Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2013

Open Access 01-12-2013 | Research

Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT)

Authors: Quang A Le, Jason N Doctor, Lori A Zoellner, Norah C Feeny

Published in: Health and Quality of Life Outcomes | Issue 1/2013

Login to get access

Abstract

Objective

To determine the minimal clinically important difference (MCID) for the health-utility measures EuroQol-5 dimensions (EQ-5D) and Quality of Well Being Self-Administered (QWB-SA) Scale in PTSD patients.

Research design and methods

Two hundred patients aged 18 to 65 years with PTSD enrolled in a doubly randomized preference trial (DRPT) examining the treatment and treatment-preference effects between cognitive behavioral therapy and pharmacotherapy with sertraline and completed the EQ-5D and QWB-SA at baseline and 10-week post-treatment. The anchor-based methods utilized a Clinical Global Impression-Improvement (CGI-I) and Clinical Global Impression-Severity. We regressed the changes in EQ-5D and QWB-SA scores on changes in the anchors using ordinary least squares regression. The slopes (beta coefficients) were the rates of change in the anchors as functions of change in EQ-5D and QWB, which represent our estimates of MCID. In addition, we performed receiver operating characteristic (ROC) curve analysis to examine the relationship between the changes in EQ-5D and QWB-SA scores and treatment-response status. The MCIDs were estimated from the ROC curve where they best discriminate between treatment responders and non-responders. The distribution-based methods used small to moderate effect size in terms of 0.2 and 0.5 of standard deviation of the pre-treatment EQ-5D and QWB-SA scores.

Results

The anchor-based methods estimated the MCID ranges of 0.05 to 0.08 for the EQ-5D and 0.03 to 0.05 for the QWB. The MCID ranges were higher with the distribution-based methods, ranging from 0.04 to 0.10 for the EQ-5D and 0.02 to 0.05 for the QWB-SA.

Conclusions

The established MCID ranges of EQ-5D and QWB-SA can be a useful tool in assessing meaningful changes in patient’s quality of life for researchers and clinicians, and assisting health-policy makers to make informing decision in mental health treatment.

Clinical trial registration

Clinicaltrials.gov; Identifier: NCT00127673.
Appendix
Available only for authorised users
Literature
1.
Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB: Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry 1995, 52: 1048–60. 10.1001/archpsyc.1995.03950240066012PubMedCrossRef
2.
Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL: Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med 2004, 351: 13–22. 10.1056/NEJMoa040603PubMedCrossRef
3.
Mendlowicz MV, Stein MB: Quality of life in individuals with anxiety disorders. Am J Psychiatry 2000, 157: 669–682. 10.1176/appi.ajp.157.5.669PubMedCrossRef
4.
Sareen J, Cox BJ, Stein MB: Physical and mental disability, disability, and suicidal behavior associated with posttraumatic stress disorder in a large community sample. Psychosom Med 2007, 69: 242–248. 10.1097/PSY.0b013e31803146d8PubMedCrossRef
5.
Doctor JN, Zoellner LA, Feeny NC: Predictors of health-related quality-of-life utilities among persons with posttraumatic stress disorder. Psych Serv 2011, 62: 272–277. 10.1176/appi.ps.62.3.272CrossRef
6.
Greenberg PE, Sisitsky T, Kessler RC: The economic burden of anxiety disorders in the 1990s. J Clin Psychiatry 1999, 60: 427–35. 10.4088/JCP.v60n0702PubMedCrossRef
7.
Eibner C, Ringel JS, Kilmer B, Pacula RL, Diaz C: The cost of post-deployment mental health and cognitive conditions. In Invisible wounds of war: psychological and cognitive injuries, their consequences, and services to assist recovery. Edited by: Tanielian T, Jaycox LH. Santa Monica: RAND; 2008.
8.
Foa E, Riggs DS, Dancu CV, Rothbaum BO: Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. J Trauma Stress 1993, 6: 459–74. 10.1002/jts.2490060405CrossRef
9.
Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA: Psychometric properties of the PTSD checklist (PCL). Behav Res Ther 1996, 34: 669–673. 10.1016/0005-7967(96)00033-2PubMedCrossRef
10.
Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM: The development of a clinician-administered PTSD scale. J of Trauma Stress 1995, 8: 75–90. 10.1002/jts.2490080106CrossRef
11.
Mancino MJ, Pyne JM, Tripathi S, Constans J, Roca V, Freeman T: Quality-adjusted health status in veterans with posttraumatic stress disorder. J Nerv Ment Dis 2006, 194: 877–879. 10.1097/01.nmd.0000244686.79689.21PubMedCrossRef
12.
Freed MC, Yeager DE, Liu X, Gore KL, Engel CC, Magruder KM: Preference-weighted health status of PTSD among veterans: an outcome for cost-effectiveness analysis using clinical data. Psych Serv 2009, 60: 1230–1238. 10.1176/appi.ps.60.9.1230CrossRef
13.
Cohen BE, Marmar CR, Neylan TC, Schiller NB, Ali S, Whooley MA: Posttraumatic stress disorder and health-related quality of life in patients with coronary heart disease: findings from the Heart and Soul study. Arch Gen Psychiatry 2009, 66: 1214–1220. 10.1001/archgenpsychiatry.2009.149PubMedCentralPubMedCrossRef
14.
Haagsma JA, Polinder S, Olff M, Toet H, Bonsel GJ, van Beeck EF: Posttraumatic stress symptoms and health-related quality of life: a two year follow up study of injury treated at the emergency department. BMC Psychiatry 2012, 12: 1. 10.1186/1471-244X-12-1PubMedCentralPubMedCrossRef
15.
Walter SJ, Brazier JE: Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 2005, 14: 1523–1532. 10.1007/s11136-004-7713-0CrossRef
16.
Revicki DA, Cella D, Hays RD, Sloan JA, Lenderking WR, Aaronson NK: Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes 2006, 4: 70. 10.1186/1477-7525-4-70PubMedCentralPubMedCrossRef
17.
Revicki DA, Hays RD, Cella D, Sloan JA: Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol 2008, 61: 102–109. 10.1016/j.jclinepi.2007.03.012PubMedCrossRef
18.
Pickard SA, Neary MP, Cella D: Estimation of minimally important differences in EQ-5D and VAS scores in cancer. Health Qual Life Outcomes 2007, 5: 70. 10.1186/1477-7525-5-70PubMedCentralPubMedCrossRef
19.
Coteur G, Feagan B, Keininger DL, Kosinski M: Evaluation of the meaningfulness of health-related quality of life of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn’s disease. Aliment Pharmocol Ther 2009, 29: 1032–1041. 10.1111/j.1365-2036.2009.03966.xCrossRef
20.
Luo N, Johnson JA, Coons SJ: Using instrument-defined health state transitions to estimate minimally important differences for four preference-based health-related quality of life instruments. Med Care 2010, 48: 365–371. 10.1097/MLR.0b013e3181c162a2PubMedCrossRef
21.
McDonough CM, Tosteson TD, Tosteson ANA, Jette AM, Grove MR, Weinstein JN: A longitudinal comparison of 5 preference-weighted health state classification systems in persons with intervertebral disk herniation. Med Dec Making 2011, 31: 270–280. 10.1177/0272989X10380924CrossRef
22.
Kaplan RM: The minimally clinically important difference in generic utility-based measures. COPD 2005, 2: 91–97. 10.1081/COPD-200052090PubMedCrossRef
23.
Kupferberg DH, Kaplan RM, Slymen DJ, Ries AL: Minimal clinically important difference for the UCSD shortness of breath questionnaire. J Cardiopulm Rehabil 2005, 25: 370–377. 10.1097/00008483-200511000-00011PubMedCrossRef
24.
Kind P: Guidelines for value sets in economic and on-economic studies using EQ-5D. In The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective. Edited by: Brooks R, Rabin R, Charro FD. Amsterdam: the Netherlands Kluwer Academic Publishers; 2003:29–42.CrossRef
25.
Shaw JW, Johnson JA, Coons SJ: US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med care 2005, 43: 203–20. 10.1097/00005650-200503000-00003PubMedCrossRef
26.
Kaplan RM, Sieber WJ, Ganiats TG: The Quality of Well-Being Scale: Comparison of the interviewer-administered version with a self-administered questionnaire. Psychol Health 1977, 12: 783–791.CrossRef
27.
National Institute of Mental Health (NIMH) Early clinical drug evaluation unit (ECDEU): Clinical global impressions. In ECDEU Assessment Manual for Psychopharmacology Revised. Edited by: Guy W. Rockville, MD: NIMH; 1976:218–222.
28.
Jacobson NS, Truax P: Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991, 59: 12–19.PubMedCrossRef
29.
Jacobson NS, Roberts LJ, Berns SB, McGlinchey JB: Methods for defining and determining the clinical significance of treatment effects: description, application, and alternatives. J Consult Clin Psychol 1999, 67: 300–307.PubMedCrossRef
30.
Foa EB, Cashman LJ, Jaycox LH, Perry K: The validation of a self-report measure of PTSD: The PTSD Diagnostic Scale. Psychol Assess 1997, 9: 445–451.CrossRef
31.
Miller KL, Walt JG, Mink DR: Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol 2010, 128: 94–101. 10.1001/archophthalmol.2009.356PubMedCrossRef
32.
Hanley JA, McNeil BJ: The meaning and use of the area under a receiving operating characteristic (ROC) curve. Radiology 1982, 143: 29–36.PubMedCrossRef
33.
Deyo RA, Diehr P, Patrick DL: Reproducibility and responsiveness of health status measures: statistics and strategies for evaluation. Control Clin Trials 1991, 12: 142S-158S. 10.1016/S0197-2456(05)80019-4PubMedCrossRef
34.
Ward MM, Marx AS, Barry NN: Identification of clinically important changes in health status using receiver operating characteristic curves. J Clin Epidemiol 2000, 53: 279–284. 10.1016/S0895-4356(99)00140-7PubMedCrossRef
35.
Turner D, Schunemann HJ, Griffith LE: Using the entire cohort in the receiver operating characteristic analysis maximizes precision of the minimal important difference. J Clin Epidemiol 2009, 62: 374–379. 10.1016/j.jclinepi.2008.07.009PubMedCrossRef
36.
Norman GR, Sloan JA, Wyrwich KW: Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003, 41: 582–592.PubMed
37.
Crosby RD, Kolotkin RL, Williams RG: Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2005, 56: 395–407.CrossRef
Metadata
Title
Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT)
Authors
Quang A Le
Jason N Doctor
Lori A Zoellner
Norah C Feeny
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2013
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-11-59

Other articles of this Issue 1/2013

Health and Quality of Life Outcomes 1/2013 Go to the issue

Research

Mapping the EQ-5D index by UPDRS and PDQ-8 in patients with Parkinson’s disease

Research

The associations of body mass index with physical and mental aspects of health-related quality of life in Chinese patients with type 2 diabetes mellitus: results from a cross-sectional survey

Research

Chronic myeloid leukemia (CML): association of treatment satisfaction, negative medication experience and treatment restrictions with health outcomes, from the patient’s perspective

Research

Development and calibration of an item bank for the assessment of activities of daily living in cardiovascular patients using Rasch analysis

Research

Subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis (RVVC) in Europe and the USA

Research

Screening for anxiety disorders in patients with coronary artery disease