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

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

Open access
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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  • T-scores below 50 for fatigue and below 55 for sleep disturbance, pain, anxiety, and depression are considered normal based on published threshold scores.

    “T-scores <50 for fatigue measures and T-scores <55 for sleep disturbance, pain, anxiety, and depression measures are considered normal based on published threshold scores [25, 26].”

    From Symptom experiences in post-treatment cancer survivors: associations with acceptance and commitment therapy constructs. (2021) · cites this paper as [25]

    The Results and Discussion describe PROMIS severity thresholds for fatigue, pain interference, anxiety, and depression, including a boundary between normal and mild symptoms near T = 50. The retrieved passages do not establish the claimed exact cutoffs of <50 and <55, and this paper does not assess sleep disturbance. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • Class 1 (32% of patients) had normal levels of all symptoms.

    “Class 1 (n=65, 32%) was the least symptomatic with normal levels of all symptoms.22,23”

    From Symptom experiences in advanced cancer: Relationships to acceptance and commitment therapy constructs (2021) · cites this paper as [23]

    The Abstract Results describe cut scores distinguishing normal from mild symptoms, supporting the use of “normal” as a symptom-severity category. The paper does not identify a Class 1 or report that 65 patients (32%) had normal levels of all symptoms. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 2

  1. [15]Zelman D Hoffman D Reed P Edwards L Dukes E 2003 Quantifying a “day of manageable pain control:” The relationship between pain severity and patient daily functional expectations Journal of Pain 4 Suppl 1 1
  2. [23]Baghaei P 2007 Applying The Rasch Rating-Scale model to set multiple cut-offs Rasch Measurement Transactions 20 4 1075 1076

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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
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
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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