Communicating the results of clinical research to participants: attitudes, practices, and future directions.
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ABSTRACT:
SUBMITTER: Shalowitz DI
PROVIDER: S-EPMC2375946 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionMany research programs are challenged to accommodate low-resource research participants' (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP.MethodsA semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants.ResultsThree content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance.ConclusionSupport to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.
| S-EPMC8592386 | biostudies-literature
Project description:Results 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.To determine the attitudes of cognitively normal research participants and members of the general public regarding disclosure of AD research results.Participants 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.Participants 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.Interest in disclosure of AD research results.Cognitively 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).Experience 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:ObjectiveTo determine the preferred means by which participants in a study of cardiac rehabilitation wish to be informed of the study's results.DesignPostal questionnaire survey of participants in a randomized controlled trial.SettingCornwall, southwest England.ParticipantsPatients recruited to the Cornwall Heart Attack Rehabilitation Management Study (CHARMS).MethodParticipants recruited to CHARMS who were alive 3 years and 9 months after the trial was completed were contacted by letter and invited to return a reply slip with four short questions indicating how they would prefer to be informed about the published results of the study.ResultsIn March 2008, 191/230 participants originally recruited to CHARMS were still alive. General practitioners deemed 166/191 (88%) survivors medically appropriate to be contacted through a postal survey, and 154/166 (93%) participants responded to the invitation to participate in the follow-up survey. 86% (143/166) of participants indicated that they wished to be informed about the results: 115 (80%) of these elected to receive information by letter and 25 (18%) of these preferred to attend a meeting. Men older than 65 years predominated in this latter group. Women respondents preferred to receive the study results by letter; none preferred communication by email or the web.ConclusionSurvivors of acute myocardial infarction who participated in a RCT of cardiac rehabilitation wanted to receive a summary of the aggregate study results. Participants had preferences regarding how they would wish to be informed about the results of the study. Most participants preferred to be informed by letter or email, but some preferred the interaction of a group or a meeting.
| S-EPMC5060540 | biostudies-literature
Project description: Not available
| S-EPMC5517532 | biostudies-literature
Project description:Delirium is a prevalent organ dysfunction in critically ill patients associated with significant morbidity and mortality, requiring advancements in the clinical and research realms to improve patient outcomes. Increased clinical recognition and utilisation of delirium assessment tools, along with clarification of specific risk factors and presentations in varying patient populations, will be necessary in the future. To improve predictive models for outcomes, the continued development and implementation of delirium assessment tools and severity scoring systems will be required. The interplay between the pathophysiological pathways implicated in delirium and resulting clinical presentations and outcomes will need to guide the development of appropriate prevention and treatment protocols. Multicentre randomised controlled trials of interventional therapies will then need to be performed to test their ability to improve clinical outcomes. Physical and cognitive rehabilitation measures need to be further examined as additional means of improving outcomes from delirium in the hospital setting.
| S-EPMC3638881 | biostudies-literature
Project description:IntroductionKeloids and hypertrophic scars are fibroproliferative disorders of the skin that result from abnormal healing of injured or irritated skin. Multiple studies suggest that genetic, systemic and local factors may contribute to the development and/or growth of keloids and hypertrophic scars. A key local factor may be mechanical stimuli. Here, we provide an up-to-date review of the studies on the roles that genetic variation, epigenetic modifications and mechanotransduction play in keloidogenesis.MethodsAn English literature review was performed by searching the PubMed, Embase and Web of Science databases with the following keywords: genome-wide association study; epigenetics; non-coding RNA; microRNA; long non-coding RNA (lncRNA); DNA methylation; mechanobiology; and keloid. The searches targeted the time period between the date of database inception and July 2018.ResultsGenetic studies identified several single-nucleotide polymorphisms and gene linkages that may contribute to keloid pathogenesis. Epigenetic modifications caused by non-coding RNAs (e.g. microRNAs and lncRNAs) and DNA methylation may also play important roles by inducing the persistent activation of keloidal fibroblasts. Mechanical forces and the ensuing cellular mechanotransduction may also influence the degree of scar formation, scar contracture and the formation/progression of keloids and hypertrophic scars.ConclusionsRecent research indicates that the formation/growth of keloids and hypertrophic scars associate clearly with genetic, epigenetic, systemic and local risk factors, particularly skin tension around scars. Further research into scar-related genetics, epigenetics and mechanobiology may reveal molecular, cellular or tissue-level targets that could lead to the development of more effective prophylactic and therapeutic strategies for wounds/scars in the future.
| S-EPMC6700880 | biostudies-literature
Project description:NEDDylation, a post-translational modification through three-step enzymatic cascades, plays crucial roles in the regulation of diverse biological processes. NEDD8-activating enzyme (NAE) as the only activation enzyme in the NEDDylation modification has become an attractive target to develop anticancer drugs. To date, numerous inhibitors or agonists targeting NAE have been developed. Among them, covalent NAE inhibitors such as MLN4924 and TAS4464 currently entered into clinical trials for cancer therapy, particularly for hematological tumors. This review explains the relationships between NEDDylation and cancers, structural characteristics of NAE and multistep mechanisms of NEDD8 activation by NAE. In addition, the potential approaches to discover NAE inhibitors and detailed pharmacological mechanisms of NAE inhibitors in the clinical stage are explored in depth. Importantly, we reasonably investigate the challenges of NAE inhibitors for cancer therapy and possible development directions of NAE-targeting drugs in the future.
| S-EPMC10388525 | biostudies-literature
Project description:Cyclic vomiting syndrome (CVS) is characterized by severe episodic emesis in adults and children. Cannabinoid hyperemesis syndrome is an increasingly recognized CVS-like illness that has been associated with chronic cannabis use. There are significant gaps in our understanding of the pathophysiology, clinical features, comorbidities, and effective management options of CVS. Recommendations for treating CVS are based on limited clinical data, as no placebo-controlled, randomized trials have yet been conducted. Diseases associated with CVS, including migraine, mitochondrial disorders, autonomic dysfunction, and psychiatric comorbidities, provide clues about pathophysiologic mechanisms and suggest potential therapies. We review our current understanding of CVS and propose future research directions with the aim of developing effective therapy. Establishing a multicenter, standardized registry of CVS patients could drive research on multiple fronts including developing CVS-specific outcome measures to broaden our understanding of clinical profiles, to serve as treatment end points in clinical trials, and to provide a platform for patient recruitment for randomized clinical trials. Such a robust database would also facilitate conduct of research that aims to determine the underlying pathophysiological mechanisms and genetic basis for CVS, as well as identifying potential biomarkers for the disorder. Soliciting government and industry support is crucial to establishing the necessary infrastructure and achieving these goals. Patient advocacy groups such as the Cyclic Vomiting Syndrome Association (CVSA), which partner with clinicians and researchers to disseminate new information, to promote ongoing interactions between patients, their families, clinicians, investigators, to support ongoing CVS research and education, must be an integral part of this endeavor.
| S-EPMC6899706 | biostudies-literature
Project description:Realistic environmental problems drive the growth of pro-environment behavior research, among which the most important progress is about the theoretical innovation and development of pro-environmental behavior. Thus, the main purpose of this paper was to review the literature and help researchers to understand the theoretical progress of pro-environmental behavior. This study systematically analyzed 1806 papers published in SCI-EXPANDED and SSCI databases. It presented the research overview of pro-environmental behavior in terms of status of literature publication, research hotspots and topics. On this basis, this paper further focused on key theoretical papers and summarized three paths of theoretical progress for pro-environmental behavior: theoretical development, theoretical exploration and theoretical integration. Along the theoretical development path, studies mainly apply theories of psychology, sociology and economics to analyze and explain the formation and consequences of pro-environmental behavior. In terms of theoretical exploration, existing studies propose and develop value-belief-norm theory, behavioral theories related to contexts and pro-environmental behavior decision models. Theoretical integration is the direction of future research, such as the combination of rationality and sensibility, and the combination of external and internal causes. Therefore, this paper summarized the theoretical progress of pro-environmental behavior and proposed future research directions, which contribute to its theoretical development.
| S-EPMC9180624 | biostudies-literature
Project description:Age is the strongest risk factor for physical disability and Alzheimer's disease (AD) and related dementias. As such, other aging-related risk factors are also shared by these two health conditions. However, clinical geriatrics and gerontology research has included cognition and depression in models of physical disability, with less attention to the pathophysiology of neurodegenerative disease. Similarly, AD research generally incorporates limited, if any, measures of physical function and mobility, and therefore often fails to consider the relevance of functional limitations in neurodegeneration. Accumulating evidence suggests that common pathways lead to physical disability and cognitive impairment, which jointly contribute to the aging phenotype. Collaborations between researchers focusing on the brain or body will be critical to developing, refining, and testing research paradigms emerging from a better understanding of the aging process and the interacting pathways contributing to both physical and cognitive disability. The National Institute of Aging sponsored a workshop to bring together the Claude D. Pepper Older Americans Independence Center and AD Center programs to explore areas of synergies between the research concerns of the two programs. This article summarizes the proceedings of the workshop and presents key gaps and research priorities at the intersection of AD and clinical aging research identified by the workshop participants.
| S-EPMC6454460 | biostudies-literature