the sampling distribution, allowed comparison of treatment regimens and increased the external validity and policy relevance of the findings (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). The other studies (n=3) had not mentioned the power of sample size in which one of them claimed to have large enough sample size.

34 Synthesis of Findings from the Reviewed Studies Multiple interventions All studies (n=7) involved multiple interventions. All studies (n=7) involved telephone counseling services as intervention. Two studies involved using of NRT combined with telephone counseling; another two studies involved provision of self-help materials combined with telephone counseling; another one study involved various number and duration of telephone counseling sessions, with or without nicotine patches; another one study involving assigning participants to one of seven interventions which compared five-session abbreviated counseling, three- session counseling and five full length sessions with or without booster sessions; another one compared 2 types of proactive telephone calls with different content. Some observations after reviewing the studies will be discussed as follow. It was impossible to compare the effectiveness of a single intervention and drew out results but many important findings were observed among these studies and discussed as following Telephone counseling Contents All the studies involved telephone counseling as one of the interventions and all reported significant result. The contents of the telephone counseling were varied from general contents to more individualized contents. General content included

35 35 encouragement, guidance, reinforcement for quitting smoking, assisting in problem-solving, communicating, caring, motivating change, providing quitting strategies, assessing quitting history, motivation, self-efficacy, social support and planning of the quit date, relapse prevention and promoting adoption of the self-image of a nonsmoker (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005; Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007; Mermelstein, Hedeker and Wong, 2003; Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). Individualized contents included specific content depending on woman s readiness to quit smoking, content tailored to the stage of cessation and individual s personal characteristics (McClure, Westbrook, Curry and Wetter, 2005; Mermelstein, Hedeker and Wong, 2003). A study had reported that telephone counseling with content emphasized supportive, positive reinforcement and general encouragement for progress and efforts toward quitting or maintaining abstinence without any individualized tailoring or structured goal setting was better for women (Mermelstein, Hedeker and Wong, 2003) Schedule of telephone counseling Four studies did not mention the schedule of telephone counseling or schedule of counseling was simply negotiated by the counselors and participants. Two studies provided telephone counseling shortly before and after quit date and the

36 36 subsequent calls occurred weekly and tapering to bi-weekly, both studies found that intervention involving telephone counseling had significant effect in quitting. (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005; Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). The remaining study (n=1) made use of a relapse-sensitive call schedule at 1, 2, 3, 6 and 10 weeks after baseline which meant more telephone counseling were made in the early stages of the quit attempt when the risk of relapse is the highest, the result showed that intervention involving telephone counseling using the relapse-sensitive call schedule had significant effect in quitting (Macleod, Charles, Arnaldi and Adams, 2003) Counselors Counselors in all studies were specially trained in telephone counseling and all these studies found significant result in quitting for interventions involving telephone counseling. Four studies involved counselors with a lot of experience in telephone counseling (McClure, Westbrook, Curry and Wetter, 2005; Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007; Macleod, Charles, Arnaldi and Adams, 2003; Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). Three studies mentioned that all counselors were provided with debriefing with regular live supervision sessions by the healthcare professionals with experience in the area of smoking cessation (McClure, Westbrook, Curry and

37 37 Wetter, 2005); Macleod, Charles, Arnaldi and Adams, 2003; Mermelstein, Hedeker and Wong, 2003) Number of telephone counseling sessions and duration of each session Most of the reviewed studies provided telephone counseling sessions ranging from 3 sessions to 7 sessions (McClure, Westbrook, Curry and Wetter, 2005; Macleod, Charles, Arnaldi and Adams, 2003; Mermelstein, Hedeker and Wong, 2003; Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002); Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). One study provided up to 12 telephone counseling sessions (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005). One study provided one telephone counseling sessions with follow-up calls (Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007). Six studies had mentioned the duration of each telephone counseling session which ranged from 10 to 40 minutes (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005; McClure, Westbrook, Curry and Wetter, 2005); Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007; Macleod, Charles, Arnaldi and Adams, 2003; Mermelstein, Hedeker and Wong, 2003); Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). One study had investigated the relationship between the number of telephone counseling sessions and duration of each section and quit rate, it found that five-session abbreviated protocol with each session 10 minutes is more cost effective than the three-session

38 38 protocol with each session 35 minutes and five full length sessions protocol with each session 42 minutes (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007) Pharmacological Three studies combining the telephone counseling and NRT with two of them offering free nicotine patches, all reported significant effect in quitting (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005; Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007; Macleod, Charles, Arnaldi and Adams, 2003). The remaining study had investigated the relationship between NRT and quit rate, it found that telephone counseling combined with NRT resulted in higher quit rate than provided telephone counseling alone (Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007). The duration of NRT depend on individual participant s need and their daily cigarette consumption Self-help materials Two studies combined the telephone counseling and self-help materials, all reported significant effect in quitting (McClure, Westbrook, Curry and Wetter, 2005; Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). The content of self-help materials was not mentioned Smoking cessation program and women smokers Two studies focusing on smoking cessation and women smokers, all

39 39 reported significant effect in quitting (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005; McClure, Westbrook, Curry and Wetter, 2005). One of them combined telephone counseling and NRT (Solomon, Marcy, Howe, Skelly, Reinier and Flynn, 2005). The other one combined telephone counseling and self-help materials (McClure, Westbrook, Curry and Wetter, 2005). There is another study involving both gender found that telephone counseling with content emphasized supportive, positive reinforcement and general encouragement for progress and efforts toward quitting or maintaining abstinence without any individualized tailoring or structured goal setting is better for women (Mermelstein, Hedeker and Wong, 2003) Frequency of follow up calls or booster sessions Two studies involved follow up calls or booster sessions after telephone counseling (Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007; Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). One of them showed that telephone counseling added with one follow-up call which supported the quit plan and encouraged use of community cessation services are most cost effective (Hollis, McAfee, Fellows, Zbikowski, Stark and Riedlinger, 2007). The other study found that with the same number of telephone counseling session and duration, participant received an extra two 15-minute booster sessions approximately four and six weeks after the final counseling call, which focused on assessment of quitting status,

40 40 current craving level, changes in motivation, review of effectiveness of coping strategies used in a recent relapse risk situation and planning for future relapse risks, had higher quit rate (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007).

41 41 Chapter 3: Implementation Potential 3.1Target Population and Clinical Setting The nurse led intensive community based smoking cessation program aims to assist women smokers age 18 or above who understand Cantonese, Putonghua and English. The programme will be available to all women smokers in the Hong Kong. In HK, 3% female aged 15 and over are smokers (the Department of Health, 2011). Women smokers who call the Integrated Smoking Cessation Hotline of the Department of Health ( ) will be invited to join our programme. The programme provides telephone counseling service performed by registered nurses specially trained in smoking cessation counseling. The hotline is run by the Tobacco Control Office (TCO) of the Department of Health (DH). TCO s main services consist of smoking cessation services, health promotion and tobacco control legislation. It coordinates DH s smoking cessation service. The hotline provides smoking cessation information and makes referrals to the smoking cessation counseling services of the DH. There is no telephone counseling available in the DH. 3.2 Transferability Philosophy of care The TCO aims to build a smoke-free culture in Hong Kong. Our program provides an effective and user-friendly smoking cessation service to assist women

42 42 smokers to quit. So, it satisfies the philosophy of care of the TCO Number of clients In Hong Kong, 3% female aged 15 and over are smokers in 2010 which accounted to people (the Hong Kong Census and Statistics Department, 2010). In Hong Kong, 98.5% of women smokers had never used the current smoking cessation service and only 20% of clients of the Smoking Cessation Health Centre (SCHC) were women smokers (The University of Hong Kong, 2007). Smokers are four times as likely to use quitline as face-to-face counseling (Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). Telephone counseling is more user-friendly than face to face counseling because it can save plenty of traveling time and money. Besides, telephone counseling can access to more smokers than face to face counseling. Moreover, researches showed that smokers would prefer telephone counseling over face-to-face counseling (McEwen, 2006). According to the US Preventive Services Task Force, smoking cessation delivered through telephone counseling is rated as the highest priority category with the lowest delivery rate (Zhu et al, 2002) Time for implementation With reference to the Task Development Time Lines (Mckenzie, Neiger & Smeltzer, 2005), the adoption of the innovation will go through three stages including

43 43 the development, implementation and evaluation. The development stage will involve setting up communication team, getting approval and budget for the innovation and recruiting smoking cessation counselor and the research assistant. Besides, the development stage will involve promoting the innovation to, collecting comment about the innovation from and keeping communication with the head of the TCO, the members of the development team, the recruited smoking cessation counselor and the research assistant, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place. Moreover, the development stage will involve designing an assessment form, designing an evaluation plan, setting up room and equipment needed for the innovation, conducting the pilot test. The development stage will take about 6 months. Then, the implementation will take about 2 years and 1 month. Each smokers will received up to 5 telephone counseling sessions with 10 minutes each and 2 booster sessions with 15 minutes each (total 80 minutes). Assume each call need 15 minutes to successfully contact the client by the counselors (total 105), so each client will required 185 minutes from the counselor. If one counselor works 7 hours a day, 20 days a month and 12 month a year, she can serve 545 cases in 1 year. As 2 more months is needed for the last case to complete all the calls and 10 more months is needed to assess the 1 year abstinent rate of the last case, 2 year is

44 44 needed to complete the 545 cases if no case drops out. The evaluation stage will take about 1 month. So the whole innovation will take around 2 years and 7 months to complete. The details of the time schedule for implementation of the innovation are shown in appendix Characteristics of participants The reviewed literatures mainly conducted outside Hong Kong with participants varied in ethic, depression level and education level. However, evidence showed that different in ethic, depression level and education level is not correlated to quit rate (Mermelstein, Hedeker and Wong, 2003). So, people with different in ethic, depression level and education levels do not response differently to the same treatment intervention.

45 Feasibility Freedom to run the program The innovation requires approval from the department head. The innovation will also will invite experienced nurse of the TCO to become the members of the development team. In order to get the approval, evidence on the effectiveness and cost effectiveness of the innovation is needed. The evidence on the effectiveness of the program has been discussed previously. The cost effectiveness of the program will be discussed as follow Consensus among the staff and administrators The effectiveness of the program is sufficiently proved and discussed above. During the pilot test, evaluation of the pilot test, implementation stage, evaluation of the implementation, one nurse and one research assistant are needed for the telephone counseling, data collection, analyzing the outcome and drawing out improvement plan. Both of them are newly recruited, so workload of the original staff will not increase. During the development stage, the two nursing counselors involved in the development team who are staffs of the TCO and one newly recruited research assistant will be involved. These two nursing counselors are experienced smoking cessation counselors who interested in the program and want to join the program. So, the program will mainly involve original staff in development stage only. As a result

46 46 the workload of the original staff will not increase during most of the time of the program. The program need to cooperate with the Integrated Smoking Cessation Hotline ( ) for recruiting cases. The hotline will be responsible for referring women smokers who require counseling services to the program. So, the running of the program will not cause much change to the original operation and workload of staff. Moreover, our program will make use of the free nicotine replacement therapy (NRT) provided the DH. Therefore, the resistance of the program should be minimal Friction As telephone counseling is more wide reaching and user-friendly, it is possible that the number of women smokers who request counseling service may increase. So, a nurse counselor and a research assistant will be specially recruited. Besides, the program requires extra telephone service and telephone for carrying out the telephone counseling. Moreover, a room is needed for telephone counseling which can be any room in a smoking cessation clinic under the DH. The additional cost for manpower, telephone service, telephone will be compensated as long as more women smokers quit smoking successfully. Therefore the friction for the implementation of the innovation should be small Establishment of a development team A development team will be established for the setting up and assist in

47 47 running of the program. The team consists of two nurses and a research assistant. The nurses will be experienced smoking cessation counselors in the TCO with more than 5 years experience who have experience in training smoking cessation counselor and are interested in the program. They will be responsible for recruiting and training the recruited smoking cessation counselor. The team will provide evidence and persuade the department head in order get approval and budget for the program. It will promote the program through posters, website of DH, etc. It will collect comments from the public, the head of the TCO, the members of the development team, the recruited smoking cessation counselor and the research assistant, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place about the program. Beside, it will help finding a room for the program. It will set the assessment form and draw the evaluation plan for the innovation. In addition, the team will finalize the details of the intervention involved in the program. It will prepare the necessary equipment and facilities for the running of the program. Smoking status of women smokers will be assessed regularly by research assistant during the pilot study and actual implementation of the innovation through the phone or . Also, the research assistant will be responsible for all the data entry work and help in analyzing the collected data. The last but not least, the team will assess quality of telephone

48 48 counseling during the pilot test and evaluation of the implementation Required equipment and facilities The program consists of two main components which are telephone counseling and NRT. Telephone counseling may require extra telephone and telephone line. Usually, the company providing telephone service will offer free telephones. The DH has already provided free NRT and our program will make use of them. Computer is needed for reserving the data and analyzes the outcome of the program which can be any computer already available in the smoking cessation centre where the innovation will take place. Stationary such as pen and paper is needed during the initial assessment and follow up which should be already available in the smoking cessation clinic. Our program will make use of the CO monitor to carry out the breath test which is already available in the smoking cessation centre Availability of measurement tools There is a need for initial assessment and evaluation of outcome. Initial assessment of smoking status will be done by phone. Evaluation of outcome including quit rate and cigarette consumption will be done by biochemical conformation using the CO monitor and self report through the phone. The evaluation will take place on Day 30 after the quit date and at 12-month follow-up. The 30 day point of prevalent abstinence will be used to define quitting. For the biochemical conformation, women

49 49 were told to provide breath sample to prove the smoking status at 12-month follow-up Recruitment potential The four smoking cessation centres of the Department of Health, which recruits cases through the hotline ( ), serves around 3000 cases each year in which about 25 percent are female. So, around 750 female smokers will be recruited each year through the hotline. As a research showed that telephone counseling is 4 times as likely to be used by smokers as the face to face counseling (Zhu et al, 2002), so around 750 x 4/5 = 600 female smokers will choose telephone counseling offer by our program than the current face to face counseling. Although the research is done in western countries but literature showed that race will not affect the quit rate if the same interventions are provided.

50 Cost-benefit Ratio of the Program Benefit of the program The nurse led intensive community based smoking cessation program provides services including the telephone counseling and NRT which are well supported to be effective in smoking cessation. In the U.S, telephone counseling has history of about 20 years and proved to be useful but such service is still not available under the Department of Health. When comparing to the current mode of counseling of the DH that is the face to face counseling during mainly office hours, telephone counseling allows smokers to receive counseling at any place and smokers will be more flexible in choosing the time of counseling. So, telephone counseling is more wide reaching and user-friendly especially for women smokers in Hong Kong. In Hong Kong, female workforce participation is comparable to men with 76.6 women for every 100 men in the workforce and 90 percent of the female labour force has regular employment (The Hong Kong Liaison Office of the international trade union movement, 2006). Besides, Hong Kong ranked fifth out of 50 countries in terms of the number of working hours and more than 50 percent of workers work more than 47 hours a week (Lai, 2008). Many Hong Kong women still need to do the house work after work. So, Hong Kong women are relatively busy. Therefore, telephone counseling will be more user-friendly and more preferable than face to face

51 51 counseling among women smokers in Hong Kong Set up costs The set up costs of the nurse led intensive community based smoking cessation program will include the cost of setting up the innovation, pilot test and the evaluation. For the setting up the innovation, two nurses and one research assistant will be included in the development team, they are responsible for get approval and budget, promoting the innovation, collecting comments, keeping communication with the staffs, designing assessment form and evaluation plan, developing tailored intervention, setting up room and equipment and recruiting and training smoking cessation counselor. It will take 4.5 months for setting up of the innovation. The cost for employing the two nurses and one research will be HKD according to the monthly salaries which are based on the Hong Kong Government s public officer s pay scales. The program will get approval to run in one of the smoking cessation centres of the DH. So, it will make use of the CO monitor, computers, stationary, room and facilities there to save the set up cost. For the pilot test, one nursing smoking cessation counselor, one research assistant and one phone line will be needed for telephone counseling and data collection such as self report of smoking status by phone. The pilot test requires one nurse, one research assistant and one telephone line. It will last one month. We will only recruit 20 cases in the pilot test in order to let the

52 52 staff have time to warm up. Our program will make use of the free nicotine replacement therapy provided by the DH. As breath test will only take place at one year follow up, no mouth piece will be needed for the pilot test. So, pilot test will cost HKD For the evaluation, one nurse and one research assistant will be needed to collect data, analyse data and draw out the improvement plan. The evaluation of the pilot test will take 1 month and cost HKD So the total set up costs will be HKD The details of the set up cost are listed in appendix Running costs The running cost will include the cost for implementation and final evaluation. For the implementation of the innovation, one recruited nursing smoking cessation counselor, one recruited research assistant and two phone lines will be needed for telephone counseling, follow up and data collection. The follow up call is done by research assistant which is separated from the counselors. Two telephone line is needed in implementation but one telephone line for pilot test because the research assistant need to measure the one year abstinent rate by phone during the implementation. Implementation phase will take 2 year to complete which is explained above which includes 10 months waiting the last case to complete measuring the 1 year abstinent rate. The innovation will stop recruiting case one year after the implementation. The last case will need 2 month to complete all sessions of

53 53 counseling and NRT that is why the trained nursing counselor and two telephone lines are needed for 14 months. That is why no nursing counselor is needed after the 14 months and only one research assistant and 1 telephone line are needed afterwards for a total of 10 months. As mention above we can serve 545 cases a year and we will be able to recruit 600 cases a year. So, we assume we are going to serve 545 cases a year. Each case required one mouth piece. Each mouth piece costs $0.5. So, the costs for implementation will be HKD For the final evaluation, the recruited nurse and the research assistant will be involved in collecting and analyzing all the data collected, drawing out the final report on the outcome and effect size of the implementation and providing the suggestions for further implementation. The final evaluation will take 1 month and cost HKD The total running costs will be HKD The details of the running costs are listed in appendix Nonmaterial costs The nurse led intensive community based smoking cessation program will only have minimal nonmaterial costs. The nonmaterial costs may refer to reduced staff morale, turnover and absenteeism. In our program, most of the manpower including the nurse counselor responsible for providing telephone counseling service and research assistant are recruited outside the Department of Health. Only two nurses of the development team who are needed for the setting up of the innovation will

54 54 come from the original manpower. The setting up period is about 6 months only. The two nurses who join the program should be those who are interested in the program. As a result, the manpower will remain nearly the same during and after implementation of the program. On the other hand, the workload of original staff may decrease because some of the women smokers will be recruited by our program instead. So, staff morale, turnover and absenteeism will keep nearly constant Comparing the total cost of our program and the estimate costs of diseases caused by active and passive smoking in female smokers The set up costs and running cost added up to =HKD Our program will use five-session abbreviated protocol with two booster sessions, the estimated quit rate will be 30.8 % (p<0.005) (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007). So, the program can assist 168 women to quit each year. The estimate costs of diseases caused by active and passive smoking in 2007 was HKD 5.3 billion each year in Hong Kong in which include HKD2.6 billion for acute and chronic health care, HKD 0.9 billion for long term care and HKD 1.8 billion for the productivity losses (The University of Hong Kong, 2007). The above costs of smoking have not included the number of lives lost due to smoking. In 2005, 9% deaths among all women in Hong Kong are related to active smoking which involved approximately 1167 lives a year (The University of Hong Kong, 2005). In mid 2006,

55 55 the population in Hong Kong is and the percentage of people aged 15 or above is 86 % (The Hong Kong Census and Statistics Department, 2010), there was 11.8% of people aged 15 or above are daily smokers in 2007 (The Department of Health, 2011), so the estimate costs of diseases caused by active and passive smoking per smoker each year will be / ( x 86% x 11.8%) = HKD7616. if we can help 168 women smokers to quit each year we can save 7616 x 168 = HKD which is greater than the cost of our program HKD In fact the cost of smoking is greater than HKD7616 per smoker each year because smoking can kill lives and lives should be invaluable. As a result, the nurse led intensive community based smoking cessation program is cost effective and worth to implement.

56 56 Chapter 4: EBP Guideline 4.1 Aims and Objectives of the Guideline The following recommendations come from the review of the 7 selected literatures. The following parts will focus on the interventions which are proved to be effective. They will include the details of how the interventions should be applied and implemented. The guideline will help all healthcare professionals especially nurses in smoking cessation area using telephone counseling and NRT to assist women smokers quitting smoking. The objectives of the guideline include: 1. Smoking cessation in women smokers 2. Increase women smokers knowledge and ability to quit by providing strategies of quitting and giving encouragement 3. Strengthen women smokers ability in relapse prevention 4. Strengthen nurses knowledge and skills in smoking cessation counseling 4.2 Users and Setting The guideline is specially designed for healthcare professionals especially nurses in a quitline, community or clinic settings. For our program, it will be located in one of the smoking cessation centers of the DH. 4.3 Target Population

57 57 The program targets at all the women smokers aged 18 or above in Hong Kong. All participants are the callers of the Integrated Smoking Cessation Hotline of the Department of Health ( ). 4.4 Levels of Evidence and Grades of Recommendation The SIGN grading system (Scottish Intercollegiate Guidelines Network, 2008) attached in appendix 10 was used to grade the levels of evidence and strength of recommendations in the guideline.

58 Details of the EBP Guideline Recommendation 1: A Telephone counseling is recommended in smoking cessation. {Zhu et al, 2002 (1+); Macleod et al, 2003 (1++); Mermelstein et al, 2003 (1+); Hollis et al, 2007 (1++)} According to Cochrane review and the US clinical practice guideline, telephone counseling is effective in smoking cessation. It is more convenient, more accessible and more flexible than traditional counseling such as group counselling and face to face counseling. It can serve broader and more diverse group of smokers and can generate a large population impacts. Research showed that with the same promotional effort, smokers are four times as likely to use telephone counseling as face-to-face clinics. Even though the research was not done in Hong Kong but it is proved that the quit rate was not affected by race. Telephone counseling is better than face to face counseling especially for those living in remote areas or with busy schedules. Some smokers may be reluctant or embarrassed to get involved in face-to-face counseling due to stigma. Telephone counseling is better than group counseling because it can be individualized to address the smokers specific stage of change and individual barriers to quit. Among services recommended by the U.S. Preventive Services Task Force,

59 59 telephone counseling has ranked as the highest priority category with the lowest delivery rate. Nowadays, quitlines have been established in the United States, Canada, Australia, New Zealand and many countries in the European Union. Most of the quitlines are free of charge.

60 60 Recommendation 2: A Abbreviated protocol with five sessions and two booster sessions is recommended. {Rabius et al, 2007 (1+)} The abbreviated protocol includes five telephone counseling sessions with 10 minutes each and followed by two telephone booster sessions 15 minutes each (total 80 minutes). Research showed that the abbreviated protocol with two booster sessions is more effective than the abbreviated protocol without two booster sessions (total 50 minutes). The abbreviated protocol with two booster sessions is more effective and cost effective than the 5 full length protocol (5 calls with each call lasts minutes)with and without the booster sessions and the three session protocol (3 calls with each call lasts 35 minutes ) with and without booster sessions. Based on the study, the American Cancer Society is now offering the abbreviated protocol with two booster sessions. The two booster sessions are used to assess the planning for future relapse risks and review the effectiveness of coping strategies used in a recent relapse risk situation, changes in motivation, current craving level, quitting status.

61 61 Recommendation 3: A A relapse-sensitive telephone counseling schedule is recommended. {Rabius et al, 2007 (1+)} In contrast to the traditional schedule of weekly sessions, we adopted a relapse-sensitive telephone counseling schedule in which follow-up calls are arranged according to the chance of relapse. A relapse-sensitive telephone counseling schedule can reduce relapse rate because more telephone counseling will take place in the early stage of the quitting when the chance of relapse is the greatest which means smokers will have the strongest need for help soon after they start to quit. As a result, smokers will receive the first call from counselor within one week after they call the hotline ( ) and accept the referrals. During the first call (approximately days before the quit date), counselors will carry out the initial assessment and start counseling the smokers. The second call will be 2-3 days before the quit date and the third, forth, and fifth calls will be at 1-2 days, 6-9 days and days after the quit date. The two booster sessions will be scheduled at four and six weeks after the final counseling call.

62 62 Recommendation 4: A Motivational interviewing techniques, stage assessment and relapse prevention should be included in the content of telephone counseling and the follow up calls. {Hollis et al, 2007 (1++)} All telephone counselling sessions should be based on the motivational interviewing model. Motivational interviewing involves evocation but not education, exploration but not explanation, autonomy instead of authority and collaboration in stead of confrontation. It makes use of the stage of change model because smokers at different levels of readiness to quit will need different counseling approach. The details of motivational interviewing are stated in appendix 22.

63 63 Recommendation 5: A The program will involve experienced telephone counsellors for smoking cessation with theoretical and practical training in a wide range of counselling techniques including motivational interviewing, the counselors should be provided with appropriate feedback and guidance. {Macleod et al, 2003 (1++); Hollis et al, 2007 (1++)} Telephone counsellors should have at least 1 year experience in smoking cessation and should receive theoretical training in smoking cessation and a wide range of counselling techniques including motivational interviewing before joining the study. The counselor will be provided with appropriate supervision, feedback and guidance during the training session and immediately after each telephone counseling during the pilot test by the two experienced smoking cessation counselors who are the members of the development team, skillful in motivational interviewing and have experience in training smoking cessation counselor.

64 64 Recommendation 6: A Combining telephone counseling with free nicotine replacement therapy (NRT) is recommended. {Macleod et al, 2003 (1++); Hollis et al, 2007 (1++)} According to the recent Cochrane review offering free NRT and telephone counseling increase quit rates by 28%. Combining telephone counselling together with NRT increases quit rates when comparing to the use of NRT alone. When statistically controlling the weeks of patch use, the odds of 90-day continuous abstinence at 6 months were higher in telephone counseling with free NRT group (OR= 1.46; 95% CI, ) than NRT alone group. In Hong Kong, free NRT therapy is provided by the Department of Health in form of nicotine gum, nicotine patches and nicotine inhaler. Unlike smoking, NRT contain nicotine without other harmful substances. Smokers are physiologically addicted to smoking because of nicotine. Replacing nicotine can reduce the withdrawal symptoms and cravings and helping smokers to overcome the physiological dependence. Besides, NRT are delivering nicotine in a slower manner with lower concentration than smoking. The details of the usage, dosage and tips of using nicotine gum, patches and inhalers will be described in appendix 23.

65 65 Recommendation 7: A A baseline assessment for smoking behavior and history is recommended. {Zhu et al, 2002 (1+); Macleod et al, 2003 (1++); Macleod et al, 2003 (1++); McClure et al, 2005(1++); Solomon et al, 2005 (1+); Hollis et al, 2007 (1++); Rabius et al, 2007 (1+)} Counselors will carry out the initial assessment during the first counseling session. A baseline assessment should include average cigarettes consumption per day, nicotine dependence level measured by the Fagerstrom Test for Nicotine Dependence (FTND) (appendix 24), age of starting smoking, any quit attempts or use of NRT before, motivation to quit, confidence to stay quitting under different situations, number of smokers at home, any close friends are smokers and perceived support for quitting. Responses to the motivation, confidence, smoking among friends and family, and the perceived support questions were indicated along 4- point scales (1 = not at all or none; 4 = a lot). The intention to quit question contained a 5-point scale (1 = definitely not; 5 = definitely). Other questions such as the demographic characteristics, any use of antidepressants, stress level in the previous month and concern about weight gain will also be included. Depression level ranged from 1 (not at all) to 4 (a lot); level of stress and weight gain concern ranged from 0 (not at all) to 10 (extremely).

66 66 Recommendation 8: A The 30-day point prevalence abstinence at the 12-month follow-up is used for measuring quit rate. {Hollis et al, 2007 (1++)} The 30-day point prevalence abstinence is a more stable measure than 7-day point prevalence abstinence. Measuring abstinence rate at 12-month follow-up is recommended because most of the long-term quitters need some time to confirm an initial quit date and they usually experience slips in the first few months after quitting.

67 67 Recommendation 9: A A modified bogus pipeline is used to evaluate the smoking status of quitters. {McClure et al, 2005(1++)} For a modified bogus pipeline, all clients were told that they will be asked to provide a breath sample to verify the smoking status. This biochemical confirmation of abstinence will obtain only at the 12-month follow-up. Breath Test is about 90 percent accurate, so it is considered an acceptable test. It is cheaper than most of the other tests such as the blood, urine and saliva tests.

68 68 Chapter 5: Implementation Plan 5.1 Communication Plan Identifying the stakeholders An effective communication with all stakeholders is important in developing a positive relationship and to gain their support throughout the implementation of the proposed innovation. The most critical component in stakeholder communication is identifying the target stakeholders. So, it is essential to search and consider deliberately when finding all potential stakeholders. It can be a tragedy to realize late in the innovation a critical person or group has not received any of the communication. As a result, identification of stakeholders is fundamental to running a successful innovation. There are seventh groups of stakeholders that can affect or be affected by this nurse led intensive community based smoking cessation programme which include the financial department of Tobacco Control Office (TCO), head of the TCO, the members of the development team, the recruited smoking cessation counselor and the research assistant, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place and adult women smokers who will participate in our innovation.

69 69 The first group is the financial department of the TCO. It is responsible for approving funding for the innovation. They would concern for the cost-benefit ratio of the program. So, we will draw out a reasonable estimation of how much the value of benefits exceeds the costs of inputs in order to justify the innovation. The second group is the head of the TCO, who is responsible for approving the innovation and this approval is needed in order to get the funding of the innovation from the financial department of the TCO. The head of the TCO would concern the necessity of the innovation, the detail of the benefits of the target groups, whether the costs is reasonable, the transferability and feasibility of the innovation, the experience and quality of the recruited personnel to make sure the organizers of the innovation have the potential and ability to achieve the goal and run the innovation. All the above information will be included in our proposal before meeting with head of the TCO. The third group is the recruited smoking cessation counselor and the recruited research assistant because they are responsible for setting up and running the innovation. We should make sure they have a comprehensive understanding of the innovation and acquire the skills required by the innovation. The fourth group is the manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health. The Integrated Smoking Cessation

70 70 Hotline is responsible for recruiting cases for our innovation. So, they should know which kind of participants we are looking for, what is the aim of our innovation, what interventions we are going to provide and the quality of our recruited counselor in order to convince our target participant to join us. The fifth group is the manager and staffs of the smoking cessation centre where the innovation will take place. It is because our innovation will occupy a room in the centre and will utilize some equipment e.g. computers, printers, stationeries, CO monitors etc. We need to explain the aim, origin, context of the innovation and describe the benefits of the target groups in detail and describe the experience and quality of the recruited personnel to convince them that we have the potential and ability to achieve the goal. We will describe in sequence how the interventions will be taken place to reassure them that their daily operation will not be affected. The sixth group is the adult women smokers who are the target participants of this nurse led intensive community based smoking cessation programme. They are the focus of the innovation. The effectiveness of the innovation in smoking cessation is mainly depended on this group of stakeholders. We will describe the benefits of the innovation in detail and describe in sequence the interventions of our innovation. We will describe the experience and quality of the recruited personnel of our innovation in the area of smoking cessation to convince them we have the potential and ability to

71 71 achieve the goal. The seventh group is the members of the development team of the innovation. They are the critical component of our innovation because they are deeply involved in the communication process, training process, evaluation process, setting up and supervision and running of the innovation. The proposer of the innovation will describe the prevalence and urgency of setting up the innovation, the latest research findings, the need of gender specific smoking cessation programme and recent smoking cessation service gap in Hong Kong, transferability and feasibility of the research findings. Once we identified all the stakeholders, we can now start communication for the innovation. In fact, many misunderstanding or barriers are due to lack of communication or poor communication skills. So, the communication should be interactive, active, continuous which will become a facilitator of the innovation and provide great support to the innovation Communication process Communication among stakeholders is a step by step process. The top-down approach is used in this innovation. The top-down approach is commonly used in latest programme management. In top-down approach, all the directions come from the top. Objectives of the innovation are set up by the top manager. Top manager

72 72 constructs guidelines, plans and gets approval and money for the programme. The expectations of the development teams should be clearly passed to all stakeholders. Firstly, the proposer of the innovation will hold initial meeting with two nurses of the TCO who are interested in the innovation and want to become members of the development team. The meeting will mention about the prevalence of women smoking in Hong Kong and the consequences to the women smokers, healthcare sector and the society as a whole. Besides, the latest research findings in smoking cessation and the gap of smoking cessation services in Hong Kong will be discussed. Moreover, the meeting will explain the transferability and feasibility of the innovation. The aim of this initial meeting is providing a chance to the members of the development team to have a comprehensive understanding of the innovation. It unites the team members and help establishing the innovation. Secondly, the development team will send a proposal of the innovation to the head of the TCO to get the approval for the innovation because the innovation will be carried out in a smoking cessation centre of the Department of Health. After sending the proposal, we will have a face-to-face meeting with the head of the TCO. In the proposal and during the meeting, the team will affirm the need of our innovation. For example, in Hong Kong, the percentage of female smokers increased from 2.6 percent in 1990 to 3 percent in 2010 (The Department of Health, 2011). 9%

73 73 of all women deaths are related to active smoking which involved approximately 1167 lives a year (The University of Hong Kong, 2005). The estimated costs of disease caused by active and passive smoking was 5.3 billion each year (The University of Hong Kong, 2007). However, the 5.3 billion did not include the value of lives lost (The University of Hong Kong, 2007). So, there is a need for a gender specific smoking cessation programme for women smokers in Hong Kong. Researches proved that combining pharmacological and non-pharmacological intervention is needed to help quitting smoking in women (Palmer, 2000). There are various types of counseling including telephone counseling, face to face counseling and group counseling. The reasons of choosing telephone counseling were that telephone counseling had proved to be effective for smoking cessation (McEwen, 2006). Moreover, in Hong Kong, 98.5% of women smokers had never tried the existing smoking cessation service (The University of Hong Kong, 2007). In addition, female workers in Hong Kong with regular employment account for more than 90 percent of the female labour force and female workforce participation is comparable to men with 76.6 women for every 100 men in the workforce (The Hong Kong Liaison Office of the international trade union movement, 2006). Besides, most of them need to work and take care of family at the same time. So, telephone counseling is more user-friendly as smokers can save a lot of time and money traveling to and from the

74 74 smoking cessation clinics for the counseling sessions. Furthermore, telephone counseling is cost effective and wide reaching (Lewis, 2010). The last but not least, smokers are four times as likely to use quitline as face-to-face counseling (Zhu, Anderson, Tedeschi, Rosbrook, Johnson, Byrd and Gutierrez-Terrell, 2002). However, the Department of Health, which is the main public organization in Hong Kong providing the smoking cessation services, has no telephone smoking cessation counseling services and they only provides face to face counseling. We will summarize and seriously consider all the comments and suggestions from the head of the TCO in order to improve the program and get the approval. Furthermore, we will keep reporting the head of TCO about the progress of our innovation. Thirdly, we will need to communicate with the financial department of the TCO by handing in the cost-benefit table. We will prove that the innovation is not costly. It is because the innovation will only occupy a room in one of the smoking cessation centre of the Department of Health. Moreover, the innovation will make use of the existing facilities and equipment from that smoking centre such as computers, printers, CO monitors. We will make a reasonable estimation of how much the benefits of the innovation exceed the costs caused by smoking of our target population in order to justify the innovation and get the funding from TCO. Fourthly, we will hold regular meeting, provide training, supervision and

75 75 advice to the recruited smoking cessation counselor and the recruited research assistant. They should have a comprehensive understanding of the innovation because they are responsible for carrying out the innovation and responsible for convincing the other stakeholders to support the innovation. Also, they need to help in setting up a place for the innovation and prepare all facilities and equipment needed. These meeting, training, supervision and advice also aim to make sure the recruited smoking cessation counselor is able to master the counseling skills such as motivational interviewing techniques, stage assessment and relapse prevention and make sure the recruited research assistant know what data is going to collect, what should be avoid during the data collection process to reduce bias and what is going to analyse. Fifthly, we will communicate with the manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health by holding meeting and circulating proposal of the innovation. They will be responsible for recruiting cases for the innovation, so they need to know our recruitment requirement that is the adult women smokers. Besides, they need to know goals and benefits of our innovation and the interventions provided by our innovation as they need to explain these details to the women smokers who call the hotline and are interested in our innovation. Sixthly, we will communicate with the manager and staffs of the smoking cessation centre where the innovation will take place by holding meeting and

76 76 circulating proposal of the innovation because our innovation will occupy and utilize room, equipment and facilities in this centre. We need to explain the goals, benefits of our innovation to them to convince them that our innovation is worth supporting. In addition, we will reassure to them that the innovation has got the approval from the head of the TCO. Moreover, we will explain to them that their daily operation will not be affected. We will describe in details the process, setting, interventions and rundown of our innovation to these staffs in sequences because uncertainty will easily increase anxiety or worry. Besides, we will reassure them that extra manpower will be recruited to run the innovation. So, our program will not increase their workload. On the other hand, their workload may decrease because the women smokers initially counseled by them will be counseled by the counselors recruited by our innovation. Furthermore, we will have regular meeting with these staffs to collect their comments on our innovation and to see if our innovation cause any incontinence to them in order to improve our innovation, gain their support and reduce conflicts. Furthermore, we will keep reporting the progress of our innovation to let them feel our respect to them to enhance the communication. Seventhly, the recruited women smokers will be described in details the benefits of quitting and the costs of continuing smoking to strengthen their confident to quit smoking and encourage them to join our innovation. Besides, we will point out

77 77 why our innovation is better the other smoking cessation programs available in the Department of Health in order to convince them that they have chosen the right program. For example, we will explain to them that combining the use of nicotine replacement therapy and telephone counseling is effective and more user-friendly. The participants will be described in details what interventions they are going to receive which include such as the intensity and frequency of counseling sessions and the dosage, usage, duration and precaution of using nicotine replacement therapy, so that they will utilize the smoking cessation services correctly.

78 Pilot Testing There will be four main objectives of carrying out the pilot testing for the nurse led intensive community based smoking cessation programme. The first objective is to test the effectiveness of the training sessions on the skills, knowledge and confidence of the recruited nurse to carry out the telephone counseling. The second objective is to test the satisfaction level of the innovation among women smokers in the real world setting. The third objective is to test the feasibility of the innovation in the real world setting. The forth objective is to measure the actual material cost and non-material cost of the innovation To test the effectiveness of the training sessions The goal of the pilot test is to find out whether the training offered is effective in strengthening the telephone counseling skills, knowledge and confidence of recruited smoking cessation counselors in counseling adult women smokers in the proposed setting. The training is provided by two experienced smoking cessation counselors of the Department of Heath who are nurses with more than 5 years experience in smoking cessation counseling and have experience in training smoking cessation counselors and is interested in our innovation and want to become the members of the development team. Training should be a two way process. On one hand, the trainer will assess the performance of the trainee in knowledge, attitude and

79 79 practice on smoking cessation counseling by collecting pre and post training quantitative data using an assessment tool called Questionnaire for data collection regarding knowledge, attitude and practice on cessation counseling (Johnston, Chan, Chan, Lam,2004) (appendix 25). It is an existing questionnaire used in Hong Kong. The assessment is a continuous process. Assessment will be taken place after the few hours training session and also during the counseling sessions involving the recruited smoking cessation counselor and the recruited adult women smokers. The trainers, who are also the supervisors, will provide feedback and advice on the content and skills of smoking cessation counseling to the recruited nursing counselor. On the other hand, the recruited nursing counselor should actively involve in the training sessions and seek advice whenever he or she comes across difficulty during the training sessions or during the telephone counseling sessions with the women smokers. This helps the trainers to identify the weaknesses of the trainee and provide appropriate and individualized suggestions to the trainee To test the satisfaction level of the innovation among women smokers in the real world setting All women smokers involved in the pilot test will be encouraged to express their satisfaction level over our innovation. They will be asked to rate their level of satisfaction from one to ten (i.e. one referring to extremely not satisfy and ten

80 80 referring to very satisfy). They will also be asked to give comments and suggestions about our innovation. This assesses whether the whole process of the innovation and performance of the counselor is satisfactory from the receivers point of view. The data collected is effective in analyzing whether our innovation is successful and user-friendly and useful in the drawing up improvement plan To test the feasibility of the innovation in the real world setting The pilot test is essential to assess the smoothness of program and spot out the possible barriers which will be encountered during the program. The recruited and trained nursing counselor and the recruited research assistant will be involved in the pilot testing, in order to test the logistics flow of the innovation. 20 women smokers will be recruited within the one month pilot test. Each participant will be asked to give comments and suggestions for the logistics flow of the innovation and the whole counselling process after each counselling. The comments and suggestions of the pilot tests will be summarized, analyzed and evaluated. Improvement plan will be drawn and applied in the nurse led intensive community based smoking cessation program To measure the actual material cost and non-material cost Our program will share the equipment (e.g. computer, printer and CO monitors) and stationery (e.g. paper, pen, pencil) with the smoking cessation centre where our innovation will take place. The actual material cost (e.g. mouth pieces for

81 81 CO monitors) and non-material cost (e.g. free-up experienced nursing smoking cessation counselor of the development team in draw up improvement plan after the pilot test) will be measured accurately. The report will be very useful in running similar program in the future. After the pilot test, the development team, the trained nursing counselor and research assistant will conduct meetings to develop an improvement plan before implementing the innovation. The improvement plan will be discussed with the manager of the smoking cessation centre head of the TCO, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place in order to finalize the improvement plan and get the approval to carry the improvement plan.

82 82 Chapter 6: Evaluation Plan The evaluation plan was used to assess the translation of this nurse led intensive community based smoking cessation programme from the recent literature into practice. Moreover, it assesses the outcome of the proposed programme and collects useful data and suggestions for improvement of future program in this area. We will apply the objective oriented approach for the evaluation plan. Evidence will be collected to prove whether the objectives of the program are achieved or not (Fitzpatrick et al., 2004). The following three outcomes evaluations are used which include patient outcome, staff outcome and system outcome. 6.1 Patient Outcome Evaluation There are two major areas of the patient outcome: 1) Smoking cessation in women smokers which is the primary outcome, 2) The satisfaction level of the women smokers towards the innovation which is the secondary outcome. Time and methods of data collection method will be described in details in the following section. Data will be collected in three period of time: Day 0 (the time of recruitment), Day 30 after the quit date (short term evaluation) and at 12-month follow-up (long term evaluation). So, three sets of the patient outcome evaluation will be collected. The primary outcome will be the quit rate of the women smokers which will be collected on Day 30 after the quit date and at 12-month follow-up mentioned

83 83 above. The secondary outcome will be the satisfaction level, it will be collected on Day 30 after the quit date and at 12-month follow-up Primary outcome: smoking cessation in women smokers Self reported and biochemical conformation using the CO monitor will be used to evaluate the primary outcome. On day 0 (the time of recruitment), the recruited counselor will assess the smoking history and status of women smokers through the telephone. The data will be act as baselines. On day 30 (short term evaluation), the participants will be asked through telephone to assess the smoking status that is whether they smoked in the past 30 days. At the 12 month follow up (long term evaluation), the participants will be asked whether they have quit smoking and perform a breathe test using CO monitor to prove if they claim they have quit smoking. The goal is to monitor the progress of smoking cessation. The 30-day point prevalence abstinence at the 12-month follow-up will be used to define smoking cessation. A RCT focusing on telephone counseling and has level of evidence 1+ (Rabius, Pike, Hunter, Wiatrek and McAlister, 2007) found that the 30-day point prevalent abstinence at 6 months is 30.8 % (p<0.005). In another RCT with interventions similar to our innovation (i.e. combining telephone counseling and NRT) and have level of evidence 1++ (Macleod, Charles, Arnaldi and Adams, 2003) found

84 84 that 28-day continuous abstinence at 6 months is 30%. As the aim of the nurse led intensive community based smoking cessation programme is to help women smokers to quit smoking, the expected quit rate of our innovation will be between 20-30% Secondary outcomes: satisfaction level of the women smokers towards the nurse led intensive community based smoking cessation programme Women smokers will be encouraged to express their satisfaction level over our innovation. They will be asked to rate their satisfaction level from one to ten (i.e. one referring to extremely not satisfy and ten referring to very satisfy) at Day 30 and at the 12 month follow up. Two tailed z-test and 95% confidence interval will be used in order to determine the change of quit rate after utilizing the smoking cessation interventions of our programme. The final results will be reported within one month after the innovation to the head of the TCO, the members of the development team, the recruited smoking cessation counselor and the research assistant, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place. The report can act as a guide for running similar smoking cessation programme in the future.

85 Staff Outcome Evaluation The staff outcome refers to the skill and knowledge of the trained counselors in counselling women smokers and their level of satisfaction towards the nurse led intensive community based smoking cessation programme. There are three points of outcome evaluation for staff which include: Day 0 (before the start of the training of the recruited staffs), Day 45 (after the pilot test) and Month 25 (at the end of the innovation) Knowledge, skills of the trained counselors in the smoking cessation counseling The recruited smoking cessation counselor is expected to increase their knowledge and skills in smoking cessation counselling. There will be a pre-test and post-test measurement tool called Questionnaire for data collection regarding knowledge, attitude and practice on cessation counseling used to measure their knowledge and skills in smoking cessation counselling (Johnston, Chan, Chan, Lam, 2004) (appendix 25). The pre-test (Day 0) will be acted as the baseline measurement. The post test results measured on Day 45 (after the pilot test) and Month 25(at the end of the innovation) will be used to assess the change in Knowledge, skills of the trained counselors in the smoking cessation counselling over the whole period of the

86 86 innovation Satisfaction level towards the programme It is important to assess the satisfaction level of recruited staffs towards the programme. They will be encouraged to rate their satisfaction level from one to ten (i.e. one referring to extremely not satisfy and ten referring to very satisfy) on Day 45 (after the pilot test) and Month 25(at the end of the innovation). Paired t-tests will be used to measure the increase in knowledge and skills of smoking cessation counselling. Moreover, Chi-square tests will be used to determine the association between knowledge and skills in smoking cessation counselling and staff satisfaction. The above results will be reported within one month after the innovation to the head of the TCO, the members of the development team, the recruited smoking cessation counselor and the research assistant, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place. The report will be important for running similar smoking cessation programme in the future.

87 System Outcome Evaluation Utilization of the services provided by this nurse led intensive community based smoking cessation programme and the costs of the innovation will be included in the system outcome evaluation. The results of the evaluation will be announced within one month after the innovation Utilization of the services provided by innovation Recently, the Hong Kong government has increased cigarette taxes and established the clean indoor air laws. It is predicted that the demand for quitting will increase. Although most smokers would like to quit, less than 10% succeed in a given year (Bellenir, 2004). In Hong Kong, 98.5% of women smokers had never tried the existing smoking cessation service and only 20% of attendees of the Smoking Cessation Health Centre (SCHC) were women smokers (The University of Hong Kong, 2007). So, only 1.5% of women smokers have tried to utilize the smoking cessation services. By using the Java applets, confidence interval for one proportion will be applied to measure the sample size and power of the innovation. In Hong Kong, 3% female aged 15 and over are smokers in 2010 which accounted to people (the Hong Kong Census and Statistics Department, 2010). By using the Java applets, finite population n= 86640, worse case = 0.5, confidence =.95, the sample size is 112. As a result, our innovation is expected to recruit at least 112 women

88 88 smokers. The actual number of women smokers involved in the innovation and their corresponding smoking status will be added up to a total and stated in the final report of the innovation which will be published within one month after the innovation Costs of the innovation The cost of the nurse led intensive community based smoking cessation programme will include the manpower costs, material costs and non material costs. Manpower costs will include salary for development team for establishment of the innovation, salary for recruited counselor for providing smoking cessation counseling and salary for the research assistant. Material costs include the cost of mouth pieces for the CO monitor and phone line for telephone counseling. The non-material costs include free-up experienced nursing smoking cessation counselor of the development team to draw up improvement plan after the pilot test. The funding of the innovation will be managed and organized by one member of the development team who will be responsible for recording the entire purchasing items using the Microsoft office excel. The above results will be reported within one month after the innovation to the head of the TCO, the members of the development team, the recruited smoking cessation counselor and the research assistant, manager and staffs of the Integrated Smoking Cessation Hotline of the Department of Health, manager and staffs of the smoking cessation centre where the innovation will take place. The report can act as a

89 useful guide for running similar smoking cessation programme in the future. 89

90 90 References Bellenir, K. (2004). Smoking concerns sourcebook: Basic consumer health information about nicotine addiction and smoking cessation. Detroit, MI: Omnigraphics. Benowitz, N. L., Zevin, S., & Jacob, P. (1998). Suppression of nicotine intake during ad libitum cigarette smoking by high-dose transdermal nicotine. Journal of Pharmacology & Experimental Therapeutics. 287(3), Dodgen, C. E. (2005). Nicotine dependence: Understanding and applying the most effective treatment interventions. Washington, DC: American Psychological Association. Fitzpatrick, J. L., Sanders, J. R., & Worthen, B. R. (2004). Program evaluation: Alternative approaches and practical guidelines (3rd ed). Boston: Allyn & Bacon. Hollis, J. F., McAfee, T. A., Fellows, J. L., Zbikowski, S. M., Stark, M., & Riedlinger, K. (2007). The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline.tobacco Control, 16 Suppl 1, i53-9. Johnston J.M., Chan S.C., Chan K.K., Lam T.H. et al. (2004). Training nurse and social workers in smoking cessation counseling: a population needs

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92 92 Radcliffe Medical Press. North American Quitline Consortium. (2006). Promoting evidence based quitline services across diverse communities in North America. Retrieved August 10, 2011, from, Palmer, K. J. (2000). Smoking cessation. Auckland: Adis International. Pbert L., Flint A. J., Fletcher K.E., Young M.H., Druker S.& DiFranza J. R. (2008). Effect of a pediatric practice based smoking prevention and cessation intervention for adolescents: A randomized, controlled trial. The Journal of the American Academy of Pediatrics. 2008; 121: Public Health Resources Unit, National Health Service (2007). Appraisal tools, Critical Appraisal Skills Programme (CASP). Retrieved August 10, 2011, from Rabius, V., Pike, K. J., Hunter, J., Wiatrek, D., & McAlister, A. L. (2007). Effects of frequency and duration in telephone counselling for smoking cessation. Tobacco Control, 16 Suppl 1, i71-4. Rose, J. E., Herskovic, J. E., Trilling, Y., & Jarvik, M. E. (1985). Transdermal nicotine reduces cigarette craving and nicotine preference. Clinical Pharmacology & Therapeutics, 38(4),

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96 96 APPENDIX 1 The searching profiles of each data base (Keywords Search: Medline + Embase + Pubmed) A: Smoking cessation + Telephone counseling B: Smoking cessation + Telephone counseling +/- C: Smoking cessation + NRT NRT Combining A+B+C Limit to English and RCT only and excluded those studies only involved children and teenagers 1. Medline : Embase : Pubmed : 1833 According to the selection criteria, abstracts and full texts were reviewed and assessed for relevance 7 studies were selected

97 97 Medline (Ovid SP) (1950-) 1 Smoking/ or Smoking.mp. or Smoking Cessation/ "Tobacco Use Disorder"/ or Smoking Cessation.mp. or Smoking/ or Smoking Cessation/ 3 Tobacco, Smokeless/ or "Tobacco Use Disorder"/ or Tobacco/ or "Tobacco Use Cessation"/ or Tobacco.mp. or Tobacco Smoke Pollution/ 4 1 or 2 or Telephone.mp. or Telephone/ Hotline.mp. or Hotlines/ Telecommunications.mp. or Telecommunications/ Telemedicine.mp. or Telemedicine/ or 6 or 7 or Nicotine.mp. or Nicotine/ Nicotinic Agonists.mp. or Nicotinic Agonists/ or Nicotine/ or and and or or 14 or limit 16 to (english language and randomized controlled trial) 1929

98 98 EMBASE (EMBASE Classic + EMBASE 1947-) 1 Smoking/ or Smoking.mp. or Smoking Cessation/ "Tobacco Use Disorder"/ or Smoking Cessation.mp. or Smoking/ or Smoking Cessation/ 3 Tobacco, Smokeless/ or "Tobacco Use Disorder"/ or Tobacco/ or "Tobacco Use Cessation"/ or Tobacco.mp. or Tobacco Smoke Pollution/ 4 1 or 2 or Telephone.mp. or Telephone/ Hotline.mp. or Hotlines/ Telecommunications.mp. or Telecommunications/ Telemedicine.mp. or Telemedicine/ or 6 or 7 or Nicotine.mp. or Nicotine/ Nicotinic Agonists.mp. or Nicotinic Agonists/ or Nicotine/ or and and or or 14 or limit 16 to (english language and randomized controlled trial) 1589

99 99 Pubmed (1950- ) #8 Search ((#4) OR #5) OR #6 Limits: Randomized Controlled Trial, English 1833 #7 Search ((#4) OR #5) OR # #6 Search ((#1) AND #2) OR # #5 Search (#1) AND # #4 Search (#1) AND # #3 Search (Nicotinic Agonists) OR Nicotine #2 Search ((((Telephone) OR Hotline) OR Hotlines) OR Telecommunications) OR Telemedicine #1 Search (((((Smoking) OR Smoking Cessation) OR Tobacco Use Disorder) OR Tobacco) OR Tobacco Smoke Pollution) OR Tobacco, Smokeless

100 Study Ev. APPENDIX 2-TABLE OF EVIDENCE 1 (RCT) Bibliographic citation: Hollis, J. F., McAfee, T. A., Fellows, J. L., Zbikowski, S. M., Stark, M., & Riedlinger, K. (2007). The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline.tobacco Control, 16 Suppl 1, i53-9. Number of Patient Intervention Comparison Length of Outcomes measures Effect size 100 type level subjects characteristics follow up RCT Oregon tobacco Brief NRT(n=868 ): Brief no NRT (n=872 ): Follow up 1. Effectiveness of brief, day point prevalent abstinence (%): quitline callers Brief telephone Brief telephone counselling 1 at 6 and 12 moderate and intensive At 6 months: Intensive NRT(24.3) > Moderate -60% female counselling (one15-minute call) months telephone counselling with NRT(21.3) > Brief NRT(16.8) >Intensive no NRT(13.1) -Mean age : 41 +free nicotine patches or without NRT by > Moderate no NRT(10.7) > Brief no NRT (10.2) -Mean cigarettes Moderate no NRT(n= 718): self-reports. (p<0.0001) consumption per Moderate NRT(n= Moderate telephone At 12 months: Intensive NRT(21.2) > Moderate day: ): counselling 2 (one 30-minute 2. Cost effectiveness of NRT(20.1) > Brief NRT(17.1) >Intensive no NRT(14.3) - Plan to quit Moderate telephone to 40-minute call + a brief, moderate and > Moderate no NRT(13.8) > Brief no NRT (11.7) within the next counselling follow-up call) intensive telephone (p<0.0001) month +free nicotine patches counselling with or 2. Incremental cost/quit 4 ($):Moderate no NRT(1912)< -No Intensive no NRT(n= 720): without NRT Moderate NRT(2109)< Intensive NRT(2112)< Brief contraindications Intensive NRT(n= 721): Intensive telephone NRT(2467)< Intensive no NRT(2640) for patch use Intensive telephone counselling 3 (one 30-minute 3. Participant s 3. Satisfied with quitline (%): Intensive NRT(92.5) > - Half had some counselling to 40- minute counselling satisfaction with the Moderate NRT(88.3) > Brief NRT(82.2) >Intensive no college education +free nicotine patches session + up to four quitline by self-reports NRT(80.7) > Moderate no NRT(66.8) > Brief no NRT -Primarily Spanish telephone support calls over (53.9) (p<0.0001) speakers a three-month period) 4. Participant s feeling of 4. Right amount of contact (%): -Most have health receiving the right Intensive NRT(71.6)> Intensive no NRT(64.9) > insurance. amount of contact by Moderate NRT(58.2) > Brief NRT(48.7) > Moderate no self-reports NRT(47.8)> Brief no NRT (34.5) (p<0.0001) Remarks 1 Brief counselling used a brief negotiation model to communicate caring, motivate change and provide information on recommended quitting strategies. 2 Moderate counselling based on the motivational interviewing model. The brief follow-up call supported the quit plan and encouraged use of community cessation services. 3 Each follow-up call incorporated motivational interviewing techniques, stage assessment and relapse prevention. 4 Incremental costs per additional quit for each intervention was calculated as compared to brief no NRT. Costs were based on what was actually provided to each individual including training costs and the differential delivery costs for each intervention.

101 APPENDIX 3- TABLE OF EVIDENCE 2 (RCT) 101 Bibliographic citation: Macleod, Z. R., Charles, M. A., Arnaldi, V. C., & Adams, I. M. (2003). Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. Medical Journal of Australia, 179(7), Study Ev. Number Patient characteristics Intervention Comparison Length Outcomes measures Effect size type level of of follow subjects up RCT % female -Mean age : 42 NRT + counselling(n=412): Nicotine patches + 5 sessions NRT alone(n=442): 1, 2, 3 Nicotine patches 2 and 6 1. Effectiveness of telephone counselling day continuous abstinence: At 3 months: NRT + counselling (32%)> NRT alone -Mean cigarettes telephone counselling 1 spaced months as an adjunct to (25%) (P = 0.04) consumption per day: according to a relapse-sensitive nicotine replacement At 6 months: NRT + counselling (30%)> NRT alone 24 call schedule at 1, 2, 3, 6 and 10 therapy (NRT) in (22%) (P = 0.01) -English-speaking weeks after baseline smoking cessation by day continuous abstinence at 6 months: - Ready to quit within self-reported using a NRT + counselling (27%)> NRT alone (19%) (P = 1 week bogus pipeline 0.004) -No contraindications technique 3 for patch use primary interest 2. Mean duration of nicotine patches used: NRT + counselling (5.4 weeks; 95% CI, )> 2. Number of weeks NRT alone (4.8 weeks; 95% CI, ) NRT and its relationship with When statistically controlling the weeks of patch use, abstinence rates the odds of 90-day continuous abstinence at 6 months were higher in NRT + counselling (OR= 1.46; 95% CI, ). Remarks 1 Counseling, using a range of evidence based therapy techniques, was carried out by highly trained and experienced counsellors. The first session lasted 20 minutes and subsequent sessions lasted 10 minutes. More calls were made in the early stages of the quit attempt when the risk of relapse is the greatest. 2 Study provided only 2-week free nicotine patches, participants needed to purchase extra patches. 3 Partiticipants were informed the possibility of carbon monoxide breath testing at the 3- and 6-month monitoring calls.

102 Study Ev. APPENDIX 4- TABLE OF EVIDENCE 3 (RCT) Bibliographic citation: McClure, J. B., Westbrook, E., Curry, S. J., & Wetter, D. W. (2005). Proactive, motivationally enhanced smoking cessation counseling among women with elevated cervical cancer risk. Nicotine & Tobacco Research, 7(6), Number Patient characteristics Intervention Comparison Length of Outcomes measures Effect size 102 type level of follow up subjects RCT Female smokers with n=138 n=137 6 months and 1. 7-day day point-prevalence abstinence rate: recent abnormal pap Motivationally enhanced Usual care (UC): 12 months point-prevalence -6 months: MEC (20%) > UC (12%) (p< 0.05) smear or colposcopy phone counseling (MEC): a letter advising to quit post abstinence and -12 months: MEC (18%) > UC (12%) (p= ns) -Mean age : 33 UC + up to four + a self-help booklet enrollment. repeated -Repeated point-prevalence abstinence at 6 and 12 -Mean cigarettes proactively delivered, + contact point-prevalence months: MEC (11%) > UC (10%) (p= ns) consumption per day: 14 motivationally tailored information for the Free & abstinence by -Had a telephone phone counseling program Clear program( a self-reports using a 1.2 Post-hoc analyses: - 45% had a high school over 6 months 1 comprehensive modified bogus Participants who enrolled in Free & Clear program education or less phone-based smoking pipeline 2 reported abstinence: - Average household cessation treatment -6 months: MEC (31%) > UC (9%) (p=0.16) income < US$35,000. program) -12 months: MEC (39%) > UC (9%) (p= 07) -14.5% were covered by 2. Use of adjunct 2.Use of c adjunct cessation treatment: Medicaid. cessation treatment - Enrollment in the Free & Clear program: MEC -Two-thirds had during the study (19%) > UC (8%) (p=0.09) no immediate intention to period by self-report - Use of nicotine replacement or bupropion: MEC quit (36%) > UC (28%) (p=0.18) - Over half had never used - Use of other cessation aids: MEC (11%) > UC any form of cessation (7%) (p=0.30) assistance. Remarks 1 Their specific content was individualized depend on each woman s readiness to quit smoking. The calls were provided by trained study counselor. The mean call duration was 16 min. The timing of the next call was negotiated with each woman at the end of the call. 2 At each follow-up all women were told that they might be asked to provide a saliva or breath sample to confirm their smoking status. Biochemical confirmation of abstinence only used at the 12-month follow up.

103 Study Ev. APPENDIX 5- TABLE OF EVIDENCE 4 (RCT) Bibliographic citation: Mermelstein, R., Hedeker, D., & Wong, S. C. (2003). Extended telephone counseling for smoking cessation: does content matter? Journal of Consulting & Clinical Psychology, 71(3), No. of Patient Intervention Comparison Length of Outcomes Effect size 103 type level subjects characteristics follow up measures RCT All subjects Enhanced Basic content Over 2 (By self report, 1. The longitudinal prevalence of abstinence declined over time with an eventual plateau in received 7-week content (n=375): years at the biochemical both group, from approximately 37% at the 3-month follow-up point to approximately 30% group smoking (n=381): Emphasized end of the verification 2 ) at the 15-month follow-up. cessation Tailored to supportive, group 1. Effects of 2. Relapse rates: enhanced condition (61%) > basic condition (55% ) program before the stage of positive treatment, content of 3. Effects of history of depression: the telephone cessation reinforcement the end of telephone calls on -Subjects with a history of depression exerts marginal effects on longitudinal prevalence of counseling 1 (still smoking, and general the longitudinal abstinence (p <0.07). Besides, history of depression had no significant effect on relapse. - Female: 66% abstinent, or encouragement telephone prevalence of Effects of gender: - More than high relapsed) and for progress and call phase abstinence -For men, longitudinal prevalence of abstinence at 3, 6, 9, 12, 15 months respectively: school graduate: targeting efforts toward (3-month 2. Relapse rates at enhanced condition (43%, 34%, 34 %, 30%, 34%) > basic condition (35%, 25%, 22%, 82% individual s quitting or follow-up) 15 months 26%, 24%) -European personal maintaining and at following the -However, for women, longitudinal prevalence of abstinence at 3, 6, 9, 12, 15 months American:63% characteristics abstinence 3-month initial achievement respectively: basic condition (37%, 36%, 32%, 36%, 34%) > enhanced condition (36%, -African (motivation, without any intervals of abstinence with 32%, 27%, 30%, 27%) American: 32% self-efficacy, individualized thereafter the group program -Relapse rates: men relapsed less in the enhanced condition (p=ns), whereas women -With history of and negative tailoring or 3. Effects of four relapsed less in the basic condition (p <0.05). depression:39% mood) structured goal possible Effects of ethnicity: -Mean age : 44 setting moderators on -No significant effect for ethnicity on longitudinal prevalence of abstinence -Mean cigarettes treatment effects: -Relapse rates: European Americans (62.5%) > African Americans (45.4%) ( p <0.01) consumption per gender, ethnicity, Effects of education: day:23 education and -No significant effect for education on longitudinal prevalence of abstinence history of -Relapse rates: subjects with more than a high school education (60.5%) > subjects with no depression more than a high school education (45.4%) ( p <0.05) Remarks 1 Both group received up to six individualized telephone calls over a 10-week period. 2 Level of expired air carbon monoxide and saliva cotinine

104 Study Ev. APPENDIX 6- TABLE OF EVIDENCE 5 (RCT) Bibliographic citation: Rabius, V., Pike, K. J., Hunter, J., Wiatrek, D., & McAlister, A. L. (2007). Effects of frequency and duration in telephone counseling for smoking cessation. Tobacco Control, 16 Suppl 1, i71-4. Number Patient characteristics Intervention Comparison Length Outcomes Effect size 104 type level of of follow measures subjects up RCT Callers to the Five-session Control group (n=1564): 6 months 1. Thirty-day 1. Thirty-day point prevalence quit rates: American Cancer abbreviated protocol 1 self-help booklets follow point prevalence -All groups receiving telephone counseling (21%, p<0.005)> Society s National with boosters 2 (n=263): up quit rates with Control group (16%, p<0.005) Cancer Information Total duration of Five-session abbreviated protocol varying duration -Five-session abbreviated protocol with boosters (80 Center sessions = 80 minutes without boosters (n=1289): and frequency of min)(30.8%, p<0.05)> Five full length sessions protocol -Female 70% Total duration of sessions =50 telephone without boosters (210 min) (23.2%)> Five full length sessions -White: 75% Three-session protocol minutes counseling with protocol with boosters (240 min) (22.4%)> Three-session -High school with boosters (n=812): or without protocol with boosters (135 min) (20.3%)> Five-session education or higher: Total duration of Three-session protocol without booster sessions abbreviated protocol without boosters (50min) (19.8%, 84% sessions =135 minutes boosters (n=819): at six-month p<0.05)> Three-session protocol without boosters (105 min) -Mean age of men : Total duration of sessions =105 follow-up by (16.2%)> Control group (16.0%), p<0.005) 42.8 Five full length sessions minutes self-report 2. Booster sessions increased cessation rates: -Mean age of protocol with boosters -Five-session abbreviated protocol with boosters (30.8%, women : 43.8 (n=826): Five full length sessions protocol 2. The p<0.05)> Five-session abbreviated protocol without boosters -The median Total duration of without boosters (n=749): usefulness of (19.8%, p<0.05) consumption:20 sessions =240 minutes Total duration of sessions =210 booster -Three-session protocol with boosters (20.3%)> Three-session cigarettes per day minutes sessions by protocol without boosters (16.2%) self-report -Five full length sessions protocol without boosters (23.2%)> Five full length sessions protocol with boosters (22.4%) Remarks 1 This protocol consists of Telephone counseling of minutes in duration that are scheduled after enrolment (approximately days before the quit date), 2 3 days before the quit date and then at 1 2 days, 6 9 days and days after the quit date. For clients randomized to receive the three-session protocol, the first session and last session were eliminated. In the abbreviated five-session protocol the calls were scheduled as in the standard protocol but sharply reduced in duration to only ten minutes each. 2 The two additional 15-minute booster sessions approximately four and eight weeks after the final counseling call. These sessions focused on assessment of quitting status, current craving level, changes in motivation, review of effectiveness of coping strategies use in a recent relapse risk situation and planning for future relapse risks.

105 APPENDIX 7- TABLE OF EVIDENCE 6 (RCT) 105 Bibliographic citation: Solomon, L. J., Marcy, T. W., Howe, K. D., Skelly, J. M., Reinier, K., & Flynn, B. S. (2005). Does extended proactive telephone support increase smoking cessation among low-income women using nicotine patches? Preventive Medicine, 40(3), Study Ev. Number Patient characteristics Intervention Comparison Length of Outcomes measures Effect size type level of follow up subjects RCT Low-income women n = 171 n = 159 Follow up 1. Self-reported rate 1. At 3-month follow-up: smokers receiving Experimental condition: Control condition: at 3 months of no smoking in the -7-day point prevalent abstinence: experimental Medicaid or Vermont Free nicotine patches Free nicotine patches and 6 past 7 days, no (48%) > control (26%37) (P = 0.035) Health Assistance + up to 12 proactive telephone months smoking in the past -30-day point prevalent abstinence: experimental Plan (VHAP) health support calls 1 over 4 months 2 post 30 days at 3 and 6 (43%) > control (26%) (P = 0.002) care coverage baseline months assessments -Mean age : 34 At 6-month follow-up: -Mean cigarettes -7-day point prevalent abstinence: experimental consumption per day: (38%) > control (30%37) (P = ns) day point prevalent abstinence: experimental -Have a telephone, (33%) > control (26%) (P = ns) -Intend to quit smoking in the next 2 2. Self-reported rate day abstinence at 3 and 6 months: weeks, of no smoking in the experimental (29%) > control (20%) (P = 0.052) - No plans to move in past 30 days at both the next 6 months the 3- and 6-month - No assessments. contraindications for the use of NRT Remarks 1 The calls provide encouragement, guidance, reinforcement for quitting smoking and assist in problem-solving for high-risk-for-smoking situations. Support calls lasted an average of 10.1 min each. Counselor are women ex-smoker who received 8 hr training by first author. 2 The first call occurred before the quit date, the second on or shortly after the quit date, the third a few days later, and then subsequent calls occurred weekly and tapering to bi-weekly for up to 4 months.

106 Study Ev. APPENDIX 8- TABLE OF EVIDENCE 7 (RCT) Bibliographic citation: Zhu, S. H., Anderson, C. M., Tedeschi, G. J., Rosbrook, B., Johnson, C. E., Byrd, M., & Gutierrez-Terrell, E. (2002). Evidence of real-world effectiveness of a telephone quitline for smokers. New England Journal of Medicine, 347(14), Number Patient characteristics Intervention Comparison Length Outcomes measures Effect size 106 type level of of follow subjects up RCT Callers of California Treatment group (n=1973) Control group (n=1309) The rates of 1. Analyses factoring out both the treatment Smokers months abstinence for 1, 3, 6, subgroup A and control subgroup A who received Helpline Subgroup A (subjects called Subgroup A 1 (subjects at 1, 3, 6, and 12 months by the same intervention, the rates of abstinence for 1, -Ready to quit within back+ assigned to counselor) called back+ assigned to and 12 self-report 3, 6, and 12 months respectively: a week (n=698): counselor) (n=463): months Treatment subgroup B (21 %, 16 %, 12 %, and 8 -Chose telephone 2. The percentages of %) > control subgroup B (10%, 7 %, 5 %, and 4 counseling Self-help materials+ Self-help materials+ smokers who quit %), (p<0.001) - Female: 56% telephone counseling 2 telephone counseling for at least 24 hours -Mean age : 38 (i.e., made a serious 2.1 Attempt to quit within 3 months: -Mean cigarettes attempt to quit) in the Subgroup B (58%)>control subgroup B (49%), consumption per Subgroup B(subjects did not call Subgroup B (subjects did first three months and p<0.001 day:21 back+ assigned to counselor) not call back+ not assign the probability of months abstinence rate after attempting to -White: 62% (n=1275): to counselor) (n=846): relapse over time for quit: these attempts by Treatment subgroup B (23%)> control subgroup B Self-help materials+ Self-help materials self-report (18%), p<0.001 telephone counseling Remarks 1 The quitline, as a public health service, did not want to impair the ability of anyone in the control group to receive treatment, so subjects in the control group could receive counseling if they called back for it. 2 Study provided up to seven counseling sessions. The first session focused on quitting history, motivation, self-efficacy, social support and planning in advance of the quitting date. Sessions after the quitting date emphasized relapse prevention by reviewing and revising the plan and promoting adoption of the self-image of a nonsmoker. All counselors received 60 hours of training.

107 107 APPENDIX 9 CASP APPRAISAL TOOL FOR RCTs (Public Health Resources Unit, National Health Service, 2007) Screening Questions 1. Did the study ask a clearly-focused question? Yes Can t tell No Consider if the question is focused in terms of: the population studied the intervention given the outcomes considered 2. Was this a randomised controlled trial (RCT) Yes Can t tell No and was it appropriately so? Consider: why this study was carried out as an RCT if this was the right research approach for the question being asked Is it worth continuing? Detailed Questions 3. Were participants appropriately allocated to Yes Can t tell No intervention and control groups? Consider: how participants were allocated to intervention and control groups. Was the process truly random? whether the method of allocation was described. Was a method used to balance the randomization, e.g. stratification? how the randomization schedule was generated and how a participant was allocated to a study group if the groups were well balanced. Are any differences between the groups at entry to the trial reported? if there were differences reported that might have explained any outcome(s) (confounding) 4. Were participants, staff and study personnel Yes Can t tell No blind to participants study group? Consider: the fact that blinding is not always possible if every effort was made to achieve blinding

108 108 if you think it matters in this study the fact that we are looking for observer bias 5. Were all of the participants who entered the Yes Can t tell No trial accounted for at its conclusion? Consider: if any intervention-group participants got a control-group option or vice versa if all participants were followed up in each study group (was there loss-to-follow-up?) if all the participants outcomes were analyzed by the groups to which they were originally allocated (intention-to-treat analysis) what additional information would you liked to have seen to make you feel better about this 6. Were the participants in all groups followed Yes Can t tell No up and data collected in the same way? Consider: if, for example, they were reviewed at the same time intervals and if they received the same amount of attention from researchers and health workers. Any differences may introduce performance bias. 7. Did the study have enough participants to Yes Can t tell No minimise the play of chance? Consider: if there is a power calculation. This will estimate how many participants are needed to be reasonably sure of finding something important (if it really exists and for a given level of uncertainty about the final result). 8. How are the results presented and what is the main result? Consider: if, for example, the results are presented as a proportion of people experiencing an outcome, such as risks, or as a measurement, such as mean or median differences, or as survival curves and hazards how large this size of result is and how meaningful it is how you would sum up the bottom-line result of the trial in one sentence 9. How precise are these results? Consider:

109 109 if the result is precise enough to make a decision if a confidence interval were reported. Would your decision about whether or not to use this intervention be the same at the upper confidence limit as at the lower confidence limit? if a p-value is reported where confidence intervals are unavailable 10. Were all important outcomes considered so Yes Can t tell No the results can be applied? Consider whether: the people included in the trail could be different from your population in ways that would produce different results your local setting differs much from that of the trial you can provide the same treatment in your setting Consider outcomes from the point of view of the: individual policy maker and professionals family/carers wider community Consider whether: any benefit reported outweighs any harm and/or cost. If this information is not reported can it be filled in from elsewhere? policy or practice should change as a result of the evidence contained in this trial

110 110 APPENDIX 10 QUALITY CODING SYSTEM (Scottish Intercollegiate Guidelines Network, 2008) ++ All or most of the criteria have been fulfilled. Where they have not been fulfilled the conclusions of the study or review are thought very unlikely to alter. + Some of the criteria have been fulfilled. Those criteria that have not been fulfilled or not adequately described are thought unlikely to alter the conclusions. - Few or no criteria fulfilled. The conclusions of the study are thought likely or very likely to alter. LEVEL OF EVIDENCE (Scottish Intercollegiate Guidelines Network, 2008) 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort studies High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies e.g. case reports, case series 4 Expert opinion

111 111 APPENDIX 11- Table of Critical Appraisal 1 (CASP appraisal tool for RCT) Hollis, J. F., McAfee, T. A., Fellows, J. L., Zbikowski, S. M., Stark, M., & Riedlinger, K. (2007). The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline.tobacco Control, 16 Suppl 1, i Did the study ask a clearly-focused question? Yes Yes 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes 3. Were participants appropriately allocated to intervention and control groups? Can t tell Consent included agreeing to randomisation and to consider offering of additional free services, such as phone support and/or NRT, without committing to actually use any services offered. Once the consent was confirmed, a computer algorithm randomly assigned participants. No method or allocation concealment of randomisation was mentioned. There were no significant differences between treatment groups in demographic characteristics. 4. Were participants, staff and study personnel Can t tell For participants and counselors, blinding was not mentioned blind to participants study group? For data collectors, they were blinded to treatment condition when a conducted follow-up assessment with no method of blinding was mentioned. 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes Two secondary analyses using multiple imputation procedures were conducted to account for the missing outcome data. When using multiple imputations for missing values, the primary outcome was assumed that those with missing outcomes were still smoking. Because controversy remains about how to handle missing data in smoking trials, the study compared the primary intent to treat method to two different multiple imputation approaches. 6. Were the participants in all groups followed up and data collected in the same way? Yes Trained assessors blinded to treatment condition conducted follow-up assessments by phone without biochemical validation after randomisation. At each follow-up, assessors made at least 10 attempts to reach participants during a range of day, evening and weekend hours.

112 Did the study have enough participants to minimise the play of chance? Yes The sample sizes per cell were large enough to permit the usual normal approximation to the sampling distribution of the binomial distribution. Power was adequate (0.80, alpha=0.05) to detect a difference in abstinence of The large sample size provided the opportunity to compare the effects of six alternative treatment regimens and increased the external validity and policy relevance of the findings. However, the power calculation was not addressed. 8. How are the results presented and what is the main result? Satisfactory Percentage, p-value with odd ratio were used for categorical variables and mean with SD was used for continuous variables The added costs per incremental quit (compared to brief no NRT) were lowest and similar for the moderate no NRT, moderate NRT and intensive NRT conditions. One-year abstinence rates increased when quitline callers were offered: (1) free NRT patches shipped by mail; and/or (2) more intensive counselling with follow-up calls. The difference between the moderate (that is, two-call) and intensive (up to five-call) protocols was modest. 9. How precise are these results? Acceptable Mean with SD, p-value with odd ratio was used. Multiple logistic regressions was used to compare the moderate and intensive interventions to brief intervention, with and without an NRT offer with the moderate compared to intensive arms. The study used ordinary least squares regression to calculate mean total programme costs and standard deviations for participants in each intervention. It calculated incremental costs per additional quit for each intervention compared to brief no NRT. The difference between the moderate (that is, two-call) and intensive (up to five-call) protocols was modest. 10. Were all important outcomes considered so Yes The people included in the trial are similar to my population. the results can be applied? The setting is similar. And, the similar intervention can be provided in the proposed setting. Outcomes are favorable to

113 113 smokers. Practice should change as a result of the evidence contained in this trial. The interventions were carried out by experienced telephone tobacco counsellors. They all received additional theoretical and practical training in motivational interviewing. Training focused on how to adhere closely to the different intervention protocols using computer driven scripting. Calls were taped for quality assurance monitoring and rated counsellors regularly on adherence to key elements of each protocol. % of criteria fulfilled 90% (9/10) Level of evidence 1++

114 114 APPENDIX 12- Table of Critical Appraisal 2 (CASP appraisal tool for RCT) Macleod, Z. R., Charles, M. A., Arnaldi, V. C., & Adams, I. M. (2003). Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial. Medical Journal of Australia, 179(7), Did the study ask a clearly-focused question? 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes Yes Yes 3. Were participants appropriately allocated to intervention and control groups? Yes Participants were randomly allocated to either NRT alone or NRT plus telephone counselling by a simple randomisation procedure involving shuffling of folders each day after participants to be included were listed by the study pharmacist. There was no stratification Logistic regression analysis was used to examine increased patch use which was a potential confounding variable affecting abstinence rates All telephone counsellors had worked in the program for at least 1 year before the study, during which time they had received regular theoretical training in nicotine addiction and a wide range of counselling techniques, regular live supervision sessions conducted by a clinical psychologist with experience in the area of smoking cessation, and frequent performance reviews. The extent to which the written self-help material contributed to abstinence is difficult to determine, as it was not tested in isolation from telephone counselling. There is some evidence that but it has not been shown to contribute significantly to abstinence rates in those using NRT. There were no significant differences between treatment groups in demographic characteristics. 4. Were participants, staff and study Can t tell For participants and counselors, blinding was not mentioned personnel blind to participants study The counselling group was also asked about the perceived benefits of counselling. Data collectors were therefore not

115 115 group? blinded to participant allocation. 5. Were all of the participants who entered the trial accounted for at its Yes Statistical analyses were carried out on an intention-to-treat basis, including data for all participants according to their randomisation group. conclusion? Missing data were counted as smokers with 0 days abstinence in that period, unless continuous abstinence between calls was subsequently reported. 6. Were the participants in all groups followed up and data collected in the Yes Follow-up telephone questionnaires were administered to all participants at 1, 2, 3 and 6 months after baseline by non-counselling data collectors at the GlaxoSmithKline call centre. same way? The study had no biochemical verification of abstinence To minimize misleading reports of abstinence, a bogus pipeline technique was used with the possibility of carbon monoxide breath testing mentioned in the consent form and at the 3- and 6-month monitoring calls. 7. Did the study have enough participants to minimise the play of chance? Yes On the basis of power of 80% to detect a 10% difference between groups in abstinence rates at the 5% significance level, the study calculated that a total of 720 participants were necessary if 30% of participants in the NRT-only group achieved abstinence. To allow for attrition, the study aimed for over 800 participants. So, the study had enough patients to prevent the play of chance and showed appropriate sample size calculation. 8. How are the results presented and what is the main result? Satisfactory Percentage, p-value with 95% CI and odd ratio were used for categorical variables and mean with SD was used for continuous variables Telephone counselling as an adjunct to NRT increases abstinence rates beyond the use of NRT alone. 9. How precise are these results? Acceptable Statistical significance of differences between groups was tested by X 2 tests and logistic regression (categorical variables) or t tests (continuous variables). Increased patch use was a potential confounding variable affecting abstinence rates. To examine this potential confounder, logistic regression analysis was conducted with both treatment group and duration of patch use included as predictors of 90-day abstinence.

116 Were all important outcomes Yes The people included in the trial are similar to my population. considered so the results can be applied? % of criteria fulfilled 95% (9.5/10) The setting is similar. And, the similar intervention can be provided in the proposed setting. Outcomes are favorable to smokers. Practice should change as a result of the evidence contained in this trial. Level of evidence 1++

117 117 APPENDIX 13- Table of Critical Appraisal 3 (CASP appraisal tool for RCT) McClure, J. B., Westbrook, E., Curry, S. J., & Wetter, D. W. (2005). Proactive, motivationally enhanced smoking cessation counseling among women with elevated cervical cancer risk. Nicotine & Tobacco Research, 7(6), Did the study ask a clearly-focused question? Yes Yes 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes 3. Were participants appropriately allocated to intervention and control groups? Can t tell All potentially eligible and interested women were screened for eligibility. Participants were then randomly assigned into one of two treatment arms. No method and allocation concealment were mentioned. Baseline characteristics were compared by intervention group using chi-squares for discrete variables and t tests for continuous variables. There were no significant differences between treatment groups in demographic characteristics. 4. Were participants, staff and study personnel blind to Can t tell For participants and counselors, blinding was not mentioned. participants study group? For data collectors, they were blinded to participants randomization status, but method to achieve blinding was not mentioned. 5. Were all of the participants who entered the trial Yes Abstinence was analyzed using an intent-to-treat methodology. accounted for at its conclusion? Participants with missing smoking status data were counted as smokers. 6. Were the participants in all groups followed up and data collected in the same way? Yes Participants were surveyed at the same intervals by phone at baseline at baseline, 6 months postenrollment and 12 months postenrollment by self-reports through telephone. A modified bogus pipeline (biochemical verification including in-person carbon monoxide (CO) assessment, returned a saliva test strip by mail) was also used at the 12-month follow-up,

118 118 Follow-up retention was high (96% at the 6-month evaluation, 95% at the 12- month evaluation). 7. Did the study have enough participants to minimise the play of chance? Yes The sample size provided 80% power to detect an 11% difference in abstinence between the treatment groups at 1 year. The study had enough patients to prevent the play of chance. However, the power calculation was not addressed. 8. How are the results presented and what is the main Satisfactory Good use of table, no duplication of text and tables result? Percentage, p-value with 95% CI and odd ratio were used for categorical variables and mean with SD was used for continuous variables. Compared with control subjects, counseling participants were more likely to seek additional treatment services and had a higher 7-day point-prevalence abstinence rate at 6 months (20% MEC vs. 12% UC, p<.05). MEC impact was sustained at 12 months, but abstinence increased among the UC group (18% MEC vs. 20% UC, p=ns). There was no difference in repeated point-prevalence abstinence at 6 and 12 months (11% MEC vs. 10% UC, p=ns). 9. How precise are these results? Satisfactory Mean with SD, p-value with 95% CI and odd ratio were used. Abstinence rates by group were determined with chi-square analyses. Logistic regression was used to determine odds ratios and confidence intervals for abstinence effects. 10. Were all important outcomes considered so the results can be applied? Yes The people included in the trial are similar to my population. The setting is similar. So, the similar intervention can be provided in the proposed setting. Outcomes are favorable to female smokers. Practice should change as a result of the evidence contained in this trial. However, women may have been receptive to the calls because we reached them at a salient moment, shortly after an abnormal pap exam or a colposcopy. If the association between smoking and cervical cancer risk did increase women s interest in quitting, as has been demonstrated in other studies, then the results may not generalize to smokers who are not otherwise at elevated risk for disease. The relative

119 119 importance of linking this intervention to a salient health event or condition warrants further consideration. We cannot rule out the possibility that the UC offered through this study (i.e., advice to quit linked to cervical cancer risk, self-help materials, and treatment referral) had a synergistic effect with the standard clinical care. In retrospect, a no-treatment control group (i.e., true usual care) may have been a better comparator group in this study. % of criteria fulfilled 90% (9/10) Level of evidence 1++

120 120 APPENDIX 14- Table of Critical Appraisal 4 (CASP appraisal tool for RCT) Mermelstein, R., Hedeker, D., & Wong, S. C. (2003). Extended telephone counseling for smoking cessation: does content matter? Journal of Consulting & Clinical Psychology, 71(3), Does extended proactive telephone support increase smoking cessation among low-income women using nicotine patches? 1. Did the study ask a clearly-focused question? 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes Yes Yes 3. Were participants appropriately allocated to intervention and control groups? Can t tell Groups were randomly assigned to condition with no method, schedule or allocation concealment were mentioned There were no differences between conditions on any of the participants demographic and smoking history characteristics or on percentage with a history of depression. There were no differences at any point between conditions in rates of usage of the pharmacological adjuncts. Great emphasis was placed on adherence to the condition protocol. Mermelstein led weekly 2-hr supervision meetings with all the counselors, debriefing the calls and providing appropriate feedback and guidance. Adherence to protocol was judged to be high. The study did not include a comparison group who received only the group treatment and no follow-up telephone calls. Thus, we cannot conclude whether the telephone calls improved the outcomes of the group program alone. 4. Were participants, staff and study personnel blind to participants study Yes Counselors were kept blind to condition until the last group meeting. Counselors were crossed with condition within each cohort. group? For data collectors participants and counselors, blinding was not mentioned after group meeting 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes There were no differences in drop-out rates for the two conditions between either the first and last group session or between the end of group treatment and any follow-up point. Attrition was minimal during the follow-up.

121 121 Overall, 96% of the participants provided data at all follow-up points. At each follow-up point, the percentage missing ranged from 1% at the 6-month point to 4% at the 15-month follow-up. 6. Were the participants in all groups followed up and data collected in the same way? Yes Smoking behavior and psychosocial variables were assessed by self-report through telephone and biochemical verification at baseline, at each treatment contact, the end of the group treatment, the end of the telephone call phase (3-month follow-up), and at 3-month intervals thereafter through a 15-month follow-up. For biochemical verification, expired air carbon monoxide and saliva cotinine were used to verify abstinence at each major assessment point (end of group treatment and at the 3-, 6-, 9-, 12-, and 15-month follow-ups). Participants who self-reported abstinence were asked to return to the research office for a verification visit. 7. Did the study have enough participants to minimise the play of chance? Can t tell The study had a large sample size to make sure that the study had adequate power not just to detect condition differences but also to detect interaction effects. However, the power calculation was not addressed. 8. How are the results presented and what is Yes Good use of table, no duplication of text and tables the main result? Percentage and p-value were for categorical variables, mean with SD was used for continuous variables There was a significant interaction between treatment condition and gender. For men, the enhanced condition produced better abstinence rates through 15 months and lower relapse rates. For women, the basic condition was better. History of depression did not interact with condition. The current study focused on history of depression rather than current mood state it also may be unreasonable to expect that a prior depressive episode would exert a strong influence on current quitting efforts and that more proximal measures of negative mood may show a stronger association. 9. How precise are these results? Yes Mean with SD and p-value was used. The study used Cox proportional hazards regression models to compare condition groups in terms of time to relapse. As with the GEE models, these models provide tests of significance based on Wald s chi-square statistics.

122 122 In addition, use of sophisticated analytic techniques allowed the study to examine the longitudinal trends in cessation, relapse, and recycling rather than considering point prevalence outcomes alone. The analytic approach used also allowed for the study to include participants who may have had missing data at a follow-up, our rates of complete data were quite high. 10. Were all important outcomes considered so the results can be applied? Yes The people included in the trial are similar to my population. The setting is similar. And, the similar intervention can be provided in the proposed setting. Outcomes are favorable to smokers. Practice should change as a result of the evidence contained in this trial. % of criteria fulfilled 90% (9/10) Level of evidence 1+

123 123 APPENDIX 15- Table of Critical Appraisal 5 (CASP appraisal tool for RCT) Rabius, V., Pike, K. J., Hunter, J., Wiatrek, D., & McAlister, A. L. (2007). Effects of frequency and duration in telephone counseling for smoking cessation. Tobacco Control, 16 Suppl 1, i Did the study ask a clearly-focused question? 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes Yes Yes 3. Were participants appropriately allocated to intervention and control groups? Yes Participants were randomized by a computer generated random number sequence, without stratification, into one of seven experimental groups, with a proportional assignment of one in four to a control group in which self-help booklets were mailed to the caller but no counseling was provided. The remaining three out of four participants were randomized in a three by two factorial design in which they received one of three counseling protocols: five full length sessions with 210 minutes of planned counseling time, three sessions with 105 minutes of counseling time, or five sessions with 50 minutes of counseling time. There were no significant differences between groups in these baseline variables. 4. Were participants, staff and study Can t tell For data collectors, participants and counselors, blinding was not mentioned. personnel blind to participants study group? 5. Were all of the participants who entered the trial accounted for at its conclusion? Yes The response rates for the six-month follow-up interviews were above or near 50% in the different experimental groups. Causes of non-response were refusals 2%, moved 17% and no answer 24%. Assuming non-respondents to be continuing smokers. Quit rates were calculated following the intent to treat principle There were no systematic group differences in response rates or other factors that might reduce the internal validity of this experiment. 6. Were the participants in all groups Yes All participants were telephoned for interviews to assess their current smoking status at six-month follow-up by self-report.

124 124 followed up and data collected in the same way? 7. Did the study have enough participants Can t tell The number of patients needed was not mentioned. to minimise the play of chance? The power calculation was not addressed. 8. How are the results presented and what Satisfactory Good use of table, no duplication of text and tables is the main result? P-value was used. Based on these findings, the abbreviated protocol with five sessions and two boosters is considered to be an option for improving cost efficiency in the delivery of this service. 9. How precise are these results? Satisfactory In the planned comparisons between groups, X 2 statistics were used to test the significance of differences in quit rates in the entire group P-value was used. 10. Were all important outcomes considered so the results can be applied? Yes The people included in the trial are similar to my population. The setting is similar. And, the similar intervention can be provided in the proposed setting. Outcomes are favorable to smokers. Practice should change as a result of the evidence contained in this trial. % of criteria fulfilled 90% (9/10) Level of evidence 1+

125 125 APPENDIX 16- Table of Critical Appraisal 6 (CASP appraisal tool for RCT) Solomon, L. J., Marcy, T. W., Howe, K. D., Skelly, J. M., Reinier, K., & Flynn, B. S. (2005). Does extended proactive telephone support increase smoking cessation among low-income women using nicotine patches? Preventive Medicine, 40(3), Did the study ask a clearly-focused question? Yes Yes. 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes. 3. Were participants appropriately allocated to intervention and control groups? Can t tell Participants were recruited throughout Vermont by posting flyers. Interested smokers called a toll-free number to be screened for eligibility by a project interviewer. Two copies of a study consent form were mailed to eligible women. Participants were randomized to either the experimental or control condition after returning her signed consent form. Randomization method and allocation concealment were not mentioned. No significant different in demographic characteristics among groups. All counselors had received 8 h of training delivered by the first author. 4. Were participants, staff and study personnel blind Can t tell For participants and counselors, blinding was not mentioned to participants study group? For data collectors, they were separated from telephone support staff. 5. Were all of the participants who entered the trial accounted for at its conclusion? 6. Were the participants in all groups followed up and data collected in the same way? Yes An intention-to-treat model was applied for all self-reported abstinence outcomes with losses to follow-up counted as smokers. yes All participants received assessment calls from trained project interviewers (separate from telephone support staff) at the same intervals at baseline, 2 weeks, and 3 and 6 months post-baseline by telephone. During each counseling call, the counselor wrote down the date and length of the call, the woman s smoking status, her use of nicotine patches, key issues discussed, and plans for further contact. This telephone support log data was

126 126 then used to determine the total number of support calls received by each participant and the mean duration of each call. 7. Did the study have enough participants to minimise the play of chance? No With the sample size, the study had power of only 0.40 to detect a difference of the magnitude of point prevalent abstinence at 6 months. Even though a 27% increase in abstinence at 6 months among experimental participants was observed compared to controls, this difference was too small to be statistically significant. 8. How are the results presented and what is the main Satisfactory There was good use of table, no duplication of text and tables. result? Percentage, p-value with 95% CI and odd ratio were used for categorical variables; mean with SD was used for continuous variables. There is a significant effect for the telephone support at 3 months, with 43% of experimental versus 26% of control condition women reporting 30-day point prevalent abstinence (P = 0.002). So, there is a short-term effect for proactive telephone support added to free nicotine replacement therapy. The difference was no longer significant at 6 months. Metaanalysis conducted with five randomized studies revealed a slight but non-significant long-term benefit of proactive telephone support when added to the provision of free nicotine patches for smoking cessation. 9. How precise are these results? Satisfactory Logistic regression was used to determine the impact of baseline variables and experimental condition on 3- and 6-month abstinence. Mean with SD, p-value with 95% CI and odd ratio were used. 10. Were all important outcomes considered so the results can be applied? Yes The people included in the trial are similar to my population. The setting is similar. So, the similar intervention can be provided in the proposed setting. Outcomes are favorable to female smokers. Practice should change as a result of the evidence contained in this trial. % of criteria fulfilled 80% (8/10) Level of evidence 1+

127 127 APPENDIX 17- Table of Critical Appraisal 7 (CASP appraisal tool for RCT) Zhu, S. H., Anderson, C. M., Tedeschi, G. J., Rosbrook, B., Johnson, C. E., Byrd, M., & Gutierrez-Terrell, E. (2002). Evidence of real-world effectiveness of a telephone quitline for smokers. New England Journal of Medicine, 347(14), Did the study ask a clearly-focused question? Yes Yes 2. Was this a randomised controlled trial (RCT) and was it appropriately so? Yes Yes 3. Were participants appropriately allocated to intervention and control groups? Can t tell The quitline staff used a randomization procedure to reduce the caseload to a manageable level: a portion of callers was randomly assigned, in effect, to a control group. Even at such times, however, the quitline, as a public health service, did not want to impair the ability of anyone in the control group to receive treatment. A design was developed that would serve as an equitable management procedure, accommodating smokers needs, and at the same time would allow a rigorous evaluation by means of a randomized, controlled trial embedded within the service. The developments of this system and its associated statistical considerations have been described. No method and allocation concealment for randomization were mentioned. The California Smokers Helpline used a previously tested, structured counseling protocol which helped to ensure consistency by guiding the content and quality of each session. All counselors received 60 hours of training, regardless of their background. No significant difference in base-line characteristics was found between the two study groups. 4. Were participants, staff and study personnel blind Can t tell For participants and counselors, blinding was not mentioned to participants study group? For data collectors, a separate staff of evaluators interviewed the participants. 5. Were all of the participants who entered the trial Can t tell All participants who were lost to follow-up were considered current smokers. accounted for at its conclusion?

128 Were the participants in all groups followed up and Yes Evaluators interviewed the participants 2, 4, 7, and 13 months after the initial contact based on self-report by telephone. data collected in the same way? 7. Did the study have enough participants to minimise Can t tell The number of patients needed was not mentioned. the play of chance? The power calculation was not addressed. 8. How are the results presented and what is the main Satisfactory Good use of table, no duplication of text and tables result? Percentage and p-value were for categorical variables mean with SD was used for continuous variables In a randomized, controlled trial of 3282 smokers, those in the treatment group (1973 callers) had abstinence rates approximately double the rates of subjects in the control group (1309 callers) at 1, 3, 6, and 12 months after quitting smoking. The success of this protocol supports Public Health Service guidelines calling for greater availability of quitlines. A telephone counseling protocol for smoking cessation, previously proven efficacious, was effective when translated to a real-world setting. 9. How precise are these results? Satisfactory To provide a better numerical estimate of the effect of counseling which referred to the difference between treatment subgroup B and control subgroup B, the study then factored out the control subgroup that received counseling (control subgroup A), along with its counterpart in the treatment group (treatment subgroup A). Because of the randomization procedure and the fact that treatment subgroup A and control subgroup A both received the same intervention, they were assumed to have the same quitting rate. Log-rank tests comparing control and treatment groups and comparing control subgroup B and treatment subgroup B showed significant differences for all four intervals. P-value was used. 10. Were all important outcomes considered so the Yes The people included in the trial are similar to my population. results can be applied? The setting is similar. And, the similar intervention can be provided in the proposed setting. Outcomes are favorable to smokers. Practice should change as a result of the evidence contained in this trial.

129 129 % of criteria fulfilled 80% (8/10) Level of evidence 1+

130 130 APPENDIX 18 Time schedule for implementation of the innovation Task Development Time Lines Jan Feb Mar Apr May Jun 2 yrs +1 month 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks 2 wks Establishment of a development team Get approval and budget for the innovation Promote the innovation Collects comment about the innovation Keep communication with the manager and staffs Design an assessment form Design an evaluation plan Develop tailored intervention

131 131 Recruit smoking cessation counselor and research assistant for smoking cessation Set up room and equipment needed for the innovation Training of smoking cessation counselors Conduct the pilot test Evaluate of the pilot test Implementation and evaluation of the innovation

132 132 APPENDIX 19 The Set Up Costs of the Innovation in Hong Kong Dollar HKD($) Number Required for Setting up the Innovation Month for Setting up the Innovation Cost for Setting up the Innovation Number Required for Pilot Test Month Invested for Pilot Test Cost for Pilot Test Month Invested for Evaluation Cost for Evaluation Nurses 30000/month Research assistant 10000/month Phone line 100/month Subtotal (HKD) Total set up cost (HKD)

133 133 APPENDIX 20 The Running Costs of the Innovation in Hong Kong Dollar Number Required HKD($) Month Invested for Implementation Cost for Implementation Number Required Month Invested for Final Evaluation Cost for Final Evaluation Nurse /month Research assistant /month Phone line 2 100/month 2 telephone line for 14 months and 1 telephone line for the next 10 months (2x14+1x10) x 100= Mouth piece /piece N/A Subtotal (HKD) Total running cost (HKD)

134 APPENDIX 21 Grades of Recommendation (Scottish Intercollegiate Guidelines Network, 2008) 134 A B C D At least one meta-analysis, systematic review or RCT rated as 1++ and directly applicable to the target population; or A systematic review of RCTs or a body of evidence consisting principally of studies rated as 1+, directly applicable to the target population and demonstrating overall consistency of results A body of evidence including studies rated as 2++, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1+ A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

135 135 APPENDIX 22 (Landow, 2008) Motivational interviewing Motivational interviewing is a semi-directive, client-centered counseling method by helping smokers to investigate and resolve ambivalence during quitting. Motivational interviewing is goal-oriented with the exploration and resolution of ambivalence as central goal. Ambivalence is resolved by conscious or unconscious weighing of positive and negative effects of quitting and not quitting. The smoking cessation counselor should not be judgmental, confrontational and adversarial. Instead, they should increase the smokers awareness of the harm caused by smoking. They should help clients to increase awareness of the benefits of quitting and become increasingly motivated to quit. Four basic skills are required to achieve successful motivational interviewing which include: the ability to ask open ended questions, the ability to offer affirmations, the ability of reflective listening, and the ability to draw summary statements. Four core principles should be involved in Motivational interviewing which include express empathy, develop discrepancy, support self-efficacy and roll with resistance. For expressing empathy, counselors should put themselves in smokers shoes. When smokers feel that counselors are seeing smoking cessation from

136 136 smokers point of view, they will be more willing to share their own experiences in depth. In return, counselors can investigate what the smokers need and their pitfalls during the whole quitting process. To conclude, expressing empathy allow counselors to have accurate understanding of the smokers experience of quitting and provide more individualized support. For developing discrepancy, counselors will assist clients to appreciate the benefits of quitting by exploring the discrepancy between the lives they want and the lives they are currently engaging in. counselors will work with smokers to find out how different between the smokers future goals and the reality if smokers continue smoking. As a result smokers will be motivated to quitting. For rolling with resistance, counselors are not trying to fight or argue against smokers; resistance, but they are trying to strength and enhance smokers ability to tackle their own solutions to the problems they have defined. Counselors may let smokers to examine new perspectives, but they will do not impose the new perspectives on clients. To conclude, rolling with resistance is effective in helping smokers who are reluctance to quit. For support self-efficacy, smokers should have autonomy in quitting and counselors will help smokers move toward successfully quitting and increase smokers confidence in quitting. Counselors should let the smokers be responsible

137 137 for deciding and carrying out actions for quitting. Counselors aim at motivating smokers and supporting their sense of self-efficacy. To conclude, motivational interviewing involves evocation but not education, exploration but not explanation, autonomy instead of authority and collaboration instead of confrontation. Motivational interviewing makes use of the stage of change model because smokers at different levels of readiness to quit will need different counseling approach. There are five stages precontemplation, contemplation, preparation, action and maintenance. In the pre-contemplation stage (stage one), people are not considering seriously about quitting. Smokers in this stage may not feel smoking is a problem. They may defend against others efforts and pressure in pushing them to quit. In the contemplation stage (stage two), smokers are aware of the consequences of smoking and are considering the possibility of quitting, but they are ambivalent about quitting. They are weighing the pros and cons of quitting. Even they know the negative aspects of quitting but they are concerning the negative effects associated with quitting. When comparing to the precontemplation, smokers in this stage are more willing to gain knowledge about smoking cessation, use related interventions and expressing their own feelings and concerns about smoking.

138 138 In the preparation stage (stage three), smokers have made an agreement to quit. Somers in this stage will try to search strategies and resources available to assisting them to quitting. In the action stage (stage four), smokers are actively involved in quitting by utilizing various smoking cessation interventions. Smokers in this stage will develop their plans to quitting and may have some ideas to deal with internal and external barriers during quitting. They are more likely to open up themselves to receive help and seek support from others. In the Maintenance stage (stage five), maintaining abstinence is the goal. Clients in this stage will continuously reformulate the skills they acquire during the quitting process to avoid relapse. They will prepare coping strategies for incidence leading to relapse. Although they may think of smoking again, they resist the temptation and remain abstinence.

139 139 APPENDIX 23 (McEwen, 2006) Use of nicotine gum, patches and inhalers 1. Nicotine gum For nicotine gum, nicotine is absorbed through the buccal mucosa and the serum nicotine levels will reach the peak in minutes. Nicotine gum can provide oral satisfaction and is preferable for smokers with irregular smoking pattern. There are two concentrations of nicotine gum that is the 2 mg and 4 mg gum. 4 mg gum is suitable for smokers who smoke more than 20 cigarettes per day and consume the first cigarette within 20 minute awake. 2 mg gum is suitable for smokers who smoke less than 20 cigarettes per day pieces nicotine gum per day is recommended for initial usage with no more than 24 pieces per day. Duration of treatment varied among smokers, but gradual reduction of dosage is recommended. The optimal duration of usage is 12 weeks with no more than 1 year. Instruction of using nicotine gum (the bite-park chewing method): Step 1 Step 2 Step 3 Place the gum in your mouth and slowly chew it 10 to 15 times until you feel a tingling sensation. Stop chewing and park the gum between your check and gums until the tingling sensation gone. Repeat this cycle until the tingling subsides. Usually each gum can last for 30 minutes.

140 140 Tips for using nicotine gum: 1 Avoid acidic drink e.g. juice, coffee, soft drink 15 minutes before and usage of nicotine gum. 2 Nicotine gum should place in different area of month. 3 Be careful when using dentures.

141 Nicotine patches For nicotine patches, nicotine is delivered through the skin and absorbed through the transdermal delivery system. Nicotine patch is preferable for smokers with regular smoking pattern or low behavioral dependence. The serum nicotine levels will reach the peak in 6-8 hours. There are three strengths of nicotine patches which are the largest, moderate and the lowest strengths. The largest strength and moderate strengths are used for initial treatment; the lowest strength is used for tapering only. There are two types of nicotine patches 16 hour patch and 24 hour patch. 16 hour patch is preferable for regular smokers with no cigarette consumption when asleep. 24 hour patch is preferable for smokers who will get up at night for smoking or have strong craving for smoking on waking.16 hour patch cause less sleep disturbance than 24 hour patch. Dosage of nicotine patches: Smokers with daily cigarettes consumption < 20 Smokers with daily cigarettes consumption 20 Initially, smokers use the 14mg or 10mg for 4-6 weeks. Then, smokers may use the 7mg or 5mg for 2-4 weeks. Initially, smokers may use the 21mg or 15mg for 4 weeks. Then, smokers may use the 14mg or 10mg for 2 weeks. Finally, smokers may use the 7mg or 5mg for 2 weeks.

142 142 Instruction of using nicotine patches: 16 hour patch (strengths: 15mg, 10mg, 5mg) 24 hour patch (strengths: 21mg, 14mg, 7mg) Attach the patch all the times except sleeping hour. Remove the patch before going to sleep. Reapply a new patch in the morning Attach the patch all the times. Change patch at regular daily. Tips for using nicotine patches: 1. Do not touch the adhesive side of the patch during application. 2. Apply to clean dry and non-hairy sites such as chest, upper arms, back and hip. 3. Avoid applying patch to inflamed or broken skin. 4. Avoid applying cream, powder or medication over the same site of the patch. 5. Press the patch gently onto the chosen site for 10 seconds. 6. Wash hands after apply the patch to avoid contamination of eyes. 7. Fold the patch in half with the sticky side together before disposing the patch. 8. Keep patches out of reach of children. 9. Apply a new one when the patch drops off.

143 Nicotine inhaler For nicotine inhaler, the vaporized nicotine is drawn into the upper respiratory tract and absorbed through the buccal mucosa. Nicotine inhaler is preferable for smokers with daily cigarettes consumption less than 20 and highly behavioral-dependent. Nicotine inhaler contains a plastic housing with mouthpiece to hold the disposable porous cartridge. Each cartridge contains 10mg nicotine and only 4mg nicotine is actually delivered. Dosage of nicotine inhaler: Daily cigarettes consumption Recommended cartridges per day Instruction of using nicotine inhaler: Step 1 Separate the two section of the inhaler. Step 2 Put the cartridge inside the inhaler. Step 3 Suck the mouth piece. Step 4 Breathe gently to draw air into the month and hold the air for a few seconds before breathing out. Inhale to back of the throat Usually 4 puffs/minute Each cartridge last 20 minutes

144 144 Smokers are recommended to use 6-12 cartridges per day for the first 2-3 months and taper to 1 to 2 cartridges per day. Using nicotine inhaler for more than 6 months is not recommended. Tips for using nicotine inhaler: 1. Shallow puffing and deep inhalation make no difference. 2. Nicotine inhaler works best in room temperature. 3. Drink more water to reduce the slight sore throat or dryness in month and throat in the first few days of usage. 4 Avoid acidic drink. 5. Avoid acidic drink e.g. juice, coffee, soft drink 15 minutes before and usage of nicotine gum. 6. Open cartridges should be used within 12 hours. 7. Cartridges should keep out of reach of children. According to the Food and Drug Administration (FDA) guidelines, NRT smokers should seek physicians before using NRT advice in the following conditions: Stop using NRT and call the health care professionals if you experience nausea, dizziness, weakness, vomiting, fast or irregular heartbeat, mouth problems with the gum, redness or swelling of the skin around the patch. Avoid using other products containing nicotine while using NRT. Women who are pregnant or breast-feeding should get approval from their health care professionals before using NRT. Smokers with diabetes, heart disease, asthma, stomach ulcers, a recent heart attack, high blood pressure, history of irregular heartbeat should seek advice from their health care professionals before using NRT.

145 Inform your health care professionals if you taking medication for depression or asthma because your prescription dose may need to be modified.

146 146 APPENDIX 24 (Dodgen, 2005) Fagerstrom Test of Nicotine Dependence 1. How soon after you wake up do you smoke your first cigarette? After 60 minutes minutes minutes 2 Within 5 minutes 3 2. Do you find it difficult to refrain from smoking in places where it is forbidden? No 0 Yes 1 3. Which cigarette would you hate most to give up? The first in the morning 1 Any other 0 4. How many cigarettes per day do you smoke? 10 or less or more 3 5. Do you smoke more frequently during the first hours after awakening than during the rest of the day? No 0 Yes 1 6. Do you smoke even if you are so ill that you are in bed most of the day? No 0 Yes 1

147 147 APPENDIX 25

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149 149

150 150