Estimating individual health-related quality of life changes in low back pain patients

Abstract Background There is a need to evaluate different options for estimating individual change in health-related quality of life for patients with low back pain. Methods Secondary analysis of data collected at baseline and 6 weeks later in a randomized trial of 749 adults with low back pain rece...

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Main Authors: Ron D. Hays, Steven P. Reise, Patricia M. Herman
Format: Article
Language:English
Published: BMC 2023-12-01
Series:BMC Musculoskeletal Disorders
Subjects:
Online Access:https://doi.org/10.1186/s12891-023-07093-3
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author Ron D. Hays
Steven P. Reise
Patricia M. Herman
author_facet Ron D. Hays
Steven P. Reise
Patricia M. Herman
author_sort Ron D. Hays
collection DOAJ
description Abstract Background There is a need to evaluate different options for estimating individual change in health-related quality of life for patients with low back pain. Methods Secondary analysis of data collected at baseline and 6 weeks later in a randomized trial of 749 adults with low back pain receiving usual medical care (UMC) or UMC plus chiropractic care at a small hospital at a military training site or two large military medical centers. The mean age was 31; 76% were male and 67% were White. The study participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 v 1.0 physical function, pain interference, pain intensity, fatigue, sleep disturbance, depression, anxiety, satisfaction with participation in social roles, physical summary, and mental health summary scores (T-scored with mean = 50 and standard deviation (SD) = 10 in the U.S. general population). Results Reliability estimates at the baseline ranged from 0.700 to 0.969. Six-week test–retest intraclass correlation estimates were substantially lower than these estimates: the median test–retest intraclass correlation for the two-way mixed-effects model was 0. 532. Restricting the test–retest reliability estimates to the subset who reported they were about the same as at baseline on a retrospective rating of change item increased the median test–retest reliability to 0.686. The amount of individual change that was statistically significant varied by how reliability was estimated, and which SD was used. The smallest change needed was found when internal consistency reliability and the SD at baseline were used. When these values were used, the amount of change needed to be statistically significant (p < .05) at the individual level ranged from 3.33 (mental health summary scale) to 12.30 (pain intensity item) T-score points. Conclusions We recommend that in research studies estimates of the magnitude of individual change needed for statistical significance be provided for multiple reliability and standard deviation estimates. Whenever possible, patients should be classified based on whether they 1) improved significantly and perceived they got better, 2) improved significantly but did not perceive they were better, 3) did not improve significantly but felt they got better, or 4) did not improve significantly or report getting better.
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spelling doaj.art-bd42190601944bd794e129ff38e2b6e22023-12-17T12:04:14ZengBMCBMC Musculoskeletal Disorders1471-24742023-12-012411610.1186/s12891-023-07093-3Estimating individual health-related quality of life changes in low back pain patientsRon D. Hays0Steven P. Reise1Patricia M. Herman2Division of General Internal Medicine & Health Services Research, UCLA Department of MedicineDepartment of Psychology, UCLARAND CorporationAbstract Background There is a need to evaluate different options for estimating individual change in health-related quality of life for patients with low back pain. Methods Secondary analysis of data collected at baseline and 6 weeks later in a randomized trial of 749 adults with low back pain receiving usual medical care (UMC) or UMC plus chiropractic care at a small hospital at a military training site or two large military medical centers. The mean age was 31; 76% were male and 67% were White. The study participants completed the Patient-Reported Outcomes Measurement Information System (PROMIS®)-29 v 1.0 physical function, pain interference, pain intensity, fatigue, sleep disturbance, depression, anxiety, satisfaction with participation in social roles, physical summary, and mental health summary scores (T-scored with mean = 50 and standard deviation (SD) = 10 in the U.S. general population). Results Reliability estimates at the baseline ranged from 0.700 to 0.969. Six-week test–retest intraclass correlation estimates were substantially lower than these estimates: the median test–retest intraclass correlation for the two-way mixed-effects model was 0. 532. Restricting the test–retest reliability estimates to the subset who reported they were about the same as at baseline on a retrospective rating of change item increased the median test–retest reliability to 0.686. The amount of individual change that was statistically significant varied by how reliability was estimated, and which SD was used. The smallest change needed was found when internal consistency reliability and the SD at baseline were used. When these values were used, the amount of change needed to be statistically significant (p < .05) at the individual level ranged from 3.33 (mental health summary scale) to 12.30 (pain intensity item) T-score points. Conclusions We recommend that in research studies estimates of the magnitude of individual change needed for statistical significance be provided for multiple reliability and standard deviation estimates. Whenever possible, patients should be classified based on whether they 1) improved significantly and perceived they got better, 2) improved significantly but did not perceive they were better, 3) did not improve significantly but felt they got better, or 4) did not improve significantly or report getting better.https://doi.org/10.1186/s12891-023-07093-3Individual changePatient-reported outcomesPROMIS®Estimation
spellingShingle Ron D. Hays
Steven P. Reise
Patricia M. Herman
Estimating individual health-related quality of life changes in low back pain patients
BMC Musculoskeletal Disorders
Individual change
Patient-reported outcomes
PROMIS®
Estimation
title Estimating individual health-related quality of life changes in low back pain patients
title_full Estimating individual health-related quality of life changes in low back pain patients
title_fullStr Estimating individual health-related quality of life changes in low back pain patients
title_full_unstemmed Estimating individual health-related quality of life changes in low back pain patients
title_short Estimating individual health-related quality of life changes in low back pain patients
title_sort estimating individual health related quality of life changes in low back pain patients
topic Individual change
Patient-reported outcomes
PROMIS®
Estimation
url https://doi.org/10.1186/s12891-023-07093-3
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