Establishing an electronic health record-supported approach for outreach to and recruitment of persons at high risk of type 2 diabetes in clinical trials: The vitamin D and type 2 diabetes (D2d) study experience.

AIMS: To establish recruitment approaches that leverage electronic health records in multicenter prediabetes/diabetes clinical trials and compare recruitment outcomes between electronic health record-supported and conventional recruitment methods. METHODS: Observational analysis of recruitment approaches in the vitamin D and type 2 diabetes (D2d) study, a multicenter trial in participants with prediabetes. Outcomes were adoption of electronic health record-supported recruitment approaches by sites, number of participants screened, recruitment performance (proportion screened who were randomized), and characteristics of participants from electronic health record-supported versus non-electronic health record methods. RESULTS: In total, 2423 participants were randomized: 1920 from electronic health record (mean age of 60 years, 41% women, 68% White) and 503 from non-electronic health record sources (mean age of 56.9 years, 58% women, 61% White). Electronic health record-supported recruitment was adopted by 21 of 22 sites. Electronic health record-supported recruitment was associated with more participants screened versus non-electronic health record methods (4969 vs 2166 participants screened), higher performance (38.6% vs 22.7%), and more randomizations (1918 vs 505). Participants recruited via electronic health record were older, included fewer women and minorities, and reported higher use of dietary supplements. Electronic health record-supported recruitment was incorporated in diverse clinical environments, engaging clinicians either at the individual or the healthcare system level. CONCLUSION: Establishing electronic health record-supported recruitment approaches across a multicenter prediabetes/diabetes trial is feasible and can be adopted by diverse clinical environments.

Individual, parental and built environmental features as influencing factors of active travel to school in northeast China: findings from a cross-sectional study.

OBJECTIVES: Active travel to school (ATS)-associated factors had been studied in some developed countries but rarely in China. We studied the associated factors of ATS at individual, parental and built environment domains in northeast China. DESIGN AND PARTICIPANTS: A cross-sectional survey was conducted among 4-6 grade students in 2017. Sociodemographic features and information of parents were collected using questionnaires, and SuperMap (a geographical information system software) was used to catch built environment features. Logistic regression models were used to examine the relationship between multilevel factors and ATS. RESULTS: Our study sample comprised 3670 primary school students aged from 8 to 15 (boys=51.0%, ATS=48.8%). Perceived to be fat (OR 1.25, 95% CI 1.00 to 1.55, p<0.05), feeling easy to walk for a short distance (OR 1.63, 95% CI 1.21 to 2.20, p<0.05), mother unemployed (OR 1.52, 95% CI 1.13 to 2.06, p<0.05), higher land use mix (OR 1.23, 95% CI 1.11 to 1.37, p<0.001) and higher density of public transport stations (OR 1.22, 95% CI 1.09 to 1.37, p<0.05) were positively associated with increased possibility of ATS, while higher household annual income (OR 0.60, 95% CI 0.44 to 0.83, p<0.05) and possession of private vehicles (OR 0.56, 95% CI 0.45 to 0.69, p<0.001) were negatively associated with possibility of ATS. CONCLUSIONS: The significant factors associated with ATS were at every examined level, which implies multilevel interventions are needed to encourage ATS. Further interventions could focus on the children's willingness to lead students to opt for healthy behaviours, and children from wealthier families should be encouraged to choose ATS. Also, the government should improve built environment walkability so as to encourage ATS.

Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: effects on sexual function, body composition, muscle performance and physical function in a randomized trial.

OBJECTIVE: This study aims to determine the dose-dependent effects of testosterone on sexual function, body composition, muscle performance, and physical function in hysterectomized women with or without oophorectomy. METHODS: Seventy-one postmenopausal women who previously underwent hysterectomy with or without oophorectomy and had total testosterone levels less than 31 ng/dL or free testosterone levels less than 3.5 pg/mL received a standardized transdermal estradiol regimen during the 12-week run-in period and were randomized to receive weekly intramuscular injections of placebo or 3, 6.25, 12.5, or 25 mg of testosterone enanthate for 24 weeks. Total and free testosterone levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis, respectively. The primary outcome was change in sexual function measured by the Brief Index of Sexual Functioning for Women. Secondary outcomes included changes in sexual activity, sexual distress, Derogatis Interview for Sexual Functioning, lean body mass, fat mass, muscle strength and power, and physical function. RESULTS: Seventy-one women were randomized; five groups were similar at baseline. Sixty-two women with analyzable data for the primary outcome were included in the final analysis. The mean on-treatment total testosterone concentrations were 19, 78, 102, 128, and 210 ng/dL in the placebo, 3-mg, 6.25-mg, 12.5-mg, and 25-mg groups, respectively. Changes in composite Brief Index of Sexual Functioning for Women scores, thoughts/desire, arousal, frequency of sexual activity, lean body mass, chest-press power, and loaded stair-climb power were significantly related to increases in free testosterone concentrations; compared with placebo, changes were significantly greater in women assigned to the 25-mg group, but not in women in the lower-dose groups. Sexual activity increased by 2.7 encounters per week in the 25-mg group. The frequency of androgenic adverse events was low. CONCLUSIONS: Testosterone administration in hysterectomized women with or without oophorectomy for 24 weeks was associated with dose and concentration-dependent gains in several domains of sexual function, lean body mass, chest-press power, and loaded stair-climb power. Long-term trials are needed to weigh improvements in these outcomes against potential long-term adverse effects.