Conflict of interest policies for organizations producing a large number of clinical practice guidelines.
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ABSTRACT:
SUBMITTER: Norris SL
PROVIDER: S-EPMC3358298 | biostudies-other | 2012
REPOSITORIES: biostudies-other
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Project description:BackgroundConflicts of interest (COI) jeopardize the validity of Clinical Practice Guidelines (CPGs). When the Institute of Medicine promulgated COI policies in 2011, few organizations met these requirements, but it is unknown if organizations have improved their policies since that time. We sought to evaluate current adherence to IOM standards of COI policies.Methods and findingsWe conducted a retrospective document review of COI policies and CPGs from organizations that published five or more CPGs between January 1, 2018 and December 31, 2019. Organizations were identified via CPG databases. COI policies were obtained from an internet search. We collected data on i) the number of organizations that have COI policies specific to CPG development, ii) the number of policies meeting each IOM standard and iii) the number of IOM standards met by each policy. COI disclosures from five CPGs of each organization were assessed for adherence to IOM standards. Among the 46 organizations that published 5 or more CPGs, 36 (78%) had a COI policy. Standard 2.2b (requiring divestment of financial COI) was met least frequently, by 2 of 36 (6%) organizations. Standard 2.1 (requiring disclosure of COI) was met most frequently, by 33 of 36 (92%) organizations. A total of 31 of 36 (86%) organizations met 4 or fewer of the 7 IOM standards. Among the 16 organizations limiting COI to a minority of the CPG panel (standard 2.4c) and the 15 organizations prohibiting COI among chairs or co-chairs (standard 2.4d), 12 (75%) and 10 (67%) organizations violated the respective standard in at least one CPG. The main limitations of our study are the exclusion of organizations producing fewer CPGs and ability to assess only publicly available policies.ConclusionAmong organizations producing CPGs, COI policies frequently do not meet IOM standards, and organizations often violate their own policies. These shortcomings may undermine the public trust in and thus the utility of CPGs. CPG-producing organizations should improve their COI policies and their strategies to manage COI to increase the trustworthiness of CPGs.
| S-EPMC8087455 | biostudies-literature
Project description:BackgroundThere is an emerging literature on the existence and effect of industry relationships on physician and researcher behavior. Much less is known, however, about the effects of these relationships and other conflicts of interest (COI) on clinical practice guideline (CPG) development and recommendations. We performed a systematic review of the prevalence of COI and its effect on CPG recommendations.Methodology/principal findingsWe searched Medline (1980 to March, 2011) for studies that examined the effect of COI on CPG development and/or recommendations. Data synthesis was qualitative. Twelve studies fulfilled inclusion criteria; 9 were conducted in the US. All studies reported on financial relationships of CPG authors with the pharmaceutical industry; 1 study also examined relationships with diagnostic testing and insurance companies. The majority of guidelines had authors with industry affiliations, including consultancies (authors with relationship, range 6-80%); research support (4-78%); equity/stock ownership (2-17%); or any COI (56-87%). Four studies reported multiple types of financial interactions for individual authors (number of types per author: range 2 to 10 or more). Data on the effect of COI on CPG recommendations were confined to case studies wherein authors with specific financial ties appeared to benefit from the related CPG recommendations. In a single study, few authors believed that their relationships influenced their recommendations. No studies reported on intellectual COI in CPGs.Conclusions/significanceThere are limited data describing the high prevalence of COI among CPG authors, and only case studies of the effect of COI on CPG recommendations. Further research is needed to explore this potential source of bias.
| S-EPMC3198464 | 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:Academic medical centers (AMCs) have increasingly adopted conflict of interest policies governing physician-industry relationships; it is unclear how policies impact prescribing.To determine whether 9 American Association of Medical Colleges (AAMC)-recommended policies influence psychiatrists' antipsychotic prescribing and compare prescribing between academic and nonacademic psychiatrists.We measured number of prescriptions for 10 heavily promoted and 9 newly introduced/reformulated antipsychotics between 2008 and 2011 among 2464 academic psychiatrists at 101 AMCs and 11,201 nonacademic psychiatrists. We measured AMC compliance with 9 AAMC recommendations. Difference-in-difference analyses compared changes in antipsychotic prescribing between 2008 and 2011 among psychiatrists in AMCs compliant with ? 7/9 recommendations, those whose institutions had lesser compliance, and nonacademic psychiatrists.Ten centers were AAMC compliant in 2008, 30 attained compliance by 2011, and 61 were never compliant. Share of prescriptions for heavily promoted antipsychotics was stable and comparable between academic and nonacademic psychiatrists (63.0%-65.8% in 2008 and 62.7%-64.4% in 2011). Psychiatrists in AAMC-compliant centers were slightly less likely to prescribe these antipsychotics compared with those in never-compliant centers (relative odds ratio, 0.95; 95% CI, 0.94-0.97; P < 0.0001). Share of prescriptions for new/reformulated antipsychotics grew from 5.3% in 2008 to 11.1% in 2011. Psychiatrists in AAMC-compliant centers actually increased prescribing of new/reformulated antipsychotics relative to those in never-compliant centers (relative odds ratio, 1.39; 95% CI, 1.35-1.44; P < 0.0001), a relative increase of 1.1% in probability.Psychiatrists exposed to strict conflict of interest policies prescribed heavily promoted antipsychotics at rates similar to academic psychiatrists and nonacademic psychiatrists exposed to less strict or no policies.
| S-EPMC4360919 | biostudies-literature
Project description:Authors of clinical practice guidelines (CPGs) disclose financial conflicts of interest (FCOIs) to promote transparency ethics. Typically, they do so on standard declaration forms containing generic open-ended questions on FCOIs. Yet, the literature is scant on the format and effect of alternative disclosure forms. Does supplementing a standard form with subsequent detailed disclosure forms tailored to the context of the CPG improve the yield or accuracy of FCOIs declarations?For an international CPG in gastroenterology on the endoscopic surveillance for colorectal neoplasia in inflammatory bowel disease, we compared the use of a standard FCOIs disclosure form with a contextual FCOIs disclosure form that detailed commercial relations related to the CPG topic. This included manufacturers of endoscopes, endoscopy equipment and accessories. Participants completed the generic form early, and the supplementary contextual form six months later. We then compared the FCOI disclosures obtained.26 participants provided FCOIs disclosures using both disclosure forms. We found discrepancies regarding (1) the disclosure of FCOIs (presence/absence), and (2) the listing of financial entities. While the number of participants who disclosed a FCOI remained the same (30.8%) using the two forms, disclosures were not from the same individuals: two additional participants disclosed a FCOI, whereas two participants withdrew previous disclosures. Among those who reported a FCOI in either form, we noted inconsistencies in disclosures for 70% of the participants. This included changes in FCOIs disclosure status or modifications of "their commercial relations".Accurate reporting of FCOIs advances the transparency and ethical integrity of CPGs. Our experience suggests that a contextual FCOIs disclosure form tailored to content of the CPG with narrow, detailed questions provides supplementary, more complete FCOIs declarations than generic forms alone. The finding raises challenges on how forms are best written and formatted, optimally timed, and more effectively processed with sensitivity to professional behaviour, so as to heighten transparency.
| S-EPMC5571907 | biostudies-literature
Project description:ObjectiveTo determine the prevalence of financial conflicts of interest among members of panels producing clinical practice guidelines on screening, treatment, or both for hyperlipidaemia or diabetes.DesignCross sectional study.SettingRelevant guidelines published by national organisations in the United States and Canada between 2000 and 2010.ParticipantsMembers of guideline panels.Main outcome measuresPrevalence of financial conflicts of interest among members of guideline panels and chairs of panels.ResultsFourteen guidelines met our search criteria, of which five had no accompanying declaration of conflicts of interest by panel members. 288 panel members had participated in the guideline development process. Among the 288 panel members, 138 (48%) reported conflicts of interest at the time of the publication of the guideline and 150 (52%) either stated that they had no such conflicts or did not have an opportunity to declare any. Among 73 panellists who formally declared no conflicts, 8 (11%) were found to have one or more. Twelve of the 14 guideline panels evaluated identified chairs, among whom six had financial conflicts of interest. Overall, 150 (52%) panel members had conflicts, of which 138 were declared and 12 were undeclared. Panel members from government sponsored guidelines were less likely to have conflicts of interest compared with guidelines sponsored by non-government sources (15/92 (16%) v 135/196 (69%); P<0.001).ConclusionsThe prevalence of financial conflicts of interest and their under-reporting by members of panels producing clinical practice guidelines on hyperlipidaemia or diabetes was high, and a relatively high proportion of guidelines did not have public disclosure of conflicts of interest. Organisations that produce guidelines should minimise conflicts of interest among panel members to ensure the credibility and evidence based nature of the guidelines' content.
| S-EPMC3191201 | biostudies-literature
Project description:IntroductionThe education of medical students should be based on the best clinical information available, rather than on commercial interests. Previous research looking at university-wide conflict of interest (COI) policies used in Canadian medical schools has shown very poor regulation. An analysis of COI policies was undertaken to document the current policy environment in all 17 Canadian medical schools.MethodsA web search was used to initially locate COI policies supplemented by additional information from the deans of each medical school. Strength of policies was rated on a scale of 0 to 2 in 12 categories and also on the presence of enforcement measures. For each school, we report scores for all 12 categories, enforcement measures, and summative scores.ResultsCOI policies received summative scores that ranged from 0 to 19, with 0 the lowest possible score obtainable and 24 the maximum. The highest mean scores per category were for disclosure and ghostwriting (0.9) and for gifts and scholarships (0.8).DiscussionThis study provides the first comprehensive evaluation of all 17 Canadian medical school-specific COI policies. Our results suggest that the COI policy environment at Canadian medical schools is generally permissive. Policy development is a dynamic process. We therefore encourage all Canadian medical schools to develop restrictive COI policies to ensure that their medical students are educated based on the best clinical evidence available, free of industry biases and COI relationships that may influence the future medical thinking and prescribing practices of medical students in Canada once they graduate.
| S-EPMC3701639 | biostudies-literature
Project description:BackgroundMedical faculties have a role in ensuring that their students are protected from undue commercial influence during their training, and are educated about professional-industry interactions. In North America, many medical faculties have introduced more stringent conflict of interest (COI) policies during the last decade. We asked whether similar steps had been taken in France. We hypothesized that such policies may have been introduced following a 2009-2010 drug safety scandal (benfluorex, Mediator) in which COIs in medicine received prominent press attention.MethodsWe searched the websites of all 37 French Faculties of Medicine in May 2015 for COI policies and curriculum, using standardized keyword searches. We also surveyed all deans of medicine on institutional COI policies and curriculum, based on criteria developed in similar US and Canadian surveys. Personal contacts were also consulted. We calculated a summary score per faculty based on 13 criteria. [range 0-26; higher scores denoting stronger policies].ResultsIn total, we found that 9/37 (24%) of French medical schools had either introduced related curriculum or implemented a COI-related policy. Of these, only 1 (2.5%) had restrictive policies for any category. No official COI policies were found at any of the schools. However, at 2 (5%), informal policies were reported. The maximum score per faculty was 5/26, with 28 (76%) scoring 0.ConclusionThis is the first survey in France to examine COI policies at medical faculties. We found little evidence that protection of medical students from undue commercial influence is a priority, either through institutional policies or education. This is despite national transparency legislation on industry financing of health professionals and limits on gifts. The French National Medical Students Association (ANEMF) has called for more attention to COI in medical education; our results strongly support such a call.
| S-EPMC5221756 | biostudies-literature
Project description:ObjectiveWe undertook this investigation to characterize conflict of interest (COI) policies of biomedical journals with respect to authors, peer-reviewers, and editors, and to ascertain what information about COI disclosures is publicly available.MethodsWe performed a cross-sectional survey of a convenience sample of 135 editors of peer-reviewed biomedical journals that publish original research. We chose an international selection of general and specialty medical journals that publish in English. Selection was based on journal impact factor, and the recommendations of experts in the field. We developed and pilot tested a 3-part web-based survey. The survey included questions about the presence of specific policies for authors, peer-reviewers, and editors, specific restrictions on authors, peer-reviewers, and editors based on COI, and the public availability of these disclosures. Editors were contacted a minimum of 3 times.ResultsThe response rate for the survey was 91 (67%) of 135, and 85 (93%) of 91 journals reported having an author COI policy. Ten (11%) journals reported that they restrict author submissions based on COI (e.g., drug company authors' papers on their products are not accepted). While 77% report collecting COI information on all author submissions, only 57% publish all author disclosures. A minority of journals report having a specific policy on peer-reviewer 46% (42/91) or editor COI 40% (36/91); among these, 25% and 31% of journals state that they require recusal of peer-reviewers and editors if they report a COI. Only 3% of respondents publish COI disclosures of peer-reviewers, and 12% publish editor COI disclosures, while 11% and 24%, respectively, reported that this information is available upon request.ConclusionMany more journals have a policy regarding COI for authors than they do for peer-reviewers or editors. Even author COI policies are variable, depending on the type of manuscript submitted. The COI information that is collected by journals is often not published; the extent to which such "secret disclosure" may impact the integrity of the journal or the published work is not known.
| S-EPMC1924760 | biostudies-literature
Project description:BackgroundA majority of academic medical centers (AMCs) have now adopted conflict of interest policies (COI) to address relationships with pharmaceutical and device industries that can increase the risk of bias in patient care, education and research. However, AMCs may have little information on the impact of their policies. This paper provides a new method, which is a free, publicly-available survey, to fill this information gap and improve COI programs at AMCs.Methods & findingsThe survey, piloted in three AMCs and designed in collaboration with national conflicts of interest policy experts, covers a range of universal compliance-related concerns, which allows institutions to tailor questions to align with their own policies and culture. The survey was low-burden, and provided important data for these AMCs to evaluate their policies. A descriptive analysis of the pooled pilot site data (n = 1578) was performed, which found that a majority of respondents did not have financial ties with industry and a majority was satisfied with specific COI policies at their institutions. The analysis also showed that the survey is sensitive to differences that AMCs will find meaningful. For instance, individuals with industry ties were significantly more likely than individuals without ties to think that COI policies unnecessarily hindered interactions with industry (p = .004), were ineffective at reducing harm to patients (p < .001), and were ineffective in reducing bias in medical education (p>.001).ConclusionThe survey is now free and publicly available for use by any institution. AMCs can use the results to update and refine policies, and to provide ongoing education regarding existing policies.
| S-EPMC5351836 | biostudies-literature