Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results.
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ABSTRACT:
SUBMITTER: Moorthy VS
PROVIDER: S-EPMC4396122 | biostudies-literature | 2015 Apr
REPOSITORIES: biostudies-literature
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Rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trial results.
Moorthy Vasee S VS Karam Ghassan G Vannice Kirsten S KS Kieny Marie-Paule MP
PLoS medicine 20150414 4
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Project description:Importance:Public reporting of procedural outcomes has been associated with lower rates of percutaneous coronary intervention (PCI) and worse outcomes after myocardial infarction. Contemporary data are limited on the influence of public reporting on interventional cardiologists' clinical decision making. Objective:To survey a contemporary cohort of interventional cardiologists in Massachusetts and New York about how public reporting of PCI outcomes influences clinical decision making. Design, Setting, and Participants:An online survey was developed with public reporting experts and administered electronically to eligible physicians in Massachusetts and New York who were identified by Doximity (an online physician networking site) and 2014 Medicare fee-for-service claims for PCI procedures. The personal and hospital characteristics of participants were ascertained via a comprehensive database from Doximity and the American Hospital Association annual surveys of US hospitals (2012 and 2013) and linked to survey responses. Associations between survey responses and characteristics of participants were evaluated in univariable and multivariable analyses. Main Outcomes and Measures:Reported rate of avoidance of performing PCIs in high-risk patients and of perception of pressure from colleagues to avoid performing PCIs. Results:Of the 456 physicians approached, 149 (32.7%) responded, including 67 of 129 (51.9%) in Massachusetts and 82 of 327 (25.1%) in New York. The mean (SD) age was 49 (9.2) years; 141 of 149 participants (94.6%) were men. Most participants reported practicing at medium to large, nonprofit hospitals with high-volume cardiac catheterization laboratories and cardiothoracic surgery capabilities. In 2014, participants had higher annual PCI volumes among Medicare patients than nonparticipants did (median, 31; interquartile range [IQR], 13-47 vs median, 17; IQR, 0-41; P < .001). Among participants, 65% reported avoiding PCIs on at least 2 occasions becase of concern that a bad outcome would negatively impact their publicly reported outcomes; 59% reported sometimes or often being pressured by colleagues to avoid performing PCIs because of a concern about the patient's risk of death. After multivariable adjustment, more years of experience practicing interventional cardiology was associated with lower odds of PCI avoidance. The state of practice was not associated with survey responses. Conclusions and Relevance:Current PCI public reporting programs can foster risk-averse clinical practice patterns, which do not vary significantly between interventional cardiologists in New York and Massachusetts. Coordinated efforts by policy makers, health systems leadership, and the interventional cardiology community are needed to mitigate these unintended consequences.
| S-EPMC6145664 | biostudies-literature
Project description:ImportanceResults of Alzheimer disease (AD) research assessments typically are not disclosed to participants. Recent research has suggested interest in disclosure, but, to our knowledge, few studies have accounted for awareness of potential benefits and limitations of disclosure.ObjectiveTo determine the attitudes of cognitively normal research participants and members of the general public regarding disclosure of AD research results.Design, setting, and participantsParticipants in a longitudinal aging study (Alzheimer Disease Research Center [ADRC]) were given preintervention and postintervention surveys about disclosure attitudes. In a general public sample (The American Panel Survey), participants responded to a similar survey about disclosure attitudes.InterventionsParticipants in the ADRC sample were randomly assigned to a group (n = 119) that read an education intervention about the usefulness of AD biomarkers or to a placebo group (n = 100) that read as its intervention general information about the ADRC. Participants in the general public sample read a brief vignette describing participation in a longitudinal AD study.Main outcome and measureInterest in disclosure of AD research results.ResultsCognitively normal ADRC participants (n = 219) were 60.7% (n = 133) female, 83.6% (n = 183) of white race, and reported a mean of 15.91 years of education. Twenty-nine individuals refused participation. The American Panel Survey participants (n = 1418) indicated they did not have AD and were 50.5% (n = 716) female, 76.7% (n = 1087) of white race, and reported a mean of 13.85 years of education. Overall, 77.6% of eligible participants (1583 of 2041) completed the survey in July 2014. Interest in disclosure was high among the ADRC participants (55.1% [119 of 216] were "extremely interested"). Viewing the education intervention predicted lower interest in disclosure (odds ratio, 2.01; 95% CI, 1.15-3.53; P = .02). High subjective risk of AD, a family history of AD, and minimal attendance at research meetings were associated with high interest after the intervention. In the general public, interest was lower overall (12.5% [174 of 1389] were "extremely interested"), but the subset of participants most likely to join an AD research study reported higher interest (43.5% [40 of 92] were extremely interested).Conclusions and relevanceExperience with AD appears to increase interest in disclosure of AD research results. Learning about potential limitations of disclosure somewhat tempered interest. These findings should inform the development of disclosure policies for asymptomatic individuals in AD studies.
| S-EPMC4694568 | biostudies-literature
Project description:Background Physicians have expressed significant mistrust with public reporting of interventional cardiology outcomes. Similar data are not available on alternative reporting structures, including nonpublic quality improvement programs with internally distributed measures of interventional quality. We thus sought to evaluate the perceptions of public and nonpublic reporting of interventional cardiology outcomes and its impact on clinical practice. Methods and Results A standardized survey was distributed to 218 interventional cardiologists in the Veterans Affairs Healthcare System, with responses received from 62 (28%). The majority of respondents (90%) expressed some or a great deal of trust in the analytic methods used to generate reports in a nonpublic quality improvement system within Veterans Affairs, while a minority (35%) expressed similar trust in the analytic methods in a public reporting system that operates outside Veterans Affairs (P<0.001). Similarly, a minority of respondents (44%) felt that in-hospital and 30-day mortality accurately reflected interventional quality in a nonpublic quality improvement system, though a smaller proportion of survey participants (15%) felt that the same outcome reflected procedural quality in public reporting systems (P<0.001). Despite these sentiments, the majority of operators did not feel pressured to avoid (82% and 75%; P=0.383) or perform (72% and 63%; P=0.096) high-risk procedures within or outside Veterans Affairs. Conclusions Interventional cardiologists express greater trust in analytic methods and clinical outcomes reported in a nonpublic quality improvement program than external public reporting environments. The majority of physicians did not feel pressured to avoid or perform high-risk procedures, which may improve access to interventional care among high-risk patients.
| S-EPMC6915263 | biostudies-literature
Project description:The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among 705 MyCode pediatric participants and their parents, and health behaviors of parents whose children receive an adult- or pediatric-onset genomic result. Data will be gathered via quantitative surveys using validated measures of distress, family functioning, quality of life, body image, perceived cancer/heart disease risk, genetic counseling satisfaction, genomics knowledge, and adjustment to genetic information; qualitative interviews with adolescents and parents; and electronic health records review of parents’ cascade testing uptake and initiation of risk reduction behaviors. The investigators will also conduct empirical and theoretical legal research to examine the loss of chance doctrine and its applicability to genomic research.
| 2296574 | ecrin-mdr-crc
Project description:This study aimed to explore public views on disclosure of tobacco components in an effort to develop a comprehensive regulatory system facilitating implementation of the Framework Convention on Tobacco Control (FCTC) Articles 9 and 10 in Korea.In all, 1200 representative Koreans 19 years old or older were enrolled and information on their general characteristics, smoking status, awareness of the effects of smoking on health, and views on the public disclosure of tobacco components was collected by telephone using a structured questionnaire. Factors associated with acceptance of the need for public disclosure of tobacco components were identified via multivariate analysis.Most participants considered it necessary to publicly disclose tobacco components (95.9%) and were aware of the risk to health posed by smoking (76.0%). The prevalent view was that tobacco companies should be legally required to publicly disclose details of the components of cigarettes, their levels per cigarette, and their effects on health. The most effective means of disclosure were considered to be the mass media, printed materials, and labels on cigarette packs. Females and never-smokers (odds ratio [OR]: 4.39, 95% confidence interval [95% CI]: 1.76-10.94) more readily accepted the need for public disclosure, whereas those of lower educational level and/or who were less aware of the harm to health posed by smoking (OR: 0.05, 95% CI: 0.01-0.18) were less likely to be accepting.The attitude of the general population ensures that FCTC Articles 9 and 10 will be successfully implemented in Korea. Further public consultation on the details of disclosure would be useful for the development of a comprehensive regulatory system.
| S-EPMC5058792 | biostudies-literature
Project description:OBJECTIVE:To determine the effect of the public disclosure of industry payments to physicians on patients' awareness of industry payments and knowledge about whether their physicians had accepted industry payments. DESIGN:Interrupted time series with comparison group (difference-in-difference analyses of longitudinal survey). SETTING:Nationally representative US population-based surveys. Surveys were conducted in September 2014, shortly prior to the public release of Open Payments information, and again in September 2016. PARTICIPANTS:Adults aged 18 and older (n=2180). MAIN OUTCOME MEASURES:Awareness of industry payments as an issue; awareness that industry payments information was publicly available; knowledge of whether own physician had received industry payments. RESULTS:Public disclosure of industry payments information through Open Payments did not significantly increase the proportion of respondents who knew whether their physician had received industry payments (p=0.918). It also did not change the proportion of respondents who became aware of the issue of industry payments (p=0.470) but did increase the proportion who knew that payments information was publicly available (9.6% points, p=0.011). CONCLUSIONS:Two years after the public disclosure of industry payments information, Open Payments does not appear to have achieved its goal of increasing patient knowledge of whether their physicians have received money from pharmaceutical and medical device firms. Additional efforts will be required to improve the use and effectiveness of Open Payments for consumers.
| S-EPMC6398799 | biostudies-literature
Project description:Calling cards technology using self-reporting transposons enables the identification of DNA-protein interactions through RNA sequencing . Here, we have drastically reduced the cost and labor requirements of calling card experiments in bulk populations of cells by introducing a DNA barcode into the calling card itself. An additional barcode incorporated during reverse transcription enables simultaneous transcriptome measurement in a facile and affordable protocol. We demonstrate that barcoded self-reporting transposons recover in vitro binding sites for four basic helix-loop-helix transcription factors with important roles in cell fate specification: ASCL1, MYOD1, NEUROD2, and NGN1. Further, simultaneous calling cards and transcriptional profiling during transcription factor overexpression identified both binding sites and gene expression changes for two of these factors. In sum, RNA-based identification of transcription factor binding sites and gene expression through barcoded self-reporting transposon calling cards and transcriptomes is an efficient and powerful method to infer gene regulatory networks in a population of cells.
2022-02-04 | GSE195992 | GEO
Project description:BackgroundTargeted surveillance of at-risk individuals in families with increased risk of hereditary cancer is an effective prevention strategy if relatives are identified, informed and enrolled in screening programs. Despite the potential benefits, many eligible at-risk relatives remain uninformed of their cancer risk. This study describes the general public's opinion on disclosure of hereditary colorectal cancer (CRC) risk information, as well as preferences on the source and the mode of information.MethodsA random sample of the general public was assessed through a Swedish citizen web-panel. Respondents were presented with scenarios of being an at-risk relative in a family that had an estimated increased hereditary risk of CRC; either 10% (moderate) or 70% (high) lifetime risk. A colonoscopy was presented as a preventive measure. Results were analysed to identify significant differences between groups using the Pearson's chi-square (χ2) test.ResultsOf 1800 invited participants, 977 completed the survey (54%). In the moderate and high-risk scenarios, 89.2 and 90.6% respectively, would like to receive information about a potential hereditary risk of CRC (χ2, p = .755). The desire to be informed was higher among women (91.5%) than men (87.0%, χ2, p = .044). No significant differences were found when comparing different age groups, educational levels, place of residence and having children or not. The preferred source of risk information was a healthcare professional in both moderate and high-risk scenarios (80.1 and 75.5%). However, 18.1 and 20.1% respectively would prefer to be informed by a family member. Assuming that healthcare professionals disclosed the information, the favoured mode of information was letter and phone (38.4 and 33.2%).ConclusionsIn this study a majority of respondents wanted to be informed about a potential hereditary risk of CRC and preferred healthcare professionals to communicate this information. The two presented levels of CRC lifetime risk did not significantly affect the interest in being informed. Our data offer insights into the needs and preferences of the Swedish population, providing a rationale for developing complementary healthcare-assisted communication pathways to realise the full potential of targeted prevention of hereditary CRC.
| S-EPMC7493346 | biostudies-literature
Project description:With the increasing attention of the capital market to environmental, social and governance information, sustainability reporting has become an important carrier for stakeholders to gain insight into sustainability of companies. But the emerged "greenwashing" problem has also brought haze to the value creation of capital market. To study the consequences of the pseudo-social responsibility behavior of "greenwashing", this paper takes China's listed companies as the research sample to empirically examine the relationship between sustainability reporting "greenwashing" and "shared value" creation. It is found that the "greenwashing" behavior of corporate sustainability reporting significantly reduces the "shared value" creation, while the degree of sustainability information asymmetry and the quality of information disclosure play a partial mediation role between them. Further analysis shows that the more effective internal control of a company and the greater pressure of external media supervision, the more conducive to weaken the negative impact of "greenwashing" on "shared value" creation. This paper enriches the literature on the economic consequences of "greenwashing" in sustainability disclosure and the influencing factors of "shared value" creation, extends the research on information disclosure and "shared value" from financial information to non-financial information. The results call for the state to promote legislative work, formulate unified standards and compress the "greenwashing" gray space; Governments could implement mandatory disclosure, implement independent authentication and strengthen "greenwashing" social supervision; Companies should strengthen capacity building and improve the "greenwashing" governance mechanism with the help of digital empowerment.
| S-EPMC9847897 | biostudies-literature
Project description:ObjectivesIn VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, at least 50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic results, explored adherence challenges during VOICE.MethodsWe systematically recruited participants with pharmacokinetic data (median six plasma samples), categorized as low (0%, N = 79), inconsistent (1-74%, N = 28) or high (≥75%; N = 20) on the basis of frequency of tenofovir detection. Following disclosure of pharmacokinetic results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded and thematically analysed.ResultsWe interviewed 127 participants from South Africa, Uganda and Zimbabwe. The most common reactions to pharmacokinetic results included surprise (41%; low pharmacokinetic), acceptance (39%; inconsistent pharmacokinetic) and happiness (65%; high pharmacokinetic). On the basis of participants' explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen) and adherence. Fear of product side effects/harm was a frequent concern, fuelled by stories shared among participants. Although women with high pharmacokinetic levels reported similar concerns, several described strategies to overcome challenges. Women at all pharmacokinetic levels suggested real-time drug monitoring and feedback to improve adherence and reporting.ConclusionRetrospective provision of pharmacokinetic results seemingly promoted candid discussions around nonadherence and study participation. The effect of real-time drug monitoring and feedback on adherence and accuracy of reporting should be evaluated in trials.
| S-EPMC4638164 | biostudies-literature