Conflict Of Interest Disclosure Statement Research Articles

Neuron-specific enolase during the therapy in patients with alcohol use disorder and mood disorders

IntroductionStudies of the pathophysiology of mental disorders indicate the involvement of neurobiological processes, including the release of neurospecific proteins in biological substances.ObjectivesThe purpose of this study was to research the level of neuron-specific enolase in patients with alcohol use disorder and mood disorders during the therapy.MethodsThe studied groups included patients with alcohol use disorder (AUD, F10.2, ICD-10; n=41), patients with mood disorders (MD, F32, F33, ICD-10; n=39), patients with co-morbidity of AUD and MD (n=31) and 20 healthy controls. Severity of depressive symptoms was assessed with HDRS-17 and CGI-S scales. The concentration of NSE were measured in serum by enzyme immunoassay. Рarticipants of the study were examined with clinical scales and laboratory analysis at baseline and on the 28th day of treatment. For statistical analysis we used the SPSS software.ResultsThe results of the study showed that all patients are characterized by an increased level of NSE (p>0.005 compared with control). Patients with AUD characterized by changes in the concentration of NSE during therapy (p>0.005 compared with patients after therapy). In patients with MD revealed correlation between the level of NSE on the 28th day of antidepressive therapy and the HDRS-17 score before treatment (r=0,421; p=0,018). In patients with co-morbidity correlation between the level of NSE and the CGI-S score before therapy was found (r=-0,537; p=0,001).ConclusionsThe revealed correlations indicate the relationship between the severity of depressive symptoms and the level of NSE. Disclosure statement: This study was supported by the Russian Science Foundation, grant No. 19-15-00023.Conflict of interestDisclosure statement: This study was supported by the Russian Science Foundation, grant No. 19-15-00023.

Under Disclosure of Conflicts of Interest Is Less Frequent in Senior Authors: A Cross-sectional Review of All Authors Submitting to JAAOS Between 2014 and 2018.

The interactions between physicians and industry are necessary for advancement of clinical practice and improvement in medical devices. Physician-industry relationships also introduces financial conflicts of interest into research publications. Payments to physicians do not inherently introduce bias in research, but failure to disclose potential conflicts of interest can negatively impact the perceived integrity of authors, editors, and journals. The conflict of interest disclosure statement in all articles published in the Journal of the American Academy of Orthopaedic Surgery between 2014 and 2018 were compared to the financial payments indexed in the Center for Open Payments Database. Payment type, magnitude, and payer were obtained for each payment meeting inclusion criteria. Statistical comparisons were made using Mann-Whitney comparisons due to non-normal distribution of payment amounts. 704 articles involving 2596 authors were reviewed, with 1268 authors meeting inclusion criteria. 634 authors had accurate disclosure statements. The total amount of disclosed payments was $169 million, whereas undisclosed payments were $14.2 million. The amount of disclosed payments on a per-author basis, $55,844 ($12,559, $186,129), was significantly greater than undisclosed payments, $2,171 ($568, $7,238). The lowest rates of correct disclosure were in education (29.2%), gifts (38.7%) and honoraria (57.8%). First and middle authors disclosed correctly at a significantly lower rate than last authors. The magnitude of undisclosed payments was significantly lower than disclosed payments, indicating that these payments do not register with authors as significant enough to disclose.

Public Speaker Characteristics at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel

We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. Cross-sectional study. We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P < .001). We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.

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...

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.

1154 Discordance Between Self-Reported COI and CMS Open Payment Database Among Gastroenterology Guideline Authors

INTRODUCTION: The 2011 IOM Standards of developing trustworthy guidelines emphasizes transparency and mitigating conflict of interest. This study aims to assess the transparency of reported conflict of interest in gastroenterology guidelines using the “Sunshine” CMS Open Payment Database for comparison. METHODS: Guidelines using GRADE methodology and guideline authors from American Association for the Study of Liver Disease, American College of Gastroenterology, American Gastroenterology Association, and American Society of Gastrointestinal Endoscopy societies from 2013 to October 15, 2018, were abstracted. We reviewed conflict of interest disclosure statements for each author on all guidelines, even if they had no conflict of interest. We analyzed the Sunshine data for each author for the year the guideline was published and the year prior. RESULTS: In guideline documents, 222/823 (26.6%) authors self-reported conflict of interest. Out of 823 authors, 510 (61.9%) of them were reviewed on the Sunshine database, and the remaining authors were not found on the database. 172 of the 510 (33.7%) self-reported at least one conflict of interest. However, 338 (66.2%) did not disclose any conflict of interest. Out of the 338, 325 (96.1%) and 220 (65%) authors did receive general payments in the same year the guideline was published and the year prior, respectively. Out of those who received payments, 213 (65.5%) and 147 (66.8 %) had general payment amounts above $500 in the same year the guideline was published and the year prior, respectively. CONCLUSION: There is a discordance between guideline self-disclosures and the sunshine database. Two-thirds of all guideline authors with CMS reported payments on the sunshine database do not seem to report conflict of interest on the guideline they published during the same time period. We encourage authors to frequently check this publically accessible database to ensure accuracy in its reporting. Additionally, authors and guideline societies should strive to increase conflict of interest reporting to allow for an even further transparent guideline development process.

Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines

BackgroundRecent studies have highlighted the presence of disclosed and undisclosed financial conflicts of interest among authors of clinical practice guidelines. ObjectiveWe sought to determine to what extent urology guideline authors receive and report industry payments in accordance with the Physician Payment Sunshine Act. Design, setting, and participantsWe selected the 13 urology guidelines that were published by the American Urological Association (AUA) after disclosure was mandated by the Physician Payment Sunshine Act. Payments received by guideline authors were searched independently by two investigators using the Open Payments database. Outcome measures and statistical analysisOur primary outcome measure was the number of authors receiving payments from industry, stratified by amount thresholds. Our secondary outcome measure was the number of authors with accurate conflict of interest disclosure statements. Results and limitationsWe identified a total of 54 author disclosures. Thirty-two authors (59.3%) received at least one payment from industry. Twenty (37.0%) received >$10 000 and six (11.1%) received >$50 000. Median total payments were $578 (interquartile range $0–19 228). Twenty (37.0%) disclosure statements were inaccurate. Via Dollars for Docs, we identified $74 195.13 paid for drugs and devices directly related to guideline recommendations. We were limited in our ability to determine when authors began working on guideline panels, as this information was not provided, and by the lack of specificity in Dollars for Docs. ConclusionsMany of the AUA guideline authors received payments from industry, some in excess of $50 000. A significant portion of disclosure statements were inaccurate, indicating a need for more stringent enforcement of the AUA disclosure policy. Patient summaryPharmaceutical company payments to doctors have been shown to influence how doctors treat patients. If these doctors are charged with making clinical recommendations to other doctors, in the form of clinical practice guidelines, the issue of industry payments becomes more severe. We found that many urologists on guideline panels receive money from industry and that a significant portion did not disclose all payments received.

BMJ Best Practice

BMJ Best Practice

Erratum: Re: “Application of Low‐Level Laser Therapy for Noninvasive Body Contouring” Lasers in Surgery and Medicine, 2012;44(3):211–217

In the recent Clinical Report titled, “Application of Low-Level Laser Therapy for Noninvasive Body Contouring” Lasers Surg Med. 2012 Feb;44(3):211–17. DOI: 10.1002/lsm.22007.), the article should have included the following author conflict of interest disclosure statement: Jillian Maloney, MD, presently provides research guidance for Erchonia, the manufacturer of the device used in this study. However, she did not treat any patients or communicate with the participating physicians. This erratum is published to correct the error.

Conflict of interest disclosure in off-label oncology clinical trials.

6041 Background: Off-label prescribing of anti-cancer targeted therapies is increasingly prevalent. Post-regulatory evidence and reporting requirements for reimbursement for off-label oncologic indications are less stringent than the threshold for United States Food and Drug Administration registration. What are the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements in published reports of studies of cancer targeted therapies conducted in the post-regulatory setting? Methods: As a part of a federally-funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to authoritative compendia in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and the presence of COI and funding disclosure statements. Results: Sixty-nine studies were included in the systematic review. Prevalence of COI and funding disclosures was low, at 33% and 58%, respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high impact factor journals (p&lt;0.001), large study sample size (p=0.001), enrollment exclusively in the US (p=0.04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (p=0.03). Studies with multiple sites were more likely to include a funding disclosure statement (p=0.01). Conclusions: There is need for more consistent disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anti-cancer targeted therapies.

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Journal of the Japanese Society of Pediatric Surgeons Conflict of Interest Disclosure Statement

Modified Fecal Transplantation

Willana Lifesciences Ashburn House 4 Derbyshire Road Sale, Cheshire M33 3EG, UK This research was funded by a grant from the UK Northwest Regional Development Agency to Willana Lifesciences. Conflict of Interest Disclosure Statement: Dr Martin is the owner of Willana Lifesciences.

Self‐reported Financial Conflicts of Interest During Scientific Presentations in Emergency Medicine

This study was a review of the scientific abstracts presented at a national conference for the required conflict of interest (COI) disclosure both before the meeting and during presentation. All presenters were given specific instructions regarding COI reporting at the time of abstract acceptance. All poster presentations were required to have a COI statement. Three physicians using standardized data abstraction forms reviewed abstracts accepted for poster presentation at the 2010 annual meeting of the Society for Academic Emergency Medicine (SAEM). Posters were reviewed for the presence of a required COI disclosure statement, and these results were compared to the mandatory continuing medical education (CME) disclosure form that was sent by the presenters to the SAEM central office before the meeting. There were 412 posters accepted for presentation at the 2010 SAEM annual meeting. The reviewers observed 382 (93%) of the total posters for the conference. Sixty-nine abstracts (18%) reported a COI. Only 26 (38%) of these were actually reported to the SAEM office on the CME disclosure form before the meeting; the remaining 62% were found on the poster alone. COI that were reported on the CME disclosure form were found on the poster 46% of the time. The remaining posters without a COI actually displayed the mandatory disclosure statement only 14% of the time. This review of presentations at a national meeting found a lack of compliance with printed guidelines for COI disclosure during scientific presentation. Efforts to increase uniformity and clarity may result in increased compliance.