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1.
Br J Cancer ; 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34599297

RESUMO

BACKGROUND: No previous review has assessed the extent and effect of industry interactions on medical oncologists and haematologists specifically. METHODS: A systematic review investigated interactions with the pharmaceutical industry and how these might affect the clinical practice, knowledge and beliefs of cancer physicians. MEDLINE, Embase, PsycINFO and Web of Science Core Collection databases were searched from inception to February 2021. RESULTS: Twenty-nine cross-sectional and two cohort studies met the inclusion criteria. These were classified into three categories of investigation: (1) extent of exposure to industry for cancer physicians as whole (n = 11); (2) financial ties among influential cancer physicians specifically (n = 11) and (3) associations between industry exposure and prescribing (n = 9). Cancer physicians frequently receive payments from or maintain financial ties with industry, at a prevalence of up to 63% in the United States (US) and 70.6% in Japan. Among influential clinicians, 86% of US and 78% of Japanese oncology guidelines authors receive payments. Payments were associated with either a neutral or negative influence on the quality of prescribing practice. Limited evidence suggests oncologists believe education by industry could lead to unconscious bias. CONCLUSIONS: There is substantial evidence of frequent relationships between cancer physicians and the pharmaceutical industry in a range of high-income countries. More research is needed on clinical implications for patients and better management of these relationships. REGISTRATION: PROSPERO identification number CRD42020143353.

2.
Res Integr Peer Rev ; 6(1): 11, 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34340719

RESUMO

BACKGROUND: Australian health and medical research funders support substantial research efforts, and incentives within grant funding schemes influence researcher behaviour. We aimed to determine to what extent Australian health and medical funders incentivise responsible research practices. METHODS: We conducted an audit of instructions from research grant and fellowship schemes. Eight national research grants and fellowships were purposively sampled to select schemes that awarded the largest amount of funds. The funding scheme instructions were assessed against 9 criteria to determine to what extent they incentivised these responsible research and reporting practices: (1) publicly register study protocols before starting data collection, (2) register analysis protocols before starting data analysis, (3) make study data openly available, (4) make analysis code openly available, (5) make research materials openly available, (6) discourage use of publication metrics, (7) conduct quality research (e.g. adhere to reporting guidelines), (8) collaborate with a statistician, and (9) adhere to other responsible research practices. Each criterion was answered using one of the following responses: "Instructed", "Encouraged", or "No mention". RESULTS: Across the 8 schemes from 5 funders, applicants were instructed or encouraged to address a median of 4 (range 0 to 5) of the 9 criteria. Three criteria received no mention in any scheme (register analysis protocols, make analysis code open, collaborate with a statistician). Importantly, most incentives did not seem strong as applicants were only instructed to register study protocols, discourage use of publication metrics and conduct quality research. Other criteria were encouraged but were not required. CONCLUSIONS: Funders could strengthen the incentives for responsible research practices by requiring grant and fellowship applicants to implement these practices in their proposals. Administering institutions could be required to implement these practices to be eligible for funding. Strongly rewarding researchers for implementing robust research practices could lead to sustained improvements in the quality of health and medical research.

3.
Environ Health ; 20(1): 90, 2021 08 19.
Artigo em Inglês | MEDLINE | ID: mdl-34412643

RESUMO

BACKGROUND: Critical knowledge of what we know about health and disease, risk factors, causation, prevention, and treatment, derives from epidemiology. Unfortunately, its methods and language can be misused and improperly applied. A repertoire of methods, techniques, arguments, and tactics are used by some people to manipulate science, usually in the service of powerful interests, and particularly those with a financial stake related to toxic agents. Such interests work to foment uncertainty, cast doubt, and mislead decision makers by seeding confusion about cause-and-effect relating to population health. We have compiled a toolkit of the methods used by those whose interests are not aligned with the public health sciences. Professional epidemiologists, as well as those who rely on their work, will thereby be more readily equipped to detect bias and flaws resulting from financial conflict-of-interest, improper study design, data collection, analysis, or interpretation, bringing greater clarity-not only to the advancement of knowledge, but, more immediately, to policy debates. METHODS: The summary of techniques used to manipulate epidemiological findings, compiled as part of the 2020 Position Statement of the International Network for Epidemiology in Policy (INEP) entitled Conflict-of-Interest and Disclosure in Epidemiology, has been expanded and further elucidated in this commentary. RESULTS: Some level of uncertainty is inherent in science. However, corrupted and incomplete literature contributes to confuse, foment further uncertainty, and cast doubt about the evidence under consideration. Confusion delays scientific advancement and leads to the inability of policymakers to make changes that, if enacted, would-supported by the body of valid evidence-protect, maintain, and improve public health. An accessible toolkit is provided that brings attention to the misuse of the methods of epidemiology. Its usefulness is as a compendium of what those trained in epidemiology, as well as those reviewing epidemiological studies, should identify methodologically when assessing the transparency and validity of any epidemiological inquiry, evaluation, or argument. The problems resulting from financial conflicting interests and the misuse of scientific methods, in conjunction with the strategies that can be used to safeguard public health against them, apply not only to epidemiologists, but also to other public health professionals. CONCLUSIONS: This novel toolkit is for use in protecting the public. It is provided to assist public health professionals as gatekeepers of their respective specialty and subspecialty disciplines whose mission includes protecting, maintaining, and improving the public's health. It is intended to serve our roles as educators, reviewers, and researchers.


Assuntos
Métodos Epidemiológicos , Conflito de Interesses , Projetos de Pesquisa , Incerteza
4.
Nutrients ; 13(7)2021 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-34371932

RESUMO

BACKGROUND: There are numerous guidelines developed for bone health. Yet, it is unclear whether the differences in guideline development methods explain the variability in the recommendations for vitamin D and calcium intake. The objective of this systematic review was to collate and compare recommendations for vitamin D and calcium across bone health guidelines, assess the methods used to form the recommendations, and explore which methodological factors were associated with these guideline recommendations. METHODS: We searched MEDLINE, EMBASE, CINAHL, and other databases indexing guidelines to identify records in English between 2009 and 2019. Guidelines or policy statements on bone health or osteoporosis prevention for generally healthy adults aged ≥40 years were eligible for inclusion. Two reviewers independently extracted recommendations on daily vitamin D and calcium intake, supplement use, serum 25 hydroxyvitamin D [25(OH)D] level, and sunlight exposure; assessed guideline development methods against 25 recommended criteria in the World Health Organization (WHO) handbook for guideline development; and, identified types identified types of evidence underpinning the recommendations. RESULTS: we included 47 eligible guidelines from 733 records: 74% of the guidelines provided vitamin D (200~600-4000 IU/day) and 70% provided calcium (600-1200 mg/day) recommendations, 96% and 88% recommended vitamin D and calcium supplements, respectively, and 70% recommended a specific 25(OH)D concentration. On average, each guideline met 10 (95% CI: 9-12) of the total of 25 methodological criteria for guideline development recommended by the WHO Handbook. There was uncertainty in the association between the methodological criteria and the proportion of guidelines that provided recommendations on daily vitamin D or calcium. Various types of evidence, including previous bone guidelines, nutrient reference reports, systematic reviews, observational studies, and perspectives/editorials were used to underpin the recommendations. CONCLUSIONS: There is considerable variability in vitamin D and calcium recommendations and in guideline development methods in bone health guidelines. Effort is required to strengthen the methodological rigor of guideline development and utilize the best available evidence to underpin nutrition recommendations in evidence-based guidelines on bone health.


Assuntos
Remodelação Óssea/efeitos dos fármacos , Osso e Ossos/efeitos dos fármacos , Cálcio/administração & dosagem , Suplementos Nutricionais , Guias de Prática Clínica como Assunto/normas , Recomendações Nutricionais , Vitamina D/administração & dosagem , Adulto , Osso e Ossos/fisiopatologia , Cálcio/efeitos adversos , Suplementos Nutricionais/efeitos adversos , Medicina Baseada em Evidências/normas , Feminino , Nível de Saúde , Disparidades em Assistência à Saúde/normas , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/diagnóstico , Osteoporose/epidemiologia , Osteoporose/fisiopatologia , Osteoporose/prevenção & controle , Vitamina D/efeitos adversos
5.
8.
Intern Med J ; 2020 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-32744396

RESUMO

BACKGROUND: Payments to medical oncologists and clinical haematologists can negatively affect prescribing practice, but the extent of payments to these specialists is unknown in Australia. AIMS: We aimed to analyse the extent of payments from the pharmaceutical industry to Australian cancer physicians as reported during the first collated period of the Disclosure Australia website. METHODS: We performed a retrospective, cross-sectional analysis of payments made from November 2018 to April 2019, using a file downloaded from the Disclosure Australia website. We checked the names of listed medical practitioners against Medical Board of Australia records to assign specialties. The number of medical oncologists, clinical haematologists, other specialist physicians and non-specialist physician medical practitioners was calculated, along with the payments to each of these groups. RESULTS: A total of $7,332,407 was paid to 2775 medical practitioners. Of these, 236 were medical oncologists, 189 were haematologists and 1145 were other specialist physicians. This represents 31.7% of Australian medical oncologists and 30.9% of Australian haematologists, compared to 11.7% of all other specialist physicians and 1.1% of all other non-specialist physician medical practitioners. Medical oncologists received significantly higher payments (median $2,131.26) than other specialist physicians (median $1,376.00, 2-tailed p=0.004) and other medical practitioners (median $709.00, 2-tailed p<0.001), while haematologists received significantly higher payments (median $1,519.95) than other medical practitioners (2-tailed p<0.001), but similar payments to other specialist physicians (2-tailed p=0.08). CONCLUSION: Australian cancer physicians receive payments at a higher proportional frequency and in greater dollar amounts than other specialist physicians and other medical practitioners in general. This article is protected by copyright. All rights reserved.

9.
Int J Health Policy Manag ; 9(8): 335-343, 2020 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-32610737

RESUMO

BACKGROUND: The development of reliable, high quality health-related guidelines depends on explicit and transparent processes, methods aimed at minimising risks of bias and the inclusion of all relevant expertise and perspectives. While the methodological aspects of guidelines have been a focus to improve their quality, less is known about the social processes involved, for example, how guideline group members interact and communicate with one another, and how the evidence is considered in informing recommendations. With this in in mind, we aimed to empirically examine the perspectives and experiences of the key participants involved in developing public health guidelines for the Australian National Health and Medical Research Council (NHMRC). DESIGN: This study was conducted using constructivist grounded theory as described by Charmaz, which informed our sampling, data collection, coding and analysis of interviews with key participants involved in developing public health guidelines. SETTING: Australian public health guidelines commissioned by the NHMRC. PARTICIPANTS: Twenty experts that were involved in Australian NHMRC public health guideline development, including working committee members with content topic expertise (n=16) and members of evidence review groups responsible for evaluating the evidence (n=4). RESULTS: Public health guideline development in Australia is a divided process. The division is driven by 3 related factors: the divergent disciplinary background and expertise that each group brings to the process; the methodological limitations of the framework, inherited from clinical medicine, that is used to assess the evidence; and barriers to communication between content experts and evidence reviewers around respective roles and methodological limitations. CONCLUSION: Our findings suggest several improvements for a more functional and unified guideline development process: greater education of the working committee on the methodological process employed to evaluate evidence, improved communication on the role of the evidence review groups and better facilitation of the process so that the evidence review groups feel their contribution is valued.

12.
Syst Rev ; 9(1): 77, 2020 04 08.
Artigo em Inglês | MEDLINE | ID: mdl-32268911

RESUMO

BACKGROUND: A previous study found that 2 of 29 (6.9%) meta-analyses published in high-impact journals in 2009 reported included drug trials' funding sources, and none reported trial authors' financial conflicts of interest (FCOIs) or industry employment. It is not known if reporting has improved since 2009. Our objectives were to (1) investigate the extent to which pharmaceutical industry funding and author-industry FCOIs and employment from included drug trials are reported in meta-analyses published in high-impact journals and (2) compare current reporting with results from 2009. METHODS: We searched PubMed (January 2017-October 2018) for systematic reviews with meta-analyses including ≥ 2 randomized controlled trials (RCTs) of patented drugs. We included 3 meta-analyses published January 2017-October 2018 from each of 4 high-impact general medicine journals, high-impact journals from 5 specialty areas, and the Cochrane Database of Systematic Reviews, as in the previous study. RESULTS: Among 29 meta-analyses reviewed, 13 of 29 (44.8%) reported the funding source of included trials compared to 2 of 29 (6.9%) in 2009, a difference of 37.9% (95% confidence interval, 15.7 to 56.3%); this included 7 of 11 (63.6%) from general medicine journals, 3 of 15 (20.0%) from specialty medicine journals, and 3 of 3 (100%) Cochrane reviews. Only 2 of 29 meta-analyses (6.9%) reported trial author FCOIs, and none reported trial author-industry employment. PROTOCOL PUBLICATION: A protocol was uploaded to the Open Science Framework prior to initiating the study. https://osf.io/8xt5p/ LIMITATIONS: We examined only a relatively small number of meta-analyses from selected high-impact journals and compared results to a similarly small sample from an earlier time period. CONCLUSIONS: Reporting of drug trial sponsorship and author FCOIs in meta-analyses published in high-impact journals has increased since 2009 but is still suboptimal. Standards on reporting of trial funding described in the forthcoming revised PRISMA statement should be adapted and enforced by journals to improve reporting.


Assuntos
Publicações Periódicas como Assunto , Preparações Farmacêuticas , Conflito de Interesses , Indústria Farmacêutica , Humanos , Fator de Impacto de Revistas
15.
Environ Int ; 135: 105039, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31864023

RESUMO

BACKGROUND: The World Health Organization (WHO) and the International Labour Organization (ILO) are developing joint estimates of the work-related burden of disease and injury (WHO/ILO Joint Estimates). For this, systematic reviews of studies estimating the prevalence of exposure to selected occupational risk factors will be conducted to provide input data for estimations of the number of exposed workers. A critical part of systematic review methods is to assess risk of bias (RoB) of individual studies. In this article, we present and describe the development of such a tool, called the Risk of Bias in Studies estimating Prevalence of Exposure to Occupational risk factors (RoB-SPEO) tool; report results from RoB-SPEO's pilot testing; note RoB-SPEO's limitations; and suggest how the tool might be tested and developed further. METHODS: Selected existing RoB tools used in environmental and occupational health systematic reviews were reviewed and analysed. From existing tools, we identified domains for the new tool and, if necessary, added new domains. For each domain, we then identified and integrated components from the existing tools (i.e. instructions, domains, guiding questions, considerations, ratings and rating criteria), and, if necessary, we developed new components. Finally, we elicited feedback from other systematic review methodologists and exposure scientists and agreed upon RoB-SPEO. Nine experts pilot tested RoB-SPEO, and we calculated a raw measure of inter-rater agreement (Pi) for each of its domain, rating Pi < 0.4 as poor, 0.4 ≤ Pi ≥ 0.8 as substantial and Pi > 0.80 as almost perfect agreement. RESULTS: Our review found no standard tool for assessing RoB in prevalence studies of exposure to occupational risk factors. We identified six existing tools for environmental and occupational health systematic reviews and found that their components for assessing RoB differ considerably. With the new RoB-SPEO tool, assessors judge RoB for each of eight domains: (1) bias in selection of participants into the study; (2) bias due to a lack of blinding of study personnel; (3) bias due to exposure misclassification; (4) bias due to incomplete exposure data; (5) bias due to conflict of interest; (6) bias due to selective reporting of exposures; (7) bias due to difference in numerator and denominator; and (8) other bias. The RoB-SPEO's ratings are low, probably low, probably high, high or no information. Pilot testing of the RoB-SPEO tool found substantial inter-rater agreement for six domains (range of Pi for these domains: 0.51-0.80), but poor agreement for two domains (i.e. Pi of 0.31 and 0.33 for biases due to incomplete exposure data and in selection of participants into the study, respectively). Limitations of RoB-SPEO include that it has not yet been fully performance-tested. CONCLUSIONS: We developed the RoB-SPEO tool for assessing RoB in prevalence studies of exposure to occupational risk factors. The tool will be applied and its performance tested in the ongoing systematic reviews for the WHO/ILO Joint Estimates.


Assuntos
Doenças Profissionais , Exposição Ocupacional , Fatores de Risco , Ferimentos e Lesões , Viés , Humanos , Prevalência , Organização Mundial da Saúde , Ferimentos e Lesões/epidemiologia
16.
Environ Health ; 18(1): 93, 2019 11 04.
Artigo em Inglês | MEDLINE | ID: mdl-31684947

RESUMO

BACKGROUND: The sciences, and especially the research subspecialties of occupational and environmental health, are being misused. The misuse serves to interfere with the advancement of policies that depend on rational evidence needed for policies to protect public health. METHODS: We selectively surveyed the independent scientific literature. In addition, the efforts of respected international professional organizations of scientists whose focus is on maintaining and improving public health have been considered. This commentary is unique in assembling not only the factual basis for sounding alarms about significant bias in occupational and environmental health research, but also about the manipulative mechanisms used, and, in turn, the methods needed to keep science honest. RESULTS: Scientific integrity is based on the principle that research is conducted as objectively as possible; it cannot be compromised by special interests whose primary goals are neither to seek truth nor to protect human health. Evidence demonstrates a significant risk of bias in research reports sponsored by financial interests. Practices of corporate malfeasance include the orchestrated contamination of editorial boards of peer-reviewed scientific journals with industry apologists; interference with activities of national regulatory bodies and international review panels engaged in safeguarding occupational and public health; constructing roadblocks by capitalizing on uncertainty to undermine scientific consensus for much-needed government regulation of carcinogenic, endocrine-disrupting and/or immunotoxic agents; promoting "causation" criteria that lack foundation and effectively block workers' access to legal remedies for harms from occupational exposures resulting in morbidity and premature mortality; and, violating standards of professional conduct by seducing reputable scientists with financial incentives that make them beholden to corporate agendas. CONCLUSIONS: Well-orchestrated assaults on science continue unabated and must now be met head-on. Success could be achieved by promoting and protecting the integrity of research. Furthermore, avoiding influence by conflicted corporate affiliates in occupational and public health regulations is needed. Identifying, managing and, ideally, eliminating corporate influence on science and science policy are needed to protect research integrity. Protecting the public's health, preventing disease, and promoting well-being must be the unambiguous goals of research in occupational and environmental health.


Assuntos
Conflito de Interesses , Saúde Ambiental , Saúde do Trabalhador , Projetos de Pesquisa , Regulamentação Governamental , Indústrias
20.
Tob Control ; 28(6): 712-718, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-30242044

RESUMO

The Foundation for a Smoke-Free World was launched in September 2017 with an announced 12-year funding commitment of $1 billion from Philip Morris International (PMI). The Foundation claims that its governing documents (certificate of incorporation, bylaws and a pledge agreement) ensure that it has an independent research agenda and stringent protections from conflicts of interest. We analysed the text of these governing documents. Their provisions have multiple loopholes, particularly regarding conflicts of interest. Further, these documents cannot substitute for other important documentation such as information about PMI's internal business case for investing $1 billion in the Foundation, an unwaivable conflict of interest policy, annual disclosure statements, copies of pre-Foundation establishment correspondence between key individuals, all signed contracts or salary information, none of which, as of July 2018, the Foundation has made publicly available. Even if these were released, however, it is problematic that the Foundation's fundamental purpose was decided on and its leader selected following a tobacco company-paid, privately negotiated arrangement with the Foundation's president. It cannot be regarded as independent.


Assuntos
Comércio , Indústria do Tabaco , Comércio/ética , Comércio/métodos , Comércio/tendências , Documentação/métodos , Documentação/normas , Fundações/organização & administração , Humanos , Abandono do Hábito de Fumar , Indústria do Tabaco/economia , Indústria do Tabaco/ética , Indústria do Tabaco/métodos , Indústria do Tabaco/tendências , Produtos do Tabaco/economia
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