ABSTRACT
Background: Recruitment to clinical trials is a challenge for researchers that became more pronounced because of COVID-19 public health protective measures, especially with respect to studies enrolling older adults. We completed an effectiveness and cost analysis of the recruitment methods used in The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study, a randomized controlled trial of a deprescribing intervention that recruited older adults with chronic use of sedatives during the pandemic. Methods: Study recruitment began during the COVID-19 pandemic. Strategies included random digit dialing (RDD), a targeted mail campaign and advertising through newspapers, online platforms (Google and Facebook), and television. Other awareness raising and recruitment strategies involved seniors' organizations, pharmacies, television news stories, and referrals. Recruitment effectiveness and cost analysis involved enrollment rate (ER), cost per randomized participant (CPRP), fractional cost (FC), fractional enrollment (FE), fractional enrollment-cost ratio (FEC), and efficacy index (EI) calculations. Results: There were 1295 interested older adults with 594 randomized into the study for an enrollment rate of 46%. The efficacy index (EI) was highest for Facebook ads (EI = 0.683) followed by television (EI = 0.426), and newsprint ads (EI = 0.298). The cost of RDD was highest per randomized participant at $1117.90 and produced the lowest EI (0.013). Conclusion: Facebook ads had the best efficacy index for recruiting older adults to the YAWNS NB study during the COVID-19 pandemic and television ads produced the most enrollments. RDD was expensive and yielded few recruits. Recruitment costs can be significant for recruiting community-dwelling older adults. This experience can inform recruitment strategy and budget development for future community studies enrolling older adults, especially in the context of the COVID-19 pandemic.
ABSTRACT
AIMS: Growing evidence suggests an association between the use of sedative-hypnotic medications and risk of dementia. The aim of this study is to examine this association using a meta-analysis approach. METHODS: MEDLINE (PubMed) and Scopus were systematically searched for studies published in English only. The quality of studies was evaluated using the Newcastle-Ottawa scale, and an overall odds ratio was pooled using a random-effects model. RESULTS: A total of 35 articles were included in the analysis. Pooled odds ratios (ORs) for dementia from all records were (OR; 1.33, 95% CI 1.19-1.49) for benzodiazepine (BZD) combined use (Subgroup-1), (OR: 1.46, 95% CI 1.23-1.73) for short-acting BZD use (Subgroup-2), (OR: 1.72, 95% CI 1.48-1.99) for long-acting BZD use (Subgroup-3), (OR: 1.13, 95% CI 0.97-1.32) for BZDs without specification of duration of action (Subgroup-4), (OR: 1.64, 95% CI 1.13-2.38) for the combined BZDs and Z-drugs, (OR: 1.43, 95% CI 1.17-1.74) for Z-drugs only, (OR: 1.14, 95% CI 0.88-1.46) for antidepressant use, (OR: 0.97, 95% CI 0.68-1.39) for antipsychotic use and (OR: 0.98, 95% CI 0.85-1.13) for anticonvulsant use. When sensitivity analysis was performed, association between overall use of BZDs and short-acting BZDs with the increased risk of dementia disappeared after exclusion of studies that were not adjusted for age covariate (OR: 1.2, 95% CI 1.0-1.44) and (OR: 1.22, 95% CI 0.75-2.01), respectively. Adjustment for protopathic bias by introduction of a lag period showed no evidence of increased risk of dementia with the use of BZDs (Subgroup-1) (OR: 1.14, 95% CI 0.82-1.58), Z-drugs (OR: 1.29, 95% CI 0.78-2.13), and combined BZDs and Z-drugs (OR: 1.51, 95% CI 0.91-2.53). Combined use of BZDs and Z-drugs showed more positive association when only studies of non-user design were analysed (OR: 2.75, 95% CI 2.23-3.39). CONCLUSIONS: All the investigated sedative-hypnotics showed no association with increased risk of dementia except for BZDs. However, the observed association with BZDs did not persist after exclusion of studies with potential reverse causation and confounding by indication. Therefore, this association needs to be assessed carefully in future research.