Volledig artikel met een commentaar-artikel van de Endocrine Society.
Financial Conflicts of Interest Among Authors of Endocrine Society Clinical Practice Guidelines
Abstract vertaald met Google translate
Er is een toename van klinische praktijkrichtlijnen in de endocrinologie en een samenvallende toegenomen belangstelling voor transparantie met betrekking tot relaties tussen artsen en de industrie.
We verzamelden zelf gerapporteerde onthullingen en open betalingsgegevens voor 169 auteurs van 26 klinische praktijkrichtlijnen die tussen 2010 en 2017 door de Endocrine Society zijn gepubliceerd.
Belangenconflicten waarbij farmaceutische en hulpmiddelbedrijven geneesmiddelen of producten produceerden die relevant waren voor de richtlijnen van een specifieke klinische praktijk van de auteur, werden als relevant beschouwd.
Open betaalgegevens zijn gegroepeerd in onderzoek- en niet-onderzoeksgroepen (adviesbureaus, honoraria, reizen, voeding).
We vergeleken het beleid van de Endocrine Society met betrekking tot zeven belangenconflictenaanbevelingen van de National Academy of Medicine in 2011.
Relevante niet-onderzoeken financiële belangenconflicten werden door 42% van de auteurs van richtlijnen voor klinische praktijken zelf gerapporteerd.
Open betalingen werden geregistreerd voor 74% (84 van de 113) van de Amerikaanse auteurs tussen 2013 en 2016.
Betalingen aan 84 Amerikaanse auteurs bedroegen $ 5,5 miljoen voor niet-onderzoeksactiviteiten en $ 30,9 miljoen voor onderzoek.
De niet-onderzochte betalingen waren verdeeld in consulting (46%), honoraria (26%), reizen (25%) en voedsel (3%).
De Endocrine Society volgt gedeeltelijk de aanbevelingen van de National Academy of Medicine om belangenconflicten te beperken.
Lezers moeten zich bewust zijn van de manier waarop richtlijnen voor klinische praktijken worden ontwikkeld en van het beleid van de organisaties en tijdschriften die ze publiceren.
Beroepsverenigingen en redacteuren van tijdschriften moeten ernaar streven dat hun beleid en praktijken objectieve en onbevooroordeelde richtlijnen voor klinische praktijken bevorderen.
COI Information for Endocrine Society CPGs
Endocrine Society Adherence to National Academy of Medicine Recommendations (5)
What Readers Should Know About CPGs
Readers of CPGs are looking for unbiased and trustworthy recommendations that are based on what is best for the patient and the health care system. It is important that readers of endocrine CPGs have an understanding of how CPGs are developed and the process of author selection.
For example, the Endocrine Society limits the percentage of authors with COIs to <50%.
The current division of COIs into research and nonresearch categories is overly simplistic and does not capture the different natures of the nonresearch COIs.
Readers should acknowledge that not all COIs are equal and that each COI should be judged on its individual characteristics. For example, monetary payments related to consultancies and speaker honoraria may be perceived differently from airfare, accommodations, and meals. Many of the current policies were only recently instituted and do not apply to older CPGs.
When selecting authors for CPGs, one should acknowledge that experts will likely have more potential conflicts and disclosures than nonexperts because those considered experts often have performed funded research in the area. Although some might argue that COIs are unavoidable when selecting experts to author CPGs, several CPGs in prestigious journals have done so.
For example, no COIs were reported among all four authors of a diabetes CPG sponsored by the American College of Physicians (40).
Readers should also be aware of eight red flags identified by Lenzer et al. (41) that may compromise the quality and trustworthiness of CPGs: sponsor(s) is a professional society that receives substantial industry funding; sponsor is a proprietary company or is undeclared or hidden;
committee chair(s) has any financial conflict; multiple panel members have any financial conflict; there is any suggestion of committee stacking that would preordain a recommendation regarding a controversial topic; there is no or limited involvement of an expert in methodology in the evaluation of evidence; there is no external review; and no nonphysician experts/patient representative/community stakeholders are included (41).
Relevant financial COIs are commonplace among authors of endocrine CPGs. The Endocrine Society partially adheres to the National Academy of Medicine’s COI recommendations. To enable readers to fully appreciate COIs among authors of their CPGs, endocrine organizations and journal editors could do a better job of describing their processes of CPG development, disclosing the specific types of COIs for each author, and describing if and how COIs were managed. To promote CPGs that are as objective as possible, leaders of professional societies and journal editors should regularly assess whether their policies are as effective as they can be.
https://academic.oup.com/jcem/article-p ... -00526.pdf
Commentaar-artikel van de Endocrine Society
Conflicts of Interest in Clinical Practice Guidelines: Accelerating an Evolution. An Endocrine Society Consensus Statement
An analysis of the Endocrine Society’s clinical practice guidelines (CPGs) published from 2010 to 2017—presented by Irwig et al. in the current issue of The Journal of Endocrinology and Metabolism—suggested that the Endocrine Society met five of seven National Academy of Medicine (NAM) standards concerning financial conflicts of interest in CPGs.
As current contributors to the Endocrine Society’s CPG efforts, we offer additional context related to the 2011 NAM standards and the current environment concerning industry support in medicine, and we comment on the nature of industry support received by the Society’s CPG authors according to Irwig and colleagues’ analysis of the Centers for Medicare and Medicaid Services’ Open Payments database.
Perhaps most importantly, we outline the Society’s recent and ongoing efforts to enhance the value of its CPGs. Such efforts include a 2016 revision of CPG author conflict of interest rules—a change that was invisible to the investigatory methods used by Irwig et al.—in addition to other processes designed to enhance CPG objectivity.
We conclude our commentary by recognizing that good-faith attempts to enhance transparency and to reduce conflicts of interest (real or apparent) in CPGs will ultimately serve the best interests of patients and providers; we confirm the Endocrine Society’s resolute commitment to providing high-quality, evidence-based clinical guidance via a CPG development process that faithfully accords with current CPG best practices.
In the current edition of the Journal of Clinical Endocrinology and Metabolism, Irwig et al. (1) examine potential financial conflicts of interest among authors of Endocrine Society clinical practice guidelines (CPGs). In particular, the authors systematically reviewed 169 content experts who authored 26 CPGs published from 2010 to 2017. Irwig et al. (1) report that during this time, 62% of CPG chairs disclosed at least one relevant conflict, and 42% of CPG authors disclosed at least one relevant, nonresearch-related conflict.
They also evaluated the Centers for Medicare and Medicaid Services’ Open Payments database and reported that from 2013 to 2016, 84 of the 113 US CPG authors had Open Payment entries amounting to nearly $36 million, 85% of which was directly related to research.
The authors then considered these data vis-à-vis the 2011 National Academy of Medicine (NAM; formerly the Institute of Medicine) standards concerning financial conflicts of interest in CPGs (2), concluding that the Endocrine Society met five of seven of the NAM recommendations.
The authors (1) closed their paper with a general call to professional societies to strengthen CPG policies and practices in a way that maximizes CPG objectivity.
Irwig et al. (1) have provided a service to the Endocrine Society community by highlighting the connections between CPG authors and industry financing.
We fully believe they offered this analysis as a good-faith call to strengthen our Society’s CPG efforts.
We in the Society value our CPGs as an essential tool in our mission to improve the health and well-being of persons worldwide affected by endocrine disorders.
To be maximally effective in this regard, CPGs must faithfully reflect the best available science and the state of the art in clinical endocrinology practice, and there should be no doubt about the validity of guidelines, nor the processes that generated them.
As current contributors to the Endocrine Society’s CPG efforts, we offer additional context to the manuscript of Irwig et al (1).
We do this, in part, by considering their analysis in the historical context of the 2011 NAM standards (2) and the current environment concerning industry support in medicine. Perhaps more importantly, we also outline the Society’s ongoing efforts to enhance the value of its CPGs.
The NAM has defined CPGs as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options” (2).
Although government-funded, evidence-based review groups have issued reports and provided recommendations for many clinical conditions, evidence-based reviews and CPGs have also been produced by specialty organizations.
Disease-oriented advocacy groups and professional societies that develop CPGs do so with decidedly altruistic motives: to assist clinicians in their efforts to provide the best possible medical care to their patients based on the best available scientific evidence.
However, candidates for CPG authorship—typically investigators at the top of their fields—frequently receive research support from industry in addition to compensation for consultative work and participation on advisory boards.
For example, such experts are often involved in the phase III registration trials for new drugs or provide scientific input into the design and implementation of phase III and IV trials.
We trust that, in most cases, expert physician-investigator involvement with industry involves a desire to advance the field for the benefit of future patients.
However, the community has long recognized that such relationships with industry complicate the CPG landscape by introducing potential conflicts of interest. In response to the need for a roadmap to navigate these tricky waters, the NAM issued a comprehensive report on conflict of interest in medical research, education, and practice in 2009 (3), and conflicts of interest were further addressed in the 2011 NAM report on CPGs (2).
A concomitant sea change in attitudes about pharmaceutical industry–physician relationships occurred at all levels of medicine, from medical schools to doctors’ offices. For example, in the clinical arena, “pharma-free” environments became a common goal, and examples of inappropriate pharmaceutical industry interactions such as extravagant marketing-related meals, paid junkets, and high-priced gifts were appropriately banned.
But in the setting of CPG development, a priori exclusion of all experts who constructively and responsibly partner with industry can be problematic. Indeed, in many cases, expert investigators with industry ties possess unique expertise and important insights.
Although the NAM provided a roadmap for successful production of CPGs with respect to evidence-based analyses and transparency in reporting financial conflicts of interest, it did not fully address how to resolve such conflicts nor how to eliminate the surrounding perception of “pharmaceutical corruption,” as denoted by Rosenbaum in a three-part series of articles published in the New England Journal of Medicine in 2015 (4–6).
Transparency is often considered the antidote to the possibility of bias introduced by industry partnerships. However, as noted by Rosenbaum (6), transparency may actually make it more difficult to distinguish impressions from reality. For example, full disclosure of industry relationships does not clarify whether the work of CPG authors was unduly influenced by such relationships.
We emphasize here that Irwig et al. did not suggest that industry support inappropriately influenced practice recommendations. We also reiterate that the vast majority (85%) of the Open Payment entries reported in the manuscript were committed as direct research support to CPG authors.
Also of note, 7% and 4% of payments related to consulting and honoraria, respectively: According to Centers for Medicare and Medicaid Services, these two categories denote compensation for a physician’s advice and expertise on a particular medical product or treatment (7).
Notably absent in the analysis of Irwig et al. (1) were descriptions of payments for speaking engagements, gifts, entertainment, or ownership or investment interests, all of which would have been identified using specific labels in the Open Payments database (7).
Although fiduciary and promotional relationships with industry are of special concern in the setting of CPG development, we acknowledge that all conflicts of interest—perhaps more accurately described as dualities of interest—have the capacity to influence CPGs in a way that may not serve the best interest of patients, our primary stakeholders.
When present, such undue influence is categorically unacceptable. We also recognize that beliefs about physician–industry interactions are rarely neutral, and even when dualities of interest do not unduly influence a CPG, the appearance of potentially inappropriate conflicts can negatively affect clinician and patient trust in CPG recommendations.
Accordingly, policies designed to minimize dualities of interest and, when necessary, to mitigate their effects, are expected to enhance public trust in CPGs.
As part of its ongoing efforts to strengthen the CPG development process, the Society reevaluated and strengthened its CPG author conflict of interest rules in 2016. Since that time, beginning with the Lipid Management in Patients with Endocrine Disorders CPG (under development), the Society implemented a strict policy whereby CPG chairs and cochairs may not have potential conflicts of interest, and the Society now ensures that no more than a minority of selected writing committee authors have potentially relevant conflicts of interests.
Indeed, to the degree possible, the Society has been working to minimize the number of CPG authors with potentially conflicting interests.
Of interest in this regard, CPG author selection is now informed by careful consideration of both self-disclosed dualities of interest and to publicly available data, although it is important to recognize that the Open Payments database is only updated annually and that the veracity of Open Payment entries is difficult to confirm.
When involvement of experts with dualities of interest is judged necessary, the Society is giving consideration to including such individuals as advisors to writing committees rather than as writing committee authors.
We also note that dualities of interest are now being disclosed with more detail: The Society’s three CPGs published in 2018 include such information in detailed conflict of interest tables.
Moreover, potential conflicts will be collected and disclosed with increasing granularity, with particular attention given to details regarding the precise nature of industry support, its duration, and its potential relevance to the disorder being evaluated.
Importantly, because CPG publication occurs at least 24 months after author selection, it takes years to fully implement changes to CPG development policy; thus, these recently implemented changes remained invisible to the investigatory methods used by Irwig et al. (1).
We also wish to highlight the Society’s other ongoing efforts to ensure objectivity in its CPGs. For example, the Society has long used an extensive CPG review process that explicitly includes formal reviews of draft CPGs by experts with no relevant conflicts of interest.
The Society has also taken steps to improve demonstrable adherence to the Grading of Recommendations Assessment, Development and Evaluation system; and we carefully assess our guidelines using either the National Guideline Clearinghouse Extent Adherence to Trustworthy Standards tool or the Appraisal of Guidelines for Research and Evaluation II tool.
Moreover, we are actively developing more detailed and transparent descriptions of our CPG methodology. We agree with Irwig et al. (1) that when writing committee members have dualities of interest, we as a Society need to do a better job at reporting our efforts to manage such dualities (e.g., an author with relevant conflicts is not allowed to draft guideline sections related to the conflict).
In summary, the Endocrine Society aims to provide high-quality, evidence-based clinical guidance to clinicians who treat patients with endocrine disorders, and we aspire to a CPG development process that fully complies with current CPG best practices.
In 2016, the Society initiated substantial efforts to strengthen its CPG development policy, and the Society is committed to continuing these efforts—all with a view to producing the most reliable and trustworthy clinical practice guidelines possible.
We recognize that good-faith attempts to enhance transparency and to reduce conflicts of interest (real or apparent) will ultimately serve the best interests of patients and providers.
The Society also holds itself accountable to all its stakeholders. In this regard, we express our sincere appreciation to Irwig et al. (1) for their manuscript.
https://academic.oup.com/jcem/article-p ... -01878.pdf