Actual Enrollment Research Articles

Census growth and challenges of a novel Hospital at Home program: A retrospective cohort study

AbstractBackgroundHospital at Home (HaH) is a growing care model requiring significant investments. Critical to starting a program is estimating census and enrollments. The objective of this study was to compare expected versus actual consults, enrollments, and barriers in a novel HaH program.MethodsThis was an observational, retrospective cohort study at a single urban academic medical center. Adult inpatients considered for enrollment to HaH were included. Demographic data, diagnoses and outcomes data were extracted for HaH patients. Volume and outcomes of HaH consults were recorded, including reasons for ineligibility or a patient declining to enroll.ResultsOver the first year of implementation, 248 patients enrolled. The average daily census (ADC) grew over months 1–6, then plateaued at a mean of 4.4 patients during month 10, with an overall ADC range from 0 to 7 patients. From months 7 to 12, there were 724 consults for a home hospital assessment, of which 22.5% (163/724) of patients were enrolled, 21.8% (158/724) declined to enroll, 29.3% (212/724) were ineligible for the program, and 26.4% (191/724) had consults that were deferred until the time of discharge and never explicitly consented or refused. The most common reasons for program ineligibility were complex care needs, insurance status, and not meeting inpatient status. The most common reasons patients declined to enroll were a preference to remain in the brick‐and‐mortar hospital and home conditions not suitable for HaH.ConclusionsThis retrospective, cohort study defines the challenges of enrolling patients in an HaH program and provides areas for other programs to examine as they start or grow a program.

Evaluating Patient Participation in Clinical Trials for CLL and SLE in Germany—A Mixed-Methods Study on Enrollment Potential Based on Claims Data

Background: In recent years, the pharmaceutical industry in Germany has faced a significant decline in the number of clinical trials conducted. Methods: This study evaluates patient participation in clinical trials for oncology and chronic diseases in Germany, integrating quantitative and qualitative research. Data from the Institute for Applied Health Research Berlin (InGef (Institut für angewandte Gesundheitsforschung, Berlin, Germany)), covering about 88% of the German population, and expert interviews were used. Results: In 2022, 84.6% of 47,305 systemic lupus erythematosus patients (SLE) and 11.9% of 102,300 chronic lymphocytic leukemia patients (CLL) received guideline-based care based on study definitions. Eligibility for clinical trials between 2017 and 2022 was estimated for 8272 SLE and 886 CLL patients, with the actual enrolment of 21 of 2221 SLE patients and 86 of 340 CLL patients reflecting the respective potential. Conclusions: Findings indicate an unexploited potential to enroll patients with chronic diseases compared to the relatively higher enrolment rates observed for oncology diseases, such as CLL. Securing the continuation of clinical trials and utilizing the value of trial participation is of importance for strengthening Germany as an innovation hub and for ensuring that patients have timely access to medical innovations.

Racial representation in multicenter clinical trials leading to drug approvals for gynecological cancer indications by the US Food and Drug Administration (FDA).

66 Background: Enrollment disparities in gynecologic (Gyn) cancer clinical trials in the United States (US) are well-documented. However, there is limited data evaluating how recruitment sites in international clinical trials contribute to racial representation, specifically in Gyn cancers. Here, we examined racial enrollment and geographic location in clinical trials that have led to approval for Gyn cancer applications. Methods: Agents approved by the FDA for Gyn cancer treatment and corresponding clinical trials were identified from the FDA Drug Approvals and Databases. Enrollment data were abstracted from ClinicalTrials.gov then cross-checked with published manuscripts and FDA labels. Using Gyn disease site prevalence from the 2021 SEER database, we calculated expected enrollment proportions by race and compared these to actual clinical trial enrollment data. The binomial test was used to compare expected vs. observed proportions with White patients as the reference group. Results: From 2014 to 2024, 9 drugs received 22 FDA approvals for ovarian (n=13), endometrial (n=4), or cervical cancer (n=5). These approvals were based on 28 clinical trials enrolling a total of 13,763 patients (75.7% White, 3.4% Black, 12.0% Asian, 8.9% Other/Unknown). These trials included 1 (3.6%) US only study, 3 (10.7%) non-US, primarily Europe-based studies (PAOLA-1, AURELIA, STUDY42 [Europe + Australia]), and 24 (85.7%) international studies across the US and 46 other countries. Considering the distribution of race (White: 86.3%, Black: 8.4%, Asian: 4.9%) of Gyn cancers in the US, Black patients had lower enrollment (45% of expected enrollment) vs. White patients (95% of expected enrollment, P<0.0001). African countries were rarely included among the recruitment sites. Two international trials reported patient recruitment from South Africa (3.2% Black, 6/188 patients, 38% of expected enrollment).However, Asian patients had higher enrollment (269% of expected enrollment, P<0.0001) compared to White patients. In 13 trials that included study sites in East Asia, Asian patients comprised 16% of the trial population (1310/8205 patients; 327% of expected enrollment) vs. 3.2% in trials that did not open in Asia (n=15) (181/5558 patients; 67% of expected enrollment). Conclusions: Black patients were underrepresented in pivotal trials that led to FDA approvals for Gyn cancers. Overrepresentation of Asian patients was likely due to international enrollment from East Asia. Post-marketing retrospective studies or additional studies focused on underrepresented groups are needed to assess true drug efficacy and safety in US populations that are disproportionately affected by Gyn cancer mortality.

Examining the effect of nudging on college students' behavioral engagement and willingness to participate in online courses.

Nudging is a subtle behavioral intervention that has been successful in various domains such as healthy eating and energy conservation, yet its application in mental health remains underexplored. This study examines the effect of nudging to increase engagement with online mental health resources in a university setting. We assigned 2539 first-year undergraduate and graduate students in China to either a nudging group, which received course information augmented with behavioral cues (including framing effects and social norms), or a control group, which received only basic course information. Outcomes measured included self-reported willingness to enroll, willingness to recommend enrollment, and actual enrollment actions. Results indicated that students in the nudging group demonstrated significantly higher engagement levels than those in the control group across all metrics. These findings suggest the potential of nudging strategies to effectively enhance college students' participation in online mental health education.

A non-parametric approach to predict the recruitment for randomized clinical trials: an example in elderly inpatient settings

BackgroundAccurate prediction of subject recruitment, which is critical to the success of a study, remains an ongoing challenge. Previous prediction models often rely on parametric assumptions which are not always met or may be difficult to implement. We aim to develop a novel method that is less sensitive to model assumptions and relatively easy to implement.MethodsWe create a weighted resampling-based approach to predict enrollment in year two based on recruitment data from year one of the completed GRIPS and PACE clinical trials. Different weight functions accounted for a range of potential enrollment trajectory patterns. Prediction accuracy was measured by Euclidean distance for enrollment sequence in year two, total enrollment over time, and total weeks to enroll a fixed number of subjects, against the actual year two enrollment data. We compare the performance of the proposed method with an existing Bayesian method.ResultsWeighted resampling using GRIPS data resulted in closer prediction evidenced by better coverage of observed enrollment with the prediction intervals and smaller Euclidean distance from actual enrollment in year 2, especially when enrollment gaps were filled prior to the weighted resampling. These scenarios also produced more accurate predictions for total enrollment and number of weeks to enroll 50 participants. These same scenarios outperformed an existing Bayesian method for all 3 accuracy measures. In PACE data, using a reduced year 1 enrollment resulted in closer prediction evidenced by better coverage of observed enrollment with the prediction intervals and smaller Euclidean distance from actual enrollment in year 2, with the weighted resampling scenarios better reflecting the seasonal variation seen in year (1) The reduced enrollment scenarios resulted in closer prediction for total enrollment over 6 and 12 months into year (2) These same scenarios also outperformed an existing Bayesian method for relevant accuracy measures.ConclusionThe results demonstrate the feasibility and flexibility for a resampling-based, non-parametric approach for prediction of clinical trial recruitment with limited early enrollment data. Application to a wider setting and long-term prediction accuracy require further investigation.

In-person learning during the pandemic: Student take-up and school-level effects of remote and hybrid instruction on student outcomes

While studies have examined the effects of schools offering in-person learning during the pandemic, this study provides analysis of student enrollment decisions (remote versus in-person) in response to schools providing in-person learning opportunities. In Connecticut during the 2020-21 school year, we find that student take-up of in-person learning opportunities was low with students on average enrolled in-person for only half of the days offered, and take-up was even lower in schools with larger shares of disadvantaged students. The provision of in-person learning opportunities has been previously shown to mitigate pandemic learning losses. By exploiting data on actual enrollment, we show that the protective benefits of in-person learning are twice as large as previously estimated once we account for the low rates of student take-up. Finally, we provide evidence suggesting that a key mechanism behind the benefits of in-person learning is alleviating the burden faced by schools and teachers in delivering remote education. First, we show that the benefits to individual students of their in-person learning are substantially smaller than the overall benefits a student receives from their school average level of in-person enrollment. Second, we show that a combination of remote and in-person learning (hybrid) with a full-time on-line presence of students when at home was worse than hybrid learning with students never or only partially online. This second finding is consistent with qualitative evidence showing that teachers found hybrid learning especially challenging when having to manage both in-person and remote students for the entire class period.

The Status of Access to Medicines and Enrollment in Welfare Schemes by Rural Elderly People of Southerner Rajasthan

Abstract Introduction: Multiple layers of vulnerability pose challenges for rural elderly to access health. Enrollment in government schemes is also limited by this section of society. This study focused on access to medicines and status welfare schemes for rural elderly. Subjects and Methods: It was a cross-sectional survey done in 84 villages in six districts of Rajasthan with 1266 elderly participants. The data were captured through a pretested questionnaire which was filled by trained data collectors. Results: The knowledge, as well as the actual enrollment of the elderly in various health care and welfare schemes, was very poor. Gender and caste analysis showed that women and lower castes were at the worst end in the enrollment and availing entitlements. Knowledge of health schemes was also less among them. The monthly average expenditure for participants on regular medication was Rs. 1570.35 and the time to procure the same was 6.10 h. Discussion: The elderly are vulnerable to the worst health outcomes and gender and cast categories add to it. Access to medicines is an essential component of health accessibility. However, it is largely neglected. Money and time in accessing required medicines seem to be too high to afford for these elderly people. Limited availability of public health facilities, poverty in old age, and the absence of private pharmacies in villages have contributed to the problem significantly. Welfare schemes have the potential to address these issues; however, enrollment and actual reach of benefits still need to be improved in rural areas.

Understanding uptake in demand-side broadband subsidy programs: The affordable connectivity program case

The Affordable Connectivity Program (ACP) represents a historic investment by the federal government to address the digital divide. Its goals are both to increase the rate of broadband adoption and make it easier for low-income households to sustain service. But what have been the drivers of ACP enrollment? We know a great deal about trends in adoption and the geography of enrollment among eligible households. But those metrics – especially a focus on enrollment rates among eligible households – are only so useful in explaining ACP sign-ups.This invites analysis that investigates the drivers of ACP enrollment in a comprehensive way, which this paper proposes to do. The paper hypothesizes that ACP enrollment decisions are not solely individual (i.e., that a household's enrollment decision is structured only by income level), but also influenced by community-wide considerations, such as housing costs, share of occupied houses, presence of anchor institutions such as public libraries, and population density (i.e., whether a place is urban or rural). The paper develops a regression model that predicts ACP enrollment rates among eligible households at the 5-digit zip code geography as a function of the variables discussed above, as well as others such as the racial and ethnic make-up of a zip code area. The analysis also controls for existing levels of broadband subscriptions and computer ownership in a given area. The difference between predicted and actual ACP enrollment rates at the 5-digit zip code level is proposed as a metric of ACP performance. These findings are supplemented with a geographically weighted regression (GWR) model that allows the relationship between each explanatory variable and ACP enrollment to vary by locality. This allows for analyzing and visualizing how these relationships vary across space.The empirical findings show that high levels of economic distress are a strong determinant of ACP enrollment in a given area, but social and community-wide indicators are important as well. The GWR results demonstrate that important differences in these relationships exist across geographies. Understanding spatial variations in ACP performance can help policymakers and other stakeholders better target resources to address the digital divide.

Latin America and cancer clinical trials: Underrepresented region with significant growth potential.

e23038 Background: Latin America (LATAM) represents 8.4% of the world's population and has a growing cancer incidence compared with other regions. However, most clinical trials are conducted in high-income countries. The clinical research regulatory regimen in LATAM has been evolving consistently in the last decade and now is stable and mature, and data quality is comparable to other geographies. Enhanced LATAM involvement in global clinical trials would help these studies to meet recruitment goals, increase diversity, and reduce costs and perhaps timelines associated with clinical research. This abstract shows the current landscape of clinical research in LATAM trough data and experience of a global clinic research organization (CRO) (Fortrea). Methods: We obtained the 2020 cancer incidence in Brazil, Mexico, Argentina, Chile, Peru, Colombia, LATAM, and worldwide, from the World Health Organization’s GLOBOCAN database, as well as the information about ongoing, terminated, or completed clinical trials in these regions using Citeline’s database, from 2018 to 2023. We gathered LATAM countries' regulatory approval timelines from Fortrea’s database. Results: Overall, 7.7% of all cancer cases in 2020 were diagnosed in LATAM; however, only 3.64% of oncology trials were conducted there. The major disparities are in prostate cancer (15.2% vs 3.9% of cases and trials, respectively), followed by thyroid (10.8% vs 3.7%), cervix uteri (9.8% vs 4.6%), leukemia (8.1% vs 3.6%), and colorectal (7% vs 2.51%). Brazil had 3.1% of all cases but 1.9% of trials, while Mexico had 1% vs 1.3%, Argentina had 0.7% and 1.3%, Chile had 0.3% vs 0.7%, Peru had 0.4% vs 0.6%, and Colombia had 0.6% and 0.45% respectively. Regarding trial phases, 0.7% of Phase I trials were run in LATAM, 2.2% of Phase II, 15.6% of Phase III, and 2.8% of Phase IV. In the Table below, we present the proportion of clinical trials in LATAM in the past 5 years, based on the actual enrollment first date. Regulatory approval timelines in LATAM vary among countries, being 4.5 months in Argentina, 4 to 7 months in Brazil, 4.6 months in Chile, 7 months in Colombia, 2.8 months in Mexico, and 9 months in Peru. Conclusions: As a region, LATAM has been underrepresented in the clinical research scenario in the past five years, including in much-needed areas like prostate, colorectal, and cervical cancer. It is better represented in phase III studies but has almost negligible participation in other trial phases. There are differences among individual countries, with Brazil being underrepresented as opposed to Argentina and Mexico. Start-up timelines are variable among countries but overall comparable to other regions. We notice a significant potential to increase the number of clinical trials in LATAM. [Table: see text]

Benchmarking Site Activation and Patient Enrollment.

Clinical trial conduct poses numerous challenges, many pertaining to patient recruitment. The primary objectives of this study were to update benchmarks on site activation and patient enrollment gathered in previous Tufts CSDD studies and examine current usage of recruitment and retention tactics. The data collection focused on site activation and patient enrollment metrics used for studies. Analyses were conducted comparing results from 2012, 2019 and 2023. The results indicate that actual enrollments exceeded planned enrollments for a majority of studies and timelines were shorter than expected. In addition, differences were found for enrollment achievement by global region and site type. Further investigation into studies conducted during a later time frame and post-pandemic could be compared with current benchmarks to examine differences.

Maternal Labour Supply and School Enrolment Laws: Empirical Evidence from Brazilian Primary School Reforms

Abstract The relationship between childcare provision and mothers’ labour supply decisions is highly debated due to the potential reverse causality and resultant empirical challenges. We contribute meaningfully to this debate by discussing the effects from a reform on Brazil’s primary education system on maternal labour supply. This reform, which advanced the compulsory children’s enrolment in primary education schools from the age of 7–6, is interpreted as the provision of free childcare. Due to the imperfect compliance of the reform implementation, children’s month of birth is used as an instrumental variable to control for the endogeneity present in any actual school enrolment. We show that the reform presented a positive effect on the labour supply of (1) the Brazilian single mothers and (2) the least educated mothers, increasing their participation in labour market by 12.9 % and furthermore a probability of becoming full time workers by 10.9 %.

Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials

ObjectiveTo describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. MethodsGynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. Results2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013–2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years – REMGs made up 19.6% of trial participants in 2007–2009 compared to 38.1% in 2016–2018 (p < 0.0001). ConclusionLess than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

Done with a degree? Immigration-specific disparities among holders of bachelor's degrees in the transition to graduate studies in Germany.

In many Western societies, immigrants make more ambitious educational choices than their native counterparts of equal academic achievement and social origin. These ambitious decisions have been mainly observed at early and middle educational stages, whereas research on choices within higher education is scarce. Against this background, we investigate whether immigrants make more ambitious decisions than natives do also after having graduated from bachelor's programs in Germany. We theoretically derive that variations in immigration-specific differences in educational choices can be expected based on social origin and country of origin, as well as between the application for and the actual enrollment in graduate studies. Using survey data on educational trajectories of bachelor's degree holders, we observe our expectations to be confirmed for the investigated sample. First, immigration-specific differences in educational choices vary by social origin and are increased for graduates from low social origins. This finding supports that immigrants strive for status maximization, an idea that we understand as a theoretical specification of the motive for status gain. Second, they vary by country of origin, which suggests cultural factors to be subordinate. Third, immigration-specific differences in applications are more pronounced than differences in actual transitions, indicating that immigrants have fewer chances of transforming their aspirations into actual transitions. We conclude by discussing these three aspects more broadly.

Evaluating Agile Neural Educational System for Effective Resource Management

The major challenge of most basic schools is inadequate educational resources despite a conscious effort to constantly provide. This is a result of inaccurate data management leading to inappropriate predictions for effective planning. The actual efficiency of a system is determined by its ability to predict real-life data with speed and accuracy. In this work, the neural educational expert system (ES) is evaluated using mathematical models for predicting the availability of resources for the growing school-aged population using a criteria-based formative evaluation to know resource life and its effect on availability. This will help in the decision to add more resources by knowing when and how the resources should be added. Technical mathematical model generation through differential equations is used to fuse the factors affecting the availability of educational resources. The real-life data is used in prediction regarding the actual enrollment of learners and the availability of resources. The model is evaluated and critically analyzed to know the degree of accuracy and the steady state. The findings revealed that the resources decay and attrite at an exponential rate in the long run and the constant number of resources provided cannot cater for the rate of decay, resulting in inadequacy. A proposed algorithm for managing the resources is presented.

Parental Factors Associated With Intentions to Initiate a Family-Based Pediatric Weight Management Program.

Background: Childhood obesity can be addressed through family-based pediatric weight management; however, treatment enrollment in the United States is low. This study aimed to identify parental factors associated with intentions to initiate a family-based pediatric weight management program. Methods: Cross-sectional survey data were collected from an online panel of US parents with at least one 5- to 11-year-old child identified as likely to have overweight or obesity. Participants viewed a video about a hypothetical family-based pediatric weight management program, rated their 30-day initiation intentions for that program, and answered additional related questionnaires. Results: Participants (n = 158) identified as White/Caucasian (53%) or Black/African American (47%), were primarily female (61.4%) and married/cohabitating (81.6%) with children who were predominantly girls (53.2%) and, on average, 9-year-olds. Higher parents' perception of program effectiveness predicted initiation intentions (p < 0.001), while concern for their child's weight and parent depression and anxiety levels did not. Higher initiation intentions and perceived program effectiveness were reported by Black/African American participants (p < 0.01) and those with at least a bachelor's degree (p < 0.01) compared to White/Caucasian participants and those without a bachelor's degree, respectively. Initiation intentions were higher for those with greater financial security (p = 0.020) and fewer than three children in the home (p = 0.026). Participants endorsed initiation barriers of time constraints (25%), possible lack of enjoyment for the child (16.9%), and lack of family support (15%). Conclusions: Future program enrollment efforts may need to focus on strategies to increase perceived program effectiveness, although further research is needed that measures actual enrollment in real-world contexts.

Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study.

Recruiting study participants for clinical research is a challenging yet essential task. Social media platforms, such as Facebook, offer the opportunity to recruit participants through paid advertisements. These ad campaigns may be a cost-effective approach to reaching and recruiting participants who meet specific study criteria. However, little is known about the extent to which clicks on social media advertisements translate to the actual consent and enrollment of participants who meet the study criteria. Understanding this is especially important for clinical trials conducted remotely, such as telehealth-based studies, which open the possibility to recruit over large geographical areas and are becoming more common for the treatment of chronic health conditions, such as osteoarthritis (OA). The aim of this study was to report on the conversion of clicks on a Facebook advertisement campaign to consent to enrollment in an ongoing telehealth physical therapy study for adults with knee OA, and the costs associated with recruitment. This was a secondary analysis using data collected over the first 5 months of an ongoing study of adults with knee OA. The Delaware Physical Exercise and Activity for Knee Osteoarthritis program compares a virtually delivered exercise program to a control group receiving web-based resources among adults with knee OA. Advertisement campaigns were configured on Facebook to reach an audience who could be potentially eligible. Clicking on the advertisement directed potential participants to a web-based screening form to answer 6 brief questions related to the study criteria. Next, a research team member called individuals who met the criteria from the screening form and verbally asked additional questions related to the study criteria. Once considered eligible, an electronic informed consent form (ICF) was sent. We described the number of potential study participants who made it through each of these steps and then calculated the cost per participant who signed the ICF. In sum, between July and November 2021, a total of 33,319 unique users saw at least one advertisement, 9879 clicks were made, 423 web-based screening forms were completed, 132 participants were successfully contacted, 70 were considered eligible, and 32 signed the ICF. Recruitment costed an average of US $51.94 per participant. While there was a low conversion from clicks to actual consent, 32% (32/100) of the total sample required for the study were expeditiously consented over 5 months with a per-subject cost well below traditional means of recruitment, which ranges from US $90 to US $1000 per participant. Clinicaltrails.gov NCT04980300; https://clinicaltrials.gov/ct2/show/NCT04980300.

Diagnostic yield of genetic screening in a diverse, community-ascertained cohort

BackgroundPopulation screening for genetic risk of adult-onset preventable conditions has been proposed as an attractive public health intervention. Screening unselected individuals can identify many individuals who will not be identified through current genetic testing guidelines.MethodsWe sought to evaluate enrollment in and diagnostic yield of population genetic screening in a resource-limited setting among a diverse population. We developed a low-cost, short-read next-generation sequencing panel of 25 genes that had 98.4% sensitivity and 99.98% specificity compared to diagnostic panels. We used email invitations to recruit a diverse cohort of patients in the University of Washington Medical Center system unselected for personal or family history of hereditary disease. Participants were sent a saliva collection kit in the mail with instructions on kit use and return. Results were returned using a secure online portal. Enrollment and diagnostic yield were assessed overall and across race and ethnicity groups.ResultsOverall, 40,857 people were invited and 2889 (7.1%) enrolled. Enrollment varied across race and ethnicity groups, with the lowest enrollment among African American individuals (3.3%) and the highest among Multiracial or Other Race individuals (13.0%). Of 2864 enrollees who received screening results, 106 actionable variants were identified in 103 individuals (3.6%). Of those who screened positive, 30.1% already knew about their results from prior genetic testing. The diagnostic yield was 74 new, actionable genetic findings (2.6%). The addition of more recently identified cancer risk genes increased the diagnostic yield of screening.ConclusionsPopulation screening can identify additional individuals that could benefit from prevention, but challenges in recruitment and sample collection will reduce actual enrollment and yield. These challenges should not be overlooked in intervention planning or in cost and benefit analysis.

Racial and ethnic disparities in the enrolment of medicare medication therapy management programs.

Racial/ethnic disparities have been found in prior literature examining enrolment in Medicare medication therapy management programs. However, those studies were based on various eligibility scenarios because enrolment data were unavailable. This study tested for potential disparities in enrolment using actual MTM enrolment data. Medicare Parts A&B claims, Medication Therapy Management Data Files, and the Area Health Resources File from 2013 to 2014 and 2016 to 2017 were analysed in this retrospective analysis. An adjusted logistic regression compared odds of enrolment between racial/ethnic minorities and non-Hispanic Whites (Whites) in the total sample and subpopulations with diabetes, hypertension, or hyperlipidaemia. Trends in disparities were analysed by including interaction terms in regressions between dummy variables for race/ethnic minority groups and period 2016-2017. Disparities in MTM enrolment were detected between Blacks and Whites with diabetes in 2013-2014 (Odds Ratio = 0.78, 95% Confidence Interval = 0.75-0.81). This disparity improved from 2013-2014 to 2016-2017 for Blacks (Odds Ratio=1.08, 95% Confidence Interval = 1.04-1.11) but persisted in 2016-2017 (Odds Ratio = 0.84, 95% Confidence Interval = 0.81-0.87). A disparity was identified between Blacks and Whites with hypertension in 2013-2014 (Odds Ratio = 0.92, 95% Confidence Interval = 0.89-0.95) but not in 2016-2017. Enrolment for all groups, however, declined between periods. For example, in the total sample, the odds of enrolment declined from 2013-2014 to 2016-2017 by 22% (Odds Ratio=0.78, 95% Confidence Interval=0.75-0.81). Racial disparities in MTM enrolment were found between Blacks and Whites among Medicare beneficiaries with diabetes in both periods and among individuals with hypertension in 2013-2014. As overall enrolment fell between periods, concerns about program enrolment remain.

Interest in using buprenorphine-naloxone among a prospective cohort of street-involved young people in Vancouver, Canada

IntroductionLimited research examines buprenorphine-naloxone interest among adolescents and young adults (AYA). This longitudinal study examined factors associated with initial buprenorphine-naloxone interest and the time to a positive change in buprenorphine-naloxone interest or enrollment, in addition to identifying reasons for buprenorphine-naloxone disinterest. MethodsThe study derived data from a cohort of street-involved AYA in Vancouver, Canada between December 2014 and June 2018. The analysis was restricted to AYA who reported weekly or daily illicit opioid use in the last six months but had not initiated buprenorphine-naloxone. The study examined factors associated with initial buprenorphine-naloxone interest using multivariable logistic regression, while multivariable Cox regression identified factors associated with the time to a positive change in buprenorphine-naloxone interest or actual enrollment over follow-up among AYA initially disinterested in buprenorphine-naloxone. ResultsOf 281 participants who reported weekly illicit opioid use but were not on buprenorphine-naloxone, 52 (18.5 %) AYA reported initial buprenorphine-naloxone interest, while 68 (24.2 %) AYA who were initially disinterested in buprenorphine-naloxone reported interest or enrollment over follow-up. In multivariable logistic regression, initial interest was positively associated with older age (Adjusted Odds Ratio [AOR] = 1.09, 95 % Confidence Interval [CI]: 1.03–1.15), but negatively associated with self-reported Indigenous identity (AOR = 0.22, 95 % CI: 0.07–0.68). In multivariable Cox regression, recent detoxification program access (Adjusted Hazard Ratio [AHR] = 0.85, 95 % CI: 0.73–0.98) was positively associated with the time to a positive change in buprenorphine-naloxone interest or enrollment. Common reasons for buprenorphine-naloxone disinterest included not wanting opioid agonist treatments (OAT) (initial n = 67, follow-up n = 105); not wanting to experience precipitated withdrawal (initial n = 42, follow-up n = 54), being satisfied with or preferring other OAT (initial n = 33, follow-up n = 52), not knowing what buprenorphine-naloxone is (initial n = 27, follow-up n = 9), previous negative treatment experiences (initial n = 19, follow-up n = 20), and wanting to continue opioid use (initial n = 13, follow-up n = 9), among others. ConclusionsWe documented persistent disinterest in buprenorphine-naloxone among AYA, though participants' reasons for disinterest provide insight into the potential benefits of expanding micro-dosing induction; ensuring treatment is culturally safe; and communicating changes in buprenorphine-naloxone programming to AYA. Nevertheless, a need remains to improve the continuum of harm reduction and treatment supports for AYA.

Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery

Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear. To examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials. This cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022. The main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls. In total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial's prespecified enrollment target. This cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.