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. 2022 Feb 24;2022(2):CD000313. doi: 10.1002/14651858.CD000313.pub6

Bonetti 2018.

Study characteristics
Methods Parallel randomised trial
Study conducted between February and December 2015
Participants Patients aged >=18 years admitted to a specialised cardiology ward due to stable angina, acute coronary syndrome, congestive heart failure, valvular disease, arrhythmias, or hypertension
Number of patients randomised: 133 (T: 66, C: 67); Analysed: 102 (primary endpoint; I: 51, C: 51)
Mean age: T: 65 years (SD 10), C: 65 years (SD 13)
Sex (female): T = 16/51 (31%), C = 19/53 (36%)
Other relevant characteristics: On average participants had 4 co‐morbidities, took 7.5 medications at discharge and were in hospital for 11 days
Interventions Setting: Tertiary hospital, Curitiba, Brazil
Pre‐admission assessment: no
Case finding on admission: cardiovascular pharmacy residents assessed patients eligibility according to the eligibility criteria
Inpatient assessment and preparation of a discharge plan based on individual patient needs: two cardiovascular pharmacists provided individual counselling sessions (number not specified) to the patient and their carer, if applicable. The sessions included a medication needs assessment, as well as an educational component covering indications and possible adverse drug events, among other topics.
Implementation of the discharge plan: patients were given a personalised leaflet summarising the information covered by the sessions.
Monitoring phase: patients were contacted by telephone to reinforce the previous counselling session (3 and 15 days post‐discharge)
Control: usual care, provided by pharmacists and other healthcare providers
Outcomes Main outcomes: emergency department visits (related to heart disease, not related to heart disease), total hospital readmission, hospital readmission (related to heart disease, not related to heart disease), mortality
Other outcomes: drug taking procedures, beliefs about medicine, medication adherence, number of medication problems
Follow‐up at 30 days
Notes Funding: not reported
Conflicts of interest: no potential conflict of interest was reported.
Ethical approval: “This trial was in accordance with the ethical standards of the institution’s committee.”
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “random number list (...) using Microsoft Office Excel 2010” (Methods)
Allocation concealment (selection bias) Low risk Quote: “generated by a third person” (Methods)
Baseline outcome data Low risk Comments: Groups similar for days of hospitalisation and number of comorbidities. Other main outcomes referred to ED visits, readmission, and mortality (Table 1)
Baseline characteristics similar Low risk Comment: Baseline characteristics presented and similar between groups (Table 1)
Blinding (performance bias and detection bias)
All outcomes Unclear risk Comment: how data for the main outcomes were collected isn't clear (methods)
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: Attrition rate high albeit similar between groups (IG: 23%, CG: 21%). Unclear why participants were lost to ambulatory follow‐up (Fig.1)
Study adequately protected against contamination High risk Quote: “There were five trained pharmacists in this setting, including one of the residents who provided the intervention.” (Methods)
Selective reporting (reporting bias) Unclear risk Comment: We identified two publications, which refer to different outcomes, neither lists all outcomes collected for the study
Other bias Low risk Comment: No other apparent risk of bias