Tannenbaum 2014.
| Methods | Randomised trial | |
| Participants | 303 elderly patients on benzodiazepines (intervention 148: control 155) The study included 30 community pharmacies (cluster units) Montreal, Canada. Year of study: 2010 to 2012. |
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| Interventions | Written educational material to facilitate benzodiazepine withdrawal The patient empowerment intervention consisted of an 8‐page booklet based on social constructivist learning and self‐efficacy theory. The intervention comprised a self‐assessment component about the risks of benzodiazepine use, presentation of the evidence for benzodiazepine‐induced harms, knowledge statements designed to create cognitive dissonance about the safety of benzodiazepine use, education about drug interactions, peer champion stories to augment self‐efficacy, suggestions for equally or more effective therapeutic substitutes for insomnia or anxiety or both, and stepwise tapering recommendations. The intervention asked participants to discuss the de‐prescribing recommendations with their physician or pharmacist or both. The intervention was personalised according to the participant’s pharmacy profile to include the name of the specific benzodiazepine the participant was taking. The intervention was mailed to the intervention group within 1 week of group allocation while the usual care (wait list) group received the educational tool 6 months following group allocation. Duration: 6 months |
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| Outcomes | Discontinuation of benzodiazepine use | |
| Notes | Funding source: Canadian Institutes of Health Research Conflict of interest: Mr Martin received a bursary from the Michel Saucier Endowed Chair in Pharmacology,Health,and Aging of the Faculty of Pharmacy of the Universitéde Montréal, and Drs Tannenbaum and Ahmed were clinician scientists funded by the Fonds de Recherche en Santé de Quebec. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A statistician, blinded to pharmacy and cluster size, generated a random allocation sequence using computer‐generated random digit numbers. |
| Allocation concealment (selection bias) | Low risk | Up until the point of randomisation, neither the research assistant, the cluster representative (the pharmacist), nor the client knew the allocation of the clusters. After randomisation, only the research assistant was aware of treatment allocation. |
| Blinding of participants and personnel (performance bias) All Outcomes/Outcome 1 | Low risk | Pharmacists and participants were not informed, and remained unaware of the fact that there was another group in the study; nor were they informed of the procedures for the other arm. |
| Blinding of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | 1 investigator and 1 research nurse, blinded to group allocation, independently assessed outcomes according to a prespecified protocol. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Between group attrition < 10%. |
| Selective reporting (reporting bias) | Low risk | All reported |
| Other bias | Low risk | None |