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Background Research has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment. Methods Eight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs. Results The eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR – Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received. Conclusions The SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work to test it more widely is recommended.

Background Age as an eligibility criterion for V-V ECMO is widely debated and varies among healthcare institutions. We examined how age relates to mortality in patients undergoing V-V ECMO for ARDS. Methods Systematic review and meta-regression of clinical studies published between 2015 and June 2024. Studies involving at least 6 ARDS patients treated with V-V ECMO, with specific data on ICU and/or hospital mortality and patient age were included. The search strategy was executed in PubMed, limited to English-language. COVID-19 and non-COVID-19 populations were analyzed separately. Meta-regressions of mortality outcomes on age were performed using gender, BMI, SAPS II, APACHE II, Charlson comorbidity index or SOFA as covariates. Results In non-COVID ARDS, the meta-regression of 173 studies with 56,257 participants showed a significant positive association between mean age and ICU/hospital mortality. In COVID-19 ARDS, a significant relationship between mean age and ICU mortality, but not hospital mortality, was found in 103 studies with 21,255 participants. Sensitivity analyses confirmed these findings, highlighting a linear relationship between age and mortality in both groups. For each additional year of mean age, ICU mortality increased by 1.2% in non-COVID ARDS and 1.9% in COVID ARDS. Conclusions The relationship between age and ICU mortality is linear and shows no inflection point. Consequently, no age cut-off can be recommended for determining patient eligibility for V-V ECMO.

Background The utility of patient screening logs and their impact on improving trial recruitment rates are unclear. We conducted a retrospective exploratory analysis of screening data collected within a multicentre randomised controlled trial investigating chemotherapy for upper tract urothelial carcinoma. Methods Participating centres maintained a record of patients meeting basic screening criteria stipulated in the trial protocol, submitting logs regularly to the clinical trial coordinating centre (CTC). Sites recorded the number of patients ineligible, not approached, declined and randomised. The CTC monitored proportions of eligible patients, approach rate (proportion of eligible patients approached) and acceptance rate (proportion recruited of those approached). Data were retrospectively analysed to identify patterns of screening activity and correlation with recruitment. Results Data were collected between May 2012 and August 2016, during which time 71 sites were activated—a recruitment period of 2768 centre months. A total of 1138 patients were reported on screening logs, with 2300 requests for logs sent by the CTC and 47% of expected logs received. A total of 758 patients were reported as ineligible, 36 eligible patients were not approached and 207 declined trial participation. The approach rate was 91% (344/380), and the acceptance rate was 40% (137/344); these rates remained consistent throughout the data collection. The main reason patients provided for declining (99/207, 48%) was not wanting to receive chemotherapy. There was a moderately strong correlation ( r  = 0.47) between the number reported on screening logs and the number recruited per site. Considerable variation in data between centres was observed, and 54/191 trial participants (28%) enrolled during this period were not reported on logs. Conclusions Central collection of screening logs can identify reasons for patients declining trial participation and help monitor trial activity at sites; however, obtaining complete data can be challenging. There was a correlation between the number of patients reported on logs and recruitment; however, this was likely confounded by sites’ available patient population. The use of screening logs may not be appropriate for all trials, and their use should be carefully considered in relation to the associated workload. No evidence was found that central collection of screening logs improved recruitment rates in this study, and their continued use warrants further investigation. Trial registration ISRCTN98387754 . Registered on 31 January 2012

Hypertrophic cardiomyopathy (HCM) is a primary myocardial disorder which frequently leads to symptoms such as dyspnea and exercise intolerance, often due to severe dynamic left ventricular outflow tract obstruction (LVOTO). Current guideline-recommended pharmacotherapies have variable therapeutic responses to relieve LVOTO. In recent phases 2 and 3, clinical trials for symptomatic obstructive HCM (oHCM), mavacamten, a small molecule inhibitor of β-cardiac myosin has been shown to improve symptoms, exercise capacity, health status, reduce LVOTO, along with having a beneficial impact on cardiac structure and function. VALOR-HCM is designed as a multicenter (approximately 20 centers in United States) phase 3, double-blind, placebo-controlled, randomized study. The study population consists of approximately 100 patients (≥18 years old) with symptomatic oHCM who meet 2011 American College of Cardiology/American Heart Association and/or 2014 European Society of Cardiology HCM-guideline criteria and are eligible and willing to undergo septal reduction therapy (SRT). The study duration will be up to 138 weeks, including an initial 2-week screening period, followed by16 weeks of placebo-controlled treatment, 16 weeks of active blinded treatment, 96 weeks of long-term extension, and an 8-week posttreatment follow-up visit. The primary endpoint will be a composite of the decision to proceed with SRT prior to or at Week 16 or remain guideline eligible for SRT at Week 16. Secondary efficacy endpoints will include change (from baseline to Week 16 in the mavacamten group vs placebo) in postexercise LVOT gradient, New York Heart Association class, Kansas City Cardiomyopathy Questionnaire clinical summary score, NT-proBNP, and cardiac troponin. Exploratory endpoints aim to characterize the effect of mavacamten on multiple aspects of oHCM pathophysiology. In severely symptomatic drug-refractory oHCM patients meeting guideline criteria of eligibility for SRT, VALOR-HCM will primarily study if a 16-week course of mavacamten reduces or obviates the need for SRT using clinically driven endpoints.

Management guidelines assume that results from clinical trials can be generalised, although seldom is data available to test this assumption. We aimed to determine the proportion of patients commencing tumour necrosis factor inhibition (TNFi) who would have been eligible for relevant clinical trials, and whether treatment response differs between these groups and the trials themselves. The British Society for Rheumatology Biologics Register for Ankylosing Spondylitis (BSRBR-AS) recruited a real-world cohort of TNFi-naïve spondyloarthritis patients with data collection from clinical records and patient questionnaires. Participant characteristics were extracted from trials identified from a recent Health Technology Assessment of TNFi for ankylosing spondylitis/non-radiographic axial spondyloarthritis. Descriptive statistics were used to determine the differences, including treatment response, between BSRBR-AS participants who would/would not have been eligible for the clinical trials and with trial participants. Among 2420 BSRBR-AS participants, those commencing TNFi (34%) had shorter symptom duration (15 vs 22 years) but more active disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 6.4 vs 4.0; Bath Ankylosing Spondylitis Disease Functional Index (BASFI) 6.2 vs 3.8). Of those commencing TNFi, 41% met eligibility criteria for ≥1 of fourteen relevant trials; they reported higher disease activity (BASDAI 6.9 vs 6.1) and poorer function (BASFI 6.6 vs 6.0). 61.7% of trial participants reported a positive treatment response, vs 51.3% of BSRBR-AS patients (difference: 10.4%; 95% CI 4.4% to 16.5%). Potential eligibility for trials did not influence treatment response (difference 2.0%; -9.4% to 13.4%). Fewer patients in the real world respond to TNFi than is reported in the trial literature. This has important implications for the generalisability of trial results, and the cost-effectiveness of TNFi agents.

Objectives. To assess the impact of the expansion of Medicaid eligibility in the United States on the opioid epidemic, as measured through increased access to opioid analgesic medications and medication-assisted treatment. Methods. Using Medicaid enrollment and reimbursement data from 2011 to 2016 in all states, we evaluated prescribing patterns of opioids and the 3 Food and Drug Administration–approved medications used in treating opioid use disorders by using 2 statistical models. We used difference-in-differences and interrupted time series models to measure prescribing rates before and after state expansions. Results. Although opioid prescribing per Medicaid enrollee increased overall, we observed no statistical difference between expansion and nonexpansion states. By contrast, per-enrollee rates of buprenorphine and naltrexone prescribing increased more than 200% after states expanded eligibility, while increasing by less than 50% in states that did not expand. Methadone prescribing decreased in all states in this period, with larger decreases in expansion states. Conclusions. The Medicaid expansion enrolled a population no more likely to be prescribed opioids than the base Medicaid population while significantly increasing uptake of 2 drugs used in medication-assisted treatment.

Data integrity has long been a challenge in decentralized trials compared to traditional site‐based trials. One key area impacted by these challenges is eligibility assessment, which is critical in clinical trials but often limited in depth during remote screening procedures. Integrating personal health records may help address this issue. This randomized, open‐label, single‐center, fully remote study evaluated the feasibility of using personal health records for eligibility assessment in 20 healthy Korean adults. During initial screening interviews, most participants reported being healthy with no significant medical history or prior medication use. However, after reviewing their personal health records, including their past 2‐year health check‐ups and recent 3‐month prescription records, medical histories were revealed for 9 participants (45.0%, 17 cases), and 10 (50.0%, 68 cases) showed prior medication use. These findings suggest that personal health record‐based interviews could substantially improve data integrity in eligibility assessments. In addition, the study incorporated various decentralized elements, such as electronic consent acquisition, self‐recorded diary submission, smartwatch‐based AI system for drug administration monitoring, and digital reporting of adverse events and concomitant medications. While compliance was generally adequate and participants reported high satisfaction, some experienced challenges retrieving personal health records and using the smartwatch, highlighting digital accessibility as a barrier in decentralized trials. Receiving and returning research materials through the parcel and blood sampling process at local hospitals also received high ratings, but this high score reflects Korea's unique infrastructure, including extensive delivery systems and accessible local hospitals. Trial Registration KCT0009827.

Care Integration for Dually Eligible BeneficiariesPeople who are dually enrolled in Medicare and Medicaid face issues related to fragmented care and poor health outcomes associated with inadequate coordination of benefits and services.

ABSTRACT Objectives: to analyze the factors related to eligibility and discontinuation of prenatal care in a freestanding birth center (FBC). Methods: a cross-sectional study, conducted at the Casa Angela FBC, SP, Brazil, involving 9,954 women registered between 2020-2022. Descriptive analysis was performed, including odds ratios. Results: 43.6% were eligible for prenatal care and 62.9% had their care discontinued. A higher level of education, higher income, Asian/Indigenous ethnicity, and living with a partner increased the chance of eligibility; older maternal age, a higher number of pregnancies, brown/black skin, and private health insurance decreased this chance. Brown/black skin and Indigenous ethnicity increased the chance of prenatal care discontinuation; older maternal age, a higher number of pregnancies, higher education, higher income, Asian ethnicity, living with a partner, and private health insurance decreased this chance. Conclusions: sociodemographic factors and clinical and obstetric history influence both the ineligibility and discontinuation of prenatal care in CPN. RESUMEN Objetivos: analizar los factores relacionados con la elegibilidad e interrupción del seguimiento prenatal en un centro de parto normal peri-hospitalario (CPNp). Métodos: estudio transversal realizado en el CPNp Casa Angela, SP, Brasil, con 9.954 mujeres registradas entre 2020-2022. Se realizaron análisis descriptivo y cálculo de la razón de probabilidades. Resultados: el 43,6% eran elegibles para el cuidado prenatal y el 62,9% tuvieron una interrupción del seguimiento. Mayor nivel educativo, ingresos elevados, etnia asiática/indígena y vivir con pareja aumentaron la probabilidad de elegibilidad; mayor edad, número de embarazos, color de piel parda/negra y seguro de salud disminuyeron esta probabilidad. Color de piel parda/negra y etnia indígena aumentaron la probabilidad de interrupción del cuidado prenatal; mayor edad, número de embarazos, mayor nivel educativo, ingresos elevados, etnia asiática, vivir con pareja y seguro de salud disminuyeron esta probabilidad. Conclusiones: factores sociodemográficos e historial clínico y obstétrico influyen en la inelegibilidad y en la interrupción del seguimiento prenatal en CPNp. RESUMO Objetivos: analisar os fatores relacionados à elegibilidade e interrupção do acompanhamento pré-natal em um centro de parto normal peri-hospitalar (CPNp). Métodos: estudo transversal, realizado no CPNp Casa Angela, São Paulo, SP, com 9.954 mulheres cadastradas entre 2020-2022. Realizada análise descritiva, com cálculo da razão de chances. Resultados: 43,6% das mulheres eram elegíveis para o pré-natal e 62,9% tiveram interrupção do acompanhamento. Maior escolaridade, renda elevada, etnia asiática/indígena e residir com companheiro(a) aumentaram a chance de elegibilidade; maior idade materna, número de gestações, cor da pele parda/preta e convênio de saúde diminuíram essa chance. Cor da pele parda/preta e etnia indígena aumentaram a chance de interrupção do pré-natal; maior idade materna, número de gestações, maior escolaridade, renda elevada, etnia asiática, residir com companheiro(a) e convênio de saúde diminuíram essa chance. Conclusões: fatores sociodemográficos e história clínica e obstétrica influenciam a inelegibilidade e interrupção do acompanhamento pré-natal em CPNp.

The recent coronavirus disease 2019 (COVID-19) global pandemic has resulted in unprecedented job losses in the United States, disrupting health insurance coverage for millions of people. Several models have predicted large increases in Medicaid enrollment among those who have lost jobs, yet the number of Americans who have gained coverage since the pandemic began is unknown. We compiled Medicaid enrollment reports covering the period from March 1 through June 1, 2020, for twenty-six states. We found that in these twenty-six states, Medicaid covered more than 1.7 million additional Americans in roughly a three-month period. Relative changes in Medicaid enrollment differed significantly across states, although enrollment growth was not systemically related to job losses. Our results point to the important effects of state policy differences in the response to COVID-19.