Female Representation in Clinical Practice Guideline Panels in 2 Major Cancer Organizations.

Over the last decade, the proportion of female panelists in NCCN CPGPs has doubled, with more than 50% of members of 60 CPGPs in 2020 being women. In ESMO, although there was an increase in female representation in a few CPGPs from 2010 to 2020, overall female representation remains low (<30%). By continuing to examine these trends, we can create awareness and work toward developing appropriate targeted interventions to improve gender disparities in the major organizations that create CPGs for cancer care.

Level of Scientific Evidence Underlying the National Comprehensive Cancer Network Clinical Practice Guidelines for Hematologic Malignancies: Are We Moving Forward?

Background: The level of scientific evidence in National Comprehensive Cancer Network (NCCN) guidelines for malignant hematological conditions haven't been recently investigated. We describe the distribution of categories of evidence and consensus (EC) among the 10 most common hematologic malignancies with regard to recommendations for staging, initial and salvage therapy, and surveillance. Methods: We reviewed the level of evidence for the 10 most common hematological malignancies by incidence in the United States as of 2020. The NCCN definitions for EC are: category 1, high level of evidence, such as randomized controlled trials, with uniform consensus; category 2A, lower level of evidence with uniform consensus; category 2B, lower level of evidence without a uniform consensus but with no major disagreement; and category 3, any level of evidence but with major disagreement. We compared our results with previously published results from 2011. Results: Of 1353 recommendations, 5%, 91%, 4%, and 1% fell into EC categories 1, 2A, 2B, and 3, respectively, while in 2011 the comparable percentages were 3%, 93%, 4%, and 0%, respectively. Recommendations with category 1 EC were found in all guidelines, except for Burkitt lymphoma. Of all therapeutic recommendations, 6.3% were category 1 EC, with the majority of these (56.4%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were multiple myeloma (12.4%), chronic lymphocytic leukemia/small lymphocytic lymphoma (6.9%), and acute myeloid leukemia (5.6%). Conclusions: Recommendations in the 2020 NCCN guidelines are largely developed from lower levels of evidence but with uniform expert opinion, underscoring the urgent need and available opportunities to expand the current evidence base in malignant hematological disorders.

Self-reported Financial Conflict of Interest in Nephrology Clinical Practice Guidelines.

INTRODUCTION: There is ongoing controversy concerning the potential influence of industry and financial conflict of interest (FCOI) in the development of clinical practice guidelines (CPG). The influence of industry in renal guideline development has been discussed in the past with emphasis on the National Kidney foundation (NKF) and Kidney and Dialysis Outcomes Quality Initiative guidelines. In this study we evaluate the self-reported FCOI among guideline panel members in Kidney Disease: Improving Global Outcomes (KDIGO) CPGs. METHODS: We examined 10 of the most recent KDIGO CPGs developed between 2009 and 2018. Using disclosure lists, we catalogued FCOIs for panelists for each individual CPG. The categories were Advisor/Consultant, Honoraria, Travel Stipend, Grant/Research Support, Speaker, Equity Interest, Employee, Board of Trustees, Royalties, Advisory Board, Employment, Ownership, Data Monitoring Committee, Expert Testimony, and Development of Education Materials. We also reviewed FCOIs for members of evidence review team (ERT). We also catalogued the company involved in each disclosure. One conflict describes 1 instance of participation of an individual in 1 category in each guideline. "Company" describes a commercial, industry, or institute affiliation reported in each episode. RESULTS: One hundred two (66.4%) of the total 151 panelists reported FCOI. A total of 662 conflicts were disclosed. Being a consultant or advisor was the most common category. One hundred fifty-one companies were associated with FCOI disclosure. One company was most frequently reported, involving 60 (9%) of 662 conflicts. Of the 52 members in the ERT, there was 1 instance of FCOI. CONCLUSION: FCOI is prevalent in KDIGO guidelines with almost two thirds of the panelists self-reporting FCOI. The evidence review team had only 1 instance of FCOI.

Category of evidence and consensus underlying National Comprehensive Cancer Network guidelines: Is there evidence of progress?

National Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive and widely used standard for clinical care, financial reimbursements and quality improvement initiatives in oncology. We studied the distribution of categories of evidence and consensus (EC) in the guidelines for the common cancers in the United States. We evaluated the EC categories in staging, therapy and surveillance recommendations in 2019 guidelines and compared them with the same in 2010. The latest 2019 version of NCCN guidelines were obtained. The definitions for various categories of EC used were, Category 1 (high level evidence, uniform consensus), Category 2A (lower level of evidence [LOE], uniform consensus), Category 2B (lower LOE, no uniform consensus but with no major disagreement) and Category 3 (any LOE, major disagreement). We compared our results with previously published results from 2010 guidelines. Total number of recommendations increased by 77% from 1023 (2010) to 1818 (2019). Of the 1818 recommendations, Category 1, 2A, 2B and 3 EC were 7%, 87%, 6% and 0%, respectively, while in 2010 they were 6%, 83%, 10% and 1%. Breast (30%), lung (10%) and kidney (10%) cancer had the highest proportions of Category 1 therapeutic recommendations in their respective guidelines. No Category 1 recommendations were found in screening or surveillance guidelines or in pancreatic and uterine cancer guidelines. Recommendations in 2019 NCCN guidelines are largely Category 2A (lower levels of evidence, uniform expert opinion), unchanged from the previous study in 2010.

Financial conflicts of interest among National Comprehensive Cancer Network clinical practice guideline panelists in 2019.

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.

Level of scientific evidence underlying recommendations arising from the National Comprehensive Cancer Network clinical practice guidelines.

PURPOSE: The level of scientific evidence on which the National Comprehensive Cancer Network (NCCN) guidelines are based has not been systematically investigated. We describe the distribution of categories of evidence and consensus (EC) among the 10 most common cancers with regard to recommendations for staging, initial and salvage therapy, and surveillance. METHODS: NCCN uses a system of guideline development distinct from other major professional organizations. The NCCN definitions for EC are as follows: category I, high level of evidence with uniform consensus; category IIA, lower level of evidence with uniform consensus; category IIB, lower level of evidence without a uniform consensus but with no major disagreement; and category III, any level of evidence but with major disagreement. RESULTS: Of the 1,023 recommendations found in the 10 guidelines, the proportions of category I, IIA, IIB, and III EC were 6%, 83%, 10%, and 1%, respectively. Recommendations with category I EC were found in kidney (20%), breast (19%), lung (6%), pancreatic (6%), non-Hodgkin's lymphoma (6%), melanoma (6%), prostate (4%), and colorectal (1%) guidelines. Urinary bladder and uterine guidelines did not have any category I recommendations. Eight percent of all therapeutic recommendations were category I. Guidelines with the highest proportions of category I therapeutic recommendations were for breast (30%) and kidney (28%) cancers. No category I recommendations were found on screening or surveillance. CONCLUSION: Recommendations issued in the NCCN guidelines are largely developed from lower levels of evidence but with uniform expert opinion. This underscores the urgent need and available opportunities to expand evidence base in oncology.

Does off-pump surgery offer benefit in high respiratory risk patients? A respiratory risk stratified analysis in a propensity-matched cohort.

OBJECTIVE: The role of off-pump surgery in high respiratory risk patients remains unclear. In this study, we aim to evaluate the effect of off-pump surgery on high respiratory risk patients. METHODS: To achieve comparative groups, a five digit propensity score matching with 18 pre-operative variables was performed on 4406 consecutive CABG patients operated between January 2000 and September 2003. Respiratory risk stratification was performed with the following variables: (1) FEV(1)<65% of predicted, (2) patients>75 years old, (3) history of current smoking, (4) body mass index more than 40 kg/m(2) and (5) NYHA class IV dyspnoea in combination with current respiratory medication. The presence of two or more variables defined high risk. The primary end point was post-operative ventilation time. We also compared alveolar arterial gradients (A-a gradient) on admission to ITU, 2 and 4h using Friedman rank time analysis. RESULTS: We matched 1353 off-pump patients with 1353 unique on-pump patients. Respiratory risk stratified selection resulted in 73 off-pump and 55 on-pump high-risk patients. In the off-pump group, four (5.5%) patients had more than two selection criteria, compared to one (1.8%) for on-pump patients (p=0.29). The off-pump group had more patients with FEV1<65% compared to on-pump: 65 (89.0%) versus 40 (72.7%); p=0.017. The median ventilation time was significantly shorter for off-pump patients (7h [IQR: 5-14] vs 12h [IQR: 7-18], p=0.003). In the off-pump group, three (4.1%) patients had a ventilation time>48 h compared to eight (14.6%) in the on-pump group, p=0.037. A-a gradient measurements on admission to ITU were lower in off-pump patients (median: 182.3 [IQR: 126.6-216.2]) compared to on-pump patients (median: 194.7 [IQR 139.7-245.4], p=0.064). CONCLUSION: Off-pump surgery offers benefit to high respiratory risk patients by reducing post-operative ventilation time. Off-pump patients also have lower A-a gradients in the early post-operative period but this failed to reach significance.