Schnipper 2006.
| Methods | Randomised controlled trial | |
| Participants | A total of 178 participants were randomised ‐ 92 to medication review and 86 to control. Participants were admitted to the general medicine service at a university hospital in the USA Mean age: 59.3 years; 34% male; median number of drugs: 8.0 | |
| Interventions | The pharmacist intervention on the day of discharge consisted of several parts. First, discharge medication regimens were compared with preadmission regimens, and all discrepancies were reconciled with assistance of the medical team. Participants were screened for previous drug‐related problems, including non‐adherence, lack of efficacy and side effects. The pharmacist reviewed with the participant the indications, directions for use and potential adverse effects of each discharge medication, and discussed significant findings with the medical team Co‐interventions: follow‐up telephone call, during which the pharmacist compared the participant's self reported medication list with the discharge list, exploring any discrepancies The pharmacist also asked about medication adherence, possible adverse drug events and adherence with scheduled follow‐up and laboratory appointments. Significant findings were communicated to the participant's primary care physician |
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| Outcomes | Primary outcome measure: preventable adverse drug events
Secondary outcome measures: all adverse drug events (preventable or not), participant satisfaction, health care utilisation (readmission + emergency department contact), medication adherence, medication discrepancies All outcomes had 30 days of follow‐up |
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| Notes | Funding: This study was supported by the Division of General Medicine at Brigham and Women’s Hospital (BWH), Boston, MA, the Fish and Anderson Fundsat BWH and an unrestricted grant from the Merck Co Foundation, West Point, PA. Dr Schnipper is supported by Mentored Clinical Scientist Development Award HL072806 from the National Heart, Lung and Blood Institute, Bethesda, MD | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was performedby a computer‐generated algorithm |
| Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes were opened only after patient consent was obtained |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Study was described as not blinded |
| Blinding of outcome assessment (detection bias) Hospital readmissions (all‐cause) | Low risk | Outcomes were assessed by research assistants and manuscript authors blinded to treatment assignment |
| Blinding of outcome assessment (detection bias) Hospital readmissions (due to adverse drug events) | Unclear risk | Outcomes were assessed by research assistants and manuscript authors blinded to treatment assignment. Nevertheless, coding of the causality of hospital readmissions due to adverse events may be biased (e.g. by participants knowing their allocation and expressing this to the rating physician) |
| Blinding of outcome assessment (detection bias) Hospital emergency department contacts (all‐cause) | Low risk | Outcomes were assessed by research assistants and manuscript authors blinded to treatment assignment |
| Blinding of outcome assessment (detection bias) Hospital emergency department contacts (due to adverse drug events) | Unclear risk | Outcomes were assessed by research assistants and manuscript authors blinded to treatment assignment. Nevertheless, coding of the causality of hospital emergency department visits due to adverse events may be biased (e.g. by participants knowing their allocation and expressing this to the rating physician) |
| Blinding of outcome assessment (detection bias) Adverse drug events | Unclear risk | Outcomes were assessed by research assistants and manuscript authors blinded to treatment assignment. Nevertheless, coding of the causality of adverse events may be unblinded (e.g. by participants knowing their allocation and expressing this to the rating physician) |
| Incomplete outcome data (attrition bias) Hospital readmissions (all‐cause) | Unclear risk | Uneven loss to follow‐up: medication review 33/92 participants; control group 18/84 participants. Unclear how many participants lost to follow‐up had died |
| Incomplete outcome data (attrition bias) Hospital readmissions (due to adverse drug events) | Unclear risk | Uneven loss to follow‐up: medication review 33/92 participants; control group 18/84 participants. Unclear how many participants lost to follow‐up had died |
| Incomplete outcome data (attrition bias) Hospital emergency department contacts (all‐cause) | Unclear risk | Uneven loss to follow‐up: medication review 33/92 participants; control group 18/84 participants. Unclear how many participants lost to follow‐up had died |
| Incomplete outcome data (attrition bias) Hospital emergency department contacts (due to adverse drug events) | Unclear risk | Uneven loss to follow‐up: medication review 33/92 participants; control group 18/84 participants. Unclear how many participants lost to follow‐up had died |
| Incomplete outcome data (attrition bias) Adverse drug events | Unclear risk | Uneven loss to follow‐up: medication review 33/92 participants; control group 18/84 participants. Unclear how many participants lost to follow‐up had died |
| Selective reporting (reporting bias) | Unclear risk | No deaths reported, but some mortality data were likely to have been available (e.g. when hospital records of contacting spouses of participants were searched) |
| Contamination bias | High risk | No cluster‐randomisation |
| Other bias | Low risk | No evidence of other types of bias |