Evaluating the intersection of climate vulnerability and cancer burden in North Carolina.

Climate-related extreme weather events disrupt healthcare systems and exacerbate health disparities, particularly affecting individuals diagnosed with cancer. This study explores the intersection of climate vulnerability and cancer burden in North Carolina (NC). Using county-level data from the US Climate Vulnerability Index (CVI) and the NC Department of Health and Human Services, we analyzed cancer incidence and mortality rates from 2017-2021.

Evaluation of real-world evidence to assess health outcomes related to deprescribing medications in older adults: an International Society for Pharmacoepidemiology-endorsed systematic review of methodology.

Background: Observational studies using real-world data (RWD) can address gaps in knowledge on deprescribing medications but are subject to methodological issues. Limited data exist on the methods employed to use RWD to measure the effects of deprescribing.

Objective: To describe methodological approaches used in observational studies of deprescribing medications in older adults.

The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals.

Purpose: The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers.

Methods: A multidisciplinary executive committee (EC) was established to guide the Oncology QCARD Initiative. The EC conducted a landscape review of published literature, guidances, and guidelines to evaluate relevant dimensions of data quality measurement.

Impact of observability period on the classification of COPD diagnosis timing among Medicare beneficiaries with lung cancer.

Background: Investigators often use claims data to estimate the diagnosis timing of chronic conditions. However, misclassification of chronic conditions is common due to variability in healthcare utilization and in claims history across patients.

Objective: We aimed to quantify the effect of various Medicare fee-for-service continuous enrollment period and lookback period (LBP) on misclassification of COPD and sample size.

Pharmacist-facilitated Patient Reported Outcome Measure (PROM) monitoring: developing an EHR SmartForm© to monitor side effects of oral oncolytics during routine telehealth encounters.

Purpose: Patient reported outcome measures (PROMs) are increasingly used in oncology care, but pharmacists providing direct patient care have been overlooked. We engaged pharmacists and adults receiving oral oncolytics (chemotherapy medication taken by mouth) to develop a SmartForm© in the electronic health record (EHR) for PROM monitoring. Pharmacists verbally ask the patient side effect questions during routine telehealth encounters and enter responses in real time.

The Healthy User Effect in Pharmacoepidemiology.

The healthy user effect is a well-recognized bias in the field of pharmacoepidemiology and can be expected to overstate the effect of a preventive intervention when comparing long term users or "adherers" to non-users. Similar to the healthy worker effect observed in occupational epidemiology, the healthy user effect can be separated into a healthy initiator effect (baseline confounding) and a healthy adherer effect (selection bias). Restriction approaches and new user designs that implicitly condition on the indication and, similar healthy behaviors or health status can often mitigate the healthy initiator effect (confounding) or healthy adherer effect (selection bias) at the start of a study.

Investigating the relationship between radiographic joint space width loss and deep learning-derived magnetic resonance imaging-based cartilage thickness loss in the medial weight-bearing region of the tibiofemoral joint.

Objective: To investigate the relationship between measures of radiographic joint space width (JSW) loss and magnetic resonance imaging (MRI)-based cartilage thickness loss in the medial weight-bearing region of the tibiofemoral joint over 12-24 months. To stratify this relationship by clinically meaningful subgroups (sex and pain status).

Design: We analyzed a subset of knees (n ​= ​256) from the Osteoarthritis Initiative (OAI) likely in early stage OA based on joint space narrowing (JSN) measurements.

Hazard Ratios and Alternative Effect Measures: An Applied Illustration.

Purpose: Although the limitations of hazard ratios (HRs) for quantifying treatment effects in right-censored data have been widely discussed, HRs are still preferentially reported over other, more interpretable effect measures. This may stem from the fact that there are few applied examples that directly contrast the HR and its interpretation with alternative effect measures.

Methods: We analyzed data from two randomized clinical trials comparing panitumumab plus standard-of-care chemotherapy (SOCC) with SOCC alone as first- and second-line treatment for metastatic colorectal cancer.

Cancer information and population health resource: a resource for catchment area data and cancer outcomes research.

Background: The University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center has developed a novel data resource, the Cancer Information and Population Health Resource (CIPHR), for conducting catchment area evaluation and cancer population health research that links the North Carolina Central Cancer Registry (NCCCR) to medical and pharmacy claims data from Medicare, Medicaid, and private plans operating within North Carolina. This study's aim was to describe the CIPHR data and provide examples of potential cohorts available in those data.

Methods: We present the underlying populations included in the NCCCR and claims data before linkage and demonstrate estimated sample sizes when these data are linked and commonly used insurance enrollment criteria are applied.

Real-world lessons: combining cancer registry and retail pharmacy data for oral cancer drugs.

Background: Recent cancer care advances have introduced new oral therapies, and yet population registries lack detailed treatment data, hampering investigations into therapy uptake, adherence, and outcomes.

Objective: This study aimed to assess the representativeness and completeness of linking Surveillance, Epidemiology, and End Results (SEER) cancer registry data with data from two major retail pharmacy chains, collectively covering a large segment of the US market.

Methods: A deterministic data linkage between 11 SEER cancer registries and retail pharmacy data (excluding mail order fills) was conducted for individuals diagnosed with selected cancers from 2013 to 2017, with follow-up through 2019.

Use of Sensitivity Analyses to Assess Uncontrolled Confounding from Unmeasured Variables in Observational, Active Comparator Pharmacoepidemiologic Studies: A Systematic Review.

Understanding the potential for, direction, and magnitude of uncontrolled confounding is critical for generating informative real-world evidence. Many sensitivity analyses are available to assess robustness of study results to residual confounding, but it is unclear how researchers are using these methods. We conducted a systematic review of published active comparator cohort studies of drugs or biologics to summarize use of sensitivity analyses aimed at assessing uncontrolled confounding from an unmeasured variable.

Longitudinal Changes in a Claims-Based Frailty Proxy Measure Compared to Concurrent Changes in the Fried Frailty Phenotype.

Background: Frailty is a dynamic aging-related syndrome, but measuring frailty transitions is challenging. The Faurot frailty index is a validated Medicare claims-based frailty proxy based on demographic and billing information. We evaluated whether 3-year changes in the Faurot frailty index were consistent with concurrent changes in the frailty phenotype in a cohort of older adults.

Dose delay, dose reduction, and early treatment discontinuation in Black and White women receiving chemotherapy for nonmetastatic breast cancer.

Background: To describe reasons for deviations from planned chemotherapy treatments in women with nonmetastatic breast cancer that contribute to less-than-planned receipt of chemotherapy.

Methods: Electronic medical records for patients receiving chemotherapy were reviewed for adverse events and treatment modifications. Log-binomial regression models were used to estimate relative risks (RRs) with 95% CIs to examine associations between chemotherapy modifications, patient characteristics, and treatment modalities.

Identifying target populations to align with decision-makers' needs.

Randomized trials estimate the average treatment effect within individuals who are eligible, invited, and agree to enroll. However, decision-makers often require evidence that extends beyond the trial's enrolled population to inform policy or actions for their specific target population. Each decision-maker has distinct target populations, the composition of which may not often align with that of the trial population.

Skeletal muscle density performance for screening frailty in older adults with cancer and the impact of diabetes: The CARE Registry.

Introduction: Skeletal muscle density (SMD) measurements from imaging scans identify myosteatosis and could screen patients for geriatric assessment. We assessed SMD performance as a screening tool to identify older adults with cancer likely to be frail and who could benefit from in-depth assessment; we compared performance by sex and diabetes status.

Materials And Methods: We analyzed patients in the Cancer & Aging Resilience Evaluation (CARE) Registry.

COPD With Lung Cancer Among Older United States Adults: Prevalence, Diagnostic Timeliness, and Association With Earlier Stage Tumors.

Rationale: Chronic obstructive pulmonary disease (COPD) is a common comorbidity among patients with lung cancer, and an important determinant of their outcomes, however, it is commonly underdiagnosed.

Objective: Our objective was to estimate the prevalence of COPD among a cohort of U.S.

A comparison of dementia diagnoses and cognitive function measures in Medicare claims and the Minimum Data Set.

Background: Gold standard dementia assessments are rarely available in large real-world datasets, leaving researchers to choose among methods with imperfect but acceptable accuracy to identify nursing home (NH) residents with dementia. In healthcare claims, options include claims-based diagnosis algorithms, diagnosis indicators, and cognitive function measures in the Minimum Data Set (MDS), but few studies have compared these. We evaluated the proportion of NH residents identified with possible dementia and concordance of these three.

Validation of algorithms in studies based on routinely collected health data: general principles.

Clinicians, researchers, regulators, and other decision-makers increasingly rely on evidence from real-world data (RWD), including data routinely accumulating in health and administrative databases. RWD studies often rely on algorithms to operationalize variable definitions. An algorithm is a combination of codes or concepts used to identify persons with a specific health condition or characteristic.

Longitudinal trajectories of a claims-based frailty measure during adjuvant chemotherapy in women with stage I-III breast cancer.

Background: Frailty is a dynamic syndrome characterized by reduced physiological reserve to maintain homeostasis. Prospective studies have reported frailty worsening in women with breast cancer during chemotherapy, with improvements following treatment. We evaluated whether the Faurot frailty index, a validated claims-based frailty measure, could identify changes in frailty during chemotherapy treatment and identified predictors of trajectory patterns.