Establishing Clinically Significant Patient-reported Outcomes for Diverticular Disease
Copyright © 2021 Elsevier Inc. All rights reserved..
BACKGROUND: Diverticular disease can undermine health-related quality of life. The diverticulitis quality of life (DV-QOL) instrument was designed and validated to measure patient-reported burden of diverticular disease. However, values reflecting meaningful improvement (i.e., minimal clinically important difference [MCID]) and the patient acceptable symptom state (PASS) have yet to be established. We sought to establish the MCID and PASS of the DV-QOL and describe the characteristics of those with DV-QOL above the PASS threshold.
MATERIALS AND METHODS: We performed a prospective cohort study of adults with diverticular disease from seven centers in Washington and California (2016-2018). Patients were surveyed at baseline, then quarterly up to 30 mo. To determine the MCID and PASS for DV-QOL, we applied various previously established distribution- and anchor-based approaches and compared the resulting values.
RESULTS: The study included 177 patients (mean age 57 y, 43% women). A PASS threshold of 3.2/10 distinguished between those with and without health-related quality of life-impacting diverticulitis with acceptable accuracy (area under the curve 0.76). A change of 2.2 points in the DV-QOL was the most appropriate MCID: above the distribution-based MCIDs and corresponding to patient perception of importance of change (AUC 0.70). Patients with DV-QOL ≥ PASS were more often men, younger, had Medicaid, had more serious episodes of diverticulitis, and had an occupational degree or high-school education or less.
CONCLUSIONS: Our study is the first to define MCID and PASS for DV-QOL. These thresholds are critical for measuring the impact of diverticular disease and the evaluation of treatment effectiveness.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:264 |
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| Enthalten in: |
The Journal of surgical research - 264(2021) vom: 07. Aug., Seite 20-29 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Khor, Sara [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 23.09.2021 Date Revised 02.08.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jss.2021.01.045 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM323011756 |
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| 500 | |a Date Revised 02.08.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Diverticular disease can undermine health-related quality of life. The diverticulitis quality of life (DV-QOL) instrument was designed and validated to measure patient-reported burden of diverticular disease. However, values reflecting meaningful improvement (i.e., minimal clinically important difference [MCID]) and the patient acceptable symptom state (PASS) have yet to be established. We sought to establish the MCID and PASS of the DV-QOL and describe the characteristics of those with DV-QOL above the PASS threshold | ||
| 520 | |a MATERIALS AND METHODS: We performed a prospective cohort study of adults with diverticular disease from seven centers in Washington and California (2016-2018). Patients were surveyed at baseline, then quarterly up to 30 mo. To determine the MCID and PASS for DV-QOL, we applied various previously established distribution- and anchor-based approaches and compared the resulting values | ||
| 520 | |a RESULTS: The study included 177 patients (mean age 57 y, 43% women). A PASS threshold of 3.2/10 distinguished between those with and without health-related quality of life-impacting diverticulitis with acceptable accuracy (area under the curve 0.76). A change of 2.2 points in the DV-QOL was the most appropriate MCID: above the distribution-based MCIDs and corresponding to patient perception of importance of change (AUC 0.70). Patients with DV-QOL ≥ PASS were more often men, younger, had Medicaid, had more serious episodes of diverticulitis, and had an occupational degree or high-school education or less | ||
| 520 | |a CONCLUSIONS: Our study is the first to define MCID and PASS for DV-QOL. These thresholds are critical for measuring the impact of diverticular disease and the evaluation of treatment effectiveness | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a Diverticulitis quality of life | |
| 650 | 4 | |a Health-related quality of life (HRQoL) | |
| 650 | 4 | |a Minimal clinically important difference (MCID) | |
| 650 | 4 | |a Patient acceptable symptom state (PASS) | |
| 650 | 4 | |a Patient-reported outcomes | |
| 650 | 4 | |a Symptomatic uncomplicated diverticular disease (SUDD) | |
| 700 | 1 | |a Flum, David R |e verfasserin |4 aut | |
| 700 | 1 | |a Strate, Lisa L |e verfasserin |4 aut | |
| 700 | 1 | |a Hantouli, Mariam N |e verfasserin |4 aut | |
| 700 | 1 | |a Harris, Heather M |e verfasserin |4 aut | |
| 700 | 1 | |a Lavallee, Danielle C |e verfasserin |4 aut | |
| 700 | 1 | |a Spiegel, Brennan Mr |e verfasserin |4 aut | |
| 700 | 1 | |a Davidson, Giana H |e verfasserin |4 aut | |
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