Actual Enrollment Research Articles

A phase Ib/II, multicenter, open-label study of DSP-7888 dosing emulsion in combination with immune checkpoint inhibitors (CPI) nivolumab or pembrolizumab in adult patients (pts) with advanced solid tumors, including platinum-resistant ovarian cancer (PROC).

TPS6099 Background: DSP-7888 is a therapeutic cancer vaccine composed of two synthetic peptides derived from Wilms’ tumor 1 (WT1) to promote both cytotoxic and helper T-lymphocyte-mediated immune responses against WT1-expressing tumors. WT1 is overexpressed in various solid tumors, including ovarian cancer. Combining cancer vaccines like DSP-7888 with a CPI may reduce resistance to immunomodulators and improve clinical benefit. A phase Ib/II study is being conducted to evaluate DSP-7888 in combination with a CPI in pts with advanced solid tumors, including PROC (NCT03311334). Methods: This phase Ib/II, open-label, multicenter, two-part dose-search/dose-expansion study investigates DSP-7888 + nivolumab or pembrolizumab in pts with advanced solid tumors (phase Ib), including PROC (phase II). The phase Ib primary objectives are safety, tolerability, and identification of the recommended phase II dose (RP2D). The phase II primary objective is evaluation of objective response rate (ORR); secondary objectives are clinical activity, safety, and tolerability. Pts aged ≥18 years with unresectable, metastatic cancer approved for treatment with nivolumab (phase Ib, Arm 1, n=6–12, 7 enrolled) or pembrolizumab (phase Ib, Arm 2, n=6–12, 6 enrolled), or with PROC (phase II) are eligible. Phase II will enroll ~40 pts into two groups based on programmed death-ligand 1 status (combined positive score of ≥10 [Group 1] or <10 [Group 2]). Clinical activity will be assessed continuously using Bayesian analysis and actual enrollment may increase by ~20 pts/group based on this analysis. Pts in phase II will receive DSP-7888 intradermally (RP2D from phase Ib) once a week (wk) for 6 wks in the induction phase then every 3 wks in the maintenance phase. Beginning Day 1, pembrolizumab will be administered intravenously every 3 wks. In phase II, objective disease will be assessed every 6 wks for 24 wks, then every 12 wks until progression. Endpoints include ORR (per RECIST v1.1) (primary), duration of response, disease control rate (DCR), progression-free survival (PFS), 6-month PFS rate (per RECIST v1.1), and overall survival, immune (i)ORR, iDCR, and iPFS (per iRECIST) (secondary). Exploratory endpoints include blood and tumor tissue biomarkers. Safety and tolerability, assessed by adverse events, will be evaluated throughout the duration of the study and follow-up. This study is currently recruiting patients. Clinical trial information: NCT03311334.

Identifying and overcoming clinical trial enrollment barriers: Can an integrated clinical pathways tool help bridge the gap?

2046 Background: Barriers to clinical trial (CT) enrollment continue to be a national challenge, with only about 3% of adult cancer patients treated within a CT. A key recommendation from the 2013 NCI-ASCO Cancer Trial Accrual Symposium was to use information technology to enhance identification of potentially eligible patients for CTs. We assessed if the implementation of a Clinical Oncology Pathways System (COP) with integrated CT information increased enrollment of CT’s, and categorized physician-identified reasons for non-enrollment. Methods: In 2018, Roswell Park Comprehensive Cancer Center (RP) implemented ClinicalPath pathways (formerly Via Oncology) for medical oncology. The COP software embeds interventional CTs that are open to accrual at RP in the pathway specific to a patient’s disease type, stage and biomarkers. The provider is presented with relevant CTs and must select screening for the trial or provide a reason for bypassing the CT from a drop-down list prior to being presented standard care options. CT screening requests from the COP system from 6/1/18-5/31/19 were reviewed. Screening requests and actual enrollment data were matched. The accrual-to-study ratio (ASR), defined as the number of consented accruals divided by the number of CTs open to accrual at RP at any time during the period, was calculated for the study period and the baseline from 6/1/14-6/1/18. The reasons physicians did not elect to screen for CTs were summarized. Results: There can be multiple trials presented for each pathway decision.There were 1,606 decision points with at least one embedded trial. Of these, 1,289 decision points matched 2,242 CTs that were not selected for screening. 317 trials were selected for screening. The most common reasons for not screening were patient ineligibility (41%), provider bypassing the CT by selecting treatment “off pathway” (28%), patient not interested (12%), patient already on CT (8%) and “other” (9%). Audits confirmed that the majority of ineligible patients had co-morbidities such as organ dysfunction or brain metastasis that precluded them from the CT. Among the 317 trials selected for CT screening, 108 (34%) patients enrolled in CTs. The ASR increased from the four-year historical average baseline of 4.08 to 4.33 one year post-implementation. Conclusions: The use of COP with embedded CT was associated with a modest increase in ASR. Stringent eligibility criteria was the primary barrier to enrollment. Adopting a broader set of clinical trial eligibility criteria could increase enrollment to CT.

Leaving the pond—Choosing an ocean: Effects of student composition on STEM major choices at university.

Self-concept in mathematics (MSC) and interest in mathematics are important predictors of whether a student will choose to major in a science, technology, engineering, or mathematics (STEM) field at university. Research on the big-fish-little-pond effect (BFLPE) has shown that both predictors are affected by the achievement composition of students in schools. That is, given the same individual ability, students in higher achieving schools exhibit lower MSC and interest in mathematics than students in lower achieving schools due to social comparison processes. The BFLPE has been replicated in high school settings many times, but less is known about the long-term effects of this context effect. In the present study, we investigated the long-term effects of the BFLPE on the aspiration to major in and the actual decision to major in a STEM field at university. We used data from a German longitudinal study. The results showed no direct BFLPE on the aspiration to enroll in a STEM major at the end of high school or on actual enrollment in a STEM major 2 years after graduating from high school. However, small negative indirect effects of the BFLPE via MSC and interest in mathematics on the aspiration to and enrollment in a STEM major occurred. In sum, the longitudinal BFLPE on STEM major choice was small. (PsycInfo Database Record (c) 2020 APA, all rights reserved)

Bayesian accrual modeling and prediction in multicenter clinical trials with varying center activation times.

Investigators who manage multicenter clinical trials need to pay careful attention to patterns of subject accrual, and the prediction of activation time for pending centers is potentially crucial for subject accrual prediction. We propose a Bayesian hierarchical model to predict subject accrual for multicenter clinical trials in which center activation times vary. We define center activation time as the time at which a center can begin enrolling patients in the trial. The difference in activation times between centers is assumed to follow an exponential distribution, and the model of subject accrual integrates prior information for the study with actual enrollment progress. We apply our proposed Bayesian multicenter accrual model to two multicenter clinical studies. The first is the PAIN-CONTRoLS study, a multicenter clinical trial with a goal of activating 40 centers and enrolling 400 patients within 104 weeks. The second is the HOBIT trial, a multicenter clinical trial with a goal of activating 14 centers and enrolling 200 subjects within 36 months. In summary, the Bayesian multicenter accrual model provides a prediction of subject accrual while accounting for both center- and individual patient-level variation.

Participation in structured STEM‐focused out‐of‐school time programs in secondary school: Linkage to postsecondary STEM aspiration and major

AbstractIn this paper, we explore how secondary school students' participation in structured, math‐ and science‐focused programs outside of school is associated with the aspiration to, and actual enrollment in, a STEM major in college. Moreover, we examine how varying sociodemographic backgrounds are related to their participation in these programs. Using expectancy‐value theory and social cognitive career theory as our conceptual frameworks, we conduct a path analysis based on a nationally representative panel dataset. Results indicate that students who participate in structured science‐focused out‐of‐school programs in eighth grade are more likely to express an aspiration to and choosing a STEM major in college. The intersection of sociodemographic backgrounds further highlights the intricate differences in math‐focused programs participation outside of school between Latinx and White adolescents of varying socioeconomic status.

A Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post Infusion of T -Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells with Post Transplant Cyclophosphamide

Phase II trial evaluating the Efficacy and Safety of Sargramostim Post Infusion of T -Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells with Post-Transplant Cyclophosphamide Background: T-replete HLA mismatched haploidentical transplantation (Haplo) with post-transplant cyclophosphamide (PTCY) is widely used for patients lacking a suitably matched donor. Patients who receive haplo with PTCY usually start growth factor support (G-CSF) on day +5 for neutropenia prophylaxis. G-CSF is a specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage. Granulocyte-macrophage colony-stimulating factor (GM-CSF) on the other hand, is not restricted to neutrophils because it also affects monocytes and eosinophils and plays a central role in antifungal host response. In a prior randomized study among 206 matched allogeneic HCT patients (wang et al, J Clin Oncol. 2015;33(34):3999-4006), neutropenia prophylaxis with GM-CSF +/- G-CSF had significantly lower 100-day TRM, lower 100-day cumulative mortality, lower infection related mortality and lower 600-day invasive fungal disease related mortality compared to G-CSF. Given the increase number of HLA mismatched haplos with PTCY performed each year and the high risk of infectious complications associated with this type of transplant, we suggest that GM-CSF administration post haplo and PTCY can yield similar count recovery rate to GCSF with a potential of lowering risk of infectious complications. Endpoints : The primary endpoint is to establish equivalent effectiveness of sargramostim to a matched control cohort of G-CSF treated patients in time to neutrophil engraftment (ANC>500 x 3 days) post haplo with PTCY. Secondary endpoints: estimates of OS, DFS, relapse rate, GVHD and TRM. Donor chimerism at days 30, 60, 100 and 6 months post-transplant. Incidence and grade of cytokine release syndrome between day 0 and 30. Incidence of infectious complications and infection related mortality at day 100. Immune profiling assay "CYTOF" will be measured at days 30, 60, 90 and 180 for functional and phenotypic immune analysis. Other secondary endpoints include length of hospital stay and charges-based cost comparison during the first 100 days between sargramostim and G-CSF matched controls. All primary and secondary endpoints will be reported for the study group and compared to a matched control cohort from our database containing patients who received haplo with PTCY using G-CSF for neutropenia prophylaxis. A set of 20 patients, who are not on the Sargramostim study and receiving haplo transplant with G-CSF at the same time of the study accrual period, will be consented for immunoprofiling assay at days 30, 60, 100 and 180. Methods: Patients aged 18-78 years with an available 5/10-8/10 HLA- matched related donor with high risk hematological malignancy with adequate organ function will be enrolled for the study. Patients will receive Sargramostim 250mg/m2 /day subcutaneous starting day +5 post haplo/PTCY and continue till ANC>1000x 3 days or >1500x 1 day. If grade 3 or 4 adverse reactions occur, reduce dose by 50% or temporarily discontinue the dose until the reaction abates. Conditioning regimens to be used include previously published and currently used at our center (Flu/Cy/TBI, Flu/high dose TBI or Flu/Mel). Treatment will be in the outpatient setting and admissions if clinically indicated. Sample Size Determination : Time to ANC>500 will be evaluated between the prospectively enrolled patients and matched historical controls. Based on the data of haplo transplants done at Northside in 2010-2016, the standard deviations (SD) was 3 days for time to ANC500. The correlation in measurements between prospective patient and matched control is conservatively assumed to be 0.1. SD for differences between matched pairs would be 3.55 days for time to ANC500. To control the type I error to be 5%, the 90% paired t confidence interval for difference in time to ANC500 should be constructed and its upper boundary will be compared to the non-inferiority margin 2 days. The size of 35 prospective patients provides the power 90% for concluding that time to ANC500 for Sargramostim is no more than 2 days longer than historical controls. The actual enrollment size is decided to be 38 to accommodate 10% of drop off rate. Enrollment: The study is expect to start enrolling patients October 2019. Disclosures No relevant conflicts of interest to declare.

Evaluación de estudiantes de primer año en programas de pedagogía sobre actitudes e intereses para la docencia

La ley 20.903 que creó el Sistema de Desarrollo Profesional Docente y que rige a las carreras de pedagogía desde el año 2016, reconoce la complejidad de la labor docente y, a partir de distintos requerimientos, exige a las instituciones formadoras, el diseño, aplicación y acompañamiento en una evaluación diagnóstica para los estudiantes que ingresan a un programa de formación en pedagogía. Desde el año 2017, la Facultad de Educación de la Universidad de las Américas ha definido un perfil de ingreso para sus estudiantes y, con la finalidad de constatarlo con el perfil de ingreso real, ha diseñado distintas instancias diagnósticas, de habilidades comunicativas, de pensamiento lógico matemático, de percepción de habilidades TIC y de actitudes e intereses para la enseñanza. La evidencia demuestra la pertinencia del perfil de egreso dado los altos porcentajes de logro alcanzados por los estudiantes en este test durante el año 2017, sin embargo, se hace necesario avanzar en evidenciar aquellas actitudes e intereses, de forma no solo declarativa, sino desde el despliegue práctico, por ejemplo, en la resolución de problemas.

Promoting Enrollment in Parenting Programs Among a Filipino Population: A Randomized Trial.

Evidence-based parenting programs prevent the onset and escalation of youth conduct problems. However, participation rates in such programs are low among hard-to-reach populations, including Filipino individuals. Compared with other ethnic groups, Filipino adolescents have significant mental health disparities. We evaluated the effectiveness of a theory-based, culturally tailored video versus a usual-care mainstream video on enrollment in an evidence-based parenting program among Filipino caregivers of children ages 6 to 12 years and tested theoretical mediators of intervention effect. We randomly assigned 215 Filipino participants to view either a theory-based, culturally tailored video based on the Health Belief Model and Theory of Planned Behavior or a control video. The primary outcome was actual enrollment in an evidence-based parenting intervention. Mediators (knowledge and perceived susceptibility) were modeled as latent variables in a structural equation model. After the intervention, participants in the intervention group had significantly higher knowledge of Filipino adolescent behavioral health disparities and higher perceived susceptibility to adolescent risky sexual activity and illegal drug use. Controlling for child sex, parents in the intervention group had significantly greater odds of actual enrollment in the Incredible Years program (odds ratio = 2.667; 95% confidence interval: 1.328-5.354; P = .006). The intervention effects were mediated by increased knowledge and perceived susceptibility. Results demonstrated the effectiveness of a theory-based, culturally tailored intervention aimed at increasing participation of a hard-to-engage population in parenting interventions. Videos that include parents and health professionals with whom audiences can identify can be used to produce shifts in knowledge and behavior.

Abstract TP60: Comparison of Predicted vs. Actual Enrollment Into the NIH StrokeNet DEFUSE 3 Trial: Effectiveness of a Population-Based Epidemiology Feasibility Assessment in Improving Enrollment Into Clinical Trials

Introduction: The NIH StrokeNet trial network aims to improve recruitment and retention into stroke clinical trials. In addition to StrokeNet infrastructure, a population-based feasibility assessment is performed prior to submission to NIH. We sought to describe the impact of this assessment on the design and recruitment efficiency of the DEFUSE 3 trial, the first trial to be proposed and completed entirely within NIH StrokeNet. Methods: We identified all ischemic stroke (IS) cases in the region in 2005 by screening all local hospital ICD-9 codes 430-436 among residents of the Greater Cincinnati/Northern Kentucky (GCNK) region, a biracial population of 1.3 million through chart abstraction and physician review. Initial proposed, and final revised DEFUSE 3 trial entry criteria were analyzed for population-based eligibility. Results: DEFUSE 3 is an acute reperfusion ischemic stroke (IS) trial conducted at 38 US centers between 5/16-5/17. Initial inclusion/exclusion criteria proposed by trial PIs predicted that 2.4% (46 of 1843 in 2005) of IS patients would be eligible for DEFUSE-3. After criteria revision, this increased to 4.0% (74/1843). Four exclusion criteria were changed by study PIs after receiving feedback: upper age limit, baseline disability, time since last seen normal, and NIHSS (Table). Overall, 57% (104/182) of enrolled patients qualified via the broadened study entry criteria. In subsequent implementation, the trial randomized 0.47 patients per site per month which was nearly twice the expected enrollment rate. Conclusion: Feedback from formal epidemiologic feasibility assessment to trial investigators during multicenter clinical trial design led to a broadening of entry criteria, and more than half of eventually enrolled patients were eligible only because of the expanded criteria. Iterative trialist-epidemiologist interaction is a promising approach to improve multicenter clinical trial planning and efficient study conduct.

Effectiveness of HIV Linkage to HIV Positive Clients on Treatment in Hospitals in Uganda: The Case of Mengo and Mukono Hospitals HIV Departments

The HIV situation remains a challenge with an expected 36.7 million people infected. In Uganda more than 1,300,000 to 1,600,000 people were living with HIV/AIDS in 2015 out of 44.27 million Ugandans (UNAIDS, 2017), enrolling 230 HIV new infections daily. Despite of the endeavors in HIV/AIDS testing, linkage and enrolment remains a major challenge, adding to a majority testing positive without linkage to care. With this background, the study focused on the analysis of current prevalence rate, opportunistic infections, deaths, and attitude of those tested positive towards enrolling for treatment. The study also examined issues of stigma, denial, distance, negligence, and ignorance. The objectives of the study were to assess the linkage time lag between the time of testing and the time of actual enrollment of clients that test HIV positive. It also aimed to check the reported linkages and actual enrollments and to examine the reasons as to why those linked for care don’t enroll for HIV care services.

Information Provision and Postgraduate Studies

This is the first paper to experimentally examine effects of information provision on beliefs about pecuniary and non-pecuniary returns of postgraduate education, enrollment intentions and realized enrollment. We find that our treatment causally affects beliefs measured six month after treatment. The effects on beliefs differ by gender and academic background, and we find that stated enrollment intentions change accordingly: in particular males significantly adjust their beliefs and intentions to undertake postgraduate studies. We follow the students further and provide evidence on actual enrollment one year after treatment. Taken together, this study highlights the relevance of information provision on pecuniary and non-pecuniary labor market returns for postgraduate study decisions.

Informing Students about College: An Efficient Way to Decrease the Socio-Economic Gap in Enrollment: Evidence from a Randomized Field Experiment

Although the proportion of students enrolled in college increased in the last decades, students from non-college family backgrounds remain underrepresented in higher education around the world. This study sheds light on whether the provision of information in a randomized controlled trial with more than 1,000 German high school students results in higher college enrollment rates. One year prior to high school graduation, we treated students in randomly selected schools by giving an in-class presentation on the benefits and costs of higher education as well as on possible funding options for college education. We collected data from students prior to the information intervention and followed them for four consecutive years. We find evidence that an information intervention increases students’ application as well as their enrollment rates, in particular for students from non-college backgrounds with enrollment intentions prior to treatment. Moreover, treated students persist in college at a similar rate as students in the control group, i.e. they are not more likely to drop out of college. Our results indicate that a low-cost information intervention is an efficient tool to encourage students to translate their college intentions into actual enrollment.

Bridging the intention-behavior gap for cardiac rehabilitation participation: the role of perceived barriers

Purpose: Patients referred to cardiac rehabilitation after an acute coronary syndrome event commonly report strong intention to attend, but at least one-third do not participate. This study explored whether well-documented cardiac rehabilitation barriers (e.g., comorbidities, logistical/time constraints, and low social support) moderate the association between intention to participate and actual program enrollment and attendance.Method: Following referral but prior to commencing a 12-week outpatient cardiac rehabilitation program, 100 patients with acute coronary syndrome completed measures of intention to attend cardiac rehabilitation, perceived cardiac rehabilitation barriers, and social support. Program enrollment and attendance were determined by chart review.Results: Despite high reported intention to attend (M = 6.08/7.00, SD = 1.80), nearly one-in-five did not enroll. Weaker intention to attend (b = 0.46, SE = 0.16, p = 0.004) and greater cardiac rehabilitation barriers (b= −1.67, SE = 0.70, p = 0.017) corresponded to lower program enrollment. Similarly, weaker intention (b = 2.29, SE = 0.50, p < 0.001) and greater barriers (b =−6.19, SE = 1.55, p < 0.001) predicted poorer attendance. Barriers moderated the association between intention to participate and cardiac rehabilitation enrollment (b=−0.60, SE = 0.29, p = 0.037) and attendance (b = −3.12, SE = 1.02, p = 0.003).Conclusions: Perceived cardiac rehabilitation barriers influence whether patients successfully translate their intention to attend into actual program participation. Enhancing self-efficacy to overcome barriers may represent an important intervention target among prospective cardiac rehabilitation patients.Implications for RehabilitationPatients with acute coronary syndrome report strong intention to attend cardiac rehabilitation upon referral, yet cardiac rehabilitation programs remain underutilized.Assessing and addressing perceived barriers during the transition to cardiac rehabilitation, even when patients present as highly motivated to attend, may be critical to promoting program uptake.Rehabilitation professionals should ask patients about specific barriers to attending cardiac rehabilitation (e.g., financial constraints, transportation problems) and provide individualized solutions (e.g., fee subsidization, home- or web-based programs) to increase participation.

PHP20 - Insurance Marketplace Enrollment and In-Person Assistance Under the Affordable Care Act

The Affordable Care Act (ACA) established the health insurance Marketplaces to provide people the opportunity to obtain health care coverage. Assisters have worked with people who may have difficulty understanding the new system and selecting the right plan. This study described the availability of assisters and examined the relationship between assisters and Marketplace enrollment. The 2016 Marketplace enrollment data, 2016 Small Area Health Insurance Estimates data, and a database of assister programs constructed using healthcare.gov were analyzed at the county level. The hierarchical generalized linear model was used to examine the effect of assisters on Marketplace enrollment. The study analyzed 2,261 counties nested within 34 states. About half of counties did not provide assisters at all. Counties had the average 45.8 % of the potential Marketplace enrollees but had only 11.4 % of actual enrollment among the potential enrollees. The Marketplace enrollment among the non-elderly individuals was positively associated with the number of assisters and Medicaid expansion. Assisters were hardly available despite their critical role in the Marketplace. The expansion of assisters will improve Marketplace enrollment by educating people on financial assistance and increasing awareness of the Marketplace.

Enlisting the willing: A study of healthcare professional–initiated and opt-in biobanking consent reveals improvement opportunities throughout the registration process

Biobanking consent processes should accord with patients' preferences and be offered in a consistent and systematic manner. However, these aims can be difficult to achieve under healthcare professionals' (HCPs) time-constrained workflows, resulting in low participation rates.This current perspective provides a brief overview of HCP involvement in consent and reports new data on participant attrition at each step of the biobanking consent process as experienced by 113 patients at an Australian tertiary cancer centre. To determine attrition in this HCP-driven consent process, we reviewed medical records for the following events: inclusion of biobanking consent forms; visible patient and HCP signatures; consent status selected (decline or accept) and specimen registration with local biobank. Accessible medical records revealed the following data: 75 of 85 records included viewable forms; 22 of 85 records included patient and 19 of 85 included HCP signatures; 15 of 85 records included signed and completed forms and 3 of 85 had samples banked with annotated clinical data. We compared these data with self-reported experiences of being approached to participate by HCPs. Of the 15 participants (17.6%) who successfully completed consent, only five could recall being asked and providing consent.The low enrolment rate is a considerable lost opportunity because most patients (59%) who were not asked to participate indicated they would have consented if asked. Furthermore, in comparing self-reported experiences with medical records, we believe cancer patients' preferences for participation are mismatched with actual biobanking enrolment, which has considerable attrition at each step in the consent process.

Video intervention increases participation of black breast cancer patients in therapeutic trials

There is a striking racial and ethnic disparity in incidence and mortality of cancer yet minorities remain markedly underrepresented in clinical trials. This pilot study set out to determine the impact of a 15-min culturally tailored educational video on three outcomes relating to clinical trials: likely participation, attitudes (assessed based on six barriers), and actual enrollment. Breast cancer patients with Stage I-III, if diagnosed within previous 6 months, or metastatic disease who self-identified as black or African American were invited to participate. The primary outcome measure was the decision to participate in a therapeutic clinical trial after the intervention. Patients’ intention to enroll on a therapeutic clinical trial and the change in attitudes toward clinical trials were measured by the previously developed Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) questionnaire. Of the 200 patients that participated, 39 (19.5%) patients signed consent to participate in a therapeutic clinical trial; 27 (13.5%) patients enrolled, resulting in a 7.5% increase from our baseline comparison of 6% clinical trial enrollment rate in black cancer patients (p < .001). Pre-test versus post-test assessment demonstrated the proportion of patients expressing likelihood to enroll in a therapeutic trial following the intervention increased by 14% (p < .001). Among 31 AIET items, 25 (81%) showed statistically significant and positive change post-intervention. The findings suggest the promising utility of a culturally tailored video intervention for improving black patients’ attitudes regarding clinical trial participation and resultant enrollment. Future efforts should continue to target facilitators of population-specific recruitment, enrollment, and retention in therapeutic and non-therapeutic clinical trials.

Inequitable Access to Health Care by the Poor in Community-Based Health Insurance Programs: A Review of Studies From Low- and Middle-Income Countries

Out-of-pocket payments for health care services lead to decreased use of health services and catastrophic health expenditures. To reduce out-of-pocket payments and improve access to health care services, some countries have introduced community-based health insurance (CBHI) schemes, especially for those in rural communities or who work in the informal sector. However, there has been little focus on equity in access to health care services in CBHI schemes. We searched PubMed, Web of Science, African Journals OnLine, and Africa-Wide Information for studies published in English between 2000 and August 2014 that examined the effect of socioeconomic status on willingness to join and pay for CBHI, actual enrollment, use of health care services, and drop-out from CBHI. Our search yielded 755 articles. After excluding duplicates and articles that did not meet our inclusion criteria (conducted in low- and middle-income countries and involved analysis based on socioeconomic status), 49 articles remained that were included in this review. Data were extracted by one author, and the second author reviewed the extracted data. Disagreements were mutually resolved between the 2 authors. The findings of the studies were analyzed to identify their similarities and differences and to identify any methodological differences that could account for contradictory findings. Generally, the rich were more willing to pay for CBHI than the poor and actual enrollment in CBHI was directly associated with socioeconomic status. Enrollment in CBHI was price-elastic-as premiums decreased, enrollment increased. There were mixed results on the effect of socioeconomic status on use of health care services among those enrolled in CBHI. We found a high drop-out rate from CBHI schemes that was not related to socioeconomic status, although the most common reason for dropping out of CBHI was lack of money to pay the premium. The effectiveness of CBHI schemes in achieving universal health coverage in low- and middle-income countries is questionable. A flexible payment plan where the poor can pay in installments, subsidized premiums for the poor, and removal of co-pays are measures that can increase enrollment and use of CBHI by the poor.

The dynamics of study-work choice and its effect on intended and actual university attainment

ABSTRACTWe study the dynamics of study-work choices of Australian high school students and how these choices affect intended and actual enrolment in universities when they finish their school education. A dynamic random effect multi-equation model is constructed and estimated. We find that study-work choices are state dependent, driven by student heterogeneity and the school environment they are in. They are also related to behaviours of the fellow students in the same school. We find that study-work choices significantly affect enrolment in universities but they hardly have any effect on students’ preference for university attainment.

Wearable Technologies and Health Behaviors: New Data and New Methods to Understand Population Health

We study a randomized control trial in a large employer population of access to “wearable” technologies and the associated planning and monitoring tools on improved health behaviors (sleep and exercise). Both ITT and IV estimates based on actual plan enrollment for the treatment group suggest statistically significant but economically small changes in behavior after three months. We then implement machine learning-based models to assess treatment effect heterogeneity. We find little evidence for heterogeneous treatment effects base on observables. We also present detailed data on sleep patterns underscoring the value of this new data source to researchers.

Indications of Recruitment Challenges in Research with U.S. Military Service Members: A ClinicalTrials.gov Review.

The success of military-relevant health research often depends on recruiting adequate numbers of U.S. military service members as research participants. Researchers have reported difficulties in recruiting service member research participants. Reviews of ClinicalTrials.gov, an online clinical trial registry of publicly and privately sponsored studies, have identified challenges in participant recruitment and barriers to study completion in various research populations. The purpose of this study was to identify indications of difficulty recruiting U.S. military service members as research participants based on data from study records in ClinicalTrials.gov. Records of studies starting between 2005 and 2014 were collected from ClinicalTrials.gov and updated through January 2016. Three hundred and two studies that included ≥25% U.S. military service member research participants were (1) compared to a comparison group of 302 studies, each with <5% service member participants and (2) compared by the proportion of service member participants within studies in the military group ("many" ≥25% but <100% service members and "all" 100% service members). Groups were evaluated and compared for recruitment status; reasons for study withdrawal, termination, or suspension; achievement of ≥85% of the anticipated enrollment; and differences in achieving recruitment goals according to study sponsor. Twelve percent of studies in the military group had been withdrawn, terminated, or suspended; enrollment and funding problems were the most common reasons. The comparison group had 11% of studies withdrawn, terminated, or suspended; the most common reasons were enrollment problems and sponsor decision. All study groups had indications of difficulty adequately achieving participant enrollment goals. Among studies with known anticipated and actual enrollment, approximately half in both the military group (47.9%) and comparison group (50.3%) achieved ≥85% of the anticipated enrollment (p = 0.722). Half of studies with many service members and 44% of studies with all service members achieved ≥85% of the anticipated enrollment (p = 0.600). In comparing the many and all service member subgroups, significant differences were found in the median values for anticipated enrollment and actual enrollment, even when accounting for Bonferroni correction. Evaluations of mean values did not show a statistical difference between the military subgroups. There were no significant differences according to study sponsor (military, academic, Veterans Affairs, National Institutes of Health, nonprofit organization, or industry) for a study achieving or not achieving ≥85% of the anticipated enrollment. This review supports anecdotal reports of difficulty recruiting service members as research participants. However, the findings also indicate that in many regards, there is not much difference in the difficulties recruiting service members versus other research participants. Findings suggest that it is often difficult to recruit research participants regardless of the specific population or type of study sponsor, and that studies with either many or all service member participants have similar achievement of recruitment goals. Findings in this study may be useful for those who design research that includes service members or for those who are apprehensive about including service members in their research.