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Background An important obstacle when undertaking clinical research in children is the consent procedure. Understanding the factors influencing this process is vital in improving children's involvement in clinical research. Objective To report the rates and causes for recruitment refusal into two studies of childhood pneumonia and empyema and investigate the underlying factors contributing to refusal. Methods Two paediatric respiratory studies investigating childhood pneumonia and empyema and requiring informed consent were carried out at the same site. During the period from April 2010 to March 2011, the number of eligible children who gave or refused consent for each study was documented. Each research team included a paediatric research nurse and paediatric research registrar (doctor). Information was collected prospectively on each consent refusal. Rates of refusal by role of person taking consent, severity of illness and reason for refusal were then analysed. Results A total of 116 children were eligible for enrolment into pneumonia study and 28 into empyema study, giving 144 consent procedures. Ten (7%) parents refused the consent. The rate of refusal did not differ between medical and nursing staff. Eighty percent of the children who were not enrolled had severe disease. Refusals were linked with not wanting the child to undergo further investigations, research delaying discharge, and anxiety regarding written consent and length of information sheets. Conclusion Consent refusal was not related to the role of the person seeking consent. Severity of child's illness appears to determine parent's decision regarding participation in clinical research.

In the Affordable Care Act (ACA) Marketplaces, enrollees must periodically demonstrate their eligibility to receive income-linked health insurance premium subsidies. Marketplaces can verify eligibility using existing records, but only with consumers' consent, which must be renewed at specified times. In a randomized experiment in September 2020, we tested the effect of email nudges reminding consumers to provide consent for verification of their continued eligibility for premium subsidies in California's ACA Marketplace. More than 20,000 households that had applied for subsidies but whose consent for eligibility verification would soon expire were sent one, two, or three emails reminding them to renew consent. Sending three emails increased consent updates by 1.9 percentage points (3.2 percent) and increased receipt of subsidies by 2.0 percentage points (4.0 percent). However, nearly 40 percent of households receiving three emails did not update their consent by the end of the open enrollment period, thus preventing their continued receipt of subsidies. To improve the affordability of Marketplace coverage, new policies and structural changes may be needed to reduce administrative barriers that can inhibit access to subsidies.

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.

Policy makers are increasingly investing in efforts to better integrate Medicare and Medicaid services for people who are eligible for both programs, including expanding Dual-Eligible special Needs Plans (DsNPs). In recent years, however, a potential threat to integration has emerged in the form of D-SNP \"look-alike\" plans, which are conventional Medicare Advantage plans that are marketed toward and primarily enroll dual eligibles but are not subject to federal regulations requiring integrated Medicaid services. To date, limited evidence exists documenting national enrollment trends in look-alike plans or the characteristics of dual eligibles in these plans. We found that look-alike plans experienced rapid enrollment growth among dual eligibles during the period 2013-20, increasing from 20,900 dual eligibles across four states to 220,860 dual eligibles across seventeen states, for an elevenfold increase. Nearly one-third of dual eligibles in look-alike plans were previously in integrated care programs. Compared with D-SNPs, lookalike plans were more likely to enroll dual eligibles who were older, Hispanic, and from disadvantaged communities. Our findings suggest that look-alike plans have the potential to compromise national efforts to integrate care delivery for dual eligibles, including vulnerable subgroups who may benefit the most from integrated coverage.

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.

The Supplemental Nutrition Assistance Program (SNAP) is a highly effective program, vital to our nation’s health and well-being. SNAP’s entitlement funding structure allows it to provide benefits to anyone who meets the program’s eligibility requirements, and this structure also enables SNAP to respond quickly when need increases. Research shows that SNAP reduces poverty for millions, improves food security, and is linked with improved health. Despite SNAP’s successes, there is room to build on its considerable accomplishments. Evidence suggests that current benefit levels are not adequate for many households. Some vulnerable groups have limited SNAP eligibility, and some eligible individuals face barriers to SNAP participation. Policymakers should address these shortcomings by increasing SNAP benefits and expanding SNAP eligibility to underserved groups. The federal government and states should also continue improving policies and procedures to improve access for eligible individuals.

The use of electronic health records (EHRs) holds the potential to enhance clinical trial activities. However, the identification of eligible patients within EHRs presents considerable challenges. We aimed to develop a CriteriaMapper system for phenotyping eligibility criteria, enabling the identification of patients from EHRs with clinical characteristics that match those criteria. We utilized clinical trial eligibility criteria and patient EHRs from the Mount Sinai Database. The CriteriaMapper system was developed to normalize the criteria using national standard terminologies and in-house databases, facilitating computability and queryability to bridge clinical trial criteria and EHRs. The system employed rule-based pattern recognition and manual annotation. Our system normalized 367 out of 640 unique eligibility criteria attributes, covering various medical conditions including non-small cell lung cancer, small cell lung cancer, prostate cancer, breast cancer, multiple myeloma, ulcerative colitis, Crohn’s disease, non-alcoholic steatohepatitis, and sickle cell anemia. About 174 criteria were encoded with standard terminologies and 193 were normalized using the in-house reference tables. The agreement between automated and manual normalization was high (Cohen’s Kappa = 0.82), and patient matching demonstrated a 0.94 F1 score. Our system has proven effective on EHRs from multiple institutions, showing broad applicability and promising improved clinical trial processes, leading to better patient selection, and enhanced clinical research outcomes.

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

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.