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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

引用

Journal of Cancer Metastasis and Treatment 2020年第1期6卷 74-87页

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 Department of Medical Social Sciences Northwestern University Feinberg School of MedicineChicagoIL 60611USA Princess Margaret Cancer Center University Health NetworkToronto M5G 1Z5Canada Robert H Lurie Comprehensive Cancer Center Northwestern UniversityChicagoIL 60611USA Department of Health Outcomes and Behavior Moffitt Cancer CenterTampaFL 33612USA Department of Radiation Oncology Sidney Kimmel Medical College and Cancer Center at Thomas Jefferson UniversityPhiladelphiaPA 19107USA Centre for Health Services Research The University of QueenslandQLD 4102Australia Applied Health Research Centre Li Ka Shing Knowledge InstituteSt Michael’s HospitalToronto M5B 1W8Canada Divisions of Rheumatology and Allergy and Clinical Immunology Johns Hopkins UniversityBaltimoreMD 21224USA Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center BaltimoreMD 21231USA University of Michigan Rogel Cancer Center Ann ArborMI 48109USA Department of Behavioral Science Center for Health Equity Transformation and Markey Cancer CenterUniversity of Kentucky College of MedicineLexingtonKY 40536USA

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 ***:Literature review and iterative expert *** on a literature review of irAes,we developed a framework of immunotherapy classes and their associated *** experts then reviewed iterations of symptom summaries and item maps linked to the immunotherapy *** provided content review and feedback was shared across experts until consensus was *** iterative process facilitated creation of a Primary Symptom List associated with immune checkpoint modulators(ICMs),drawn from the larger set of *** FACIT items were mapped to the symptom list,and new items were written as needed to create the item ***: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 *** includes gastrointestinal,skin,pulmonary,neurologic,musculoskeletal,and multiple miscellaneous and constitutional ***: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 *** 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

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