11006 Background: While women representation and sex disparities in National Comprehensive Cancer Network (NCCN) and European Society of Medical Oncology (ESMO) has been studied in a limited set of CPGs, the sex representation and disparity trend over time among all NCCN and ESMO CPG panelists has not been studied. Our study evaluates the current sex disparities and female representation for all NCCN and ESMO CPGs as of 2020 and compared it to the 2010 CPGs of both organizations. Methods: The 2010 and 2020 version of NCCN and ESMO CPGs were examined from their respective websites and archives. We catalogued the number of female versus male panelist for each CPG. We discerned the sex of the panelists based on google search and the panelists’ affiliated institutional websites. Results: 60 NCCN (2020), 51 NCCN (2010), 78 ESMO (2020) and 55 ESMO (2010) CPGs inclusive of all cancers by site, detection prevention and risk reduction, supportive care, and guidelines for specific population were reviewed. NCCN 2020 CPGs had 55.5% female representation. 35 (58%) NCCN CPGs had predominant female representation (>50% of the members being female) whereas 24 CPG (40%) were male predominant (>50% of the members being male). Solid tumors had 24 CPGs with male predominance and hematological malignancies had 14 CPGs with female predominance. Cancers specific to women had higher proportion of female panelist. NCCN 2010 CPGs had 27.1% female representation. Both solid tumors and hematological malignancies had male predominance (82% and 75% respectively). Breast cancer screening, palliative care and older adult oncology CPGs were female predominant. ESMO 2020 had 27.8% female representation. Both solid tumors (37 CPGs) and hematological malignancies (17 CPGs) had predominant male representation (72% and 85% respectively). Breast and ovarian cancer CPGs were female predominant. ESMO 2010 had 23.2% female representation. Male representation was predominant in both solid tumors (35 CPGs) and hematological malignancies (9 CPGs). Breast, cervical and ovarian cancer CPGs were female predominant. Conclusions: Over the last decade, proportion of female panelists in NCCN CPGs has doubled with more than 50% representation among its 60 CPGs, indicating adequate representation of women. In ESMO, although there has been a significant improvement in female representation in hematological malignancies over time, it continues to have overall female underrepresentation (<30%).[Table: see text]
Conflicts of interest (COI) among the UpToDate oncology management authors.
Journal of Clinical Oncology | June 2, 2021 | Volume: 39 | Issue: 15_suppl | Pages: e13573-e13573
e13573 Background: UpToDate is an evidence based clinical resource designed to provide current clinical information. It is a widely used clinical practice tool providing evidenced based recommendations for diagnosis, management, and therapy. The extent of COI among the UpToDate authors has not been well studied. Our study evaluated the extent of COI of UpToDate authors involved in medical management recommendations for the 10 most common cancers in United States. Methods: We examined the latest November 2020 version of the UpToDate clinical management recommendations for 10 most common cancers. Using disclosure lists, we catalogued COIs for participants in each work group. The categories included: Category I- Grant/Research/Clinical Trial Support; Category II- Consultant/Scientific Advisory Boards/Expert witness; Category III- Speakers Bureau; Category IV- Equity Ownership/Stock Options/Patent holder/Employment/Other Financial Interest; and Category V- Spouse/Domestic Partner/Dependent Potential Conflict. We cataloged the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of an individual in 1 company in 1 category for each cancer section. Results: There was a total of 207 authors including section and deputy editors of oncology management section. All authors completed their COI disclosures (100%). 128 (62%) of a total of 207 individuals reported COIs. A total of 1343 episodes were disclosed. We found that each author had an average of 10.49 episodes overall. Authors involved in Category I, II, III, IV & V were 6.3%, 13.5%, 3.2%, 4.7% and 1.6% respectively. 29.36% authors were involved both in Category I and II. A total of 672 company affiliations were associated with COI disclosure. AstraZeneca (6.10%), Merck (4.31%) and Novartis (2.68%) were the companies most frequently reported. The guideline with the maximum episodes (223) was prostate cancer. Conclusions: COIs are prevalent among authors of UpToDate clinical management recommendations. More than ½ of the participants disclosed at least 1 COI, but there appears to be a substantial number of experienced experts without COIs. Further research studies are necessary to determine the impact of these COIs on clinical practice patterns and resource utilization. Distribution of COI and total episodes.[Table: see text]
MO1037WOMEN REPRESENTATION IN CLINICAL PRACTICE GUIDELINES AMONG MAJOR NEPHROLOGY GUIDELINES
Nephrology Dialysis Transplantation | May 30, 2021 | Volume: 36 | Issue: Supplement_1 | Pages: No page available
Abstract Background and Aims While the percentage of women entering nephrology has increased over the years, women representation and sex disparities in the authorship of major nephrology Clinical practice guidelines (CPG) has not been examined. Our study evaluates current sex disparities and women representation, and the nationalities of women authors in nephrology CPGs developed by the Kidney Disease: Improving Global Outcomes (KDIGO), Kidney Disease Outcomes Quality Initiative (KDOQI), and the European Renal Best Practice (ERBP), the official guideline body of the ERA-EDTA. Method We examined the number of female versus male guideline workgroup members (panelists) for all available CPGs in each of the three organizations as of Dec. 2020, which are available on their respective websites. We discerned the sex of the panelists based on google search and their affiliated institutional websites. We obtained the nationalities of the workgroup members from the authorship information of the respective CPG. Results Of the total 488 panelists in all three organizations, 115 (23.6%) were females and 373 (76.4%) males. KDIGO had 184 panelists, of which 46 (25%) were females. The CPGs with the highest and the least women representation are ‘Diabetes in Chronic Kidney Disease (CKD)’ (41.2%) and ‘Anemia in CKD’ (11.8%), respectively. The countries with the highest number of women representations are the USA (20), followed by Canada (6), and China (4). In KDOQI, 39 (31%) of 127 panelists were female. While CPGs related to ‘Evaluation and management of CKD’ and ‘Nutrition in children with CKD’ each had 50% female panelists, ‘Blood pressure management in CKD’ CPG had 10% female panelists. 28 (72%) of the total 39 women were from the USA. The ERBP had 30 (17%) females of the total 177 panelists. ‘CKD in older patients’ CPG comprised 42.1% female panelists. CPGs for ‘Glycemic control in diabetes’ and ‘Glucose lowering drugs in diabetes’ had no female panelists. Belgium and UK each had six women representatives, while France and The Netherlands 4 women representatives each. Conclusion The guidelines developed by the most prominent organizations – KDIGO, KDOQI, and ERA-EDTA have less than 25% women representation. While it is encouraging to note that there is more women representation in some of the CPGs developed by KDIGO in 2020, evaluating the barriers contributing to the under-representation of women in major nephrology organizations is warranted. Also notable is a lack of women representation from developing countries.
QIM21-078: Women Representation in Clinical Practice Guidelines (CPGs) Among Major Cancer Organizations
Journal of the National Comprehensive Cancer Network | March 17, 2021 | Volume: 19 | Issue: 3.5 | Pages: QIM21-078
Background Clinical practice guidelines (CPGs) are evidence‐based guidelines that serve as a standard of care in oncology practice, reimbursements, and quality improvement initiatives. To our knowledge, the extent of financial conflicts of interest (FCOIs) in National Comprehensive Cancer Network (NCCN) guidelines have not been systemically evaluated. The current study evaluated the extent of FCOIs in the NCCN CPGs for the most common malignancies in the United States. Methods The authors examined the latest 2019 versions of the NCCN CPGs for the 10 most common cancers by incidence in the United States. Using disclosure lists, they catalogued the FCOIs for the panelists under various categories outlined in the CPG. The authors also tabulated the companies and institutions involved in each panel disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes an industrial, commercial, or institutional affiliation reported by a panelist in each episode. Results Of the 491 panelists on the CPG panel, 483 (98.3%) completed FCOI disclosures. A total of 224 (46.4%) reported at least 1 FCOI episode. A total of 1103 episodes were disclosed with an average of 4.9 episodes reported per panelist with FCOIs. Acting as part of scientific advisory boards, as a consultant, or as an expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1103 episodes of FCOI. The top companies were Bristol‐Myers Squibb, Merck, Genentech, and AstraZeneca. Among cancers, the prevalence of FCOIs was highest for lung cancer (56%), bladder cancer (52%), pancreatic cancer (52%), non‐Hodgkin lymphoma (50%), kidney cancer (49%), colorectal cancer (43%), breast cancer (42%), melanoma (40%), prostate cancer (38%), and uterine cancer (32%). Among the panelists with FCOIs, 26%, 17%, and 57%, respectively, reported 1, 2, and >3 episodes. There were 127 episodes noted among the CPG chairs and/or vice chairs who reported FCOIs (mean, 6.4 episodes). The chairs and/or vice chairs of CPGs for uterine cancer, pancreatic cancer, melanoma, and prostate cancer were not found to have any FCOIs. Conclusions FCOIs are very prevalent among NCCN CPG panelists. In nearly one‐half of the CPGs, the majority of the panelists had at least 1 FCOI. Greater than one‐half of the CPG chairs and/or vice chairs reported multiple FCOIs. Further research studies are necessary to determine the impact of these FCOIs.
Acute Interstitial Nephritis and Checkpoint Inhibitor Therapy
Background The objective of this case cohort study was to describe our experience in the care of patients with immune checkpoint inhibitor–related acute interstitial nephritis (ICI-AIN) including rechallenge. Methods A descriptive case series of patients that received an ICI and had an AKI (defined as a ≥1.5-fold increase in serum creatinine) as an immune-related adverse event (irAE), with biopsy-proven or clinically suspected ICI-AIN from January 1, 2014 to December 1, 2018 at Mayo Clinic, Rochester. We studied details regarding diagnosis, clinical course, management, and outcomes of rechallenge of immunotherapy. Complete response (CR) was defined as return of kidney function back to baseline or <0.3 mg/dl above baseline creatinine; partial response (PR) was defined as creatinine >0.3 mg/dl from baseline, but less than twofold above the baseline by the end of steroid course. Results A total of 14 cases of biopsy-proven (35%) or clinically suspected (65%) ICI-AIN was identified. All patients had their ICI withheld and 12 patients received steroids. Steroid regimens were highly variable. The starting equivalent dose of prednisone was higher in those that had a CR versus a PR (median 0.77 mg/kg versus 0.66 mg/kg). Proton pump inhibitors (PPIs) were used in 11 patients and were stopped in eight (73%) patients at the time of the AKI event. A CR was seen in five (63%) of the eight patients who discontinued PPIs. Rechallenge was attempted in four of the 14 patients: three were successful with no recurrence of AKI, but one patient had recurrent AKI and fatal pneumonitis. Conclusions Careful review, withholding ICI and concomitant known AIN-inducing medications, along with prompt initial steroid management were the key in complete renal kidney recovery. A kidney biopsy should be strongly considered. Rechallenge of immunotherapy after a kidney irAE, although challenging, is possible and would need careful evaluation on an individual basis. Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/K360/2020_01_30_KID0000152019.mp3
Financial conflicts of interest among the National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline (CPG) Panelists in 2019.
Journal of Clinical Oncology | October 16, 2019 | Volume: 37 | Issue: 27_suppl | Pages: 15-15
15 Background: CPG are evidence-based guidelines, which serve as a standard of care in practice, quality improvement, and reimbursement. The extent of financial conflicts of Interest (FCOI) in NCCN guidelines has not been recently evaluated. Our study evaluated the extent of FCOI in the NCCN CPG among the 10 most common malignancies in the US. Methods: We examined the latest 2019 version of the NCCN CPG for the 10 most common cancers by incidence in the US. Using disclosure lists, we catalogued the FCOIs for the panelists under various categories outlined in the CPG. We also tabulated the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes a commercial, industry, or institute affiliation reported by a panelist in each episode. Results: Of the 491 panelists on the CPG, 483 (98.3%) completed FCOI disclosures. 224 (46.38%) reported at least 1 FCOI. A total of 1,103 episodes were disclosed with an average of 4.9 episodes per panelist with FCOI. Being a part of scientific advisory boards, consultant, or expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1,103 episodes of FCOI. The top companies were Bristol Myers Squibb, Merck, Genentech and AstraZeneca. Among the top 10 cancers, the prevalence of FCOI were lung (56%), bladder (52%), pancreatic (52%), non-Hodgkin lymphoma (50%), kidney (49%), colorectal (43%), breast (42%), melanoma (40%), prostate (38%), and uterine (32%). Among the panelists with FCOI, 26%, 17%, and 57% reported 1, 2, and > 3 episodes, respectively. There were 127 episodes among the CPG chairs/vice chairs who reported FCOI (mean 6.4). The chairs/vice chairs of uterine, pancreatic, melanoma, and prostate cancer CPG did not have any FCOI. Conclusions: FCOI are very prevalent among the top 10 NCCN CPG panelists. In almost half of the CPG, the majority of the panelists had at least 1 FCOI. Over half of the CPG chairs/vice chairs reported multiple FCOI. Further studies are necessary to determine the impact of these FCOI.