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Globalization and Health Mar 2023Self-regulation of payment disclosure by pharmaceutical industry trade groups is a major global approach to increasing transparency of financial relationships between...
BACKGROUND
Self-regulation of payment disclosure by pharmaceutical industry trade groups is a major global approach to increasing transparency of financial relationships between drug companies and healthcare professionals and organisations. Nevertheless, little is known about the relative strengths and weaknesses of self-regulation across countries, especially beyond Europe. To address this gap in research and stimulate international policy learning, we compare the UK and Japan, the likely strongest cases of self-regulation of payment disclosure in Europe and Asia, across three dimensions of transparency: disclosure rules, practices, and data.
RESULTS
The UK and Japanese self-regulation of payment disclosure had shared as well unique strengths and weaknesses. The UK and Japanese pharmaceutical industry trade groups declared transparency as the primary goal of payment disclosure, without, however, explaining the link between the two. The rules of payment disclosure in each country provided more insight into some payments but not others. Both trade groups did not reveal the recipients of certain payments by default, and the UK trade group also made the disclosure of some payments conditional on recipient consent. Drug company disclosure practices were more transparent in the UK, allowing for greater availability and accessibility of payment data and insight into underreporting or misreporting of payments by companies. Nevertheless, the share of payments made to named recipients was three times higher in Japan than in the UK, indicating higher transparency of disclosure data.
CONCLUSIONS
The UK and Japan performed differently across the three dimensions of transparency, suggesting that any comprehensive analysis of self-regulation of payment disclosure must triangulate analysis of disclosure rules, practices, and data. We found limited evidence to support key claims regarding the strengths of self-regulation, while often finding it inferior to public regulation of payment disclosure. We suggest how the self-regulation of payment disclosure in each country can be enhanced and, in the long run, replaced by public regulation to strengthen the industry's accountability to the public.
Topics: Humans; Japan; Disclosure; Drug Industry; Self-Control; United Kingdom
PubMed: 36869318
DOI: 10.1186/s12992-022-00902-9 -
PloS One 2023Disclosure of LGBTQ+ identities at work may reap benefits, but may also exacerbate harms. Faced with ambiguous outcomes, people engage in complex concealment/disclosure...
Disclosure of LGBTQ+ identities at work may reap benefits, but may also exacerbate harms. Faced with ambiguous outcomes, people engage in complex concealment/disclosure decision-making. For health professionals, in contexts of pervasive heteronormativity where disclosure to patients/clients is deemed to violate professional boundaries, stakes are high. This qualitative study with 13 LGBTQ+ health professionals across Canada used semi-structured interviews to explore factors affecting disclosure decision-making, particularly attending to power structures at multiple levels. Most participants engaged in constant risk-benefit assessment, disclosing strategically to colleagues, rarely to clients/patients. At the individual level they were affected by degree of LGBTQ+ visibility. At the institutional level they were affected by the culture of particular professional fields and practice settings, including type of care and type of patients/clients, as well as colleague interactions. Professional power-held by them, and held by others over them-directly affected disclosures. Finally, intersections of queer identities with other privileged or marginalized identities complicated disclosures. Power relations in the health professions shape LGBTQ+ identity disclosures in complex ways, with unpredictable outcomes. Concepts of professionalism are infused with heteronormativity, serving to regulate the gender and sexual identity expression of queer professionals. Disrupting heteronormativity is essential to forge more open professional cultures.
Topics: Humans; Disclosure; Canada; Sexual and Gender Minorities; Gender Identity; Health Personnel
PubMed: 36724163
DOI: 10.1371/journal.pone.0280558 -
Cancer Jan 2012Disclosure of conflicts of interest in biomedical research is receiving increased attention. The authors sought to define current disclosure policies and how they relate...
BACKGROUND
Disclosure of conflicts of interest in biomedical research is receiving increased attention. The authors sought to define current disclosure policies and how they relate to disclosure statements provided by authors in major oncology journals.
METHODS
The authors identified all oncology journals listed in the Thomson Institute for Scientific Information and sought their policies on conflict-of-interest disclosure. For a subset of journals with an Impact Factor >2.0, they catalogued the number and type of articles and the details of the published disclosures in all papers from the 2 most recent issues.
RESULTS
Disclosure policies were provided by 112 of 131 journals (85%); 99 (88%) of these requested that authors disclose conflicts of interest (mean Impact Factor for these journals: 4.6), whereas the remaining 13 (12%) did not (mean Impact Factor: 2.9). Ninety-three journals (94%) required financial disclosure, and 42 (42%) also sought nonfinancial disclosures. For a subset of 52 higher-impact journals (Impact Factor >2.0), we reviewed 1734 articles and identified published disclosures in 51 journals (98%). Many of these journals (31 of 51, 61%) included some disclosure statement in >90% of their articles. Among 27 journals that published editorials/commentaries, only 14 (52%) included disclosures with such articles. There was no publication of any nonfinancial conflicts of interest in any article reviewed.
CONCLUSIONS
Disclosure policies and the very definition of conflict of interest varied considerably among journals. Although most journals had some policy in this area, a substantial proportion did not publish disclosure statements consistently, with deficiencies particularly among editorials and commentaries.
Topics: Authorship; Conflict of Interest; Disclosure; Editorial Policies; Journal Impact Factor; Medical Oncology; Publications
PubMed: 21717432
DOI: 10.1002/cncr.26237 -
Violence Against Women Apr 2013Disclosure of a rape to informal support sources (e.g., friends) is a relatively common experience, but it is not well understood. This study expands our limited...
Disclosure of a rape to informal support sources (e.g., friends) is a relatively common experience, but it is not well understood. This study expands our limited knowledge of the characteristics and life experiences of disclosure recipients among a national sample of 2,000 female college students. Over 40% of respondents reported having received a rape disclosure, and more than two thirds of these recipients encouraged victims to formally report their rapes to the police or other authorities. Correlates of disclosure receipt and encouragement of reporting, including personal assault history, mental health history, and substance use, are presented and discussed.
Topics: Adolescent; Adult; Age Factors; Crime Victims; Disclosure; Female; Friends; Humans; Mental Health; Police; Rape; Social Behavior; Social Support; Students; Substance-Related Disorders; Truth Disclosure; Universities; Young Adult
PubMed: 23651638
DOI: 10.1177/1077801213487746 -
Europace : European Pacing,... Feb 2023Industry collaboration with arrhythmia and devices research is common. However, this results in conflicts of interest (CoI) for researchers that should be disclosed....
AIMS
Industry collaboration with arrhythmia and devices research is common. However, this results in conflicts of interest (CoI) for researchers that should be disclosed. This study aimed to examine the quality of CoI disclosures in arrhythmia and devices presentations.
METHODS
Recorded presentations from the Arrhythmia & Devices section of the ESC Annual Congress 2016-2020 were assessed. The number of words, conflicts, and time displayed was documented for CoI declarations. Meta-data including sponsorship by an industry partner, presenter sex, and institution were obtained.
RESULTS
Of 1153 presentations assessed, 999 were suitable for inclusion. CoI statements were missing from 7.2% of presentations, and 58% reported ≥1 conflict. Those with conflicts spent less time-per-word on their disclosures (median 150 ms, interquartile range [IQR] 83-273 ms) compared with those without conflicts (median 250 ms, IQR 125-375 ms). One-in-eight presentations were sponsored (12.8%, n = 128). CoI statements were more likely to be missing in sponsored presentations (14.8%, n = 19) compared with non-sponsored presentations (6.1%, n = 53), P = 0.0003. Sponsored presentations contained a greater median number of CoIs (10, IQR 6-18) compared with non-sponsored sessions (1, IQR 0-5), P < 0.0001. Time-per-word spent on COI disclosures was 50% lower in sponsored sessions (125 ms, IQR 75-231 ms) compared with non-sponsored sessions (250 ms, IQR 125-375 ms), P < 0.0001.
CONCLUSION
The majority of those presenting arrhythmia and devices research have CoIs to declare. Declarations were often missing or displayed for short periods of time. Presenters in sponsored sessions, while being more conflicted, had a lower standard of declaration suggesting a higher risk of potential bias which viewers had insufficient opportunity to assess.
Topics: Humans; Conflict of Interest; Cardiac Electrophysiology; Disclosure
PubMed: 36413616
DOI: 10.1093/europace/euac205 -
Industry funding of patient and health consumer organisations: systematic review with meta-analysis.BMJ (Clinical Research Ed.) Jan 2020To investigate pharmaceutical or medical device industry funding of patient groups. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To investigate pharmaceutical or medical device industry funding of patient groups.
DESIGN
Systematic review with meta-analysis.
DATA SOURCES
Ovid Medline, Embase, Web of Science, Scopus, and Google Scholar from inception to January 2018; reference lists of eligible studies and experts in the field.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Observational studies including cross sectional, cohort, case-control, interrupted time series, and before-after studies of patient groups reporting at least one of the following outcomes: prevalence of industry funding; proportion of industry funded patient groups that disclosed information about this funding; and association between industry funding and organisational positions on health and policy issues. Studies were included irrespective of language or publication type.
REVIEW METHODS
Reviewers carried out duplicate independent data extraction and assessment of study quality. An amended version of the checklist for prevalence studies developed by the Joanna Briggs Institute was used to assess study quality. A DerSimonian-Laird estimate of single proportions with Freeman-Tukey arcsine transformation was used for meta-analyses of prevalence. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of the evidence for each outcome.
RESULTS
26 cross sectional studies met the inclusion criteria. Of these, 15 studies estimated the prevalence of industry funding, which ranged from 20% (12/61) to 83% (86/104). Among patient organisations that received industry funding, 27% (175/642; 95% confidence interval 24% to 31%) disclosed this information on their websites. In submissions to consultations, two studies showed very different disclosure rates (0% and 91%), which appeared to reflect differences in the relevant government agency's disclosure requirements. Prevalence estimates of organisational policies that govern corporate sponsorship ranged from 2% (2/125) to 64% (175/274). Four studies analysed the relationship between industry funding and organisational positions on a range of highly controversial issues. Industry funded groups generally supported sponsors' interests.
CONCLUSION
In general, industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship. Transparency about corporate funding is also inadequate. Among the few studies that examined associations between industry funding and organisational positions, industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of sponsors above those of the public.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42017079265.
Topics: Consumer Organizations; Disclosure; Drug Industry; Financial Management; Observational Studies as Topic; Organizational Policy
PubMed: 31969320
DOI: 10.1136/bmj.l6925 -
Orthopaedics & Traumatology, Surgery &... Dec 2021Authors are responsible for their own Disclosure of Interests in submitting to Orthopaedics & Traumatology: Surgery & Research (OTSR). Disclosure may be incomplete or...
What are the rates and validity of French authors' conflicts of interest disclosures in Orthopaedics & Traumatology: Surgery & Research? Analysis of the year 2017 with comparison versus the Transparence.sante.gouv.fr database.
INTRODUCTION
Authors are responsible for their own Disclosure of Interests in submitting to Orthopaedics & Traumatology: Surgery & Research (OTSR). Disclosure may be incomplete or false, by deliberate or unintended omission. Omission may impact the analysis of results or at least the reader's perception of it. The rate of validity of disclosure in OTSR is not known, and we therefore conducted a bibliometric study on articles published in 2017, in order to: 1) determine the proportion of articles in which authors disclose interests; and 2), when interests are disclosed, to assess their validity by comparison against the Transparence.gov.fr database.
HYPOTHESIS
Disclosure rates exceed 75%.
MATERIAL AND METHOD
We analyzed all articles published in OTSR in 2017, and extracted those with at least one French author. We also analyzed data from the Transparence.gouv.fr corporate declaration database, for comparison with the authors' own disclosures in each article. Significant interest was defined by a €1000 threshold, although higher thresholds (>€5000, >€10,000 and >€100,000) were also investigated.
RESULTS
In 2017, 337 articles were published in OTSR, 210 of which had at least 1 French author. Of these, 201 (95.7%) had at least 1 author with significant interest (>€1000) according to the Transparence data. In 189 of these 201 articles (94%), authors had failed to disclose at least 1 direct or indirect conflict of interest. This omission rate fell to 22/45 (48.9%) for more substantial interests, which were more faithfully disclosed. At the €1000 threshold, in only 8/201 articles (4%) did authors disclose all their interests with perfect validity, but this rate increased up to 25/45 (55.5%) at higher thresholds. At the €1000 threshold, 66 of the 201 articles cited the trade-name of interest, resulting in 54/66 (82%) correct disclosure of direct interest; this rate increased up to 25/26 (96%) at higher thresholds.
DISCUSSION
At a threshold of €1000, the rate of complete and valid disclosure was 4% and the rate of omission 94%. At higher thresholds, rates were better, with just 48.9% omission and, above all, 55.5% validity, even if these rates were lower than hypothesized (75%). Authors and editors need to take greater care. Disclosures were often made, but incompletely, and authors need reminding that they must disclose not only interests related to the article in question but also all interests that might directly or indirectly influence their interpretation of the results reported, allowing readers to make up their own minds.
LEVEL OF EVIDENCE
IV; systematic retrospective study.
Topics: Conflict of Interest; Disclosure; Humans; Orthopedics; Retrospective Studies; Traumatology
PubMed: 34592417
DOI: 10.1016/j.otsr.2021.103080 -
Journal of Public Health Management and... 2017We systematically reviewed the statistical disclosure control techniques employed for releasing aggregate data in Web-based data query systems listed in the National... (Review)
Review
We systematically reviewed the statistical disclosure control techniques employed for releasing aggregate data in Web-based data query systems listed in the National Association for Public Health Statistics and Information Systems (NAPHSIS). Each Web-based data query system was examined to see whether (1) it employed any type of cell suppression, (2) it used secondary cell suppression, and (3) suppressed cell counts could be calculated. No more than 30 minutes was spent on each system. Of the 35 systems reviewed, no suppression was observed in more than half (n = 18); observed counts below the threshold were observed in 2 sites; and suppressed values were recoverable in 9 sites. Six sites effectively suppressed small counts. This inquiry has revealed substantial weaknesses in the protective measures used in data query systems containing sensitive public health data. Many systems utilized no disclosure control whatsoever, and the vast majority of those that did deployed it inconsistently or inadequately.
Topics: Data Interpretation, Statistical; Disclosure; Humans; Information Dissemination; Internet; Public Health Informatics
PubMed: 27798533
DOI: 10.1097/PHH.0000000000000473 -
International Journal of Health... Jul 2022Pharmaceutical companies regularly fund patient organizations. It is important for patient organizations' credibility that there be transparency regarding this financial...
Pharmaceutical companies regularly fund patient organizations. It is important for patient organizations' credibility that there be transparency regarding this financial support. In Europe, the pharmaceutical industry promises to deliver transparency through self-regulation, as opposed to legally binding provisions, but self-regulation's effectiveness is contested. We compared the industry's transparency of funding in four Nordic countries that, given their general reputation for high transparency, offered a critical test of self-regulation's ability to deliver on its transparency promise. For 2017-2019, we compared: national rules regarding funding disclosure; disclosure practices as evidenced by the availability, accessibility, and format of company transparency reports; and disclosure data, including payment descriptions and sums. Transparency problems differed in kind and magnitude between countries. In Norway and Finland, unlike in Sweden and Denmark, data on funding were difficult to access and analyze and sometimes seemed incomplete or missing. We explain that a key factor allowing for country differences is the freedom given to a country's pharmaceutical industry trade associations to form self-regulatory rules, provided they do not fall below the weak, European-level minimum requirements. Transparency could be improved by aligning rules and practices with the FAIR data principles: that is, corporate disclosures should be findable, accessible, interoperable, and reusable.
Topics: Conflict of Interest; Disclosure; Drug Industry; Financial Support; Humans; Self-Control
PubMed: 35230175
DOI: 10.1177/00207314221083871 -
Head & Face Medicine Apr 2020
Topics: Publishing; Science; Truth Disclosure
PubMed: 32245486
DOI: 10.1186/s13005-020-00220-8