Consent Rates Reported in Published Pediatric Randomized Controlled Trials.

OBJECTIVE: To determine the average reported consent rate for published pediatric randomized controlled trials (RCTs) and whether this rate varies by trial characteristics. STUDY DESIGN: A review of pediatric RCTs published in Medline in 2009, 2010, or 2015 was performed. Secondary analyses of prior trials, trials including adults, trials not requiring consent, or trials with missing or unclear consent data were excluded. Consent rate was defined as the number of patients enrolled divided by number of eligible patients where families were approached. Random effects meta-regression was conducted to determine the weighted average consent rate. RESULTS: Of 2347 trials identified, 1651 were excluded. An additional 418 of 696 (60%) were excluded because the consent rate was missing or unclear. The average consent rate for 278 included RCTs was 82.6% (95% CI, 80.3%-84.8%) and was higher for vaccination compared with behavioral trials and for industry-funded compared with National Institutes of Health-funded or other government-funded trials. The average consent rate was <70% for 26% of included trials. Of these trials, US trials (28/77 [36.4%]) had a higher probability of a consent rate of <70% than non-US studies (35/64 [21.3%]) and multinational (9/37 [24.3%]) studies. There was slight variation by funding category. CONCLUSIONS: Although the average consent rate for published trials was reasonably high, approximately one-quarter of trials had consent rates of <70%. Consent rates reporting has improved over time, but remains suboptimal. Our findings should assist with the planning of future pediatric RCTs, although consent data from unpublished trials are also needed.

Short interpregnancy interval as a risk factor for preterm birth in non-Hispanic Black and White women in California.

OBJECTIVE: Short interpregnancy interval (IPI) is associated with adverse pregnancy outcomes, including preterm birth (PTB < 37 weeks GA). We investigated whether short IPI (< 6 months) contributes to the higher PTB frequency among non-Hispanic Blacks (NHB). STUDY DESIGN: Using a linked birth cohort > 1.5 million California live births, we examined frequencies of short IPI between racial/ethnic groups and estimated risks by multivariable logistic regression for spontaneous PTB. We expanded the study to births 1991-2012 and utilized a "within-mother" approach to permit methodologic inquiry about residual confounding. RESULTS: NHB women had higher frequency (7.6%) of short IPI than non-Hispanic White (NHW) women (4.4%). Adjusted odds ratios for PTB and short IPI were 1.64 (95% CI 1.54, 1.76) for NHW and 1.49 (1.34, 1.65) for NHB. Using within-mother analysis did not produce substantially different results. CONCLUSIONS: Short IPI is associated with PTB but does not explain risk disparity between NHWs and NHBs.

Patient safety strategies targeted at diagnostic errors: a systematic review.

Missed, delayed, or incorrect diagnosis can lead to inappropriate patient care, poor patient outcomes, and increased cost. This systematic review analyzed evaluations of interventions to prevent diagnostic errors. Searches used MEDLINE (1966 to October 2012), the Agency for Healthcare Research and Quality's Patient Safety Network, bibliographies, and prior systematic reviews. Studies that evaluated any intervention to decrease diagnostic errors in any clinical setting and with any study design were eligible, provided that they addressed a patient-related outcome. Two independent reviewers extracted study data and rated study quality. There were 109 studies that addressed 1 or more intervention categories: personnel changes (n = 6), educational interventions (n = 11), technique (n = 23), structured process changes (n = 27), technology-based systems interventions (n = 32), and review methods (n = 38). Of 14 randomized trials, which were rated as having mostly low to moderate risk of bias, 11 reported interventions that reduced diagnostic errors. Evidence seemed strongest for technology-based systems (for example, text message alerting) and specific techniques (for example, testing equipment adaptations). Studies provided no information on harms, cost, or contextual application of interventions. Overall, the review showed a growing field of diagnostic error research and categorized and identified promising interventions that warrant evaluation in large studies across diverse settings.

A systematic review of the care coordination measurement landscape.

BACKGROUND: Care coordination has increasingly been recognized as an important aspect of high-quality health care delivery. Robust measures of coordination processes will be essential tools to evaluate, guide and support efforts to understand and improve coordination, yet little agreement exists among stakeholders about how to best measure care coordination. We aimed to review and characterize existing measures of care coordination processes and identify areas of high and low density to guide future measure development. METHODS: We conducted a systematic review of measures published in MEDLINE through April 2012 and identified from additional key sources and informants. We characterized included measures with respect to the aspects of coordination measured (domain), measurement perspective (patient/family, health care professional, system representative), applicable settings and patient populations (by age and condition), and data used (survey, chart review, administrative claims). RESULTS: Among the 96 included measure instruments, most relied on survey methods (88%) and measured aspects of communication (93%), in particular the transfer of information (81%). Few measured changing coordination needs (11%). Nearly half (49%) of instruments mapped to the patient/family perspective; 29% to the system representative and 27% to the health care professionals perspective. Few instruments were applicable to settings other than primary care (58%), inpatient facilities (25%), and outpatient specialty care (22%). CONCLUSIONS: New measures are needed that evaluate changing coordination needs, coordination as perceived by health care professionals, coordination in the home health setting, and for patients at the end of life.