financial support

财政支持
  • 文章类型: Journal Article
    背景:临床实践指南(CPGs)基于科学证据提供疾病管理建议。然而,CPG开发商和制药业之间的财务利益冲突可能会偏向这些建议,可能影响患者护理。适当管理这些利益冲突对于保持CPG的完整性尤为重要。该研究旨在评估日本制药业与心血管疾病CPG作者之间的财务关系程度。
    结果:该研究分析了2015年1月至2022年12月日本循环学会发布的从制药业向心血管疾病CPG作者的个人支付。付款数据,包括说话,咨询,以及2016年至2020年的写作费用,均从包含所有主要制药公司披露的个人付款的公开数据库中提取。从37名合格的日本流通协会CPG中总共确定了929名独特作者。值得注意的是,这些作者中有94.4%收到了制药公司的个人付款,总计>7080万美元。在5年内,每位作者的平均±SD付款额为76314±138663美元),每位作者的平均付款额为20792美元(四分位距:4262美元-76998美元)。CPG主席收到的报酬明显高于其他作者。每个CPG中超过80%的作者都收到了个人付款。
    结论:研究表明,日本的制药公司与心脏病学CPG作者之间存在相当大的财务关系。这一发现偏离了国际利益冲突管理政策,建议日本流通协会需要采取更严格的利益冲突管理策略,以确保开发值得信赖和基于证据的CPG。
    BACKGROUND: 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.
    RESULTS: 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.
    CONCLUSIONS: 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.
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  • 文章类型: Journal Article
    背景:临床实践指南帮助医疗保健专业人员提供循证护理。然而,制药公司的财务利益往往会影响指导方针的内容。这项研究旨在阐明日本胃肠病学指南作者与制药业之间的财务联系程度。
    方法:使用制药公司披露的付款数据,我们评估了2016年至2021年日本胃肠病学会指南作者之间的财务利益冲突(COI).此外,我们评估了支持指南建议的证据质量以及与财务COI的关联.最后,我们根据全球标准评估了指南制定过程中作者的COI管理.
    结果:总体而言,在2016年至2019年期间,88.2%(231/262)的指南作者获得了$12,968(四分位数间距[IQR]:$1,839-$70,374)的讲座付款,写作,和咨询。主席收到的付款高得多(中位数:$86,444[IQR:$15,455-$165,679])。值得注意的是,41名(15.6%)作者的未申报付款超过申报要求。低或极低质量的证据支持41.0%的建议。每位作者的四年付款中位数与基于低质量证据的建议比例之间存在负相关(优势比:0.966[95%置信区间[95%CI]:0.945-0.987],p=0.002)和与中等质量证据呈正相关(赔率比:1.018[95%C]:1.011-1.025),p<0.001)。尽管如此,日本胃肠病学会指南的制定过程仍然不够透明,与全球标准相比,COI政策不足。
    结论:制药公司和指南作者之间存在广泛的财务COI,超过40%的建议基于低质量证据.遵循全球标准制定更严格和透明的COI准则政策是必要的。
    BACKGROUND: Clinical practice guidelines assist healthcare professionals in providing evidence-based care. However, pharmaceutical companies\' financial interests often influence guideline content. This study aimed to elucidate the magnitude of financial ties among Japanese gastroenterology guideline authors and the pharmaceutical industry.
    METHODS: Using pharmaceutical company disclosed payment data, we evaluated financial conflicts of interest (COI) among Japanese Society of Gastroenterology guideline authors between 2016 and 2021. Additionally, we assessed the evidence quality supporting guideline recommendations and associations with financial COI. Finally, we evaluated author COI management during guideline development against global standards.
    RESULTS: Overall, 88.2% (231/262) of guideline authors received a median of $12 968 (interquartile range [IQR]: $1839-$70 374) in payments between 2016 and 2019 for lectures, writings, and consulting. Chairpersons received significantly higher payments (median: $86 444 [IQR: $15 455-$165 679]). Notably, 41 (15.6%) authors had undeclared payments exceeding declaration requirements. Low or very low-quality evidence supported 41.0% of recommendations. There was a negative association between the median 4-year payment per author and the proportion of recommendations based on low-quality evidence (odds ratio: 0.966 [95% confidence interval [95% CI]: 0.945-0.987], P = 0.002) and positive association with moderate-quality evidence (odds ratio: 1.018 [95% CI: 1.011-1.025], P < 0.001). Still, the Japanese Society of Gastroenterology guideline development process remains less transparent, with insufficient COI policies relative to global standards.
    CONCLUSIONS: There were extensive financial COI between pharmaceutical companies and guideline authors, and more than 40% of recommendations were based on low-quality evidence. More rigorous and transparent COI policies for guideline development adhering to global standards are warranted.
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  • 文章类型: Journal Article
    目的:评估日本和美国银屑病关节炎(PsA)临床实践指南(CPG)作者之间的财务利益冲突(COI)和非财务COI,并评估PsACPG的证据质量和建议强度。
    方法:我们使用2016年至2018年日本主要制药公司和美国公开支付数据库的支付数据进行了回顾性分析。包括日本皮肤病学协会(JDA)和美国风湿病学会(ACR)发布的PsACPGs的所有作者。
    结果:在日本的23名CPG作者中,21人(91.3%)收到至少1笔付款,2016年至2018年总计3335413美元。25位美国作家21人(84.0%)收到至少1笔付款,同期总计4,081,629美元。在日本,每位作者的3年平均±SD支付额为145,018±114,302美元,在美国为162,825±259,670美元。JDAPsACPG的共有18位作者(78.3%)和ACRPsACPG的12位作者(48.0%)分别拥有价值474,663美元和218,501美元的未披露财务COI。至少有1名CPG作者的引文占总引文的百分比在日本为3.4%,在美国为33.6%。总之,在JDA和ACR中,71.4%和88.8%的PsA建议得到了低或非常低的证据质量的支持。
    结论:有必要对制药公司披露的信息和医生的自我报告进行更严格的交叉检查,以及更严格和透明的COI政策。
    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.
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  • 文章类型: Journal Article
    我们旨在评估指南委员会作者和用于支持欧洲心脏病学会(ESC)指南的研究研究作者之间财务利益冲突的频率和性质。
    我们评估了撰写五个关键ESC临床实践指南(CPG)的医生的竞争利益:瓣膜性心脏病(VHD),心房颤动(AF),心包疾病(PD),心力衰竭(HF)和心肌血运重建(IHD)。此外,我们检查了建议中引用的与药物相关的研究的资金来源.如果一项研究是由工业界赞助的,我们对所有作者的披露进行了审查,以评估与研究资助者是否存在经济利益冲突.
    总共,在五项指南中有603项建议(PD112、VHD111、HF169、IHD97和AF114),其中,271(45%(PD26,VHD23,HF72,IHD84和AF66))与药物相关。至少80%的指南委员会作者,除了警署指引,有相关的财务利益冲突,最常见的是直接个人付款(68%-82%)。在整个指南中,行业对研究的支持从5%(PD)到65%(IHD)不等。如果一项研究是由行业资助的,作者经常(55-90%)与行业赞助商发生冲突。
    撰写临床指南的大多数医生都存在相关的经济利益冲突。此外,行业赞助研究频繁,作者经常与研究资助者发生冲突。我们建议撰写临床指南的医生应避免此类财务利益冲突,以保持临床指南的科学完整性和独立性。
    We aimed to assess the frequency and nature of financial conflicts of interest among both the guideline committee authors and the authors of research studies used to support the European Society of Cardiology (ESC) guidelines.
    We evaluated the competing interests of the doctors that write five of the key ESC clinical practice guidelines (CPG): valvular heart disease (VHD), atrial fibrillation (AF), pericardial diseases (PD), heart failure (HF) and myocardial revascularisation (IHD). In addition, we examined the funding sources of studies cited in the recommendations that were related to pharmaceutical agents. If a study was sponsored by industry, the disclosures of all authors were reviewed to assess whether there was a financial conflict of interest with the study funder.
    In total, there were 603 recommendations (PD 112, VHD 111, HF 169, IHD 97 and AF 114) across the five guidelines, of which, 271 (45% (PD 26, VHD 23, HF 72, IHD 84 and AF 66)) related to pharmaceutical agents. At least 80% of guideline committee authors, except for the PD guidelines, had a relevant financial conflict of interest, with the most frequent being a direct personal payment (68-82%). Industry support for studies varied across the guidelines from 5% (PD) to 65% (IHD). If a study was funded by industry, authors were frequently (55-90%) conflicted with the industry sponsor.
    The majority of the doctors that write clinical guidelines have a relevant financial conflict of interest. In addition, industry sponsorship of studies is frequent, and authors are often conflicted with the study funder. We propose that physicians that write clinical guidelines should be free of such financial conflicts of interest to maintain scientific integrity and independence in the clinical guidelines.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    Clinical Practice Guidelines (CPGs) play significant roles in most medical fields. However, little is known about the extent of financial Conflicts of Interest (FCOIs) related to pharmaceutical companies (Pharma) selling dermatology prescription products and dermatology CPG authors in Japan. The aims of this study were to elucidate the characteristics and distribution of payments from Pharma to dermatology CPG authors in Japan, and to evaluate the extent of transparency and accuracy in their FCOI disclosures. We analyzed the records of 296 authors from 32 dermatology CPGs published by the Japanese Dermatological Association from the beginning of 2015 to the end of 2018. Using the payment data reported by 79 Pharma between 2016-2017 in Japan, we investigated the characteristics of the CPG authors and the payments from the Pharma to them. Furthermore, we evaluated the transparency and accuracy of the FCOI disclosures of the individual CPG authors. Of the 296 CPGs authors, 269 authors (90.6%) received at least one payment from the Pharma. The total monetary value of payments for the 2-year period was $7,128,762. The median and mean monetary value of payments from the Pharma reporting were $10,281 (interquartile range $2,796 -$34,962) and $26,600 (standard deviation $40,950) for the two years combined. Of the 26 CPG authors who disclosed FCOIs due to the monies received from Pharma, only the atopic dermatitis CPG authors and the acne vulgaris CPG authors published their potential FCOIs. In Japan, most dermatology CPG authors received financial payments from Pharma. The transparency of the CPGs, as reported by the CPG authors, was inadequate, and a more rigorous framework of reporting and monitoring FCOI disclosure is required to improve the accuracy and transparency with relation to possible Conflicts of Interest.
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  • 文章类型: Journal Article
    BACKGROUND: Evidence-based clinical practice guidelines are one of the most important sources to inform clinical decision-making. They contain recommendations to support treatment decisions. These recommendations should be free from bias and should only aim to increase patient benefit. To ensure this, recommendations should be free from bias caused by conflicts of interest. When conflicts of interest exist, they should be completely transparent. The aim of this study was to analyze the payments from pharmaceutical and medical device industry to clinical practice guideline panel members (GPM). In addition, we assessed the completeness and accuracy of the GPMs\' conflict of interest statements.
    METHODS: A manual search for international guidelines was conducted on the website of the National Guideline Clearinghouse. We included all available clinical practice guidelines published in 2017. We extracted the names of all guideline group members and identified the payments they had received from industry over the four years preceding the publication using the \"open payments\" database.
    RESULTS: In total, 81 guidelines were identified. We found data on payments for 543 out of 659 GPMs. For 34% of the GPMs, there was no declaration of individual conflicts of interest in either the guideline or related documents. The sum of payments across all guidelines to all GPMs was 10,844,938 USD. The average payment amounted to 19,972 USD and the median 1,227 USD. Sixty two percent of GPMs received at least 500 USD. Of these, 17% stated that they had no conflict of interest to declare.
    CONCLUSIONS: The amount of industrial payments in some subject areas raises doubt about the independence of guideline recommendations. Stricter rules are needed to avoid and manage conflicts of interest of guideline authors. The analysis carried out indicates that conflict of interest involving GPMs is a considerable problem.
    CONCLUSIONS: GPMs receive sizeable payments from industry. The payments are often inadequately disclosed or not disclosed at all. This threatens the objectivity of the recommendations in clinical practice guidelines.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    Clinical practice guidelines (CPGs) are crucial to the practice of evidence-based medicine. Declared author financial conflicts of interest (FCOIs) are common in CPGs and have been associated with endorsement of treatment. Less is known about undeclared FCOIs.
    The American Society of Clinical Oncology (ASCO) website was searched to identify all CPGs for systemic therapy published between August 2013 and June 2018. Data on self-reported author FCOIs and funding sources were extracted. The Open Payments database was then searched to identify compensation to CPG authors. Concordance between declared and undeclared but verified FCOIs was assessed with Cohen\'s κ.
    For 26 CPGs, 314 nonduplicate authors were identified; 184 of these authors (59%) disclosed FCOIs. Among the remaining 130 authors, data in Open Payments were unavailable for 71 authors (non-US residents or authors affiliated with a nonprofit organization). Among the 59 authors who declared no FCOIs and for whom Open Payments data were available, 55 (93%) had received payment from industry. The κ value for agreement between disclosed and verified FCOIs was 0.092. Among the 243 authors with FCOIs verifiable via Open Payments, 239 (98%) received payment from industry. Thirty-four authors (62%) received more than $1000 in nonresearch funding, and 19 (35%) received more than $5000. Among the 52 first and last authors, 44 (85%) received payment from industry; 14 of these payments (32%) were not declared.
    FCOIs among authors of ASCO CPGs are common and are not disclosed by a substantial proportion of authors with Open Payments data. Improved transparency of FCOIs should become standard practice among CPG authors. Professional societies and journal editors need to create a mechanism to verify self-reported FCOIs.
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