Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial.

AIM: To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Maori or whanau (extended-family) of Maori, given the high smoking prevalence in this population. DESIGN: Pragmatic, open-label, randomized, community-based non-inferiority trial. SETTING: Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand. PARTICIPANTS: Adult daily smokers who identified as Maori or whanau of Maori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi-media advertising. INTERVENTIONS: A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low-intensity cessation behavioural support from the prescribing doctor and community stop-smoking services or a research assistant. Day 5 of treatment was the designated quit date. MEASUREMENTS: The primary outcome was carbon monoxide-verified continuous abstinence at 6 months, analysed as intention-to-treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post-quit date included: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. FINDINGS: Verified continuous abstinence rates at 6 months post-quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = -0.22 to 8.79; relative risk 1.55; 95% CI = 0.97-2.46]. Sensitivity analyses confirmed that the findings were robust. Self-reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49-0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping. CONCLUSION: A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Maori or whanau (extended-family) of Maori, with significantly fewer adverse events.

Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial.

BACKGROUND: Combination nicotine replacement therapy shows additive cessation benefits. We aimed to find out the effectiveness of combining nicotine patches with an e-cigarette (with and without nicotine) on six-month smoking abstinence. METHODS: We did a pragmatic, three-arm, parallel-group trial in New Zealand in adult smokers who were e-cigarette naive and motivated to quit smoking. Participants were recruited from the general population using national media advertising. Participants were randomly assigned (1:4:4), with the use of stratified block randomisation, to receive 14 weeks (2 weeks before the agreed quit date) of 21 mg, 24h nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette. We advised participants to use one patch daily, with e-cigarette use as and when necessary or desired. Participants and researchers were masked to e-liquid nicotine content. We offered 6 weeks of telephone-delivered behavioural support. The primary outcome was exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months after the agreed quit date. Primary analysis was by intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis. This paper presents the main analyses and is registered with ClinicalTrials.gov, NCT02521662. FINDINGS: Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette group, n=499). 62 (50%) of 125 participants in the patches only group withdrew or were lost to follow-up by 6 months compared with 161 (32%) of 500 in the patches plus nicotine e-cigarette group and 162 (33%) of 499 in the patches plus nicotine-free e-cigarette group. 35 (7%) participants in the patches plus nicotine e-cigarette group had CO-verified continuous abstinence at 6 months compared with 20 (4%) in the patches plus nicotine-free e-cigarette group (risk difference [RD] 2·99 [95% CI 0·17-5·81]), and three (2%) people in the patches only group (RD 4·60 [1·11-8·09]). 18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group. In the patches plus nicotine e-cigarette group, two life-threatening serious adverse events were reported (two separate heart attacks in the one participant). In the patches plus nicotine-free e-cigarette group, one death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack). No significant between-group differences were noted for serious adverse events, and none were treatment-related. INTERPRETATION: Combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette, can lead to a modest improvement in smoking cessation over and above that obtained from using patches plus a nicotine-free e-cigarette (or patches alone), with no indication of any serious harm in the short-term. Future e-cigarette trials should focus on their use alone or in combination with usual smoking cessation support, given issues with differential loss to follow-up and withdrawal if a usual care group is used as a comparator. FUNDING: Health Research Council of New Zealand.

Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

INTRODUCTION: Evidence indicates e-cigarettes can help people quit smoking; however, more confirmatory trials are needed. To date, no trials have evaluated the effectiveness and safety of combining nicotine patches with e-cigarettes (with and without nicotine) for smoking cessation. METHODS AND ANALYSIS: This study is a pragmatic, three-arm, community-based, single-blind, randomised trial undertaken in New Zealand. Eligible participants are daily/non-daily smokers, aged ≥18 years, naive e-cigarette users and motivated to quit smoking in the next 2 weeks. Participants (n=1809), recruited using multi-media advertising, are randomised to 14 weeks of (1) 21 mg nicotine patches (n=201); (2) 21 mg nicotine patches+18 mg/mL nicotine e-cigarette (n=804); or (3) 21 mg nicotine patches+nicotine free e-cigarette (n=804). Participants receive weekly withdrawal-oriented behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically verified continuous abstinence (CA) at 6 months post quit-date. The primary comparison is nicotine patch + nicotine e-cigarette versus nicotine patch + nicotine free e-cigarette, and the secondary comparison is nicotine patch versus nicotine patch +nicotine e-cigarette (90% power, p=0.05, to detect an absolute difference in 6 month CA rates of 8% and 15% respectively). Secondary outcomes, collected by phone interview at quit date, then 1, 3, 6 and 12 months post-quit date, include self-reported CA, 7 day point prevalence abstinence, cigarettes per day (if smoking, or when smoking for non-daily smokers), time to relapse (if returned to smoking), belief in ability to quit, use of other cessation support, side effects/serious adverse events, treatment compliance, seeking additional support around e-cigarette use, daily use of both e-cigarettes and cigarettes, use of treatment past 14 weeks, views on treatment and recommendation to others, weight and cost-per-quitter. ETHICS AND DISSEMINATION: The Northern A Health and Disability Ethics Committee approved the trial. Findings will be disseminated through publication, conference/meeting presentations, and media. TRIAL REGISTRATION NUMBER: NCT02521662; Pre-results.

Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial.

BACKGROUND AND AIMS: Cytisine, a nicotinic acetylcholine receptor partial agonist (like varenicline) found in some plants, is a low-cost, effective smoking cessation medication that may appeal to Maori [the indigenous people of New Zealand (NZ)]. The RAUORA trial aims to determine the effectiveness, safety and cost-effectiveness of cytisine (Tabex® ) versus varenicline (Champix® ) for smoking cessation in Maori and the whanau (extended family) of Maori. DESIGN: Pragmatic, community-based, open-label randomized non-inferiority trial. SETTING: Lakes District Health Board region, NZ. PARTICIPANTS: Daily smokers (n = 2140) who self-identify as Maori or whanau of Maori, and are: aged ≥ 18 years, motivated to quit smoking in the next 2 weeks, eligible for subsidized varenicline, able to provide verbal consent and have daily access to a mobile phone/internet. Recruitment uses multi-media advertising. INTERVENTION AND COMPARATOR: Participants are randomized (1 : 1 ratio) to receive a prescription for 12 weeks of cytisine tablets [following the manufacturer's dosing regimen for 25 days, then one 1.5-mg tablet every 6 hours (two per day) until 12 weeks] or varenicline tablets (following the manufacturer's dosing regimen). Both groups receive brief stop-smoking advice from the prescribing doctor and withdrawal-orientated behavioural support via community-based stop-smoking counselling services (frequency, duration and mode of delivery tailored for participants) or a research assistant (six weekly 10-15-minute calls). Participants are advised to reduce their smoking over the first 4 days of treatment, with day 5 as their designated quit-date. MEASUREMENTS: The primary outcome is carbon monoxide-verified continuous abstinence at 6 months post-quit date. Secondary outcomes at 1, 3, 6 and 12 months post-quit date include: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance, treatment acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health-related quality of life. COMMENTS: This trial compares cytisine and varenicline when used by the indigenous people of NZ and their extended family for smoking cessation.

A co-designed mHealth programme to support healthy lifestyles in Maori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial.

BACKGROUND: The OL@-OR@ mobile health programme was co-designed with Maori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Maori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. METHODS: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Maori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. FINDINGS: Between Jan 24 and Aug 14, 2018, we enrolled 337 Maori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Maori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Maori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Maori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84-1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73-1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67-1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37-1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79-1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). INTERPRETATION: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Maori and Pasifika individuals. FUNDING: Healthier Lives He Oranga Hauora National Science Challenge.

A Co-Designed, Culturally-Tailored mHealth Tool to Support Healthy Lifestyles in Maori and Pasifika Communities in New Zealand: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: New Zealand urgently requires scalable, effective, behavior change programs to support healthy lifestyles that are tailored to the needs and lived contexts of Maori and Pasifika communities. OBJECTIVE: The primary objective of this study is to determine the effects of a co-designed, culturally tailored, lifestyle support mHealth tool (the OL@-OR@ mobile phone app and website) on key risk factors and behaviors associated with an increased risk of noncommunicable disease (diet, physical activity, smoking, and alcohol consumption) compared with a control condition. METHODS: A 12-week, community-based, two-arm, cluster-randomized controlled trial will be conducted across New Zealand from January to December 2018. Participants (target N=1280; 64 clusters: 32 Maori, 32 Pasifika; 32 clusters per arm; 20 participants per cluster) will be individuals aged ≥18 years who identify with either Maori or Pasifika ethnicity, live in New Zealand, are interested in improving their health and wellbeing or making lifestyle changes, and have regular access to a mobile phone, tablet, laptop, or computer and to the internet. Clusters will be identified by community coordinators and randomly assigned (1:1 ratio) to either the full OL@-OR@ tool or a control version of the app (data collection only plus a weekly notification), stratified by geographic location (Auckland or Waikato) for Pasifika clusters and by region (rural, urban, or provincial) for Maori clusters. All participants will provide self-reported data at baseline and at 4- and 12-weeks postrandomization. The primary outcome is adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score at 12 weeks that assesses smoking behavior, fruit and vegetable intake, alcohol intake, and physical activity. Secondary outcomes include self-reported body weight, holistic health and wellbeing status, medication use, and recorded engagement with the OL@-OR@ tool. RESULTS: Trial recruitment opened in January 2018 and will close in July 2018. Trial findings are expected to be available early in 2019. CONCLUSIONS: Currently, there are no scalable, evidence-based tools to support Maori or Pasifika individuals who want to improve their eating habits, lose weight, or be more active. This wait-list controlled, cluster-randomized trial will assess the effectiveness of a co-designed, culturally tailored mHealth tool in supporting healthy lifestyles. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Register ACTRN12617001484336; http://www.ANZCTR.org.au/ACTRN12617001484336.aspx (Archived by WebCite at http://www.webcitation.org/71DX9BsJb). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10789.

The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial.

BACKGROUND: Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions. METHODS: This is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups. DISCUSSION: People with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates. TRIAL REGISTRATION: Australian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

Smokers' identity and quit advice in general practice: General practitioners need to focus more on female smokers.

OBJECTIVE: We examined smoker and non-smoker self-identities among smokers visiting their general practitioner (GP) for other reasons than smoking cessation counselling. We determined whether identity impacted on patients' appreciation of GP-initiated conversations about smoking and quit advice, and subsequent quit attempts, and examined the role of gender. METHODS: Secondary analyses of a cluster-randomised controlled trial in which baseline and 12-month follow-up data were collected among 527 daily (n=450) and non-daily smokers (n=77). RESULTS: Participants identified more with smoking than non-smoking. Participants with stronger non-smoker self-identities were more often female, appreciated the conversation about smoking more, were more likely to receive quit-advice and to have attempted to quit at 12-month follow-up. Participants with stronger smoker self-identities were also more often female, and appreciated the conversation more. Men with stronger non-smoker self-identities were more often asked about smoking and advised to quit, and appreciated the conversation more than women. CONCLUSION: Non-smoker identity was more important for receiving quit-advice, appreciation, and quit attempts than smoker identity. Future research needs to unravel why female smokers appreciated the conversation less than male smokers. PRACTICE IMPLICATIONS: We suggest to incorporate an identity-component in smoking cessation interventions. GPs should increase their focus on female patients who smoke.

National guidelines for smoking cessation in primary care: a literature review and evidence analysis.

National guidelines for smoking cessation in primary care can be effective in improving clinical practice. This study assessed which parties are involved in the development of such guidelines worldwide, which national guidelines address primary care, what recommendations are made for primary care settings, and how these recommendations correlate with each other and with current evidence. We identified national guidelines using an online resource. Only the most recent version of a guideline was included. If an English version was not available, we requested a translation or summary of the recommendations from the authors. Two researchers independently extracted data on funding sources, development methodologies, involved parties, and recommendations made within the guidelines. These recommendations were categorised using the pile-sort method. Each recommendation was cross-checked with the latest evidence and was awarded an evidence-rating. We identified 43 guidelines from 39 countries and after exclusion, we analysed 26 guidelines (22 targeting general population, 4 targeted subpopulations). Twelve categories of recommendations for primary care were identified. There was almost universal agreement regarding the need to identify smokers, advice them to quit and offer behavioural and pharmacological quit smoking support. Discrepancies were greatest for specific recommendations regarding behavioural and pharmacological support, which are likely to be due to different interpretations of evidence and/or differences in contextual health environments. Based on these findings, we developed a universal checklist of guideline recommendations as a practice tool for primary care professionals and future guideline developers. SMOKING CESSATION SUPPORT IN PRIMARY CARE: UNIVERSAL GUIDELINES SOUGHT: An international team call for a universal guideline for primary-care practitioners who help patients to stop smoking. Although many nations have such guidelines, no studies have examined whether these guidelines are consistent with the current evidence. Marjolein Verbiest at the National Institute for Health Innovation, The University of Auckland, New Zealand, and co-workers of the International Primary Care Respiratory Group and the National Centre for Smoking Cessation and Training reviewed, evaluated and compared 26 national guidelines. Almost all guidelines place importance on identifying smokers, advising them to quit and providing behavioural and medication-based support. However, there were discrepancies in the support offered, which could be due to different interpretations of evidence, costs of medication and cultural differences. The authors offer a checklist for primary care that can inform future universal guidelines suitable for primary care.

Use of action planning to increase provision of smoking cessation care by general practitioners: role of plan specificity and enactment.

BACKGROUND: Strategies are needed to help general practitioners (GPs) promote smoking cessation as recommended by guidelines. This study examines whether the quality of action planning among GPs improves their provision of smoking cessation care. METHODS: The effectiveness of a 1-h training programme was examined in a cluster randomised controlled trial in which 49 GPs participated. GPs who followed the training (intervention group; n = 25) formulated action plans related to i) enquiring about smoking, ii) advising to quit smoking, and iii) arranging follow-up for smokers motivated to quit. GPs also formulated a coping plan for encountering smokers not motivated to quit. The quality of these plans (plan specificity) was rated and, 6 weeks after the training, GPs reported on the performance of these plans (plan enactment). Multilevel regression analyses were used to examine the effects of plan specificity and plan enactment on patient-reported smoking cessation activities of the GPs in the intervention group (n = 1,632 patients) compared with the control group (n = 1,769 patients). RESULTS: Compared to the control group, GPs who formulated a highly specific action plan during the training asked their patients about smoking more often after the training compared to prior to the training (OR 2.11, 95% CI 1.51-2.95). GPs were most likely to have asked patients about smoking after the training compared to prior to the training when they had enacted a highly specific formulated action plan (OR 3.08, 95% CI 2.04-4.64). The effects of GP plan specificity and plan enactment on asking patient about smoking were most prominent among GPs who, at baseline, intended to provide smoking cessation care. CONCLUSIONS: A highly specific action plan formulated by a GP on when, how, and by whom patients will be asked about smoking had a positive effect on GPs' asking patients about smoking, especially when these professionals also reported to have enacted this plan. This effect was most prominent among GPs who intended to provide smoking cessation care prior to the intervention. Training in devising personalised coping plans is recommended to further increase GPs' provision of advice to quit smoking and arranging follow-up support to quit smoking.

Sequence-analysis of video-recorded practitioner-patient communication about smoking in general practice: do smokers express negative statements about quitting?

OBJECTIVE: To examine the extent to which smokers express negative statements about quitting and the extent to which these statements influence general practitioners' (GPs') and practice nurses' (PNs') (dis)continuation of guideline-recommended smoking cessation care. METHODS: Fifty-two video-consultations were observed (GP-consultations: 2007-2008; PN-consultations: 2010-2011). Dialogues were transcribed verbatim and professionals' and patients' speech units were coded and analysed using sequential analyses (n=1424 speech units). RESULTS: GPs focused on asking about smoking (GPs: 42.4% versus PNs: 26.2%, p=0.011) and advising them to quit (GPs: 15.3% versus PNs: 3.5%, p<0.001), whereas PNs focused on assisting them with quitting (GPs: 25.4% versus PNs: 55.2%, p<0.001). Overall, patients expressed more negative statements about quitting than positive statements (negative: 25.3% versus positive: 11.9%, p<0.001), especially when PNs assessed their willingness to quit (OR 3.61, 95% CI 1.44-9.01) or assisted them with quitting (OR 2.23, 95% CI 1.43-3.48). PRACTICE IMPLICATIONS: An alternative approach to smoking cessation care is proposed in which GPs' tasks are limited to asking, advising, and arranging follow-up. This approach seems the least likely to evoke negative statements of patients about quitting during dialogues with GPs and is compatible with the tasks and skills of PNs who could, subsequently, assist smokers with quitting.

One-hour training for general practitioners in reducing the implementation gap of smoking cessation care: a cluster-randomized controlled trial.

INTRODUCTION: This study examined the effectiveness of low-intensity, practice-tailored training for general practitioners (GPs) aimed at personal and organizational barriers that arise when routinely asking patients' smoking status, advising to quit, and arranging follow-up. METHODS: A cluster-randomized controlled trial with 49 GPs and 3,401 patients (677 smokers). Two patient groups participated: 2,068 patients (433 smokers) at baseline and 1,333 patients (244 smokers) postintervention. At follow-up, 225 smokers of both groups participated. The primary outcome was GP smoking cessation counseling (asking about smoking status, advising to quit, prescribing pharmacotherapy, and referring for behavioral support). Secondary outcomes were GPs' attitudes toward smoking cessation care, patients' intention to quit, and long-term quit rates. Outcomes were measured with GP self-report and patient report. RESULTS: Patients of trained GPs reported more often being asked about smoking behavior compared with patients of untrained GPs (OR = 1.94, 95% CI = 1.45-2.60). According to GP self-report, the training increased the provision of quit-smoking advices (difference 0.56 advice per day; 95% CI = 0.13-0.98) and the ability and intention of providing smoking cessation care. We found no effect on GPs' arrangement of follow-up, smokers' intention to quit, and long-term quit rates. CONCLUSIONS: After 1 hour of training, we found significant differences between trained and untrained GPs on the frequency in which they asked about smoking (patient reported) and advised smokers to quit (GP self-reported). The training did not increase prescriptions of pharmacotherapy, referrals to behavioral support, or quit rates. Future training methods should focus on the GPs' ability, tools, and skills to arrange follow-up to ensure intensive smoking cessation support.

An increase in primary care prescriptions of stop-smoking medication as a result of health insurance coverage in the Netherlands: population based study.

AIMS: To examine the impact of two national tobacco control interventions in the past decade on (dispensed) prescriptions of stop-smoking medication. DESIGN: Ecological study with interrupted time-series analyses of quarterly data points of three nation-wide representative databases. SETTING: The Netherlands 2001-2012, with the introduction of the guideline for smoking cessation care for general practitioners (GP) in 2007 and full insurance coverage for smoking cessation treatment in 2011. PARTICIPANTS: GPs, pharmacists and people in the general population aged 15 years and older. MEASUREMENTS: Time-series plots were inspected visually and segmented regression analyses were performed to estimate the change in level and slope of (dispensed) prescriptions of stop-smoking medication and smoking prevalence in the years preceding and after the tobacco control interventions. FINDINGS: No measurable effects of the GP guideline on (dispensed) prescriptions were observed. Shortly after the start of health insurance coverage, an estimated increase in primary care prescriptions of 6.3 per 1000 smokers [95% confidence interval (CI) = 2.9-9.8; P = 0.001] and 17.3 dispensed items per 1000 smokers (95% CI = 12.5-22.0; P < 0.000) was accompanied by a sudden drop in smoking prevalence of 2.9% (95% CI = 4.6-1.1; P = 0.002) in the first quarter of 2011. Immediately after the coverage abolition, smoking prevalence increased by 1.2% (95% CI = 0.5-2.8; P = 0.156) and dispensed prescription rates decreased with 21.6 per 1000 smokers (95% CI = 26.0-17.2; P < 0.000). CONCLUSIONS: Full health insurance coverage for smoking cessation treatment in the Netherlands was accompanied by a significant increase in the number of (dispensed) prescriptions of stop-smoking medication and a decrease in smoking prevalence.

Training health professionals in smoking cessation.

BACKGROUND: Cigarette smoking is one of the leading causes of preventable death world wide. There is good evidence that brief interventions from health professionals can increase smoking cessation attempts. A number of trials have examined whether skills training for health professionals can lead them to have greater success in helping their patients who smoke. OBJECTIVES: To determine the effectiveness of training health care professionals in the delivery of smoking cessation interventions to their patients, and to assess the additional effects of training characteristics such as intervention content, delivery method and intensity. SEARCH METHODS: The Cochrane Tobacco Addiction Group's Specialised Register, electronic databases and the bibliographies of identified studies were searched and raw data was requested from study authors where needed. Searches were updated in March 2012. SELECTION CRITERIA: Randomized trials in which the intervention was training of health care professionals in smoking cessation. Trials were considered if they reported outcomes for patient smoking at least six months after the intervention. Process outcomes needed to be reported, however trials that reported effects only on process outcomes and not smoking behaviour were excluded. DATA COLLECTION AND ANALYSIS: Information relating to the characteristics of each included study for interventions, participants, outcomes and methods were extracted by two independent reviewers. Studies were combined in a meta-analysis where possible and reported in narrative synthesis in text and table. MAIN RESULTS: Of seventeen included studies, thirteen found no evidence of an effect for continuous smoking abstinence following the intervention. Meta-analysis of 14 studies for point prevalence of smoking produced a statistically and clinically significant effect in favour of the intervention (OR 1.36, 95% CI 1.20 to 1.55, p= 0.004). Meta-analysis of eight studies that reported continuous abstinence was also statistically significant (OR 1.60, 95% CI 1.26 to 2.03, p= 0.03).Healthcare professionals who had received training were more likely to perform tasks of smoking cessation than untrained controls, including: asking patients to set a quit date (p< 0.0001), make follow-up appointments (p< 0.00001), counselling of smokers (p< 0.00001), provision of self-help material (p< 0.0001) and prescription of a quit date (p< 0.00001). No evidence of an effect was observed for the provision of nicotine gum/replacement therapy. AUTHORS' CONCLUSIONS: Training health professionals to provide smoking cessation interventions had a measurable effect on the point prevalence of smoking, continuous abstinence and professional performance. The one exception was the provision of nicotine gum or replacement therapy, which did not differ between groups.