Bonnerup 2014.
Methods | Randomised controlled trial | |
Participants | A total of 375 participants were randomised ‐ 124 to high‐risk subgroup, 64 to medication review and 60 to control group. Patients admitted to 1 acute medical department at university hospital in Denmark. High‐risk subgroup: mean age of control group: 78.2 years; mean number of drugs: 11.0 | |
Interventions | Patients presenting with risk of prescribing errors identified by a risk score called MERIS (ranging from 0 to 37). A MERIS score between 14 and 26 warranted a medication review by a clinical pharmacist, whereas a risk score ≥ 26 led to medication review by a clinical pharmacologist. Medication reviews consisted of (1) collecting information concerning the participant's drug treatment and the clinical status of the participant, (2) conducting a participant interview and (3) performing a critical examination of a participant's overall drug treatment. Recommendations or information arising from the medication reviews were delivered to hospital physicians as a note in the electronic medical record. If fast response was needed (e.g. if the participant was about to be discharged, if urgent action was required), the note was accompanied by direct contact with a physician | |
Outcomes | Primary outcome: number of prescribing errors during participants' hospitalisation Secondary outcomes: healthcare utilisation (divided into all‐cause readmissions, contacts with general practitioners and visits to emergency departments), health‐related quality of life, mortality All outcomes had 90 days of follow‐up (after hospital discharge) . |
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Notes | Funding: not described | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was generated by a computer programme in the hospital pharmacy in random blocks of a maximum of 20 |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque and sealed envelopes containing randomisation codes were delivered to study pharmacists who allocated participants |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not described, but probably not blinded |
Blinding of outcome assessment (detection bias) Mortality (all‐cause) | Low risk | Mortality data were taken from a non‐biased national register (participants identifiable through unique patient‐specific social security numbers) |
Blinding of outcome assessment (detection bias) Hospital readmissions (all‐cause) | Low risk | Readmission data were taken from a non‐biased national register |
Blinding of outcome assessment (detection bias) Hospital emergency department contacts (all‐cause) | Low risk | Emergency department contacts were taken from a non‐biased national register |
Incomplete outcome data (attrition bias) Mortality (all‐cause) | Low risk | No missing data were described; all data should be available from a non‐biased national register |
Incomplete outcome data (attrition bias) Hospital readmissions (all‐cause) | Low risk | No missing data were described; all data should be available from a non‐biased national register |
Incomplete outcome data (attrition bias) Hospital emergency department contacts (all‐cause) | Low risk | No missing data were described; all data should be available from a non‐biased national register |
Selective reporting (reporting bias) | Low risk | Relevant outcomes were collected and were similar to information provided on www.clinicaltrials.gov |
Contamination bias | High risk | No cluster‐randomisation |
Other bias | Unclear risk | We included only a subgroup of patients with high risk of medication errors (i.e. MERIS risk score ≥ 14 as specified in the manuscript). Inclusion of only this subgroup of patients may induce bias, as risk score assessment was performed after allocation to groups (i.e. may introduce unbalance) |