PMID- 33744774
OWN - NLM
STAT- MEDLINE
DCOM- 20210923
LR  - 20220802
IS  - 1095-8673 (Electronic)
IS  - 0022-4804 (Print)
IS  - 0022-4804 (Linking)
VI  - 264
DP  - 2021 Aug
TI  - Establishing Clinically Significant Patient-reported Outcomes for Diverticular 
      Disease.
PG  - 20-29
LID - S0022-4804(21)00082-2 [pii]
LID - 10.1016/j.jss.2021.01.045 [doi]
AB  - 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.
CI  - Copyright (c) 2021 Elsevier Inc. All rights reserved.
FAU - Khor, Sara
AU  - Khor S
AD  - Department of Surgery, University of Washington, Seattle, Washington; The 
      Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, School of 
      Pharmacy, University of Washington, Seattle, Washington.
FAU - Flum, David R
AU  - Flum DR
AD  - Department of Surgery, University of Washington, Seattle, Washington.
FAU - Strate, Lisa L
AU  - Strate LL
AD  - Department of Medicine, Division of Gastroenterology, Harborview Medical Center, 
      Seattle, Washington.
FAU - Hantouli, Mariam N
AU  - Hantouli MN
AD  - Department of Surgery, University of Washington, Seattle, Washington.
FAU - Harris, Heather M
AU  - Harris HM
AD  - Department of Surgery, University of Washington, Seattle, Washington.
FAU - Lavallee, Danielle C
AU  - Lavallee DC
AD  - Department of Surgery, University of Washington, Seattle, Washington.
FAU - Spiegel, Brennan Mr
AU  - Spiegel BM
AD  - Department of Medicine, Division of Health Services Research, Cedars-Sinai, Los 
      Angeles, California.
FAU - Davidson, Giana H
AU  - Davidson GH
AD  - Department of Surgery, University of Washington, Seattle, Washington. Electronic 
      address: ghd@uw.edu.
LA  - eng
GR  - R01 DK103915/DK/NIDDK NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, N.I.H., Extramural
DEP - 20210318
PL  - United States
TA  - J Surg Res
JT  - The Journal of surgical research
JID - 0376340
SB  - IM
MH  - Adult
MH  - Aged
MH  - Colectomy/*standards
MH  - Diverticulitis, Colonic/complications/diagnosis/psychology/*surgery
MH  - Elective Surgical Procedures/*standards
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Minimal Clinically Important Difference
MH  - *Patient Reported Outcome Measures
MH  - Practice Guidelines as Topic
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires/statistics & numerical data
MH  - Treatment Outcome
PMC - PMC9011199
MID - NIHMS1685169
OTO - NOTNLM
OT  - Diverticulitis quality of life
OT  - Health-related quality of life (HRQoL)
OT  - Minimal clinically important difference (MCID)
OT  - Patient acceptable symptom state (PASS)
OT  - Patient-reported outcomes
OT  - Symptomatic uncomplicated diverticular disease (SUDD)
COIS- Declaration of interest: none Disclosures: The authors report no proprietary or 
      commercial interest in any product mentioned or concept discussed in this 
      article.
EDAT- 2021/03/22 06:00
MHDA- 2021/09/24 06:00
PMCR- 2022/08/01
CRDT- 2021/03/21 21:10
PHST- 2020/09/18 00:00 [received]
PHST- 2021/01/12 00:00 [revised]
PHST- 2021/01/25 00:00 [accepted]
PHST- 2021/03/22 06:00 [pubmed]
PHST- 2021/09/24 06:00 [medline]
PHST- 2021/03/21 21:10 [entrez]
PHST- 2022/08/01 00:00 [pmc-release]
AID - S0022-4804(21)00082-2 [pii]
AID - 10.1016/j.jss.2021.01.045 [doi]
PST - ppublish
SO  - J Surg Res. 2021 Aug;264:20-29. doi: 10.1016/j.jss.2021.01.045. Epub 2021 Mar 18.