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. 2017 Oct 4;2017(10):CD003942. doi: 10.1002/14651858.CD003942.pub3

Roberts 2001.

Study characteristics
Methods Cluster‐RT
Study duration: 12 months
Participants 3230 participants
Setting: nursing homes
Diagnostic criteria: none provided
Age: participant characteristics not provided in terms of mean age, just percent of sample in intervention and control groups that were in particular age ranges
Sex: participant characteristics not provided
Country: Australia
Comorbidity: not provided
Ethnicity: participant characteristics not provided
Date of study: unknown although paper was initially received for publication in May 2000
Interventions 1 intervention group
The 12‐month intervention involved 3 phases: introducing a new professional role to stakeholders with relationship building, nurse education, and medication review by pharmacists who had a postgraduate diploma in clinical pharmacy.
The clinical pharmacy service model introduced to each nursing home was supported with activities such as focus groups facilitated by a research nurse, written and telephone communication, and face‐to‐face professional contact between nursing home staff and clinical pharmacists on issues such as drug policy and specific resident problems, together with education and medication review. This was a multifaceted intervention directly targeting nursing homes. Most of the contact with GPs was indirect using the existing relationships between nursing homes and visiting GPs. A number of focus groups and personal interviews about the project were conducted with GPs.
Control nursing homes continued with usual care.
Outcomes Mortality was collected at the end of the 12‐month study.
Notes No significant changes were observed in annual mortality rates or frequency of hospitalisations between intervention and control nursing home groups.
It is unclear from Table 5, which shows the mortality and hospitalisation data, how the study authors arrived at their figures or their conclusions. Therefore, we were unable to use the data to calculate hospitalisations.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Nursing homes were selected for the intervention treatment by random draws from a hat.
Allocation concealment (selection bias) Low risk Not clear if this was done although the homes were independently assigned to the control or intervention groups. However, according to the EPOC criteria, the risk of bias for this study is low because units, in this case nursing homes, were assigned rather than individuals.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Unclear, although with the objective outcomes that we are interested in this is less of a concern (according to EPOC risk of bias criteria).
Incomplete outcome data (attrition bias)
All outcomes Low risk Control and intervention groups did not appear to differ in terms of attrition.
Blinding of outcome assessment (detection bias)
All outcomes Low risk This is less important for our purpose as we are looking at objective outcomes (hospitalisations, ED visits, and mortality).
Selective reporting (reporting bias) Low risk No evidence of this
Protection against contamination bias Low risk There is indication to suggest that the intervention was contaminated by the control group.
Other bias Unclear risk The limited duration of the study and size of the sample may have compromised the ability to detect an effect. We considered other bias due to cluster randomisation.