Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach.

OBJECTIVES: While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The "South African Values and Ethics for Universal Health Coverage" (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. METHODS: The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five. RESULTS: The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context. CONCLUSIONS: The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

Caffeine Improves Triathlon Performance: A Field Study in Males and Females.

The ergogenic effect of caffeine on endurance exercise is commonly accepted. We aimed to elucidate realistically the effect of caffeine on triathlon event performance using a field study design, while allowing investigation into potential mechanisms at play. A double-blind, randomized, crossover field trial was conducted. Twenty-six triathletes (14 males and 12 females; mean ± SD: age = 37.8 ± 10.6 years, habitual caffeine intake = 413 ± 505 mg/day, percentage body fat = 14.5 ± 7.2%, and training/week = 12.8 ± 4.5 hr) participated in this study. Microencapsulated caffeine (6 mg/kg body weight) was supplemented 60 min pretrial. Performance data included time to completion, rating of perceived exertion, and profile of mood states. Blood samples taken before, during, and postrace were analyzed for cortisol, testosterone, and full blood count. Capillary blood lactate concentrations were assessed prerace, during transitions, and 3, 6, 9, 12, and 15 min after triathlons. Caffeine supplementation resulted in a 3.7% reduction in swim time (33.5 ± 7.0 vs. 34.8 ± 8.1 min, p < .05) and a 1.3% reduction in time to completion (149.6 ± 19.8 vs. 151.5 ± 18.6 min, p < .05) for the whole group. Gender differences and individual responses are also presented. Caffeine did not alter the rating of perceived exertion significantly, but better performance after caffeine supplementation suggests a central effect resulting in greater overall exercise intensity at the same rating of perceived exertion. Caffeine supplementation was associated with higher postexercise cortisol levels (665 ± 200 vs. 543 ± 169 nmol/L, p < .0001) and facilitated greater peak blood lactate accumulation (analysis of variance main effect, p < .05). We recommend that triathlon athletes with relatively low habitual caffeine intake may ingest 6 mg/kg body weight caffeine, 45-60 min before the start of Olympic-distance triathlon to improve their performance.

The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa.

OBJECTIVES: This article explores the perceived value, including associated strengths and challenges, of using a context-specified ethics framework to guide deliberative health technology appraisals. METHODS: The South African Values and Ethics for Universal Health Coverage (SAVE-UHC) approach, piloted in South Africa, consisted of 2 phases: (1) convening a national multistakeholder working group to develop a provisional ethics framework and (2) testing the provisional ethics framework through simulated health technology assessment appraisal committee meetings (SACs). Three SACs each reviewed 2 case studies of sample health interventions using the framework. Participants completed postappraisal questionnaires and engaged in focus group discussions. RESULTS: The SACs involved 27 participants across 3 provinces. Findings from the postappraisal questionnaires demonstrated general support for the SAVE-UHC approach and content of the framework, high levels of satisfaction with the recommendations produced, and general sentiment that participants were able to actively contribute to appraisals. Qualitative data showed participants perceived using a context-specified ethics framework in deliberative decision making: (1) supported wider consideration of and deliberation about morally relevant features of the health coverage decisions, thereby contributing to quality of appraisals; (2) could improve transparency; and (3) offered benefits to those directly involved in the priority-setting process. Participants also identified some challenges and concerns associated with the approach. CONCLUSIONS: The SAVE-UHC approach presents a novel way to develop and pilot a locally contextualized, explicit ethics framework for health priority setting. This work highlights how the combination of a context-specified ethics framework and structured deliberative appraisals can contribute to the quality of health technology appraisals and transparency of health priority setting.

Nutritional Practices and Body Composition of South African National-Level Spinal Cord-Injured Endurance Hand Cyclists.

Nutritional practices and body composition of para-athletes can impact their health and athletic performance. There is a paucity of research on the nutritional practices, including dietary and supplement intake, body composition and bone health of spinal cord-injured (SCI) endurance hand cyclists. This study assessed the body composition and dietary and supplement intake of 12 national-level SCI endurance hand cyclists (age: 44.0 ± 9.3 years). Bone mineral density (BMD) was assessed in a sub-sample of participants (n = 4) using dual-energy x-ray absorptiometry (DXA). Estimated body fat percentage was healthy (18.4 ± 5.1%) and lumbar spine BMD for the sub-sample was adequate, however hip BMD was low (Z-score and/or T-scores < −2). Carbohydrate intake for male and female participants was below the recommended intake (3.8 (2.9−4.1) and 2.4 (2.0−2.7) g/kg BW, respectively). Overall protein intake was adequate, whilst fat intake was high for both males and females (39.7 (37.7−41.6) and 42.1 (39.0−45.3)% of total energy, respectively). The reported intakes for a few key micronutrients were also below the recommended dietary allowance (RDA) and/or adequate intake (AI) for males (vitamin D, calcium). The prevalence of supplement use before, during, and after training was 40%, 100%, and 60%, respectively. In conclusion, the hand cyclists could benefit from nutritional guidance to match their daily carbohydrate intake with exercise requirements and optimise their fat intake. Optimal vitamin D and calcium intake is also important especially in the light of poor bone health below the lesion level.