Saez de la Fuente 2011.

Study characteristics
Methods	Aim of study: to evaluate the utility of a pharmacotherapeutic information programme at hospital discharge in polymedicated patients and the profile of modifications in treatment of the patient at 30 to 50 days of hospital discharge Study design: RCT (unit of allocation: individual) Number of arms/groups: 2
Participants	Description: both patient/consumer and carer Geographic location: Spain Setting: hospital discharge Inclusion criteria: using prescription medications for 3 or more months, ≥ 4 active ingredients at discharge Exclusion criteria: transfer to geriatric residence, dementia and/or psychiatric illness, incapacitated in the absence of a caregiver responsible for medication at the time of the interview, Barthel Index < 20 Number of participants randomised: 59 (29 and 30) Number of participants included in analysis: 50 (26 and 24) (but methods says ITT) Age: median (range): 73 (28 to 93) vs 75 (14 to 96) Gender: female n (%): 10 (34.5%) vs 11 (36.7%) Ethnicity: not specified Number of medications: median (IQR): active ingredients/patient at discharge: 8.3 (7.4 to 9.3) vs 7.6 (6.5 to 8.7); pharmaceutical forms/patient: 7.9 (7.1 to 8.8) vs 7.1 (6.0 to 8.1) Frailty/Functional impairment: Barthel Index: median (IQR) 100 (85 to 100) vs 100 (65 to 100) Cognitive impairment: dementia/psychiatric illness: 8 (26.7%) vs 8 (26.7%) Comorbidities: not specified
Interventions	Group 1 ‐ Pharmacotherapeutic discharge information programme: verbal and written information about treatment at hospital discharge ‐ unclear who provided information, suspect pharmacist (as pharmacist conducted interview). Format and content unclear Group 2 ‐ Usual care ‐ no discharge information provided Co‐intervention: N/A Provider: unclear ‐? Pharmacist Where: discharge from hospital When and how often: once, pre‐discharge Intervention personalised: yes (info provided presumably tailored to individual medication regimen)
Outcomes	Timing of outcome assessment: discharge and 30 to 50 days (mean 42.1, SD 9.6 days) Medication adherence (subjective): Morisky‐Green Medication Compliance: 4 questions: (1) Do you ever forget to take the medications, yes or no? (2) Take the medicines at the indicated time, yes or no? (3) When you feel better, do you stop taking the medication, yes or no? (4) If you sometimes feel worse when taking your medication, do you stop taking the medication, yes or no? ==> To consider good adherence, the response of all questions must be adequate (no, yes, no, no) Adverse clinical health outcomes (objective): deaths: number of deaths during follow‐up Adverse clinical health outcomes (subjective): ED and hospital admissions: telephone questionnaire ‐ number of ED or hospital re‐admissions during follow‐up
Notes	Trial registration: not specified Consumer involvement: not specified Funding source: not specified Dropout: 9 lost to follow up (3 died, 5 in hospital, 1 moved) Note: caregiver at discharge: 15 (57.7%) vs 17 (70.8%) Language translation: yes ‐ translated to English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	At the time of discharge, patients were distributed randomly in 2 groups by a block method with a 1: 1 ratio between groups
Allocation concealment (selection bias)	Unclear risk	Not specified
Blinding of participants and personnel (performance bias) All outcomes	High risk	Patients not blinded; unclear about personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Pharmacist was interviewer. At the time of the telephone interview, the interviewer was unaware of treatment of the patient, as well as the previous result of adherence to discharge
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Minimal dropout; unclear why those in hospital were not counted as re‐admissions
Selective reporting (reporting bias)	Low risk	Appears per protocol
Other bias	Low risk	None apparent