Tannenbaum C, Martin P, Tamblyn R, et al. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med 2014;174(6):890-98
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/24733354
Full text article: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1860498
| Methods | Study design: Open-label cluster randomized controlled trial
Number of groups: Two groups |
| Participants | Number of participants: 303 randomized
· Active deprescribing group: 148 randomized, 123 completed · Control group: 155 randomized, 138 completed Age: 75.0 ± 6.5 years Sex: 210 female, 93 male Participants with dementia: No Inclusion criteria: · Minimum of five active prescriptions · One being an active benzodiazepine prescription (short, medium, or long-acting) dispensed for at least three consecutive months before screening Exclusion criteria: · Diagnosis of severe mental illness · Dementia · Active prescription for any antipsychotic medication · Cholinesterase inhibitor or memantine in the preceding 3months · Residence in a long-term care facility Concomitant medicines: Country: Canada Setting: Community – randomized at the community pharmacy level |
| Interventions | Medicine: Benzodiazepine
Withdrawal schedule: Titrated over 21 weeks with participants provided with a “visual 21-week tapering protocol showing a picture-based diminishing schedule of full-pill, half-pill, and quarter-pill consumption.” Comparator: Usual care |
| Outcomes | Successful deprescribing
Adverse drug withdrawal effects |
| Dates | Dates: July 2010 and November 2012
Follow-up duration: 6 months |
| Funding sources | Canadian Institutes of Health Research (grant KTE-CFCL-108262) |
| Notes | Authors conflict of interest declaration stated: “Mr.Martin received a bursary from the Michel Saucier Endowed Chair in Pharmacology, Health, and Aging of the Faculty of Pharmacy of the Université de Montréal, and Drs Tannenbaum and Ahmed are clinician scientists funded by the Fonds de Recherche en Santé de Quebec. No other disclosures are reported.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Low risk | “A full list of pharmacies within 200km of the research center was obtained through collaboration with the pharmacy chain’s headquarters. This list was randomized, and pharmacies were systematically contacted by the research team to assess interest in participating.”… “A 1:1 allocation ratio was assigned by an independent statistician using non-stratified blocked randomization for groups of four pharmacies using computer-generated random digits.” |
| Allocation concealment (selection bias) | High risk | “Group allocation was concealed from both the pharmacists and their clients by telling them that the intervention would be delivered to the clients at some point during the next year.” |
| Blinding of participants and personnel (performance bias) | Unclear risk | The paper stated group allocation was concealed, but the method was not described. |
| Blinding of outcome assessment (detection bias) | Low risk | Blinding claimed, but method not described.
“One investigator (P.M.) and one research nurse, blinded to group allocation, independently assessed outcomes according to a pre-specified protocol.” |
| Incomplete outcome data (attrition bias) | Low risk | “Both intention-to-treat and per-protocol analyses were performed.” Drop-outs seem reasonable. |
| Selective reporting (reporting bias) | Low risk | Pre-specified outcomes have been reported. |
| Other bias | Low risk |
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