De Vries 1994 (Voc).
Methods | Country: Netherlands Site: 6 vocational and 8 high schools, Maastricht. Focus: Smoking prevention Design: Cluster RCT (Group 1: never smoking prevention cohort). | |
Participants | Baseline: (1986) approximately 1784 (inferred from attrition rate); Intervention = 343 vocational students and 585 high school students; Control = 217 vocational and 384 high school students.
Age: 2nd grade of secondary school.
Gender: Not stated. Ethnicity: No data Baseline smoking data: Nonsmokers total population: intervention N = 426 (48.4%), control N = 304 (50.7%); nonsmokers at vocational schools: intervention N = 113 (64.6%), control N = 83 (56.6%); nonsmokers at high schools: intervention N = 313 (42.5%), control N = 221 (48.4%). |
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Interventions | Category: Social influences vs control [school type (vocational vs high school)]. Programme deliverer: Peer leaders and teachers (received training and manuals). Intervention: 5 x 45 min lessons: 1) Introduction, reasons for smoking; 2) Short‐term effects of smoking; 3) Pressure from peers "dealt with resisting peer pressure, which was also modelled on video. Refusal skills were practiced in role‐plays"; 4) Adults and advertising; 5) Alternatives; and decision making. Students formed their own groups and chose their own peer leaders. Teachers co‐ordinated the lessons and assisted the peer leaders. Control: Not stated. |
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Outcomes | Self reported smoking: (1) Never smoked (not even one puff), (2) initial smoker, tried up to 5 times, (3) quitter (4) occasional smoker, but not every week, (5) weekly regular smoker: smokes at least 1 cigarette a week, (6) daily regular smoker, smokes at least 1 cigarette a day. Weekly and daily regular smokers were combined into a 'regular smokers' category. Questionnaires were confidential. Saliva was collected and CO levels correlated with smoking (r = 0.79 to 0.85). Follow‐up: 1 yr from pretest. |
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Notes | Quality of intervention delivery: No process analysis. 'Students, peer leaders and teachers had their own manuals, summarizing the activities and providing instructions' Statistical quality: Was a power computation performed? No Was an intention‐to‐treat analysis performed? Not stated Was a correction for clustering made? Not stated Were appropriate statistical methods used? Linear regression for quantitative effect measures and for binary effect measures; multi‐level analyses using VARCL. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The first author provided additional information that a table of random numbers was used for school assignment. Clusters: Schools Cluster constraint: Not stated Baseline comparability: Baseline 'regular smokers' : experimental 8.3%, control 7.4%; (vocational schools 16.2% and 15.1%; high schools 4.2 and 3.1%). No other data on baseline comparability. |
Allocation concealment (selection bias) | Unclear risk | No statement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "The respondents were informed that the results would be treated confidentially by the research team and that neither volunteers nor teachers had access to the data". [we assessed this as meaning that neither researchers nor participants were blinded as to intervention]. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 1 yr attrition was 14.3% and did not differ between the experimental and control groups. More pretest smokers (27%) dropped out than nonsmokers (13%; P < 0.001), but no differential attrition between groups. |
Selective reporting (reporting bias) | Low risk | No selective reporting |