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Journal of Biomedical Informatics Apr 2011Formalizing eligibility criteria in a computer-interpretable language would facilitate eligibility determination for study subjects and the identification of studies on...
Formalizing eligibility criteria in a computer-interpretable language would facilitate eligibility determination for study subjects and the identification of studies on similar patient populations. Because such formalization is extremely labor intensive, we transform the problem from one of fully capturing the semantics of criteria directly in a formal expression language to one of annotating free-text criteria in a format called ERGO annotation. The annotation can be done manually, or it can be partially automated using natural-language processing techniques. We evaluated our approach in three ways. First, we assessed the extent to which ERGO annotations capture the semantics of 1000 eligibility criteria randomly drawn from ClinicalTrials.gov. Second, we demonstrated the practicality of the annotation process in a feasibility study. Finally, we demonstrate the computability of ERGO annotation by using it to (1) structure a library of eligibility criteria, (2) search for studies enrolling specified study populations, and (3) screen patients for potential eligibility for a study. We therefore demonstrate a new and practical method for incrementally capturing the semantics of free-text eligibility criteria into computable form.
Topics: Clinical Trials as Topic; Computational Biology; Databases, Factual; Eligibility Determination; Information Storage and Retrieval; Semantics; Vocabulary, Controlled
PubMed: 20851207
DOI: 10.1016/j.jbi.2010.09.007 -
Journal of the National Cancer Institute Nov 2022In 2018, the Cancer Therapy Evaluation Program (CTEP) at the US National Cancer Institute published new protocol template language that focused on organ function and...
In 2018, the Cancer Therapy Evaluation Program (CTEP) at the US National Cancer Institute published new protocol template language that focused on organ function and prior and concurrent cancers in an effort to modernize eligibility criteria for cancer treatment trials. We conducted an analysis of CTEP-supported trials to evaluate the uptake and incorporation of the new language. The analysis included evaluation of 122 protocols approved in the years 2018-2020 for inclusion of the modernized eligibility criteria and consistency with new protocol template language related to 7 major eligibility criteria. These were cardiac function, liver function, kidney function, HIV status, prior and/or concurrent malignancies, treated and/or stable brain metastasis, and new and/or progressive brain metastases. Overall, CTEP trials evaluated in this period demonstrated that eligibility criteria were implemented to a relatively high degree ranging from a low of 54.1% for prior and/or concurrent malignancies to a high of 93.4% for eligibility criteria related to HIV infection. The findings demonstrate that modernized eligibility criteria can be successfully implemented but that consistent implementation requires sustained focused effort. As a result of these findings, CTEP began a new initiative in January 2022 that incorporates a specific review of eligibility criteria for new protocols to promote and improve consistency with the modernization effort.
Topics: United States; Humans; National Cancer Institute (U.S.); HIV Infections; Eligibility Determination; Brain Neoplasms
PubMed: 36047830
DOI: 10.1093/jnci/djac152 -
Journal of Thoracic Oncology : Official... Oct 2017Eligibility criteria and screening procedures are designed to optimize the scientific yield and maximize the safety of clinical trials. However, they may also heighten...
INTRODUCTION
Eligibility criteria and screening procedures are designed to optimize the scientific yield and maximize the safety of clinical trials. However, they may also heighten trial complexity, hinder enrollment, decrease generalizability, and increase costs. We analyzed the types and number of eligibility criteria and screening procedures among thoracic oncology clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group.
METHODS
We identified trials and obtained protocols from the Eastern Cooperative Oncology Group website. Eligibility criteria were grouped and categorized as comorbidity (classified by organ system), administrative requirements, prior treatment, and measurable disease requirements. Associations between trial characteristics and eligibility criteria were analyzed by using the Kruskal-Wallis and Wilcoxon tests.
RESULTS
A total of 74 lung cancer trials activated in 1986-2016 were identified. The total number of eligibility criteria was associated with trial principal therapy (a median of nine for surgical, 18 for radiation, and 20 for medical therapy [p = 0.02]), trial primary end point (a median of 20 for overall survival, 28 for progression-free survival, and 17 for other [p = 0.001]), number of therapies (p = 0.05), and year of activation (a median of 16 for 1986-1995, 19 for 1996-2005, and 27 for 2006-2016 [P < 0.001]). The increase in trial eligibility requirements over time was limited to medical therapy trials. Over time, there was also an increase in blood test screening procedures (p = 0.05) but not in imaging, cardiac assessment, or pulmonary function screening procedures.
CONCLUSIONS
The number of eligibility criteria and screening procedures in medical therapy lung cancer clinical trials continues to rise. Continued efforts to simplify protocol eligibility and procedures are warranted to promote trial adherence, enrollment, completion, and generalizability.
Topics: Clinical Trials as Topic; Eligibility Determination; Humans; Lung Neoplasms; Research Design; Thoracic Neoplasms
PubMed: 28802905
DOI: 10.1016/j.jtho.2017.07.020 -
BMC Health Services Research Mar 2020To evaluate the association between social capital and 30-day readmission to the hospital among Medicare beneficiaries overall, beneficiaries with dementia and related...
BACKGROUND
To evaluate the association between social capital and 30-day readmission to the hospital among Medicare beneficiaries overall, beneficiaries with dementia and related memory disorders, and beneficiaries with dual eligibility for Medicaid.
METHODS
Using Health and Retirement Study (HRS) data linked with 2008-2015 Medicare claims from traditional Medicare beneficiaries hospitalized during the study period (1246 unique respondents, 2212 total responses), we examined whether dementia and related memory disorders and dual eligibility were associated with social capital. We then estimated a multiple regression model to test whether social capital was associated with a reduced likelihood of readmission.
RESULTS
Dementia was associated with an - 0.241 standard deviation (sd) change in social capital (95% CI: - 0.378, - 0.103), dual eligibility with a - 0.461 sd change (95% CI: - 0.611, - 0.310), and the occurrence of both was associated with an additional - 0.236 sd change (95% CI: - 0.525, - 0.053). 30-day readmission rates were 14.47% over the study period. In both adjusted and unadjusted models, social capital was associated with small and nonsignificant differences in 30-day readmissions. These effects did not vary across dementia status and socioeconomic status.
CONCLUSIONS
Dementia and dual eligibility were associated with lower social capital, but social capital was not associated with the risk of readmission for any population.
Topics: Aged; Aged, 80 and over; Cohort Studies; Dementia; Eligibility Determination; Female; Humans; Male; Medicaid; Medicare; Patient Readmission; Risk Assessment; Social Capital; United States
PubMed: 32209077
DOI: 10.1186/s12913-020-05092-x -
JAMA Network Open Jun 2020The Centers for Medicare & Medicaid Services is beginning to consider adjusting for social risk factors, such as dual eligibility for Medicare and Medicaid, when...
IMPORTANCE
The Centers for Medicare & Medicaid Services is beginning to consider adjusting for social risk factors, such as dual eligibility for Medicare and Medicaid, when evaluating hospital performance under value-based purchasing programs. It is unknown whether dual eligibility represents a unique domain of social risk or instead represents clinical risk unmeasured by variables available in traditional Medicare claims.
OBJECTIVE
To assess how dual eligibility for Medicare and Medicaid is associated with risk-adjusted readmission rates after surgery.
DESIGN, SETTING, AND PARTICIPANTS
A retrospective cohort study was conducted of 55 651 Medicare beneficiaries undergoing general, vascular, and gynecologic surgery at 62 hospitals in Michigan between January 1, 2014, and December 1, 2016. Representative cohorts were derived from traditional Medicare claims (n = 29 710) and the Michigan Surgical Quality Collaborative (MSQC) clinical registry (n = 25 941), which includes additional measures of clinical risk. Statistical analysis was conducted between April 10 and July 15, 2019. The association between dual eligibility and risk-adjusted 30-day readmission rates after surgery was compared between models inclusive and exclusive of additional measurements of clinical risk. The study also examined how dual eligibility is associated with hospital profiling using risk-adjusted readmission rates.
EXPOSURES
Dual eligibility for Medicare and Medicaid.
MAIN OUTCOMES AND MEASURES
Risk-adjusted all-cause 30-day readmission after surgery.
RESULTS
There were a total of 3986 dual-eligible beneficiaries in the Medicare claims cohort (2554 women; mean [SD] age, 72.9 [6.9] years) and 1608 dual-eligible beneficiaries in the MSQC cohort (990 women; mean [SD] age, 72.9 [6.8] years). In both data sets, higher proportions of dual-eligible beneficiaries were younger, female, and nonwhite than Medicare-only beneficiaries (Medicare claims cohort: female, 2554 of 3986 [64.1%] vs 12 879 of 25 724 [50.1%]; nonwhite, 1225 of 3986 [30.7%] vs 2783 of 25 724 [10.8%]; MSQC cohort: female, 990 of 1608 [61.6%] vs 12 578 of 24 333 [51.7%]; nonwhite, 416 of 1608 [25.9%] vs 2176 of 24 333 [8.9%]). In the Medicare claims cohort, dual-eligible beneficiaries were more likely to be readmitted (15.5% [95% CI, 13.7%-17.3%]) than Medicare-only beneficiaries (13.3% [95% CI, 12.7%-13.9%]; difference, 2.2 percentage points [95% CI, 0.4-3.9 percentage points]). In the MSQC cohort, after adjustment for more granular measures of clinical risk, dual eligibility was not significantly associated with readmission (difference, 0.6 percentage points [95% CI, -1.0 to 2.2 percentage points]). In both the Medicare claims and MSQC cohorts, adding dual eligibility to risk-adjustment models had little association with hospital ranking using risk-adjusted readmission rates.
CONCLUSIONS AND RELEVANCE
This study suggests that dual eligibility for Medicare and Medicaid may reflect unmeasured clinical risk of readmission in claims data. Policy makers should consider incorporating more robust measures of social risk into risk-adjustment models used by value-based purchasing programs.
Topics: Aged; Aged, 80 and over; Eligibility Determination; Female; Humans; Male; Medicare; Michigan; Patient Readmission; Retrospective Studies; Surgical Procedures, Operative; United States
PubMed: 32520361
DOI: 10.1001/jamanetworkopen.2020.7426 -
JAMA Oncology Sep 2022Clinical trial sponsors rely on eligibility criteria to control the characteristics of patients in their studies, promote the safety of participants, and optimize the...
IMPORTANCE
Clinical trial sponsors rely on eligibility criteria to control the characteristics of patients in their studies, promote the safety of participants, and optimize the interpretation of results. However, in recent years, complex and often overly restrictive inclusion and exclusion criteria have created substantial barriers to patient access to novel therapies, hindered trial recruitment and completion, and limited generalizability of trial results. A LUNGevity Foundation working group developed a framework for lung cancer clinical trial eligibility criteria. The goals of this framework are to (1) simplify eligibility criteria, (2) facilitate stakeholders' (patients, clinicians, and sponsors) search for appropriate trials, and (3) harmonize trial populations to support intertrial comparisons of treatment effects.
OBSERVATIONS
Clinicians and representatives from the pharmaceutical industry, the National Cancer Institute, the US Food and Drug Administration (FDA), the European Medicines Agency, and the LUNGevity Foundation undertook a process to identify and prioritize key items for inclusion in trial eligibility criteria. The group generated a prioritized library of terms to guide investigators and sponsors in the design of first-line, advanced non-small cell lung cancer clinical trials intended to support marketing application. These recommendations address disease stage and histologic features, enrollment biomarkers, performance status, organ function, brain metastases, and comorbidities. This effort forms the basis for a forthcoming FDA draft guidance for industry.
CONCLUSIONS AND RELEVANCE
As an initial step, the recommended cross-trial standardization of eligibility criteria may harmonize trial populations. Going forward, by connecting diverse stakeholders and providing formal opportunity for public input, the emerging FDA draft guidance may also provide an opportunity to revise and simplify long-standing approaches to trial eligibility. This work serves as a prototype for similar efforts now underway for other cancers.
Topics: Brain Neoplasms; Carcinoma, Non-Small-Cell Lung; Clinical Trials as Topic; Eligibility Determination; Humans; Lung Neoplasms; Neoplasms; United States; United States Food and Drug Administration
PubMed: 35925576
DOI: 10.1001/jamaoncol.2022.1664 -
PloS One 2017To determine if pregnant, literate women and female community health volunteers (FCHVs) in Nepal can accurately determine a woman's eligibility for medical abortion (MA)...
OBJECTIVE
To determine if pregnant, literate women and female community health volunteers (FCHVs) in Nepal can accurately determine a woman's eligibility for medical abortion (MA) using a toolkit, compared to comprehensive abortion care (CAC) trained providers.
STUDY DESIGN
We conducted a prospective diagnostic accuracy study in which women presenting for first trimester abortion, and FCHVs, independently assessed each woman's eligibility for MA using a modified gestational dating wheel to determine gestational age and a nine-point checklist of MA contraindications or cautions. Ability to determine MA eligibility was compared to experienced CAC-providers using Nepali standard of care.
RESULTS
Both women (n = 3131) and FCHVs (n = 165) accurately interpreted the wheel 96% of the time, and the eligibility checklist 72% and 95% of the time, respectively. Of the 649 women who reported potential contraindications or cautions on the checklist, 88% misidentified as eligible. Positive predictive value (PPV) of women's assessment of eligibility based on gestational age was 93% (95% CI 92, 94) compared to CAC-providers' (n = 47); PPV of the medical contraindications checklist and overall (90% [95% CI 88, 91] and 93% [95% CI 92, 94] respectively) must be interpreted with caution given women's difficulty using the checklist. PPV of FCHVs' determinations were 93% (95% CI 92, 94), 90% (95% CI 89,91), and 93% (95% CI 91, 94) respectively.
CONCLUSION
Although a promising strategy to assist women and FCHVs to assess MA eligibility, further refinement of the eligibility tools, particularly the checklist, is needed before their widespread use.
Topics: Abortion, Induced; Adult; Community Health Workers; Eligibility Determination; Female; Gestational Age; Humans; Middle Aged; Nepal; Pregnancy; Prospective Studies; Volunteers; Women's Health; Young Adult
PubMed: 28880926
DOI: 10.1371/journal.pone.0178248 -
The American Journal of Managed Care Nov 2022The Advance Premium Tax Credit (APTC) is designed to remedy lack of health insurance due to cost; however, approximately 30 million Americans remain without health...
OBJECTIVES
The Advance Premium Tax Credit (APTC) is designed to remedy lack of health insurance due to cost; however, approximately 30 million Americans remain without health insurance and millions of households leave billions in tax credits unclaimed each year. A prerequisite of APTC is to file one's taxes; however, few studies have examined tax filing and APTC jointly. This study examined the relationship between tax filing and applying for APTC, as well as perceived barriers to and sociodemographic characteristics associated with applying for the APTC.
STUDY DESIGN
Descriptive study.
METHODS
Researchers surveyed 372 Marketplace-insured members who were eligible for APTC.
RESULTS
Most of the sample filed personal taxes in 2019 and planned to file taxes in 2020, yet only 23% applied for the APTC in 2019, and 26.3% were planning to apply in 2020. Most commonly, respondents were not going to apply because they believed they were not eligible (53.5%), they did not know about the APTC (15.8%), and they did not know whether they were eligible (9.9%). Logistic regression modeling found that employment, income, and race were significantly associated with applying for the APTC.
CONCLUSIONS
Barriers to applying for the APTC were unrelated to tax filing and were specific to a lack of knowledge about the APTC and eligibility. These results indicate the need to build knowledge and awareness of the APTC and eligibility and to target groups least likely to apply. Implications and future directions are discussed.
Topics: Humans; United States; Taxes; Insurance, Health; Eligibility Determination; Income; Employment
PubMed: 36374617
DOI: 10.37765/ajmc.2022.89262 -
The American Journal of Managed Care Mar 2019To describe the extent and implications of "churn" between different Medicaid eligibility classifications in a pediatric population: (1) aged, blind, and disabled (ABD)...
OBJECTIVES
To describe the extent and implications of "churn" between different Medicaid eligibility classifications in a pediatric population: (1) aged, blind, and disabled (ABD) Medicaid eligibility, determined by disability status and family income; and (2) Healthy Start Medicaid eligibility, determined by family income alone.
STUDY DESIGN
As a result of a 2013 policy change, children with ABD eligibility transitioned from fee-for-service to capitated care. We used Ohio Medicaid claims data from July 2013 through June 2015 to explore the relationships among instability in eligibility category, demographics, and utilization.
METHODS
To examine the potential financial effect of categorical churn, an effective capitation rate was created to capture the proportion of the maximum potential capitation rate that was realized.
RESULTS
More than 20% of children exited ABD-based eligibility at least once. Switching was associated with younger age and rural residence and was not associated with healthcare use.
CONCLUSIONS
Switching between eligibility categories is common and affects average capitation but not health service use.
Topics: Age Factors; Child; Child, Preschool; Disabled Children; Eligibility Determination; Female; Health Services; Humans; Income; Male; Medicaid; Ohio; Rural Population; United States; Visually Impaired Persons
PubMed: 30875179
DOI: No ID Found -
American Journal of Public Health Dec 2021
Topics: COVID-19; Child; Children's Health Insurance Program; Eligibility Determination; Humans; Insurance Coverage; Medicaid; SARS-CoV-2; United States
PubMed: 34878874
DOI: 10.2105/AJPH.2021.306550