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. 2022 Nov 10;2022(11):CD005955. doi: 10.1002/14651858.CD005955.pub3

Risk of bias for analysis 1.4 Quality of life at discharge from hospital.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Subgroup 1.4.1 Rehabilitation‐related activities
Ekerstad 2017 High risk of bias Randomisation was based on the availability of beds, and there was no allocation concealment as participants were allocated a ward prior to enrolment. Participant characteristics appeared balanced. Low risk of bias Participants and clinicians delivering care were aware of treatment assignments. There was no evidence of deviations from intended interventions and intention to treat analysis was used. Low risk of bias No missing data. High risk of bias The EQ‐VAS is considered appropriate, and there were no differences in the measurement or ascertainment between groups. The assessors were not blinded, and it was therefore considered likely that knowledge of the intervention could influence the outcome, given the likely strong belief in the benefits of the intervention ward. Some concerns A detailed pre‐specified statistical plan was not found, but it is not thought that the results were from multiple outcome measures or multiple analyses. High risk of bias The study is judged to be at high risk of bias due to bias in the measurement of the outcome and bias arising from the randomisation process.
Subgroup 1.4.2 Structured exercise
Hu 2020 Low risk of bias Allocation sequence was random (computer generated random numbers) and sequence concealed (blinded project coordinator allocated participants). Participant characteristics were balanced. Low risk of bias Participants and those delivering the interventions were aware of intervention allocations. There was no evidence of deviations from the intended interventions and as such it is presumed intention to treat analysis was used. High risk of bias At discharge data was available for 76% of reablement group, (78% of reminder group) and 80% of the control group. Only participants who had complete data (i.e. data collected at baseline, discharge and follow‐up) had outcomes reported. Although missing data is well‐balanced between all three groups, it is considered likely that reason for missing data is related to its true value. Low risk of bias The EQ5D is considered appropriate, and there were no differences in the measurement or ascertainment between groups. The assessors were blinded. Some concerns A pre‐specified statistical plan was not found, but it is not thought that the results were from multiple outcome measures or multiple analyses. High risk of bias The study is judged to be at high risk of bias due to missing outcome data.
Subgroup 1.4.3 Progressive resistance exercise
Martinez‐Velilla 2019 Low risk of bias Allocation sequence was random (www.randomizer.org) and personal communication with author confirms allocation concealment. Baseline differences between groups are thought to be compatible with chance. Low risk of bias Both participants and clinicians delivering care were aware of assigned interventions. There is no evidence of deviations from intended interventions and intention to treat analysis used. Some concerns Assuming that those that discontinued the study did not provide e EQ‐5D outcome data, and accounting for mortality, 83% of intervention group and 86% of control group had outcome data. Although there were participants who discontinued the study due to medical deterioration, which could have and is considered likely to have biased the results (i.e. medical deterioration being associated with poor functional outcomes), the numbers were relatively low (only 6% of the sample) and were well‐balanced between groups. We therefore feel that this was unlikely to bias the results. Low risk of bias The EQ‐5D is considered appropriate, and there were no differences in the measurement or ascertainment between groups. The assessors were blinded. Low risk of bias The trial protocol reflects the analyses as that were conducted, and it is not thought that the results were from multiple outcome measures or multiple analyses. Some concerns The study is judged to raise some concerns due to missing outcome data.
McCullagh 2020 Low risk of bias Allocation sequence was random (computer‐generated) and allocation sequence was concealed. Baseline differences are thought to be compatible with chance. Low risk of bias Both participants and clinicians delivering care were aware of assigned interventions. There is no evidence of deviations from intended interventions and intention to treat analysis used. Low risk of bias 90% of intervention group and 94% of the control group had outcome data. Given the nature of this population (older adults during and after acute hospitalisation) we considered a threshold of 90% of participants with data as sufficient. Low risk of bias The use of EQ‐5D5L to measure quality of life is considered appropriate, and there were no differences in the measurement or ascertainment between groups. The assessors were blinded. Low risk of bias The trial protocol reflects the analyses as that were conducted, and it is not thought that the results were from multiple outcome measures or multiple analyses. Low risk of bias The study is judged to be at low risk of bias for all domains for this outcome.