K. Foley

A Checklist for Ascertaining Study Cohorts in Oncology Health Services Research Using Secondary Data: Report of the ISPOR Oncology Good Outcomes Research Practices Working Group

OBJECTIVES The ISPOR Oncology Special Interest Group formed a working group at the end of 2010 to develop standards for conducting oncology health services research using secondary data. The first mission of the group was to develop a checklist focused on issues specific to selection of a sample of oncology patients using a secondary data source. METHODS A systematic review of the published literature from 2006 to 2010 was conducted to characterize the use of secondary data sources in oncology and inform the leadership of the working group prior to the construction of the checklist. A draft checklist was subsequently presented to the ISPOR membership in 2011 with subsequent feedback from the larger Oncology Special Interest Group also incorporated into the final checklist. RESULTS The checklist includes six elements: identification of the cancer to be studied, selection of an appropriate data source, evaluation of the applicability of published algorithms, development of custom algorithms (if needed), validation of the custom algorithm, and reporting and discussions of the ascertainment criteria. The checklist was intended to be applicable to various types of secondary data sources, including cancer registries, claims databases, electronic medical records, and others. CONCLUSIONS This checklist makes two important contributions to oncology health services research. First, it can assist decision makers and reviewers in evaluating the quality of studies using secondary data. Second, it highlights methodological issues to be considered when researchers are constructing a study cohort from a secondary data source.

Prescribing Patterns of Oral Antineoplastic Therapies Observed in the Treatment of Patients With Advanced Prostate Cancer Between 2012 and 2014: Results of an Oncology EMR Analysis

PURPOSE The purpose of this study was to examine, using a US electronic medical records (EMR) database, the clinical characteristics and real-world treatment sequences in men with advanced prostate cancer who initiated treatment with abiraterone acetate or enzalutamide. METHODS This retrospective, observational study evaluated adult male patients with a diagnosis of prostate cancer (International Classification of Diseases, Ninth Revision, Clinical Modification code 185) in the EMR database between July 1, 2011, and March 31, 2014, who had initiated first-line treatment with abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014. The first record for a patient initiating abiraterone acetate or enzalutamide was the index date. Patients had 6 months of pre-index medical record history and a variable length follow-up period, extending from the index date to the end of medical record data availability or date of the end of the study (March 31, 2014). The sequence of first- and second-line therapies for advanced prostate cancer therapy was reported. FINDINGS A total of 809 patients met study inclusion and exclusion criteria. This study found that the majority of patients who initiated treatment with either abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014, received a single line of therapy (72%); abiraterone acetate was the most common first-line treatment (74% of first-line patients). A subset of patients treated first-line with either abiraterone acetate or enzalutamide were transitioned to an oral second-line agent (17% of first-line abiraterone acetate-treated patients transitioned to second-line enzalutamide, and 16% of first-line enzalutamide-treated patients transitioned to second-line abiraterone acetate). Chemotherapy with docetaxel was also a commonly observed second-line treatment selection, occurring in 8% of first-line abiraterone acetate-treated patients and in 7% of first-line enzalutamide-treated patients. IMPLICATIONS This EMR study is among the first to present evidence of US physician practice prescribing patterns regarding initiation of oral antineoplastic agents and use of subsequent therapies in patients with advanced prostate cancer.

Treatment sequencing patterns of novel agents in patients with prostate cancer.

296 Background: The National Comprehensive Cancer Network (NCCN) guidelines recommend chemotherapy, immunotherapy or anti-androgen therapies for the treatment of advanced castration-resistant prostate cancer (CRPC). This study evaluated treatment sequencing of recently approved agents for CRPC [abiraterone (ABI), enzalutamide (ENZ), docetaxel (DOC), cabazitaxel (CAB), or sipuleucel-T (SIP)] among men with PC. METHODS This retrospective, observational study evaluated adult men with PC in the MarketScan Oncology EMR database, which includes data from over 900 contributing oncologists from over 100 community practices. Inclusion required a diagnosis of PC (ICD-9-CM diagnosis code 185) from 07/01/2011-03/31/2014, no treatment with ABI, ENZ, DOC, CAB, or SIP prior to 09/01/2012, no other primary cancers, and six months of medical record history prior to index date. The index date was the date of first prescription of ABI, ENZ, DOC, CAB or SIP between 09/01/2012 and 03/31/2014. First-, second- and subsequent-line treatments were evaluated prior to end of data availability or end of study. RESULTS In total, 812 PC patients were identified; mean age was 75 years and 68% had recorded metastasis. A single line of therapy was observed for 544 patients (67%). ABI was the most common first-line treatment (443; 55%), followed by DOC (167; 21%), ENZ (113; 14%), SIP (82; 10%) and CAB (7; 1%). A second line of therapy occurred in 268 patients (33%) and third line in 8%. The table below describes first-line and the two most common second-line therapies for those moving on to second-line. CONCLUSIONS Of the five agents of interest, ABI was the most commonly prescribed first-line medication for advanced PC in this patient cohort. First-line DOC was more common than first-line CAB or SIP. Further studies with longer follow-up and other treatments are warranted. [Table: see text].

Linking commercial claims and state registry data to assess cancer care quality at the medical group level: Early lessons from California.

269 Background: The Integrated Healthcare Association (IHA) is a non-profit organization which runs the largest Pay for Performance program in California. We describe a feasibility study to apply NQF cancer quality measures to linked commercial claims and state registry data and calculate results at the physician organization level. We describe phase I of the study: identifying appropriate measures and securing access to the data. METHODS We requested technical specifications for 9 NQF breast and colon cancer quality measures from the measure stewards and 2009 -2012 claims data from 7 California health plans. RESULTS Two barriers were identified in phase I: First, California Cancer Registry (CCR) data policies, designed for public health surveillance and not quality measurement, caused delays and present hurdles to public reporting. CCR data is not available until it is at least 95% complete, so 2011 data was not available until October 2013. Moreover, CCR requires that they conduct the data linkage, which required new data use agreements between the data aggregator and each participating insurer - costly in both time and legal fees. Finally, obstacles to public reporting any of the CCR data at the provider level still exist. Barrier 2: NQF measure specifications for linked claims-registry data sets do not currently exist, so the project team developed them, adding to the problem of proliferating non-harmonized quality measures. CONCLUSIONS While the application of NQF measures to claims-registry linkage appears feasible for measurement of cancer care quality at the medical group level, registry policies and the lack of standard technical specifications for linked claims-registry data sets adversely impact the timeliness, usability, and comparability of results using two widely available data sources. More flexible policies on the part of data registries and attention to measure harmonization could improve data quality and usability for cancer care quality assessment and public reporting, and should be considered. In phase 2, we will apply the measures at the physician group level, and assess the feasibility of public reporting at the physician group level.