Case example of a jail-based cancer prevention clinical trial: Social determinants of health framework, novel experimental design, and retention strategies to facilitate long-term follow-up of clinical trial participants

Clinical trials conducted with incarcerated populations are rare. We present a case example of one such jail-based cancer prevention clinical trial to demonstrate the importance of including a theory-driven approach to intervention framing, novel experimental designs to boost access to low-risk trials, and retention strategies for long-term follow-up of hard-to-reach populations. As such we offer a social determinant of health framework to ensure cancer prevention research is conducted through the lenses of health promotion and health equity. Deviations from the gold-standard randomized control design, transparent systematic allotment, and street-based outreach retention strategies contribute to the feasibility of conducting clinical trials in carceral settings and after people leave jail. Best practices presented can be used in design and conduct of future clinical trials with criminal legal system-involved populations

Measuring quality and outcomes of research collaborations: An integrative review

Introduction: Although the science of team science is no longer a new field, the measurement of team science and its standardization remain in relatively early stages of development. To describe the current state of team science assessment, we conducted an integrative review of measures of research collaboration quality and outcomes. Methods: Collaboration measures were identified using both a literature review based on specific keywords and an environmental scan. Raters abstracted details about the measures using a standard tool. Measures related to collaborations with clinical care, education, and program delivery were excluded from this review. Results: We identified 44 measures of research collaboration quality, which included 35 measures with reliability and some form of statistical validity reported. Most scales focused on group dynamics. We identified 89 measures of research collaboration outcomes; 16 had reliability and 15 had a validity statistic. Outcome measures often only included simple counts of products; publications rarely defined how counts were delimited, obtained, or assessed for reliability. Most measures were tested in only one venue. Conclusions: Although models of collaboration have been developed, in general, strong, reliable, and valid measurements of such collaborations have not been conducted or accepted into practice. This limitation makes it difficult to compare the characteristics and impacts of research teams across studies or to identify the most important areas for intervention. To advance the science of team science, we provide recommendations regarding the development and psychometric testing of measures of collaboration quality and outcomes that can be replicated and broadly applied across studies

Non-cancer clinical trials start-up metrics at an academic medical center: Implications for advancing research

The primary goal for any clinical trial after it receives a funding notification is to receive regulatory approval and initiate the trial for recruitment. Every trial must go through documentation and regulatory process before it can start recruiting participants and collecting data; this initial process of review and approval is known as the study start-up process (SSU). We evaluated the average time taken for studies to receive approvals. Using data from clinical trials conducted at the University of Kansas Medical Center, various times to reach the start of the study were calculated based on the dates of individual study. The results of this analysis showed that chart review studies and investigator-initiated trials had a shorter time to activation than other types of studies. Additionally, single-center studies had a shorter activation time than multi-center studies. The analysis also demonstrated that the overall processing time consistently had been reduced over time

Health researchers’ experiences, perceptions and barriers related to sharing study results with participants

Abstract Background Although research participants are generally interested in receiving results from studies in which they participate, health researchers rarely communicate study findings to participants. The present study was designed to provide opportunity for a broad group of health researchers to describe their experiences and concerns related to sharing results (i.e. aggregate study findings) with research participants. Methods We used a mixed–methods concurrent triangulation design, relying on an online survey to capture health researchers’ experiences, perceptions and barriers related to sharing study results with participants. Respondents were health researchers who conduct research that includes the consent of human subjects and hold a current appointment at an accredited academic medical institution within the United States. For quantitative data, the analytic strategy focused on item-level descriptive analyses. For the qualitative data, analyses focused on a priori themes and emergent subthemes. Results Respondents were 414 researchers from 44 academic medical institutions; 64.5% reported that results should always be shared with participants, yet 60.8% of respondents could identify studies in which they had a leadership role where results were not shared. Emergent subthemes from researchers’ reasons why results should be shared included participant ownership of findings and benefits of results sharing to science. Reasons for not sharing included concerns related to participants’ health literacy and participants’ lack of desire for results. Across all respondents who described barriers to results sharing, the majority described logistical barriers. Conclusions Study findings contribute to the literature by documenting researchers’ perspectives and experiences about sharing results with research participants, which can inform efforts to improve results sharing. Most respondents indicated that health research results should always be shared with participants, although the extent to which many respondents described barriers to results sharing as well as reported reasons not to share results suggests difficulties with a one-size-fits-all approach to improving results sharing

Using Health Information Technology to Engage Communities in Health, Education, and Research

The August 2011 Clinical and Translational Science Awards conference Using IT to Improve Community Health: How Health Care Reform Supports Innovation convened four Think Tank sessions. Thirty individuals, representing various perspectives on community engagement, attended the Health information technology (HIT) as a resource to improve community health and education session, which focused on using HIT to improve patient health, education, and research involvement. Participants discussed a range of topics using a semistructured format. This article describes themes and lessons that emerged from that session, with a particular focus on using HIT to engage communities to improve health and reduce health disparities in populations

Using Health Information Technology to Engage Communities in Health, Education, and Research

The August 2011 Clinical and Translational Science Awards conference Using IT to Improve Community Health: How Health Care Reform Supports Innovation convened four Think Tank sessions. Thirty individuals, representing various perspectives on community engagement, attended the Health information technology (HIT) as a resource to improve community health and education session, which focused on using HIT to improve patient health, education, and research involvement. Participants discussed a range of topics using a semistructured format. This article describes themes and lessons that emerged from that session, with a particular focus on using HIT to engage communities to improve health and reduce health disparities in populations

The role of race and ethnicity in the State Children's Health Insurance Program (SCHIP) in four states: are there baseline disparities, and what do they mean for SCHIP?

BACKGROUND: Elimination of racial and ethnic disparities in health has become a major national goal. The State Children's Health Insurance Program (SCHIP) has the potential to reduce disparities among the children who enroll if they exhibit the same disparities that have been documented in previous studies of low-income children. To determine the potential impact of SCHIP on racial and ethnic disparities, it is critical to assess baseline levels of health disparities among children enrolling in SCHIP. OBJECTIVE: To use data from the Child Health Insurance Research Initiative (CHIRI) to 1) describe the sociodemographic profile of new enrollees in SCHIP in Alabama, Florida, Kansas, and New York; 2) determine if there were differences in health insurance and health care experiences among white, black, and Hispanic SCHIP enrollees before enrollment in SCHIP; and 3) explore whether race or ethnicity, controlled for other factors, affected pre-SCHIP access to health coverage and health care. SETTING: SCHIP programs in Alabama, Florida, Kansas, and New York, which together include 26% of SCHIP enrollees nationwide. DESIGN: Telephone interview (mailed survey in Alabama) about the child's health, health insurance, and health care experiences conducted shortly after SCHIP enrollment to assess experience during the time period before SCHIP. SAMPLE: New SCHIP enrollees (0-17.9 years old in Alabama, Kansas, and New York and 11.5-17.9 years old in Florida). Stratified sampling was performed in Kansas and New York, with results weighted to reflect statewide populations of new SCHIP enrollees. MEASURES: Sociodemographic characteristics including income, education, employment, and other characteristics of the child and the family, race and ethnicity (white non-Hispanic, black non-Hispanic, and Hispanic [any race]), prior health insurance, health care access and utilization, and health status. ANALYSES: Bivariate analyses were used to compare baseline measures upon enrollment for white, black, and Hispanic SCHIP enrollees. Multivariate analyses were performed to assess health status and health care access measures (prior insurance, presence of a usual source of care (USC), and use of preventive care), controlling for demographic factors described above. Weighted analyses (where appropriate) were performed by using SPSS, STATA, or SUDAAN. RESULTS: Racial and ethnic composition varied across the SCHIP cohorts studied, with black and Hispanic children comprising the following proportion of enrollees, respectively: Alabama, 33% and <1%; Florida, 16% and 26%; Kansas, 12% and 15%; and New York, 24% and 36%. Black and Hispanic children were more likely to reside in single-parent and lower-income families. With some variation by state, children from minority groups were more likely to report poorer health status than were white children. Relative to white children, children from minority groups in Florida and New York were more likely to have been uninsured for the entire year before SCHIP enrollment. In all states, children from minority groups who had prior coverage were more likely to have previously been enrolled in Medicaid than in private health insurance and were less likely to have had employer-sponsored coverage compared with white children. Except in Alabama, there was a difference in having a USC, with children from minority groups less likely to have had a USC before SCHIP enrollment compared with white children. No consistent pattern of health care utilization before SCHIP was noted across states with respect to race or ethnicity. Findings from multivariate analyses, controlling for sociodemographic factors, generally confirmed that black and Hispanic children were more likely to have lacked insurance or a USC before enrollment in SCHIP and to have poorer health status compared with white children. CONCLUSIONS: SCHIP is enrolling substantial numbers of racial and ethnic minority children. There are baseline racial and ethnic disparities among new enrollees in SCHIP, with black and Hispanic children faring worse than white children on many sociodemographic and health system measures, and there are differences among states in the prevalence and magnitude of these disparities. After controlling for sociodemographic factors, these disparities persisted. IMPLICATIONS FOR MONITORING AND IMPROVING SCHIP: SCHIP has the potential to play a critical role in efforts to eliminate racial and ethnic disparities in health among the children it serves. However, study findings indicate that programmatic efforts are necessary to ensure that disparities are not perpetuated. Program effectiveness and outcomes should be monitored by race and ethnicity to ensure equity in access, use, and outcomes across all racial and ethnic groups. Assessing the health characteristics and needs of new SCHIP enrollees can provide a benchmark for evaluating the program's impact on eliminating racial and ethnic disparities in health and inform service delivery enhancements

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial

© 2020 American Medical Association. All rights reserved. Importance: Cryptogenic sensory polyneuropathy (CSPN) is a common generalized slowly progressive neuropathy, second in prevalence only to diabetic neuropathy. Most patients with CSPN have significant pain. Many medications have been tried for pain reduction in CSPN, including antiepileptics, antidepressants, and sodium channel blockers. There are no comparative studies that identify the most effective medication for pain reduction in CSPN. Objective: To determine which medication (pregabalin, duloxetine, nortriptyline, or mexiletine) is most effective for reducing neuropathic pain and best tolerated in patients with CSPN. Design, Setting, and Participants: From December 1, 2014, through October 20, 2017, a bayesian adaptive, open-label randomized clinical comparative effectiveness study of pain in 402 participants with CSPN was conducted at 40 neurology care clinics. The trial included response adaptive randomization. Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain). Participant allocation to 1 of 4 drug groups used the utility function and treatment\u27s sample size for response adaptation randomization. At each interim analysis, a decision was made to continue enrolling (up to 400 participants) or stop the whole trial for success (80% power). Patient engagement was maintained throughout the trial, which helped guide the study and identify ways to communicate and disseminate information. Analysis was performed from December 11, 2015, to January 19, 2018. Interventions: Participants were randomized to receive nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69). Main Outcomes and Measures: The primary outcome was a utility function that was a composite of the efficacy (participant reported pain reduction of ≥50% from baseline to week 12) and quit (participants who discontinued medication) rates. Results: Among the 402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3%]), the utility function of nortriptyline was 0.81 (95% bayesian credible interval [CrI], 0.69-0.93; 34 of 134 [25.4%] efficacious; and 51 of 134 [38.1%] quit), of duloxetine was 0.80 (95% CrI, 0.68-0.92; 29 of 126 [23.0%] efficacious; and 47 of 126 [37.3%] quit), pregabalin was 0.69 (95% CrI, 0.55-0.84; 11 of 73 [15.1%] efficacious; and 31 of 73 [42.5%] quit), and mexiletine was 0.58 (95% CrI, 0.42-0.75; 14 of 69 [20.3%] efficacious; and 40 of 69 [58.0%] quit). The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine. Conclusions and Relevance: This study found that, although there was no clearly superior medication, nortriptyline and duloxetine outperformed pregabalin and mexiletine when pain reduction and undesirable adverse effects are combined to a single end point. Trial Registration: ClinicalTrials.gov Identifier: NCT02260388