Using a monitoring and evaluation framework to improve study efficiency and quality during a prospective cohort study in infants receiving rotavirus vaccination in El Alto, Bolivia: the Infant Nutrition, Inflammation, and Diarrheal Illness (NIDI) study.

BACKGROUND: Implementing rigorous epidemiologic studies in low-resource settings involves challenges in participant recruitment and follow-up (e.g., mobile populations, distrust), biological sample collection (e.g., cold-chain, laboratory equipment scarcity) and data collection (e.g., literacy, staff training, and infrastructure). This article describes the use of a monitoring and evaluation (M&E) framework to improve study efficiency and quality during participant engagement, and biological sample and data collection in a longitudinal cohort study of Bolivian infants. METHODS: The study occurred between 2013 and 2015 in El Alto, Bolivia, a high-altitude, urban, low-resource community. The study's M&E framework included indicators for participant engagement (e.g., recruitment, retention, safety), biological sample (e.g., stool and blood), and data (e.g., anthropometry, questionnaires) collection and quality. Monitoring indicators were measured regularly throughout the study and used for course correction, communication, and staff retraining. RESULTS: Participant engagement indicators suggested that enrollment objectives were met (461 infants), but 15% loss-to-follow-up resulted in only 364 infants completing the study. Over the course of the study, there were four study-related adverse events (minor swelling and bruising related to a blood draw) and five severe adverse events (infant deaths) not related to study participation. Biological sample indicators demonstrated two blood samples collected from 95% (333 of 350 required) infants and stool collected for 61% of reported infant diarrhea episodes. Anthropometry data quality indicators were extremely high (median SDs for weight-for-length, length-for-age and weight-for-age z-scores 1.01, 0.98, and 1.03, respectively), likely due to extensive training, standardization, and monitoring efforts. CONCLUSIONS: Conducting human subjects research studies in low-resource settings often presents unique logistical difficulties, and collecting high-quality data is often a challenge. Investing in comprehensive M&E is important to improve participant recruitment, retention and safety, and sample and data quality. The M&E framework from this study can be applied to other longitudinal studies.

"The Fetus Is My Patient, Too": Attitudes Toward Abortion and Referral Among Physician Conscientious Objectors in Bogotá, Colombia.

CONTEXT: In 2006, the Colombian Constitutional Court partially decriminalized abortion. However, barriers to access, including improper use of conscientious objection, remain. METHODS: To explore conscientious objection from the objectors' perspectives, in-depth interviews were conducted in 2014 with 13 key informants and with 15 Colombian physicians who self-identified as conscientious objectors. Recruitment included snowball and purposive sampling techniques. Analysis was conducted in tandem with data collection and focused on objectors' attitudes, beliefs and behaviors related to abortion and referral. RESULTS: Objectors had varied perspectives. Three types of objectors were evident: extreme, moderate and partial. Extreme objectors refused to perform abortions or make referrals, and often lectured their patients; they also provided misleading or false medical and legal information, preventing women from accessing abortions to which they were legally entitled. Moderate objectors would not perform abortions, but respected their patients and viewed referral as a way to save "one out of two" lives. Partial objectors performed some abortions but refused to do others on the basis of gestational age or case-by-case circumstances. Across the typology, objectors linked conscientious objection with medical ethics, and many described a duty to protect the fetus, which they conceptualized as a patient. CONCLUSION: Conscientious objectors exhibit diverse opinions and behaviors. Potential areas for future investigation include identifying factors that lead objectors to refer and estimating the prevalence of each type of objector. Results suggest potential interventions that could reduce the role of conscientious objection as a barrier to care.