Routine, nonmedical and ancillary medical costs associated with participation in clinical research create barriers to enrollment for economically disadvantaged individuals. To the extent that race, ethnicity, and gender are linked to SES, such barriers impact efforts to diversify clinical research enrollment. But payment policies and practices often reflect the longstanding and singular concern that payment to participants will bias decision-making and compromise informed consent. We argue that this concern must be viewed in a larger ethical context in which the untoward consequences for the individual participant and for the broader research enterprise are considerable when either inadequate or no payment is provided for expenses incurred (“reimbursement”) and time committed (“compensation”). Fairness in payment and protection from undue influence of payment on the informed consent process are important but distinct ethical considerations. Fundamentally, approaches to payment that leave participants financially worse off as a consequence of taking part in research are inherently unjust as they have a differential impact on recruitment and retention based on socioeconomic status. Sponsors, funders, investigators, and IRBs must be cognizant of the impact of inadequate payment on clinical trial inclusion of historically understudied groups. We address practical and fair payment strategies to advance inclusion, the additional barrier of ancillary medical costs, and potential unintended consequences of payment.

In recent years, a variety of efforts have been made in political science to enable, encourage, or require scholars to be more open and explicit about the bases of their empirical claims and, in turn, make those claims more readily evaluable by others. While qualitative scholars have long taken an interest in making their research open, reflexive, and systematic, the recent push for overarching transparency norms and requirements has provoked serious concern within qualitative research communities and raised fundamental questions about the meaning, value, costs, and intellectual relevance of transparency for qualitative inquiry. In this Perspectives Reflection, we crystallize the central findings of a three-year deliberative process—the Qualitative Transparency Deliberations (QTD)—involving hundreds of political scientists in a broad discussion of these issues. Following an overview of the process and the key insights that emerged, we present summaries of the QTD Working Groups’ final reports. Drawing on a series of public, online conversations that unfolded at www.qualtd.net, the reports unpack transparency’s promise, practicalities, risks, and limitations in relation to different qualitative methodologies, forms of evidence, and research contexts. Taken as a whole, these reports—the full versions of which can be found in the Supplementary Materials—offer practical guidance to scholars designing and implementing qualitative research, and to editors, reviewers, and funders seeking to develop criteria of evaluation that are appropriate—as understood by relevant research communities—to the forms of inquiry being assessed. We dedicate this Reflection to the memory of our coauthor and QTD working group leader Kendra Koivu.1

We identified a pseudo-outbreak of Mycobacterium avium in an outpatient bronchoscopy clinic following an increase in clinic procedure volume. We terminated the pseudo-outbreak by increasing the frequency of automated endoscope reprocessors (AER) filter changes from quarterly to monthly. Filter changing schedules should depend on use rather than fixed time intervals.

The purpose of this prospective cohort study of twins and triplets was to evaluate perinatal and early childhood outcomes through 18 months of age. The study population included 141 twin pregnancies (282 twin children) and 8 triplet pregnancies (24 triplet children) recruited between May, 1996 and June, 2001. Mothers of triplets versus twins were significantly more likely to have infertility treatments, to be overweight or obese before conception, to be admitted antenatally, and to deliver by cesarean section. Length of gestation for triplets was significantly shorter (–2.31 weeks, p < .0001), and more likely to be less than 35 weeks (Adjusted Odds Ratio [AOR] 9.38, 95% confidence interval [CI] 3.22–27.29). Average birthweight for triplets was significantly lighter (–495 grams, p < .0001), and more likely to be low birthweight (AOR 11.38, 95% CI 3.11–41.61). Triplets were also more likely to be admitted to neonatal intensive care (AOR 7.97, 95% CI 2.13–29.77), to require mechanical ventilation (AOR 5.67, 95% CI 2.05–15.65), to develop respiratory distress syndrome (AOR 12.50, 95% CI 3.89–40.20), or a major morbidity (retinopathy of prematurity, necrotizing enterocolitis, ventilator support, or grade III or IV intraventricular hemorrhage, AOR 5.67, 95% CI 2.05–15.65). Weight, length, and head circumference was significantly smaller at birth for triplets compared to twins, and these differences remained through 18 months of age, along with lower mental developmental scores at the oldest age. Compared to twins, triplets have greater neonatal morbidity, and through 18 months of age lower mental and motor scores, slower postnatal growth and more residual stunting, particularly of length and head circumference.

Our aim was to evaluate the risk of death among healthy infants due to maltreatment, using national linked vital statistics data. The study population included all nonanomalous, full-term (≥ 37 weeks), non-low birthweight (> 2500 grams) infants born between 1995 and 2000 and their linked death certificates: 18,673,439 singleton pregnancies (36,864 deaths) and 77,800 twin pregnancies (356 pregnancies with a death). The underlying cause of death was characterized as due to maltreatment, sudden infant death syndrome (SIDS), and other causes, based on ICD-9 and ICD-10 codes, and modeled by maternal age using multinomial logistic regression; mothers aged 25 to 29 were the reference group. The highest risk for infant mortality was among the youngest mothers for maltreatment (AOR 2.45 and 1.95 for singleton mothers < 20 and aged 20 to 24, respectively; AOR 4.34 and 2.25 for twin mothers < 20 and aged 20 to 24, respectively). The risk of death overall and for each category was modeled by maternal age < 20, aged 20 to 24, and ≥ 25, with and without the father's age present on the birth certificate, with mothers ≥ 25 and father's age present as the reference group. All risks of death were significantly increased for mothers younger than age 25, with the highest risks among the youngest mothers and missing father's age. The pattern for twins was similar, with elevated risks among younger mothers with or without father's age present on the birth certificate. These results add to the body of knowledge regarding risk factors for infant mortality among healthy singletons and twins.

The objective of the study was to test the hypothesis that changes in arm anthropometry can be used to determine the risk of faltering growth in twin gestations. Serial data on midupper arm circumference (MUAC) and maternal weight gain were collected from a sample of 156 mothers. Changes in MUAC were monitored from 20 to 34 weeks. Women with a large loss of MUAC (greater than 1.5 cm), particularly when it occurred within two to four weeks of delivery, were significantly heavier, had higher pregravid Body Mass Indexes (BMIs), but gained less weight than mothers with no change in MUAC. In analysis of covariance models adjusting for length of gestation, black ethnicity, males per twin pair, monochorionicity, and baseline MUAC at 20 weeks, a large loss of MUAC was associated with significantly lower birthweight (2263 g vs. 2499 g) and birthweight z-score (–0.92 SDU vs. –0.39 SDU). Changes in MUAC from 20 to 34 weeks, and especially near delivery, are significantly associated with fetal growth in twin pregnancies. A positive change may indicate that the mother has adequate dietary intake or nutrient stores to continue to accrue lean body mass and support fetal growth, while a loss of MUAC indicates that dietary intake or nutrient stores may be inadequate. This simple, relatively precise, measure of change in maternal body composition during pregnancy may be useful in identifying twin pregnancies at risk for faltering intrauterine growth, particularly among overweight or obese women.

The objective of this study was to compare length of gestation, fetal growth, and birthweight by race/ethnicity and pregravid weight groups in twin pregnancies. Three thousand and thirty-six twin pregnancies of 28 weeks or more gestation were divided by race/ethnicity (White, Black and Hispanic), and pregravid body mass index (BMI) groups (less than 25.0 vs. 25.0 or more). Outcomes were modeled using multiple regression, controlling for confounders, with White non-Hispanic women as the reference group. Hispanic women had the highest average birthweight and the longest gestation, as well as the lowest proportions of low birthweight, very low birthweight, preterm and early preterm births of the 3 race/ethnicity groups. In the multivariate analyses, Hispanic women had significantly longer gestations (by 7.8 days) and faster rates of fetal growth midgestation (20 to 28 weeks, by 17.4 g/week) and late gestation (after 28 weeks, by 5.3 g/week), whereas Black women had significantly slower rates of fetal growth (by 5.7 g/week and by 4.5 g/week, respectively). These findings in twins reflect the racial and ethnic disparities previously shown in singletons, including the Hispanic paradox of longer gestations and higher rates of fetal growth.

Advances in perinatal technology that improved survival may have also resulted in prolonged death from the neonatal to the postneonatal period for some infants. The objectives of this study were to determine if the medical advances that occurred in the 1990s benefited infants of multiple births more than their singleton counterparts, and if these changes prevented or postponed mortality for the smallest and most immature infants. The study population included live births of 22 to 43 weeks' gestation from the 1989–1991 and 1999–2001 US Birth Cohort Linked Birth/Infant Death Data Sets. Odds ratios were calculated to evaluate the change in risk by plurality, gestation, and to compare the change to that for singletons. Neonatal and infant mortality rates declined for all pluralities; postneonatal mortality increased for births at less than 26 weeks, but declined at later gestations. In general, the risk of death for twins and triplets compared to singletons decreased, and the improvement in survival was greater for multiples during the early neonatal period and overall. Infant mortality rates improved by 28% for singletons, 32% for twins and triplets during the 1990s, although for the most premature infants, some deaths were postponed from the early to the late neonatal period.