Consent Codes: Upholding Standard Data Use Conditions.
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ABSTRACT:
SUBMITTER: Dyke SO
PROVIDER: S-EPMC4721915 | biostudies-other | 2016 Jan
REPOSITORIES: biostudies-other
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Project description:BackgroundThe twenty-first century opioid crisis has spurred interest in using International Classification of Diseases (ICD) code algorithms to identify patients using illicit drugs from administrative healthcare data. We conducted a systematic review of studies that validated ICD code algorithms for illicit drug use against a reference standard of medical record data.MethodsSystematic searches of MEDLINE, EMBASE, PsycINFO, and Web of Science were conducted for studies published between 1980 and 2018 in English, French, Italian, or Spanish. We included validation studies of ICD-9 or ICD-10 code algorithms for an illicit drug use target condition (e.g., illicit drug use, abuse, or dependence (UAD), illicit drug use-related complications) given the sensitivity or specificity was reported or could be calculated. Bias was assessed with the Quality Assessment of Diagnostic Accuracy Studies Version 2 (QUADAS-2) tool.ResultsSix of the 1210 articles identified met the inclusion criteria. For validation studies of broad UAD (n = 4), the specificity was nearly perfect, but the sensitivity ranged from 47% to 83%, with higher sensitivities tending to occur in higher prevalence populations. For validation studies of injection drug use (IDU)-associated infective endocarditis (n = 2), sensitivity and specificity were poor due to the lack of an ICD code for IDU. For all six studies, the risk of bias for the QUADAS-2 "reference standard" and "flow/timing domains" was scored as "unclear" due to insufficient reporting.ConclusionsFew studies have validated ICD code algorithms for illicit drug use target conditions, and available evidence is challenging to interpret due to inadequate reporting. PROSPERO Registration: CRD42019118401.
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Project description:We previously proposed a structure for recording consent-based data use 'categories' and 'requirements' - Consent Codes - with a view to supporting maximum use and integration of genomic research datasets, and reducing uncertainty about permissible re-use of shared data. Here we discuss clarifications and subsequent updates to the Consent Codes (v4) based on new areas of application (e.g., the neurosciences, biobanking, H3Africa), policy developments (e.g., return of research results), and further practical considerations, including developments in automated approaches to consent management.
| S-EPMC9931855 | biostudies-literature
Project description:BackgroundImplementation of patient preferences for use of electronic health records for research has been traditionally limited to identifiable data. Tiered e-consent for use of de-identified data has traditionally been deemed unnecessary or impractical for implementation in clinical settings.MethodsWe developed a web-based tiered informed consent tool called informed consent for clinical data and bio-sample use for research (iCONCUR) that honors granular patient preferences for use of electronic health record data in research. We piloted this tool in 4 outpatient clinics of an academic medical center.ResultsOf patients offered access to iCONCUR, 394 agreed to participate in this study, among whom 126 patients accessed the website to modify their records according to data category and data recipient. The majority consented to share most of their data and specimens with researchers. Willingness to share was greater among participants from an Human Immunodeficiency Virus (HIV) clinic than those from internal medicine clinics. The number of items declined was higher for for-profit institution recipients. Overall, participants were most willing to share demographics and body measurements and least willing to share family history and financial data. Participants indicated that having granular choices for data sharing was appropriate, and that they liked being informed about who was using their data for what purposes, as well as about outcomes of the research.ConclusionThis study suggests that a tiered electronic informed consent system is a workable solution that respects patient preferences, increases satisfaction, and does not significantly affect participation in research.
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Project description:ContextSlow codes, which occur when clinicians symbolically appear to conduct advanced cardiac life support but do not provide full resuscitation efforts, are ethically controversial.ObjectivesTo describe the use of slow codes in practice and their association with clinicians' attitudes and moral distress.MethodsWe conducted a cross-sectional survey at Rush University and University of Chicago in January 2020. Participants included physician trainees, attending physicians, nurses, and advanced practice providers who care for critically ill patients.ResultsOf the 237 respondents to the survey (31% response rate, n = 237/753), almost half (48%) were internal medicine residents (46% response rate, n = 114/246). Over two-thirds of all respondents (69%) reported caring for a patient where a slow code was performed, with a mean of 1.3 slow codes (SD 1.7) occurring in the past year per participant. A narrow majority of respondents (52%) reported slow codes are ethical if the code is medically futile. Other respondents (46%) reported slow codes are not ethical, with 19% believing no code should be performed and 28% believing a full guideline consistent code should be performed. Most respondents reported moral distress when being required to run (75%), do chest compressions for (80%), or witness (78%) a cardiac resuscitation attempt they believe to be medically futile.ConclusionSlow codes occur in practice, even though many clinicians ethically disagree with their use. The use of cardiac resuscitation attempts in medically futile situations can cause significant moral distress to medical professionals who agree or are forced to participate in them.
| S-EPMC8729118 | biostudies-literature
Project description:BACKGROUND: The (almost) universality of the genetic code is one of the most intriguing properties of cellular life. Nevertheless, several variants of the standard genetic code have been observed, which differ in one or several of 64 codon assignments and occur mainly in mitochondrial genomes and in nuclear genomes of some bacterial and eukaryotic parasites. These variants are usually considered to be the result of non-adaptive evolution. It has been shown that the standard genetic code is preferential to randomly assembled codes for its ability to reduce the effects of errors in protein translation. RESULTS: Using a genotype-to-phenotype mapping based on a quantitative model of protein folding, we compare the standard genetic code to seven of its naturally occurring variants with respect to the fitness loss associated to mistranslation and mutation. These fitness losses are computed through computer simulations of protein evolution with mutations that are either neutral or lethal, and different mutation biases, which influence the balance between unfolding and misfolding stability. We show that the alternative codes may produce significantly different mutation and translation loads, particularly for genomes evolving with a rather large mutation bias. Most of the alternative genetic codes are found to be disadvantageous to the standard code, in agreement with the view that the change of genetic code is a mutationally driven event. Nevertheless, one of the studied alternative genetic codes is predicted to be preferable to the standard code for a broad range of mutation biases. CONCLUSIONS: Our results show that, with one exception, the standard genetic code is generally better able to reduce the translation load than the naturally occurring variants studied here. Besides this exception, some of the other alternative genetic codes are predicted to be better adapted for extreme mutation biases. Hence, the fixation of alternative genetic codes might be a neutral or nearly-neutral event in the majority of the cases, but adaptation cannot be excluded for some of the studied cases.
| S-EPMC2909233 | biostudies-literature
Project description:BACKGROUND:Significant debate surrounds the issue of whether written consent is necessary for pragmatic randomized, controlled trials (RCTs) with low risk. OBJECTIVE:To assess the U.S. public's views on alternatives to written consent for low-risk pragmatic RCTs. DESIGN:National experimental survey (2 × 2 factorial design) examining support for written consent versus general notification or verbal consent in 2 research scenarios. SETTING:Web-based survey conducted in December 2014. PARTICIPANTS:2130 U.S. adults sampled from a nationally representative, probability-based online panel (response rate, 64.0%). MEASUREMENTS:Respondent's recommendation to an ethics review board and personal preference as a potential participant on how to obtain consent or notification in the 2 research scenarios. RESULTS:Most respondents in each of the 4 groups (range, 60.3% to 71.5%) recommended written informed consent, and personal preferences were generally in accord with that advice. Most (78.9%) believed that the pragmatic RCTs did not pose additional risks, but 62.5% of these respondents would still recommend written consent. In contrast, a substantial minority in all groups (28.5% to 39.7%) recommended the alternative option (general notification or verbal consent) over written consent. LIMITATION:Framing effects could have affected respondents' attitudes, and nonrespondents may have differed in levels of trust toward research or health care institutions. CONCLUSION:Most of the public favored written informed consent over the most widely advocated alternatives for low-risk pragmatic RCTs; however, a substantial minority favored general notification or verbal consent. PRIMARY FUNDING SOURCE:Time-sharing Experiments for the Social Sciences and Intramural Research Program of the National Institutes of Health Clinical Center.
| S-EPMC5573142 | biostudies-literature
Project description:The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients. A questionnaire study was conducted among 700 outpatients of a northern German university hospital to assess their attitude towards use of clinical data for scientific research without consent. There was both strong willingness to give broad consent for secondary data use (468 of 503 responders, 93.0%) and strong approval of abolishing patient consent (n = 381, 75.7%) among study participants. The willingness to give consent was moderately associated with approval of the respective stipulations by the EU-GDPR. In research settings where broad consent is widely accepted (e.g. university hospitals), abolishing consent for secondary research use of clinical data will likely be acceptable to a large majority of patients.
| S-EPMC6777530 | biostudies-literature
Project description:Background & aimsAlthough widely used, little information exists on the validity of using hospital administrative data to code acute pancreatitis (AP). We sought to determine if discharge diagnosis codes accurately identify patients whose clinical course met the standard for AP diagnosis.MethodsWe analyzed data from 401 unique patients admitted through the emergency department who received a primary inpatient discharge diagnosis of AP at 2 University of Pittsburgh Medical Center hospitals in the years 2000, 2002, and 2005. Each patient was matched with a control patient who was admitted with abdominal pain and then discharged without a diagnosis of AP. Patients were matched based on demographics, testing for serum levels of pancreatic enzymes, year of visit to the emergency department, admission to the intensive care unit, and performance of abdominal computed tomography scan. The standard used to diagnose AP was the presence of 2 of 3 features (abdominal pain, ≥ 3-fold increase in serum levels of pancreatic enzymes, and positive results from imaging analysis).ResultsThe median age of AP cases was 53 years (interquartile range, 41.5-67 years); 47.1% were male, 85% were white. The most common etiologies were biliary (33.4%), alcohol-associated (16.2%), and idiopathic (24.2%). Serum levels of pancreatic enzymes were increased by any amount, and by ≥ 3-fold, in 95.3% and 68.6% of patients diagnosed with AP and in 16.2% and 2.2% of controls, respectively. The standard for diagnosis of AP was met in 80% of cases diagnosed with this disorder; they had no history of pancreatitis. The sensitivity, specificity, and positive and negative predictive values of the AP diagnosis code were 96%, 85%, 80%, and 98%, respectively.ConclusionsApproximately 1 of 5 patients diagnosed with AP upon discharge from the hospital do not meet the guidelines for diagnosis of this disorder. Efforts should be made to more consistently use guidelines for AP diagnosis.
| S-EPMC3662547 | biostudies-literature
Project description:The relationship between data quality and data standards has not been clearly articulated. While some directly state that data standards increase data quality, others claim the opposite. Depending on the type of data standard and the aspects of data quality considered, both arguments may in fact be correct. We deconstruct a typology of data standards and ap ply a dimensional definition of data quality to clearly articulate the relationship between the two, providing a framework for data quality planning.
| S-EPMC4317361 | biostudies-other
Project description:IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020-IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.
| S-EPMC8422487 | biostudies-literature