McColl 2003 ‐ Trial 1.
Study characteristics | ||
Methods | RCT, clusters randomised | |
Data | UK. Primary care setting. All host trial participants, as a source of the retention trial sample. Total n = 6576; mean age 59.6 (SD 13.7) years, 50.8% females; 66% were married; 60% were unemployed; 54.2% had no formal education qualifications. |
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Comparisons | Participants were randomised to two different versions of a self‐response questionnaire: Intervention group 1, condition‐specific measures of quality of life preceded generic instruments Intervention group 2, the relative position of the questionnaire was reversed. |
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Outcomes | Response rates on the questionnaire | |
Notes | Retention period: 9 months | |
Risk of bias | ||
Item | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear | Not described only that participants were randomly assigned to each group. |
Adequate sequence generation? | No | A random sample of 80 participants per condition per practice was selected. |
Blinding of participants and personnel? | Yes | Not reported in the paper but unblinding not likely to impact objective outcome |
Blinding of outcome assessment? | Yes | Not reported in the paper.However, objective outcome, staff have no plausible additional opportunity to influence postal response rate once questionnaires sent. |
Incomplete outcome data addressed? All outcomes | Unclear | Not reported in the paper. |
Free of selective outcome reporting? | Unclear | Not reported in the paper. |
Other sources of bias | Yes | No further concerns raised. |
Overall Risk of Bias | No | High |