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. 2014 Nov 20;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4

Nazareth 2001.

Methods Patients were independently randomized by the health authority's central community pharmacy office using computer‐generated random numbers. 165 patients were eligible at baseline in the intervention group and 151 patients were eligible in the control group. They used blocked randomization, stratified by trial center, to ensure equal numbers of participants in each randomized group
Participants From June 1995 to March 1997, patients discharged from elderly care wards were asked by the hospital pharmacist to give informed consent. 362 patients were recruited. Patients over 75 years who were taking 4 or more medicines at discharge were asked to join the study. Patients who could not speak English or were too ill were excluded
Interventions Between 7 and 14 days after discharge, community pharmacists visited the patients at home. This visit allowed the pharmacist to check for discrepancies between the medicines the patient was taking and those prescribed on discharge. The pharmacist assessed the patient's understanding of and adherence to the medication regimen and intervened when appropriate. Interventions included counseling patients or carers on the purpose and appropriate doses of the medication, disposing of excess medicines and liaising with general practitioners. The pharmacists arranged further community visits at their discretion. All assessments and interventions were sent to the hospital‐based liaison pharmacist. A revised care plan was issued if a patient was re‐admitted to hospital during the 6‐month study period. Patients randomized to the control group were discharged from hospital following standard procedures. These included a discharge letter to the general practitioner who indicated the diagnosis, investigations and current medications. The pharmacists did not provide a review of discharge medication or follow‐up in the community
Outcomes Compliance measures were made at baseline and at follow‐up (3 and 6 months after start of intervention). The primary outcome was re‐admission to hospital in the follow‐up period. Secondary outcomes were number of deaths, attendances at hospital outpatient clinics and general practice (at home or in the surgery) and days in hospital as a percentage of days of follow‐up
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number generation used for randomization. "computer generated random numbers. We used blocked randomization, stratified by trial centre..." (pg 34)
Allocation concealment (selection bias) Low risk Central center was used for allocation. "The health authority's central community pharmacy office using computer‐generated random numbers..." "allocation code held by randomization centre was revealed only at the end of the study" (pg 34)
Selective reporting (reporting bias) Unclear risk No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias Unclear risk There seems to be some lack of uniformity in the intervention delivery ‐ 15/19 pharmacists conducted a second visit and 2 went on a third visit ‐ exact reasons for the extra visits not reported. There is a small chance that some pharmacists were more keen so they went on more visits
Blinding of outcome assessment (detection bias) 
 Adherence measure Low risk (PRIMARY) PRESCRIBED MEDICATION INTERVIEW ‐ Outcome assessors were blind. "These data were assessed by an independent blinded hospital pharmacist. Each item was rated 0 (none) or 1 (highest level) and mean scores calculated" (pg 35)
Blinding of outcome assessment (detection bias) 
 Patient outcome Low risk (PRIMARY) READMISSION TO HOSPITALS ‐ The outcome assessors blind. "These data were assessed by an independent blinded hospital pharmacist. Each item was rated 0 (none) or 1 (highest level) and mean scores calculated" (pg 35)
Blinding of participants (performance bias) 
 Adherence measure High risk (PRIMARY) PRESCRIBED MEDICATION INTERVIEW ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) 
 Patient outcome Low risk (PRIMARY) READMISSION TO HOSPITALS ‐ This is an objective measure of outcome
Blinding of personnel (performance bias) 
 Adherence measure Low risk (PRIMARY) PRESCRIBED MEDICATION INTERVIEW ‐ The author has noted that the research assistant remained blinded to allocation of patient
Blinding of personnel (performance bias) 
 Patient outcome Low risk (PRIMARY) READMISSION TO HOSPITALS ‐ This is an objective measure of outcome
Incomplete outcome data (attrition bias) 
 Adherence measure Unclear risk (PRIMARY) PRESCRIBED MEDICATION INTERVIEW ‐ Missing data are somewhat uniform across time points for adherence measure. Unable to predict whether the numbers could affect the results; therefore, marked unclear
Incomplete outcome data (attrition bias) 
 Patient outcome Unclear risk (PRIMARY) READMISSION TO HOSPITALS ‐ Unable to determine the potential effect of missing data for this outcome on results