Nascimento 2016.

Study characteristics
Methods	Aim of study: to evaluate improvement in diabetes self‐care (including adherence) after an individualised pharmacotherapy management service (home medication review and therapeutic education) in elderly patients Study design: RCT (unit of allocation: individual) Number of arms/groups: 2
Participants	Description: both patient/consumer and carer Geographic location: Portugal Setting: diabetes care clinic and patient's home Inclusion criteria: T2DM, ≥ 65 years, HbA1c ≥ 7.5% Exclusion criteria: (unclear) cancer, cognitive impairment or other condition that could "hinder communication" unless they could submit a caregiver Number of participants randomised: 90 Number of participants included in analysis: 87 (44 and 43) Age: mean ± SD: 74.2 ± 5.4 vs 72.3 ± 4.5 Gender: female: 43.2% vs 41.9% Ethnicity: not specified Number of medications: type not specified: 6.86 ± 3.32 vs 5.84 ± 2.76 Frailty/Functional impairment: not specified Cognitive impairment: cognitive impairment ‐ needed carer Comorbidities: no total score given
Interventions	Group 1 ‐ Pharmacotherapy management service for T2DM elderly patients: individualized pharmacotherapy management service at home, including analysis of necessity, safety, and effectiveness of medications taken. Also received individualised therapeutic education on diabetes care especially pharmacotherapy. Unclear whether med review and education were limited to diabetes medications only or included all medications Group 2 ‐ Usual care: standard medical care consultation (no details) Co‐intervention: N/A Provider: not specified ‐? Pharmacist Where: home When and how often: once at baseline (no details) Intervention personalised: yes ‐ individual medication review
Outcomes	Timing of outcome assessment: baseline and 6 months Medication adherence (subjective) : Medida de Adesao aos Traamentos (ref 68), a validated Portuguese/Spanish measure based on Morisky Green Test: average level of adherence to drug therapy ‐ 7 questions, on 0 to 6 scale, with 6 being highest adherence Condition specific outcomes (objective): fasting blood glucose in mg/dL and glycosylated haemoglobin (HbA1c)
Notes	Trial registration: N/A Consumer involvement: not specified Funding source: funded in part by DGS Dropout: 3 lost to follow‐up Unpublished data: mean medications: control = 5.84 ± 2.76, intervention = 6.86 ± 3.32; adherence assessed for all medications, not just diabetes medications; adherence measured using a Spanish tool that is based on Morisky
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not explicitly reported, but the way it is described raises suspicion that it could have been alternating allocation, hence not random ("were randomised into a control and an intervention group, for a consecutive sampling")
Allocation concealment (selection bias)	Unclear risk	Not specified
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Clinical data accessed by an Independent clinical laboratory ‐ unsure if blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	90 randomised, 87 completed. No reasons given, but attrition small
Selective reporting (reporting bias)	Unclear risk	Methods unclear; method of assessing adherence mentioned at end, near conclusion
Other bias	Unclear risk	Method is very brief, making assessment of rigour and bias very difficult. Adherence assessment and analysis methods are unclear