Edwardson 2018.
Methods |
Study design: cluster‐randomised controlled trial Study duration: 12 months Dropout: 25% at 12 months (all participants) Location: UK Recruitment: team managers and staff from 3 hospitals across Leiscester, as part of the University Hospitals of Leicester NHS Trust, were approached to participate in the study. Recruitment also took place through intranet online advertisements, e‐newsletters, and posters |
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Participants |
Population: office workers as self‐reported and later confirmed by site visit Intervention group: 19 clusters with 77 participants (whole group), 12 to 50 with baseline pain Control group: 18 clusters with 69 participants (whole group), 14 to 44 with baseline pain Included criteria: 18 to 70 years of age, office‐based, spent ≥ 75% of the workday sitting, worked 0.6 full‐time equivalent, worked at the same desk for at least 3 days/week, capable of standing Excluded criteria: not reported Baseline characteristics: for the whole group, baseline characteristics were similar between intervention and control groups, except for ethnicity. Physical activity, sitting, and standing were similar between groups. Baseline characteristics for participants with baseline pain not available |
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Interventions |
Intervention
Control
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Outcomes |
Outcome name, measurement tool, body region
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Identification | ||
Notes | Sponsorship source: nil relevant | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation | Unclear risk | Quote: "using computer generated lists, a statistician randomised office groups (clusters) 1:1 to either intervention or control group stratified by cluster size (≤4 and >4 participants) with a block size of six. Randomisation was performed in batches after participant clusters had completed their baseline measures" Judgement comment: randomisation at the office group level was carried out by a statistician using computer‐generated lists. Although the overall randomisation procedure was low risk, as only a select group of participants with baseline pain were included in the review, randomisation was compromised |
Allocation concealment | Unclear risk | Judgement comment: it is not stated whether allocation was concealed |
Blinding of participants and personnel | High risk | Quote: "randomisation occurred at the office group level to reduce the risk of contamination" Quote: "the team leads could not be blinded as they were responsible for study coordination, including delivery of the desks and intervention components. Team leads had no involvement in data processing and analysis" Judgement comment: participants and/or researchers were not blinded. Although attempts were made to physically separate clusters within the workplace, it is unlikely that participants would not be aware of their allocation. It would not be possible to blind research personnel due to the nature of the intervention |
Blinding of outcome assessment | Unclear risk | Quote: "team members who took measurements were blinded to group randomisation" Judgement comment: team leads were not not involved with data processing or analysis, and it is stated that team members who took measurements were blinded to group allocation but is not stated whether there was blinding of outcome assessors for all outcome measures. In addition, in this study, musculoskeletal outcomes were a secondary outcome, so it unclear whether the fact that participants were not blinded to the intervention would contribute to bias in self‐reporting of musculoskeletal outcomes |
Incomplete outcome data | Unclear risk | Judgement comment: for the whole cohort ‐ at 3‐month follow‐up, 52/69 in the control group were lost to follow‐up and 69/77 in the intervention group; at 6‐month follow‐up, 50/69 in the control group were lost to follow‐up and 65/77 in the intervention group; and at 12‐month follow‐up, 46/69 in the control group were lost to follow‐up and 63/77 in the intervention group. Attrition was greater in the control group (33%) than in the intervention group (17%). Attrition details were not provided for participants with baseline pain |
Selective reporting | Low risk | Judgement comment: all outcomes reported were reported at trial registration, and no outcomes in the trial registration were omitted |
Baseline imbalance | Unclear risk | Judgement comment: some differences in baseline symptoms were noted for some body regions (e.g. neck, shoulder) |