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

Malone 2000.

Study characteristics
Methods A prospective, multisite RT
Duration of study: 12 months
Participants Of 1054 participants enrolled at the 9 Veterans Affairs clinics, 523 were randomised to the intervention and 531 to the control group. Of these, 950 participants completed 6‐month follow‐up questionnaires and 931 completed the study. Of participants completing the study, 447 were in the intervention group and 484 were in the control group.
Setting: Veterans Affairs clinics
Interventions: clinical input by pharmacists
Diagnostic criteria: participants were considered at high risk for drug‐related problems if they met ≥ 3 of the following criteria: were taking ≥ 5, were taking ≥ 12 doses/d, had ≥ 3 chronic medical conditions, had ≥ 4 changes in their drug regimen over the past year, had a history of noncompliance with drug therapy, or were taking an agent that required therapeutic drug monitoring.
Age: (years) mean ± SD: 67 ± 10.1
Sex n (%): intervention group 21 (0.04%), control, 20 (0.04%)
Country: USA
Comorbidity: hypertension, angina, hyperlipidaemia, arthritis, diabetes and COPD
Sociodemographics: not mentioned
Ethnicity: not mentioned
Interventions 1 intervention and 1 control
The intervention group was given a protocol to follow; the protocol indicated that each participant should have ≥ 3 visits with the clinical pharmacist during the study, but participants could be seen as frequently as deemed necessary to ensure appropriate care. Visits were to occur between or concurrent with appointments with the primary care provider or other physicians.
The control group followed the usual care with no specific protocol given to clinicians.
Outcomes Number of hospitalisations
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly assigned using a central computer.
Allocation concealment (selection bias) Low risk Computer‐based
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not possible
Incomplete outcome data (attrition bias)
All outcomes Low risk Some participants did not complete the study and were reported in the study.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Unclear how it was done
Selective reporting (reporting bias) Low risk All outcomes were reported
Protection against contamination bias Unclear risk It is not possible to determine if the control group was contaminated with the intervention group.
Other bias Unclear risk It is unclear if there are other biases.