Dataset Information

Disclosure of funding sources and conflicts of interest in evidence underpinning vitamin D and calcium recommendations in bone health guidelines.

ABSTRACT:

Objective

The present study aims to examine the relationship between study funding sources, author conflicts of interest (COI) and conclusions in studies supporting vitamin D and Ca intake cited in bone health guideline recommendations.

Design

Cross-sectional.

Setting

Forty-seven global bone health guidelines with vitamin D and/or Ca recommendations for adults aged 40 years and above.

Participants

The evidence cited to support the recommendations was extracted by two independent reviewers and classified by type of recommendation, article characteristics, study design, types of funding sources and conflict of interest (COI) disclosure and direction of study conclusions.

Results

Of 156 articles cited to support the bone health recommendations, 120 (77 %) disclosed a funding source, and 43 (28 %) declared that at least one author had a COI. Compared with articles with non-commercial or no funding source, those funded by commercial sponsors tended to have a study conclusion favourable towards vitamin D/Ca (relative risk (95 % CI): 1·32 (0·94, 1·87), P = 0·16), but the association was not statistically significant (Fisher's exact test). Compared to those with a COI disclosure statement, articles with missing or unclear COI disclosure were more likely to have favourable conclusions (1·56 (1·05, 2·31), P = 0·017) (Fisher's exact test).

Conclusion

In the evidence underpinning a sample of global bone health guidelines, COI disclosure was low and studies with missing or unclear COI disclosures were more likely to have favourable study conclusions than those with disclosures, suggesting a need for greater transparency of COI in bone health guidelines.

SUBMITTER: Baram L

PROVIDER: S-EPMC9991793 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature

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Publications

Disclosure of funding sources and conflicts of interest in evidence underpinning vitamin D and calcium recommendations in bone health guidelines.

Baram Liora L Dai Zhaoli Z McDonald Sally S Bero Lisa A LA

Public health nutrition 20220124 8

<h4>Objective</h4>The present study aims to examine the relationship between study funding sources, author conflicts of interest (COI) and conclusions in studies supporting vitamin D and Ca intake cited in bone health guideline recommendations.<h4>Design</h4>Cross-sectional.<h4>Setting</h4>Forty-seven global bone health guidelines with vitamin D and/or Ca recommendations for adults aged 40 years and above.<h4>Participants</h4>The evidence cited to support the recommendations was extracted by two ...[more]

PMID: 35067274

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Project description:BackgroundAuthors 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?MethodsFor 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.Findings26 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".DiscussionAccurate 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.

Project description:Importance:Patient advocacy organizations are nonprofit organizations that represent patients with medical conditions. Although these organizations may increase disease awareness and influence health care policy, reports have suggested financial relationships between organizations and drug, device, and biotechnology companies, which may lead to potential conflicts of interest. The extent of these conflicts has not been explored among patient advocacy organizations in dermatology. Objective:To examine potential financial conflicts of interest and characterize disclosure practices among dermatology patient advocacy organizations. Design, Setting, and Participants:This cross-sectional study of the largest dermatology patient advocacy organizations using the Kaiser Health News database acquired data on total revenue from each organization's Form 990 for the year 2015. Tax forms and annual reports from 2017 were used for 2 organizations that were missing donor information for 2015. Annual reports, websites, and LinkedIn profiles were manually examined to ascertain donations and determine disclosure practices pertaining to financial support and board membership. Main Outcomes and Measures:The amount and minimum proportion of donations attributable to industry sponsorship among organizations as well as the proportion of organizations disclosing (1) industry-sponsored financial support, (2) the amount of industry-derived donations, and (3) current and past relationships between governing board members and industry sponsors. Results:This study identified 24 dermatology patient advocacy organizations with annual revenues that exceeded $500 000. Of these, 5 (21%) had total donations that exceeded $5 million and 4 (17%) reported industry donations that exceeded $500 000. Two organizations (8%) reported having at least 40% of total donations from industry sponsorship. Overall, 17 organizations (71%) reported receiving donations from industry on the annual report or the website and 12 (50%) reported the amount of donations in ranges. None of the organizations reported the exact amount or use of donations. On the basis of annual reports and websites, 3 organizations (13%) reported having a current or former industry executive on the organization's governing board. When this search was replicated using LinkedIn, this figure was at least 54%. Conclusions and Relevance:These findings suggest inconsistent disclosure of industry-derived financial support and board membership that may represent conflicts of interest. Policies that support the transparency and consistency of disclosure practices between industry and patient advocacy organizations appear to be needed to fully characterize the extent of conflicts of interest among patient advocacy organizations in dermatology and maintain trust in these important institutions.

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:ObjectiveTo (1) investigate the extent to which recently published meta-analyses report trial funding, author-industry financial ties and author-industry employment from included randomised controlled trials (RCTs), comparing Cochrane and non-Cochrane meta-analyses; (2) examine characteristics of meta-analyses independently associated with reporting funding sources of included RCTs; and (3) compare reporting among recently published Cochrane meta-analyses to Cochrane reviews published in 2010.DesignReview of consecutive sample of recently published meta-analyses.Data sourcesMEDLINE database via PubMed searched on 19 October 2018.Eligibility criteria for selecting articlesWe selected the 250 most recent meta-analyses listed in PubMed that included a documented search of at least one database, statistically combined results from ≥2 RCTs and evaluated the effects of a drug or class of drugs.Results90 of 107 (84%) Cochrane meta-analyses reported funding sources for some or all included trials compared with 21 of 143 (15%) non-Cochrane meta-analyses, a difference of 69% (95% CI 59% to 77%). Percent reporting was also higher for Cochrane meta-analyses compared with non-Cochrane meta-analyses for trial author-industry financial ties (44% versus 1%; 95% CI for difference 33% to 52%) and employment (17% versus 1%; 95% CI for difference 9% to 24%). In multivariable analysis, compared with Cochrane meta-analyses, the odds ratio (OR) for reporting trial funding was ≤0.11 for all other journal category and impact factor combinations. Compared with Cochrane reviews from 2010, reporting of funding sources of included RCTs among recently published Cochrane meta-analyses improved by 54% (95% CI 42% to 63%), and reporting of trial author-industry financial ties and employment improved by 37% (95% CI 26% to 47%) and 10% (95% CI 2% to 19%).ConclusionsReporting of trial funding sources, trial author-industry financial ties and trial author-industry employment in Cochrane meta-analyses has improved since 2010 and is higher than in non-Cochrane meta-analyses.

Dataset Information

Disclosure of funding sources and conflicts of interest in evidence underpinning vitamin D and calcium recommendations in bone health guidelines.

Objective

Design

Setting

Participants

Results

Conclusion

Publications

Disclosure of funding sources and conflicts of interest in evidence underpinning vitamin D and calcium recommendations in bone health guidelines.

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