Bonetti 2018.
Study characteristics | ||
Methods | Parallel randomised trial Study conducted between February and December 2015 |
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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 |
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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 |
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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 |
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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.” |
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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 |