Barriers and enablers to and strategies for promoting domestic plasma donation throughout the world: Overarching protocol for three systematic reviews.

INTRODUCTION: The growing demand for plasma protein products has caused concern in many countries who largely rely on importing plasma products produced from plasma collected in the United States and Europe. Optimizing recruitment and retention of a diversity of plasma donors is therefore important for supporting national donation systems that can reliably meet the most critical needs of health services. This series of three systematic reviews aims to synthesize the known barriers and enablers to source plasma donation from the qualitative and survey-based literature and identify which strategies that have shown to be effective in promoting increased intention to, and actual donation of, source plasma. METHODS AND ANALYSIS: Primary studies involving source or convalescent plasma donation via plasmapheresis will be included. The search strategy will capture all potentially relevant studies to each of the three reviews, creating a database of plasma donation literature. Study designs will be subsequently identified in the screening process to facilitate analysis according to the unique inclusion criteria of each review (i.e., qualitative, survey, and experimental designs). The search will be conducted in the electronic databases SCOPUS, MEDLINE, EMBASE, PsycINFO, and CINAHL without date or language restrictions. Studies will be screened, and data will be extracted, in duplicate by two independent reviewers with disagreements resolved through consensus. Reviews 1 and 2 will draw on the Theoretical Domains Framework and Intersectionality, while Review 3 will be informed by Behaviour Change Intervention Ontologies. Directed content analysis and framework analysis (Review 1), and descriptive and inferential syntheses (Reviews 2 and 3), will be used, including meta-analyses if appropriate. DISCUSSION: This series of related reviews will serve to provide a foundation of what is known from the published literature about barriers and enablers to, and strategies for promoting, plasma donation worldwide.

Exploring the increasing need for plasma collection: Perspectives of voluntary nonremunerated donors on payment for plasma in Canada.

OBJECTIVES: The aim of this paper is to understand how voluntary nonremunerated plasma donors in Canada view payment for plasma and the emerging commercial sector. BACKGROUND: There is a growing global demand for plasma, to produce plasma-derived medical products. Source plasma for these products is collected through voluntary nonremunerated donation, sometimes by a national blood service, or by a commercial plasma collector, remunerating donors. METHODS/MATERIALS: This paper presents findings from qualitative semi-structured interviews with source plasma donors in three new source plasma centres in Canada. Interview data were analysed using abductive analysis, an interpretivist approach that builds on grounded theory. RESULTS: This study indicates that there are a range of perspectives on payment for plasma and the emerging commercial sector, from disinterest in payment, to opposition to payment based on the belief that it could undermine donating to help others, and risk public health and safety. One fifth of participants are open to CBS paying donors if it is necessary to increase national sufficiency of plasma. Almost two thirds of participants are opposed to commercial plasma collection in Canada, claiming that it could undermine Canada's public healthcare system, raising questions about transparency and accountability of the commercial plasma industry. CONCLUSION: Findings point to important areas for future study, on publicly collected source plasma, the emerging commercial plasma sector, and the role of the donor as a social actor in a complex political system.

Emotional Labor of Nurses and Phlebotomists in a New Source Plasma Collection Site During the COVID-19 Pandemic.

As uses of plasma-derived medical products increase globally, so does the demand to collect plasma from donors. There is evidence that positive interactions with center staff motivate plasma donors to return. This paper reports on a focused ethnography investigating experiences of nurses and phlebotomists in one of Canadian Blood Services' first source plasma collection center during the COVID-19 pandemic. Participants found the transition from whole blood collection to source plasma amid a global pandemic challenging, but they adapted by coming together as a team, and then worked to put the donor experience first. Their experience resonates with scholarship on emotional labor. As blood services worldwide attempt to increase source plasma collection, there is a need to understand care work that nurses and phlebotomists perform on the front-line. This study offers insight into how blood services can support staff in plasma operations by recognizing emotional labor.

What influences decisions to donate plasma? A rapid review of the literature.

BACKGROUND AND OBJECTIVES: Plasma has become an essential ingredient for various medical treatments. Many blood collection agencies rely on voluntary non-remunerated donation when collecting plasma, but at present many do not collect sufficient plasma to meet domestic demands. This rapid review sought to explore the factors that have been found to influence people's decisions to donate plasma to inform future research. METHODS: Searches were conducted in PubMed, PsycINFO, Social Sciences Citation Index and CINAHL for peer-reviewed journal articles that discussed plasma donation and the factors associated with donor behaviour. Pertinent information from included articles was extracted and arranged in themes. RESULTS: In total, 33 articles were included in this review. Three main themes were identified by the authors. The first focused on site-level factors related to blood collection agencies' engagement with plasma donors and their influence on plasma donation experiences. The second theme considered how individual characteristics and experiences influence willingness to donate plasma. The third theme examined social and cultural-level factors, such as how social networks and community shape perceptions and experiences with donation. CONCLUSION: Our findings suggest that the current understanding of plasma donation is focused mainly on converting whole blood donors and also centres on individual-level factors to donation. Further research must examine what factors attract non-whole blood donors to become plasma donors, focusing on broader social-level influences. This review will inform policies and interventions for blood collection agencies to increase plasma donors.

Understanding the experiences of plasma donors in Canada's new source plasma collection centres during COVID-19: A qualitative study.

BACKGROUND AND OBJECTIVES: To address a national concern over the sufficiency of plasma, Canadian Blood Services (CBS) initiated a proof-of-concept programme with three new source plasma collection centres, aiming to demonstrate a cost-effective template for future source plasma collection and to alleviate the concerns and risks associated with the dependence on the United States. This study uses social capital as a framework to assess the success of the proof-of-concept collection centres. MATERIALS AND METHODS: One-hundred and one qualitative interviews with source plasma donors in three new source plasma centres in Canada were carried out. RESULTS: CBS played a critical role in motivating whole-blood donors to switch to plasma donation by building on their identity as a donor and facilitating access. Community was central to ensuring that donors returned. The importance of the social network was apparent through relationships participants developed with staff and through the relationships that staff had with each other. Donors wanted to understand more about the uses of plasma so that they could promote donation through their social networks outside the centre. CONCLUSION: Campaigns to convert existing blood donors to plasma donors should build on their identity as a donor and structure the centre as a safe and welcoming place. To retain donors, blood collection agencies should emphasize community by facilitating staff ability to work well together and connect with the donor. Blood operators have the potential to expand existing social networks and foster trust through the dissemination of knowledge about plasma more broadly in more diverse communities.

A critical contribution in a time of crisis: Examining motivations and deterrents to COVID-19 convalescent plasma donation and future donation intentions among prospective Canadian donors.

OBJECTIVES: To understand motivations and deterrents to donate COVID-19 convalescent plasma for a clinical trial and determine whether they predict intention to donate source plasma. BACKGROUND: During the COVID-19 pandemic, Canadian Blood Services was involved in three nationally coordinated convalescent plasma clinical trials, requiring the recruitment of several thousand prospective convalescent plasma donors. Understanding the motivations and deterrents of donors in the unique context of a clinical trial and ongoing pandemic can inform recruitment for source plasma donation beyond a clinical trial. METHODS AND MATERIALS: We invited 2785 Canadians who had registered interest in donating COVID-19 convalescent plasma to participate in an online survey containing a 42-item scale on motivators of and deterrents to donation. Between April 26th and May 19th, 2021, 979 responded (35.1%). We included a final sample of 820 participants with sufficient data across all scales. Exploratory and confirmatory factor analysis determined the factor structure of the scale. Regression analysis assessed the extent to which the factors predicted intention to donate. RESULTS: Four factors were identified: 'helping relationally', 'deterrents to donation', 'social facilitators', and 'access to the donation centre', each with good internal consistency (α = 0.78-95). Higher scores on the helping relationally scale were associated with higher odds of intention to donate, whereas higher scores on the deterrents scale were associated with lower odds of intention to donate. CONCLUSION: Participants were motivated by an interest in helping people who are ill and contributing to research committed to finding treatments in a time of crisis. Outside the crisis context, blood service operators seeking to recruit source plasma donors should emphasise its lifesaving potential and the impact of donation on the community.

The Market in Noninvasive Prenatal Tests and the Message to Consumers: Exploring Responsibility.

The potential for bias in industry-developed information about noninvasive prenatal testing (NIPT), in addition to the lack of regulatory oversight for this type of product, raises questions about clinical communication and adoption. We identify NIPTs marketed globally and analyze their English-language consumer-oriented brochures to determine whether they meet existing policy and ethical guidance from the Nuffield Council on Bioethics on NIPT marketing, how they establish the legitimacy of the test given the lack of regulatory oversight for NIPT, and whether content differs between the brochures from for-profit and nonprofit entities. In many of these brochures, NIPTs are misrepresented as diagnostic tests, claims lack supporting evidence, regulatory bodies that do not evaluate the test itself are referenced, and clinicians are invoked as authorities on specific NIPTs. Our findings substantiate concerns about the extent to which commercial imperatives operating in the absence of market-access regulation could exacerbate problems of misrepresentation and inaccuracy in marketing materials.

The Consultant's intermediary role in the regulation of molecular diagnostics in the US.

Molecular diagnostics are fast becoming a big business, with the promise of personalized medicine fueling the growth of "blockbuster" tests with high expectations for health system impact and commercial success. We investigate the polycentric regulatory regime for molecular diagnostics in the US, drawing attention to the prominent role of coverage and reimbursement systems in setting regulatory standards for this industry. We hone in on the private consultants who assist molecular diagnostics companies to gain broad clinical uptake of their products. Through a web-based search of consulting companies, analysis of their online materials, and 13 qualitative interviews with consultants, we describe the role of these actors in the coverage and reimbursement of novel diagnostics and highlight the production of evidence as a critical part of the process. We argue that consultants operate as regulatory intermediaries, helping to develop the evidentiary standards for payment decisions that ultimately benefit their clients, the manufacturers. We suggest that public policy discussions over how best to realize the promise of personalized medicine should be re-oriented to consider whose interests are represented in the regulatory regime governing access to these technologies.

Industry, experts and the role of the 'invisible college' in the dissemination of non-invasive prenatal testing in the US.

Enthusiasm for so-called 'personalized' or 'precision' medicine has encouraged the growth of the molecular diagnostics industry and the proliferation of high-priced proprietary tests that can predict, diagnose or inform the treatment of diverse clinical conditions. Through a case study of non-invasive prenatal testing (NIPT), we explore how the mechanisms governing the development and dissemination of this novel prenatal screening test are most aptly understood as a 'regulatory regime.' We describe how private actors tied to the manufacturers of this test form a network of "experts" that contribute to the coordination of this regime by virtue of their efforts to navigate the governance of test adoption and also form spaces in which the standards governing test adoption are developed. We draw attention to private actors in this regime to demonstrate that they are a constitutive element of the public policy system governing biomedical innovation and adoption. Through this case study of NIPT we deepen our previous analysis of the role of consultants in navigating and shaping a regulatory regime (Holloway and Miller, 2020) and offer new insight about how scientists work with consultants to shape a regulatory regime that serves industry interests. Our work indicates that the private actors tied to the manufacturers of NIPT (experts employed by industry to court scientists and lobby payers, scientists collaborating with industry, key opinion leaders involved with clinical practice guidelines, lobbyists and consultants), constitute an 'invisible college' that navigates the governance of test adoption. The formations and negotiations over standards for NIPT identified in this paper comprise a new institutional norm: a polycentric regulatory regime permeated by commercial interests. The institutionalization of this regime has implications for accountability, transparency and test quality amidst a proliferation of new proprietary molecular tests.'

Half a Century of Wilson & Jungner: Reflections on the Governance of Population Screening.

Background: In their landmark report on the "Principles and Practice of Screening for Disease" (1968), Wilson and Jungner noted that the practice of screening is just as important for securing beneficial outcomes and avoiding harms as the formulation of principles. Many jurisdictions have since established various kinds of "screening governance organizations" to provide oversight of screening practice. Yet to date there has been relatively little reflection on the nature and organization of screening governance itself, or on how different governance arrangements affect the way screening is implemented and perceived and the balance of benefits and harms it delivers. Methods: An international expert policy workshop convened by Sturdy, Miller and Hogarth. Results: While effective governance is essential to promote beneficial screening practices and avoid attendant harms, screening governance organizations face enduring challenges. These challenges are social and ethical as much as technical. Evidence-based adjudication of the benefits and harms of population screening must take account of factors that inform the production and interpretation of evidence, including the divergent professional, financial and personal commitments of stakeholders. Similarly, when planning and overseeing organized screening programs, screening governance organizations must persuade or compel multiple stakeholders to work together to a common end. Screening governance organizations in different jurisdictions vary widely in how they are constituted, how they relate to other interested organizations and actors, and what powers and authority they wield. Yet we know little about how these differences affect the way screening is implemented, and with what consequences. Conclusions: Systematic research into how screening governance is organized in different jurisdictions would facilitate policy learning to address enduring challenges. Even without such research, informal exchange and sharing of experiences between screening governance organizations can deliver invaluable insights into the social as well as the technical aspects of governance.

Conflict of interest as ethical shorthand: understanding the range and nature of "non-financial conflict of interest" in biomedicine.

OBJECTIVES: The aim of the study was to identify the range of issues labeled as "non-financial conflicts of interest" in biomedicine, articulate the associated concerns, and analyze the implications of defining these issues as conflicts of interest. STUDY DESIGN AND SETTING: This was a qualitative study, triangulating data from three purposively sampled sources: (1) literature, (2) policies, and (3) interviews. Participants were corresponding authors of sampled literature (December 2017 to January 2019). A critical, interpretive approach served as the analytic strategy. RESULTS: A total of 99 articles provided the sampling frame; we recruited 16 participants and sampled 20 policies. Participants labeled a wide range of personal attributes, social relationships, professional experiences, intellectual endeavors, and financial interests as "non-financial conflicts of interest." Despite a lack of consensus regarding the nature of the problem, many "non-financial" interests are currently subject to policy action. The term serves as ethical shorthand to describe the ways that (1) "strong beliefs," (2) "predetermined views," (3) experiences, and (4) relationships shape evidence-led processes. CONCLUSION: Expansion of the definition of conflict of interest to include non-financial interests may have unintended consequences, including exclusion of diverse perspectives. Problems labeled "non-financial conflicts of interest" should be defined in terms of what they are rather than what they are not (i.e., "non"-financial). We suggest instead, preventing financial conflicts of interest and ensuring inclusive and equitable representation within evidence-based processes.

A Troubled Solution: Medical Student Struggles with Evidence and Industry Bias.

This empirical work attends to the tensions and contradictions medical students articulate when they discuss their objection to industry's influence in medicine. Findings are based on 50 semi-structured interviews with medical students who are critical of the pharmaceutical industry's influence in medical education in the United States and Canada. These students advocate evidence-based medicine (EBM) as one solution to the problems with industry influence in medicine; namely industry bias in medical research. This investigation is an effort to understand why EBM is posed as a solution to industry bias in light of the literature demonstrating the ways that what is considered 'evidence-based' is influenced by industry. Participants articulate a struggle to find the 'best' evidence in a context where industry interests are integral in the production of medical knowledge.

Uneasy subjects: medical students' conflicts over the pharmaceutical industry.

In this article I report on an investigation of the pharmaceutical industry's influence in medical education. Findings are based on fifty semi-structured interviews with medical students in the United States and Canada conducted between 2010 and 2013. Participant responses support the survey-based literature demonstrating that there is clear and pervasive influence of the pharmaceutical industry in medical education. They also challenge the theory that medical students feel entitled to industry gifts and uncritically accept industry presence. I investigate how medical students who are critical of the pharmaceutical industry negotiate its presence in the course of their medical education. Findings suggest that these participants do not simply absorb industry presence, but interpret it and respond in complex ways. Participants were uncomfortable with industry influence throughout their medical training and found multifaceted ways to resist. They struggled with power relations in medical training and the prevailing notion that industry presence is a normal part of medical education. I argue that this pervasive norm of industry presence is located in neoliberal structural transformations within and outside both education and medicine. The idea that industry presence is normal and inevitable represents a challenge for students who are critical of industry.

'Something there is that doesn't love a wall': histories of the placental barrier.

This article appraises the late twentieth century maxim that prior to thalidomide's clarion call in 1961, a generic "we" believed that the fetus was protected from external insult by the placental barrier. Complicating this truism, we demonstrate that the placenta was, since early in the twentieth century, conceived of as a site of constant passage of entities both necessary to, and dangerous for, fetal development. Moving between evidence from specialist journals, obstetrics textbooks, and pregnancy advice manuals, we argue that the placental barrier writ large only emerged as an explicit actor after the medical community was disillusioned with it: it became something that does not exist. The article proposes that the nostalgia for a barrier lost constructs the modern-day fetus as more exposed and vulnerable than if "we" had never imagined this protection in the first place. The rhetorical shorthand of the erstwhile placental barrier has both deflected more nuanced accounts of the thalidomide story and contributed to the increasing surveillance of pregnant women's behavior, particularly in late twentieth century North America.

Too few, too weak: conflict of interest policies at Canadian medical schools.

INTRODUCTION: The education of medical students should be based on the best clinical information available, rather than on commercial interests. Previous research looking at university-wide conflict of interest (COI) policies used in Canadian medical schools has shown very poor regulation. An analysis of COI policies was undertaken to document the current policy environment in all 17 Canadian medical schools. METHODS: A web search was used to initially locate COI policies supplemented by additional information from the deans of each medical school. Strength of policies was rated on a scale of 0 to 2 in 12 categories and also on the presence of enforcement measures. For each school, we report scores for all 12 categories, enforcement measures, and summative scores. RESULTS: COI policies received summative scores that ranged from 0 to 19, with 0 the lowest possible score obtainable and 24 the maximum. The highest mean scores per category were for disclosure and ghostwriting (0.9) and for gifts and scholarships (0.8). DISCUSSION: This study provides the first comprehensive evaluation of all 17 Canadian medical school-specific COI policies. Our results suggest that the COI policy environment at Canadian medical schools is generally permissive. Policy development is a dynamic process. We therefore encourage all Canadian medical schools to develop restrictive COI policies to ensure that their medical students are educated based on the best clinical evidence available, free of industry biases and COI relationships that may influence the future medical thinking and prescribing practices of medical students in Canada once they graduate.