The 2013 Academic Emergency Medicine consensus conference focused on global health and emergency care research. One conference breakout session discussed research ethics and developed a research agenda concerning global acute care research ethics. This article represents the proceedings from that session, particularly focusing on ethical issues related to protecting human subjects while conducting acute care research. Protecting human research subjects from unnecessary risk is an important component of conducting ethical research, regardless of the research site. There are widely accepted ethical principles related to human subjects research; however, the interpretation of these principles requires specific local knowledge and expertise to ensure that research is conducted ethically within the societal and cultural norms.There is an obligation to conduct research ethically while recognizing the roles and responsibilities of all participants. This article discusses the complexities of determining and applying socially and culturally appropriate ethical principles during the conduct of global acute care research. Using case studies, it focuses both on the procedural components of ethical research conducted outside of "Western" culture and on basic ethical principles that are applicable to all human subjects research.
BackgroundPelvic bleeding from trauma and postpartum hemorrhage is often difficult to treat successfully by emergency providers particularly in low resource environments, when hospital presentation is delayed or there is a lack of immediate surgical, anesthesia, and transfusion capabilities. Pneumatic anti-shock garments (PASG) decrease pelvic blood flow and hemorrhage. A tightly fitted neoprene non-pneumatic anti-shock garment (NASG) has been shown to decrease blood loss and improve survival rates from postpartum hemorrhage.AimsThe objective of this study was to determine whether blood flow to the pelvis is decreased by use of the NASG or by an improvised PASG.MethodsA PASG was made using three bicycle tubes, placing one tube on each leg and one on the lower abdomen/pelvis, wrapping firmly with sheets and inflating the tubes to approximately 3.5 bar (45 psi). A Doppler ultrasound was used to measure distal aortic blood flow in 12 healthy adults at baseline and in both devices. Data were analyzed with one sample and paired t tests.ResultsMean flow was 1.99 l/min at baseline. Mean flow decrease was 1.11 [95% confidence interval (CI): 0.64–1.57, p = 0.0003 for the difference] for the PASG and 0.65 (95% CI: 0.03–1.26, p = 0.04) for the NASG. The PASG decreased blood flow more than the NASG (mean difference: 0.46, 95% CI: 0.02–0.90, p = 0.04).ConclusionsBoth devices decreased distal aortic blood flow, but the improvised PASG device decreased it by a larger margin.
BackgroundObstetric hemorrhage remains the leading cause of maternal mortality in resource limited areas. An inexpensive pneumatic anti-shock garment was devised of bicycle tubes and tailored cloth which can be prepared from local materials in resource-limited settings. The main purposes of this study were: 1) to determine acceptability of the device by nurses and midwives and obtain suggestions for making the device more suitable for use in their particular work environments, 2) to determine whether a three hour training course provided adequate instruction in the use of this device for the application of circumferential abdominal pelvic pressure, and 3) determine production capability and cost in a resource-limited country.MethodsFifty-eight nurse and midwife participants took part in three sessions over eight months in Nepal. Correct device placement was assessed on non-pregnant participants using ultrasound measurement of distal aortic flow before and after device inflation, and analyzed using confidence intervals. Participants were surveyed to determine acceptability of the device, obtain suggestions for improvement, and to collect data on clinical use.ResultsDevice placement achieved flow decreases with a mean of 39% (95% CI 25%-53%, p < 0.001) in the first session, 28% (95% CI 21%-33%, P < 0.001) after four months and 29% (95% CI 24%-34%, p < 0.001) at 8 months. All nurses and midwives thought the device would be acceptable for use in obstetric hemorrhage and that they could make, clean, and apply it. They quickly learned to apply the device, remembered how to apply it, and were willing and able to use the device clinically. Ten providers used the device, each on one patient, to treat obstetric hemorrhage after routine measures had failed; bleeding stopped promptly in all ten, two of whom were transported to the hospital. Production of devices in Kathmandu using local tailors and supplies cost approximately $40 per device, in a limited production setting.ConclusionsPreliminary data suggest that an inexpensive, easily-made device is potentially an appropriate addition to current obstetric hemorrhage treatment in resource-limited areas and that further study is warranted.
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