Development of a Functional Assessment of Chronic Illness Therapy item library and primary symptom list for the assessment of patient-reported adverse events associated with immune checkpoint modulators  

作　　者：Kimberly A.Webster Mary L.O’Connor Aaron R.Hansen Sheetal Kircher Heather S.L.Jim Adam P.Dicker Monika Janda Kari Ala-leppilampi Clifton O.Bingham III Josephine Feliciano Norah Lynn Henry Laurie E.Steffen McLouth David Cella 

机构地区：[1]Department of Medical Social Sciences,Northwestern University Feinberg School of Medicine,Chicago,IL 60611,USA [2]Princess Margaret Cancer Center,University Health Network,Toronto M5G 1Z5,Canada [3]Robert H Lurie Comprehensive Cancer Center,Northwestern University,Chicago,IL 60611,USA [4]Department of Health Outcomes and Behavior,Moffitt Cancer Center,Tampa,FL 33612,USA [5]Department of Radiation Oncology,Sidney Kimmel Medical College and Cancer Center at Thomas Jefferson University,Philadelphia,PA 19107,USA [6]Centre for Health Services Research,The University of Queensland,QLD 4102,Australia [7]Applied Health Research Centre,Li Ka Shing Knowledge Institute,St Michael’s Hospital,Toronto M5B 1W8,Canada [8]Divisions of Rheumatology and Allergy and Clinical Immunology,Johns Hopkins University,Baltimore,MD 21224,USA [9]Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center,Baltimore,MD 21231,USA [10]University of Michigan Rogel Cancer Center,Ann Arbor,MI 48109,USA [11]Department of Behavioral Science,Center for Health Equity Transformation and Markey Cancer Center,University of Kentucky College of Medicine,Lexington,KY 40536,USA

出　　处：《Journal of Cancer Metastasis and Treatment》2020年第1期74-87,共14页癌症转移与治疗（英文版）

基　　金：Laurie E.Steffen McLouth was supported by NCI R25 CA122061(PI:Avis);Adam P.Dicker received additional support from the National Cancer Institute,the Prostate Cancer Research Program(Dept.of Defense);the American Society of Radiation Oncology,the American Society of Clinical Oncology,NRG Oncology,and the Prostate Cancer Foundation;Josephine Feliciano received additional support from Bristol Myers Squibb and Astra Zeneca.

摘　　要：Aim:To develop a comprehensive item library of patient-reported,immunotherapy-related adverse events(irAEs)that draws from and expands on the Functional Assessment of Chronic Illness Therapy(FACIT)Measurement System.Methods:Literature review and iterative expert input.Based on a literature review of irAEs,we developed a framework of immunotherapy classes and their associated symptoms.Clinical experts then reviewed iterations of symptom summaries and item maps linked to the immunotherapy framework.Experts provided content review and feedback was shared across experts until consensus was reached.The iterative process facilitated creation of a Primary Symptom List associated with immune checkpoint modulators(ICMs),drawn from the larger set of symptoms.Existing FACIT items were mapped to the symptom list,and new items were written as needed to create the item library.Results:The full item library of irAEs is comprised of 239 items,covering 142 unique symptoms across 75 inflammatory reactions/immune conditions.A subset of 66 items comprises a Primary Symptom List considered most common/relevant to ICM treatment.This includes gastrointestinal,skin,pulmonary,neurologic,musculoskeletal,and multiple miscellaneous and constitutional symptoms.Conclusion:The FACIT Immunotherapy Item Library is a compilation of 239 self-report items that capture the wide range of AEs experienced by people receiving immune treatments.A subset of 66 items comprises a Primary Symptom List meant for ICM therapy.Use of items selected from this library is encouraged in clinical research and clinical practice evaluation.

关 键 词：Immunotherapy immune checkpoint modulators quality of life immune-related adverse events patient reported outcomes cancer ONCOLOGY 

分 类 号：R73[医药卫生—肿瘤]