ROLE OF PATIENT-REPORTED OUTCOME MEASURES (PROMs) IN SYSTEMIC LUPUS ERYTHEMATOSUS: A SYSTEMATIC REVIEW
Main Article Content
Abstract
Patient-reported outcomes (PROs) throughout care with individual patients present a critical function in the overall clinical decision-making, which leads to the optimization of the therapeutic plan for Systemic Lupus Erythematosus (SLE) patients. The current study seeks to identify and accurately evaluate all studies appraising patient-reported Health-Related Quality of Life (HRQoL) in patients with SLE. A systematic literature review was performed through SCOPUS database up to January 2021. All potential materials and relevant PROMs were summarized for non-validation studies and perform a methodological quality assessment of identified SLE-specific PROMs studies utilizing the Consensus-based Standards for the selection of health Measurement INstruments (COSMIN). Thirty articles were included in the shortlist to assess PROMs relevant from 3,946 studies initially identified, of which seven materials were used for validation studies focusing on SLE-specific PROMs. High bias (83%) was evident among generic instruments indicating low confidence that the results represent the actual treatment effect. For the validation studies using COSMIN analysis, the reliability of material was determined by the lowest score of all quality items for each criterion of measurement. The systematic review performed is unlikely to determine specific issues concerning the quality of life of the patient due to lack of evidence of its clinimetric importance due to inconsistent study design and PRO reporting in studies. However, studying SLE-specific PROMs has a favorable impact on patients and clinicians concerning its HRQOL, which can further be improved by future researchers when sufficient clinical data and investigations are conducted.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Journal of TCI is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) licence, unless otherwise stated. Please read our Policies page for more information.
References
Aggarwal, R., Wilke C., Pickard, A.S., Vats, V., Mikolaitis, R., Fogg, L., … Jolly, M. (2009). Psychometric Properties of the EuroQol-5D and Short Form-6D in Patients with Systemic Lupus Erythematosus. The Journal of Rheumatology, 36(6), 1209–1216.doi:10.3899/jrheum.081022
Borg, A., Gomez, A., Cederlund, A., Cobar, F., Qiu, V., Lindblom, J., . . . Parodis, I. (2021). Contribution of abnormal BMI to ADVERSE health-related quality of life outcomes after a 52-week therapy in patients with SLE. Rheumatology. doi:10.1093/rheumatology/keaa909
Brandt, J. E., Drenkard, C., Kan, H., Bao, G., Dunlop-Thomas, C., Pobiner, B., … Lim, S. S. (2017). External Validation of the Lupus Impact Tracker in a Southeastern US Longitudinal Cohort With Systemic Lupus Erythematosus. Arthritis Care & Research, 69(6), 842–848. doi:10.1002/acr.23009
Devilliers, H., Bonithon-Kopp, C., & Jolly, M. (2016). The lupus impact tracker is responsive to changes in clinical activity measured by the systemic lupus erythematosus responder index. Lupus, 26(4), 396–402.doi:10.1177/0961203316667494
Dietz, B., Katz, P., Dall’Era, M., Murphy, L. B., Lanata, C., Trupin, L., … Yazdany, J. (2020). Major Depression and Adverse Patient‐Reported Outcomes in Systemic Lupus Erythematosus: Results from the California Lupus Epidemiology Study. Arthritis Care & Research.doi:10.1002/acr.24398
Elefante, E., Tani, C., Stagnaro, C., Ferro, F., Parma, A., Carli, L., … Mosca, M. (2020). Impact of fatigue on health-related quality of life and illness perception in a monocentric cohort of patients with systemic lupus erythematosus. RMD Open, 6(1), e001133. doi:10.1136/rmdopen-2019-001133
Elefante, E., Tani, C., Stagnaro, C., Signorini, V., Parma, A., Carli, L., … Mosca, M. (2020). Articular involvement, steroid treatment and fibromyalgia are the main determinants of patient-physician discordance in systemic lupus erythematosus. Arthritis Research & Therapy, 22(1). doi:10.1186/s13075-020-02334-5
Fidler, L., Keen, K. J., Touma, Z., & Mittoo, S. (2016). Impact of pulmonary disease on patient-reported outcomes and patient-performed functional testing in systemic lupus erythematosus. Lupus, 25(9), 1004–1011. doi:10.1177/0961203316630818
Gavilán-Carrera, B., Vargas-Hitos, J. A., Morillas-de-Laguno, P., Rosales-Castillo, A., Sola-Rodríguez, S., Callejas-Rubio, J. L., … Soriano-Maldonado, A. (2020). Effects of 12-week aerobic exercise on patient-reported outcomes in women with systemic lupus erythematosus. Disability and Rehabilitation, 1–9.doi:10.1080/09638288.2020.1808904
Golder, V., Kandane-Rathnayake, R., Hoi, A. Y.-B., Huq, M., Louthrenoo, W., … Morand, E. F. (2017). Association of the lupus low disease activity state (LLDAS) with health-related quality of life in a multinational prospective study. Arthritis Research & Therapy, 19(1). doi:10.1186/s13075-017-1256-6
Gordon, C., Isenberg, D., Lerstrom, K., Norton, Y., Nikai, E., Pushparajah, D. S., & Schneider, M. (2013). The substantial burden of systemic lupus erythematosus on the productivity and careers of patients: a European patient-driven online survey. Rheumatology, 52(12), 2292–2301.doi:10.1093/rheumatology/ket300
Inoue, M., Shiozawa, K., Yoshihara, R., Yamane, T., Shima, Y., Hirano, T., & Makimoto, K. (2017). Predictors of poor sleep quality in patients with systemic lupus erythematosus. Clinical Rheumatology, 36(5), 1053–1062. doi:10.1007/s10067-017-3545-5
Jolly, M., Annapureddy, N., Arnaud, L., & Devilliers, H. (2019). Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial. Lupus, 096120331988606.doi:10.1177/0961203319886065
Jolly, M., Galicier, L., Aumaître, O., Francès, C., Le Guern, V., … Lioté, F. (2016). Quality of life in systemic lupus erythematosus: description in a cohort of French patients and association with blood hydroxychloroquine levels. Lupus, 25(7), 735–740. doi:10.1177/0961203315627200
Jolly, M., Toloza, S., Goker, B., Clarke, A. E., Navarra, S. V., Wallace, D., … Mok, C. C. (2017). Disease-specific quality of life in patients with lupus nephritis. Lupus, 27(2), 257–264. doi:10.1177/0961203317717082
Kasturi, S., Szymonifka, J., Burket, J. C., Berman, J. R., Kirou, K. A., Levine, A. B., … Mandl, L. A. (2017). Validity and Reliability of Patient Reported Outcomes Measurement Information System Computerized Adaptive Tests in Systemic Lupus Erythematosus. The Journal of Rheumatology, 44(7), 1024–1031.doi:10.3899/jrheum.161202
Kasturi, S., Szymonifka, J., Berman, J. R., Kirou, K. A., Levine, A. B., Sammaritano, L. R., & Mandl, L. A. (2019). Responsiveness of PROMIS ® Global Health Short Form in Outpatients with Systemic Lupus Erythematosus. Arthritis Care & Research.doi:10.1002/acr.24026
Kasturi, S., Szymonifka, J., Burket, J. C., Berman, J. R., Kirou, K. A., Levine, A. B., … Mandl, L. A. (2018). Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus. The Journal of Rheumatology, 45(3), 397–404.doi:10.3899/jrheum.170590
Lai, J.-S., Beaumont, J. L., Jensen, S. E., Kaiser, K., Van Brunt, D. L., Kao, A. H., & Chen, S.-Y. (2016). An evaluation of health-related quality of life in patients with systemic lupus erythematosus using PROMIS and Neuro-QoL. Clinical Rheumatology, 36(3), 555–562.doi:10.1007/s10067-016-3476-6
Lindblom, J., Gomez, A., Borg, A., Emamikia, S., Ladakis, D., Matilla, J., . . . Parodis, I. (2021). EQ-5D-3L full health STATE discriminates between drug and placebo in clinical trials of systemic lupus erythematosus. Rheumatology. doi:10.1093/rheumatology/keab080
Louthrenoo, W., Kasitanon, N., Morand, E., & Kandane-Rathnayake, R. (2020). Comparison of performance of specific (SLEQOL) and generic (SF36) health-related quality of life questionnaires and their associations with disease status of systemic lupus erythematosus: a longitudinal study. Arthritis Research & Therapy, 22(1). doi:10.1186/s13075-020-2095-4
Magro-Checa, C., Beaart-van de Voorde, L. J. J., Middelkoop, H. A. M., Dane, M. L., van der Wee, N. J., van Buchem, M. A., … Steup-Beekman, G. M. (2017). Outcomes of neuropsychiatric events in systemic lupus erythematosus based on clinical phenotypes; prospective data from the Leiden NP SLE cohort. Lupus, 26(5), 543–551. doi:10.1177/0961203316689145
Mahieu, M. A., Ahn, G. E., Chmiel, J. S., Dunlop, D. D., Helenowski, I. B., Semanik, P., … Ramsey-Goldman, R. (2016). Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus. Lupus, 25(11), 1190–1199.doi:10.1177/0961203316631632
Mahieu, M., Yount, S., & Ramsey-Goldman, R. (2016). Patient-Reported Outcomes in Systemic Lupus Erythematosus. Rheumatic Disease Clinics of North America, 42(2), 253–263. doi:10.1016/j.rdc.2016.01.001
Mathias, S. D., Berry, P., De Vries, J., Pascoe, K., Colwell, H. H., Chang, D. J., & Askanase, A. D. (2017). Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures. Journal of Patient-Reported Outcomes, 2(1). doi:10.1186/s41687-018-0028-7
Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. (2018). The importance of patient-reportedoutcomes in clinical trials and strategies for future optimization. Patient Related Outcome Measures, Volume 9, 353–367. doi:10.2147/prom.s156279
Moldovan, I., Katsaros, E., Carr, F., Cooray, D., Torralba, K., Shinada, S., … Nicassio, P. (2011). The Patient Reported Outcomes in Lupus (PATROL) study: role of depression in health-related quality of life in a Southern California lupus cohort. Lupus, 20(12), 1285–1292.doi:10.1177/0961203311412097
Pamuk, O. N., Onat, A. M., Donmez, S., Mengüs, C., & Kisacik, B. (2014). Validity and reliability of the Lupus QoL index in Turkish systemic lupus erythematosus patients. Lupus, 24(8), 816–821.doi:10.1177/0961203314565412
Patterson, S. L., Schmajuk, G., Jafri, K., Yazdany, J., & Katz, P. (2018). Obesity Independently Associates with Worse Patient-Reported Outcomes in Women with Systemic Lupus Erythematosus. Arthritis Care & Research. doi:10.1002/acr.23576
Petri, M., Kawata, A. K., Fernandes, A. W., Gajria, K., Greth, W., Hareendran, A., & Ethgen, D. (2013). Impaired Health Status and the Effect of Pain and Fatigue on Functioning in Clinical Trial Patients with Systemic Lupus Erythematosus. The Journal of Rheumatology, 40(11), 1865–1874. doi:10.3899/jrheum.130046
Piga, M., Congia, M., Gabba, A., Figus, F., Floris, A., Mathieu, A., & Cauli, A. (2017). Musculoskeletal manifestations as determinants of quality of life impairment in patients with systemic lupus erythematosus. Lupus, 27(2), 190–198.doi:10.1177/0961203317716319
Román Ivorra, J. A., Fernández-Llanio-Comella, N., San-Martín-Álvarez, A., Vela-Casasempere, P., Saurí-Ferrer, I., González-de-Julián, S., & Vivas-Consuelo, D. (2019). Health-related quality of life in patients with systemic lupus erythematosus: a Spanish study based on patient reports. Clinical Rheumatology. doi:10.1007/s10067-019-04485-6
Schneider, M., Mosca, M., Pego-Reigosa, J.-M., Gunnarsson, I., Maurel, F., Garofano, A., … Devilliers, H. (2017). Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings. Rheumatology, 56(5), 818–828.doi:10.1093/rheumatology/kew492