Wilson 2008.
Methods |
Design Randomised controlled trial Setting Outpatients |
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Participants |
Inclusion criteria People were included in the study if they were self reported cigarette smokers attending the RRC with a diagnosis of COPD (NICE guidelines). Exclusion criteria People were excluded if they had any alcohol/drug‐related problems, contraindications to nicotine replacement therapy, or they stated they had no intention of stopping smoking. Number randomised Total 91, individual support (IS) 27, group support (GS) 29, usual care (UC) 35 Number followed up Total 68 Age mean (SD): IS 61.0 (8), GS 60.4 (9), UC 61.4 (8) Sex n (%) male: IS 14 (52), GS 9 (41), UC 18 (51) Cigarettes/day mean (SD): IS 20.8 (11), GS 20.1 (11), UC 17.5 (7) FTND mean (SD): not reported Severity COPD (FEV1/FVC not reported) FEV1, mean (SD): IS 52.1 (20), GS 54.6 (23), UC 54.3 (20) |
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Interventions |
Behavioural treatment A. Individual support Individual counselling by chest clinic sister or respiratory nurses, or both (5 weekly session x 60 min). Stage‐matched interventions. Discussing attitudes, subjective norms, self efficacy, former quit attempts and relapse plus CO measurement. B. Group support Group counselling by chest clinic sister or respiratory nurses, or both (5 weekly session x 60 min). Stage‐matched interventions. Discussing attitudes, subjective norms, self efficacy, former quit attempts and relapse plus CO measurement. C. Usual care Brief advice by doctor (1 x 5 to 10 min) included: assessing participant's interest in stopping smoking based on stages of change; advising on personal benefits of cessation and NRT; encouragement to set a stop date and enlist the support of family and friends. Pharmacological treatment A. Individual support 12‐week course of NRT (patches) for participants wanting to stop smoking (for free). Each NRT patch administered 16 h of nicotine (8 weeks 15 mg, 2 weeks 10 mg, and 2 weeks 5 mg). B. Group support 12‐week course of NRT (patches) for participants wanting to stop smoking (for free). Each NRT patch administered 16 h of nicotine (8 weeks 15 mg, 2 weeks 10 mg, and 2 weeks 5 mg). C. Usual care Advice to use NRT |
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Outcomes |
Abstinence Prolonged and point prevalence abstinence at 6, 9, and 12 months' follow‐up Validation Exhaled CO ≤ 10, salivary cotinine ≤ 10 ng/mL |
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Notes |
Funding Smith & Nephew Foundation and Pharmacia Conflicts of interest Not reported Correspondence Additional information received after correspondence |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Subjects included in the study were allocated to one of three treatment groups by a computer‐generated list of random numbers." (Additional information from author) |
Allocation concealment (selection bias) | Low risk | The randomisation numbers were sealed in an opaque, consecutively numbered envelope, therefore all individuals involved in the study were blind to the randomisation sequence. The sealed envelopes were kept in a secure place by the researcher |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It is not possible to blind for behavioural treatment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The researcher and participants were not blinded for self reported smoking status and exhaled CO measurement. The participant, researcher, and laboratory staff were blinded until after completion of the study for salivary cotinine measurement. (Additional information from author) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Low follow‐up rates (< 80%) and differential attrition |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. (Additional information from author) |
Other bias | High risk | Participants' adherence to the intervention protocol was poor. "Attendance to the nursing interventions was poor in both groups (Fig. 2). Only 10 participants (37%) in the IS group and 7 participants (24%) in the GS group attended at least 3 weeks of the 5‐week intervention." "Only 16 (59%) participants in the IS group and 12 (41%) participants in the GS group used the free NRT patches offered." Personnel's adherence is not reported. (Additional information from author) |
ACCP‐ATS: American College of Chest Physicians ‐ American Thoracic Society; ATC: Anatomical Therapeutic Chemical classification; CB: chronic bronchitis; CCO: corrected carbon monoxide; CN: counselling and NRT; CNB: counselling, NRT, and bupropion; CO: carbon monoxide; co1: control group 1; co2: control group 2; COHb: carboxyhaemoglobin; COPD: chronic obstructive pulmonary disease; CSR: cigarette self report; ERS: European Respiratory Society; exp: experimental group; FC: face‐to‐face counselling; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; FTND: Fagerström Test for Nicotine Dependence; GOLD: Global Initiative for Chronic Obstructive Lung Disease; GP: general practitioner; GS: group support; ICPC: International Classification of Primary Care; IS: individual support; L‐MIS: minimal intervention strategy for lung patients; MIS: minimal intervention strategy; NHS: nicotine high support; NICE: National Institute for Health and Care Excellence; NLS: nicotine low support; NP: nicotine patch; NRT: nicotine replacement therapy; PHS: placebo high support; PLS: placebo low support; ppm: parts per million; RRC: Regional Respiratory Centre;
SC: smoking cessation group; SD: standard deviation; SI‐A: smoking intervention plus active bronchodilator inhaler; SI‐B: smoking intervention plus placebo inhaler; SL: smoker's lung; SR: sustained release; SST: smoke‐stop‐therapy; TQD: target quit date; UC: usual care.