An overview of real-world data sources for oncology and considerations for research.

Generating evidence on the use, effectiveness, and safety of new cancer therapies is a priority for researchers, health care providers, payers, and regulators given the rapid pace of change in cancer diagnosis and treatments. The use of real-world data (RWD) is integral to understanding the utilization patterns and outcomes of these new treatments among patients with cancer who are treated in clinical practice and community settings. An initial step in the use of RWD is careful study design to assess the suitability of an RWD source.

Association of SARS-CoV-2 Seropositive Antibody Test With Risk of Future Infection.

Importance: Understanding the effect of serum antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on susceptibility to infection is important for identifying at-risk populations and could have implications for vaccine deployment.

Objective: The study purpose was to evaluate evidence of SARS-CoV-2 infection based on diagnostic nucleic acid amplification test (NAAT) among patients with positive vs negative test results for antibodies in an observational descriptive cohort study of clinical laboratory and linked claims data.

Design, Setting, And Participants: The study created cohorts from a deidentified data set composed of commercial laboratory tests, medical and pharmacy claims, electronic health records, and hospital chargemaster data.

Real-world data suggest antibody positivity to SARS-CoV-2 is associated with a decreased risk of future infection.

Importance There is limited evidence regarding whether the presence of serum antibodies to SARS-CoV-2 is associated with a decreased risk of future infection. Understanding susceptibility to infection and the role of immune memory is important for identifying at-risk populations and could have implications for vaccine deployment. Objective The purpose of this study was to evaluate subsequent evidence of SARS-CoV-2 infection based on diagnostic nucleic acid amplification test (NAAT) among individuals who are antibody-positive compared with those who are antibody-negative, using real-world data.

Daily home opioid use in adults with sickle cell disease: The PiSCES project.

Background: Although opioid prescribing in sickle cell disease (SCD) can be controversial, little is published about patterns of opioid use.

Objective: To report on home opioid use among adults with SCD.

Design: Cohort study.

SEER cancer registry biospecimen research: yesterday and tomorrow.

The National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) registries have been a source of biospecimens for cancer research for decades. Recently, registry-based biospecimen studies have become more practical, with the expansion of electronic networks for pathology and medical record reporting. Formalin-fixed paraffin-embedded specimens are now used for next-generation sequencing and other molecular techniques.

Automated determination of metastases in unstructured radiology reports for eligibility screening in oncology clinical trials.

Enrolling adequate numbers of patients that meet protocol eligibility criteria in a timely manner is critical, yet clinical trial accrual continues to be problematic. One approach to meet these accrual challenges is to utilize technology to automatically screen patients for clinical trial eligibility. This manuscript reports on the evaluation of different automated approaches to determine the metastatic status from unstructured radiology reports using the Clinical Trials Eligibility Database Integrated System (CTED).

Effort required in eligibility screening for clinical trials.

Purpose: Determining eligibility for a clinical trial (CT) typically requires a lengthy manual review of data for a single evaluation. The cost associated with eligibility screening is typically not compensated through contracts supporting CTs.

Methods: We used a real-time tracking system that captures CT evaluations and provides information on evaluation outcomes and time spent on each eligibility screening by research staff.

Impact of automated data collection from urology offices: improving incidence and treatment reporting in urologic cancers.

Background: Urologic cancers represent a substantial proportion of the total cancer burden, yet the true burden of these cancers is unknown due to gaps in current cancer surveillance systems. Prostate and bladder cancers in particular may be underreported due to increased availability of outpatient care. Thus, there is a critical need to develop systems to completely and accurately capture longitudinal data to understand the true patterns of care and outcomes for these cancers.

Pain site frequency and location in sickle cell disease: the PiSCES project.

Treatment options for sickle cell disease (SCD) pain could be tailored to pain locations. But few epidemiologic descriptions of SCD pain location exist; these are based on few subjects over short time periods. We examined whether SCD pain locations vary by disease genotype, gender, age, frequency of pain, depression, pain crisis or healthcare utilization.

Genes involved in radiation therapy response in head and neck cancers.

Objectives: This is a pilot study designed to identify gene expression profiles able to stratify head and neck squamous cell carcinoma (HNSCC) tumors that may or may not respond to chemoradiation or radiation therapy.

Study Design: We prospectively evaluated 14 HNSCC specimens, arising from patients undergoing chemoradiotherapy or radiotherapy alone with curative intent. A complete response was assessed by clinical evaluation with no evidence of gross tumor after a 2-year follow-up period.

Comparisons of high versus low emergency department utilizers in sickle cell disease.

Study Objective: Patients with sickle cell disease often receive a substantial amount of their health care in the emergency department (ED) and some come to the ED frequently, seeking treatment for pain. As a result, patients with sickle cell disease are often stigmatized as opioid-seeking ED overutilizers. We describe the proportion of sickle cell disease patients who are high utilizers of the ED and compare them with other sickle cell disease patients on demographics, pain characteristics, health data, psychosocial characteristics, and quality of life.

Daily assessment of pain in adults with sickle cell disease.

Background: Researchers of sickle cell disease have traditionally used health care utilization as a proxy for pain and underlying vaso-occlusion. However, utilization may not completely reflect the amount of self-reported pain or acute, painful episodes (crises).

Objective: To examine the prevalence of self-reported pain and the relationship among pain, crises, and utilization in adults with sickle cell disease.

Depression and anxiety in adults with sickle cell disease: the PiSCES project.

Objective: Depression and anxiety are common in sickle cell disease (SCD) but relatively little is known about their impact on SCD adults. This study measured prevalence of depression and anxiety in SCD adults, and their effects on crisis and noncrisis pain, quality-of-life, opioid usage, and healthcare utilization.

Methods: The Pain in Sickle Cell Epidemiology Study is a prospective cohort study in 308 SCD adults.

Alcohol abuse in sickle cell disease: the Pisces Project.

Alcohol abuse is common in patients with chronic painful medical disorders, but it has not been studied in sickle cell disease (SCD). In a prospective cohort study of SCD adults, 31.4% were identified as abusing alcohol.

Patient satisfaction in specialized versus nonspecialized adult sickle cell care centers: the PiSCES study.

Background: Sickle cell disease (SCD) patients can receive their ambulatory care from either SCD specialists (caregivers with sickle cell-only clinics) or nonspecialized care centers. Patient satisfaction, an important factor that may influence compliance and outcome, can differ between the two groups because of the perceived quality of care, outcomes or practice style.

Methods: We administered a patient satisfaction survey to 308 participants in an SCD prospective cohort study.

The role of catastrophizing in sickle cell disease--the PiSCES project.

In several types of chronic pain, catastrophizing has been related to higher pain intensity, and health care utilization but it has not been explored extensively in sickle cell disease (SCD). The objective of the study was to identify the role of catastrophizing in SCD, specifically in relation to painful crises, non-crisis pain, and responses to pain. Two hundred and twenty SCD adults were enrolled in a prospective cohort study of pain and completed between 30 and 188 daily diaries in 6 months.

Gender differences in pain and healthcare utilization for adult sickle cell patients: The PiSCES Project.

Background: Many studies have found gender differences in frequency and intensity of pain. Women often report lower pain thresholds, higher pain ratings, and lower tolerance for pain. People with sickle cell disease (SCD) experience both chronic and acute pain throughout life.

Health related quality of life in sickle cell patients: the PiSCES project.

Background: Sickle cell disease (SCD) is a chronic disease associated with high degrees of morbidity and increased mortality. Health-related quality of life (HRQOL) among adults with sickle cell disease has not been widely reported.

Methods: We administered the Medical Outcomes Study 36-item Short-Form to 308 patients in the Pain in Sickle Cell Epidemiology Study (PiSCES) to assess HRQOL.

Understanding pain and improving management of sickle cell disease: the PiSCES study.

Until recent decades, sickle cell disease (SCD) was associated with recurrent, disabling pain, organ failure and death in childhood or early adulthood. SCD treatment advances have now decreased pain and prolonged survival, but episodic or chronic pain may still require substantial analgesic use and frequent hospitalization for pain episodes. This pain is poorly characterized and often poorly treated.

Breast conservation therapy rates are no different in medically indigent versus insured patients with early stage breast cancer.

Purpose: Multiple prospective, randomized studies show that breast conservation therapy (BCT) results in survival rates equal to mastectomy (Mx) for patients with early stage breast cancer (ESBC). Nevertheless, BCT remains underused in certain areas of the nation, without clearly definable reasons. Several studies have implicated socioeconomic status as one potential cause for this disparity in BCT usage.

Collaborative Initiatives in the Care of Early Stage Breast Cancer: Reduction in Variation of Breast-Conserving Therapy.

Breast-conserving therapy (BCT) has survival results comparable to those obtained with modified radical mastectomy (MST). However, studies suggest variations in the rates of breast-conserving therapy that are not explained by comorbidities or age. The Virginia Health Quality Center collaborated with 40 Virginia hospitals to address patterns of breast cancer treatment.