Access to energy and women's human capital in sub-Saharan Africa.

This study examines the link between access to energy and women's human capital by focusing on women's life expectancy and school enrollment. To evaluate this relationship, we take a supranational perspective by using data from a panel of 34 sub-Saharan African countries over a 21-year period from 2000 to 2020. To do so, the ordinary least squares estimation technique applied to a fixed effects specification was adopted. It is found that for the whole sample, access to electricity has a significant positive impact on both life expectancy and school enrollment rates of women. Nevertheless, access to clean fuels and technologies for cooking significantly only impacts women's life expectancy but has no significant effect on women's school enrollment rate. Ultimately, we conclude that access to energy improves women's human capital, with a higher impact on life expectancy than on education. From a policy standpoint, action on both women's life expectancy and school enrollment should prioritize access to electricity. In order to increase women's human capital, governments must give the energy sector priority investment by setting up a grid system or promote the use of renewable energies such as micro-hydro and solar systems.

Comparative analysis of breast and lung cancer survival rates and clinical trial enrollments among rural and urban patients in Georgia.

Objectives: Rural patients have poor cancer outcomes and clinical trial (CT) enrollment compared to urban patients due to attitudinal, awareness, and healthcare access differential. Knowledge of cancer survival disparities and CT enrollment is important for designing interventions and innovative approaches to address the stated barriers. The study explores the potential disparities in cancer survival rates and clinical trial enrollments in rural and urban breast and lung cancer patients. Our hypotheses are that for both cancer types, urban cancer patients will have longer 5-year survival rates and higher enrollment rates in clinical trials than those in rural counties. Methods: We compared breast and lung cancer patients' survival rates and enrollment ratios in clinical trials between rural (RUCC 4-9) and urban counties in Georgia at a Comprehensive Cancer Center (CCC). To assess these differences, we carried out a series of independent samples t-tests and Chi-Square tests. Results: The outcomes indicate comparable 5-year survival rates across rural and urban counties for breast and lung cancer patients, failing to substantiate our hypothesis. While clinical trial enrollment rates demonstrated a significant difference between breast and lung cancer patients at CCC, no significant variation was observed based on rural or urban classification. Conclusion: These findings underscore the need for further research into the representation of rural patients with diverse cancer types at CCC and other cancer centers. Further, the findings have considerable implications for the initiation of positive social change to improve CT participation and reduce cancer survival disparities.

Health Insurance Continuity and Mortality in Children and Adolescents/Young Adults with Blood Cancer.

BACKGROUND: Many uninsured patients do not receive Medicaid coverage until a cancer diagnosis, potentially delaying access to care for early cancer detection and treatment. We examine the association of Medicaid enrollment timing and patterns with survival among children and adolescents/young adults (AYAs) diagnosed with blood cancers, where disease onset can be acute and early detection is critical. METHODS: We identified 28,750 children and AYAs (0-39 years) newly diagnosed with blood cancers from the 2006-2013 SEER-Medicaid data. Enrollment patterns included continuous Medicaid (preceding through diagnosis), newly gained Medicaid (at/shortly after diagnosis), other noncontinuous Medicaid enrollment, and private/other insurance. We assessed cumulative incidence of death from diagnosis, censoring at last follow-up, five years post-diagnosis, or December 2018, whichever occurred first. Multivariable survival models estimated the association of insurance enrollment patterns with risk of death. RESULTS: One-fourth (26.1%) of the cohort were insured by Medicaid; of these, 41.1% had continuous Medicaid, 34.9% had newly gained Medicaid, and 24.0% had other noncontinuous enrollment. The cumulative incidence of all-cause death five-year post-diagnosis was highest in patients with newly gained Medicaid (30.2%, 95%CI = 28.4-31.9%), followed by other noncontinuous enrollment (23.2%, 95%CI = 21.3-25.2%), continuous Medicaid (20.5%, 95%CI = 19.1-21.9%), and private/other insurance (11.2%; 95%CI = 10.7-11.7%). In multivariable models, newly gained Medicaid was associated with a higher risk of all-cause (hazard ratio = 1.39, 95%CI = 1.27-1.53) and cancer-specific death (hazard ratio = 1.50, 95%CI = 1.35-1.68), compared to continuous Medicaid. CONCLUSIONS: Continuous Medicaid coverage is associated with survival benefits among pediatric and AYA patients diagnosed with blood cancers; however, less than half of Medicaid-insured patients have continuous coverage before diagnosis.

Group Response-Adaptive Randomization With Delayed and Missing Responses.

Response-adaptive randomization (RAR) procedures have been extensively studied in the literature, but most of the procedures rely on updating the randomization after each response, which is impractical in many clinical trials. In this article, we propose a new family of RAR procedures that dynamically update based on the responses of a group of individuals, either when available or at fixed time intervals (weekly or biweekly). We show that the proposed design retains the essential theoretical properties of Hu and Zhang's doubly adaptive biased coin designs (DBCD), and performs well in scenarios involving delayed and randomly missing responses. Numerical studies have been conducted to demonstrate that the new proposed group doubly adaptive biased coin design has similar properties to the Hu and Zhang's DBCDs in different situations. We also apply the new design to a real clinical trial, highlighting its advantages and practicality. Our findings open the door to studying the properties of other group response adaptive designs, such as urn models, and facilitate the application of response-adaptive randomized clinical trials in practice.

Improving clinical trial enrollment in minority racial and ethnic patients with gynecologic malignancy.

Purpose: Racial and ethnic minorities remain underrepresented in clinical trials . Underrepresentation of racial groups leads to the selection of therapeutic interventions that may not be representative of the population expected to use the medicine. This study evaluates the effectiveness of a set of implementation strategies to increase underrepresented patients in gynecologic cancer clinical trials. Methods: An interrupted time series analysis evaluating implementation strategies (pre-screening and fast-track referral) was conducted from January 2021 to May 2022. Descriptive analysis of gynecologic oncology patient screening and accrual was compared before and after intervention implementation. Results: During the study period (pre- and post-intervention), 26 patients were screened, and 9 patients enrolled in therapeutic gynecologic cancer clinical trials. Prior to the intervention, 7 patients were screened and 2 patients enrolled onto a clinical trial. Following the intervention, 19 patients were screened and 7 patients enrolled in a cancer clinical trial. Black patients comprised 13 of 19 (68.4%) of patients post-intervention compared to 1 of 7 (14.3 %) of patients screened pre-intervention (p < 0.05). All 7 patients enrolled post intervention were racial and ethnic minorities (non-Hispanic Black [4 of 7] and Hispanic White [3 of 7]) compared to no minority patients enrolled pre-intervention (p < 0.05). Screening increased 2.5-fold for all patients, and 5- fold for minority patients. Clinical trial enrollment increased 3.5-fold following intervention. Conclusions: A combination of pre-screening and fast-track referral intervention in a racial and ethnically diverse urban academic hospital was associated with a significant increase in minority screening and enrollment. Structured strategies to overcome barriers to underrepresented racial and ethnic patient accrual in academic hospitals are urgently warranted.

Why Do People Choose to Enroll or Not Enroll in the National Diabetes Prevention Program Lifestyle Change Program? A Mixed-Methods Analysis From a Sample of Adults With a Prediabetes Diagnosis.

INTRODUCTION: The Diabetes Prevention Program (DPP) is effective; enrollment is low. Little research has examined factors driving individuals' enrollment decisions. METHODS: In our final survey of a randomized trial comparing methods to increase enrollment in the DPP, we asked participants about factors impacting enrollment. We conducted interviews with a subgroup. RESULTS: Participants who completed the survey (n = 299) were primarily female (96 male); middle-aged (mean 52.9, SD = 14.7); white (86%); non-Hispanic (85%). Only 19% reported awareness of the DPP prior to the study. Cost, online availability, and behavior-change motivation were the most highly rated factors influencing enrollment. The median amount participants were willing to pay for the program was $66.50. Phone interviews included 17 individuals who were/were not interested in receiving a referral to the DPP. Those interested described risk awareness, family history, social support, and healthcare-provider influence as facilitating enrollment. Cost, time, travel, unsupportive family, incomplete knowledge about the program's impact and low self-efficacy were barriers. Among those uninterested, some were already engaging in lifestyle change, and some didn't see a benefit. CONCLUSIONS: Results suggest that, even among high-risk individuals, efforts to increase awareness and benefits of the DPP are needed, as are efforts to address cost of enrollment and low motivation. TRIAL REGISTRATION: ClinicalTrials.gov protocol ID: 00132307. The Effect of 360 Video and MAPS on Enrollment in the DPP. URL: https://www.clinicaltrials.gov/study/NCT04746781?id=00132307&rank=1.

Enrollment strategies in the era of digital revolution: Experience from a remote health management program.

We share our experience on the strategies implemented for identifying and enrolling participants in a randomized remote implementation trial. We aimed to evaluate the effectiveness of various digital and traditional screening and outreach methods in participant enrollment. This study focuses on understanding the success and challenges associated with different approaches to patient engagement.

The PATCH trial: 5% lidocaine-medicated plaster for trigeminal neuralgia-Results of a multicentric, enriched enrollment, randomized withdrawal, double-blind, vehicle-controlled, parallel-group study.

OBJECTIVE: To explore the efficacy and safety of 5% lidocaine-medicated plaster (LMP) in patients with trigeminal neuralgia (TN). BACKGROUND: TN is an excruciatingly painful type of neuropathic facial pain. Anti-epileptics are the first-line treatment for TN; however, these oral drugs alone sometimes fail to achieve satisfactory analgesic effects. Two retrospective studies have shown that LMP can be an effective and safe treatment option for some patients with TN. No other high-quality clinical studies have explored the effect and safety of LMP in patients with TN. METHODS: The PATCH trial is an enriched enrollment with randomized withdrawal, double-blind, vehicle-controlled, parallel-group trial performed at five study centers. Eligible patients with TN received LMP during a 3-week initial open-label phase. Patients who met the response criteria entered the double-blind treatment phase and were randomly assigned for treatment with either LMP (LMP group) or vehicle patches (control group) at a 1:1 ratio. Patients who met the criteria for treatment failure were withdrawn from the double-blind treatment phase, and treatment was continued in the remaining patients for up to 28 days. The primary outcome was the number of treatment failures. The secondary endpoints were the time to loss of therapeutic response (LTR) in the double-blind phase and the weekly mean pain severity in both the open-label phase and the double-blind phase of the study. RESULTS: The first patient was enrolled in this study on May 1, 2021, and the enrollment of the last patient was completed on August 26, 2022. A total of 307 patients were initially screened, 226 (74.0%) of whom entered the open-label phase. Of the 226 respondents, 124 (55.0%) were randomized to the double-blind phase. In the double-blind phase, 62 patients were assigned to the LMP group, and 62 were assigned to the control group. For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria during the double-blind phase (relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75; p < 0.001). The survival curve of the LTR showed that the LTR of LMP was significantly longer than that of the vehicle patches (hazard ratio, 0.275; 95% CI, 0.15 to 0.50; log-rank p < 0.001). LMP also significantly reduced the weekly mean pain severity in the double-blind phase of the study (p = 0.007). CONCLUSIONS: LMP produced partial relief of pain symptoms in some patients with TN. For responders, LMP may be used as an add-on therapy in a multidrug treatment protocol.

Student motivation to study music and sport - a comparison between study subjects and study programs on intrinsic and extrinsic motivational aspects.

Instruction: In both subjects, music and sport, the engagement with the subject content - learning an instrument or training in a sports club - usually begins in early childhood. This makes these subjects special and similar. It is therefore of interest to examine the motivation for choosing music and sport as subjects for university study. Methods: In the present investigation, 151 students at the beginning of their university studies were examined. Among these were 110 music university students in the Bachelor of Music (B.Mus.) and music teacher education program, and 41 sport university students in the Bachelor of Science (B.Sc.) and sport teacher education program. The study contained a custom-made questionnaire on sociodemographic data, questions on study choice alternatives and biographical musical or sporting background, as well as two standardized questionnaires on motivation for enrollment (STUWA) and on aspects that are important for the profession. Results: Music and sport students were at a rather high and similar level of intrinsic motivation to study their subjects. However, materialistic goals motivated the teacher education students more than the bachelor's students with an artistic program. The difference between the study programs was also found in the context of extrinsic-social motivation, where the teacher training students answered with higher scores. With regard to socially-induced motivation, it was shown that music students and sport teacher education students were more socially induced to study the respective subject compared to the general student population. With regard to uncertainty when choosing a course, it was found that Bachelor of Music students were more certain that they wanted to study exactly their particular subject. The ages at which music and sport were started in childhood were similar, but the first-year music students were younger than the sport students were. Compared to sports students, music students decided their area of study earlier, and bachelor's students in music in particular had fewer alternative study options than sports students. Discussion: The results provide a differentiated picture of student motivation to study and thus allow a deeper insight into the subject cultures of music and sport. They also open up opportunities for follow-up studies in comparison with other study subjects and programs.

Recruitment in Appalachian, Rural and Older Adult Populations in an Artificial Intelligence World: Study Using Human-Mediated Follow-Up.

BACKGROUND: Participant recruitment in rural and hard-to-reach (HTR) populations can present unique challenges. These challenges are further exacerbated by the need for low-cost recruiting, which often leads to use of web-based recruitment methods (eg, email, social media). Despite these challenges, recruitment strategy statistics that support effective enrollment strategies for underserved and HTR populations are underreported. This study highlights how a recruitment strategy that uses email in combination with follow-up, mostly phone calls and email reminders, produced a higher-than-expected enrollment rate that includes a diversity of participants from rural, Appalachian populations in older age brackets and reports recruitment and demographic statistics within a subset of HTR populations. OBJECTIVE: This study aims to provide evidence that a recruitment strategy that uses a combination of email, telephonic, and follow-up recruitment strategies increases recruitment rates in various HTR populations, specifically in rural, older, and Appalachian populations. METHODS: We evaluated the overall enrollment rate of 1 recruitment arm of a larger study that aims to understand the relationship between genetics and substance use disorders. We evaluated the enrolled population's characteristics to determine recruitment success of a combined email and follow-up recruitment strategy, and the enrollment rate of HTR populations. These characteristics included (1) enrollment rate before versus after follow-up; (2) zip code and county of enrollee to determine rural or urban and Appalachian status; (3) age to verify recruitment in all eligible age brackets; and (4) sex distribution among age brackets and rural or urban status. RESULTS: The email and follow-up arm of the study had a 17.4% enrollment rate. Of the enrolled participants, 76.3% (4602/6030) lived in rural counties and 23.7% (1428/6030) lived in urban counties in Pennsylvania. In addition, of patients enrolled, 98.7% (5956/6030) were from Appalachian counties and 1.3% (76/6030) were from non-Appalachian counties. Patients from rural Appalachia made up 76.2% (4603/6030) of the total rural population. Enrolled patients represented all eligible age brackets from ages 20 to 75 years, with the 60-70 years age bracket having the most enrollees. Females made up 72.5% (4371/6030) of the enrolled population and males made up 27.5% (1659/6030) of the population. CONCLUSIONS: Results indicate that a web-based recruitment method with participant follow-up, such as a phone call and email follow-up, increases enrollment numbers more than web-based methods alone for rural, Appalachian, and older populations. Adding a humanizing component, such as a live person phone call, may be a key element needed to establish trust and encourage patients from underserved and rural areas to enroll in studies via web-based recruitment methods. Supporting statistics on this recruitment strategy should help researchers identify whether this strategy may be useful in future studies and HTR populations.

Acceptance of Social Media Recruitment for Clinical Studies Among Patients With Hepatitis B: Mixed Methods Study.

BACKGROUND: Social media platforms are increasingly used to recruit patients for clinical studies. Yet, patients' attitudes regarding social media recruitment are underexplored. OBJECTIVE: This mixed methods study aims to assess predictors of the acceptance of social media recruitment among patients with hepatitis B, a patient population that is considered particularly vulnerable in this context. METHODS: Using a mixed methods approach, the hypotheses for our survey were developed based on a qualitative interview study with 6 patients with hepatitis B and 30 multidisciplinary experts. Thematic analysis was applied to qualitative interview analysis. For the cross-sectional survey, we additionally recruited 195 patients with hepatitis B from 3 clinical centers in Germany. Adult patients capable of judgment with a hepatitis B diagnosis who understood German and visited 1 of the 3 study centers during the data collection period were eligible to participate. Data analysis was conducted using SPSS (version 28; IBM Corp), including descriptive statistics and regression analysis. RESULTS: On the basis of the qualitative interview analysis, we hypothesized that 6 factors were associated with acceptance of social media recruitment: using social media in the context of hepatitis B (hypothesis 1), digital literacy (hypothesis 2), interest in clinical studies (hypothesis 3), trust in nonmedical (hypothesis 4a) and medical (hypothesis 4b) information sources, perceiving the hepatitis B diagnosis as a secret (hypothesis 5a), attitudes toward data privacy in the social media context (hypothesis 5b), and perceived stigma (hypothesis 6). Regression analysis revealed that the higher the social media use for hepatitis B (hypothesis 1), the higher the interest in clinical studies (hypothesis 3), the more trust in nonmedical information sources (hypothesis 4a), and the less secrecy around a hepatitis B diagnosis (hypothesis 5a), the higher the acceptance of social media as a recruitment tool for clinical hepatitis B studies. CONCLUSIONS: This mixed methods study provides the first quantitative insights into social media acceptance for clinical study recruitment among patients with hepatitis B. The study was limited to patients with hepatitis B in Germany but sets out to be a reference point for future studies assessing the attitudes toward and acceptance of social media recruitment for clinical studies. Such empirical inquiries can facilitate the work of researchers designing clinical studies as well as ethics review boards in balancing the risks and benefits of social media recruitment in a context-specific manner.

Modifying Pharmacy Enrollments by Employment Realities.

Objective: The objective of this commentary is to consider the fluctuations in pharmacy school enrollments and to review some of the strategies employed in other health care professions, as well as to consider policies that might lead to a closer balance between admissions to PharmD programs and employment opportunities. This balance provides job stability, decreased underemployment, and greater attractiveness to study pharmacy. Discussion: Pharmacy school entry requirements have been relaxed to enroll as many students as possible due to current declining applicant numbers. As a result, there are more pharmacist graduates than there are available jobs each year. As a result, the job outlook for pharmacists may go down in the future unless action is taken. Stricter entry requirements could help produce a higher quality pharmacy workforce in the future and relieve this disparity. Summary: Pharmacy schools try to accommodate as many students as possible, which can create a job disparity between the number of available jobs and pharmacists seeking work. Suggestions can include stricter entry requirements, certificate of need programs, required fellowships and other means to balance this misalignment.

Advancing high quality longitudinal data collection: Implications for the HEALthy Brain and Child Development (HBCD) Study design and recruitment.

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD Study aims to reflect the sociodemographic diversity of pregnant individuals in the U.S. The study will also oversample individuals who use substances during pregnancy and enroll similar individuals who do not use to allow for generalizable inferences of the impact of prenatal substance use on trajectories of child development. Without probability sampling or a randomization-based design, the study requires innovation during enrollment, close monitoring of group differences, and rigorous evaluation of external and internal validity across the enrollment period. In this article, we discuss the HBCD Study recruitment and enrollment data collection processes and potential analytic strategies to account for sources of heterogeneity and potential bias. First, we introduce the adaptive design and enrollment monitoring indices to assess and enhance external and internal validity. Second, we describe the visit schedule for in-person and remote data collection where dyads are randomly assigned to visit windows based on a jittered design to optimize longitudinal trajectory estimation. Lastly, we provide an overview of analytic procedures planned for estimating trajectories.

Impact of recruitment strategies on individual participation practices in the Canadian National Vaccine Safety Network: prospective cohort study.

Background: The Canadian National Vaccine Safety (CANVAS) network conducted a multi-center, prospective vaccine safety study to collect safety data after dose 1 and 2 of COVID-19 vaccines and follow up safety information 7 months after dose 1. Objective: This study aimed to describe and evaluate the recruitment methods used by CANVAS and the retention of participants by each modality. Methods: CANVAS deployed a multi-pronged recruitment approach to reach a larger sample, without in-person recruitment. Three primary recruitment strategies were used: passive recruitment, technology-assisted electronic invitation through the vaccine booking system (auto-invitation), or auto-registration through the vaccine registries (auto-enrollment). Results: Between December 2020 and April 2022, approximately 1.3 million vaccinated adults either self-enrolled or were auto-enrolled in CANVAS, representing about 5% of the vaccinated adult Canadian population. Approximately 1 million participants were auto-enrolled, 300,000 were recruited by auto-invitation, and 5,000 via passive recruitment. Overall survey completion rates for dose 1, dose 2 and the 7-month follow-up surveys were 51.7% (681,198 of 1,318,838), 54.3% (369,552 of 681,198), and 66.4% (452,076 of 681,198), respectively. Completion rates were lower among auto-enrolled participants compared to passively recruited or auto-invited participants who self-enrolled. However, auto-enrolled samples were much larger, which offset the lower completion rates. Conclusion: Our data suggest that auto-enrollment provided an opportunity to reach and retain a larger number of individuals in the study compared to other recruitment modalities.

Evaluating enrollment and representation in COVID-19 and HIV vaccine clinical trials.

Background: Vaccine clinical trials should strive to recruit a racially, socioeconomically, and ethnically diverse range of participants to ensure appropriate representation that matches population characteristics. Yet, full inclusion in research is often limited. Methods: A single-center retrospective study was conducted of adults enrolled at Brigham and Women's Hospital (Boston, MA) between July 2020 and December 2021. Demographic characteristics, including age, race, ethnicity, ZIP code, and sex assigned at birth, were analyzed from both HIV and COVID-19 vaccine trials during the study period, acknowledging the limitations to representation under these parameters. We compared the educational attainment of vaccine trial participants to residents of the Massachusetts metropolitan area, geocoded participants' addresses to their census block group, and linked them to reported median household income levels from publicly available data for 2020. Frequency and quartile analyses were carried out, and spatial analyses were performed using ArcGIS Online web-based mapping software (Esri). Results: A total of 1030 participants from four COVID-19 vaccine trials (n = 916 participants) and six HIV vaccine trials (n = 114 participants) were included in the analysis. The median age was 49 years (IQR 33-63) and 28 years (IQR 24-34) for the COVID-19 and HIV vaccine trials, respectively. Participants identifying as White were the majority group represented for both the COVID-19 (n = 598, 65.3%) and HIV vaccine trials (n = 83, 72.8%). Fewer than 25% of participants identified as Hispanic or Latin. Based on ZIP code of residence, the median household income for COVID-19 vaccine clinical trial participants (n = 846) was 102,088 USD (IQR = 81,442-126,094). For HIV vaccine clinical trial participants (n = 109), the median household income was 101,266 USD (IQR 75,052-108,832). Conclusion: We described the characteristics of participants enrolled for HIV and COVID-19 vaccine trials at a single center and found similitude in geographical distribution, median incomes, and proportion of underrepresented individuals between the two types of vaccine candidate trials. Further outreach efforts are needed to ensure the inclusion of individuals from lower educational and socioeconomic brackets. In addition, continued and sustained efforts are necessary to ensure inclusion of individuals from diverse racial and ethnic backgrounds.

Dual-agent dose-finding in Phase I clinical trial-An extension of rapid enrollment design.

Dual-agent treatment has become more and more popular in clinical trials. We have developed an approach called rapid enrollment dual-agent design (REDD) for dose-finding in Phase I clinical trials. This approach aims to administer treatment to patients using a dose combination that is highly probable to be the target dose combination. Unlike other non-model-based designs, rapid enrollment designs (RED and REDD) do not require waiting for all patients to complete an assessment before the assignment of the next participant. Simulations showed that across several scenarios, the average performance of REDD is comparable to that of the Bayesian optimal interval (BOIN) design and the partial order continual reassessment method (POCRM). The simulation results of REDD for late-onset toxicity assessments demonstrated that assigning patients to a dose combination as they are being enrolled, without waiting for the most recent cohort of patients to complete their follow-up, does not significantly compromise the quality of the maximum tolerated dose (MTD) estimation. Instead, it saves a considerable amount of time in clinical trial enrollment. User-friendly online applications have also been created to further facilitate the adoption of rapid enrollment designs in Phase I trials. In summary, being similar to BOIN and POCRM in performance, REDD is an approach that is easily comprehensible, straightforward to implement and offers an advantage of enrolling patients without having to wait for all current patients to complete their follow-ups for toxicity.

Targeting Community-Based Palliative and Serious Illness Care Resources: Challenges of More Stringent Diagnostic Criteria for Prospective Enrollment.

Background: For patients with serious illnesses, one aim of palliative care services is to reduce the frequency and severity of hospital-based episodes of care. Since hospital-alternative palliative care may consume costly resources, providers need to efficiently target high-intensity services toward those most at risk for such adverse episodes of care. Objective: Our objective was to investigate progressively more restrictive diagnosis-based indications of serious illness as used to prospectively identify patients with higher average rates of hospitalization. Design/Setting: We designed an observational cohort quality improvement study using historical Medicare claims records to evaluate diagnostic inclusion criteria for targeting palliative and serious illness care resources. We first isolated a Seriously Ill Population (SIP) and then defined More SIP and Most SIP subgroups. Measurements: Our primary outcome measure was the 2019 acute-care count of hospitalizations for patients in the SIP, More SIP, and Most SIP subgroups, respectively. Results: The More SIP and Most SIP subgroups exhibited higher hospitalization rates. However, they also excluded progressively more seriously ill patients who did experience hospitalizations. In addition, almost half of the Most SIP subgroup were not hospitalized at all, despite having an average hospitalization rate greater than one. Conclusion:Allocating resources (personnel and services) toward reducing hospitalizations when almost half of the targeted population never goes to the hospital could result in unnecessary expenditures and exclude patients that could potentially benefit. Engaging community-based services to detect changes in status could provide supplemental indications of when and for whom to target palliative care resources.

Up-front matching: an ongoing recruitment method for prospective observational studies that mimics randomization for selected baseline covariates.

In a prospective observational study (POS) designed to assess the average causal effect of a treatment (e.g. Drug A) compared to a comparator (e.g. Drug B) in the treatment population, enrolling all patients who are assigned to the treatments of interest for follow-up has a potentially large negative impact on the statistical efficiency and bias of the analysis of the outcomes and on the cost of the study. "Up-front matching" is an innovative enrollment method for selecting patients for long-term follow-up among those who have already been assigned to treatment or comparator which uses frequency matching and hence avoids the restrictions of individual matching that other methods have used. To achieve potential statistical and logistical efficiencies in the POS, in up-front matching, a target population is defined based on a retrospective database which then enables selecting populations of patients for follow-up that have desirable statistical properties. In particular, the resulting populations of patients who are enrolled look like the population of treatment patients were randomized to treatment or comparator for the baseline covariates that are used to select patients for follow-up. The method is illustrated in detail for a study designed to assess the effect of injectable antipsychotics versus oral antipsychotics.