Holland 2007.

Study characteristics
Methods	Aim of study: to test whether a drug review and symptom self‐management and lifestyle advice intervention by community pharmacists could reduce hospital admissions or mortality in heart failure patients Study design: RCT (unit of allocation: individual stratified) Number of arms/groups: 2
Participants	Description: both patient/consumer and carer Geographic location: UK Setting: community pharmacy (after discharge from hospital) Inclusion criteria: > 18 years, admitted as an emergency in which HF was an important ongoing clinical condition, prescribed ≥ 2 medications on discharge Exclusion criteria: residential or nursing home, awaiting surgery for heart disease/transplant, had terminal malignancy Number of participants randomised: 339 (169 intervention vs 170 control) Number of participants included in analysis: 291 (148 vs 143) Age: mean ± SD: 77.6 ± 9.0 vs 76.4 ± 9.5 Gender: female: 54 (36.2%) vs 53 (36.7%) Ethnicity: not specified Number of medications: number of prescribed items taken daily: mean ± SD 7.9 ± 2.6 vs 7.7 ± 2.3 Frailty/Functional impairment: not specified Cognitive impairment: abbreviated mental test: 9.2 ± 1.0 vs 9.3 ± 1.0 Comorbidities: not specified
Interventions	Group 1 ‐ HeartMed (visits from community pharmacist): community pharmacist received discharge letter and arranged home visit within 2 weeks of discharge to meet with patient or carer. As appropriate, educated about heart failure, drugs, exercise, diet, smoking; provided signs and symptoms daily cards; removed discontinued drugs; fed recommendations back to GP. Intervention delivered in line with advice from British Heart Foundation's booklet "Living With Heart Failure", which was also given to the patient. A follow‐up visit occurred at 6 to 8 weeks to reinforce Group 2 ‐ Usual care Co‐intervention: N/A Provider: pharmacist (community) Where: patient's home When and how often: twice ‐ at 2 weeks and at 6 to 8 weeks post discharge Intervention personalised: yes
Outcomes	Timing of outcome assessment: baseline and 6 months Medication adherence (subjective) : Medication Adherence Report Scale (MARS) scores from 5 (very poor adherence) to 25 (perfect adherence). Questionnaires mailed to patients Satisfaction with intervention (subjective): satisfaction questionnaire at 3 months Health‐related quality of life (subjective): EQ‐5D ‐ self‐assessed quality of life: 1 (perfect health) to ‐0.59 (worst imaginable health state) Adverse clinical health outcomes (objective): mortality ‐ number of deaths Adverse clinical health outcomes (objective): emergency admissions ‐ emergency admission data from Hospital Episode Statistics Condition‐specific outcomes (subjective): Minnesota Living With Heart Failure Questionnaire: 21 questions of 0 to 5 giving total score from 0 to 105. Higher scores implying worse condition. Change of 5 points is significant
Notes	Trial registration: ISRCTN59427925 Consumer involvement: not specified Funding source: British Heart Foundation project grant; Great Yarmouth and Southern Norfolk Primary Care Trusts covered excess treatment costs. Pfizer supported pharmacist training Dropout: 46 (20 vs 26) excluded before intervention, 2 (1 vs 1) lost to follow‐up Fidelity: of 149 intervention patients ‐ 136 received first visit, 119 received second visit, 13 did not receive intervention
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Third party telephone randomisation based on a computer‐generated random allocation sequence. Stratified by New York Heart Association class and recruitment site
Allocation concealment (selection bias)	Unclear risk	Participants told allocation after baseline; concealment unclear
Blinding of participants and personnel (performance bias) All outcomes	High risk	No placebo possible, so participants were told which group they were in
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not specified
Incomplete outcome data (attrition bias) All outcomes	High risk	High rate of failure to complete 6‐month assessments (only 101/169 intervention and 103/170)
Selective reporting (reporting bias)	Low risk	As per methods
Other bias	Unclear risk	Pharmacist training funded by Pfizer ‐ unclear what, if any, influence Pfizer had on content of training. Of 149 intervention patients ‐ 136 received first visit, 119 received second visit, 13 did not receive intervention