(268) Evaluation of Commonly Used Real World Data Sources Submitted to ASCO Journals: Initial Steps Toward Furthering Transparent Reporting

Publication Number: 601

Background: Real world data (RWD) are used to understand treatment, care, and outcomes of people with cancer. Reporting guidelines for observational studies, such as RECORD (health), RECORD-PE (treatment), and TRIPOD (prediction) were developed to increase the transparency of studies using RWD. These guidelines are not required for publication in ASCO Journals (JCO- Journal of Clinical Oncology, PO- Precision Oncology, OP- Oncology Practice, CCI- Clinical Cancer Informatics, GO- Global Oncology).

Objectives: Our objective was to describe the use of RWD among studies submitted to ASCO Journals and evaluate the applicability of and adherence to guidelines.

Methods: ASCO submission system was used to identify all studies submitted to ASCO Journals between 2018-2022. Based on abstract, studies were categorized on whether selected RWD were used: SEER, Medicare, National Cancer Database- NCDB, Flatiron, CancerLinQ, IQVIA, Optum, MarketScan. Through manual review of the published manuscripts, we calculated positive predictive value (PPV) of our algorithm to identify selected RWD. We estimated the acceptance rate. For each study we evaluated: (1) linkage with other RWD; (2) applicability of reporting guidelines RECORD, RECORD-PE, TRIPOD; (3) use of a flow diagram (RECORD) or study design figure for covariate, treatment, and outcome assessment (RECORD-PE).

Results: The PPV of our search algorithm was 79% (95%CI 73-84) but varied by journal (PPV 73-100). Based on our algorithm, among the 16,133 original reports submitted, 1,156 (7.2%) used one of the RWD sources. Overall acceptance rate among RWD sources was 18%. There was variability in submissions and acceptance by journal. OP and GO most and least frequently received a manuscript with the selected RWD 13% and 1%, respectively. GO accepted 77% of manuscripts that used RWD (88% were SEER); JCO acceptance was 3.5%. Medicare, SEER, and NCDB were commonly used (61%, 31%, and 11%, respectively). SEER was linked to claims, surveys, or other data in 77% of studies. The other sources accounted for < 5% each, although EHR-linked to claims/registry increased over time (OR 1.26: 95%CI 1.07-1.49). Among all the studies, RECORD, RECORD-PE, and TRIPOD were applicable to 100%, 10% and 7.7% of the studies. RECORD-PE and TRIPOD were most applicable to PO/OP/CCI and CCI, respectively. A flow diagram demonstrating selection of participants was present in 31% of the studies. A figure to visualize study design was used in < 5% of RECORD-PE relevant studies.

Conclusions: RWD are commonly submitted and published within ASCO Journals. Reporting guidelines are applicable and particularly important when linkages occur. Studies using oncology RWD may benefit from reporting guidelines tailored to the unique qualities of these data sources and populations.