Indicative planning in developed economies

Importance In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome. Objective To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth. Design, Setting, and Participants APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in the Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010). Intervention Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n=201) or placebo (n=205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses. Main Outcome Measures Primary outcome was a composite of adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage > grade 2, periventricular leukomalacia > grade 1, or necrotizing enterocolitis). Analyses were completed on an intention-to-treat basis. Results Mean (SD) gestational age at randomization was 29.2 (1.7) weeks for both groups. Adverse perinatal outcome was not significantly different between groups: 11.9% (24/201; 95% CI, 7.5%-16.4%) for nifedipine vs 13.7% (28/205; 95% CI, 9.0%-18.4%) for placebo (relative risk, 0.87; 95% CI, 0.53-1.45). Conclusions and Relevance In patients with threatened preterm labor, nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo. Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine cannot completely be excluded, its use for maintenance tocolysis does not appear beneficial at this time

Transdisciplinary Generalism: Naming the epistemology and philosophy of the generalist

Background: Transdisciplinary research and generalist practice both face the task of integrating and discerning the value of knowledge across disciplinary and sectoral knowledge cultures. Transdisciplinarity and generalism also both offer philosophical and practical insights into the epistemology, ontology, axiology, and logic of seeing the ‘whole’. Although generalism is a skill that can be used in many settings from industry to education, the focus of this paper is the literature of the primary care setting (i.e., general practice or family medicine). Generalist philosophy and practice in the family medicine setting highly values whole person care that uses integrative and interpretive wisdom to include both biomedical and biographical forms of knowledge. Generalist researchers are often caught between reductionist (positivist) biomedical measures and social science (post-positivist) constructivist theories of knowing. Neither of these approaches, even when juxtaposed in mixed-methods research, approximate the complexity of the generalist clinical encounter. A theoretically robust research methodology is needed that acknowledges the complexity of interpreting these ways of knowing in research and clinical practice. Methods: A conceptual review of literature to define the alignment between (a) the philosophy and practice of generalism in primary care and (b) both the practical (Zurich) and philosophical or methodological (Nicolescuian) schools of transdisciplinarity. Results: The alignment between generalism and transdisciplinarity included their broad scope, relational process, complex knowledge management, humble attitude to knowing, and real-world outcome focus. Conclusion: The concurrence between these approaches to knowing is offered here as Transdisciplinary Generalism – a coherent epistemology for both primary care researchers and generalist clinicians to understand, enact, and research their own sophisticated craft of managing diverse forms of knowledge