ABSTRACT
Establishing and proving methodological rigor has long been a challenge for qualitative researchers where quantitative methods prevail, but much published literature on qualitative analysis assumes a relatively small number of researchers working in relative proximity. This is particularly true for research conducted with a grounded theory approach. Different versions of grounded theory are commonly used, but this methodology was originally developed for a single researcher collecting and analyzing data in isolation. Although grounded theory has evolved since its development, little has been done to reconcile this approach with the changing nature and composition of international research teams. Advances in technology and an increased emphasis on transnational collaboration have facilitated a shift wherein qualitative datasets have been getting larger and the teams collecting and analyzing them more diverse and diffuse. New processes and systems are therefore required to respond to these conditions. Data for this article are drawn from the experiences of the Innovations for Choice and Autonomy (ICAN) Research Consortium. ICAN aims to understand how self-injectable contraceptives can be implemented in ways that best meet women's needs in Kenya, Uganda, Malawi, and Nigeria. We found that taking a structured approach to analysis was important for maintaining consistency and making the process more manageable across countries. However, it was equally important to allow for flexibility within this structured approach so that teams could adapt more easily to local conditions, making data collection and accompanying analysis more feasible. Meaningfully including all interested researchers in the analysis process and providing support for learning also increased rigor. However, competing priorities in a complex study made it difficult to adhere to planned timelines. We conclude with recommendations for both funders and study teams to design and conduct global health studies that ensure more equitable contributions to analysis while remaining logistically feasible and methodologically sound.
Subject(s)
Learning , Research Personnel , Humans , Female , Uganda , Kenya , MalawiABSTRACT
Much of the methodological literature on rapid qualitative analysis describes processes used by a relatively small number of researchers focusing on one study site and using rapid analysis to replace a traditional analytical approach. In this paper, we describe the experiences of a transnational research consortium integrating both rapid and traditional qualitative analysis approaches to develop social theory while also informing program design. Research was conducted by the Innovations for Choice and Autonomy (ICAN) consortium, which seeks to understand how self-injection of the contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) can be implemented in a way that best meets women's needs, as defined by women themselves. Consortium members are based in Kenya, Uganda, Malawi, Nigeria, and the United States. Data for the ICAN study was collected in all four countries in sub-Saharan Africa. In order to both illuminate social phenomena across study sites and inform the program design component of the study, researchers developed tools meant to gather both in-depth information about women's contraceptive decision-making and data targeted specifically to program design during the formative qualitative phase of the study. Using these two bodies of data, researchers then simultaneously conducted both a traditional qualitative and rapid analysis to meet multiple study objectives. To complete the traditional analysis, researchers coded interview transcripts and kept analytical memos, while also drawing on data collected by tools developed for the rapid analysis. Rapid analysis consisted of simultaneously collecting data and reviewing notes developed specifically for this analysis. We conclude that integrating traditional and rapid qualitative analysis enabled us to meet the needs of a complex transnational study with the added benefit of grounding our program design work in more robust primary data than normally is available for studies using a human-centered design approach to intervention development. However, the realities of conducting a multi-faceted study across multiple countries and contexts made truly "rapid" analysis challenging.
ABSTRACT
BACKGROUND: Evidence supporting venous thromboembolism (VTE) prophylaxis with direct oral anticoagulants (DOACs) in patients with nephrotic syndrome (NS) is limited to case reports. OBJECTIVE: The purpose of this study was to compare bleeding and thromboembolic events in this population. METHODS: A retrospective cohort study was conducted in adults with NS initiated on a DOAC or warfarin for VTE prophylaxis between January 2013 and July 2021 within the Ochsner Health System. Patients with study drug exposure within the preceding 7 days, acute VTE within the preceding 6 months, or ≤7 days of study drug exposure were excluded. The primary outcome was the composite rate of major bleeding and clinically relevant nonmajor bleeding. Secondary outcomes included time to major bleeding and rate of new thromboembolic events. This study was approved by the Ochsner Health System Institutional Review Board. RESULTS: Twenty-five DOAC and 19 warfarin patients were included. The primary outcome occurred in 8% vs 26.3% (P = 0.21) of patients treated with a DOAC or warfarin, respectively, and was driven by major bleeding (4% vs 21%, P = 0.25). Other secondary outcomes were similar between cohorts. The study was limited by a small sample size. CONCLUSION AND RELEVANCE: Use of DOACs for VTE prophylaxis resulted in a nonstatistically significant, but clinically relevant lower rate of major bleeding compared to warfarin. This study provides comparative data showing safe and effective use of DOACs in patients with NS. Prospective, randomized studies are needed to confirm results.
