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

Risk of bias for analysis 2.5 Walking performance 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 2.5.1 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. High risk of bias The timed up and go (TUG) (when accounting for mortality) was available for 74% and 49% of participants in intervention and control groups at hospital discharge respectively. The difference in missing data for the TUG acompared to the activity of daily living data may be due to participants being unable to complete the walking tasks. Therefore a large proportion of missing data is thought to be due to the 'true' value. High risk of bias The use of the TUG to measure walking performance is considered appropriate and there was no differences in measurement 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. Low risk of bias 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 2.5.2 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 use of the timed up and go (TUG) 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.
Killey 2006 High risk of bias Allocation not random and sequence predictable as based on alternation. There is limited data on participant characteristics, but available data suggests balanced characteristics between groups. High risk of bias Participants and those delivering the interventions were aware of intervention allocations. There was no evidence of deviations from the intended interventions. Per‐protocol analysis appears to have been used. 2 participants in the intervention group were excluded from analysis as they completed less than 70% of their walks. The 2 participants that were excluded accounted for 7% of the remaining sample, it is therefore considered that there was potential for a significant impact on the results. Some concerns Only 71% of intervention and 74% of control group had outcome data. A significant proportion of missing data was related to early discharge from hospital. These participants could be expected to have a higher functional level than those who remained in hospital. However, the missing data was well‐balanced between the two groups. High risk of bias The total distance able to walk 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 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 in three domains for this outcome.
Subgroup 2.5.3 Progressive resistance exercise
de Morton 2007 Low risk of bias Allocation of wards was random (coin toss) and the allocating officer unaware of study. Baseline differences between groups were thought to be compatible with chance. Low risk of bias Participants and clinicians delivering care were believed to be aware of treatment assignments. There was no evidence of deviations from intended interventions and intention to treat analysis was used. High risk of bias After accounting for mortality, at discharge, only 70% in intervention arm and 60% in control arm had timed up and go (TUG) assessed. There is a higher amount of missing data for the TUG than the Barthel Index which may indicate that some of the missing data is due to participants being unable to complete the TUG task. Therefore a proportion of missing data is believed to be due to the 'true' value. High risk of bias The use of the TUG to measure walking performance is considered appropriate, and there were no differences in the measurement or ascertainment between groups. The assessors were not blinded, and it is considered likely that knowledge of the intervention could influence the outcome, given the likely strong belief in the benefits of the intervention. 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 in measurement of the outcome and missing data.
Jones 2006 Low risk of bias Allocation sequence was random (computer generated random numbers). Sequence allocation was not concealed, but performed by a member of staff independent of the enrolment procedures. ). Participant characteristics were balanced between groups and differences compatible with chance. Low risk of bias It is assumed that 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. High risk of bias After accounting for mortality, timed up and go (TUG) data was available for 31% of control group and 51% of intervention group. "39.4% (63/160) were unable to complete the TUG either on admission or on discharge and therefore a change score could not be calculated." Therefore, a large proportion of missing data is due to the 'true' value. Low risk of bias The use of the TUG to measure walking performance 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.
Pedersen 2019 Low risk of bias Allocation sequence was random (computer‐generated block randomisation), and allocation sequence concealed from the investigators. Participant characteristics were well‐balanced between groups. Low risk of bias Participants and clinicians were aware of the treatment assignments. There was no evidence of deviations from the assigned interventions and an intention to treat approach was used for analysis. High risk of bias When accounting for mortality only 93% of participants in intervention group and 67% in control group completed measures at discharge. The difference in the proportion of missing data, and that the assessments were carried out home after discharge, it was judged likely that the reasons for missing data may have depended on its true value. Low risk of bias The use of the 4m timed walk for measuring gait speed/walking performance is considered appropriate, and there were no differences in the measurement or ascertainment between groups. The assessors were blinded. Low risk of bias The analysis is in accordance with a pre‐specified analysis in a published protocol, and results are not thought to be 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.