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STUDY DESIGN: Cohort study. OBJECTIVE: The aim of this study was to determine the rate of accurate conflict of interest (COI) disclosure within three prominent subspecialty Spine journals during a 4-year period. SUMMARY OF BACKGROUND DATA: Industry-physician relationships are crucial for technological advancement in spine surgery but serve as a source of bias in biomedical research. The Open Payments Database (OPD) was established after 2010 to increase financial transparency. METHODS: All research articles published from 2014 to 2017 in Spine, The Spine Journal (TSJ), and the Journal of Neurosurgery: Spine (JNS) were reviewed in this study. In these articles, all author's COI statements were recorded. The OPD was queried for all author entries within the disclose period of the journal. Discrepancies between the author's self-reported COIs and the documented COIs from OPD were recorded. RESULTS: A total of 6816 articles meeting inclusion criteria between 2014 and 2017 in Spine, TSJ, and JNS with 39,869 contributing authors. Overall, 15.8% of all authors were found to have an OPD financial relationship. Of 2633 authors in Spine with financial disclosures, 77.1% had accurate financial disclosures; 42.5% and 41.0% of authors with financial relationships in the OPD had accurate financial disclosures in TSJ and JNS, respectively. The total value of undisclosed conflicts of interest between 2014 and 2017 was $421 million with $1.48 billion in accurate disclosures. Of undisclosed payments, 68.7% were <$1000 and only 7.2% were >$10,000. Undisclosed payments included $180 million in research funding and $188 million in royalties. CONCLUSION: This study demonstrates that undisclosed COI is highly prevalent for authors in major Spine journals. This study indicates that there remains a need to standardize definitions and financial thresholds for significant COI as well as to shift the reporting burden for COI to journals who actively review potential COIs instead of relying on self-reporting. LEVEL OF EVIDENCE: 3.

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For several years and in many different ways, medical errors have been studied. As expected, the majority of efforts have been directed to prevent clinical errors during the different phases of health care. Nevertheless, less attention has been given to what happens when a negative effect has already occurred. The present work describes the doubts and difficulties that doctors deal with when facing an error and to describe the communicational tools that the literature offers to cope with them. The definition of medical error was the starting point that was used to later analyze the evidence about what, why and how to inform medical errors from an ethical and technical point of view. In the light of new legal exigencies, communicational and health protocols are revised, distinguishing those that are used for conveying bad news and medical errors. The importance of the ethical and communicational formation of the professionals is emphasized, identifying certain hindering aspects of the medical culture. This culture promotes an idea of the doctor as a professional who knows everything, does not make mistakes and acts in isolation. These do not reflect personal attributes in the professional and in the health team, required for a good professional practice.

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Disclosure of potential conflicts of interest (COI) is used by biomedical journals to guarantee credibility and transparency of the scientific process. COI disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for COI disclosure. This paper provides a comprehensive editorial perspective on classical COI-related issues. New insights into current COI policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardised questionnaire, are discussed.

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Disclosure of potential conflicts of interest is used by biomedical journals to guarantee credibility and transparency of the scientific process. Conflict of interest disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for conflicts of interest disclosure. This paper provides a comprehensive editorial perspective on classical conflict of interest-related issues. New insights into current conflicts of interest policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardized questionnaire, are discussed.

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Las revistas biomédicas utilizan la declaración de posibles conflictos de intereses para garantizar la credibilidad y la transparencia del proceso científico. Sin embargo, las revistas no abordan la declaración de conflictos de intereses de manera sistemática ni uniforme. Recientes esfuerzos editoriales conjuntos han abierto el camino a la aplicación de herramientas uniformes para la declaración de conflictos de intereses. En este artículo se presenta una visión integral sobre cuestiones clásicas relacionadas con los conflictos de intereses desde un punto de vista editorial. Además, a partir de los datos de un estudio transversal basado en el empleo de un cuestionario estandarizado, se comentan nuevas apreciaciones sobre las políticas y los actuales procedimientos editoriales relativos a los conflictos de intereses en las diversas revistas cardiovasculares nacionales de la Sociedad Europea de Cardiología.

Disclosure of potential conflicts of interest is used by biomedical journals to guarantee credibility and transparency of the scientific process. Conflict of interest disclosure, however, is not systematically nor consistently dealt with by journals. Recent joint editorial efforts paved the way towards the implementation of uniform vehicles for conflicts of interest disclosure. This paper provides a comprehensive editorial perspective on classical conflict of interest-related issues. New insights into current conflicts of interest policies and practices among European Society of Cardiology national cardiovascular journals, as derived from a cross-sectional survey using a standardized questionnaire, are discussed.

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The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

El objetivo de este artículo es proponer una hoja de ruta que fomente la transparencia de los ensayos clínicos en la Región de las Américas mediante el registro prospectivo de los ensayos y la comunicación de sus resultados. Esto brindará un acceso más amplio a datos más completos y exactos, y facilitará la toma de decisiones fundamentada en datos probatorios y la participación en las investigaciones clínicas. En consecuencia, debería tener una repercusión positiva en la salud de la población y promover la confianza en la investigación médica. Después de identificar las iniciativas existentes y analizar los registros de ensayos clínicos según las normas de la Organización Mundial de la Salud (OMS) para el registro de ensayos, se propone una hoja de ruta para salvar las brechas y promover la transparencia. El análisis demuestra que, a pesar de las numerosas iniciativas regionales y de los distintos países, hay un subregistro de los ensayos clínicos que tienen lugar en zonas no anglohablantes de la Región de las Américas. Se propone una hoja de ruta para mejorar la gobernanza en la investigación y las buenas prácticas clínicas mediante una mayor transparencia en los ensayos clínicos. La hoja de ruta propuesta incluye estrategias para ejecutar las normas internacionales de la OMS sobre el registro de los ensayos clínicos, formular normas internacionales de comunicación pública de los resultados de los ensayos, y una función potencial de la Organización Panamericana de la Salud.

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OBJECTIVE: A targeted analysis with transcript data from previous research was designed to study the perceived effects of secret-keeping on individuals with Turner syndrome (TS). STUDY DESIGN: Girls and women (n = 97) and 21 parents participated in the initial interview study. Transcripts were coded and analyzed for constructs related to secret-keeping. RESULTS: Thirty percent of participants spontaneously mentioned that their health care providers (HCP) or parents had withheld all or part of their TS diagnosis. Of those, 15 individuals were not informed of the infertility component of their diagnosis. Individuals reporting secret-keeping were more likely to have had a negative perception of the HCP's role in the disclosure process compared with those participants who did not report that a secret had been kept (P < .025). CONCLUSION: The prevalence of secret-keeping within this sample population suggests it is likely an existing concern in the greater TS population. How HCPs disclose a TS diagnosis may affect whether secrets are kept. Conversely, secret-keeping may result in a negative disclosure experience. These observations suggest the need for interventions aimed at helping HCPs disclose health-related information to parents and their children in a timely, caring, and sensitive manner.

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In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to the participant, and the conditions in which the IC is obtained. Investigators considered that IC was useful to the patients, providing information that helped the patient to make a decision about his/her participation. Nevertheless, they felt that for some aspects of the research, like drug development in general, the use of placebos, and the randomization process, many of the patients were not capable of fully understanding the information provided, referring to the complexity of the information and illiteracy as the main reasons. Many investigators were not acquainted with some of the guidelines established in the Mexican General Law of Health,(1) 36% of them admitting to not having completed their IC letters. Most investigators gave only minutes to the patient to make a decision and 20% of ICs were obtained while the patient was hospitalized. Except for one investigator, all of them considered that specific training in medical ethics would be useful for the daily clinical work.

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