Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting
Patient-Reported Outcomes Measurement Information System® (PROMIS®) physical function, cognitive function, and sleep disturbance measures are increasingly used in cancer care. However, there is limited guidance for interpreting the clinical meaning of scores. This study aimed to apply bookmarking, a standard setting methodology, to identify PROMIS score thresholds in the context of cancer care.
Using item parameters, we constructed vignettes of five items covering the range of possible scores. Focus groups were held with cancer care providers and people with cancer. Terminology for categorizing levels of severity was explored. Participants rank ordered vignettes by severity and then placed bookmarks between vignettes representing different levels of severity. Group discussion was held until consensus on bookmark placement was reached.
Clinicians selected “within normal limits,” “mild,” “moderate,” and “severe” to describe levels of severity. Both patients and clinicians were able to apply these labels, but there was not unanimous support for any set of descriptors. Clinicians and patients agreed on all severity thresholds for sleep disturbance. For cognitive and physical function, clinicians and patients agreed on the threshold between “within normal limits” and “mild.” However, patients required greater dysfunction than clinicians before applying “moderate” and “severe” labels.
Bookmarking can be applied to develop provisional score interpretation for PROMIS measures. Patients and clinicians were frequently consistent in their bookmark placement. When there was variance, patients required more dysfunction before assigning more severity. Additional research with other cancer samples is needed to evaluate the replicability and generalizability of our findings.
KeywordsPatient-reported outcomes Physical function Sleep Cognitive function Reference values PROMIS
This study was funded by the National Institutes of Health Grant U2C CA186878.
- 6.Snyder, C. F., Smith, K. C., Bantug, E. T., Tolbert, E. E., Blackford, A. L., Brundage, M. D., et al. (2017). What do these scores mean? Presenting patient-reported outcomes data to patients and clinicians to improve interpretability. Cancer, 123(10), 1848–1859.CrossRefPubMedPubMedCentralGoogle Scholar
- 8.Given, B., Given, C. W., Sikorskii, A., Jeon, S., McCorkle, R., Champion, V., et al. (2008). Establishing mild, moderate, and severe scores for cancer-related symptoms: How consistent and clinically meaningful are interference-based severity cut-points? Journal of Pain and Symptom Management, 35(2), 126–135.CrossRefPubMedGoogle Scholar
- 11.Basch, E., Reeve, B. B., Mitchell, S. A., Clauser, S. B., Minasian, L. M., Dueck, A. C., et al. (2014). Development of the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JNCI: Journal of the National Cancer Institute, 106(9), 244.CrossRefGoogle Scholar
- 13.Perie, M. (2005). Angoff and Bookmark methods. Workshop presented at the Annual Meeting of the National Council on Measurement in Education, Montreal, Canada.Google Scholar
- 15.Cook, K. F., Victorson, D. E., Cella, D., Schalet, B. D., & Miller, D. (2015). Creating meaningful cut-scores for Neuro-QOL measures of fatigue, physical functioning, and sleep disturbance using standard setting with patients and providers. Quality of Life Research, 24(3), 575–589.CrossRefPubMedGoogle Scholar
- 17.Morgan, E. M., Mara, C. A., Huang, B., Barnett, K., Carle, A. C., Farrell, J. E., et al. (2017). Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers. Quality of Life Research, 26(3), 565–586.CrossRefPubMedGoogle Scholar
- 19.Rose, M., Bjorner, J. B., Becker, J., Fries, J., & Ware, J. (2008). Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). Journal of Clinical Epidemiology, 61(1), 17–33.CrossRefPubMedGoogle Scholar
- 23.Cella, D., Riley, W., Stone, A., Rothrock, N., Reeve, B., Yount, S., et al. (2010). The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. Journal of Clinical Epidemiology, 63(11), 1179–1194.CrossRefPubMedPubMedCentralGoogle Scholar
- 24.Reeve, B. B., Hays, R. D., Bjorner, J. B., Cook, K. F., Crane, P. K., Teresi, J. A., et al. (2007). Psychometric evaluation and calibration of health-related quality of life item banks: Plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Medical Care, 45(5), S22–S31.CrossRefPubMedGoogle Scholar
- 25.R Development Core Team. (2008). R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing.Google Scholar