Ramos 2010.
Study characteristics | ||
Methods | Design: 3‐group randomized controlled trial Setting; A primary healthcare setting in Mallorca, Spain Recruitment: Patients who met inclusion criteria were invited to participate |
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Participants | 287 adults who smoked, who are preparing to quit. (81 in individual intervention, 111 in group intervention, 95 control), av. age 44, av. cpd 20 | |
Interventions |
Intervention 1: As control (below), plus individual counseling on pharmacological treatment • Participants attended 6 visits during which the following were provided: counseling, pharmacotherapy, psychological support and standard follow‐up • Physicians and nurses received training on how to implement intensive interventions Intervention 2: As control below, plus group counseling on pharmacological treatment • Participants attended 6 visits during which the following were provided: counseling, pharmacotherapy, psychological support and standard follow‐up • Physicians and nurses received training on how to implement intensive interventions Control: • Participants received pharmacotherapy (nicotine derivatives or bupropion) • Physician and nurse received basic training on how to diagnose smoking addiction and provide brief counseling • Support provided by microteam, composed of 1 physician and 1 nurse |
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Outcomes | Continuous abstinence at 12m Validation: Expired CO < 6 ppm |
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Funding Source | Health Research Fund of Spain's Ministry of Health and Consumer Affairs, Health Promotion and Preventive Activities in Primary Health Care Research Network | |
Author's declarations of interest | Authors declared that they had no competing interest | |
Notes | Strategy: Adjunctive counseling + Provider training Level: Patient + Provider Comparison type: Multicomponent vs. standard care |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Sequence Generation | Unclear risk | No details reported. |
Allocation concealment | Low risk | QUOTE: "an allocation concealment method based on the use of sequentially‐numbered, opaque, sealed envelopes was used" |
Blinding of outcome assessors All outcomes | Low risk | Smoking status biochemically validated. |
Incomplete outcome data All outcomes | High risk | Follow‐up at 12 months was very low and completed in 31% of cases in intervention 1 (individual), 28% in the intervention 2 (group) and 24% in the control group (minimal intervention). |