Naik, Aanand D.

Background Recruitment for clinical studies is challenging. To overcome barriers, investigators have previously established call-to-entry rates to assist in planning. However, rates specific to low-income minority populations are needed to account for additional barriers to enrolment these individuals face. Objective To obtain a call-to-entry rate in a low-income uninsured Hispanic population with chronic disease. Methods We used data from four of our randomised clinical studies to determine the call-to-entry rate for individuals (n=1075) with or at risk for type 2 diabetes: participants needed/potential participants contacted=recruitment rate (yield). Research staff contacted potential participants to enrol in a study that evaluated 6 month diabetes programmes at community clinics from 2015 to 2020. We recorded call-to-entry rates, reasons for declining the study, show rates, and attrition. Results The call-to-entry rate was 14.5%. Forty per cent of potential participants could not be contacted, and 30.6%, 19.1%, and 5.4% responded yes , no , and maybe , respectively. No show percentages were 54% for yes and 91.4% for maybe responders. The majority (61.6%) declined due to inability to attend; reasons to decline included work (43%), eligibility (18%), transportation (10%), out of town (9%), did not think they needed the programme (7%) and other/unknown (14%). Being a physician predicted inability to reach participants (adjusted OR 2.91, 95% CI 1.73 to 4.90). Attrition was 6.8%. Conclusions We described a call-to-entry rate and detailed recruitment data, including reasons to decline the study. This valuable information can assist investigators in study planning and overcoming enrolment barriers in low-income populations. Telehealth-based or strategies that limit transportation needs may increase participant involvement. Trial registration number NCT03394456 .

Background— Complex antithrombotic therapy (CAT) prescribed to elderly patients increases the risk of gastrointestinal bleeding. We quantified upper (UGIE) and lower gastrointestinal (LGIE) events, transfusions, and hospitalizations in a national cohort of elderly veterans prescribed CAT. Methods and Results— Veterans ≥60 years of age prescribed anticoagulant-antiplatelet, aspirin (ASA)-antiplatelet, ASA-anticoagulant, or triple therapy (ie, TRIP, anticoagulant-antiplatelet-ASA) were identified from the national pharmacy database (October 1, 2002 to September 30, 2008). Prescription-fill data were linked to Veteran Affairs and Medicare encounter files, each person-day of follow-up was assessed for CAT exposure, and outcomes were defined by using diagnostic code algorithms derived following chart abstraction. Incidence density ratios (compared with the reference category of no CAT) and survival analysis was conducted. Among 78 133 veterans (98.6% white; mean age, 72.3 [standard deviation 7.7]), 64% were prescribed ASA-antiplatelet and anticoagulant-antiplatelet and 6% were prescribed TRIP. The incidence of UGIE was 20.1/1000 patient-years, and the incidence of LGIE was 70.1/1000 patient-years. ASA-anticoagulant and TRIP were associated with the highest incidence of transfusion and hospitalization. A 40% to 60% increased risk of UGIE was observed with all strategies. LGIE was 30% higher with anticoagulant-antiplatelet, and transfusion increased with ASA-anticoagulant (hazard ratio, 6.1; 95% confidence interval, 5.2–7.1) and TRIP (hazard ratio, 5.0; 95% confidence interval, 4.2–5.8). Increased risk of hospitalization was noted with all strategies. The number needed to harm for UGIE or LGIE ranged from 52 to 65 and 15 to 23, respectively. The number needed to harm for hospitalization was 39 (anticoagulant-antiplatelet), 34 (ASA-anticoagulant), 67 (ASA-antiplatelet), and 45 (TRIP) patients. Conclusions— Among elderly patients, CAT-related LGIE and UGIE are clinically relevant risks resulting in increased hospitalizations and transfusions.