Validation of PROMIS CATs and PROMIS Global Health in an Interdisciplinary Pain Program for Patients With Chronic Low Back Pain.


Journal

Spine
ISSN: 1528-1159
Titre abrégé: Spine (Phila Pa 1976)
Pays: United States
ID NLM: 7610646

Informations de publication

Date de publication:
15 Feb 2020
Historique:
pubmed: 13 9 2019
medline: 29 7 2020
entrez: 13 9 2019
Statut: ppublish

Résumé

Retrospective cohort study. To (1) confirm validity of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference computer-adaptive tests (CATs) and (2) assess the validity of PROMIS Global Health (GH) and five additional PROMIS CATs: social role satisfaction, fatigue, anxiety, depression, and sleep disturbance in a population of patients with chronic low back pain (cLBP) who completed a 3-month Interdisciplinary Pain Program (IPP). Recent recommendations for assessing outcomes in patients with cLBP have included PROMIS scales; however, there is a need for further evaluation, and PROMIS GH has not been studied in this population. The study cohort included patients with cLBP who completed the entirety of a 3-month IPP between August 2016 and December 2018. Patient-reported outcome measures (PROMs) were analyzed before the start of the IPP and at graduation. Convergent and discriminant validity were evaluated using Pearson correlation coefficients. Known groups' validity assessed the change in PROMIS scores stratified by improvement on the Modified LBP Disability Questionnaire. Responsiveness was evaluated with standardized response means based on global impression of change. IPP was completed by 217 patients (67.7% women, age 53.8 ± 12.8). Convergent validity was supported (P < 0.01 for all pairwise PROMs comparisons). All PROMs improved significantly by graduation, with the largest improvement for PROMIS pain interference, physical function, social role satisfaction, and Modified LBP Disability Questionnaire. Known groups' validity demonstrated the greatest change on PROMIS physical function, social role satisfaction, pain interference, and depression. Responsiveness was supported for all PROMs in 170 (78.3%) patients who indicated at least minimal improvement (standardized response means 0.43-1.06). Our study provides support of PROMIS CATs, highlights the importance of including other meaningful outcome measures, such as social role satisfaction, and provides the first validation of PROMIS GH, in patients with cLBP. PROMs collection can be streamlined through the use of PROMIS CATs which offer advantages over legacy measures. 3.

Sections du résumé

STUDY DESIGN METHODS
Retrospective cohort study.
OBJECTIVE OBJECTIVE
To (1) confirm validity of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference computer-adaptive tests (CATs) and (2) assess the validity of PROMIS Global Health (GH) and five additional PROMIS CATs: social role satisfaction, fatigue, anxiety, depression, and sleep disturbance in a population of patients with chronic low back pain (cLBP) who completed a 3-month Interdisciplinary Pain Program (IPP).
SUMMARY OF BACKGROUND DATA BACKGROUND
Recent recommendations for assessing outcomes in patients with cLBP have included PROMIS scales; however, there is a need for further evaluation, and PROMIS GH has not been studied in this population.
METHODS METHODS
The study cohort included patients with cLBP who completed the entirety of a 3-month IPP between August 2016 and December 2018. Patient-reported outcome measures (PROMs) were analyzed before the start of the IPP and at graduation. Convergent and discriminant validity were evaluated using Pearson correlation coefficients. Known groups' validity assessed the change in PROMIS scores stratified by improvement on the Modified LBP Disability Questionnaire. Responsiveness was evaluated with standardized response means based on global impression of change.
RESULTS RESULTS
IPP was completed by 217 patients (67.7% women, age 53.8 ± 12.8). Convergent validity was supported (P < 0.01 for all pairwise PROMs comparisons). All PROMs improved significantly by graduation, with the largest improvement for PROMIS pain interference, physical function, social role satisfaction, and Modified LBP Disability Questionnaire. Known groups' validity demonstrated the greatest change on PROMIS physical function, social role satisfaction, pain interference, and depression. Responsiveness was supported for all PROMs in 170 (78.3%) patients who indicated at least minimal improvement (standardized response means 0.43-1.06).
CONCLUSION CONCLUSIONS
Our study provides support of PROMIS CATs, highlights the importance of including other meaningful outcome measures, such as social role satisfaction, and provides the first validation of PROMIS GH, in patients with cLBP. PROMs collection can be streamlined through the use of PROMIS CATs which offer advantages over legacy measures.
LEVEL OF EVIDENCE METHODS
3.

Identifiants

pubmed: 31513107
doi: 10.1097/BRS.0000000000003232
pii: 00007632-202002150-00015
doi:

Types de publication

Journal Article Validation Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

E227-E235

Références

Deyo RA, Dworkin SF, Amtmann D, et al. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther 2015; 95:e1–e18.
Murray CJ, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2197–2223.
Chiarotto A, Boers M, Deyo RA, et al. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain 2018; 159:481–495.
Chou R, Deyo R, Friedly J, et al. In: Noninvasive Treatments for Low Back Pain. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Feb. Report No.: 16-EHC004-EF. AHRQ Comparative Effectiveness Reviews.
Deyo RA, Katrina R, Buckley DI, et al. Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) short form in older adults with chronic musculoskeletal pain. Pain Med 2016; 17:314–324.
Papuga MO, Barnes AL. Correlation of PROMIS CAT instruments with Oswestry Disability Index in chiropractic patients. Complement Ther Clin Pract 2018; 31:85–90.
Papuga MO, Mesfin A, Molinari R, et al. Correlation of PROMIS Physical Function and Pain CAT Instruments With Oswestry Disability Index and Neck Disability Index in Spine Patients. Spine (Phila Pa 1976) 2016; 41:1153–1159.
Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol 2010; 63:1179–1194.
Tishelman JC, Vasquez-Montes D, Jevotovsky DS, et al. Patient-Reported Outcomes Measurement Information System instruments: outperforming traditional quality of life measures in patients with back and neck pain. J Neurosurg Spine 2019; 1–6.
Brodke DS, Goz V, Voss MW, et al. PROMIS PF CAT outperforms the ODI and SF-36 Physical Function Domain in spine patients. Spine (Phila Pa 1976) 2017; 42:921–929.
Patel AA, Dodwad SM, Boody BS, et al. Validation of Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs) in the surgical treatment of lumbar spinal stenosis. Spine (Phila Pa 1976) 2018; 43:1521–1528.
Purvis TE, Andreou E, Neuman BJ, et al. Concurrent validity and responsiveness of PROMIS health domains among patients presenting for anterior cervical spine surgery. Spine (Phila Pa 1976) 2017; 42:E1357–E1365.
Purvis TE, Neuman BJ, Riley LH, et al. Discriminant ability, concurrent validity, and responsiveness of PROMIS health domains among patients with lumbar degenerative disease undergoing decompression with or without arthrodesis. Spine (Phila Pa 1976) 2018; 43:1512–1520.
Chiarotto A, Terwee CB, Ostelo RW. Choosing the right outcome measurement instruments for patients with low back pain. Best Pract Res Clin Rheumatol 2016; 30:1003–1020.
Chiarotto A, Terwee CB, Kamper SJ, et al. Evidence on the measurement properties of health-related quality of life instruments is largely missing in patients with low back pain: a systematic review. J Clin Epidemiol 2018; 102:23–37.
Davin S, Lapin B, Mijatovic D, et al. Comparative effectiveness of an interdisciplinary pain program for chronic low back pain compared to physical therapy alone. Spine (Phila Pa 1976) 2019.
Hill JC, Dunn KM, Lewis M, et al. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum 2008; 59:632–641.
Katzan I, Speck M, Dopler C, et al. The Knowledge Program: an innovative, comprehensive electronic data capture system and warehouse. AMIA Annu Symp Proc 2011; 2011:683–692.
Hays RD, Bjorner JB, Revicki DA, et al. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res 2009; 18:873–880.
Yost KJ, Eton DT, Garcia SF, et al. Minimally important differences were estimated for six Patient-Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients. J Clin Epidemiol 2011; 64:507–516.
Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low Back Pain Disability Questionnaire and the Quebec Back Pain Disability Scale. Phys Ther 2001; 81:776–788.
Hagg O, Fritzell P, Nordwall A, et al. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J 2003; 12:12–20.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001; 16:606–613.
Choi SW, Schalet B, Cook KF, et al. Establishing a common metric for depressive symptoms: linking the BDI-II, CES-D, and PHQ-9 to PROMIS depression. Psychol Assess 2014; 26:513–527.
Husted JA, Cook RJ, Farewell VT, et al. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol 2000; 53:459–468.
Morris SB, DeShon RP. Combining effect size estimates in meta-analysis with repeated measures and independent-groups designs. Psychol Methods 2002; 7:105–125.
Revicki DA, Cella D, Hays RD, et al. Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes 2006; 4:70.
Schalet BD, Hays RD, Jensen SE, et al. Validity of PROMIS physical function measured in diverse clinical samples. J Clin Epidemiol 2016; 73:112–118.
Haws BE, Khechen B, Guntin JA, et al. Validity of PROMIS in minimally invasive transforaminal lumbar interbody fusion: a preliminary evaluation. J Neurosurg Spine 2018; 29:28–33.
Askew RL, Cook KF, Revicki DA, et al. Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior. J Clin Epidemiol 2016; 73:103–111.
Chen CX, Kroenke K, Stump T, et al. Comparative responsiveness of the PROMIS pain interference short forms with legacy pain measures: results from three randomized clinical trials. J Pain 2019; 20:664–675.
Sharma M, Ugiliweneza B, Beswick J, et al. Concurrent validity and comparative responsiveness of PROMIS-SF versus legacy measures in the cervical and lumbar spine population: longitudinal analysis from baseline to postsurgery. World Neurosurg 2018; 115:e664–e675.
Cella D, Lai JS, Jensen SE, et al. PROMIS fatigue item bank had clinical validity across diverse chronic conditions. J Clin Epidemiol 2016; 73:128–134.
Schalet BD, Pilkonis PA, Yu L, et al. Clinical validity of PROMIS depression, anxiety, and anger across diverse clinical samples. J Clin Epidemiol 2016; 73:119–127.
Hahn EA, Beaumont JL, Pilkonis PA, et al. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol 2016; 73:135–141.

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