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

Risk of bias for analysis 2.3 New institutionalisation at hospital discharge.

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 2.3.1 Rehabilitation‐related activities
Asplund 2000 Low risk of bias The method of allocation sequence is not described, but the use of sealed envelopes suggests a random component was used. Participant characteristics were balanced. Some concerns Participants and those delivering the interventions were aware of intervention assignments. Twenty‐five patients were excluded due to them not meeting the set eligibility criteria, however, these: protocol violations are not expected to influence the effect estimate of the outcome as per protocol analyses used. The per protocol analyses was not thought to have a substantial impact on the result given the main reason for exclusion was inappropriate recruitment. Excluding this 25, the other 6 exclusions represent approximately 1% of the total sample size. Low risk of bias Data at discharge from hospital complete for 98% of participants. Low risk of bias The measurement of new institutionalisation is considered appropriate, and there were no differences in measurement or ascertainment between groups. Assessors were not blinded, but is thought that due to the lack of judgement in scoring a 'hard outcome' like new institutionalisation, that it is unlikely that the knowledge of the intervention could influence the outcome. 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. Some concerns The study is judged to raise some concerns due to deviations from intended interventions and the selection of the reported results.
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 they were well‐balanced between groups. Intention to treat analysis was used. Low risk of bias No missing data. Low risk of bias The methods of measuring length of stay are considered appropriate, and there were no differences in measurement or ascertainment between groups. Assessors were not blinded, but is thought that due to the lack of judgement in scoring a 'hard outcome' like length of hospital stay, that it is unlikely that the knowledge of the intervention could influence the outcome. 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. Some concerns The study is judged to raise some concerns in the selection of the reported results and deviations from the intended interventions.
Fretwell 1990 Some concerns “Patients were randomised only when both a treatment and control bed were available”. Although not stated, we believe the necessity for available beds on both wards indicate that a random component was likely used. Sequence allocation concealment is not discussed, but no significant differences in patient characteristics other than those compatible with chance were observed. Some concerns Participants and those delivering the interventions were aware of intervention assignments. There were 30 randomisation errors which has been interpreted to mean 'allocated to the ward that they were not randomised to' however there is no explanation of this term. These deviations were thought likely to have affected the outcome, though were relative well‐balanced. It appears a per protocol analyses was used, though given the low number (7%) and relative balance between groups, the omission of the participants randomised incorrectly probably did not have substantial impact on the results. Low risk of bias All participants accounted for at discharge. Low risk of bias The methods of measuring new institutionalisation are considered appropriate, and there were no differences in measurement or ascertainment between groups. Assessors were not blinded, but is thought that due to the lack of judgement in scoring a 'hard outcome' like new institutionalisation, that it is unlikely that the knowledge of the intervention could influence the outcome. 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. Some concerns The study is judged to raise some concerns in deviations from the intended interventions, methods of randomisation and selection of the reported result.
Subgroup 2.3.2 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. Low risk of bias No missing data. Low risk of bias The measure of new institutionalisation considered appropriate, and there were no differences in measurement or ascertainment between groups. Assessors were not blinded, but is thought that due to the lack of judgement in scoring a 'hard outcome' like new institutionalisation, that it is unlikely that the knowledge of the intervention could influence the outcome. 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. Some concerns The study is judged to raise some concerns in the selection of the reported result.
Mudge 2008 High risk of bias Pseudo‐randomisation, allocation was based on admitting unit and bed availability, and admitting unit was determined by a rotating roster. No evidence of baseline differences in patient characteristics other than those 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 No missing data. Low risk of bias The method 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 the randomisation process.