Lambe 1986.
Methods | Site: USA, Family Medicine Center (FMC); patient population was representative of cross‐section of Monroe Country, New York. Study period: not stated. Recruitment: patients attending FMC for scheduled health care screened for eligibility. Sample size calculation: 180 participants needed for 90% power. Assumed effectiveness of advice alone 5%, hypnosis 20% effective; allowed for 10% dropout ; one‐tailed alpha error of 0.05. | |
Participants | Number of participants: 180 smokers (90 in each group). Inclusion criteria: wish to quit smoking and willing to undergo hypnosis. Exclusion criteria: aged < 18 years; psychiatric diagnosis. Overall demographics: mean age approximately 35 years; majority female; mean CPD approximately 26. | |
Interventions | a) Hypnosis (2 x 40min sessions (probably individual), 2 weeks apart. Instructions for autohypnosis; for those who accepted hypnosis treatment only). b) Cessation advice control (letter from physicians advising quitting, copy of 'Calling It Quits' booklet). All subjects received 3 telephone calls in first 4 months to offer encouragement and ascertain smoking behaviour. Duration of intervention: 4 months. Duration of follow‐up: 12 months. | |
Outcomes | Definition of smoking cessation: point‐prevalence abstinence at 6 and 12 months. Adverse events: no information provided on whether or not AE data were collected and whether any AEs occurred. | |
Notes | Funding: not stated. Author declaration of interest: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, method not stated, but Zelen design (18 subjects declined hypnosis but analysed in hypnosis group) |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded, self‐report only |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Lost to follow‐up: at 6 months: a) 24; b) 26: At 12 months: a) 30; b) 30. Only patients who could be contacted at each follow‐up period included in the original analysis. About the same number of patients lost to follow‐up across groups at 6 and 12 month follow‐up. Numbers of quitters derived from percentages, corrected for dropouts. Recalculations included all participants following ITT protocol; missing assumed smoking. |
Selective reporting (reporting bias) | Low risk | All outcomes reported as described in the methods section. |
Other bias | Unclear risk | Baseline imbalances may have favoured intervention group but analyses did not investigate this. Patients in hypnosis group tended to be younger, more educated, less likely to have Medicaid. |