Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

Williams, Courtney; Senft, Nicole; Shelburne, Nonniekaye; Norton, Wynne E.

doi:10.1001/jamanetworkopen.2021.27792

Cited by 48 publications

(44 citation statements)

References 55 publications

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“…The observational cohort showed a crossover rate of 23.6%, which is much lower than observed in this trial . Personal-level demographic and clinical characteristics have shown to play an important role in the decision to participate in clinical trials, and therefore, they are likely to differ between the trial and cohort population . Women without strong preconceived ideas on treatment choices may not only be more willing to be randomized, but they may also be more reluctant to continue allocated pessary therapy if subjective improvement would not meet their expectations.…”

Section: Discussionmentioning

confidence: 54%

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

Vaart

Vollebregt

Milani

et al. 2022

JAMA

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ImportancePelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.ObjectiveTo investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.Design, Setting, and ParticipantsThe PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022.InterventionsTwo hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.Main Outcomes and MeasuresThe primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured.ResultsAmong 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, −6.1% [1-sided 95% CI, −12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, −13.1% [1-sided 95% CI, −23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery.Conclusions and RelevanceAmong patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery.Trial RegistrationNetherlands Trial Register Identifier: NTR4883

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Section: Discussionmentioning

confidence: 54%

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

Vaart

Vollebregt

Milani

et al. 2022

JAMA

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“…The importance of research benefitting Black or African American people specifically has been expressed elsewhere as potentially motivating research participation (BeLue et al, 2006;Corbie-Smith et al, 1999;George et al, 2014;Herring et al, 2004;Iltis et al, 2021;Rogers et al, 2018;Williams et al, 2021). The expectation that research results will not benefit Black or African American people is a barrier to research participation in general (Corbie-Smith et al, 1999;Scharff et al, 2010).…”

Section: Discussionmentioning

confidence: 99%

Attitudes and beliefs regardingrace‐targetedgenetic testing of Black people: A systematic review

Iltis

Rolf

Yaeger

et al. 2023

Journal of Genetic Counseling

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Geographical ancestry has been associated with an increased risk of various genetic conditions. Race and ethnicity often have been used as proxies for geographical ancestry. Despite numerous problems associated with the crude reliance on race and ethnicity as proxies for geographical ancestry, some genetic testing in the clinical, research, and employment settings has been and continues to be race-or ethnicitybased. Race-based or race-targeted genetic testing refers to genetic testing offered only or primarily to people of particular racial or ethnic groups because of presumed differences among groups. One current example is APOL1 testing of Black kidney donors. Race-based genetic testing raises numerous ethical and policy questions. Given the ongoing reliance on the Black race in genetic testing, it is important to understand the views of people who identify as Black or are identified as Black (including African American, Afro-Caribbean, and Hispanic Black) regarding race-based genetic testing that targets Black people because of their race. We conducted a systematic review of studies and reports of stakeholder-engaged projects that examined how people who identify as or are identified as Black perceive genetic testing that specifically presumes genetic differences exist among racial groups or uses race as a surrogate for ancestral genetic variation and targets Black people. Our review identified 14 studies that explicitly studied this question and another 13 that implicitly or tacitly studied this matter. We found four main factors that contribute to a positive attitude toward race-targeted genetic testing (facilitators) and eight main factors that are associated with concerns regarding race-targeted genetic testing (barriers). This review fills an important gap. These findings should inform future genetic research and the policies and practices developed in clinical, research, public health, or other settings regarding genetic testing.

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“…Although patients may view the system (and the concept of clinical trials) as more tangential, prior studies have found that patients trust their own doctor's treatment decisions. 41,42 The clinician can play a major role in overcoming the low participation of Black patients by focusing on engaging in conversations surrounding risks and benefits of trial participation and offering trials to eligible patients. 43 This sentiment is supported both by our study results and the meta-analysis by Unger et al, 44 which demonstrated that when offered to participate, Black patients with cancer similarly enroll onto clinical trials when compared with White patients.…”

Section: Discussionmentioning

confidence: 99%

Ineligible, Unaware, or Uninterested? Associations Between Underrepresented Patient Populations and Retention in the Pathway to Cancer Clinical Trial Enrollment

Caston

Lalor

Wall

et al. 2022

JCO Oncology Practice

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PURPOSE: Cancer clinical trials can benefit current and future patients; however, Black patients, rural residents, and patients living in disadvantaged areas are often underrepresented. Using an adapted version of Unger and colleagues' model of the process of clinical trial enrollment, we evaluated the relationship between underrepresented patient populations and trial end points. METHODS: This retrospective study included 512 patients with breast or ovarian cancer who were prescribed a therapeutic drug at the University of Alabama at Birmingham from January 2017 to February 2020. Patient eligibility was assessed using open clinical trials. We estimated odds ratios and 95% CIs using logistic regression models to examine the relationship between underrepresented patient populations and trial enrollment end points: eligibility, interest, offer, enrollment, and declining enrollment. RESULTS: Of the patients in our sample, 27% were Black, 18% were rural residents, and 19% lived in higher disadvantaged neighborhoods. In adjusted models, each comparison group had similar odds of being eligible for a clinical trial. Black versus White patients had 0.40 times the odds of interest in clinical trials and 0.56 times the odds of enrollment. Patients living in areas of higher versus lower disadvantage had 0.46 times the odds of enrolling and 3.40 times the odds of declining enrollment when offered. CONCLUSION: Eligibility did not drive clinical trial enrollment disparities in our sample; however, retention in the clinical trial enrollment process appears to vary by group. Additional work is needed to understand how interventions can be tailored to each population's specific needs.

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Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

Cited by 48 publications

References 55 publications

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

Attitudes and beliefs regardingrace‐targetedgenetic testing of Black people: A systematic review

Ineligible, Unaware, or Uninterested? Associations Between Underrepresented Patient Populations and Retention in the Pathway to Cancer Clinical Trial Enrollment

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