Kottke 1989.
Methods | Study design: RCT Unit of allocation: physicians Type of comparison: PEM only vs. nothing
Groups considered in review: A and B |
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Participants | Physicians Clinical speciality: general practice/family medicine Level of training: fully trained Setting/country: general practice/US |
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Interventions | The PEM studied in this report was a smoking cessation manual entitled 'Quit‐and‐Win' that could be used as an instructor's manual, as a self‐help guide, or as 1 part of a comprehensive intervention. The physicians were advised to give a copy to any patient who smoked. They were told that their supply of Quit‐and‐Win booklets would be replenished when required | |
Outcomes | 5 process outcomes:
5 patient outcomes:
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Notes | 2 separate PEM analysis for all 10 points:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote from correspondence with the author: "believe that we assigned the physicians using a computer random generator" |
Allocation concealment (selection bias) | Unclear risk | No information was provided |
Baseline characteristics similar (selection bias) | Low risk | TABLE 1 and quote, pg. 2103: "neither the mean age of the physicians, the size of the clinics nor the patient load…differed significantly among the three groups" COMMENT: even if professionals were well balanced, patients did not have all baseline characteristics similar |
Baseline outcome measurements similar (selection bias) | Unclear risk | Outcomes were not collected at baseline |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The proportion of patient‐smokers was similar between groups, and the percentage reached at 1 year for follow‐up was similar. Quote, pg. 2103: "patients who either could not be contacted or refused to be interviewed were assumed to be continuing to smoke and were assumed not to have made any cessation attempts" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | This is a self‐report assessment by patients who were not blinded |
Contamination protection (contamination bias) | Low risk | Quote, pg. 2102: "to prevent contamination from having physicians of the same practice in different trial groups, all physicians in the same practice were either moved to the most intense level of intervention to which any of them had been originally randomized or, if not yet randomized at the time this problem was discovered, added to the group to which their partner(s) had been randomized" |
Selective reporting (reporting bias) | Low risk | All relevant outcomes in the methods section were reported in the results section |
Other bias | High risk | COMMENT: the primary outcome measure was 102 question questionnaire for patients, making this outcome measure susceptible to LOW validity |