Priority-setting for hospital funding of high-cost innovative drugs and therapeutics: A qualitative institutional case study.

OBJECTIVES: Rising costs of innovative drugs and therapeutics (D&Ts) have led to resource allocation challenges for healthcare institutions. There is limited evidence to guide priority-setting for institutional funding of high-cost D&Ts. This study sought to identify and elaborate on the substantive principles and procedures that should inform institutional funding decisions for high-cost off-formulary D&Ts through a case study of a quaternary care paediatric hospital. METHODS: Semi-structured, qualitative interviews, both virtual and in-person, were conducted with institutional stakeholders (i.e. staff clinicians, senior leadership, and pharmacists) (n = 23) and two focus groups at The Hospital for Sick Children in Toronto, Canada. Participants involved in, and impacted by, high-cost off-formulary drug funding decisions were recruited through stratified, purposive sampling. Participants were approached for study involvement between July 27, 2020 and June 7, 2022. Data was analysed through reflexive thematic analysis. RESULTS: Institutional resource allocation for high-cost D&Ts was identified as ethically challenging but critical to sustainable access to novel therapies. Important substantive principles included: 1) clinical evidence of safety and efficacy, 2) economic considerations (direct costs, opportunity costs, value for money), 3) ethical principles (social justice, professional/organizational responsibility), and 4) disease-specific considerations. Multidisciplinary deliberation was identified as an essential procedural component of decision-making. Participants identified tension between innovation and the need for evidence-based decision-making; clinician and institutional responsibilities; and value for money and social justice. Participants emphasized the role of health system-level funding allocation in alleviating the financial and moral burden of decision-making by institutions. CONCLUSIONS: This study identifies values and processes to aid in the development and implementation of institutional resource allocation frameworks for high-cost innovative D&Ts.

Gluten-Free Diet Knowledge and Adherence in Adolescents with Celiac Disease: A Cross-Sectional Study.

Objectives: This study examined the relationship between knowledge of, and adherence to, the gluten-free diet (GFD) in a local population of adolescents with celiac disease (CD). The secondary objectives were to identify information sources used to learn about the GFD and to compare adolescents' and parents' knowledge of the GFD. Methods: Adolescents (12-17 years) with CD and their parents from pediatric gastroenterology clinics in Calgary, Alberta, completed an online survey containing a knowledge assessment (Gluten-Free Diet Quiz [GFD-Q]), an adherence scale, questions about GFD information sources, and demographic/clinical information. GFD-Q scores were deemed "sufficient knowledge" with correct identification of 3/3 gluten-containing foods, ≥4/7 gluten-free foods, and ≥ 4/7 foods that may contain gluten; otherwise, scores were termed "insufficient knowledge". Results: Of the 40 adolescent-parent pairs, 15 of 40 adolescents (37%) had sufficient knowledge, and 25 of 40 adolescents (63%) had insufficient knowledge. Within the insufficient knowledge group, 14 of 25 (56%) did not correctly identify enough allowed gluten-free foods. Parents scored higher on the GFD-Q (67% had sufficient knowledge). Adolescents reported overall adherence to the GFD (88%), with adherence being similar between the sufficient and insufficient knowledge groups (80% versus 92%). The most helpful information sources included physicians, another person with CD, parent(s), and Google; apps were infrequently used. Conclusion: Adolescents report good adherence; however, they struggle with GFD knowledge, particularly in identifying gluten-free foods. Further research is required to explore GFD educational tools, including mobile apps and dietician-led teaching sessions.

Race, Kidney Transplants, Immunosuppression Research, and White Supremacy under Apartheid, 1960-80.

This paper uses the history of kidney transplantation in South Africa as a lens through which to write a racialized, micro history that illustrates the politics of medical discoveries and medical research at one of South Africa's most prestigious medical research universities, the University of the Witwatersrand (Wits) in Johannesburg. Between 1966 and the 1980s, the Wits team became the most advanced and prolific kidney transplant unit in the country. Yet the racist, oppressive Apartheid system fundamentally shaped these developments. Transplantation, as this paper shows, became an elite medical procedure, performed by a select group of white doctors on mostly white patients. For these doctors, transplantation showed their medical prowess and displayed the technical advancements they were able to make in research and clinical practice as they strove to position South Africa as a significant international player in medical research, despite academic boycotts and increasing sanctions. Transplantation became a symbol of white supremacy in a country where the black majority were excluded from anything but the most basic health care.

Is Canadian federal legislation effective in preventing youth access to vaping initiation products? A study using secret shoppers and online access in three Alberta cities.

The Tobacco and Vaping Products Act (Canada, 1997) (the "TVPA") aims to protect the health of young persons by restricting access to vaping products. We studied whether the TVPA achieves this goal by sending young 'secret shoppers' to 120 shops in Calgary, Edmonton, and Red Deer to attempt to buy nicotine-based vaping-initiation products, and by asking minors to purchase the same product online. We used three 'improper' shop scenarios: 1. a minor or minors; 2. a young adult with no or invalid identification ("ID"); and 3. a young adult with valid ID but clearly buying for an accompanying minor. Of total vendors, 42.5% (51/120) were willing to sell to the young people (p < .001). Most vendors requested ID in all scenarios (97/120, 80.8%). Of these, 28 vendors (28.9% of those requesting ID), were still willing to sell the product. All vendors who did not request ID (23/120, 19.2%) were willing to sell; vape shops were more likely than convenience stores not to request ID (25.4% v. 13.1%). In five online purchase attempts, 60% of deliverers did not meet the TVPA's ID verification requirements. The TVPA does not require packages to reveal their contents; one parent inadvertently signed for the parcel. To prevent youth access, the TVPA should require: a minimum nicotine product purchase age of 21, positive obligations on vendors to request ID, prohibition of sales to adults buying for minors, and that manufacturers disclose the product on posted or delivered parcels. The TVPA should be strictly enforced.

The nurse in the university: a history of university education for South african nurses: a case study of the university of the witwatersrand.

This paper charts the history and debates surrounding the introduction of academic, university-based training of nurses in South Africa. This was a process that was drawn out over five decades, beginning in the late 1930s. For nurses, university training was an important part of a process of professionalization; however, for other members of the medical community, nursing was seen as being linked to women's service work. Using the case-study of the University of the Witwatersrand, one of South Africa's premier universities and the place in the country to offer a university-based nursing program, we argue that an historical understanding of the ways in which nursing education was integrated into the university system tells us a great deal about the professionalization of nursing. This paper also recognises, for the first time, the pioneers of this important process.