scholarly journals Making Clinical Trials More Patient-Centered Using Digital Interactive E-Consent Tools

2019 ◽  
Author(s):  
Barbara Biesecker ◽  
Melissa Raspa ◽  
Douglas Rupert ◽  
Rebecca Moultrie ◽  
Robert Furberg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Choice ◽  
Consent Process ◽  
Delivery Mode ◽  
Compelling Evidence ◽  
Patient Centered ◽  
Research Participants ◽  
Informed Decisions ◽  
Potential Benefits ◽  
Participant Understanding

Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or “broken.” Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

2021 ◽  
pp. 174077452110095
Author(s):  
Holly A Taylor ◽  
Daphne Washington ◽  
Nae-Yuh Wang ◽  
Hiten Patel ◽  
Daniel Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process ◽  
P Value ◽  
Fact Sheet ◽  
Significant Difference ◽  
Participant Understanding

Background/Aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). Methods: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. Results: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. Conclusion: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 23-23
Author(s):  
Andrew Schumacher ◽  
Carolyn Bartley ◽  
Anne Kaplan ◽  
Benjamin Murphy ◽  
Howard Safran ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Research Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Participants ◽  
Oncology Research ◽  
Consent Document ◽  
Oncology Clinical Trials ◽  
Informed Consent Document

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.

A Technical Guide to Using Amazon's Mechanical Turk in Behavioral Accounting Research

2017 ◽  
Vol 30 (1) ◽  
pp. 111-122 ◽  
Author(s):  
Steve Buchheit ◽  
Marcus M. Doxey ◽  
Troy Pollard ◽  
Shane R. Stinson
Keyword(s):  
Third Party ◽  
Mechanical Turk ◽  
Behavioral Accounting ◽  
Online Data ◽  
Research Participants ◽  
Traditional Research ◽  
Potential Benefits ◽  
Technical Guide ◽  
Online Data Collection ◽  
Amazon's Mechanical Turk

ABSTRACT Multiple social science researchers claim that online data collection, mainly via Amazon's Mechanical Turk (MTurk), has revolutionized the behavioral sciences (Gureckis et al. 2016; Litman, Robinson, and Abberbock 2017). While MTurk-based research has grown exponentially in recent years (Chandler and Shapiro 2016), reasonable concerns have been raised about online research participants' ability to proxy for traditional research participants (Chandler, Mueller, and Paolacci 2014). This paper reviews recent MTurk research and provides further guidance for recruiting samples of MTurk participants from populations of interest to behavioral accounting researchers. First, we provide guidance on the logistics of using MTurk and discuss the potential benefits offered by TurkPrime, a third-party service provider. Second, we discuss ways to overcome challenges related to targeted participant recruiting in an online environment. Finally, we offer suggestions for disclosures that authors may provide about their efforts to attract participants and analyze responses.

scholarly journals Reducing research waste by promoting informed responses to invitations to participate in clinical trials

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Katie Gillies ◽  
Iain Chalmers ◽  
Paul Glasziou ◽  
Diana Elbourne ◽  
Jim Elliott ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Trial Participation ◽  
Specific Information ◽  
Recruitment And Retention ◽  
Research Waste ◽  
Informed Decisions ◽  
Participation Barriers ◽  
Poor Recruitment

Abstract Poor recruitment to, and retention in, clinical trials is a source of research waste that could be reduced by more informed choices about participation. Barriers to effective recruitment and retention can be wide-ranging but relevance of the questions being addressed by trials and the outcomes that they are assessing are key for potential participants. Decisions about trial participation should be informed by general and trial-specific information and by considering broader assessments of ‘informedness’ and how they impact on both recruitment and retention. We suggest that more informed decisions about trial participation should encourage personally appropriate decisions, increase recruitment and retention, and reduce research waste and increase its value.

scholarly journals Improving the External Validity of Clinical Trials: The Case of Multiple Chronic Conditions

2013 ◽  
Vol 3 (2) ◽  
pp. 30-35 ◽  
Author(s):  
Fortin Martin ◽  
Smith M. Susan
Keyword(s):  
Clinical Trials ◽  
External Validity ◽  
Chronic Conditions ◽  
Evidence Base ◽  
Specific Reference ◽  
Multiple Chronic Conditions ◽  
Patient Centered ◽  
Department Of Health ◽  
Patient Groups ◽  
Intervention Trials

The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will benefit individuals with MCCs (or multimorbidity). The evidence base supporting the management of patients with MCCs will be built through intervention trials specifically designed to address multimorbidity and identification of MCCs in participants across the clinical trial range. This article specifically focuses on issues relating to external validity with specific reference to trials involving patients with MCCs. The exclusion of such patients from clinical trials has been well documented. Randomized control trials (RCTs) are considered the “gold standard” of evidence, but may have drawbacks in relation to external validity, particularly in relation to multimorbidity. It may, therefore, be necessary to consider a broader range of research methods that can provide converging evidence on intervention effects to address MCCs. Approaches can also be taken to increase the usefulness of RCTs in general for providing evidence to inform multimorbidity management. Additional improvements to RCTs would include better reporting of inclusion and exclusion criteria and participant characteristics in relation to MCCs. New trials should be considered in terms of how they will add to the existing evidence base and should inform how interventions may work in different settings and patient groups. Research on treatments and interventions for patients with MCCs is badly needed. It is important that this research includes patient-centered measures and that generalizability issues be explicitly addressed.

scholarly journals Patient-centered assessments: how can they be used in dental clinical trials?

2020 ◽  
Vol 34 (suppl 2) ◽  
Author(s):  
Matheus França PERAZZO ◽  
Júnia Maria SERRA-NEGRA ◽  
Ramon Targino FIRMINO ◽  
Isabela Almeida PORDEUS ◽  
Paulo Antônio MARTINS-JÚNIOR ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Centered

International Dermatology Outcome Measures Initiative as Applied to Psoriatic Disease Outcomes: An Update

2016 ◽  
Vol 43 (5) ◽  
pp. 959-960 ◽  
Author(s):  
Joseph F. Merola ◽  
April W. Armstrong ◽  
Ami Saraiya ◽  
John Latella ◽  
Amit Garg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Outcome Measures ◽  
Treatment Efficacy ◽  
Regulatory Agencies ◽  
Washington Dc ◽  
Patient Centered ◽  
Psoriatic Disease ◽  
Disease Outcomes ◽  
Dermatologic Disease

Previous publications have described the International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, participating pharmaceutical industry partners, payers, and regulatory agencies. The goal of IDEOM is to create patient-centered, validated measures of dermatologic disease progression and treatment efficacy for use in both clinical trials and clinical practice. We provide an update of IDEOM activities as of our 2015 IDEOM meeting in Washington, DC, USA.

Treatment of ST-segment elevation acute coronary syndromes

ESC CardioMed ◽  
2018 ◽  
pp. 1255-1276
Author(s):  
Borja Ibanez ◽  
Sigrun Halvorsen
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Clinical Trials ◽  
Acute Coronary Syndromes ◽  
Real Life ◽  
Compelling Evidence ◽  
St Segment Elevation ◽  
Segment Elevation Myocardial Infarction ◽  
St Segment ◽  
Coronary Syndromes

Over the last 50 years, the treatment of acute ST-segment elevation myocardial infarction (STEMI) has been considerably improved. The widespread implementation of reperfusion (initially pharmacological and later mechanical) resulted in a magnificent reduction in the rates of in-hospital mortality from about 25% in the 1970s to 5% in the late 2010s. Mortality in real life, however, is higher than these figures shown in clinical trials. There is compelling evidence showing the association between duration of ischaemia and mortality. This is the basis for the timely reperfusion in STEMI. All actions should be made to reduce all components of the ischaemic time. Despite these advances, STEMI survivors are still at high risk for developing repetitive events, including reinfarctions, heart failure, and sudden death. Evolving therapies beyond timely reperfusion are contributing to further reduce the morbidity associated with STEMI.

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