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. 2021 Nov 25;2021(11):CD009985. doi: 10.1002/14651858.CD009985.pub2

Nielsen 2017.

Study characteristics
Methods RCT.
Over 16 months, 593 adult patients taking ≥ 4 medications daily were included from three Danish acute medicine wards. Patients were randomised to either the clinical pharmacist (CP) intervention or the usual care (prospective control).
Unit of allocation: patients
Unit of analysis: patients
Participants The setting was the acute medicine wards of three non‐university hospitals in Region Zealand, one in five regions of Denmark (N = 542 analysed).
IP adults (medical wards)
Interventions The purpose of the study was to investigate the clinical effect of a clinical pharmacist (CP) intervention upon admission to hospital.
Intervention: clinical pharmacist (CP) intervention upon admission to hospital on inpatient harm and to assess a potential educational bias.
1. Review and use of patient's own drugs by clinical pharmacist.
2. Clinical pharmacist taking secondary medication history.
3. Medication review by clinical pharmacist.
4. Entry of proposed prescriptions in the electronic medication system by pharmacist, ready for approval by doctor.
The intervention took place on the day the patient was admitted, and the duration of the intervention was approximately 1.5 hours.
Control: standard care with no pharmacist involvement (prospective control).
Outcomes Primary outcome measure: number of patients with in‐hospital adverse drug events, detected by Adverse Drug Event Trigger Tool.
Secondary outcome measures:
1. Length of hospital stay
2. Number of readmissions during the first year after admission
Notes ISRCTN08043800
The study was supported by grants from Hospital Pharmacies and Amgros’ Research and Development Foundation, The Health Foundation (Helsefonden) and Region Zealand Health Scientific Research Foundation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk In the prospective periods, the patients were stratified by centre and randomised to the intervention or the prospective control using computer‐generated block randomisation with a block size of six.
Allocation concealment (selection bias) Low risk Allocation was revealed to the CP by telephone whenever the CP had enrolled a patient.
Blinding of participants and personnel (performance bias)
All outcomes Low risk "Neither the CPs nor the healthcare personnel or patients were blinded to the patient allocation. The patients were informed of their allocation on request, although few actually asked." Since standard care did not include pharmacists, perfomance bias is unlikely.
Blinding of outcome assessment (detection bias)
All outcomes Low risk For the assessment of the primary outcome, a trigger panel and two outcome panels, all blinded to the allocation of patients, were formed. The trigger panel consisted of two nurses, with 7 and 15 years of clinical experience, both trained in Global Trigger Tool (GTT) as a whole and in the selected medication triggers in particular. The nurses independently reviewed the medical records of all included patients and recorded all triggers. The patients’ records were reviewed in the same order determined by a pre‐made, randomised list.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Intervention arm lost 40 participants (20%), proactive control arm lost 49 participants (25%). However, all patients were excluded for the same reason, and baseline characteristics seem balanced except for 1 aspect.
Selective reporting (reporting bias) Low risk All outcomes except direct cost for the hospital were reported.
Conflict of interest Low risk None of the authors are affiliated or involved in any organization or entity with a direct or indirect financial interest in the manuscript.
Other bias Low risk The study appears to be free of other sources of bias.