Authors Of Clinical Practice Guidelines Research Articles

Conflicts of Interest Among Cardiology Clinical Practice Guideline Authors in Japan.

Clinical practice guidelines (CPGs) offer disease management recommendations based on scientific evidence. However, financial conflicts of interest between CPG developers and the pharmaceutical industry could bias these recommendations, potentially affecting patient care. Proper management of these conflicts of interest is particularly crucial for maintaining the integrity of CPGs. The study aimed to evaluate the extent of financial relationships between the pharmaceutical industry and authors of CPGs for cardiovascular diseases in Japan. The study analyzed personal payments from the pharmaceutical industry to authors of cardiovascular disease CPGs published by the Japanese Circulation Society from January 2015 to December 2022. Payment data, including speaking, consultancy, and writing fees from 2016 to 2020, were extracted from a publicly available database containing personal payments disclosed by all major pharmaceutical companies. A total of 929 unique authors from 37 eligible Japanese Circulation Society CPGs were identified. Notably, 94.4% of these authors received personal payments from pharmaceutical companies, totaling >US $70.8 million. The mean±SD payment per author was US $76 314±138 663) and the median payment per author was US $20 792 (interquartile range: US $4262-US $76 998) over the 5-year period. Chairs of CPGs received significantly higher payments than other authors. More than 80% of authors in each CPG received personal payments. The study elucidated that there were considerable financial relationships between pharmaceutical companies and cardiology CPG authors in Japan. This finding deviates from international conflict of interest management policies, suggesting the need for more stringent conflict of interest management strategies by the Japanese Circulation Society to ensure the development of trustworthy and evidence-based CPGs.

Industry payments to American Society of Hematology Clinical Practice Guideline authors

Industry payments to American Society of Hematology Clinical Practice Guideline authors

Managing vestibular schwannomas with radiosurgery and radiotherapy: AGREE II appraisal of clinical practice guidelines.

Vestibular schwannomas (VSs) are rare, benign intracranial tumours that have prompted clinical practice guideline (CPG) creation given their complex management. Our aim was to utilize the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument to assess if such CPGs on the management of VSs with radiosurgery and radiotherapy are of acceptable quality. Relevant CPGs were identified following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocols. Experienced reviewers then extracted general CPG properties and rated their quality via the AGREE II instrument. Intraclass correlation coefficients (ICCs) were quantified to assess interrater reliability. Nine CPGs on the management of VSs with radiosurgery and radiotherapy were identified. All CPGs were created in the past six years and developed recommendations based on literature review and expert consensus. One guideline was deemed as high quality with seven others being moderate and one being low in quality. The clarity of the presentation domain had the highest mean scaled domain score of 96.0%. The domains of stakeholder involvement and applicability had the lowest means of 49.2% and 47.2%, respectively. ICCs were either good or excellent across all domains. Current CPGs on the management of VSs with radiosurgery and radiotherapy are of acceptable quality but would greatly benefit from improvements in applicability, stakeholder involvement, editorial independence and rigour of development. We recommend CPG authors reference the European Association of Neuro-Oncology (EANO) guideline as a developmental framework with the Congress of Neurological Surgeons/American Association of Neurological Surgeons (CNS/AANS) CPG being a valid alternative.

Assessment of Financial Relationships Between Otorhinolaryngologists and Pharmaceutical Companies in Japan Between 2016 and 2019.

There are prevalent financial relationships between physicians and the pharmaceutical industry in medical specialties, including otorhinolaryngology. Although these relationships might cause conflicts of interest, no studies have assessed the size and contents of the financial relationships between otorhinolaryngologists and pharmaceutical companies in Japan. This study aims toevaluate the magnitude, prevalence, and trend of the financial relationship between Japanese otolaryngologists and pharmaceutical companies. Using payment data publicly disclosed by 92 pharmaceutical companies, we examined the size, prevalence, and trend in personal payments made to the otorhinolaryngologistboard certified by the Japanese Society of Otorhinolaryngology-Head and Neck Surgery (JSO-HNS) between 2016 and 2019 in Japan. Furthermore, differences in payments were evaluated by whether otolaryngologists were clinical practice guideline authors, society board members, and academic journal editors or not. Trends in payments were evaluated by generalized estimating equations. Of 8,190 otorhinolaryngologists, 3,667 (44.8%) were paid a total of $13,873,562, in payments for lecturing, consulting, and writing by 72 pharmaceutical companies between 2016 and 2019. The median four-year combined paymentper physician was $1,022 (interquartile range: $473-$2,526). Top 1%, 5%, and 10% of otorhinolaryngologists received 42.3% (95% confidence interval (95% CI): 37.2%-47.4%), 69.3% (95% CI: 65.9%-72.8%), and 80.6% (95% CI: 78.3%-82.9%) of overall payments, respectively. The median payments per physicianwere significantly higher among otorhinolaryngologists authoring clinical practice guidelines ($11,522), society board members ($22,261), and journal editors ($35,143) than those without. The payments and number of otorhinolaryngologists receiving payments remained stable between 2016 and 2019. This study demonstrates that a minority but a large number of otorhinolaryngologists received personal payments from pharmaceutical companies for the reimbursement of lecturing, consulting, and writing in Japan. Large amounts of these personal payments were significantly concentrated on a small number of leading otorhinolaryngologists.

Representation of Authors by Gender, Race, and Ethnicity in Pathology Clinical Practice Guidelines.

United States' clinical practice guidelines (CPGs) are often produced by professional societies and used worldwide in daily medical practice. However, studies in various medical specialties demonstrate underrepresentation of women and racial and ethnic minority groups in CPGs. The representation of authors by gender, race, and ethnicity of US pathology CPGs has not been previously evaluated. To assess if women and individuals from racial and ethnic minority groups are underrepresented as authors of pathology CPGs. The gender, race, ethnicity, and terminal degrees of authors of 18 CPGs from the College of American Pathologists were coded by using photographs and other available information online and compared to their representation in academic pathology per Association of American Medical Colleges benchmark data. Two hundred seventy-five author positions (202 physician author positions) were analyzed. Women overall (119 of 275; 43.3%) and women physicians (65 of 202; 32.2%) held fewer positions than all men and men physicians. Women physicians were significantly underrepresented in physician author positions, while White men physicians were significantly overrepresented in all, first, senior, and corresponding authorship roles when compared to the proportion of women and White men physicians among pathology faculty, respectively. Asian men and women physicians were underrepresented as compared to their representation among pathology faculty. Men, particularly White men physicians, are overrepresented among pathology CPG author positions, while women physicians and some physicians from racial and ethnic minority groups are underrepresented. Further research is needed to understand the impact of these findings on the careers of underrepresented physicians and the content of guidelines.

Conflicts of Interest Among Infectious Diseases Clinical Practice Guideline Authors and the Pharmaceutical Industry

This cross-sectional study assesses the prevalence of conflicts of interest (COI) associated with guideline-recommended drugs among Infectious Diseases Society of America clinical practice guideline authors and compliance with the Council on Medical Specialty Societies and Institute of Medicine guidelines.

Cross-sectional analysis of pharmaceutical payments to Japanese board-certified gastroenterologists between 2016 and 2019

ObjectivesLimited evidence is available regarding the financial relationships between gastroenterologists and pharmaceutical companies in Japan. This study analysed the magnitude, prevalence and trends of personal payments made by major pharmaceutical...

Evaluation of Financial and Nonfinancial Conflicts of Interest and Quality of Evidence Underlying Psoriatic Arthritis Clinical Practice Guidelines: Analysis of Personal Payments From Pharmaceutical Companies and Authors' Self-Citation Rate in Japan and the United States.

To assess financial conflicts of interest (COI) and nonfinancial COI among psoriatic arthritis (PsA) clinical practice guideline (CPG) authors in Japan and the US, and to evaluate the quality of evidence and strength of recommendations of PsA CPGs. We performed a retrospective analysis using payment data from major Japanese pharmaceutical companies and the US Open Payments Database from 2016 to 2018. All authors of PsA CPGs issued by the Japanese Dermatological Association (JDA) and American College of Rheumatology (ACR) were included. Of 23 CPG authors in Japan, 21 (91.3%) received at least 1 payment, with a combined total of $3,335,413 between 2016 and 2018. Regarding 25 US authors, 21 (84.0%) received at least 1 payment, with a combined total of $4,081,629 during the same period. The 3-year combined mean± SD payment per author was $145,018 ± $114,302 in Japan and $162,825 ± $259,670 in the US. A total of 18 authors (78.3%) of the JDA PsA CPG and 12 authors (48.0%) of the ACR PsA CPG had undisclosed financial COI worth $474,663 and $218,501, respectively. The percentage of citations with at least 1 CPG author relative to total citations was 3.4% in Japan and 33.6% in the US. In sum, 71.4% and 88.8% of recommendations for PsA in the JDA and ACR were supported by low or very low quality of evidence. More rigorous cross-checking of information disclosed by pharmaceutical companies and self-reported by physicians and more stringent and transparent COI policies are necessary.

Financial conflicts of interest among US physician authors of 2020 clinical practice guidelines: a cross-sectional study

ObjectiveTo evaluate the prevalence and accuracy of industry-related financial conflict of interest (COI) disclosures among US physician guideline authors.DesignCross-sectional study.SettingClinical practice guidelines published by the Council of Medical Specialty Societies...

Financial Relationships Between Pharmaceutical Companies and Rheumatologists in Japan Between 2016 and 2019.

Given the increasing number of novel and expensive drugs for rheumatoid diseases, the financial relationships between pharmaceutical companies and rheumatologists could be prevalent and substantial. However, little was known about the information in Japan. Using payment data publicly disclosed by 92 major pharmaceutical companies, we evaluated the financial relationships between pharmaceutical companies and rheumatologists who were board certified by the Japan College of Rheumatology between 2016 and 2019. The trends in payments were estimated by the generalized estimating equations with 4-year payment data. Differences in payments between general and leading rheumatologists including the board members, clinical practice guideline authors, and medical journal editors were assessed. Of the board-certified rheumatologists, 70.7% (3563 of 5038) received a total of $55,246,485 in personal payments for lecturing, writing, and consulting from 79 pharmaceutical companies between 2016 and 2019. The median payments per rheumatologist receiving payments were $3447 (interquartile range, $1124-$11,974) in payment amounts. There were increasing trends in the payments per rheumatologist and the number of rheumatologists with payments, with average yearly change rates of 5.9% (95% confidence interval, 3.9%-7.9%; p < 0.001) and 1.2% (95% CI, 0.3%-2.0%; p = 0.008). The leading rheumatologists such as the society board members, clinical practice guideline authors, and medical journal editors received much more payments than other rheumatologists. Most rheumatologists increasingly received personal payments for lecturing, consulting, and writing reimbursements from pharmaceutical companies in Japan. These payments were significantly concentrated on rheumatologists in authoritative and influential positions.

Abstract 9931: Women Representation in Authorship of European Society of Cardiology Guidelines: Temporal Trends and a Geographic Perspective

Introduction: Diversity of authors of the international Clinical Practice Guidelines (CPG) will ensure raising broader concerns and contributing different perspectives. There is lack of data regarding gender and global distribution of authors of cardiovascular CPG. Purpose: To assess gender and geographic distribution of authors of ESC CPG and compare these over the contemporary years (2015 - 2021) vs earlier years (prior to 2015). Methods: ESC website was searched to include CPG. Sex and affiliating country of authors were determined by searching ESC 365 platform, Google Scholar, ResearchGate, LinkedIn platforms, social media or author’s affiliating institution website. Results: Thirty-eight documents were analyzed (26 contemporary documents vs 12 earlier documents). The documents included 28 CPG and 10 non-CPG documents (i.e., position papers, expert consensus, scientific statements, or task force reports). Total number of authors =748, 18.85% were women (21.84% in contemporary documents vs 8.02% in earlier documents, p&lt;0.001). Total number of chair/co-chair position was 67, 10.44% were women (11.32% in contemporary vs 7.14% in earlier documents, p&lt;0.001). Lowest proportion of women authors was in interventional cardiology CPG (13.3%) while highest proportion was in pediatric cardiology CPG (37.5%). Highest proportion of total authors (regardless gender) was from UK, Italy and Germany in 11.9%, 11.1%, and 10.3% respectively. Highest number of women authors were from UK, Netherlands and Italy in 15.5%, 12.7% and 11.3% respectively. Highest percentage of women authors among total authors from each specific country were from Austria 46.7%, Netherlands 37.5% and Sweden 35.1% Conclusion: Despite trends showing an overall increase in female authorship over years, there still remain gender and geographic disparities in writing committee/ task force shares, indicating potential for enhanced efforts to improve diversity within professional societies.

Evaluation of financial relationships between Japanese certified pediatric hematologist/oncologists and pharmaceutical companies: a cross-sectional analysis of personal payments from pharmaceutical companies between 2016 and 2019.

This cross-sectional study evaluated the magnitude of personal payments made by pharmaceutical companies to pediatric hematologist-oncologists (PHOs) board-certified by the Japanese Society of Pediatric Hematology/Oncology (JSPHO), using publicly disclosed data. Among all 307 PHOs, 215 (70.0%) PHOs received $916703 personal payments from 54 pharmaceutical companies between 2016 and 2019 in total. Median four-year payments per PHO was $1440 (interquartile range, $523-$4015). Payments per PHO significantly increased during the study period, by 23.8% (95% confidence interval: 15.3%-32.8%, P < 0.001) annually. Furthermore, leading PHOs, including university professors, society board members, and clinical practice guideline authors, received far larger personal payments from the companies.

Addressing Child Health Equity Through Clinical Decision-Making.

Addressing Child Health Equity Through Clinical Decision-Making.

Author Diversity on Clinical Practice Guideline Committees.

Reports have demonstrated that women overall and women physicians, in particular, are underrepresented as authors of clinical practice guidelines. This analysis used publicly available information to explore the diversity of rehabilitation-related clinical practice guideline authors by gender, race, and ethnicity. Primary analysis identified authors' gender, race, ethnicity, and visible minority status. Two sets were analyzed: (1) clinical practice guidelines by Department of Veterans Affairs (VA) categorized as "Rehabilitation" or "Pain" (n = 7; VA clinical practice guidelines) and (2) a set (n = 10) published in the United States (US) from 2019 to 2021 that were selected because of low numbers of inclusion at less than 20% women authors. Key findings include that among physician authors, both the VA and US clinical practice guidelines underrepresented women (15 [24.2%] and 27 [16.7%], respectively) and those coded as a racial or ethnic minority were particularly underrepresented. Notably, women authors overall were equally represented (92 [50.0%]) in the VA clinical practice guidelines. The US clinical practice guidelines had women authors who were underrepresented (36 [19.0%]). Secondary analysis of the entire set of VA clinical practice guidelines (n = 21) found gaps in diversity-related content. Clinical practice guidelines have far-reaching health and economic impacts, and addressing disparities in the diversity of author teams and/or gaps in diversity-related content is of paramount importance.

Development of the New AAP Febrile Infant Clinical Practice Guideline.

Development of the New AAP Febrile Infant Clinical Practice Guideline.

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.

An analysis of research quality underlying IDSA clinical practice guidelines: a cross-sectional study.

As a result of new developments in medicine, the need for evidence-based clinical practice guidelines (CPG) is of utmost importance. However, studies have shown that many medical societies are using low quality research to develop CPGs. To evaluate the quality of research underlying the CPGs issued by the Infectious Diseases Society of America (IDSA). We examined 29 CPGs issued between January 1, 2012 and December 31, 2019 and classified each by research quality according to levels reported by the CPG authors and previously specified by the IDSA: Levels I through III, corresponding to high, moderate, and low quality of evidence, respectively. Each ranking was cross-checked with a second researcher to improve inter-rater reliability. To analyze evolution of research quality over time, three updated CPGs were randomly selected and compared to their original versions. Chi-square analysis was then performed to determine statistical significance. We evaluated the quality of research for 2,920 recommendations within the 29 CPGs that met our criteria and found that 418 (14%) were developed using high-quality (Level I) research from randomized, controlled trials. Of the remaining recommendations, 928 (32%) were based on moderate quality research (observational studies) and 1574 (54%) on low quality research (expert opinion). A Pearson chi-squared analysis indicated no-statistically significant difference between original guidelines or their subsequent updates for Clostridium difficile (χ2=0.323; n=85; degrees of freedom [df]=2; p=0.851), candidiasis (χ2=4.133; n=195; df=2; p=0.127), or coccidiomycosis (χ2=0.531; n=95; df=1; p=0.466). The proportion of high-quality research underlying guideline recommendations is remarkably low, indicating that moderate and low quality evidence is still influencing infectious disease guidelines despite IDSA standards. Moreover, the quality of research has not significantly changed over time. IDSA CPGs are a formidable source of information for clinicians, but an increased number of quality studies should be utilized to further guide CPG development.

Financial Conflicts of Interest in Clinical Practice Guidelines: A Systematic Review.

ObjectiveTo systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).MethodsIn this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.ResultsAmong the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.ConclusionThere are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.

Undisclosed payments by pharmaceutical manufacturers to authors of inflammatory bowel disease guidelines in the United States.

Background:Payments from pharmaceutical drug manufacturers to authors of clinical practice guidelines (CPGs) may have an impact on their recommendations. In this study, we aimed to evaluate the accuracy of financial conflict of interest (FCOI) declarations among authors of Inflammatory Bowel Disease (IBD) guidelines.Methods:We collected data on industry payments to authors of IBD guidelines published by the American Gastroenterology Association (AGA), American College of Gastroenterology (ACG) and American Society of Gastrointestinal Endoscopy (ASGE). We reported the accuracy of the authors' declarations by comparing their statements in the FCOI section of the guidelines with the data reported on the Centers for Medicare and Medicaid Services website (CMS-OP). We also investigated the adherence of IBD guidelines to the National Academy of Medicine (NAM) criteria for trustworthy guidelines.Results:A total of eight clinical practice guidelines and 35 individual authors were included. Four authors had no profile identified at CMS-OP. The total payment to all included authors was $10,575,843.06, with a mean payment of $314,242.38 per author. A total of 28/35 authors (80%) received payment from pharmaceutical companies, 23/35 (65.7%) received $10,000 or more, 15/35 (42.8%) received $100,000 or more and 3/35 (8.57%) received $1,000,000 or more. Total discrepancies identified while comparing the authors' declaration of their FCOI and CMS-OP were 28: ACG had 12/14 (85.7%), AGA had 7/12 (53.8%) and ASGE had 9/10 (90%) discrepancies. None of the guidelines met all NAM criteria and 4/8 (50%) guidelines met none.Conclusions:Discrepancies exist between authors' declarations in the FOCI section and data on CMS-OP. Poor compliance with the NAM criteria was prevalent among authors of IBD guidelines. More transparency in reporting and monitoring is needed.

Pharmaceutical company payments to authors of the Japanese Clinical Practice Guidelines for Hepatitis C treatment.

Promotional activities of pharmaceutical companies (Pharma) relating to newly marketed direct-acting antivirals (DAAs) may have targeted the authors of the Japanese Clinical Practice Guidelines (CPGs) for Hepatitis C. This study aimed to assess payments made by Pharma to the CPG authors and the financial conflicts of interest (FCOIs) reported by those authors. We analyzed payments reported by Pharma to the CPG authors as well as the COI as published by the JSH, using publicly available data for 2016 and 2017. A total of 35 of 78 Pharma-reported payments of $613,973 in 2016, while 40 of 73 Pharma declared payments of $524,674 in 2017, with six companies failing to report. Payments by Pharma manufacturing DAAs accounted for 53.7% of the total (55.7% and 51.6% in 2016 and 2017 respectively). All 17 authors received payments from Pharma which totalled $1,138,647. The mean and median payments per author were $66,979 (standard deviation (SD): $64,875) and $46,033 (interquartile range [IQR]: $29,796 - $34,428) for 2016 and 2017 combined. Financial relationship between Pharma and the Hepatitis C CPG authors, which was unclear owing to the guideline regulation, was clarified. The authors had the strongest ties to the Pharma which manufactures DAAs in 2016 and 2017.