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PURPOSE: Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators, which strain resources and impede the detection of valid safety signals. To improve the quality of serious AE (SAE) reporting by physician-investigators and research staff, ASCO developed and tested a Decision Aid. METHODS: A preliminary study with crossover design was conducted in a convenience sample. Physician-investigators and research staff were randomly assigned to receive case studies. Case studies were assessed for seriousness and attribution, first unassisted and then with the Decision Aid. Participants completed a feedback survey about the Decision Aid. Effectiveness of reporting and attribution are reported as odds ratios (ORs) with 95% CI. Power to detect associations was limited because of a small sample size. RESULTS: The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4). Most of the 29 participants reported that the Decision Aid was helpful (93%) and improved decision-making time (69%) and confidence in reporting (83%), and that they would use the Decision Aid in practice (83%). CONCLUSION: The Decision Aid shows promise as a method to improve the quality of SAE attribution, which may improve the detection of valid safety signals and reduce the administrative burden of uninformative investigational new drug safety reports. Study of the Decision Aid in a larger sample with analysis stratified by participant role and SAE reporting experience would further assess the tool's impact. [ABSTRACT FROM AUTHOR]

Purpose: Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all oncology APPs and, second, to understand personal and practice characteristics (including compensation) of those APPs. Methods: We identified APPs who practice oncology from membership and claims data. We surveyed 3,055 APPs about their roles in clinical care. Results: We identified at least 5,350 APPs in oncology and an additional 5,400 who might practice oncology. Survey respondents totaled 577, which provided a 19% response rate. Results focused on 540 NPs and PAs. Greater than 90% reported satisfaction with career choice. Respondents identified predominately as white (89%) and female (94%). NPs and PAs spent the majority (80%) of time in direct patient care. The top four patient care activities were patient counseling (NPs, 94%; PAs, 98%), prescribing (NPs, 93%; PAs, 97%), treatment management (NPs, 89%; PAs, 93%), and follow-up visits (NPs, 81%; PAs, 86%). A majority of all APPs reported both independent and shared visits (65% hematology/oncology/survivorship/prevention/pediatric hematology/oncology; 85% surgical/gynecologic oncology; 78% radiation oncology). A minority of APPs reported that they conducted only shared visits. Average annual compensation was between $113,000 and $115,000, which is approximately $10,000 higher than average pay for nononcology APPs. Conclusion: We identified 5,350 oncology APPs and conclude that number may be as high as 7,000. Survey results suggest that practices that incorporate APPs routinely rely on them for patient care. Given the increasing number of patients with and survivors of cancer, APPs are important to ensure access to quality cancer care now and in the future. [ABSTRACT FROM AUTHOR]

Purpose: To describe the US hematology and medical oncology practice landscape and to report findings of the sixth annual ASCO Oncology Practice Census survey. Participants and Methods: ASCO used Medicare Physician Compare data to characterize oncology practices in the United States. Practice size, number of care sites, and geographic distribution were determined. Trends in the number and size of practices from 2013 to 2017 were examined. All US oncology practices were targeted for the survey; survey responses were linked to the practices identified from Physician Compare to augment results and assess generalizability. Results: More than 2,200 hematology/oncology practices provided care to adult patients in 2017. We observed annual decreases in the number of practices and annual increases in practice size. Of the 2017 practices, 394 (18%) completed the survey and accounted for 58% of the US hematologist/oncologist workforce (n = 7,203). Respondents tended to be larger and encompass more sites of care than nonrespondents. Surveyed practices cited payers (58%), competition (38%), and staffing (37%) as primary sources of strain. Prior authorization was dominant among payer pressures (78%). Electronic health records remained a burden on practices, with only 15% reporting full interoperability. Conclusion: The results of ASCO’s 2017 survey indicate that oncology practices are challenged by day-to-day operations, often related to payment, reimbursement, and competition. Our findings likely represent conservative estimates of such burdens because they are driven by responses from midsized to large-sized organizations, which have lower relative administrative burden, greater market influence, and potentially better ability to adapt in a changing health care environment. [ABSTRACT FROM AUTHOR]