Characteristics of Advanced Practice Nurses Receiving Top Industry Payments and Their Practice Settings: a Cross-sectional Study.

BACKGROUND: The pharmaceutical industry promotes prescribing through the cultivation of key opinion leaders. Advanced practice nurses (APNs) are a growing and influential group of prescribers across generalist and specialty practice. Public reporting of industry payments to APNs allows for exploration of their influence within practice settings. OBJECTIVE: To understand the characteristics of APNs with top industry payments including their positions of influence and other payment recipients at the same address. DESIGN AND SETTING: Cross-sectional study of US national Open Payments reports of industry payments made between January 1, 2021, and December 31, 2021. PARTICIPANTS: APNs who received > $50,000 USD in industry payments for speaking, consulting, and honoraria ("personal fees"). MEASURES: Description of top APN recipients' practice setting type, clinical specialty, presence of other payment recipients, value of payments attributed to the same address, and top manufacturers and therapeutic categories associated with payments to top APN recipients. Structured content analysis of public-facing websites for evidence of APNs' clinical, research, and teaching leadership. RESULTS: A total of 99 APNs received > $50,000 USD in aggregate personal fees and a median $74,080 USD (IQR $57,303-101,702) in aggregate payments. They shared a practice setting with a median of 1 (IQR 0-5) physician and 0 (IQR 0-3) other APN payment recipients and were often the only (39%, 42/109) or the dominant (45%, 30/67) payment recipient in their practice setting. In total, 36% held clinical leadership positions, 25% led scientific research, and 18% had university appointments. Forty-two percent (37/88) owned a clinical practice, including cosmetic clinics (51%, 19/37) and mental/behavioral health clinics (24%, 9/37). CONCLUSIONS: Top APN payment recipients attracted high-value payments in practice settings and specialities associated with high-cost drug development; however, there may be little oversight of APNs' industry relationships. Policy development related to industry relationships must be inclusive of and responsive to the activities of interprofessional providers.

Prevalence and nature of manufacturer-sponsored patient support programs for prescription drugs in Canada: a cross-sectional study.

BACKGROUND: Globally, pharmaceutical companies offer patient support programs in tandem with their products, which aim to enhance medication adherence and patient experience through education, training, support and financial assistance. We sought to identify the proportion and characteristics of such patient support programs in Canada and to describe the nature of supports provided. METHODS: We conducted a crosssectional study to identify and characterize all marketed prescription drugs available in Canada as of Aug. 23, 2022, using the Health Canada Drug Product and CompuScript databases. To describe the nature of supports provided, we conducted a content analysis of publicly available patient support program websites and Web-based documents. Using logistic regression, we identified characteristics of drugs associated with having a patient support program including brand-name or branded generic (generic medications with a proprietary name), orphan (medications for rare diseases) or biologic drug status; estimated total cost of prescriptions dispensed at retail pharmacies; and price per unit. RESULTS: Of the 2556 prescription drugs marketed by 89 companies in the study period, 256 (10.0%) had a patient support program in Canada. Many of the 89 drug manufacturers (n = 55, 61.8%) offered at least 1 patient support program, frequently relying on third-party administrators for delivery. Brandname and branded generic medications, biologic agents and drugs with orphan status were more likely to have a patient support program than generic drugs. Compared with drugs priced $1.01-$10.00 per unit, drugs priced $10.01-$100.00 per unit were nearly 8 times more likely to have a patient support program (adjusted odds ratio 7.54, 95% confidence interval 4.07- 14.64). Most sampled patient support programs included reimbursement navigation (n = 231, 90.2%) and clinical case management (n = 223, 87.1%). INTERPRETATION: About 1 in 10 drugs marketed in Canada has a manufacturersponsored patient support program, but these are concentrated around brand-name, branded generic, biologic and high-cost drugs, often for rare diseases. To understand the impact of patient support programs on health outcomes and sustainable access to cost-effective medicines, greater transparency and independent evaluation of patient support programs is necessary.

From a Criminal to a Human-Rights Issue: Re-Imagining Policy Solutions to Homelessness.

Criminalizing homelessness is ineffective, costly, and immoral; yet it remains a dominant feature in the management of this global social issue. There has been little analysis investigating why punitive homeless policies have remained popular despite their ineffectiveness. In applying Bacchi's What's the Problem Represented to Be (WPR) framework to a Canadian encampment bylaw, our analysis demonstrated that public policies criminalizing homelessness continue to prevail because homelessness is fundamentally understood as a problem of deviant, criminal individual behavior. We argue that reframing understandings of homelessness from one of criminality to a human rights issue gives way to more dignified, just, and effective solutions, such as the Housing First Model. We suggest that community health nurses can serve a key role in disrupting these criminalizing discourses across domains of policy, research, and practice by advocating for holistic, rights-based, and equity-oriented policy solutions related to homelessness.

Branded Care: The Policy Implications of Pharmaceutical Industry-Funded Nursing Care Related to Specialty Medicines.

An increasing proportion of new drugs approved for market worldwide are now high cost, specialty medicines. Pharmaceutical marketers face the challenge of convincing payers, prescribers, and patients that the cost and complexity of care associated with specialty medicines is worth the trouble, and now offer patient support programs, free of charge, to patients prescribed their drug. We conducted a secondary, qualitative, interpretive analysis of 24 interviews with leaders of patient groups and members of hospital formulary committees in Australia to describe the work of pharmaceutical company-employed or contracted nurses who provide support to patients prescribed specialty medicines, and to prompt discussion around the policy implications of relying on industry-funded nursing care within publicly funded health systems. Participants affirmed the value of specialist, holistic, person-centered nursing care, but perceived gaps within the public health system related to the availability and provision of nursing care for people living with chronic disease. Consequently, participants described the pharmaceutical industry as addressing health system gaps through sponsorship or direct provision of medication-related nursing care, but recognized that care was contingent on commercial interest. Participants highlighted a number of ethical and policy concerns stemming from industry-funded nursing care of people prescribed specialty medicines related to patient safety, continuity of care, inducement to prescribe, and health equity. This analysis suggests that outsourcing necessary medication-related care to pharmaceutical companies has implications for the health system and equitable, sustainable pharmaceutical policy that extend far beyond the care encounter.

Outsourcing practice-based education: The role of industry representatives and implications for clinical expertise.

In an era of significant human and fiscal constraints, hospitals increasingly rely on industry representatives to fill gaps related to practice-based education. Given their dual sales and support functions, the extent to which education and support functions are, or ought to be, fulfilled by industry representatives is unclear. We conducted an interpretive qualitative study at a large, academic medical centre in Ontario, Canada, during 2021-2022, interviewing 36 participants across the organization with direct and varied experiences with industry-delivered education. We found that ongoing fiscal and human resource challenges prompted hospital leaders to outsource practice-based education to industry representatives, which created an expanded role for industry beyond initial product rollouts. Outsourcing, however, generated downstream costs to the organization and undermined the goals of practice-based education. To attract and retain clinicians, participants advocated for re-investment in practice-based education in-house, with a limited and supervised role for industry representatives.

A Review of the Quality and Impact of Mobile Health Apps.

Mobile health applications (apps) have transformed the possibilities for health promotion and disease self-management; however, their promise is not fully realized owing to their reliance on commercial ecosystems for development and distribution. This review provides an overview of the types of mobile health apps and describes key stakeholders in terms of how apps are used, developed, and regulated. I outline key challenges facing consumers, public health professionals, and policy makers in evaluating the quality of health apps and summarize what is known about the impact of apps on health outcomes and health equity. I suggest that factors within the wider mobile ecosystem largely define the impact of health apps and, most notably, practices around the collection and commercialization of user data. Finally, I suggest that upstream public health strategies, grounded in an understanding of corporate influences on health, are necessary to promote healthy digital environments in which mobile health app innovation can flourish.

Association Between Conflicts of Interest and Authors' Positions on Harms of Varenicline: a Cross-Sectional Analysis.

BACKGROUND: Few studies have investigated the relationship between industry funding/conflicts of interest and authors' positions in opinion pieces on drug safety. Harmful effects of varenicline, a treatment for smoking cessation, have been highly contested. OBJECTIVE: To examine the association between pharmaceutical industry funding/authors' financial conflicts of interest and position on varenicline in opinion articles, especially in relation to the minimization of harms; to assess whether opinion pieces on drug safety issues written by authors with conflicts of interest are more frequently cited in the news or social media. DESIGN: Cross-sectional analysis. PARTICIPANTS: English language opinion pieces and narrative reviews about varenicline published between May 2006 and February 2019. MAIN MEASURES: Odds ratios and 95% confidence intervals; the Mann-Whitney two-sample statistic was used to test for differences in Altmetric scores, a measure of media attention. KEY RESULTS: Of the 221 included articles, 30.3% (67) disclosed the funding source and 62.9% (139) disclosed authors' conflicts of interest. Authors of opinion pieces on varenicline who reported financial ties to the pharmaceutical industry (as a conflict of interest or funding source) were more likely to minimise the cardiovascular and psychiatric risk of varenicline compared to those without conflicts of interest or industry funding (OR: 4.00; 95% CI: 1.32 to 12.16 for cardiovascular risk; OR: 8.51; 95% CI: 3.79 to 19.11 for psychiatric risk). These associations persisted in sensitivity analyses. No statistically significant difference in Altmetric score was found between articles with (mean 15.83, median 3) and without (mean 11.90, median 1) conflicts of interest, indicating similar media attention (p-value=0.11). CONCLUSIONS: We found that authors with financial ties to drug companies were more likely to publish opinion pieces that minimised harms of varenicline. These results raise questions about journals' editorial policies to accept reviews of treatments from authors with financial relationships with manufacturers.

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.

Disclosure, transparency, and accountability: a qualitative survey of public sector pharmaceutical committee conflict of interest policies in the World Health Organization South-East Asia Region.

BACKGROUND: Weak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021. RESULTS: We identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country's pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest. CONCLUSIONS: Robust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust.

Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives.

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Exposure, access and interaction: A global analysis of sponsorship of nursing professional associations.

AIM: To analyse the nature and extent of sponsorship of nursing professional associations and their major scientific conferences. DESIGN: Cross-sectional content analysis. METHODS: Data were extracted from the websites and conference documents of 156 national and international professional nursing associations in 2019 to identify sponsors. Sponsorship prospectuses were analysed to estimate the value and describe the nature of sponsorship arrangements. We analysed sponsorship patterns using social network analysis. RESULTS: Most associations (84/156, 54%) did not report any sponsors. Sponsorship was concentrated among specialty nursing associations in high-income countries. Half of identified sponsors promoted products used in clinical care (50%; 981/1969); the majority represented the medical device industry (69%; 681/981). Top sponsors generally favoured opportunities that promoted interaction with conference attendees. CONCLUSION: Globally, commercial sponsorship of nursing associations is a common, but not the dominant source of support for these activities. Half of sponsors were commercial entities that manufactured or distributed products used during clinical care, which presents a risk of commercial influence over education and ultimately, clinical practice. Sponsors favoured opportunities to interact directly with nurses, determine educational content, or foster continued interaction.

"There are ways drug companies will get into DTC decisions": How Australian drug and therapeutics committees address pharmaceutical industry influence.

AIMS: One tool for protecting quality use of medicines in hospitals is a drug and therapeutics committee (DTC) that oversees medicines availability. Pharmaceutical industry marketing to prescribers is associated with less appropriate prescribing and increased costs. There is little data on decision-making practices of DTCs so it is unknown whether or how they might be vulnerable to pharmaceutical industry influence. This project explores DTC decision-making with a focus on how pharmaceutical industry influence on access and use of medicines is identified and managed. METHODS: We used a qualitative methodology with individual interviews of 29 participants who were current or recent members of public hospital DTCs across New South Wales, Australia. Participants included medical, pharmacy and nursing staff and 1 citizen. Committees were linked to specific hospitals or regions, and some were affiliated with paediatric, neonatal, rural or mental health services. RESULTS: Drug committee processes for oversight of medicines in public hospitals are vulnerable to pharmaceutical industry influence at several points. Applications for formulary additions are sometimes initiated and completed by company representatives. Conflict of interest disclosures among applicants and committee members may be incomplete. In some institutions, medicines are available from pharmaceutical companies without committee review, including through free samples and industry-supported medicines access programmes. Participants noticed the presence and impact of pharmaceutical company marketing activities to local clinicians, resulting in increased prescriber demand for products. CONCLUSION: Improved DTC practices and review of hospital policies concerning pharmaceutical marketing activities might preserve the independence of evidence-based decision-making for safe, cost-effective prescribing.

A Politics of Objectivity: Biomedicine's Attempts to Grapple with "non-financial" Conflicts of Interest.

Increasingly, policymakers within biomedicine argue that "non-financial" interests should be given equal scrutiny to individuals' financial relationships with industry. Problematized as "non-financial conflicts of interest," interests, ranging from intellectual commitments to personal beliefs, are managed through disclosure, restrictions on participation, and recusal where necessary. "Non-financial" interests, though vaguely and variably defined, are characterized as important influences on judgment and thus, are considered risks to scientific objectivity. This article explores the ways that "non-financial interests" have been constructed as an ethical problem and the implications for research integrity. I conducted an interpretive, qualitative study, which triangulated two data sources: documents (including published accounts of identifying and managing "non-financial" interests and conflict of interest policies) and in-depth interviews with 16 leaders within evidence-based medicine, responsible for contributing to, directing, or overseeing conflict of interest policy development and implementation. This article outlines how evolutions in the definition of conflict of interest have opened the door to include myriad "non-financial" interests, resulting in the generalisation of a statistical concept-risk of bias-to social contexts. Consequently, biases appear equally pervasive among participants while in reality, a politics of objectivity is at play, with allegations of conflict of interest used as a means to undermine others' credibility, or even participation. Iterations of the concept of conflict of interest within biomedicine have thus consistently failed to articulate or address questions of accountability including whose interests are able to dominate or distort evidence-led processes and why. Consequently, current policy solutions meant to mitigate bias may instead serve exclusionary purposes under the guise of impartiality while remaining vulnerable to interference from powerful stakeholders.

'Spin' in published biomedical literature: A methodological systematic review.

In the scientific literature, spin refers to reporting practices that distort the interpretation of results and mislead readers so that results are viewed in a more favourable light. The presence of spin in biomedical research can negatively impact the development of further studies, clinical practice, and health policies. This systematic review aims to explore the nature and prevalence of spin in the biomedical literature. We searched MEDLINE, PreMEDLINE, Embase, Scopus, and hand searched reference lists for all reports that included the measurement of spin in the biomedical literature for at least 1 outcome. Two independent coders extracted data on the characteristics of reports and their included studies and all spin-related outcomes. Results were grouped inductively into themes by spin-related outcome and are presented as a narrative synthesis. We used meta-analyses to analyse the association of spin with industry sponsorship of research. We included 35 reports, which investigated spin in clinical trials, observational studies, diagnostic accuracy studies, systematic reviews, and meta-analyses. The nature of spin varied according to study design. The highest (but also greatest) variability in the prevalence of spin was present in trials. Some of the common practices used to spin results included detracting from statistically nonsignificant results and inappropriately using causal language. Source of funding was hypothesised by a few authors to be a factor associated with spin; however, results were inconclusive, possibly due to the heterogeneity of the included papers. Further research is needed to assess the impact of spin on readers' decision-making. Editors and peer reviewers should be familiar with the prevalence and manifestations of spin in their area of research in order to ensure accurate interpretation and dissemination of research.

Variations in processes for guideline adaptation: a qualitative study of World Health Organization staff experiences in implementing guidelines.

BACKGROUND: The World Health Organisation (WHO) publishes a large number of clinical practice and public health guidelines to promote evidence-based practice across the world. Due to the variety of health system capacities and contextual issues in different regions and countries, adapting the recommendations in the guidelines to the local situation is vital for the success of their implementation. We aim to understand the range of experiences with guideline adaptation from the perspectives of those working in WHO regional and country offices. Our findings will inform development of guidance on how to improve adaptability of WHO guidelines. METHODS: A grounded theory-informed, qualitative study was carried out between March 2018 and December 2018. Seventeen semi-structured interviews were conducted with participants who included WHO guideline developers and staff in the headquarters, regional and country offices recruited from a sample of published WHO guidelines. Participants were eligible for recruitment if they had recent experience in clinical practice or public health guideline implementation. Deidentified transcripts of these interview were analysed through three cycles of coding. RESULTS: We categorised the adaptation processes described by the participants into two dominant models along a spectrum of guideline adaptation processes. First, the Copy or Customise Model is a pragmatic approach of either copying or customising WHO guidelines to suit local needs. This is done by local health authorities and/or clinicians directly through consultations with WHO staff. Selections and adjustments of guideline recommendations are made according to what the implementers deemed important, feasible and applicable through the consensus discussions. Second, the Capacity Building Model focuses on WHO building local capacity in evidence synthesis methods and adaptation frameworks to support local development of a national guideline informed by international guidelines. CONCLUSIONS: In comparing and contrasting these two models of guideline adaptation, we outline the different kinds of support from WHO that may be necessary to improve the effectiveness and efficiency of the respective models. We also suggest clarifications in the descriptions of the process of guideline adaptation in WHO and academic literature, to help guideline adaptors and implementers decide on the appropriate course of action according to their specific circumstances. ETHICS: This project was conducted with ethics approval from The University of Sydney (Project number: 2017/723) and WHO (Protocol ID: 00001).

Constructing a problem and marketing solutions: A critical content analysis of the nature and function of industry-authored oral health educational materials.

AIMS AND OBJECTIVES: To document the nature of industry-authored educational materials focused on oral health; and analyse how they construct the relationships between nurses and industry. BACKGROUND: Nurses frequently rely on pharmaceutical and medical device companies for continuing education. However, industry-sponsored education is a key aspect of multi-faceted promotional campaigns and may introduce bias into clinical decision-making. DESIGN: Critical qualitative content analysis reported according to the COREQ checklist. METHODS: We purposively sampled educational documents from the websites of 4 major manufacturers of oral health products for acute care. Two researchers analysed each document using an open-ended coding form. We conducted an interpretive analysis using inductive coding methods. RESULTS: We included 63 documents that emphasised the importance of education in the form of training, expert guidance, evidence syntheses and protocols to support oral care practices. Industry promoted its relationship with nursing as an oral health authority through three dominant messages: (1) Pneumonia is a source of morbidity, mortality and treatment costs, which informed nurses about a critical problem; (2) Comprehensive oral care reduces pneumonia risk, which instructed nurses about product-oriented solutions; and (3) Frequent oral care is important, which emphasised compliance to standardised protocols. These messages formed an accountability logic that prompted clinicians to address a problem for which the company's products served as a solution. In doing so, industry validated dominant administrative concerns including compliance, while promoting product uptake. CONCLUSIONS: Industry-authored educational materials may promote industry interests, rather than nursing or patient agendas. Dependence on industry's information and product solutions may have unintended, negative consequences for nursing practice. RELEVANCE TO CLINICAL PRACTICE: Though industry's educational materials present as convenient, helpful and evidence-based, they may serve to redirect care processes in ways that reinforce company goals rather than clinical priorities. Nurses should seek independent sources of continuing education where possible.

Commercialization of User Data by Developers of Medicines-Related Apps: a Content Analysis.

BACKGROUND: Developers of medicines-related apps collect a variety of technical, health-related, and identifying user information to improve and tailor services. User data may also be used for promotional purposes. Apps, for example, may be used to skirt regulation of direct-to-consumer advertising of medicines. Researchers have documented routine and extensive sharing of user data with third parties for commercial purposes, but little is known about the ways that app developers or "first" parties employ user data. OBJECTIVE: We aimed to investigate the nature of user data collection and commercialization by developers of medicines-related apps. APPROACH: We conducted a content analysis of apps' store descriptions, linked websites, policies, and sponsorship prospectuses for prominent medicines-related apps found in the USA, Canada, Australia, and UK Google Play stores in late 2017. Apps were included if they pertained to the prescribing, administration, or use of medicines, and were interactive. Two independent coders extracted data from documents using a structured, open-ended instrument. We performed open, inductive coding to identify the range of promotional strategies involving user data for commercial purposes and wrote descriptive memos to refine and detail these codes. KEY RESULTS: Ten of 24 apps primarily provided medication adherence services; 14 primarily provided medicines information. The majority (71%, 17/24) outlined at least one promotional strategy involving users' data for commercial purposes which included personalized marketing of the developer's related products and services, highly tailored advertising, third-party sponsorship of targeted content or messaging, and sale of aggregated customer insights to stakeholders. CONCLUSIONS: App developers may employ users' data in a feedback loop to deliver highly targeted promotional messages from developers, and commercial sponsors, including the pharmaceutical industry. These practices call into question developers' claims about the trustworthiness and independence of purportedly evidenced-based medicines information and may create a risk for mis- or overtreatment.

Why Having a (Nonfinancial) Interest Is Not a Conflict of Interest.

A current debate about conflicts of interest related to biomedical research is to question whether the focus on financial conflicts of interest overshadows "nonfinancial" interests that could put scientific judgment at equal or greater risk of bias. There is substantial evidence that financial conflicts of interest such as commercial sponsorship of research and investigators lead to systematic biases in scientific research at all stages of the research process. Conflation of "conflicts of interest" with "interests" in general serves to muddy the waters about how to manage conflicts of interest. We call for heightened disclosure of conflicts of interest and policy action beyond disclosure as the sole management strategy. We propose a different strategy to manage interests more broadly to ensure fair representation and accountability.

Health promoter, advocate, legitimiser - the many roles of WHO guidelines: a qualitative study.

BACKGROUND: Properly implemented evidence-based clinical and public health guidelines can improve patient outcomes. WHO has been a major contributor to guideline development, publishing more than 250 guidelines on various topics since 2008. However, well-developed guidelines can only be effective if they are adequately and appropriately implemented. Herein, we aimed to explore whether and how WHO guidelines are implemented in local contexts to inform the success of future guideline implementation. METHODS: Seventeen interviews were carried out between March 2018 and December 2018 with WHO guideline developers, headquarter staff, and regional and country office staff. Participants were purposely sampled from a variety of WHO guidelines and snowball sampling was used to identify regional and country office staff. The deidentified transcripts were analysed through three phases of coding, using grounded theory as the analytic approach. RESULTS: WHO guidelines played a variety of roles in the work of WHO at all levels. WHO officers and local government officials used WHO guidelines to influence health policy. We categorised the uses of guidelines as (1) directly changing policy, (2) justifying policy change, (3) engaging stakeholders, (4) being guarantors of legitimacy, (5) being advocacy tools, and (6) intertwining with WHO's various roles. Participants refuted the perception of the guidelines as mere lists of technical recommendations that needed to be implemented in different contexts. We found that the existence, quality and credibility, rather than the content of the guidelines, are the keys to health policy change initiatives in different local contexts. CONCLUSIONS: Used as a guarantor of legitimacy by policy-makers, WHO guidelines can be better positioned to influence health policy and practice change. Understanding the various roles of guidelines can help WHO developers package guidelines to optimise their effective implementation. ETHICS: This project was conducted with ethics approval from The University of Sydney (Project number: 2017/723) and WHO (Protocol ID: 00001).