Participation and retention can be high in randomized controlled trials targeting underserved populations: a systematic review and meta-analysis

Ojha, Rohit P.; Jackson, Bradford E.; Lu, Yan; Burton, Mandy; Blair, Somer; MacDonald, Brooke R.; Chu, Tzu-Chun; Teigen, Kari; Acosta, Melissa

doi:10.1016/j.jclinepi.2017.11.014

Cited by 7 publications

(5 citation statements)

References 12 publications

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“…Such overrepresentation may partly reflect targeted efforts to engage underserved or underrepresented groups (17)(18)(19)25), but the consequences of targeted overrepresentation are unknown for the broader survivor population and require further investigation. Nevertheless, our findings more broadly reflect the growing body of literature refuting the notion that underserved populations are resistant to participating in research (26)(27)(28)(29) and reinforces the feasibility of engaging perceived "difficult to reach" populations in survivorship research.…”

Section: Discussionsupporting

confidence: 76%

Adult Cancer Survivors' Engagement and Interest in Patient-Centered Research

Lubas

Gehr

et al. 2020

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: Limited information is available about the representativeness of survivors engaging in patient-centered research, despite the potential for threats to generalizability. We thus aimed to assess the representativeness of survivors engaged or interested in research development.Methods: We used data from the Health Information National Trends Survey, a nationally representative survey, to identify survivors of adult cancers. Our outcomes of interest were based on responses to questions about engagement or interest in developing patient-centered research. We estimated the ratio of relative frequencies (RRF) and corresponding 95% confidence limits (CL) of sociodemographic and survivorship characteristics between survivors engaged or interested in patient-centered research and the overall survivor population.Results: Our study population comprised 934 survivors, of whom 5% reported being engaged in patient-centered research and 26% reported an interest in participating. Relative frequencies of characteristics were discordant for engaged survivors but largely similar for interested survivors compared with all survivors. In particular, engaged survivors had a higher relative frequency of individuals ages 50 to 64 years (RRF ¼ 1.7; 95% CL, 1.1-2.5), Hispanic (RRF ¼ 2.9; 95% CL, 1.2-6.9), non-Hispanic Black (RRF ¼ 2.9; 95% CL, 1.1-2.5), and unemployment (RRF ¼ 4.7; 95% CL, 1.4-16).Conclusions: We observed several meaningful differences in the characteristics of survivors engaged in patient-centered research compared with all survivors, which raises concerns about the generalizability of findings from such studies.Impact: Patient-centered research may not benefit the broader survivor community if survivors engaging in research development are not representative of all survivors. Greater attention to recruiting mechanisms is necessary to avoid creating disparities.

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Section: Discussionsupporting

confidence: 76%

Adult Cancer Survivors' Engagement and Interest in Patient-Centered Research

Lubas

Gehr

et al. 2020

Cancer Epidemiology, Biomarkers &Amp; Prevention

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“…In the context of evaluating perioperative interventions for CPSP, an IPD meta-analysis could resolve a number of major challenges, including standardizing outcomes. Notwithstanding the challenges of IPD (eg, greater resources required, risk of selection and availability bias due to barriers in accessing IPD),45 46 planning IPD meta-analysis is an important future direction of next generation CPSP meta-research.…”

Section: Discussionmentioning

confidence: 99%

Quality of meta-analyses of non-opioid, pharmacological, perioperative interventions for chronic postsurgical pain: a systematic review

McGregor

Warner

Linde

et al. 2022

Reg Anesth Pain Med

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BackgroundIn an attempt to aggregate observations from clinical trials, several meta-analyses have been published examining the effectiveness of systemic, non-opioid, pharmacological interventions to reduce the incidence of chronic postsurgical pain.ObjectiveTo inform the design and reporting of future studies, the purpose of our study was to examine the quality of these meta-analyses.Evidence reviewWe conducted an electronic literature search in Embase, MEDLINE, and the Cochrane Database of Systematic Reviews. Published meta-analyses, from the years 2010 to 2020, examining the effect of perioperative, systemic, non-opioid pharmacological treatments on the incidence of chronic postsurgical pain in adult patients were identified. Data extraction focused on methodological details. Meta-analysis quality was assessed using the A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) critical appraisal tool.FindingsOur search yielded 17 published studies conducting 58 meta-analyses for gabapentinoids (gabapentin and pregabalin), ketamine, lidocaine, non-steroidal anti-inflammatory drugs, and mexiletine. According to AMSTAR 2, 88.2% of studies (or 15/17) were low or critically low in quality. The most common critical element missing was an analysis of publication bias. Trends indicated an improvement in quality over time and association with journal impact factor.ConclusionsWith few individual trials adequately powered to detect treatment effects, meta-analyses play a crucial role in informing the perioperative management of chronic postsurgical pain. In light of this inherent value and despite a number of attempts, high-quality meta-analyses are still needed.PROSPERO registration numberCRD42021230941.

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“…Evidence regarding the effectiveness of shorter duration trastuzumab therapy is inconsistent but generally indicates reduced effectiveness and may not justify reduced harms [ 57 – 59 ]. Nevertheless, this evidence is based on trials with inadequate representation of socioeconomically marginalized breast cancer patients, which compromises generalizability and reiterates the need for greater diversity in clinical trials [ 60 ]. Meanwhile, evidence from our study may be useful in settings that provide care for socioeconomically marginalized breast cancer patients, particularly for raising awareness about potential unmet needs for cardiotoxicity prevention, detection, and management.…”

Section: Discussionmentioning

confidence: 99%

Cardiotoxicity among socioeconomically marginalized breast cancer patients

Gehr

Anikpo

et al. 2022

Breast Cancer Res Treat

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Purpose Evidence of cardiotoxicity risk related to anthracycline or trastuzumab exposure is largely derived from breast cancer cohorts that under-represent socioeconomically marginalized women, who may be at increased risk of cardiotoxicity because of high prevalence of cardiovascular disease risk factors. Therefore, we aimed to estimate cardiotoxicity risk among socioeconomically marginalized breast cancer patients treated with anthracyclines or trastuzumab and describe clinical consequences of cardiotoxicity. Methods We linked electronic health records with institutional registry data from a Comprehensive Community Cancer Program within a safety-net health system. Eligible patients were adult females, diagnosed with first primary invasive breast cancer between 2013 and 2017, and initiated anthracyclines or trastuzumab as part of first-line therapy. We estimated cumulative incidence (risk) of cardiotoxicity with corresponding 95% confidence limits (CL) using the Aalen-Johansen estimator with death as competing risk. Results Our study population comprised 169 women with breast cancer (103 initiated anthracyclines and 66 initiated trastuzumab). Cumulative incidence of cardiotoxicity was 21% (95% CL: 12%, 32%) at one year and 25% (95% CL: 15%, 35%) at three years among women who initiated trastuzumab, whereas cumulative incidence was 3.9% (95% CL: 1.3%, 8.9%) at one year and 5.9% (95% CL: 2.4%, 12%) at three years among women who initiated anthracyclines. More than half of patients with cardiotoxicity experienced interruption of cancer treatment. Conclusion Our findings suggest high risk of cardiotoxicity among socioeconomically marginalized breast cancer patients after initiation of anthracyclines or trastuzumab. Strategies are needed for optimizing cancer treatment effectiveness while minimizing cardiotoxicity in this population.

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Participation and retention can be high in randomized controlled trials targeting underserved populations: a systematic review and meta-analysis

Cited by 7 publications

References 12 publications

Adult Cancer Survivors' Engagement and Interest in Patient-Centered Research

Adult Cancer Survivors' Engagement and Interest in Patient-Centered Research

Quality of meta-analyses of non-opioid, pharmacological, perioperative interventions for chronic postsurgical pain: a systematic review

Cardiotoxicity among socioeconomically marginalized breast cancer patients

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