Level of scientific evidence underlying palliative care recommendations arising from the National Comprehensive Cancer Network (NCCN) clinical practice guidelines.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19537-e19537
Author(s):  
Felipe Melo Cruz ◽  
Fernando Mauro Lima Prearo ◽  
Daniel Iracema Cubero ◽  
Auro Del Giglio

e19537 Background: The palliative care NCCN recommendations are classified according to the level of scientific evidence in four groups: 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. Palliative care guidelines have not yet been judged as to the relative content of each of the aforementioned types of recommendations. Methods: We analyzed the distribution of categories of evidence cited in the 10 supportive care NCCN guidelines, version 2.2011. Results: Of the 2,537 recommendations found in the 10 guidelines, the proportion of category I, IIA and IIB recommendations were 2.9%, 95.7%, 1.4%, respectively. There wasn’t any category III recommendation (table 1). The fields with a higher rate of category I recommendations were fatigue (14.3%) and chemotherapy induced nausea and vomiting (12.7%). No category I recommendations were found on Senior Adult Oncology, Cancer and Chemotherapy induced Anemia and Adult Cancer Pain. Conclusions: : Palliative care NCCN recommendations are largely based on lower level of evidence, but with uniform expert opinion. This data show the urgent need to expand palliative care research in oncology. [Table: see text]

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 32-32
Author(s):  
Aakash Desai ◽  
Harry E Fuentes ◽  
Sri Harsha Tella ◽  
Caleb J Scheckel ◽  
Thejaswi Poonacha ◽  
...  

Background: National Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive and widely used standard for clinical care in malignant hematology by clinicians and payers in the US. The level of scientific evidence in NCCN guidelines for malignant hematological conditions has not 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: NCCN uses a system of guideline development distinct from other major professional organizations. The NCCN definitions for EC are: category I, high level of evidence such as randomized controlled trials 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. We compared our results with previously published results from 2011 guidelines. Results: Total recommendations increased by 16.6% from 1160 (2011) to 1353 (2020). Of the 1353 recommendations, Category 1, 2A, 2B and 3 EC were 5%, 91%, 4%, 1% while in 2011 they were 3%, 93%, 4% and 0% respectively. Recommendations with category 1 EC were found in all guidelines, except for Burkitt's Lymphoma. 6.3% of therapeutic recommendations were category 1 EC with the majority (56.4%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were Multiple Myeloma (12.4%), CLL/SLL (6.9%) and AML (5.6%). Between 2011 and 2020, the proportion of category I recommendations increased significantly only in Follicular lymphoma and CLL/SLL. No category 1 EC recommendations existed in staging or surveillance. Conclusion: Recommendations issued in the 2020 NCCN guidelines are largely developed from lower levels of evidence but with uniform expert opinion. Despite the major advances in hematology in the past decade, this is largely unchanged. Our study underscores the urgent need and available opportunities to expand the current evidence base in malignant hematological disorders which forms the platform for clinical practice guidelines. Figure Disclosures No relevant conflicts of interest to declare.


2011 ◽  
Vol 29 (2) ◽  
pp. 186-191 ◽  
Author(s):  
Thejaswi K. Poonacha ◽  
Ronald S. Go

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.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 509-509
Author(s):  
Benny Kusuma ◽  
Ronald S. Go

Abstract Abstract 509 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 hematologic malignancies 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 1160 recommendations found in the 10 guidelines, the proportions of category I, IIA, IIB, and III EC were 3%, 93%, 4%, and 0%, respectively. Recommendations with category I were found in acute myeloid leukemia (4%), multiple myeloma (7%), Hodgkin's lymphoma (1%), diffuse large B-cell lymphoma (4%), follicular lymphoma (11%). Chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, marginal zone lymphoma, AIDS-related B-cell lymphoma, and Burkitt lymphoma did not have any category I recommendations. Three percent of all therapeutic recommendations were category I. Guideline with the highest proportion of category I therapeutic recommendations was for diffuse large B-cell lymphoma (46%). No category I recommendations were found on staging 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. Disclosures: No relevant conflicts of interest to declare.


Author(s):  
Catarina Correia ◽  
Nuno Almeida ◽  
Pedro Narra Figueiredo

<b><i>Introduction:</i></b> Clinical practice guidelines (CPG) contain recommendations that aim to guide physicians in the diagnosis of and therapeutic approach toward patients affected by gastrointestinal (GI) pathologies. These CPG systematically combine scientific evidence and clinical judgment, culminating in recommendations that have been shown to improve patient care. <b><i>Material and Methods:</i></b> European and North American guidelines published in the area of gastroenterology in 2018 and 2019 were considered for inclusion. To standardize the results, only guidelines that used GRADE as an evidence system were included. Thus, in the end, 1,233 recommendations from 29 guidelines published between 2018 and 2019 were analyzed. <b><i>Results:</i></b> Of the 1,233 recommendations collected, 324 (26.3%) had a low level of evidence and 127 (10.3%) had a very low level of evidence, indicating little evidence or expert opinion. Of the 29 publications analyzed, 14 (48.3%) did not present any recommendation with a high level of evidence. Regarding the 1,233 individual recommendations expressed in these 29 publications, only 336 (27.25%) assumed a high level of evidence, with 277 (82.44%) referring to liver pathology. Of the recommendations evaluated, 77 were from North American societies and the remaining 1,156 were European recommendations. In relation to the first group, only 3 (3.9%) had a high level of evidence belonging to the Guidelines for Sedation and Anesthesia in GI Endoscopy. <b><i>Conclusions:</i></b> More than 25% of all recommendations currently accepted to guide patients with gastroenterological disorders are based on low-quality evidence or expert opinion. Thus, these documents should guide our performance, but clinical sense and multidisciplinarity must not be overlooked in dubious cases and with weak scientific evidence. Research should focus on the development of randomized controlled trials and systematic reviews to improve the evidence supporting the guidelines that guide clinical practice.


Healthcare ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 36
Author(s):  
Massimo Romanò

Palliative care is indicated in patients with heart failure since the early phases of the disease, as suggested by international guidelines. However, patients are referred to palliative care very late. Many barriers could explain the gap between the guidelines’ indications and clinical practice. The term palliative is perceived as a stigma by doctors, patients, and family members because it is charged with negative meanings, a poor prognosis, and no hope for improvement. Many authors prefer the term supportive care, which could facilitate a discussion between doctors, patients, and caregivers. There is substantial variation and overlap in the meanings assigned to these two terms in the literature. Prognosis, as the main indication to palliative care, delays its implementation. It is necessary to modify this paradigm, moving from prognosis to patients’ needs. The lack of access to palliative care programs is often due to a lack of palliative care specialists and this shortage will be greater in the near future. In this study, a new model is proposed to integrate early over the course of the disease the palliative care (PC) specialist in the heart failure team, allowing to overcome the barriers and to achieve truly simultaneous care in the treatment of heart failure (HF) patients.


Author(s):  
Jiaxing Xie ◽  
Zhufeng Wang ◽  
Jingyi Liang ◽  
Huimin Lin ◽  
Zhaowei Yang ◽  
...  

Abstract Background Little is known about the quality and potential impacts of the guidelines for COVID-19 management. Methods We systematically searched PubMed, Web of Science, Cochrane Library, guideline databases and specialty society Web sites to evaluate the quality of the retrieved guidelines using the Appraisal of Guidelines for Research and Evaluation II. Results A total of 66 guidelines were identified. Only 24% were categorized as “recommended” for clinical practice. The 211 identified recommendations for COVID-19 management were classified into four topics: respiratory support(27), ARDS management(31), anti-viral or immunomodulatory therapy(95), or other medicines(58). Only 63% and 56% recommendations were supported by, respectively, assessment of the strength of recommendation or level of evidence. There were notable discrepancies between the different guidelines regarding the recommendations on COVID-19 management. Conclusions The quality of the guidelines for COVID-19 management is heterogeneous, and the recommendations are rarely supported by evidence.


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 248-248
Author(s):  
Laura Bobolts ◽  
Dinah Faith Huff ◽  
William J. Hrushesky ◽  
Charles Lee Bennett ◽  
Kevin Knopf ◽  
...  

248 Background: The National Comprehensive Cancer Network (NCCN) invites petitions to its scientific panels. Most ( > 95%) are from the pharmaceutical industry lobbying to include their products in the NCCN Guidelines. Rarely, physicians request scientific scrutiny of the guidelines. We report the experience of Oncology Analytics (OA) with petition submissions and the possible impact on guidelines. Methods: From 2011-2015, OA made 7 petitions to NCCN. The content of each was tracked into subsequent NCCN Guidelines to ascertain whether any changes resulted. Results: 1) The Survivorship Panel was petitioned to add liposomal doxorubicin to the list of cardiotoxic anthracyclines: No changes were made. 2-3) The NSCLC Panel was asked in 2014 to remove the category 2A listing for trastuzumab and afatinib as HER-2 targeted drugs, and cabozantinib as a RET rearrangement target based on absence of phase I-III full text scientific literature. This was done, however, cabozantinib was reverted to 2A status late 2015 based on abstract-only data. 4) Per FDA approval, the NSCLC Panel was asked to recommend bevacizumab only in combination with carboplatin/paclitaxel for 1st line non-squamous NSCLC based on a survival advantage in ECOG 4599: No changes were made. 5) Given the FDA-approval, the Ovarian Cancer Panel was requested to add doxorubicin: This was done. 6) A 2012 Supportive Care Panel petition pointed out the absence of data supporting palonosetron as the preferred 5-HT3 antagonist with aprepitant for moderate or high emetic risk chemotherapy: No change was made upon request; however, preferred status was removed in 2015 from high emetic risk. 7) Based on a preponderance of evidence, a Supportive Care Panel petition requested re-categorization of the febrile neutropenia risk for carboplatin/paclitaxel from intermediate to low except in patients of Japanese ancestry and/or carboplatin AUC > 6: This was done. Conclusions: Majority of NCCN physician petitions came from OA, yet constituted less than 5% of all petitions submitted. NCCN does not provide direct petitioner feedback, so we cannot say for certain that our petitions led to changes in subsequent guidelines. Not all requests resulted in NCCN changes, despite level one supportive data or accentuating an absence of data.


2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 14-14
Author(s):  
Aakash Desai ◽  
Ronald S. Go ◽  
Thejaswi Poonacha

14 Background: National Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive and widely used standard for clinical care in oncology by clinicians and payors in the US. The level of scientific evidence in NCCN guidelines has not been studied since it’s last review in 2010. We describe the categories of evidence and consensus (EC) among the 10 most common cancers in the US as of 2019 and compare them with 2010 guidelines. Methods: We obtained the 2019 version of NCCN guidelines. The definitions for various categories of EC used were: Category 1 (high level evidence such as randomized controlled trials with uniform consensus), 2A (lower level of evidence with uniform consensus), 2B (lower level of evidence without a uniform consensus but with no major disagreement) and 3 (any level of evidence but with major disagreement). We compared our results with previously published results from 2010 guidelines. Results: Total 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% while in 2010 they were 5%, 85%, 9% and 1% respectively. Recommendations with category 1 EC were found in lung (13%), prostate (11%), melanoma (8%), breast (7%), NHL (5%), kidney (2%), bladder (2%) and colorectal (2%) guidelines. Pancreatic and uterine cancer guidelines had no recommendations with category 1 EC. 19% of therapeutic recommendations were category 1 EC with the majority (65%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were breast (30%), lung (10%), and kidney (10%) cancers. No category 1 EC recommendations existed in screening or surveillance. Although we found an increase in the total number of recommendations, the distribution of different types of categories of EC are largely similar to 2010. Conclusions: Recommendations in 2019 NCCN guidelines are largely derived from lower levels of evidence with uniform expert opinion. Despite the major advances in oncology in the past decade, this is largely unchanged. Our study underscores the urgent need and available opportunities to expand the current evidence base in oncology which forms the platform for clinical practice guidelines.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4433-4433
Author(s):  
Ellin Berman ◽  
Cyrus V. Hedvat ◽  
Joseph G. Jurcic ◽  
Mark Heaney ◽  
Peter G. Maslak ◽  
...  

Abstract Abstract 4433 One of the aims of the National Comprehensive Cancer Network (NCCN) is to provide physicians with state-of- the- art treatment pathways for specific malignancies. These guidelines are frequently updated, and disease- based committee members either meet or speak with each other at least once a year. However, it is not known to what extent these guidelines are actually used in clinical practice. In order to determine how physicians in a single large academic cancer center utilize NCCN guidelines for patients with chronic myelogenous leukemia (CML), we reviewed 20 randomly chosen patients with CML diagnosed between 2002 –2007 and 2008– 2010, using 2008 as the year when the more contemporary testing schedule for FISH and PCR was established. Nine physicians, median age 51 years (range 35–61) with a median clinical care experience of 21 years (range 2–30), cared for these patients. The median age of the patients was 58 (range 22–56), 11 were male, and median follow up was 4 years (range 1–8). Eleven patients began treatment in 2008 or later. CML guidelines were divided into two main components: (1) documentation of CML by bone marrow (BM) studies at time of diagnosis, and after 6 and 12 months of imatinib (IM) therapy, and (2) frequency of testing with either BM or peripheral blood (PB) FISH and PCR for BCR-ABL. Of the 20 patients, 17 had diagnostic BMs performed on their initial visit here, and 3 had PB confirmation of disease, having had BMs done on the outside 1, 2, and 5 months prior to their initial visit. Thirteen of the 20 patients had BMs performed after 6 months of IM therapy, and 11 had BMs performed at 12 months; 5 patients had negative karyotype and FISH studies on their 6th month BM and thus did not have a repeat BM at month 12. Thus, NCCN guidelines were followed in 80% of patients. The most common deviation from NCCN guidelines was the frequency of interim PB and/or BM testing using FISH and PCR. While the median interval for PB testing was every 3 months (range 1 to 6), significant numbers of patients had much more frequent testing. For example, 13 of the 20 patients had serial PB FISH performed after at least one negative FISH result; 3 patients had > 5 samples analyzed and one patient had 10 samples tested after at least one negative result. In all these patients, subsequent FISH tests results after the first negative test were also negative. Two patients had BM testing performed after PB PCR was negative in at least two prior samples; BM PCR results were also negative. Three patients had simultaneous BM and PB PCR performed which provided similar results. At the time of last testing, 19 of the 20 patients had a complete cytogenetic response, 13 patients had a complete molecular response, and 6 patients had a major molecular response. One patient with significant co-morbidities took IM intermittently and had no response to therapy. There were no differences between the two groups with regards to frequency of BM or PB FISH or PCR testing. In summary, in this CML patient population, important therapeutic tests such as BM sampling at diagnosis and at treatment decision points (12 months) were met in the majority of patients. However, interim testing varied widely and in many instances, was redundant, even after publication of NCCN contemporary guidelines. In order to eliminate such unnecessary testing and conserve important resources, improved internal audits and communication between the laboratory and the clinical staff is needed. Disclosures: Jurcic: Actinium Pharmaceuticals, Inc.: Membership on an entity’s Board of Directors or advisory committees, Research Funding. Lamanna:Celgene: Membership on an entity’s Board of Directors or advisory committees.


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