Conflict Of Interest Disclosure Research Articles

Research Review: Conflicts of Interest (COIs) in autism early intervention research - a meta-analysis of COI influences on intervention effects.

The presence, types, disclosure rates, and effects of conflicts of interest (COIs) on autism early intervention research have not previously been studied. The purpose of this study was to examine these issues. This study is a secondary analysis of a comprehensive meta-analysis of all group-design, nonpharmacological early intervention autism research conducted between 1970 and 2018. We coded reports for the presence/absence of COI statements, the types of COIs that were disclosed, and for 8 types of COIs, including (a) the author developed the intervention, (b) the author is affiliated with a clinical provider, (c) the author is employed by a clinical provider, (d) the author is affiliated with an institution that trains others to use the intervention, (e) the author receives payment or royalties related to the intervention, (f) the study was funded by an intervention provider, (g) the study used a commercially available measure developed by the author, and (h) proceeds of the intervention fund the author's research. Frequencies and proportions were calculated to determine prevalence of COIs and COI disclosures. Meta-analysis was used to estimate summary effects by COI type and to determine if they were larger than for reports with no coded COIs. Seventy percent of reports were coded for≥1 COI, but only~6% of reports contained COI statements fully accounting for all coded COIs. Metaregressions did not detect significant influences of any COI type on summary effects; however, point estimates for each COI type were larger than for reports with no coded COIs. Conflicts of interest are prevalent but under-reported in autism early intervention research. Improved reporting practices are necessary for researcher transparency and would enable more robust examination of the effects of COIs on research outcomes.

Industry Funding and Self-Declared Conflict of Interest in Hand Surgery Publications

Accurate financial disclosure is essential to prevent bias in scientific reporting. We aimed (1) to document the extent of industry financial payments to hand surgery literature authors and (2) to uncover discrepancies in author self-declared conflict of interest (COI). We screened all scientific and review articles published in 2017 from the American editions of 4 peer-reviewed journals (Journal of Hand Surgery [JHS], Journal of Bone and Joint Surgery [JBJS], Plastic and Reconstructive Surgery [PRS], and Journal of the American Academy of Orthopaedic Surgeons [JAAOS]) to identify authors of hand, wrist, elbow, and peripheral nerve topics. We compared self-reported disclosures with industry-reported payments on the Centers for Medicare and Medicaid Services' Open Payments Database (OPD) for 3 years prior to publication or per journal policy. We individually examined each for relevance of the corporate payer to the article's subject matter. We found 630 eligible authors from 395 articles. The total amount of industry-reported payments over 3 years prior to publication was $24,396,607.80. The median total payments per author per year was $118.40, with interquartile range from $0 to $1,364; 68% of authors received some industry payment; the most common being food and beverage (66% of authors). Senior authors received significantly more industry payments (median, $2,985.67/y) than first and middle authors ($70.27 and $113.17, respectively). Of all authors examined, 58% had undisclosed payments, but only 14% were relevant to the article subject matter. Authors in JAAOS & JBJS, senior authors, and those receiving more than $500,000 from industry were less likely to accurately report all payments. Industry payments to hand surgery authors were lower than those reported to other orthopedic specialties and tended to be concentrated in a few authors receiving large amounts. Relevant COI disclosure inaccuracies are infrequent within hand surgery literature. Uniform policies of complete disclosure across journals may remove author judgment regarding payment relevance to published material and help eliminate remaining COI errors. Authors may reference the OPD prior to submitting disclosures to prevent potential discrepancies and identify errors within the database. Relationships with industry offer opportunities for innovation, education, and research, but overlooking COI self-reporting may erode confidence in the academic integrity of the hand surgery literature.

The Future of Organized Dentistry: Past Is Prologue

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsPeter A. DuBoisPeter A. DuBois joined the California Dental Association as executive director in March 2003. In addition to serving as CDA’s executive director, he also serves as CEO of its holding company and vice chair of the boards of CDA’s subsidiaries and charitable foundation. Conflict of Interest Disclosure: None reported.

Societal Needs and the Role of Health Care in Shaping the Future of Dentistry in the 21st Century

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsHarold C. SlavkinHarold C. Slavkin, DDS, is dean and professor emeritus, division of biomedical sciences and the Center for Craniofacial Molecular Biology at the Herman Ostrow School of Dentistry of USC. From 1995-2000, he served as the director of the National Institute of Dental and Craniofacial Research within the National Institutes of Health in Bethesda, Md. Conflict of Interest Disclosure: None reported.

Conflict of interest disclosure with high-quality advice: The disclosure penalty and the altruistic signal.

Advisors often have conflicts of interest: a potential clash between professional responsibilities and self-interests. Disclosure — informing advisees of the conflict — is a common policy response to manage such conflicts. However, extant research on disclosure has often confounded disclosure with poor quality advice. In this paper, we explore whether laws requiring conflict of interest disclosure damage the advisor-advisee relationship more than is intended. Across six experiments (N = 1,766), we examine situations in which advisors give high quality advice but still must disclose a conflict of interest. As predicted, such disclosures yield negative attributions regarding the advisor’s character, even when advice is of high quality (and advisees have full information to judge advice quality), and even when the advisor’s professional responsibility and self-interest are aligned, or the advice runs counter to the advisor’s self-interest. This disclosure penalty decreases trust in honest advisors but can be mitigated if the advisees are explicitly told that their advisor’s conflict of interest arose from external factors beyond the advisor’s control. When advisors’ recommendations run counter to their self-interests, conflict of interest disclosure creates an independent competing effect — the altruistic signal — which increases trust. The net effect on trust depends on which effect — the disclosure penalty or altruistic signal — is stronger. We discuss the implications of these findings for law and policy.

Treatment of the Dreaded Black Triangle: A Case Report and an Introduction to Injection Molded Composite Dentistry

Click to increase image sizeClick to decrease image size Additional informationNotes on contributorsDavid J. ClarkDavid J. Clark, DDS, founded the Academy of Microscope Enhanced Dentistry. He lectures worldwide and maintains a private practice in Tacoma, Wash. Conflict of Interest Disclosure: Dr. Clark has financial interest in Bioclear Matrix Systems and receives honoraria from 3M.

An audit of reporting of conflict of interest policies among three stakeholders in Indian biomedical journals.

Background:A conflict of interest (COI) in publication exists when the primary interest of publication is influenced by a secondary interest (financial or non-financial). International guidelines are available that can be used by journal editors to formulate their own COI policies. The present study was carried out with the objective of evaluating COI policies existing among Indian biomedical journals.Materials and Methods:MEDLINE/PubMed and MedIND/IndMed databases were searched. Inclusions were journals that were active and indexed. Outcome measures were proportion of journals: (a) mentioning COI disclosure statement for authors, reviewers, and editors, (b) adequately explaining COI, (c) referring to three international guidelines, and (d) the proportion of PubMed/other than PubMed indexed journals mentioning COI policy for authors, reviewers, and editors and providing an adequate explanation for COI. Apart from descriptive statistics, associations between indexing and COI Policy for all three stakeholders were evaluated.Results:A total of n = 106 journals formed the final sample. Among them, 82 (77%) were PubMed and 24 (23%) were MedIND/IndMed indexed. COI disclosure statement was mentioned in 93 (87.7%) journals for authors, 10 (9.4%) for reviewers, and 06 (5.6%) for editors. Only 35 (33%) journals adequately explained COI. A total of 61 (57.5%) journals endorsed all the three international guidelines. PubMed indexing was found to be associated with approximately 19 times the odds of COI policies being present on the journal's home page relative to the journals indexed with other indexing agencies (crude odds ratio - 18.8, 95% confidence interval [4.6, 77],P < 0.0001).Conclusion:Very few Indian biomedical journals have COI policies for reviewers and editors and most did not explain it adequately. Nearly, a fifth of the journals we evaluated did not follow any guideline for disclosing COI.

Are Industry Payments Associated With the Level of Evidence in Oral and Maxillofacial Surgery?

The purpose of the present study was to determine whether the industry payments in oral and maxillofacial surgery (OMS) are associated with a study's level of evidence (LOE). A retrospective cohort study was designed and implemented to query the Journal of Oral and Maxillofacial Surgery from 2002 to 2016. The primary predictor variables were the presence of a self-reported conflict of interest (COI) and the type of COI. The outcome variable was the LOE. The secondary outcome variables investigated were the topic of the study and the inclusion of trainees. The inclusion criteria entailed contributions from domestic academic OMS training programs. Disclosure of the COIs and type of COI, the LOE, topic of the study, and inclusion of trainees were recorded for every report from January 2002 until December 2016. Descriptive statistics were calculated, and χ2tests were performed to determine a significant relationship primarily between the COIs and LOE. The sample included 1455 reports, and 4.2% of the sample size had disclosed a COI. The studies that disclosed industry payments demonstrated a significant positive correlation with the LOE (P<.01), especially for cohort studies. Also, the type of COI was significantly associated with the LOE (P<.05). Industry payments were not shown to be significantly related statistically to topic of the study (P=.16); however, the stock-related payments were associated with the topic (P<.05). No association was found between COI disclosure and trainee contribution. The results have indicated that industry payments are associated with the LOE in the OMS literature. Further studies are needed to elucidate both the accuracy of the financial disclosures by comparing them with publicly available open payment databases and the perceptions of the OMSs, their trainees, and their patients regarding the influence of industry payments on the specialty's academic interests.

Association Between Public Trust and Provider Specialty Among Physicians With Financial Conflicts of Interest

ObjectivesTo characterize public perception of physicians’ conflicts of interest (COIs) across medical and surgical specialties. Patients and MethodsA cross-sectional 6-arm randomized survey of a nonprobability sample from Amazon’s Mechanical Turk occurred on December 11 to 16, 2018. Survey respondents were randomly assigned to vignettes that varied the physician specialty with COI. The primary outcome was mean difference in Mayer Trust, and the secondary outcome included the proportion who desire to discontinue care. ResultsThere were 1729 of 1920 respondents who completed the experiment (90.1% completion rate). Respondents were male (52.5%; n=907), white (71.4%; n=1234), and between the ages of 25 and 44 years (70.9%; n=1227). Mean ± SD Mayer Trust across the 6 specialties was 3.7±.60, with the only between-specialty differences observed for psychiatry compared with the other specialties (F=5.4; P<.001). The median dollar amount that would affect respondents’ trust in a physician was $5000 (interquartile range, $100-$100,000). A total of 75.1% (n=1298) of respondents desired COI information, with 41.6% (n=720) discontinuing care. Age older than 34 years (adjusted odds ratio [aOR], 0.7; 95%, CI, 0.49-0.99; P=.047), nonwhite race (aOR, 1.3; 95% CI, 1.02-1.6; P=.03), educational attainment of 4 or more years of college (aOR, 1.31; 95% CI, 1.05-1.6; P=.016), and physician specialty as a psychiatrist (aOR, 1.5; 95% CI, 1.03-2.2; P=.034) were predictors for discontinuing care. ConclusionPublic COI disclosure is a common method for managing financial conflicts. Although survey respondents were more likely to discontinue care with a physician with COI, they will act on this knowledge of COI differently depending on the specialty of the physician. The finding that psychiatry is an outlier may be a chance finding that warrants further confirmation. Continued efforts to ensure best practices for disclosure are required.

Are Investors Warned by Disclosure of Conflicts of Interest? The Moderating Effect of Investment Horizon

ABSTRACTFinancial analysts are required to disclose conflicts of interest (COI) in their research reports, but there is limited evidence on the effectiveness of COI disclosures. We investigate whether the influence of disclosing COI in analyst reports on investors' decision making depends on investment horizon. Experimental results show that short-term investors who view a COI disclosure are significantly less willing to invest in the recommended stock compared to short-term investors who do not view such a disclosure, while the presence of a COI disclosure does not significantly affect long-term investors' willingness to invest. Results further demonstrate that the COI disclosure decreases short-term investors' willingness to invest by reducing their perception of analysts' trustworthiness and expertness. This study provides evidence on when and how the COI disclosure can influence investors' behavior and enhances our understanding of investors' reactions to cautionary disclaimers.Data Availability: Contact the authors.

Supplemental Material for Conflict of Interest Disclosure With High-Quality Advice: The Disclosure Penalty and the Altruistic Signal

Supplemental Material for Conflict of Interest Disclosure With High-Quality Advice: The Disclosure Penalty and the Altruistic Signal

Effect of revealing authors’ conflicts of interests in peer review: randomized controlled trial

ObjectiveTo assess the effect of disclosing authors’ conflict of interest declarations to peer reviewers at a medical journal.DesignRandomized controlled trial.SettingManuscript review process at the Annals of Emergency Medicine.ParticipantsReviewers (n=838) who...

Undisclosed Financial Conflicts of Interest of Authors of Clinical Drug Trials Published in Influential Medical Journals: A Cohort Study

The International Committee of Medical Journal Editors requires authors to disclose all financial conflicts of interest (COI) that can be perceived as influencing the related trials. Undisclosed financial COI may influence the perception of the authors' scientific impartiality and erode the public trust in the reported results. Data regarding completeness of COI disclosure in high-impact–factor general medicine journals are limited. We compared payments disclosed by US-based physicians who were first or last authors of clinical drug trials published between August 2016 and August 2018 in the New England Journal of Medicine, JAMA, and Lancet, to payments reported by industry to the Centers for Medicare & Medicaid Services Open Payments Database. Of 247 included authors, 198 (80%) have not disclosed some or all received payments. The median undisclosed sum was $8409 (US Dollars) (interquartile range [IQR] $123 to $44,890). Most authors (n=170, 69%) have received more than $10,000 per year (median $120,403, IQR $58,905 to $242,014). The median undisclosed sum for these authors was $26,530 (IQR $7462 to $71,562). Median undisclosed sums for authors of papers from studies performed with and without industry funding were $20,899 (IQR $4191 to $59,883) and $149 (IQR $0 to $3276), respectively. In 10 (8%) of 125 industry-funded trials, the first or last author had not disclosed personal payments from the study sponsor (median $9741, IQR $4508 to $101,484). These findings could raise concerns about the authors' equipoise toward the trial results and influence the public perception of the credibility of reported data. Health care professionals, reviewers, and journal editors should demand more transparent reporting of financial COI.

Conflict of interest disclosure and interpretation - rest assured the medical professional in the audience is perceptive, alert and smart

Introduction: We present data from a systematic survey on conflict of interest (COI) disclosure and its interpretation by the doctors participating in continuing medical education (CME). Methods: A brief 12 question online Google survey with multiple choice options (read, select, and click) was done among Indian practicing doctors using links shared through WhatsApp through the internet over a 72 h period. Results: Of the 386 replies, 373 unique replies were eligible for evaluation. The majority found CME activities beneficial. About 73% of participants would watch out for bias, even if the speaker shows COI disclosure slide. The use of brand/trade names was considered as a flag for bias by the majority. About 99% wanted the speaker to show a final take home message slide. Cross verification of the data presented by comparing to published data was done in more than 75% of instances by only 25% of the participating doctors. A significantly higher number of doctors found bias when CME activities were being organized by the health-care industry as compared to programs of medical bodies/societies/organizations. Discussion: COI considerations are given due to the importance of medical professionals. However, doctors are smart enough to understand the limitations of such disclosures and remain alert to ensure they are not influenced by any bias. Take home message slide gives the presenters opportunity to share their insights and allows the audience to make their own judgment on the impartiality of the data presented. The doctors are aware that bias could be more when CME activities are organized by healthcare industry and take appropriate precautions. Conclusion: COI is is given due importance by the medical professionals. COI disclosures are often incomplete. Doctors remain alert to ensure they are not influenced by biased presentations. Concluding take home message slide is unanimously recommended. Presentation bias is more when healthcare industry is directly organizing educational and promotional activities.

Conflict of interest disclosure – the audience is not naive!

Conflict of interest disclosure – the audience is not naive!

Conflict of interest management in the Japanese Society of Hematology

A conflict of interest (COI) is a conflict between private interests and one's official responsibilities. COI is unavoidable and thus needs to be managed. Debates about COI in medical research area began in the United States in the 1980s. COI clause was added to the Helsinki Declaration in the year of 2000 after the Gelsinger affair. Discussions in Japan subsequently followed, and COI management guidelines have been sequentially presented by different organizations, particularly after the Diovan incident in 2013. Guidelines presented by the Japan Medical Association (JMA) in 2017 are currently regarded as standard. COI disclosure is required at research presentations and medical practice guideline announcements, among others, and should be carefully managed in the latter. In 2018, the Japanese Society of Hematology announced revision of the Japanese Society of Internal Medicine common guidance, presenting it in accordance with the JMA's guidelines. In the "Specific Clinical Research" section defined in the "Clinical Research Method Enforcement Rule", people who should not take a representative position or who should pay special attention when taking it are defined.

A 10-year follow up of publishing ethics in China: what is new and what is unchanged

BackgroundOrgan donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on Chinese journals active in donation and transplant publishing regarding the evolution of their publishing guidelines.MethodsEleven Chinese journals were analyzed for 7 properties: (1) ethics committee approval; (2) procedure consent; (3) publishing consent; (4) authorship criteria; (5) conflict of interest; (6) duplicate publication; and (7) data integrity. Results were compared with our 2008 study data. Additionally, open access status, impact factor, and MEDLINE-indexing were explored.ResultsMost journals heightened the ethical requirements for publishing, compared to the results of 2008. All 11 now require their published manuscripts to have data integrity. Ten of 11 require ethics committee approval and informed consent for the publication of research studies, whereas in the original study only 2 journals evidenced these requirements. Nine of 11 have criteria for authorship, require conflict of interest disclosure, and forbid duplicate publishing. None of the journals have a policy to exclude data that was obtained from unethical organ donation practices. Nine of 11 journals are MEDLINE-indexed but only 2 are open-access.ConclusionsMost journals have improved their general ethical publishing requirements but none address unethical organ donation practices.

Conflict of interest disclosure as a reminder of professional norms: Clients first!

Conflicts of interest create an incentive for advisors to give biased advice, and disclosure is a popular remedy. Across a series of studies, with monetary stakes creating conflicts of interest, I show that disclosure of the conflict of interest can increase as well as decrease bias in advice. The effect of disclosure depends on whether the perceived norms of the context in which the advice is provided are “clients first” or “self-interests first.” Disclosure increases the salience of these norms, which in turn, affects the level of bias in advice. As people draw on multiple sources of information to perceive norms, norms will vary by context and for expert versus non-expert advisors. For non-experts (research participants asked to play the role of advisors), disclosure tends to increase bias in settings in which self-interested advice is deemed to be the norm (e.g., giving financial advice) and decrease bias in settings in which placing advisees first is deemed to be the norm (e.g., giving medical advice). However, for experts (professional financial and medical advisors), whose norms often emphasize placing advisees’ interests first, disclosure (typically) decreases bias in advice. When considering the benefits and pitfalls of disclosure, professional norms toward clients or self-interests appear to play an important role.

Conflicts of interest in randomized controlled trials reported in neurosurgical journals.

Randomized controlled trials (RCTs) form the basis of today's evidence-based approach to medicine, and play a critical role in guidelines and the drug and device approval process. Conflicts of interest (COIs) are commonplace in medical research, but little is known about their influence. The authors aimed to evaluate the extent and influence of COIs in recent RCTs published in core neurosurgical journals using a cross-sectional analysis. Through review of 6 general neurosurgical journals, all interventional RCTs published from January 2009 to January 2019 were identified. Because it is difficult to objectively assess study outcome, the authors opted for a strict rating approach based on the statistical significance of unambiguously reported primary endpoints, and the reported statistical protocol. A total of 129 RCTs met the inclusion criteria. During the study period, the Journal of Neurosurgery published the largest number of RCTs (n = 40, 31%). Any potential COI was disclosed by 57%, and a mean of 12% of authors had a personal COI. Nonfinancial industry involvement was reported in 10%, while 31% and 20% received external support and sponsoring, respectively. Study registration was reported by 56%, while 51% of studies were blinded. Registration showed an increasing trend from 17% to 76% (p < 0.001). The median randomized sample size was 92 (interquartile range 50-153), and 8% were designed to investigate noninferiority or equality. Sixty-three RCTs (49%) unambiguously reported a primary endpoint, of which 13% were composite primary endpoints. In 43%, study outcome was positive, which was associated with a noninferiority design (31% vs 3%, p = 0.007) and a composite primary endpoint (46% vs 9%, p = 0.002). Potential COIs were not significantly associated with study positivity (69% vs 59%, p = 0.433). In the multivariate analysis, only a composite primary endpoint remained predictive of a positive study outcome (odds ratio 6.34, 95% confidence interval 1.51-33.61, p = 0.017). This analysis provides an overview of COIs and their potential influence on recent trials published in core neurosurgical journals. Reporting of primary endpoints, study registration, and uniform disclosure of COIs are crucial to ensure the quality of future neurosurgical randomized trials. COIs do not appear to significantly influence the outcome of randomized neurosurgical trials.

Editors’ and authors’ individual conflicts of interest disclosure and journal transparency. A cross-sectional study of high-impact medical specialty journals

ObjectiveTo assess the fulfilment of authors’ and editors’ individual disclosure of potential conflicts of interest in a group of highly influential medicine journals across a variety of specialties.DesignCross-sectional analysis.Setting and...