Intellectual Conflicts Of Interest Research Articles

Intravenous vitamin C therapy in adult patients with sepsis: A rapid practice guideline.

This Rapid Practice Guideline provides an evidence-based recommendation to address the question: in adults with sepsis or septic shock, should we recommend using or not using intravenous vitamin C therapy? The panel included 21 experts from 16 countries and used a strict policy for potential financial and intellectual conflicts of interest. Methodological support was provided by the Guidelines in Intensive Care, Development, and Evaluation (GUIDE) group. Based on an updated systematic review, and the grading of recommendations, assessment, development, and evaluation approach, we evaluated the certainty of evidence and developed recommendations using the evidence-to-decision framework. We conducted an electronic vote, requiring >80% agreement among the panel for a recommendation to be adopted. At longest follow-up, 90 days, intravenous vitamin C probably does not substantially impact (relative risk 1.05, 95% confidence interval [CI] 0.94 to 1.17; absolute risk difference 1.8%, 95% CI -2.2 to 6.2; 6 trials, n = 2148, moderate certainty). Effects of vitamin C on mortality at earlier timepoints was of low or very low certainty due to risk of bias of the included studies and significant heterogeneity between study results. Few adverse events were reported with the use of vitamin C. The panel did not identify any major differences in other outcomes, including duration of mechanical ventilation, ventilator free days, hospital or intensive care unit length of stay, acute kidney injury, need for renal replacement therapy. Vitamin C may result in a slight reduction in duration of vasopressor support (MD -18.9 h, 95% CI -26.5 to -11.4; 21 trials, n = 2661, low certainty); but may not reduce sequential organ failure assessment scores (MD -0.69, 95% CI -1.55 to 0.71; 24 trials, n = 4002, low certainty). The panel judged the undesirable consequences of using IV vitamin C to probably outweigh the desirable consequences, and therefore issued a conditional recommendation against using IV vitamin C therapy in sepsis. The panel suggests against use of intravenous vitamin C in adult patients with sepsis, beyond that of standard nutritional supplementation. Small and single center trials on this topic should be discouraged.

Intellectual conflicts of interest among cardiology and pulmonology clinical practice guidelines.

Intellectual conflicts of interest (COI), like financial COI, may threaten the validity and trustworthiness of clinical practice guidelines (CPGs). However, comparatively little is known about intellectual COI in CPGs. This study sought to estimate the prevalence of intellectual COI and corresponding management strategies among cardiology and pulmonology CPGs. We conducted a retrospective document review of CPGs published by cardiology or pulmonology professional societies from the United States, Canada, or Europe from 2018 to 2019 available via the Emergency Care Research Institute, Guidelines International Network, or Medscape databases. We assessed the percentage of authors with an intellectual COI, defined as i) authorship on a study reviewed by the CPG, ii) authorship of a prior editorial related to a CPG recommendation, or iii) authorship of a prior related CPG. Management strategies assessed included use of GRADE methodology, inclusion of a methodologist, and recusals due to intellectual COI. Outcomes were assessed overall and compared between cardiology and pulmonology CPGs. Among the 39 CPGs identified (14 cardiology, 25 pulmonology), there were a total of 737 authors, of whom 473 (64%) had at least one intellectual COI. Among all CPGs, a median of 67% (Interquartile Range 50%-76%) of authors had at least one intellectual COI, and COI was more prevalent among cardiology compared with pulmonology CPGs (84% vs 57%, p<0.001). There was variable use of management strategies among the CPGs, including use of GRADE methodology (64% of CPGs), inclusion of a methodologist (49%), and recusals due to intellectual COI (0%). Intellectual conflicts of interest appear to be highly prevalent and under-reported among cardiology and pulmonology CPGs, which may threaten their validity. Greater attention to and improved management of intellectual COI by CPG-producing organizations is needed.

Why do we fear bottles and pacifiers?

Why do we fear bottles and pacifiers?

Awake proning in patients with COVID-19-related hypoxemic acute respiratory failure: A rapid practice guideline.

This rapid practice guideline provides evidence-based recommendations for the use of awake proning in adult patients with acute hypoxemic respiratory failure due to COVID-19. The panel included 20 experts from 12 countries, including one patient representative, and used a strict conflict of interest policy for potential financial and intellectual conflicts of interest. Methodological support was provided by the guidelines in intensive care, development, and evaluation (GUIDE) group. Based on an updated systematic review, and the grading of recommendations, assessment, development, and evaluation (GRADE) method we evaluated the certainty of evidence and developed recommendations using the Evidence-to-Decision framework. We conducted an electronic vote, requiring >80% agreement amongst the panel for a recommendation to be adopted. The panel made a strong recommendation for a trial of awake proning in adult patients with COVID-19 related hypoxemic acute respiratory failure who are not invasively ventilated. Awake proning appears to reduce the risk of tracheal intubation, although it may not reduce mortality. The panel judged that most patients would want a trial of awake proning, although this may not be feasible in some patients and some patients may not tolerate it. However, given the high risk of clinical deterioration amongst these patients, awake proning should be conducted in an area where patients can be monitored by staff experienced in rapidly detecting and managing clinical deterioration. This RPG panel recommends a trial of awake prone positioning in patients with acute hypoxemic respiratory failure due to COVID-19.

European Stroke Organisation (ESO) standard operating procedure for the preparation and publishing of guidelines.

The first European Stroke Organization (ESO) standard operating procedure (SOP) published in 2015 aimed at the implementation the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to provide evidence-based guidelines for stroke management. This second ESO-SOP is aiming at further increase of the practicability of ESO guidelines and its technical implications. Authors comprised of the members of the ESO guideline Board and ESO Executive Committee. The final document was agreed on by several internal reviews. The second SOP comprises of the following aspects: rational for the SOP, the introduction of expert consensus statements, types of guideline documents, structures involved and detailed description of the guideline preparation process, handling of financial and intellectual conflicts of interest (CoI), involvement of ESO members in the guideline process, review process, authorship and publication policy, updating of guidelines, cooperation with other societies, and dealing with falsified data. This second SOP supersedes the first SOP published in 2015.

Financial and Intellectual Conflicts of Interest Among Japanese Clinical Practice Guidelines Authors for Allergic Rhinitis.

To elucidate financial and intellectual conflicts of interest (COIs) among clinical practice guideline (CPG) authors of allergic rhinitis in Japan and to evaluate the extent of transparency and accuracy in COIs by CPG authors of allergic rhinitis. A cross-sectional analysis of the payment data from all 79 pharmaceutical companies in Japan between 2016 and 2017. Japan. We considered all 27 CPG authors from 2 different versions of the most prominent CPGs for allergic rhinitis in Japan. Using payment data disclosed by 79 major pharmaceutical companies between 2016 and 2017, we assessed the magnitude and characteristics of financial COIs of CPG authors. We also evaluated the intellectual COIs of the CPG authors by counting self-citations of research articles related to CPG statements and recommendations. Of 27 CPG authors, 26 authors (96.3%) received at least 1 payment from a combined total of $1,333,552 between 2016 and 2017. The 2-year combined average and median monetary values per author were $49,391 (SD, $67,438) and $18,400 (interquartile range: $6,216-$72,494), respectively. Pharmaceutical companies with novel drugs predominantly made these payments. The percentage of citations with at least 1 CPG author relative to total citations was 47.6% in 2016 and 27.9% in 2020. There were no formal COI disclosure statements in either version. This study found that allergic rhinitis CPG authors had significant financial relationships with pharmaceutical companies, particularly those marketing novel drugs. In addition, CPG authors had relatively high self-citation rates, a potential marker of intellectual COIs. More rigorous and comprehensive COI management strategies are needed.

Reporting of conflicts of interest by authors of primary studies on health policy and systems research: a cross-sectional survey

ObjectivesThe objective of this study was to assess the frequency and types of conflict of interest (COI) disclosed by authors of primary studies of health policy and systems research (HPSR).DesignWe...

Financial Conflicts of Interest are of Higher Ethical Priority than "Intellectual" Conflicts of Interest.

The primary claim of this paper is that intellectual conflicts of interest (COIs) exist but are of lower ethical priority than COIs flowing from relationships between health professionals and commercial industry characterized by financial exchange. The paper begins by defining intellectual COIs and framing them in the context of scholarship on non-financial COIs. However, the paper explains that the crucial distinction is not between financial and non-financial COIs but is rather between motivations for bias that flow from relationships and those that do not. While commitments to particular ideas or perspectives can cause all manner of cognitive bias, that fact does not justify denying the enormous power that relationships featuring pecuniary gain have on professional behaviour in term of care, policy, or both. Sufficient reason exists to take both intellectual COIs and financial COIs seriously, but this paper demonstrates why the latter is of higher ethical priority. Multiple reasons will be provided, but the primary rationale grounding the claim is that intellectual COIs may provide reasons to suspect cognitive bias but they do not typically involve a loss of trust in a social role. The same cannot be said for COIs flowing from relationships between health professionals and commercial industries involving financial exchange. The paper then assumes arguendo that the primary rationale is mistaken and proceeds to show why the claims that intellectual COIs are more significant than relationship-based COIs are dubious on their own merits. The final section of the paper summarizes and concludes.

Conflicts of interest disclosure forms and management in critical care clinical practice guidelines.

Trustworthy clinical practice guidelines (CPGs) require identification and careful management of conflicts of interest (COIs) among all participants in the guideline development. Furthermore, COIs are more common than anticipated. However, there are no universally accepted methods to identify and manage COIs. To describe and summarize the current COI disclosure forms and management policies in selected critical care professional societies that develop high-impact CPGs. In addition, we aim to provide suggestions to guideline developers on how to identify and manage different types of COIs. We searched PubMed and MEDLINE for CPGs published between 2013 and 2018 in English language and addressed general critical care topics. We then ranked the CPGs according to the numbers of citations and selected the first five critical care professional societies that sponsored the guidelines. We obtained the most recent COI declaration forms and management policies. Two reviewers abstracted data on different types of COI in each of the disclosure forms and management policies. All selected professional critical care societies require that members declare direct financial COIs; four societies inquire specifically about intellectual COIs (involvement in primary research). Three out of five societies require members to disclose indirect institutional financial COIs; however, none inquire about other forms of institutional COI. We developed, by consensus, a streamlined framework to classify and manage different types of COIs. The current COI disclosure forms of selected professional societies provide more attention to financial disclosures and COIs and less attention to detecting and managing intellectual COIs, while rarely addressing institutional COIs. We provide some suggestions for guideline developers on the classification and management of different COIs in the context of CPGs.

Overdiagnosis or not? 2017 ACC/AHA high blood pressure clinical practice guideline: Consequences of intellectual conflict of interest.

American Heart Association/the American College of Cardiology and nine other professional organizations have issued a new hypertension clinical practice guideline (CPG) on November 2017, which has lowered the hypertension threshold to 130/80 mmHg. American Academy of Family Medicine has decided to not endorse this new CPG for various reasons including flaws in CPG development process and a limited additional benefit for lower treatment targets. The major concern was intellectual conflict of interest (COI). Substantial weight was given to SPRINT trial, which provided the basis for the recommended change in blood pressure targets. It is a serious intellectual COI that the Chair of the SPRINT trial steering committee was commissioned as chair of the guideline panel. The new threshold would lead to 46 percent of the U.S. adult population being categorized as having hypertension, while using the previous threshold that figure would be 32 percent. Should we call this change as overdiagnosis?

PSYCHOLOGIES OF SMALL DIFFERENCES.

Depression and AnxietyVolume 33, Issue 5 p. 357-358 Commentary PSYCHOLOGIES OF SMALL DIFFERENCES John C. Markowitz M.D., Corresponding Author John C. Markowitz M.D. Professor of Clinical Psychiatry, Columbia University, Research Psychiatrist, New York State Psychiatric Institute, New YorkCorrespondence to: John C. Markowitz, M.D., New York State Psychiatric Institute, 1051 Riverside Drive, Unit #129, New York, NY 10032. E-mail: jcm42@cumc.columbia.eduSearch for more papers by this author John C. Markowitz M.D., Corresponding Author John C. Markowitz M.D. Professor of Clinical Psychiatry, Columbia University, Research Psychiatrist, New York State Psychiatric Institute, New YorkCorrespondence to: John C. Markowitz, M.D., New York State Psychiatric Institute, 1051 Riverside Drive, Unit #129, New York, NY 10032. E-mail: jcm42@cumc.columbia.eduSearch for more papers by this author First published: 26 April 2016 https://doi.org/10.1002/da.22488Citations: 2 The author has no formal conflicts of interest in writing this commentary—but, as he suggests in this commentary, we all have intellectual conflicts of interest. He aspires to evenhandedness. The author thanks Barbara Milrod, M.D. for her comments on an earlier draft of this commentary. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume33, Issue5FOCUS ON TREATMENTMay 2016Pages 357-358 RelatedInformation

Requirements of Clinical Journals for Authors' Disclosure of Financial and Non-Financial Conflicts of Interest: A Cross Sectional Study.

ImportanceIt is unclear how medical journals address authors’ financial and non-financial conflict of interest (COI).ObjectiveTo assess the policies of clinical journals for disclosure of financial and non-financial COI.MethodsCross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine’s “core clinical journals”. The study did not involve human subjects. Investigators who abstracted the data, reviewed “instructions for authors” on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person.ResultsAll but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process.ConclusionWhile financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies.

Evidence-based medicine remains one's best defense against quackery.

Clinicians draw on several sources of knowledge in making decisions and recommendations for their patients. Some of this wisdom is drawn from tacit knowledge and best practice as it has evolved over decades, while many other decisions draw on scientific substrates to inform conclusions [1]. Specifically, the practice of medicine has evolved on a strong tradition of subjecting new interventions and tests to the rigor of the scientific method. Evidence-based medicine (EBM) is a conceptual framework that is dependent upon this perspective to ensure that health care is delivered as an integration of evidence from research along with patient values and preferences to optimize care. As medicine becomes more complex, it is increasingly difficult to achieve the lofty goals of EBM in the face of an unmanageable huge amount of scientific research published on a daily basis, and ongoing variability in the robustness of the research enterprise. With specific reference to the latter, there are a myriad of forces at play that can threaten the trustworthiness of published research. From clinical trials that select unfair comparators, and are thus biased to show benefit, to clinical practice guidelines written by panelists with financial and intellectual conflicts of interest, there are many ways that the lines between objective science and quackery can become blurred [2]. This commentary will present some of the reasons why current evidence-based methodology remains the most promising approach we have to recognize and avoid the infiltration of quackery into health care. In this issue, Naudet et al. explore some of the relationships between EBM and the notion of quackery [3]. Although the authors suggest that the scientific and more incontrovertible elements of EBM should serve as protection or even an antidote to quackery, they characterize EBM itself as being tainted with the kinds of limitations that contribute to its own unique version of and promulgation of quackery. By quackery, the authors initially make reference to the multiple healing modalities that have failed the test of randomized controlled trials (RCT). Following that, the essay focuses on the limitations of the placebo in clinical research, noting that in many therapeutic relationships, there are in fact factors at play that contribute to healing that are difficult to measure with traditional scientific approaches. While this has merit in general terms, the randomized trial remains the gold standard for extricating the placebo effect, and thus objectively measuring the true impact of a therapeutic intervention. The major thrust therefore of this thought-provoking contribution is the limitations of the double-blind placebocontrolled trial. These concerns paint EBM as focused almost exclusively on the narrow element of RCTs and their contribution to care. It is important to clarify that EBM uses several more methods, and has a far greater reach [4]. This limited conceptualization of EBM also appears to lack precision for key terminology. For example, when referring to double-blind placebo-controlled trials, the authors seem not to appreciate that double blinding is commonly misinterpreted in the literature with varying definitions [5]. By doing this, they also disregard the current approaches to improve and standardize methodologies to avoid possible biases. In this case, to minimize the risk of blinding bias, there are five groups involved in study execution that should be unaware of treatment allocation to allow an ideal scientific assessment of the intervention & Eddy S. Lang Eddy.Lang@albertahealthservices.ca

Considering intellectual, in addition to financial, conflicts of interest proved important in a clinical practice guideline: a descriptive study

ObjectivesThe American College of Chest Physicians Antithrombotic Guidelines ninth iteration placed restrictions on panelists with recommendations on which they disclosed a primary conflict of interest (COI). We aimed to describe panelists' financial and intellectual COI and evaluate to what extent, beyond assessing financial COI, assessing intellectual COI affected COI management. Study Design and SettingWe classified financial and intellectual COI into primary (causes voting restriction) and secondary (no restrictions). We analyzed disclosures respectively with panelists and recommendations as units of analysis. ResultsOne hundred two panelists made 4,030 disclosures for 431 recommendations. The median number (and range) of panelists per recommendation who disclosed the various categories of COI was 0 (0–5) for primary financial COI, 0 (0–4) for secondary financial COI, 0 (0–7) for primary intellectual COI, and 1 (0–6) for secondary intellectual COI. Of the 431 recommendations, 63 (15%) had at least one panelist with a primary intellectual COI but no primary financial COI. ConclusionCOI had a relatively low prevalence and a skewed distribution, many panelists with none and some with many disclosures. A substantial number of disclosures should have resulted in restrictions based on intellectual COI in the absence of financial COI.

DSM-5: a diagnosis and a drug should not be denied to anyone

In May 2013 the American Psychiatric Association approved the 5th revised edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM), that since 1958 has been a reference document for the classification of psychiatric conditions. Even before its publication the DSM-5 has raised a controversy widely covered by media, the strongest argument of its critics being the fact that DSM-5 favors the medicalization of conditions that belong to ordinary human experiences. Using DSM-5 as a diagnostic tool in clinical practice may favor over-diagnosis and over-treatment, for example by labeling many healthy people experiencing forgetfulness as affected by "cognitive impairment", while grieving after the death of a loved one may be diagnosed as a "major depressive disorder". Moreover, the scientific integrity of the committee that produced the DSM-5 has been questioned, arguing that the tendency to expand the boundaries of mental illness may have been driven by financial and intellectual conflicts of interest and by ties with drug companies of some of its members.

The Peer Review Congresses

Original scientific reports in peer-reviewed journals are the cornerstones of new medical knowledge. Yet medical journalism, unlike research, is not a science but rather, like medical practice, a mix of art and science. All journals face the continuing challenges of providing their readers with information they can trust, improving their systems for evaluating manuscripts, and dealing with increasing concerns about financial and intellectual conflicts of interest. Diagnosing the ills of biomedical publications and advancing solutions are the missions of the International Congresses on Peer Review and Biomedical Publication, the seventh and most recent of which was held in Chicago in September 2013, organized by The JAMA Network and the BMJ and once again led by Drummond Rennie, MD.

Editorial: Active Management of Financial Conflicts of Interest on the Editorial Board of CORR

At Clinical Orthopaedics and Related Research®, we have tried to mitigate the impact of financial conflict of interest (COI) through robust disclosure, which we require of authors upon manuscript submission, and of editors as a condition of their participation on out Editorial Board. However, there is ample evidence [7, 8] that simple disclosure of financial COI does not alleviate its influence. In fact, there is evidence [3, 5, 6] that disclosure alone has contrary effects. Given these issues, how we disclose and manage financial COI reflects on our integrity as clinicians and scientists, and affects our professional reputation in the eyes of the public [1, 2, 4]. Importantly, while an author’s financial conflicts may bias the presentation and, perhaps, even the results of a study, unmanaged financial COI on an editorial board may influence the development of the scientific literature by affecting what is and is not published. Currently, CORR’s financial conflict of interest policy focuses on disclosure. Like many journals, our Senior Editors’ financial disclosure forms are kept current, are maintained on file, and are available upon request to anyone who wishes to see them. In addition, our Senior Editors are asked to recuse themselves from manuscripts if the editor or anyone in his/her family has a financial relationship relevant to the topic of the study. Upon deeper consideration, we believe our standards should be more rigorous. Therefore, we have enacted the following changes, which we believe will improve the depth and transparency of our disclosures, and will allow authors the opportunity to participate in the management of editorial-board level financial COI as it might influence the processing of their work: Our Senior Editors and the Editor-in-Chief will update their financial disclosure forms annually at a minimum. These disclosures will include full “CORR® disclosures” (with dollar values), just as we ask of our authors. We will disclose all the financial conflicts of our Senior Editors and Editor-in-Chief, including medicolegal consulting, society-related financial relationships, and compensated work with other publishers for the last 12 months. We will print these disclosures in every issue of CORR®. They will be posted online at www.clinorthop.org, and on our publisher’s website, http://www.springer.com/medicine/orthopedics/journal/11999, rather than simply making them available upon request. Importantly, effective January 2014, we will permit the corresponding author of a manuscript to request one or more Senior Editors be disqualified from involvement with the processing of that paper, if the author believes that any of our Senior Editors has a relevant financial conflict of interest pertaining to the material presented in the manuscript. Authors who wish to request the disqualification of one or more Senior Editors for financial COI reasons should do so at the time of manuscript submission, by making the request in the electronic cover letter that accompanies the paper. This will be a confidential process and the Senior Editor(s) in question will not be aware of the disqualification request. Although we are proud of these changes, they do not solve the problem entirely. Financial conflicts of interest are not the only kind of influence that may affect the processing of original research—every reviewer and editor brings to the task his or her experiences, knowledge, and beliefs, and these intellectual conflicts may be as important, or more important, than financial relationships. However, such influences are hard to identify, and we expect our editors and reviewers to do what they can to recognize and avoid such biases. Since more than one editor is involved with the processing of every paper, this should mitigate the influence of any such “intellectual conflicts of interest,” should these occur. Finally, it is worth noting that our panel of Senior Editors is modest in size, and so the removal of a particular Senior Editor from involvement with a manuscript may result in another Senior Editor with less specific subject-matter expertise becoming involved with the paper. We believe this is offset by our high-quality roster of expert peer-reviewers, and by our Deputy Editors, who can address any subject-matter-specific questions or concerns that arise. We believe that by publishing Senior Editors’ financial relationships prominently (in each issue of our journal and online), and by providing authors the opportunity to disqualify a Senior Editor because of such a relationship, we are introducing a level of transparency to the peer-review process and fairness to authors that are important to preserve the integrity of orthopaedic science. We hope other journals will consider steps like the ones we are taking at CORR®, which will provide a higher quality of disclosure, and, critically, will allow authors to help us actively manage financial conflicts of interest among the editors at our journal who make manuscript disposition decisions. And, as always, we welcome feedback on this and all of our editorial policies. Please email us at [email protected].

Experiences With a Novel Policy for Managing Conflicts of Interest of Guideline Developers

Background The executive committee of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) developed a novel policy for managing conflicts of interest (COIs): Methodologists bore primary responsibility for each chapter, there was equal emphasis on intellectual and financial COI, and content experts with COIs participated, but with restrictions for recommendations on which they had conflicts. The objective of this study was to explore the experiences of the methodologists and content experts with the COI policy after its implementation. Methods One investigator conducted two rounds of semistructured interviews with the methodologist and the leading content expert of each chapter until data saturation was achieved. Two investigators analyzed the transcripts of the interviews in duplicate using an immersion-crystallization approach. We also conducted member checking. Results We interviewed 15 participants and presented the results to the remaining four for verification. In comparison with their views expressed prior to AT9 development, methodologists remained more positive about the policy than content experts. Six of 10 content experts expressed a more positive view than prior to participation in the AT9 process. The other four content experts remained skeptical, especially regarding the emphasis on intellectual COI. The restrictions of the policy on conflicted individuals were not fully implemented. Conclusions After its implementation, some content experts were more favorable to the policy, but some retained major reservations. The influence of the policy on recommendations may have been more through the leading role of the methodologists than exclusion of conflicted participants in making recommendations. The executive committee of the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (AT9) developed a novel policy for managing conflicts of interest (COIs): Methodologists bore primary responsibility for each chapter, there was equal emphasis on intellectual and financial COI, and content experts with COIs participated, but with restrictions for recommendations on which they had conflicts. The objective of this study was to explore the experiences of the methodologists and content experts with the COI policy after its implementation. One investigator conducted two rounds of semistructured interviews with the methodologist and the leading content expert of each chapter until data saturation was achieved. Two investigators analyzed the transcripts of the interviews in duplicate using an immersion-crystallization approach. We also conducted member checking. We interviewed 15 participants and presented the results to the remaining four for verification. In comparison with their views expressed prior to AT9 development, methodologists remained more positive about the policy than content experts. Six of 10 content experts expressed a more positive view than prior to participation in the AT9 process. The other four content experts remained skeptical, especially regarding the emphasis on intellectual COI. The restrictions of the policy on conflicted individuals were not fully implemented. After its implementation, some content experts were more favorable to the policy, but some retained major reservations. The influence of the policy on recommendations may have been more through the leading role of the methodologists than exclusion of conflicted participants in making recommendations.

P084 Experiences With The Novel Policy For Managing Conflicts Of Interest Implemented In The 9th Edition Of The American College Of Chest Physicians Antithrombotic Guidelines (At9)

BackgroundThe executive committee of the American College of Chest Physicians 9th edition of the Antithrombotic Guidelines (AT9) developed a novel policy for managing conflicts of interest (COI): methodologists bore primary...

A guide to GRADE guidelines for the readers of JTH

More than 70 organizations worldwide have adopted the GRADE methodology for guideline development. The ninth iteration of the American Collage of Chest Physicians guidelines (AT9) adopted structural and policy changes that resulted in a greater adherence to GRADE guidance than previous iterations. The most important of these changes include minimizing the impact of financial and intellectual conflict of interest, increasing the rigor of evidence evaluation, acknowledging uncertainty in estimates of typical values and preferences, and awareness of the large variability in values and preferences. One of the consequences of the greater adherence to GRADE methodology is an increase in weak vs. strong recommendations in AT9. The result of the GRADE process highlights the desirability of higher-quality evidence both regarding the outcomes of alternative management strategies and regarding the distribution of values and preferences in patients considering those alternatives. It also encourages shared decision making in encounters between physicians and patients. Although some physicians might find the uncertainty underlying medical practice discouraging or unsettling, relative to denying or obscuring the uncertainty, acknowledging and addressing the uncertainty will lead to more credible, realistic, and useful recommendations.