Cited by 190Cancer survivorship and carePsychometric Methodologies and TestingPain Management and Opioid Use

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Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment

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Cella, David, Choi, Seung, Garcia, Sofia, Cook, Karon F., Rosenbloom, Sarah, Lai, Jin-Shei, Tatum, Donna Surges, Gershon, Richard·2014·Quality of Life Research

DOI 10.1007/s11136-014-0732-6PMC PMC4710358

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Abstract

Background Although the use of patient-reported outcome measures (PROs) has increased markedly, clinical interpretation of scores remains lacking. We developed a method to identify clinical severity thresholds for pain, fatigue, depression, and anxiety in people with cancer.Methods Using available Patient-Reported Outcomes Measurement Information System (PROMIS) item bank response data collected on 840 cancer patients, symptom vignettes across a range of symptom severity were developed and placed on index cards. Cards represented symptom severity at five-point intervals differences on the T score metric [mean = 50; standard deviation (SD) = 10]. Symptom vignettes for each symptom were anchored on these standardized scores at 0.5 SD increments across the full range of severity. Clinical experts, blind to the PROMIS score associated with each vignette, rank-ordered the vignettes by severity, then arrived at consensus regarding which two vignettes were at the upper and lower boundaries of normal and mildly symptomatic for each symptom. The procedure was repeated to identify cut scores separating mildly from moderately symptomatic, and moderately from severely symptomatic scores. Clinician severity rankings were then compared to the T scores upon which the vignettes were based.Results For each of the targeted PROs, the severity rankings reached by clinician consensus perfectly matched the numerical rankings of their associated T scores. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.Conclusions The study results provide empirically generated PROMIS T score thresholds that differentiate levels of symptom severity for pain interference, fatigue, anxiety, and depression. The convergence of clinical judgment with self-reported patient severity scores supports the validity of this methodology to derive clinically relevant symptom severity levels for PROMIS symptom measures in other settings.

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Authors: Cella, D., Choi, S., Garcia, S., Cook, K. F., Rosenbloom, S., Lai, J.-S., Tatum, D. S., & Gershon, R.
Affiliations: Northwestern University (US)
Corresponding author: Cella, David
ORCID: Cella, David
Choi, Seung
Garcia, Sofia
Cook, Karon F.
Rosenbloom, Sarah
Lai, Jin-Shei
Gershon, Richard
Venue: Quality of Life Research
Publisher: Springer Science and Business Media LLC
Published: 2014-06-18
Volume: 23
Issue: 10
Pages: 2651-2661
ISSN: 0962-9343 (ISSN-L)
1573-2649
DOI: 10.1007/s11136-014-0732-6
PMC: PMC4710358
OpenAlex: W2086090717
Cited by: 190
References: 29
Citations by year: 2026: 14 · 2025: 15 · 2024: 19 · 2023: 25 · 2022: 26 · 2021: 17 · 2020: 17 · 2019: 20 · 2018: 14 · 2017: 8 · 2016: 7 · 2015: 7 · 2014: 1
FWCI: 3.70
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.springer.com/tdm (tdm)
Locations: Quality of Life Research (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Comprehensive Cancer Network
National Cancer Institute (R01CA060068, U2CCA186878, R01CA60068)
Topics: Health Sciences › Medicine › Oncology › Cancer survivorship and care
Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
Keywords: patient-reported outcomes, cancer symptoms, pain interference, fatigue, depression, anxiety, cut-off values, expert opinion, T-score
MeSH terms: Adult, Aged, Aged, 80 and over, Anxiety, Depression, Fatigue, Female, Humans, Male, Middle Aged, Neoplasms, Pain, Severity of Illness Index, Self Report, Patient Outcome Assessment

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Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment

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