Byrne 2005.
Methods | Country: Australia Sites: Canberra high schools (intervention), high and secondary schools in Canberra and Adelaide (control). Focus: Smoking rates of participants Design: Cluster RCT (Group 1: never smoking prevention cohort, not included in analysis). |
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Participants | Baseline: 2719 (intervention), 6410 (control). Age: 11 ‐ 17 years (grades 7‐10). Gender: 48% M (intervention), 52% M (control). Ethnicity: Not stated. Baseline smoking data: Rates of smoking over previous 12m at outset. Health programme = 9.7%, fitness programme = 9.5%, social skills = 12.5%, control = 14.4%. |
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Interventions | Category: Social Influences vs information. Programme deliverer: Usual class teachers (all trained by research group) Intervention: 3 programmes aimed at knowledge acquisition and behaviour change. Each programme based on four class sessions which had a distinctive active learning approach:
Control: Non‐randomised, from a separate, older study. No stated intervention. |
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Outcomes | Smoking behaviour. Self reported Follow‐up: Immediately after intervention (intervention), end of one yr study (intervention and control). |
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Notes | Quality of intervention delivery: No comment on quality of delivered material, or how many of the sessions were completed, or how many sessions participants attended. Statistical quality: Was a power computation performed? "the design had sufficient statistical power to provide an adequate test of the effectiveness of interventions" (but no power computations presented). Was an intention‐to‐treat analysis performed? No. Was a correction for clustering made? No. Were appropriate statistical methods used? Χ² appropriate for categorical data. No correction for multiple comparisons. Analysis only on participants who completed all three data collection points in intervention group. Control group only two collections points – intake and 12m. Control group data from previous study and only limited. Can only analyse between interventions, not vs control. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Schools were selected to reflect socioeconomic diversity across the city". Classes within selected schools randomised to one of three intervention programmes. No method of randomisation stated. No controls within selected schools. Control group from previous study. Clusters: Schools Cluster constraint: Not stated. Baseline comparability: No significant differences in smoking rates at baseline between groups. Classes did not differ on gender and had representations in classes from all age groups in the school (intervention). |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | As classes were within the same school there was no mention of how the study dealt with interclass discussion and comparison of interventions. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Intervention group: 86.2% of the original group had completed data immediately after intervention (n = 2344). At end of one yr 62.3% completed follow up (n = 1694). No differential attrition analysis. Control group: 65.5% of the original cohort completed the 12m follow‐up (n = 4198). No explanation of low levels of response at 12m. |
Selective reporting (reporting bias) | Low risk | Only goal was reporting smoking outcomes. |