Patients’ views of consent for research enrollment during acute myocardial infarction

Dickert, Neal W.; Fehr, Alexandra; Llanos, Alex; Scicluna, Victoria M.; Samady, Habib

doi:10.3109/17482941.2014.994642

Cited by 24 publications

(28 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This may have been driven by lower representation of behavioral studies in the acute setting, and behavioral studies’ lower acceptance rates may be a result of the fact that they often require greater “agency” on the part of the participant. However, an increased rate of acceptance in acute studies also coheres with observations that decision making and the nature of consent likely differ in more‐acute settings . Specifically, the presence of significant time pressure, stress, and physical symptoms likely limits patients’ understanding of clinical trials for which they are eligible and may change the nature of their decision making.…”

Section: Discussionmentioning

confidence: 70%

“…However, an increased rate of acceptance in acute studies also coheres with observations that decision making and the nature of consent likely differ in more-acute settings. 11,12 Specifically, the presence of significant time pressure, stress, and physical symptoms likely limits patients' understanding of clinical trials for which they are eligible and may change the nature of their decision making. Second, markedly different acceptance between Western Europe and the United States underscores perceptions that cultural factors play a role in enrollment decisions and highlights the need to expand education in the United States regarding the importance of trials to health system improvement.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Trends in Consent for Clinical Trials in Cardiovascular Disease

Kerkhoff

Butler

Kelkar

et al. 2016

JAHA

Self Cite

View full text Add to dashboard Cite

BackgroundCardiovascular clinical trials depend on patient enrollment. Enrollment rates appear inadequate, but little is known about how frequently patients accept or decline offers of enrollment. The objective of this study was to assess trends and predictors of patient acceptance of offers to enroll in clinical trials for cardiovascular disease.Methods and ResultsWe utilized an established database containing all randomized, controlled trials (n=1224) in cardiovascular disease published between 2001 and 2012 in the 8 highest‐impact general medical and cardiology journals. Studies were eligible if the number of patients approached and number of patients declining enrollment could be ascertained from published materials. All studies were screened for eligibility. Each eligible study was reviewed by 3 co‐authors. All discrepancies were resolved by the group. The main outcome was acceptance rate, defined as the number of patients enrolled divided by the number patients who were eligible and approached. Only 21.7% (n=266) of studies provided information sufficient to assess patient enrollment and refusals. The median acceptance rate across trials was 83.2%. Significant predictors of higher enrollment included: enrollment in the acute setting (P=0.031); geographical region (P<0.001 for group); and trial sponsorship (P=0.006 for group).ConclusionsRates of reporting data sufficient to calculate acceptance rates are low. This compromises the ability to identify drivers of low enrollment and assess trial generalizability. However, the high rates of acceptance observed suggest that factors other than patients’ decisions may be the primary drivers of declining rates of trial enrollment.

show abstract

Section: Discussionmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Trends in Consent for Clinical Trials in Cardiovascular Disease

Kerkhoff

Butler

Kelkar

et al. 2016

JAHA

Self Cite

View full text Add to dashboard Cite

show abstract

“…Two surveys found that most patients prefer to give consent for standard-of-care trials in less acute situations (13,14). Even patients who recognize the limitations inherent in obtaining consent in the emergency setting report that they want to have a say in whether they are enrolled in research (15,16). And patients sometimes decline to enroll in acute care trials, suggesting that some patients may not want to participate in emergency care trials.…”

Section: Discussionmentioning

confidence: 99%

Targeted Consent for Research on Standard of Care Interventions in the Emergency Setting

Wendler

Dickert

Silbergleit

et al. 2017

Critical Care Medicine

Self Cite

View full text Add to dashboard Cite

Objective There has been significant debate over what consent process, if any, should be used for clinical trials that compare two or more interventions within the standard of care. Some claim that all clinical trials should obtain in-depth research consent because they use subjects to obtain data for the benefit of future patients. Others argue that clinical trials which are limited to interventions within the standard of care do not need to obtain research consent at all. Settling this debate is especially challenging in the emergency setting. The potential for significant morbidity and mortality provides a strong reason to obtain research consent for standard-of-care trials in the emergency setting. Yet, the emergency setting also introduces significant barriers to traditional in-depth research consent. The present paper considers to what extent a targeted consent process can resolve these tensions. Data Synthesis We first identified the ethical goals that are promoted by obtaining consent for standard-of-care research and the barriers to obtaining consent that arise in the emergency setting. We then evaluated whether, despite the barriers, it is possible to develop a targeted consent process that promotes the goals for consent in the context of standard-of-care trials. Conclusions Targeted consent offers an ethically appropriate way to obtain consent for many standard-of-care trials in the emergency setting. For studies subject to US regulations, and those subject to other regulations that include similar consent requirements, targeted consent's verbal disclosure and written form provide a way to satisfy research regulations without blocking valuable studies. For trials that qualify for a waiver of the consent requirements, targeted consent's verbal disclosure is preferable to waiving consent, provided a slight delay is consistent with appropriate care, and there is a capacitated patient or surrogate available.

show abstract

“…1 10 Field testing was conducted with 11 eligible participants; these interviews were excluded from analysis. Consistent with the qualitative and quantitative aims of this study, interviews contained both closed-ended and open-ended questions.…”

Section: Methodsmentioning

confidence: 99%

Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design

et al. 2016

View full text Add to dashboard Cite

show abstract

Patients’ views of consent for research enrollment during acute myocardial infarction

Abstract: This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients' goals while recognizing the limitations inherent to this context.

Cited by 24 publications

References 8 publications

Trends in Consent for Clinical Trials in Cardiovascular Disease

Trends in Consent for Clinical Trials in Cardiovascular Disease

Targeted Consent for Research on Standard of Care Interventions in the Emergency Setting

Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design

Contact Info

Product

Resources

About