Dataset Information

Policies on Conflicts of Interest in Health Care Guideline Development: A Cross-Sectional Analysis.

ABSTRACT:

Objective

To assess whether organisations that develop health care guidelines have conflict of interest (COI) policies and to review the content of the available COI policies.

Methods

Survey and content analysis of COI policies available in English, French, Spanish, and Italian conducted between September 2014 and June 2015. A 24-item data abstraction instrument was created on the basis of guideline development standards.

Results

The survey identified 29 organisations from 19 countries that met the inclusion criteria. From these organisations, 19 policies were eligible for inclusion in the content analysis. Over one-third of the policies (7/19, 37%) did not report or did not clearly report whether disclosure was a prerequisite for membership of the guideline panel. Strategies for the prevention of COI such as divestment were mentioned by only two organisations. Only 21% of policies (4/19) used criteria to determine whether an interest constitutes a COI and to assess the severity of the risk imposed.

Conclusions

The finding that some organisations, in contradiction of widely available standards, still do not have COI policies publicly available is concerning. Also troubling were the findings that some policies did not clearly report critical steps in obtaining, managing and communicating disclosure of relationships of interest. This in addition to the variability encountered in content and accessibility of COI policies may cause confusion and distrust among guideline users. It is in the interest of guideline users and developers to design an agreed-upon, comprehensive, clear, and accessible COI policy.

SUBMITTER: Morciano C

PROVIDER: S-EPMC5113001 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Policies on Conflicts of Interest in Health Care Guideline Development: A Cross-Sectional Analysis.

Morciano Cristina C Basevi Vittorio V Faralli Carla C Hilton Boon Michele M Tonon Sabina S Taruscio Domenica D

PloS one 20161115 11

<h4>Objective</h4>To assess whether organisations that develop health care guidelines have conflict of interest (COI) policies and to review the content of the available COI policies.<h4>Methods</h4>Survey and content analysis of COI policies available in English, French, Spanish, and Italian conducted between September 2014 and June 2015. A 24-item data abstraction instrument was created on the basis of guideline development standards.<h4>Results</h4>The survey identified 29 organisations from ...[more]

PMID: 27846255

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Project description:ImportanceConflicts of interest (COI) disclosure policies are critical to enhancing the integrity of research. However, it is unclear how Chinese medical journals interpret and enforce such policies.ObjectivesThe goal of this investigation is to determine the current status of COI disclosure policy enforcement in Chinese medical journals and to promote comprehensive COI policies.MethodsIn this cross-sectional study conducted from September 1st to October 29th 2017, journal instructions, websites and print issues of journals indexed by the Core Journals of China (version 2014), in the medical and health sector, were reviewed to identify whether COI disclosure policies existed and how complete these policies were.ResultsOf 248 eligible journals, 78 (31%) mentioned COI policies; 9 (4%) applied standardized disclosure forms; 18 (7%) required disclosure statements in articles; 4 (2%) mentioned policy bases; none validated disclosed COIs; 2 (1%) mentioned how they dealt with breaches; 18 (7%) involved the management of disclosed COIs; and 62 (25%) and 55 (22%) noted financial and nonfinancial COIs, respectively. Seventy-eight journals (31%) mentioned COIs in research and authors' obligation towards disclosure; 2 (1%) and 6 (2%) mentioned family members' and institutional COIs, respectively. Twenty-two and 11 journals mentioned at least one form of financial and nonfinancial COI type in research, respectively. Seven journals (3%) required disclosure of the source of financial support in research, but no journals mentioned the amount of support. Seven (3%) and 12 (5%) journals mentioned COIs in the editorial process and peer-review, respectively. Clinical journals (45%) paid more attention to COI policies than non-clinical journals.ConclusionsApproximately one-third of Chinese medical journals had COI policies, and of the journals that mentioned financial COIs most required nonfinancial COIs. However, the extent to which journals implemented COI policies was insufficient. There is a generic lack of standardized disclosure forms and management of COIs in most journals. The subject and details of COIs involved in the editorial and peer-review process received less attention than those in research.

Project description:BackgroundFew studies have investigated the relationship between industry funding/conflicts of interest and authors' positions in opinion pieces on drug safety. Harmful effects of varenicline, a treatment for smoking cessation, have been highly contested.ObjectiveTo examine the association between pharmaceutical industry funding/authors' financial conflicts of interest and position on varenicline in opinion articles, especially in relation to the minimization of harms; to assess whether opinion pieces on drug safety issues written by authors with conflicts of interest are more frequently cited in the news or social media.DesignCross-sectional analysis.ParticipantsEnglish language opinion pieces and narrative reviews about varenicline published between May 2006 and February 2019.Main measuresOdds ratios and 95% confidence intervals; the Mann-Whitney two-sample statistic was used to test for differences in Altmetric scores, a measure of media attention.Key resultsOf the 221 included articles, 30.3% (67) disclosed the funding source and 62.9% (139) disclosed authors' conflicts of interest. Authors of opinion pieces on varenicline who reported financial ties to the pharmaceutical industry (as a conflict of interest or funding source) were more likely to minimise the cardiovascular and psychiatric risk of varenicline compared to those without conflicts of interest or industry funding (OR: 4.00; 95% CI: 1.32 to 12.16 for cardiovascular risk; OR: 8.51; 95% CI: 3.79 to 19.11 for psychiatric risk). These associations persisted in sensitivity analyses. No statistically significant difference in Altmetric score was found between articles with (mean 15.83, median 3) and without (mean 11.90, median 1) conflicts of interest, indicating similar media attention (p-value=0.11).ConclusionsWe found that authors with financial ties to drug companies were more likely to publish opinion pieces that minimised harms of varenicline. These results raise questions about journals' editorial policies to accept reviews of treatments from authors with financial relationships with manufacturers.

Project description:BackgroundMedical students encounter pharmaceutical promotion from the very start of their training. Medical schools have an important role to play in educating medical students regarding the interactions between healthcare professionals (HCPs) and industry and in protecting them from commercial influence and conflict of interest (COI). In 2019, medical student associations in Belgium and abroad called for more preparation in dealing with COI and for a more independent medical training. As little information is available on the situation in our country, we undertook an assessment of conflict of interest policies at Belgium's medical schools. We relied on a methodology already used in studies from USA, Canada, Australia, France and Germany and adapted it to the Belgian context.MethodsWe identified 10 medical schools in Belgium. We searched the website of each medical school in November 2019 with standardized keywords for COI policies and learning activities on COI in the curriculum. The deans of medicine were invited to participate by sending us information that we could have overlooked during our web-based searches. We also consulted personal contacts within faculties among students and teachers. Based on a list of 15 criteria adapted from North American and French studies, we calculated a total for each faculty of medicine with a maximum score of 30 points.ResultsBy December 2019, we had gathered a set of written documents for four faculties of medicine (40%) containing policies with varying degrees of precision and relevance to our survey. We found elements of the curriculum addressing the COI issue for one faculty (10%). In all cases, these policies consisted of "moderate" initiatives with little or no "restrictive" elements. Only one faculty showed interest in our study by providing us with relevant information (10%). Half of the faculty notified us of their refusal to participate in the study (50%) and the other faculties either did not respond or did not provide us with any information (40%). The maximum score obtained was 3 out of 30 points with six faculties scoring 0 (60%).ConclusionThere is little transparency regarding interactions between medical students and pharmaceutical companies at Belgian medical faculties, which may create COI issues. Initiatives to protect students from pharmaceutical promotion and to train them to manage their future interaction with pharmaceutical companies have a limited scope and are isolated. This is inconsistent with international recommendations from Health Action International, World Health Organization or the American Medical Students' Association. The Belgian government has legislated in favor of more transparency in the relation between HCPs and pharmaceutical industry. Indeed, it made the disclosure of benefits granted by the industry compulsory and limited their value. Our results show that there is still some way to go to ensure an independent medical training for future Belgian physicians.

Project description:The requirements of the health policy and services journals for authors to report their financial and non-financial conflicts of interest (COI) are unclear. The present article aims to assess the requirements of health policy and services journals for authors to disclose their financial and non-financial COIs.This is a cross-sectional study of journals listed by the Web of Science under the category of 'Health Policy and Services'. We reviewed the 'Instructions for Authors' on the journals' websites and then simulated the submission of a manuscript to obtain any additional relevant information made available during that step. We abstracted data in duplicate and independently using a standardised form.Out of 72 eligible journals, 67 (93%) had a COI policy. A minority of policies described how the disclosed COIs of authors would impact the editorial process (34%). None of the policies had clear-cut criteria for rejection based on the content of the disclosure. Approximately a fifth of policies (21%) explicitly stated that inaccurate or incomplete disclosures might lead to manuscript rejection or retraction. No policy described whether the journal would verify the accuracy or completeness of authors' disclosed COIs. Most journals' policies (93%) required the disclosure of at least one form of financial COI. While the majority asked for specification of source of payment (71%), a minority asked for the amount (18%). Overall, 81% of policies explicitly required disclosure of non-financial COIs.A majority of health policy and services journal policies required the disclosure of authors' financial and non-financial COIs, but few required details on disclosed COIs. Health policy journals should provide specific definitions and instructions for disclosing non-financial COIs. A framework providing clear typology and operational definitions of the different types of COIs will facilitate both their disclosure by authors and reviewers and their assessment and management by the editorial team and the readers.

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.

Project description:Background and objectivesRigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development.Design, setting, participants, & measurementsThis cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated.ResultsAmong 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan.ConclusionsMost of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.

Project description:BackgroundReligiously affiliated hospitals provide nearly 20% of US beds, and many prohibit certain end-of-life and reproductive health treatments. Little is known about physician experiences in religious institutions.ObjectiveAssess primary care physicians' experiences and beliefs regarding conflict with religious hospital policies for patient care.DesignCross-sectional survey.ParticipantsGeneral internists, family physicians, and general practitioners from the AMA Masterfile.Main measuresIn a questionnaire mailed in 2007, we asked physicians whether they had worked in a religiously affiliated hospital or practice, whether they had experienced conflict with the institution over religiously based patient care policies and how they believed physicians should respond to such conflicts. We used chi-square and multivariate logistic regression to examine associations between physicians' demographic and religious characteristics and their responses.Key resultsOf 879 eligible physicians, 446 (51%) responded. In analyses adjusting for survey design, 43% had worked in a religiously affiliated institution. Among these, 19% had experienced conflict over religiously based policies. Most physicians (86%) believed when clinical judgment conflicts with religious hospital policy, physicians should refer patients to another institution. Compared with physicians ages 26-29 years, older physicians were less likely to have experienced conflict with religiously based policies [odds ratio (95% confidence interval) compared with 30-34 years: 0.02 (0.00-0.11); 35-46 years: 0.07 (0.01-0.72); 47-60 years: 0.02 (0.00-0.10)]. Compared with those who never attend religious services, those who do attend were less likely to have experienced conflict [attend once a month or less: odds ratio 0.06 (0.01-0.29); attend twice a month or more: 0.22 (0.05-0.98)]. Respondents with no religious affiliation were more likely than others to believe doctors should disregard religiously based policies that conflict with clinical judgment (13% vs. 3%; p = 0.005).ConclusionsHospitals and policy-makers may need to balance the competing claims of physician autonomy and religiously based institutional policies.

Dataset Information

Policies on Conflicts of Interest in Health Care Guideline Development: A Cross-Sectional Analysis.

Objective

Methods

Results

Conclusions

Publications

Policies on Conflicts of Interest in Health Care Guideline Development: A Cross-Sectional Analysis.

Similar Datasets

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