Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. OBJECTIVE To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. DESIGN, SETTING, AND PARTICIPANTS Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. INTERVENTIONS The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. MAIN OUTCOMES AND MEASURES Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. RESULTS A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. CONCLUSIONS AND RELEVANCE Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01148186
Background Across countries and disciplines, studies show male researchers receive more research funding than their female peers. Because most studies have been observational, it is unclear whether imbalances stem from evaluations of female research investigators or of their proposed research. In 2014, the Canadian Institutes of Health Research created a natural experiment by dividing investigator-initiated funding applications into two new grant programmes: one with and one without an explicit review focus on the calibre of the principal investigator. Methods We analysed application success among 23 918 grant applications from 7093 principal investigators in all investigator-initiated Canadian Institutes of Health Research grant programmes between 2011 and 2016. We used generalised estimating equations to account for multiple applications by the same applicant and compared differences in application success between male and female principal investigators under different review criteria. Findings Overall application success across competitions was 15•8%. After adjusting for age and research domain, the predicted probability of success in traditional programmes was 0•9 percentage points lower for female applicants than male applicants (95% CI 2•0 lower-0•2 higher; odds ratio 0•934, 95% CI 0•854-1•022). In the new programme, in which review focused on the proposed science, the gap remained 0•9 percentage points (3•2 lower-1•4 higher; 0•998, 0•794-1•229). In the new programme with an explicit review focus on the calibre of the principal investigator, the gap was 4•0 percentage points (6•7 lower-1•3 lower; 0•705, 0•519-0•960). Interpretation Gender gaps in grant funding are attributable to less favourable assessments of women as principal investigators, not of the quality of their proposed research. We discuss reasons less favourable assessments might occur and strategies to foster fair and rigorous peer review.
Virtually every clinical research report includes basic demographic characteristics about the study participants, such as age, and how many participants were male/men or female/women. Some research articles refer to this latter variable as sex, others refer to it as gender. As one of the first pieces of data reported, the importance of including sex appears undisputed. But what does the sex-gender category really entail, and how should it be reported?With emerging evidence that both sex and gender have an effect, for instance, on how an individual selects, responds to, metabolizes, and adheres to a particular drug regimen, 1 there is an ethical and scientific imperative to report to whom research results apply. This Viewpoint explains the contexts in which sex and gender are relevant and provides suggestions for improving reporting of this characteristic.
Disaggregating the dataAnalysing experimental results by sex and/or gender is critical for improving accuracy and avoiding misinterpretation of data (Fig.
IMPORTANCE High rates of inappropriate prescribing persist among older adults in many outpatient settings, increasing the risk of adverse drug events and drug-related hospitalizations. OBJECTIVE To compare the effectiveness of a consumer-targeted, pharmacist-led educational intervention vs usual care on discontinuation of inappropriate medication among community-dwelling older adults. DESIGN, SETTING, AND PARTICIPANTS A cluster randomized trial (D-PRESCRIBE [Developing Pharmacist-Led Research to Educate and Sensitize Community Residents to the Inappropriate Prescriptions Burden in the Elderly]) that recruited community pharmacies in Quebec, Canada, from February 2014 to September 2017, with follow-up until February 2018, and randomly allocated them to intervention or control groups. Patients included were adults aged 65 years and older who were prescribed 1 of 4 Beers Criteria medications (sedative-hypnotics, first-generation antihistamines, glyburide, or nonsteroidal anti-inflammatory drugs), recruited from 69 community pharmacies. Patients were screened and enrolled before randomization. INTERVENTIONS Pharmacists in the intervention group were encouraged to send patients an educational deprescribing brochure in parallel to sending their physicians an evidence-based pharmaceutical opinion to recommend deprescribing. The pharmacists in the control group provided usual care. Randomization occurred at the pharmacy level, with 34 pharmacies randomized to the intervention group (248 patients) and 35 to the control group (241 patients). Patients, physicians, pharmacists, and evaluators were blinded to outcome assessment. MAIN OUTCOMES AND MEASURES Discontinuation of prescriptions for inappropriate medication at 6 months, ascertained by pharmacy medication renewal profiles. RESULTS Among 489 patients (mean age, 75 years; 66% women), 437 (89%) completed the trial (219 [88%] in the intervention group vs 218 [91%] in the control group). At 6 months, 106 of 248 patients (43%) in the intervention group no longer filled prescriptions for inappropriate medication compared with 29 of 241 (12%) in the control group (risk difference, 31% [95% CI, 23% to 38%]). In the intervention vs control group, discontinuation of inappropriate medication occurred among 63 of 146 sedative-hypnotic drug users (43.2%) vs 14 of 155 (9.0%), respectively (risk difference, 34% [95% CI, 25% to 43%]); 19 of 62 glyburide users (30.6%) vs 8 of 58 (13.8%), respectively (risk difference, 17% [95% CI, 2% to 31%]); and 19 of 33 nonsteroidal anti-inflammatory drug users (57.6%) vs 5 of 23 (21.7%), respectively (risk difference, 35% [95% CI, 10% to 55%]) (P for interaction = .09). Analysis of the antihistamine drug class was not possible because of the small sample size (n = 12). No adverse events requiring hospitalization were reported, although 29 of 77 patients (38%) who attempted to taper sedative-hypnotics reported withdrawal symptoms. CONCLUSIONS AND RELEVANCE Among older adults in Quebec, a pharmacist-led educational intervention compared with usual ca...
BackgroundThere has been a recent swell in activity by health research funding organizations and science journal editors to increase uptake of sex and gender considerations in study design, conduct and reporting in order to ensure that research results apply to everyone. However, examination of the implementation research literature reveals that attention to sex and gender has not yet infiltrated research methods in this field.DiscussionThe rationale for routinely considering sex and gender in implementation research is multifold. Sex and gender are important in decision-making, communication, stakeholder engagement and preferences for the uptake of interventions. Gender roles, gender identity, gender relations, and institutionalized gender influence the way in which an implementation strategy works, for whom, under what circumstances and why. There is emerging evidence that programme theories may operate differently within and across sexes, genders and other intersectional characteristics under various circumstances. Furthermore, without proper study, implementation strategies may inadvertently exploit or ignore, rather than transform thinking about sex and gender-related factors. Techniques are described for measuring and analyzing sex and gender in implementation research using both quantitative and qualitative methods.SummaryThe present paper describes the application of methods for integrating sex and gender in implementation research. Consistently asking critical questions about sex and gender will likely lead to the discovery of positive outcomes, as well as unintended consequences. The result has potential to strengthen both the practice and science of implementation, improve health outcomes and reduce gender inequities.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-016-0247-7) contains supplementary material, which is available to authorized users.
Our purpose in this study was to determine the prevalence of undetected disorders of bone and mineral metabolism in women with osteoporosis and to identify the most useful and cost-efficient screening tests to detect these disorders. A cross-sectional study was conducted among 664 postmenopausal women with osteoporosis at the Osteoporosis and Metabolic Bone Disease Program at the Mount Sinai Hospital in New York between January 1992 and June 1996. Women without a history of diseases or medications known to adversely affect bone who completed extensive laboratory testing including complete blood count, chemistry profile, 24-h urinary calcium, 25(OH)vitamin D, and PTH were included. Among 173 women who met the inclusion criteria for the study, previously undiagnosed disorders of bone and mineral metabolism were identified in 55 women (32%). Disorders of calcium metabolism and hyperparathyroidism were the most frequent diagnoses. A testing strategy involving measurement of 24-h urine calcium, serum calcium, and serum PTH for all women and serum TSH among women on thyroid replacement therapy would have been sufficient to diagnose 47 of these 55 women (85%) at an estimated cost of $75 per patient screened. Previously undiagnosed disorders affecting the skeleton are common in otherwise healthy women with low bone density. A simple testing strategy is likely to identify most such disorders.
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