Curtin 2020.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | 130 participants were randomised (65 to medication review and 65 to control) Participants were admitted to 2 acute hospitals (Cork University Hospital and Mercy University Hospital, Ireland) Mean age: 85 years 38% male Mean number of regular prescribed medications: 11 |
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Interventions | After baseline data collection was completed, the research physician used the STOPPFrail criteria to identify de‐prescribing targets. For participants randomised to the intervention arm, a medication withdrawal plan was devised by the research physician. The recommended medication withdrawal plan was communicated directly to one of the participant’s attending physicians and also documented in the patient’s medical record. The attending physician assessed whether to accept the drug withdrawal plan and implement the recommended changes. Participants in the control group received usual pharmaceutical care (i.e. hospital physician and pharmacist care). |
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Outcomes |
Primary outcome: mean change in the number of long‐term prescribed medicines consumed by participants at 3 months after randomisation Secondary outcomes: measured at 3 months and included the following:
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Notes | Funding: Denis Curtin, Emma Jennings and Denis O’Mahony are supported by the European Union’s Horizon 2020 research and innovation programme (grant number 634238). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised to study arms in a 1:1 ratio, using block randomisation. Block sizes of 4 and 6 were generated using the website randomization.com by an administrator external to the study. Randomisation was not stratified by hospital site. |
Allocation concealment (selection bias) | Low risk | The allocation sequence was concealed in sequentially numbered, opaque envelopes until the research physician had enrolled participants, completed baseline data collection and identified deprescribing targets using the STOPPFrail criteria. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The attending physicians and participants were not blinded to intervention or control group allocation. |
Blinding of outcome assessment (detection bias) Mortality (all‐cause) | Low risk | Outcome data were collected by 3 research physicians who were blinded to the group allocation of participants. |
Blinding of outcome assessment (detection bias) Hospital readmissions (all‐cause) | Low risk | Outcome data were collected by 3 research physicians who were blinded to the group allocation of participants. |
Blinding of outcome assessment (detection bias) Hospital emergency department contacts (all‐cause) | Low risk | Outcome data were collected by 3 research physicians who were blinded to the group allocation of participants. |
Blinding of outcome assessment (detection bias) Adverse drug events | Low risk | Outcome data were collected by 3 research physicians who were blinded to the group allocation of participants. |
Blinding of outcome assessment (detection bias) Health‐related quality of life | High risk | Outcome data were collected by 3 research physicians who were blinded to the group allocation of participants. They contacted directors of nursing homes by telephone and requested that a nurse or care assistant, familiar with the participant, complete the QUALIDEM instrument. Where possible, the ICECAP‐O was to be completed by the same person who completed the questionnaire at baseline. In some instances, the research physicians contacted the relevant person by telephone to complete the ICECAP‐O. |
Incomplete outcome data (attrition bias) Mortality (all‐cause) | Low risk | One participant withdrew from the intervention group during follow‐up. 1 of 65 in medication review group and 0 of 65 in control group were lost to follow‐up. Judged as low risk. |
Incomplete outcome data (attrition bias) Hospital readmissions (all‐cause) | Low risk | One participant withdrew from the intervention group during follow‐up. Judged as low risk. |
Incomplete outcome data (attrition bias) Hospital emergency department contacts (all‐cause) | Low risk | One participant withdrew from the intervention group during follow‐up. Judged as low risk. |
Incomplete outcome data (attrition bias) Adverse drug events | Low risk | One participant withdrew from the intervention group during follow‐up. Judged as low risk. |
Incomplete outcome data (attrition bias) Health‐related quality of life | High risk | High loss to follow‐up: ICECAP‐O: intervention group 64% (38/59), control group 51% (30/59) QUALIDEM: intervention group 37% (22/59), control group 36% (21/59) |
Selective reporting (reporting bias) | Low risk | No unpublished outcomes when paper is compared to trial registration at clinicaltrials.gov. |
Contamination bias | High risk | No cluster‐randomisation. |
Other bias | Low risk | No evidence of other types of bias. |