Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research.
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ABSTRACT:
SUBMITTER: Lacasse JR
PROVIDER: S-EPMC3037872 | biostudies-other | 2011
REPOSITORIES: biostudies-other
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Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research.
Lacasse Jeffrey R JR Leo Jonathan J
BMC research notes 20110131
<h4>Background</h4>While the impact of conflicts-of-interest (COI) is of increasing concern in academic medicine, there is little research on the reaction of practicing clinicians to the disclosure of such conflicts. We developed two research vignettes presenting a fictional antidepressant medication study, one in which the principal investigator had no COI and another in which there were multiple COI disclosed. We confirmed the face validity of the COI vignette through consultation with experts ...[more]
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Project description:BackgroundThere is much concern regarding undisclosed corporate authorship ("ghostwriting") in the peer-reviewed medical literature. However, there are no studies of how disclosure of ghostwriting alone impacts the perceived credibility of research results.FindingsWe conducted a randomized vignette study with experienced nurses (n = 67), using a fictional study of antidepressant medication. The vignette described a randomized controlled trial and gave efficacy and adverse effect rates. Participants were randomly assigned to one of two authorship conditions, either (a) traditional authorship (n = 35) or (b) ghostwritten paper (n = 32), and then completed a perceived credibility scale. Our primary hypothesis was that the median perceived credibility score total would be lower in the group assigned to the ghostwritten paper. Our secondary hypotheses were that participants randomized to the ghostwritten condition would be less likely to (a) recommend the medication, and (b) want the psychiatrist in the vignette as their own clinician. We also asked respondents to estimate efficacy and adverse effect rates for the medication.There was a statistically significant difference in perceived credibility among those assigned to the ghostwriting condition. This amounted to a difference of 9.0 points on the 35-point perceived credibility scale as tested through the Mann-Whitney U test. There was no statistically significant difference between groups in terms of recommending the medication, wanting the featured clinician as their own, or in estimates of efficacy or adverse effects (p > .05 for all such comparisons).ConclusionIn this study, disclosure of ghostwriting resulted in lower perceived credibility ratings.
| S-EPMC3532151 | biostudies-literature
Project description:BackgroundThere is little guidance regarding how to disclose researchers' financial interests to potential research participants.ObjectiveTo determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement.Design and participantsSixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer.ApproachFocus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis.ResultsParticipants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know.ConclusionsFinancial interests are important to potential research participants, but obstacles to effective disclosure exist.
| S-EPMC1831594 | biostudies-literature
Project description:Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.
| S-EPMC3031202 | biostudies-literature
Project description:BackgroundSystematic reviews are increasingly used to inform health policy-making. The conflicts of interest (COI) of the authors of systematic reviews may bias their results and influence their conclusions. This may in turn lead to misguided public policies and systems level decisions. In order to mitigate the adverse impact of COI, scientific journals require authors to disclose their COIs. The objective of this study was to assess the frequency and different types of COI that authors of systematic reviews on health policy and systems research (HSPR) report.MethodsWe conducted a cross sectional survey. We searched the Health Systems Evidence (HSE) database of McMaster Health Forum for systematic reviews published in 2015. We extracted information regarding the characteristics of the systematic reviews and the associated COI disclosures. We conducted descriptive analyses.ResultsEighty percent of systematic reviews included authors' COI disclosures. Of the 160 systematic reviews that included COI disclosures, 15% had at least one author reporting at least one type of COI. The two most frequently reported types of COI were individual financial COI and individual scholarly COI (11% and 4% respectively). Institutional COIs were less commonly reported than individual COIs (3% and 15% respectively) and non-financial COIs were less commonly reported than financial COIs (6% and 14% respectively). Only one systematic review reported the COI disclosure by editors, and none reported disclosure by peer reviewers. All COI disclosures were in the form of a narrative statement in the main document and none in an online document.ConclusionA fifth of systematic reviews in HPSR do not include a COI disclosure statement, highlighting the need for journals to strengthen and/or better implement their COI disclosure policies. While only 15% of identified disclosure statements report any COI, it is not clear whether this indicates a low frequency of COI versus an underreporting of COI, or both.
| S-EPMC6077276 | biostudies-literature
Project description:ObjectiveTo systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).MethodsIn this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.ResultsAmong the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.ConclusionThere are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.
| S-EPMC8105509 | biostudies-literature
Project description:IntroductionThe tobacco control community has raised some concerns about whether studies on electronic cigarettes (e-cigarettes) published in scientific journals hide conflicts of interest (COI) and whether such reports are biased. This study assessed potential COI in the e-cigarette scientific literature.MethodsCross-sectional study was conducted on e-cigarette publications indexed in PubMed up to August 2014. We extracted information about the authors (affiliations, location, etc.), publication characteristics (type, topic, subject, etc.), results and conclusions, presence of a COI statement, and funding by and/or financial ties to pharmaceutical, tobacco, and/or e-cigarette companies. An algorithm to determine the COI disclosure status was created based on the information in the publication. Prevalence ratios (PRs) and confidence intervals (CIs) were calculated to identify associations with COI disclosure, controlling for several independent variables.ResultsOf the 404 publications included in the analysis, 37.1% (n=150) had no COI disclosure statement, 38.6% declared no COI, 13.4% declared potential COI with pharmaceutical companies, 3.0% with tobacco companies, and 10.6% with e-cigarette companies. The conclusions in publications with COI, which were mainly tied to pharmaceutical companies, were more likely to be favourable to e-cigarette use (PR=2.23; 95% CI: 1.43-3.46). Publications that supported the use of e-cigarettes for both harm reduction (PR=1.81; 95%CI: 1.14-2.89) and smoking cessation (PR=2.02; 95% CI: 1.26-3.23) were more likely to have conclusions that were favourable to e-cigarettes.ConclusionsOne-third of the publications reporting studies on e-cigarettes did not have a COI disclosure statement, and this proportion was even higher in news articles, editorials and other types of publications. Papers with conclusions that were favourable to e-cigarette use were more likely to have COI. Journal editors and reviewers should consider evaluating publications, including funding sources, to determine whether the results and conclusions may be biased.
| S-EPMC6659563 | biostudies-literature
Project description:Background. Tobacco companies have actively promoted the substitution of cigarettes with purportedly safer tobacco products (e.g., smokeless tobacco, e-cigarettes) as tobacco harm reduction (THR). Given the tobacco, e-cigarette, and pharmaceutical industries' substantial financial interests, we quantified industry influence on support for THR. Objectives. To analyze a comprehensive set of articles published in peer-reviewed journals assessing funding sources and support for or opposition to substitution of tobacco or nicotine products as harm reduction. Search Methods. We searched PubMed, Embase, Web of Science, and PsycINFO with a comprehensive search string including all articles, comments, and editorials published between January 1, 1992, and July 26, 2016. Selection Criteria. We included English-language publications published in peer-reviewed journals addressing THR in humans and excluded studies on modified cigarettes, on South Asian smokeless tobacco variants, on pregnant women, on animals, not mentioning a tobacco or nicotine product, on US Food and Drug Administration-approved nicotine replacement therapies, and on nicotine vaccines. Data Collection and Analysis. We double-coded all articles for article type; primary product type (e.g., snus, e-cigarettes); themes for and against THR; stance on THR; THR concepts; funding or affiliation with tobacco, e-cigarette, pharmaceutical industry, or multiple industries; and each author's country. We fit exact logistic regression models with stance on THR as the outcome (pro- vs anti-THR) and source of funding or industry affiliation as the predictor taking into account sparse data. Additional models included article type as the outcome (nonempirical or empirical) and industry funding or affiliation as predictor, and stratified analyses for empirical and nonempirical studies with stance on THR as outcome and funding source as predictor. Main Results. Searches retrieved 826 articles, including nonempirical articles (21%), letters or commentaries (34%), editorials (5%), cross-sectional studies (15%), systematic reviews and meta-analyses (3%), and randomized controlled trials (2%). Overall, 23.9% disclosed support by industry; 49% of articles endorsed THR, 42% opposed it, and 9% took neutral or mixed positions. Support from the e-cigarette industry (odds ratio [OR]?=?20.9; 95% confidence interval [CI]?=?5.3, 180.7), tobacco industry (OR?=?59.4; 95% CI?=?10.1, +infinity), or pharmaceutical industry (OR?=?2.18; 95% CI?=?1.3, 3.7) was significantly associated with supportive stance on THR in analyses accounting for sparse data. Authors' Conclusions. Non-industry-funded articles were evenly divided in stance, while industry-funded articles favored THR. Because of their quantity, letters and comments may influence perceptions of THR when empirical studies lack consensus. Public Health Implications. Public health practitioners and researchers need to account for industry funding when interpreting the evidence in THR debates.
| S-EPMC6603486 | biostudies-literature
Project description:BackgroundIndustry and orthopaedic surgeons often partner to develop new technology, which can lead to orthopaedic surgeons having financial conflicts of interest (FCOI). It is essential these FCOI be conveyed clearly to patients. It is unclear, however, whether and to what degree patients understand the ramifications of physician FCOI.Questions/purposesWe evaluated (1) patients' concerns regarding their surgeon having FCOI or the presence of institutional FCOI, (2) the effect of surgeon FCOI on patients' willingness to have surgery, and (3) patients' understanding of FCOI.MethodsWe asked 101 patients (66% female) receiving total joint arthroplasty from the orthopaedic practices of two surgeons at an academic health center to complete a descriptive, correlational designed survey at their 6-week followup appointment. The data collected included patient demographics, knowledge of FCOI, and the influence of FCOI on patient attitudes toward surgery and their surgeon.ResultsA minority of patients (13%) reported discussing FCOI with prior physicians and only 55% agreed or strongly agreed a surgeon should disclose FCOI. Only 15% of patients believed such conflicts would make them less likely to have their surgeon operate on them. Level of education was weakly correlated (Spearman's rho = 0.29) with patient understanding of FCOI.ConclusionsOverall, patients had a poor understanding of FCOI. Both level of education and previous discussions of FCOI predicted better understanding. This study emphasizes communication of FCOI with patients needs to be enhanced.
| S-EPMC3549175 | biostudies-literature
Project description:Background There is a high prevalence of financial conflicts of interest (COI) between physicians and industry. Objectives To conduct a systematic review with meta-analysis examining the completeness of self-reported financial COI disclosures by physicians, and identify factors associated with non-disclosure. Data sources MEDLINE, Embase and PsycINFO were searched for eligible studies up to April 2020 and supplemented with material identified in the references and citing articles. Data extraction and synthesis Data were independently abstracted by two authors. Data synthesis was performed via systematic review of eligible studies and random-effects meta-analysis. Main outcomes and measures The proportion of discrepancies between physician self-reported disclosures and objective payment data was the main outcome. The proportion of discrepant funds and factors associated with non-disclosure were also examined. Results 40 studies were included. The pooled proportion of COI discrepancies at the article level was 81% (range: 54%–98%; 95% CI 72% to 89%), 79% at the payment level (range: 71%–89%; 95% CI 67% to 89%), 93% at the authorship level (range: 71%–100%; 95% CI 79% to 100%) and 66% at the author level (range: 8%–99%; 95% CI 48% to 78%). The proportion of funds discrepant was 33% (range: 2%–77%; 95% CI 12% to 58%). There was high heterogeneity between studies across all five analyses (I2=94%–99%). Most undisclosed COI were related to food and beverage, or travel and lodging. While the most common explanation for failure to disclose was perceived irrelevance, a median of 45% of non-disclosed payments were directly or indirectly related to the work. A smaller monetary amount was the most common factor associated with nondisclosure. Conclusions Physician self-reports of financial COI are highly discrepant with objective data sources reporting payments from industry. Stronger policies are required to reduce reliance on physician self-reporting of financial COI and address non-compliance.
| S-EPMC8039229 | biostudies-literature
Project description:BackgroundThe primary aim of our study was to evaluate the effects of undisclosed financial conflicts of interest in Achilles tendon rupture repair-focused systematic reviews.MethodsFollowing a cross-sectional study design, we searched MEDLINE and Embase for Achilles tendon rupture repair systematic reviews. We performed screening and data extraction in a blind, triplicate fashion. Each systematic review was evaluated on the individual characteristics of the study, presence of undisclosed and disclosed conflicts of interest, favorability of results and conclusions, and the relationship between conflicts of interest and the favorability of results and conclusions.ResultsOur search produced 172 total systematic reviews pertaining to Achilles tendon rupture repair; of those, only 12 were included in our study. Undisclosed conflicts of interest were found in half (6/12) of the included reviews. However, no significant association was found between conflict of interest and the favorability of results and conclusions.ConclusionUndisclosed conflicts of interests were discovered in a large percentage of our sample. This lack of disclosure did not appear to increase the likelihood of the systematic review results or conclusions reporting favorability of the intervention being investigated.Level of evidenceLevel II.
| S-EPMC8702762 | biostudies-literature