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Fertility and Sterility Jan 2014Physicians who are told or discover information that would be material to another party's participation in an assisted reproductive technology (ART) arrangement (such as... (Review)
Review
Physicians who are told or discover information that would be material to another party's participation in an assisted reproductive technology (ART) arrangement (such as lawyer's, donor's, gestational carrier's, or intended parent's) should encourage disclosure to that party. In some instances, it is ethically and legally permissive for the physician to either disclose material information to an affected party or to transfer care of a patient to another willing provider. In all cases involving the legal status or rights of the parties, referral to legal professionals is advised.
Topics: Disclosure; Humans; Physicians; Professional Misconduct; Professional Staff Committees; Reproductive Medicine; Reproductive Techniques, Assisted; Societies, Medical
PubMed: 24314920
DOI: 10.1016/j.fertnstert.2013.11.007 -
PLoS Biology Nov 2018Currently, there is a growing interest in ensuring the transparency and reproducibility of the published scientific literature. According to a previous evaluation of 441...
Currently, there is a growing interest in ensuring the transparency and reproducibility of the published scientific literature. According to a previous evaluation of 441 biomedical journals articles published in 2000-2014, the biomedical literature largely lacked transparency in important dimensions. Here, we surveyed a random sample of 149 biomedical articles published between 2015 and 2017 and determined the proportion reporting sources of public and/or private funding and conflicts of interests, sharing protocols and raw data, and undergoing rigorous independent replication and reproducibility checks. We also investigated what can be learned about reproducibility and transparency indicators from open access data provided on PubMed. The majority of the 149 studies disclosed some information regarding funding (103, 69.1% [95% confidence interval, 61.0% to 76.3%]) or conflicts of interest (97, 65.1% [56.8% to 72.6%]). Among the 104 articles with empirical data in which protocols or data sharing would be pertinent, 19 (18.3% [11.6% to 27.3%]) discussed publicly available data; only one (1.0% [0.1% to 6.0%]) included a link to a full study protocol. Among the 97 articles in which replication in studies with different data would be pertinent, there were five replication efforts (5.2% [1.9% to 12.2%]). Although clinical trial identification numbers and funding details were often provided on PubMed, only two of the articles without a full text article in PubMed Central that discussed publicly available data at the full text level also contained information related to data sharing on PubMed; none had a conflicts of interest statement on PubMed. Our evaluation suggests that although there have been improvements over the last few years in certain key indicators of reproducibility and transparency, opportunities exist to improve reproducible research practices across the biomedical literature and to make features related to reproducibility more readily visible in PubMed.
Topics: Access to Information; Biomedical Research; Conflict of Interest; Disclosure; Humans; Information Dissemination; Publications; Reproducibility of Results
PubMed: 30457984
DOI: 10.1371/journal.pbio.2006930 -
Medical Law Review Aug 2021This article examines the current BHIVA/BASHH guidelines on the disclosure of HIV+ status in the context of sexual activity. It assesses whether the guidance provided on...
This article examines the current BHIVA/BASHH guidelines on the disclosure of HIV+ status in the context of sexual activity. It assesses whether the guidance provided on how to avoid criminal prosecution accurately reflects the prevailing position in law. Given that aspects of the guidance related to non-disclosure of HIV infection in the context of low or negligible risk are as yet untested in UK law, it is argued that there is some uncertainty as to whether the professional body guidelines and the law can be reconciled with each other. The article also considers whether the BHIVA/BASHH guidelines stray beyond the boundaries of medical advice as normally understood (focused on the protection of health and the prevention of onward transmission), by posing both as legal advice on how to avoid prosecution and offering what could be viewed as a moral judgement as to when disclosure is required. While a bio-medical assessment of risk naturally shapes clinical guidelines and may also inform views as to appropriate sexual behaviour and risk-taking, it is unclear whether scientific assessment of risk should be the sole guide when it comes to determining the nature of any disclosure obligation or the medical advice to be given on this matter.
Topics: Criminal Law; Disclosure; HIV Infections; Humans; Moral Obligations; Practice Guidelines as Topic; Professional-Patient Relations; Sexual Partners; United Kingdom
PubMed: 34008024
DOI: 10.1093/medlaw/fwab011 -
CMAJ : Canadian Medical Association... Oct 2015
Topics: Biomedical Research; Clinical Trials as Topic; Disclosure; Humans; Scientific Misconduct
PubMed: 26438588
DOI: 10.1503/cmaj.1150063 -
The Journal of Adolescent Health :... Apr 2021The purpose of the study was to increase the proportion of youth living with HIV (YLWH) aged ≥11 years who undergo developmentally appropriate disclosure about their...
PURPOSE
The purpose of the study was to increase the proportion of youth living with HIV (YLWH) aged ≥11 years who undergo developmentally appropriate disclosure about their HIV status.
METHODS
A quality improvement project was initiated at an urban pediatric HIV clinic between July 2018 and March 2020. The primary outcome measure was the proportion of YLWH aged ≥11 years who were disclosed to about their HIV status. The proportion of undisclosed YLWH who had documented nondisclosure status was also assessed as a process measure. Plan-Do-Study-Act (PDSA) cycles for change included monthly clinic staff check-ins to discuss new disclosures, quarterly team meetings to discuss strategies to improve disclosure, and modifying a clinic note template to prompt providers to document disclosure status. Annotated run charts were used to analyze the data.
RESULTS
Before the first PDSA cycle, 26/46 (57%) of the target population of YLWH aged ≥11 years had their HIV status disclosed to them, and none of the undisclosed youth had disclosure status documented in their medical record. After 20 months and six PDSA cycles, the proportion of YLWH aged ≥11 years disclosed to about their HIV status increased to 80% and the proportion of undisclosed YLWH with documentation of their disclosure status increased to 100%.
CONCLUSIONS
Several interventions integrated throughout the pediatric HIV care process were associated with an increase in the proportion of YLWH with developmentally appropriate HIV disclosure and documentation of disclosure status, an important psychosocial aspect of care in these individuals.
Topics: Adolescent; Child; Disclosure; HIV Infections; Humans; Truth Disclosure
PubMed: 33187819
DOI: 10.1016/j.jadohealth.2020.10.010 -
The New England Journal of Medicine Jun 2007
Review
Topics: Communication; Disclosure; Humans; Joint Commission on Accreditation of Healthcare Organizations; Jurisprudence; Medical Errors; Truth Disclosure; United States
PubMed: 17596606
DOI: 10.1056/NEJMra070568 -
The Oncologist Dec 2021Little is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician-targeted sales aids for oncology drugs.... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Little is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician-targeted sales aids for oncology drugs. Using three factorial experiments, we examined whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of this type of data.
SUBJECTS, MATERIALS, AND METHODS
The studies used a 2 (disclosure of data limitations: technical, nontechnical) × 2 (disclosure of clinical uncertainty: present, absent) + 1 (control: no disclosure) between-subjects experimental design to examine the impact of disclosures as they relate to presentations of preliminary or exploratory data in promotional communications for oncology products. In each experiment, we randomized oncologists and primary care physicians with oncology experience to view one version of a two-page sales aid. Following this exposure, physicians completed a web-based survey. The design was replicated in three concurrently conducted experiments using sales aids for different fictitious oncology drugs, each featuring one of three common data displays: a forest plot (n = 495), a Kaplan-Meier curve (n = 504), or a bar chart (n = 532).
RESULTS
Results provide initial evidence that in some contexts disclosures can improve understanding of the clinical utility of certain information about a drug and the limitations of results presented in a data display. Disclosures can also temper perceptions of how much evidence is presented that supports a conclusion that the drug is an appropriate treatment. In terms of the language used in the disclosure of data limitations, physicians in all three experiments strongly preferred the nontechnical disclosures.
CONCLUSION
The findings from the three experiments in this study suggest that disclosures have the potential to increase relevant knowledge, but more research is needed to establish best practice recommendations for using disclosures to convey contextual information relevant for interpreting data displays in promotional communications.
IMPLICATIONS FOR PRACTICE
This article reports the results from three large, online experimental studies that address a growing concern that drug companies often share favorable clinical trial results with physicians in promotional materials that lack important context for physicians to interpret the data. This series of studies investigates whether strategic use of two types of disclosures (disclosure of data limitations and a disclosure of clinical uncertainty) improves understanding and reduces misinterpretations among physicians. The results from these studies help identify communication factors that impact how physicians critically appraise preliminary or exploratory clinical trial data to inform policy and regulatory efforts.
Topics: Clinical Decision-Making; Disclosure; Humans; Physicians, Primary Care; Prescription Drugs; Uncertainty
PubMed: 34510619
DOI: 10.1002/onco.13972 -
Croatian Medical Journal Dec 2013This article overviews evidence on common instances of conflict of interest (COI) in research publications from general and specialized fields of biomedicine. Financial... (Review)
Review
This article overviews evidence on common instances of conflict of interest (COI) in research publications from general and specialized fields of biomedicine. Financial COIs are viewed as the most powerful source of bias, which may even distort citation outcomes of sponsored publications. The urge to boost journal citation indicators by stakeholders of science communication is viewed as a new secondary interest, which may compromize the interaction between authors, peer reviewers and editors. Comprehensive policies on disclosure of financial and non-financial COIs in scholarly journals are presented as proxies of their indexing in evidence-based databases, and examples of successful medical journals are discussed in detail. Reports on clinical trials, systematic reviews, meta-analyses and clinical practice guidelines may be unduly influenced by author-pharmaceutical industry relations, but these publications do not always contain explicit disclosures to allow the readers to judge the reliability of the published conclusions and practice-changing recommendations. The article emphasizes the importance of adhering to the guidance on COI from learned associations such as the International Committee of Medical Journal Editors (ICMJE). It also considers joint efforts of authors, peer reviewers and editors as a foundation for appropriately defining and disclosing potential COIs.
Topics: Biomedical Research; Conflict of Interest; Databases, Factual; Disclosure; Guidelines as Topic; Humans; Peer Review; Periodicals as Topic; Reproducibility of Results
PubMed: 24382859
DOI: 10.3325/cmj.2013.54.600 -
Health Policy (Amsterdam, Netherlands) Oct 2021The pharmaceutical industry makes large numbers of payments to healthcare organisations (HCOs) and healthcare professionals (HCPs). Ireland has a large pharmaceutical... (Observational Study)
Observational Study
BACKGROUND
The pharmaceutical industry makes large numbers of payments to healthcare organisations (HCOs) and healthcare professionals (HCPs). Ireland has a large pharmaceutical industry presence and national debate on legislating for greater industry payment transparency. This study characterises payments in Ireland to HCPs and HCOs during 2015-2019, and the content, consistency and methodology of the data source.
METHODS
An observational study of TransfersOfValue.ie, the disclosure website for the Irish Pharmaceutical Health Association pharmaceutical companies. We conducted a quantitative analysis, summarising payments to HCOs, HCPs and for research and development (R&D). We quantified disclosure rates of names for HCP and HCO payment recipients. We also conducted a content analysis of the methodology notes and website content.
RESULTS
Payments totalling €163 million were reported by 47 companies during 2015-2019, €84.6 million for R&D, with non-R&D payments of €45.1 million to HCOs and €33.6 million to HCPs. HCOs were named for 91.2% of payments, and HCPs for 55.1-62.8% across study years. For 2019, ten companies disclosed >€1 million in payments, and three disclosed >€1 million in HCO and HCP payments. Content analysis of 132 data reports and 46 methodology notes indicated substantial variation in methodologies for reporting between companies.
CONCLUSIONS
There are substantial payments in Ireland, often the recipient is undisclosed, and companies differ in their reporting. A mandatory disclosure system could enhance transparency.
Topics: Conflict of Interest; Disclosure; Drug Industry; Health Personnel; Humans; Ireland
PubMed: 34429238
DOI: 10.1016/j.healthpol.2021.07.016 -
Journal of Youth and Adolescence Jun 2023Self-disclosure builds high quality relationships, but knowledge of self-disclosure in youth mentoring relationships is limited by a lack of research and reliance on... (Observational Study)
Observational Study
Using Observational Dyadic Methods in Youth Mentoring Research: Preliminary Evidence of the Role of Actors' and Partners' Self-disclosure in Predicting Relationship Quality.
Self-disclosure builds high quality relationships, but knowledge of self-disclosure in youth mentoring relationships is limited by a lack of research and reliance on self-reports. To demonstrate the value of observational methods and dyadic modeling of mentoring communication processes, this study examined the associations between behavioral observation of self-disclosure and self-reported relationship quality in 49 mentee-mentor dyads (mentees: 73.5% female; x̄ age = 16.2, range = 12-19; mentors: 69.4% female; x̄ age = 36.2, range = 19-59). Video-recorded observations of disclosure were coded on three dimensions: amount (number of topics and detail of disclosure), intimacy (disclosure of personal or sensitive information), and openness (willingness to disclose). More intimate mentor disclosure was associated with higher mentee relationship quality, whereas higher amount of mentor disclosure combined with low intimacy was associated with lower mentee relationship quality. Greater mentee openness correlated with higher mentor relationship quality, but more intimate mentee disclosures were associated with lower mentee relationship quality. These preliminary findings illustrate the potential of methods that enable in-depth investigation of dyadic processes to advance understanding of how behavioral processes may influence mentoring relationships.
Topics: Humans; Female; Adolescent; Adult; Male; Mentors; Mentoring; Disclosure; Self Disclosure; Communication; Program Evaluation
PubMed: 36871089
DOI: 10.1007/s10964-023-01757-y