Validation of the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 and -29 Item Short Forms Among Kidney Transplant Recipients

Overview

Journal Qual Life Res

Specialties Pharmacology
Rehabilitation Medicine

Date 2018 Nov 24

PMID 30467780

Citations 42

Authors

Evan Tang

Oladapo Ekundayo

John Devin Peipert

Nathaniel Edwards

Aarushi Bansal

Candice Richardson

Susan J Bartlett

Doris Howell

Madeline Li

David Cella

Marta Novak

Istvan Mucsi

Affiliations

Soon will be listed here.

Abstract

Objective: The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to address the lack of generalizable and universal measure of patient-reported outcomes to assess health-related quality of life. It has not been validated for patients with chronic kidney disease. We aim to validate the PROMIS-57 and PROMIS-29 questionnaires among kidney transplant recipients.

Methods: A cross-sectional sample of stable kidney transplant recipients was recruited. Each participant completed PROMIS-57, a 57-question instrument covering seven domains-physical function, anxiety, depression, fatigue, pain, sleep disturbance, and social functioning-alongside validated legacy questionnaires [Patient Health Questionnaire (PHQ9), General Anxiety Disorder (GAD7), Edmonton Symptom Assessment Scale revised (ESASr), and Kidney Disease Quality of Life (KDQoL-36)]. PROMIS-29, a 29-question instrument, is nested within PROMIS-57 and measures the same domains. Structural validity of PROMIS was assessed with confirmatory factor analysis, reported using the Comparative Fit Index (CFI). Construct validity was assessed with known-groups comparisons. Internal consistency was evaluated with Cronbach's α and convergent validity was assessed with Spearman's Rho. Test-retest reliability was assessed through the intraclass correlation coefficient (ICC).

Results: Mean (± SD) age of the 177 participants was 50 (± 17), 57% were male and 55% Caucasian. Internal consistency of each domain was high (Cronbach's α > 0.88). Confirmatory factor analysis showed good structural validity for most domains (CFI > 0.95, RMSEA < 0.05). Test-retest reliability indicated good agreement (ICC > 0.6). Known-groups comparisons by clinical and socio-demographic differences were found as hypothesized.

Conclusions: Our results provide evidence that PROMIS-57 and PROMIS-29 are highly reliable and valid instruments among kidney transplant recipients. We propose it as a valuable tool to assess important domains of the illness experience.

Citing Articles

Associations of Pretransplant Patient-Reported Outcomes Measurement Information System Physical Function Score With Kidney Transplant Outcomes.

Yamauchi J, Cizik A, Fornadi K, Thomas D, Raghavan D, Jweehan D Transpl Int. 2025; 38:13884.

PMID: 39944218 PMC: 11813690. DOI: 10.3389/ti.2025.13884.

Responsiveness and clinically important differences of the PROMIS short form-depression 8a, anxiety 8a, and PASS-20 in individuals with chronic low back pain.

Phongsaphakjarukorn N, Kanlayanaphotporn R, Jensen M, Janwantanakul P Pain Rep. 2024; 9(4):e1170.

PMID: 38910868 PMC: 11191038. DOI: 10.1097/PR9.0000000000001170.

Validation of a Core Patient-Reported Outcome Measure for Life Participation in Kidney Transplant Recipients: the SONG Life Participation Instrument.

Jaure A, Vastani R, Teixeira-Pinto A, Ju A, Craig J, Viecelli A Kidney Int Rep. 2024; 9(1):87-95.

PMID: 38312789 PMC: 10831350. DOI: 10.1016/j.ekir.2023.10.018.

Dietary fatty acids improve perceived sleep quality, stress, and health in migraine: a secondary analysis of a randomized controlled trial.

Faurot K, Park J, Miller V, Honvoh G, Domeniciello A, Mann J Front Pain Res (Lausanne). 2023; 4:1231054.

PMID: 37954068 PMC: 10634433. DOI: 10.3389/fpain.2023.1231054.

Changes in Health-Related Quality of Life in Patients with Therapy-Resistant Migraine during Treatment with Erenumab in an Ambulatory Care Setting.

Haneke H, Sulaiman S, Nickel S, Raffaelli B, Jansen J, Kirchberger V J Clin Med. 2023; 12(17).

PMID: 37685685 PMC: 10488376. DOI: 10.3390/jcm12175619.

References

Franke G, Reimer J, Kohnle M, Luetkes P, Maehner N, Heemann U . Quality of life in end-stage renal disease patients after successful kidney transplantation: development of the ESRD symptom checklist - transplantation module. Nephron. 1999; 83(1):31-9. DOI: 10.1159/000045470. View

Kroenke K, Spitzer R, Williams J . The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001; 16(9):606-13. PMC: 1495268. DOI: 10.1046/j.1525-1497.2001.016009606.x. View

Fiebiger W, Mitterbauer C, Oberbauer R . Health-related quality of life outcomes after kidney transplantation. Health Qual Life Outcomes. 2004; 2:2. PMC: 317371. DOI: 10.1186/1477-7525-2-2. View

Wild S, Roglic G, Green A, Sicree R, King H . Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004; 27(5):1047-53. DOI: 10.2337/diacare.27.5.1047. View

Weir J . Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005; 19(1):231-40. DOI: 10.1519/15184.1. View

Muehrer R, Becker B . Life after transplantation: new transitions in quality of life and psychological distress. Semin Dial. 2005; 18(2):124-31. DOI: 10.1111/j.1525-139X.2005.18214.x. View

Overbeck I, Bartels M, Decker O, Harms J, Hauss J, Fangmann J . Changes in quality of life after renal transplantation. Transplant Proc. 2005; 37(3):1618-21. DOI: 10.1016/j.transproceed.2004.09.019. View

Wright E, Kiely M, Johnston C, Smith A, Cull A, Selby P . Development and evaluation of an instrument to assess social difficulties in routine oncology practice. Qual Life Res. 2005; 14(2):373-86. DOI: 10.1007/s11136-004-5332-4. View

Watnick S, Wang P, Demadura T, Ganzini L . Validation of 2 depression screening tools in dialysis patients. Am J Kidney Dis. 2005; 46(5):919-24. DOI: 10.1053/j.ajkd.2005.08.006. View

10.

Cetingok M, Hathaway D, Winsett R . Differences in quality of life before transplantation among transplant recipients with respect to selected socioeconomic variables. Prog Transplant. 2006; 15(4):338-44. DOI: 10.1177/152692480501500405. View

11.

Barotfi S, Molnar M, Almasi C, Kovacs A, Remport A, Szeifert L . Validation of the Kidney Disease Quality of Life-Short Form questionnaire in kidney transplant patients. J Psychosom Res. 2006; 60(5):495-504. DOI: 10.1016/j.jpsychores.2005.09.009. View

12.

Davison S, Jhangri G, Johnson J . Cross-sectional validity of a modified Edmonton symptom assessment system in dialysis patients: a simple assessment of symptom burden. Kidney Int. 2006; 69(9):1621-5. DOI: 10.1038/sj.ki.5000184. View

13.

Spitzer R, Kroenke K, Williams J, Lowe B . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006; 166(10):1092-7. DOI: 10.1001/archinte.166.10.1092. View

14.

Davison S, Jhangri G, Johnson J . Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients. Nephrol Dial Transplant. 2006; 21(11):3189-95. DOI: 10.1093/ndt/gfl380. View

15.

Cukor D, Peterson R, Cohen S, Kimmel P . Depression in end-stage renal disease hemodialysis patients. Nat Clin Pract Nephrol. 2006; 2(12):678-87. DOI: 10.1038/ncpneph0359. View

16.

Bruera E, Kuehn N, Miller M, Selmser P, Macmillan K . The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991; 7(2):6-9. View

17.

Kroenke K, Spitzer R, Williams J, Monahan P, Lowe B . Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007; 146(5):317-25. DOI: 10.7326/0003-4819-146-5-200703060-00004. View

18.

Reeve B, Hays R, Bjorner J, Cook K, Crane P, Teresi J . Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care. 2007; 45(5 Suppl 1):S22-31. DOI: 10.1097/01.mlr.0000250483.85507.04. View

19.

Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B . The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007; 45(5 Suppl 1):S3-S11. PMC: 2829758. DOI: 10.1097/01.mlr.0000258615.42478.55. View

20.

Karaminia R, Tavallaii S, Lorgard-Dezfuli-Nejad M, Moghani Lankarani M, Hadavand Mirzaie H, Einollahi B . Anxiety and depression: a comparison between renal transplant recipients and hemodialysis patients. Transplant Proc. 2007; 39(4):1082-4. DOI: 10.1016/j.transproceed.2007.03.088. View