| 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 1.2.1 Rehabilitation‐related activities |
| Counsell 2000 |
Low risk of bias |
Allocation sequence was random (computer generated random numbers) and sequence concealed (opaque sealed envelope). Participant characteristics were balanced. |
Some concerns |
Participants and those delivering the interventions were aware of intervention assignments. Seventy‐nine participants were not admitted to the unit to which they were assigned. Deviations may have affected the effect estimate, however the were well‐balanced between groups. Intention to treat analysis was used. |
Low risk of bias |
Functional data was obtained in 1476 of 1483 of surviving patients (99.5%) at discharge. |
High risk of bias |
The Physical Performance and Mobility Examination (PPME) 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 due to measurement of the outcome. |
| Subgroup 1.2.2 Structured exercise |
| Gazineo 2021 |
Low risk of bias |
Allocation sequence was random (generated using an online system) and the allocation sequence was concealed until participants were enrolled (opaque concealed and sealed envelopes). Participant characteristics were well‐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 intention to treat analysis used. |
Low risk of bias |
No missing data after accounting for mortality. |
High risk of bias |
The Barden Activity Subscale to measure functional mobility 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 due to measurement of the outcome. |
| McGowan 2018a |
Low risk of bias |
Allocation sequence was random (www.randomization.com) and the allocation sequence was only known by the chief investigator who was not involved with screening patients. 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 not explicitly stated, but all participants appear to have been analysed in the group to which they were randomised. |
Low risk of bias |
96% of participants had complete data sets. |
High risk of bias |
The use of the Elderly Mobility Scale (EMS) to measure functional mobility 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. |
Low risk of bias |
The trial protocol and registration reflects the analyses as that were conducted, and it is not thought that the results were from multiple outcome measures or multiple analyses. |
High risk of bias |
The study is judged to raise some concerns due to the measurement of the outcome. |
| Subgroup 1.2.3 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. |
Some concerns |
After accounting for mortality, discharge Functional Ambulation Classification (FAC) scores were available for 75% in intervention group and 70% in control group. Although it is feasible that following discharge patients with lower levels of functional ability are more likely to be missing, we do not think this applies in this situation as assessment prior to discharge. We do not see a situation where it would be more likely to miss an assessment due to high/low level of disability at discharge. |
High risk of bias |
The use of the FAC to measure functional mobility 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. |
| 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 Short Physical Performance Battery (SPPB) 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 use of the SPPB to measure functional mobility 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 Short Physical Performance Battery (SPPB) 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 SPPB to measure functional mobility 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. |
| Ortiz‐Alonso 2020 |
High risk of bias |
The allocation sequence was based on recruitment blocks of 4‐8 weeks. Activity of daily living (ADL) scores at baseline and admission were significantly lower in the intervention group than the control group, this is thought to be an important prognostic factor and therefore a concern regarding the randomisation process. |
Low risk of bias |
Methods were designed to blind participants from group assignments however due to the nature of the intervention and lack of sham intervention the success of this blinding is felt unlikely. Ward staff and research staff were not blinded to the participant's assigned intervention. There were no deviations from the intended interventions due to trial context described and although intention to treat analysis not specified given the lack of deviations it is assumed. |
Low risk of bias |
After adjusting for mortality 97% in intervention group and 97% in control group had outcome data. |
High risk of bias |
The use of the Short Physical Performance Battery (SPPB) for measuring functional mobility 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. |
Low risk of bias |
Analysis reflects plan in trial registration and study 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 the randomisation process and measurement of the outcome. |
| 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 de Morton Mobility Index (DEMMI) 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 |
As per RoB2 algorithm, the study is judged to be at high risk of bias due to missing outcome data. |
