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Gepubliceerd in: Quality of Life Research 12/2019

13-08-2019

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

Auteurs: Nan E. Rothrock, Karon F. Cook, Mary O’Connor, David Cella, Ashley Wilder Smith, Susan E. Yount

Gepubliceerd in: Quality of Life Research | Uitgave 12/2019

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Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusions

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.
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Literatuur
1.
go back to reference Chen, J., Ou, L., & Hollis, S. J. (2013). A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Services Research,13, 211–211.CrossRef Chen, J., Ou, L., & Hollis, S. J. (2013). A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Services Research,13, 211–211.CrossRef
2.
go back to reference Howell, D., Molloy, S., Wilkinson, K., Green, E., Orchard, K., Wang, K., et al. (2015). Patient-reported outcomes in routine cancer clinical practice: A scoping review of use, impact on health outcomes, and implementation factors. Annals of Oncology,26(9), 1846–1858.CrossRef Howell, D., Molloy, S., Wilkinson, K., Green, E., Orchard, K., Wang, K., et al. (2015). Patient-reported outcomes in routine cancer clinical practice: A scoping review of use, impact on health outcomes, and implementation factors. Annals of Oncology,26(9), 1846–1858.CrossRef
3.
go back to reference Wagner, L. I., Schink, J., Bass, M., Patel, S., Diaz, M. V., Rothrock, N., et al. (2015). Bringing PROMIS to practice: Brief and precise symptom screening in ambulatory cancer care. Cancer,121(6), 927–934.CrossRef Wagner, L. I., Schink, J., Bass, M., Patel, S., Diaz, M. V., Rothrock, N., et al. (2015). Bringing PROMIS to practice: Brief and precise symptom screening in ambulatory cancer care. Cancer,121(6), 927–934.CrossRef
4.
go back to reference Seneviratne, M. G., Bozkurt, S., Patel, M. I., Seto, T., Brooks, J. D., Blayney, D. W., et al. (2019). Distribution of global health measures from routinely collected PROMIS surveys in patients with breast cancer or prostate cancer. Cancer,125(6), 943–951.CrossRef Seneviratne, M. G., Bozkurt, S., Patel, M. I., Seto, T., Brooks, J. D., Blayney, D. W., et al. (2019). Distribution of global health measures from routinely collected PROMIS surveys in patients with breast cancer or prostate cancer. Cancer,125(6), 943–951.CrossRef
5.
go back to reference Lohr, K. N., Aaronson, N. K., Alonso, J., Audrey Burnam, M., Patrick, D. L., Perrin, E. B., et al. (1996). Evaluating quality-of-life and health status instruments: Development of scientific review criteria. Clinical Therapeutics,18(5), 979–992.CrossRef Lohr, K. N., Aaronson, N. K., Alonso, J., Audrey Burnam, M., Patrick, D. L., Perrin, E. B., et al. (1996). Evaluating quality-of-life and health status instruments: Development of scientific review criteria. Clinical Therapeutics,18(5), 979–992.CrossRef
6.
go back to reference 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.CrossRef 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.CrossRef
7.
go back to reference Cappelleri, J. C., & Bushmakin, A. G. (2014). Interpretation of patient-reported outcomes. Statistical Methods in Medical Research,23(5), 460–483.CrossRef Cappelleri, J. C., & Bushmakin, A. G. (2014). Interpretation of patient-reported outcomes. Statistical Methods in Medical Research,23(5), 460–483.CrossRef
8.
go back to reference 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.CrossRef 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.CrossRef
9.
go back to reference Palos, G. R., Mendoza, T. R., Mobley, G. M., Cantor, S. B., & Cleeland, C. S. (2006). Asking the community about cutpoints used to describe mild, moderate, and severe pain. The Journal of Pain,7(1), 49–56.CrossRef Palos, G. R., Mendoza, T. R., Mobley, G. M., Cantor, S. B., & Cleeland, C. S. (2006). Asking the community about cutpoints used to describe mild, moderate, and severe pain. The Journal of Pain,7(1), 49–56.CrossRef
10.
go back to reference Coon, C. D., & Cook, K. F. (2018). Moving from significance to real-world meaning: Methods for interpreting change in clinical outcome assessment scores. Quality of Life Research,27(1), 33–40.CrossRef Coon, C. D., & Cook, K. F. (2018). Moving from significance to real-world meaning: Methods for interpreting change in clinical outcome assessment scores. Quality of Life Research,27(1), 33–40.CrossRef
11.
go back to reference 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.CrossRef 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.CrossRef
12.
go back to reference Cizek, G. J. (1993). Reconsidering standards and criteria. Journal of Educational Measurement,30(2), 93–106.CrossRef Cizek, G. J. (1993). Reconsidering standards and criteria. Journal of Educational Measurement,30(2), 93–106.CrossRef
13.
go back to reference Perie, M. (2005). Angoff and Bookmark methods. Workshop presented at the Annual Meeting of the National Council on Measurement in Education, Montreal, Canada. Perie, M. (2005). Angoff and Bookmark methods. Workshop presented at the Annual Meeting of the National Council on Measurement in Education, Montreal, Canada.
14.
go back to reference Cella, D., Choi, S., Garcia, S., Cook, K. F., Rosenbloom, S., Lai, J.-S., et al. (2014). Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment. Quality of Life Research,23(10), 2651–2661.CrossRef Cella, D., Choi, S., Garcia, S., Cook, K. F., Rosenbloom, S., Lai, J.-S., et al. (2014). Setting standards for severity of common symptoms in oncology using the PROMIS item banks and expert judgment. Quality of Life Research,23(10), 2651–2661.CrossRef
15.
go back to reference 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.CrossRef 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.CrossRef
16.
go back to reference Nagaraja, V., Mara, C., Khanna, P. P., Namas, R., Young, A., Fox, D. A., et al. (2018). Establishing clinical severity for PROMIS® measures in adult patients with rheumatic diseases. Quality of Life Research,27(3), 755–764.CrossRef Nagaraja, V., Mara, C., Khanna, P. P., Namas, R., Young, A., Fox, D. A., et al. (2018). Establishing clinical severity for PROMIS® measures in adult patients with rheumatic diseases. Quality of Life Research,27(3), 755–764.CrossRef
17.
go back to reference 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.CrossRef 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.CrossRef
18.
go back to reference Cook, K., Cella, D., & Reeve, B. (2019). PRO-bookmarking to estimate clinical thresholds for patient-reported symptoms and function. Medical Care,57, S13–S17.CrossRef Cook, K., Cella, D., & Reeve, B. (2019). PRO-bookmarking to estimate clinical thresholds for patient-reported symptoms and function. Medical Care,57, S13–S17.CrossRef
19.
go back to reference 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.CrossRef 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.CrossRef
20.
go back to reference Rose, M., Bjorner, J. B., Gandek, B., Bruce, B., Fries, J. F., & Ware, J. E. (2014). The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. Journal of Clinical Epidemiology,67(5), 516–526.CrossRef Rose, M., Bjorner, J. B., Gandek, B., Bruce, B., Fries, J. F., & Ware, J. E. (2014). The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. Journal of Clinical Epidemiology,67(5), 516–526.CrossRef
21.
go back to reference Lai, J. S., Wagner, L. I., Jacobsen, P. B., & Cella, D. (2014). Self-reported cognitive concerns and abilities: two sides of one coin? Psycho-Oncology,23(10), 1133–1141.CrossRef Lai, J. S., Wagner, L. I., Jacobsen, P. B., & Cella, D. (2014). Self-reported cognitive concerns and abilities: two sides of one coin? Psycho-Oncology,23(10), 1133–1141.CrossRef
22.
go back to reference Buysse, D. J., Yu, L., Moul, D. E., Germain, A., Stover, A., Dodds, N. E., et al. (2010). Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep,33(6), 781–792.CrossRef Buysse, D. J., Yu, L., Moul, D. E., Germain, A., Stover, A., Dodds, N. E., et al. (2010). Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep,33(6), 781–792.CrossRef
23.
go back to reference 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.CrossRef 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.CrossRef
24.
go back to reference 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.CrossRef 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.CrossRef
25.
go back to reference R Development Core Team. (2008). R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing. R Development Core Team. (2008). R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing.
Metagegevens
Titel
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
Auteurs
Nan E. Rothrock
Karon F. Cook
Mary O’Connor
David Cella
Ashley Wilder Smith
Susan E. Yount
Publicatiedatum
13-08-2019
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 12/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-019-02261-2

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