Conflict Of Interest Declarations Research Articles

Are conflict of interest declarations appropriate to allow sufficient consideration of potential bias in presentations?

Potential conflicts of interest (CoI) are common in medical research, necessitating the use of CoI declarations. There is currently no consensus document or external authority guiding CoI declarations in conference settings, resulting in declarations of variable quality and utility. We explored four CoI declaration parameters (sufficient slide display time; the presence of any verbal explanation pertaining to relevant CoI; the use of an adequate font size; and whether the nature and relevance of the CoI was described). Parameters were graded from one to three points, with the sum of parameters providing an overall declaration quality out of 12. We then applied this scoring system to recordings of presentations from the British Cardiovascular Society (BCS) annual conference 2018 which were available online. Sixty-nine presentations were suitable for inclusion, of which 47 (68%) contained a CoI statement. Thirty-six of the 47 (77%) presentations declared that they had no CoI. In the remaining 11 (23%) with reported CoI, the median time spent displaying CoI was 1 second (interquartile range (IQR) 0.7-3.3). The median quality score for presentations was 7 (IQR 6-10). This study demonstrates utility in considering aspects of CoI declarations at conferences to improve transparency.

The role of National Immunization Technical Advisory Groups (NITAG) in strengthening health system governance: Lessons from three middle-income countries—Argentina, Jordan, and South Africa (2017–2018)

IntroductionToward the Global Vaccine Action Plan 2020 goal, almost 90% of countries have established a National Immunization Technical Advisory Group (NITAG). However, little is known about NITAG's contributions to governance. MethodsIn 2017–2018, a two-step, qualitative retrospective study was conducted. Jordan (JO), Argentina (AR), and South Africa (SA) were selected owing to government-financed NITAGs from middle-income countries (MICs), geographic diversity, and a vaccine introduction with NITAG support. Country case studies were developed, collecting data through desk review and face-to-face key informant interviews (KIIs) from Ministry of Health (MoH) and NITAG. Case studies were analyzed together, to assess governance applying the European Observatory on Health Systems and Policies framework focusing on transparency, accountability, participation, integrity, and policy capacity (TAPIC). ResultsDocument review and 53 KII (22 AR, 20 SA, 11 JO) showed NITAGs played a pivotal role as advisors promoting a culture of evidence-informed policies. NITAGs strengthened governance, although practices varied among countries. Meetings were conducted behind-closed-doors, participation restricted to members, only in one country agendas, and recommendations were public (AR). To increase participation, policy capacity, and transparency, countries considered adding experts in communications, advocacy, and economics. AR and SA contemplated including community members. NITAGs functioned autonomously from the government, with no established internal or external monitoring or supervision. NITAG meeting minutes allowed the review of integrity, adherence to terms of reference, standard operating procedures, and conflict of interest (CoI). For the most part, NITAGs abided by their mandates. Significant issues were related to the level of MoH support and oversight of CoI declaration and documentation. ConclusionsSystematically implementing governance approaches could improve processes, better tailor policies, and implementation. The long-term survival and resilience of NITAGs in these countries showed they play a significant role in strengthening governance. Lessons learned could be useful to those promoting country-driven evidence-informed decision-making.

Erratum for Amblard et al., “Novel Hepatitis B Virus Capsid Assembly Modulator Induces Potent Antiviral Responses In Vitro and in Humanized Mice”

Volume 64, no. 2, e01701-19, 2020, https://doi.org/10.1128/AAC.01701-19. Acknowledgments: the following conflict of interest declarations should be included in the Acknowledgments section. “R. F. Schinazi, F. Amblard, and L. Bassit along with Emory University are entitled to equity and royalties related to products licensed to Aligos Therapeutics, Inc., being further evaluated in the research described in this paper. The terms of this arrangement have been reviewed and approved by Emory University in accordance with its conflict of interest policies.”

Reproducible research practices and transparency in reproductive endocrinology and infertility articles

To analyse the published literature in reproductive endocrinology and infertility (REI) to examine the transparency and the use of reproducible research practices of the scientific literature and to identify possible avenues for improvement. Meta-epidemiologic study. We examined the first 20 consecutive full-text original articles presenting primary data from five REI-specific journals for 2013 and for 2018, and eligible REI articles published in 2013-2018 in five high-impact general journals. Eligible articles were required to be full-text original articles, presenting primary data. Not applicable. Not applicable. Not applicable. Each article was assessed for study type, trial registration, protocol and raw data availability, funding and conflict of interest declarations, inclusion in subsequent systematic reviews and/or meta-analyses, sample size, and whether the work claimed to be novel or replication. Sample sizes and citation counts also were obtained. A total of 222 articles were deemed eligible; 98 from REI journals published in 2013, 90 from REI journals published in 2018, and 34 from high-impact journals. There were 37 studies registered, 15 contained a protocol, and two stated actively that they were willing to share data. Most studies provided a statement about funding and conflicts of interest. Two articles explicitly described themselves as replications. All randomized controlled trial published in REI journals were registered prospectively; many meta-analyses were not registered. High-impact journal articles had a greater median sample size and more citations and were more likely to be registered, to have a protocol, and to claim novelty explicitly when compared with REI 2013 and 2018 articles. Research in REI can be improved in prospective registration, routine availability of protocols, wider sharing of raw data whenever feasible, and more emphasis on replication.

Reproducible and transparent research practices in published neurology research

BackgroundThe objective of this study was to evaluate the nature and extent of reproducible and transparent research practices in neurology publications.MethodsThe NLM catalog was used to identify MEDLINE-indexed neurology journals. A PubMed search of these journals was conducted to retrieve publications over a 5-year period from 2014 to 2018. A random sample of publications was extracted. Two authors conducted data extraction in a blinded, duplicate fashion using a pilot-tested Google form. This form prompted data extractors to determine whether publications provided access to items such as study materials, raw data, analysis scripts, and protocols. In addition, we determined if the publication was included in a replication study or systematic review, was preregistered, had a conflict of interest declaration, specified funding sources, and was open access.ResultsOur search identified 223,932 publications meeting the inclusion criteria, from which 400 were randomly sampled. Only 389 articles were accessible, yielding 271 publications with empirical data for analysis. Our results indicate that 9.4% provided access to materials, 9.2% provided access to raw data, 0.7% provided access to the analysis scripts, 0.7% linked the protocol, and 3.7% were preregistered. A third of sampled publications lacked funding or conflict of interest statements. No publications from our sample were included in replication studies, but a fifth were cited in a systematic review or meta-analysis.ConclusionsCurrently, published neurology research does not consistently provide information needed for reproducibility. The implications of poor research reporting can both affect patient care and increase research waste. Collaborative intervention by authors, peer reviewers, journals, and funding sources is needed to mitigate this problem.

Conflict of interest policies and disclosure requirements in neurosurgical journals.

An increasing amount of funding in neurosurgery research comes from industry, which may create a conflict of interest (COI) and the potential to bias results. The reporting and handling of COIs have become difficult, particularly as explicit policies themselves and definitions thereof continue to vary between medical journals. In this study, the authors sought to evaluate the prevalence and comprehensiveness of COI policies among leading neurosurgical journals. The authors conducted a cross-sectional study of publicly available online disclosure policies in the 20 highest-ranking neurosurgical journals, as determined by Google Scholar Metrics, in July 2016. Overall, 89.5% of the highest-impact neurosurgical journals included COI policy statements. Ten (53%) journals requested declaration of nonfinancial conflicts, while 2 journals specifically set a time period for COIs. Sixteen journals required declaration from the corresponding author, 13 from all authors, 6 from reviewers, and 5 from editors. Four journals were included in the International Committee of Medical Journal Editors (ICMJE) list of publications that follow the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (currently known as Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals). Five journal policies included COI declaration verification, management, or enforcement. The neurosurgery journals with more comprehensive COI policies were significantly more likely to have higher h5-indices (p = 0.003) and higher impact factors (p = 0.01). In 2016, the majority of, but not all, high-impact neurosurgical journals had publically available COI disclosure policies. Policy inclusiveness and comprehensiveness varied substantially across neurosurgical journals, but COI comprehensiveness was associated with other established markers of individual journals' favorability and influence, such as impact factor and h5-index.

Conflict of Interest Declarations by Contributing Editors of the Special Issue on Early-Career Scientists, Sponsored by Illumina

Conflict of Interest Declarations by Contributing Editors of the Special Issue on Early-Career Scientists, Sponsored by Illumina

Editors Should Declare Conflicts of Interest

Editors have increasing pressure as scholarly publishing tries to shore up trust and reassure academics and the public that traditional peer review is robust, fail-safe, and corrective. Hidden conflicts of interest (COIs) may skew the fairness of the publishing process because they could allow the status of personal or professional relationships to positively influence the outcome of peer review or reduce the processing period of this process. Not all authors have such privileged relationships. In academic journals, editors usually have very specialized skills and are selected as agents of trust, entrusted with the responsibility of serving as quality control gate-keepers during peer review. In many cases, editors form extensive networks, either with other professionals, industry, academic bodies, journals, or publishers. Such networks and relationships may influence their decisions or even their subjectivity towards a set of submitting authors, paper, or institute, ultimately influencing the peer review process. These positions and relationships are not simply aspects of a curriculum, they are potential COIs. Thus, on the editorial board of all academic journals, editors should carry a COI statement that reflects their past history, as well as actual relationships and positions that they have, as these may influence their editorial functions.

Team Physician, Team Subspecialist: A Potential Scientific Conflict of Interest?

Team Physician, Team Subspecialist: A Potential Scientific Conflict of Interest?

Correction to: SEOM clinical guideline for treatment of kidney cancer (2017).

The conflict of interest declaration was published incorrectly in the original version.

Industry payments to physician journal editors.

BackgroundOpen Payments is a United States federal program mandating reporting of medical industry payments to physicians, increasing transparency of physician conflicts of interest (COI). Study objectives were to assess industry payments to physician-editors, and to compare their financial COI rate to all physicians within the specialty.Methods and findingsWe performed a retrospective analysis of prospectively collected data, reviewing Open Payments from August 1, 2013 to December 31, 2016. We reviewed general payments (“… not made in connection with a research agreement”) and research funding to “top tier” physician-editors of highly-cited medical journals. We compared payments to physician-editors and physicians-by-specialty. In 35 journals, 333 (74.5%) of 447 “top tier” US-based editors met inclusion criteria. Of these, 212 (63.7%) received industry-associated payments in the study period. In an average year, 141 (42.3%) of physician-editors received any direct payments to themselves including general payments and research payments, 66 (19.8%) received direct payments >$5,000 (National Institutes of Health threshold for a Significant Financial Interest) and 51 (15.3%) received >$10,000. Mean annual general payments to physician-editors was $55,157 (median 3,512, standard deviation 561,885, range 10–10,981,153). Median general payments to physician-editors were mostly higher compared to all physicians within their specialty. Mean annual direct research payment to the physician-editor was $14,558 (median 4,000, range 15–174,440). Mean annual indirect research funding to the physician-editor’s institution (highly valued by academic leaders such as departmental chairs and deans) was $175,282 (median 49,107, range 0.18–5,000,000). The main study limitation was difficulty identifying physician-editors primarily responsible for making manuscript decisions.ConclusionsA substantial minority of physician-editors receive payments from industry within any given year, sometimes quite large. Most editors received payment of some kind during the four-year study period. Given the extent of editors’ influences on the medical literature, more robust and accessible editor financial COI declarations are recommended.

Association of Compensation From the Surgical and Medical Device Industry to Physicians and Self-declared Conflict of Interest

Surgical and medical device manufacturers have a cooperative relationship with clinicians. When evaluating published works, one should assess the integrity and academic credentials of the authors, who serve as putative experts. A relationship with a relevant manufacturer may increase the potential risk for bias in relevant studies. To characterize the association of industrial payments by device manufacturers, self-declared conflict of interest (COI), and relevance of publications among physicians receiving the highest compensation. This population-based bibliometric analysis identified 10 surgical and medical device manufacturing companies and the 10 physicians receiving the highest compensation from each company using the 2015 Open Payments Database (OPD) general payments data. For each of the 100 physicians, the total amount of general payments, number of payments, institution type, and academic rank were recorded. Royalty or license payments were excluded. A search of PubMed identified articles published by each physician from January 1 through December 31, 2016, and their associated COI declaration. Scopus was used to identify bibliometric data reported as the h index (number of papers by a researcher with at least h citations each). Discrepancy between self-declared COI and industry payments. The 100 physicians included in the sample population (88% men) were paid a total of $12 446 969, with a median payment of $95 993. Fifty physicians (50.0%) were faculty at academic institutions. The mean (SD) h index was 18 (18; range, 0-75) for the authors. In 2016, 412 articles were published by these physicians, with a mean (SD) of 4 (6) publications (range, 0-25) and median of 1 (36 physicians had no publications). Of these articles, 225 (54.6%) were relevant to the general payments received by the authors. Only in 84 of the 225 relevant publications (37.3%) was the potential COI declared by the authors. A high level of inconsistency was found between self-declared COI and the OPD among the physicians receiving the highest industry payments. Therefore, a policy of full disclosure for all publications, regardless of relevance, is proposed. No statistically significant association was demonstrated between academic rank or productivity and industrial payments.

Management of financial conflicts of interests in clinical practice guidelines in Germany: results from the public database GuidelineWatch

BackgroundThe reliability of clinical practice guidelines has been disputed because guideline panel members are often burdened with financial conflicts of interest (COI). Current recommendations for COI regulation advise not only detailed declaration but also active management of conflicts. To continuously assess COI declaration and management in German guidelines we established the public database LeitlinienWatch (GuidelineWatch).MethodsWe analyzed all German guidelines at the highest methodological level (S3) that included recommendations for pharmacological therapy (n = 67) according to five criteria: declaration and assessment of COI, composition of the guideline development group, independence of the coordinators and lead authors, imposed abstentions because of COI and public external review. Each criterion was assessed using predefined outcome categories.ResultsMost guidelines (76%) contained a detailed declaration of COI. However, none of the guidelines provided full transparency of COI assessment results. The guideline group was composed of a majority of participants with COI in 55% of the guidelines, no guideline was free of participants with COI. Only 9% of guidelines had coordinators and lead authors without any financial COI. Most guidelines (70%) did not provide a rule for abstentions for participants with COI. In 21% of guidelines there was a rule, but abstentions were either not practiced or not documented, whereas in 7% partial abstentions and in 2% complete abstentions were documented. Two thirds of the guideline drafts (67%) were not externally reviewed via a public website.ConclusionsCOI are usually documented in detail in German guidelines of the highest methodological level. However, considerable improvement is needed regarding active management of COI, including recruitment of independent experts for guideline projects, abstention from voting for participants with COI and external review of the guideline draft. We assume that the publicly available ratings on GuidelineWatch will improve the handling of conflicts of interest in guideline development.

P.120 Conflict of interest in neurosurgery: an analysis of disclosure policies in neurosurgical journals

Background: Industry funding of neurosurgery research is on the rise and this creates a conflict of interest (COI) with the potential to bias results. The reporting and handling of COI is impacted by the variation in policies and definitions between journals. In this study we sought to evaluate the prevalence and comprehensiveness of COI policies amongst leading neurosurgical journals. Methods: We conducted a cross-sectional study of publicly available online disclosure policies in the 20 highest-ranking neurosurgical journals, as determined by Google Scholar Metrics, in July of 2016. Results: Eighteen (89.5%) of the top neurosurgical journals included COI policy statements. Ten journals requested declaration of non-financial conflicts, while two journals defined a time period of interest for conflicts. Sixteen journals required declaration from the corresponding author, 13 from all authors, six from reviewers and five from editors. Five journals included COI declaration verification, management or enforcement. Journals with more comprehensive COI policies were significantly more likely to have higher h5-indices (p=0.003) and higher impact factors (p=0.01). Conclusions: In 2016, the majority of high-impact neurosurgical journals had publicly available COI disclosure policies. Policies varied substantially across neurosurgical journals; but COI comprehensiveness was associated with impact factor and h5-index. More comprehensive and consistent COI policies will facilitate increased transparency in neurosurgery research.

Declaring Conflict of Interest – Current State of Affairs in the Ophthalmic Literature

ABSTRACTThe importance of transparency with financial ties in biomedical research is widely recognized, and most peer-reviewed journals require declarations of Conflicts of Interest (COI). Nonetheless, variability in the consistency of declarations of COI has been sparsely assessed. To assess consistency and rates of COI declarations in the ophthalmic literature and the effectiveness of journal COI policies. We analyzed consistency and completeness of declaration of COI in the ophthalmic literature and compared the levels of completeness to specific journal requirements. Six-hundred forty-two peer reviewed articles satisfied the inclusion criteria. In 64%, COIs were unreported, in 25% declaration of COI was incomplete, and 11% of the articles reviewed had complete declaration of COI. Of the 33 journals in which the most frequently published authors’ articles appeared, 10 required the authors to complete the International Committee of Medical Journal Editors (ICMJE) form or an equivalent form, but this did not affect the rates of COI declaration. In a random sampling of the most frequently published authors in the field of ophthalmology, declaration of COI was low and highly inconsistent. Requiring a standardized COI form has no significant effect on the rate of accurate COI reporting. Our findings lend support to the growing body of literature that shows that journals and editors may need to take a more active role in ensuring accurate and consistent COI reporting.

Abstract WP418: A Systematic Comparison of Key Features of Ischaemic Stroke Prevention Guidelines in Low- and Middle-income vs High-income Countries

Introduction: Implementation of contextually appropriate, evidence-based, expert-recommended stroke prevention guideline is particularly important in Low- and Middle-Income Countries (LMICs), which bear disproportional larger burden of stroke while possessing fewer resources. Focus therefore, should be on approaches enabling healthcare systems to improve control of vascular risk factors. Objective: We aimed to compare important features of stroke prevention guidelines between LMICs and High Income Countries (HICs). Methods: We systematically searched PubMed, AJOL, SciELO, and LILACS databases for stroke prevention guidelines published between January 2005 and December 2015 by country. Primary search items included: “Stroke” and “Guidelines”. We critically appraised the articles for evidence level, issuance frequency and implementation aspects to clinical practice. Results: Among 45 stroke prevention guidelines published, 28 (62%) met eligibility criteria: 7 from LMICs (25%) and 21 from HICs (75%). LMIC-issued guidelines were less likely to have conflict of interest declarations (57% vs. 100%, p=0.01), involve high quality systematic reviews (57% vs. 95%, p= 0.03), had good dissemination channels (14% vs 71%, p=0.02). The patient views and preferences were the most significant stakeholder considerations in HICs (43%, p=0.04) compared with LMICs. Conclusion: The quality and quantity of stroke prevention guidelines in LMICs are less than those of HICs and need to be significantly improved upon.

The Fragility Index: a P-value in sheep's clothing?

This editorial refers to ‘How robust are clinical trials in heart failure?’, by K.F. Docherty et al. , doi:10.1093/eurheartj/ehw427. Randomized controlled trials (RCTs) are designed to assess objectively the safety and efficacy of a specific intervention. While public reporting of the study design, conflict of interest declarations, and the peer review process strive to fortify study findings, the veracity of published research studies has been called into question.1 Recently, the Fragility Index (FI) has been introduced as an intuitive measure of the robustness of RCTs.2 This new statistic has been recently reported in the critical care setting,3 and studied and advocated for heart failure in the paper by Docherty et al .4 In this Editorial, we will provide a brief explanation of the FI and express why caution needs to be exercised when interpreting FI. The FI is a statistical summary of an RCT that utilizes 1:1 randomization and an outcome measure that can be categorized into two levels (e.g. 30-day mortality, yes or no). When a study reaches a statistically significant difference (and the sample size per group is fixed), one can show that the number of positive responses differs between the groups. Without loss of generality, assume that a study is comprised of a novel intervention and a control condition and that fewer events will be observed in the intervention group (i.e. the intervention provides a protective effect to the patients). Suppose that the study results suggest that the intervention is protective and that the result is statistically significant. Upon careful observation, it is noted that the number of events is reasonably small and that in absolute number there is not a large difference between the two study groups. One might naturally ask the question ‘how would the results be interpreted if one of …

Declarations, accusations and judgement: examining conflict of interest discourses as performative speech-acts.

Concerns over conflicts of interest (COI) in academic research and medical practice continue to provoke a great deal of discussion. What is most obvious in this discourse is that when COIs are declared, or perceived to exist in others, there is a focus on both the descriptive question of whether there is a COI and, subsequently, the normative question of whether it is good, bad or neutral. We contend, however, that in addition to the descriptive and normative, COI declarations and accusations can be understood as performatives. In this article, we apply J.L. Austin's performative speech-act theory to COI discourses and illustrate how this works using a contemporary case study of COI in biomedical publishing. We argue that using Austin's theory of performative speech-acts serves to highlight the social arrangements and role of authorities in COI discourse and so provides a rich framework to examine declarations, accusationsand judgements of COI that often arise in the context of biomedical research and practice.

Level of evidence, sponsorship, conflict of interest policy and commercial impact of PubMed-listed clinical urolithiasis-related trials in 2014.

To evaluate published trials on urolithiasis regarding level of evidence, type of sponsorship and declared conflicts of interest (COIs), and to elucidate a potential commercial impact. We performed a systematic PubMed(®) literature search using a predefined Boolean search term to identify PubMed-listed clinical research studies on urolithiasis in 2014 (fourth quarter). All authors screened the results for eligibility criteria and two independent reviewers evaluated and performed data extraction of predefined endpoints, including level of evidence, declaration of COI and sponsorship/funding (as indicated in the published print version), and commercial impact. A total of 110 clinical trials in urolithiasis listed in PubMed met the inclusion criteria. Levels of evidence 1, 2, 3 and 4 were found in 15%, 14%, 21% and 51% of trials, respectively. A COI was indicated in a total of 90% of publications, 93% of which declared no existing conflict of interest. Sponsorship was indicated in 36% of publications, 55% of which stated public funding, 33% institutional funding, 10% industrial funding and 2% both public and industrial funding. A total of 11% of the published trials were rated as having a high commercial impact. The present study provides evidence of increasing levels of evidence for published clinical trials on urolithiasis in 2014 (as compared with earlier data). Ninety percent of publications indicated conflicts of interest, whereas sponsoring of studies was declared only by one-third. A considerable number of trials involved issues of high commercial impact. Recently established legal programmes and voluntary acts on self-reporting of financial relationships will enhance transparency in the future; however, increased public funding will be needed to further promote the quality of trials on urolithiasis.

Políticas de declaración de conflictos de interés en revistas biomédicas españolas de orientación clínica

Professional and financial ties between the pharmaceutical industry and persons and institutions carrying out research, conducting medical training, and practicing medicine can lead to individual or corporate interests influencing decision-making and professional judgment. These conflicts of interest threaten the integrity of research, the objectivity of medical education, the quality of patient care and, more generally, public confidence in medicine. A strategy to protect research integrity and maintain public trust is for authors to communicate their possible conflicts of interest in the studies they publish. This paper analyses the editorial policies of the 16 clinically oriented biomedical journals published in Spain that were included in the JCR in 2011, in relation to authors’ conflict of interest declarations. Results show that, in their instructions to authors, most journals mention the need to disclose possible conflicts of interest and offer some sort of description of such situations. However, the definitions are lax concerning which economic relations should be declared and do not specify the extent of personal relationships. In most cases there is no standard form for declaring conflicts of interest; there is no indication of the period of time during which a relationship can be considered likely to generate a conflict; there is no indication of who will evaluate these statements and how they will be evaluated; and there is no indication as to whether these statements will be published in the articles.