Baseline health status and setting impacted minimal clinically important differences in COPD: an exploratory study

Harma Alma, Corina de Jong, Danijel Jelusic, Michael Wittmann, Michael Schuler, Boudewijn Kollen, Robbert Sanderman, Janwillem Kocks, Konrad Schultz, Thys van der Molen

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Abstract

Objectives: Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD). Study Design and Setting: Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor- and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative for Obstructive Lung Disease (GOLD) classification, comorbidities, and baseline health status. Results: In total, 658 patients were included with 2,299 change score measurements. MCID estimates for improvement and deterioration ranged for all subgroups 0.50–6.30 (CAT), 0.10–0.84 (CCQ), and 0.33–12.86 (SGRQ). Larger MCID estimates for improvement and smaller ones for deterioration were noted in patients with worse baseline health status, females, elderly, GOLD I/II patients, and patients with less comorbidities. Estimates from PR were larger. Conclusion: Baseline health status and setting affected MCID estimates of COPD health status questionnaires. Patterns were observed for gender, age, spirometry classification, and comorbidity levels. These outcomes would advocate the need for tailored MCIDs.

Original languageEnglish
Pages (from-to)49-61
Number of pages13
JournalJournal of clinical epidemiology
Volume116
Early online date27 Jul 2019
DOIs
Publication statusPublished - 1 Dec 2019

Fingerprint

Chronic Obstructive Pulmonary Disease
Health Status
Obstructive Lung Diseases
Comorbidity
Rehabilitation
Lung
Spirometry
Minimal Clinically Important Difference
Surveys and Questionnaires
Clinical Trials

Keywords

  • UT-Hybrid-D
  • Clinical COPD Questionnaire (CCQ)
  • COPD Assessment Test (CAT)
  • Health status
  • Minimal clinically important difference (MCID)
  • St. George's Respiratory Questionnaire (SGRQ)
  • Chronic obstructive pulmonary disease (COPD)

Cite this

Alma, Harma ; de Jong, Corina ; Jelusic, Danijel ; Wittmann, Michael ; Schuler, Michael ; Kollen, Boudewijn ; Sanderman, Robbert ; Kocks, Janwillem ; Schultz, Konrad ; van der Molen, Thys. / Baseline health status and setting impacted minimal clinically important differences in COPD : an exploratory study. In: Journal of clinical epidemiology. 2019 ; Vol. 116. pp. 49-61.
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Alma, H, de Jong, C, Jelusic, D, Wittmann, M, Schuler, M, Kollen, B, Sanderman, R, Kocks, J, Schultz, K & van der Molen, T 2019, 'Baseline health status and setting impacted minimal clinically important differences in COPD: an exploratory study' Journal of clinical epidemiology, vol. 116, pp. 49-61. https://doi.org/10.1016/j.jclinepi.2019.07.015

Baseline health status and setting impacted minimal clinically important differences in COPD : an exploratory study. / Alma, Harma; de Jong, Corina; Jelusic, Danijel; Wittmann, Michael; Schuler, Michael; Kollen, Boudewijn; Sanderman, Robbert; Kocks, Janwillem; Schultz, Konrad; van der Molen, Thys.

In: Journal of clinical epidemiology, Vol. 116, 01.12.2019, p. 49-61.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - Baseline health status and setting impacted minimal clinically important differences in COPD

T2 - an exploratory study

AU - Alma, Harma

AU - de Jong, Corina

AU - Jelusic, Danijel

AU - Wittmann, Michael

AU - Schuler, Michael

AU - Kollen, Boudewijn

AU - Sanderman, Robbert

AU - Kocks, Janwillem

AU - Schultz, Konrad

AU - van der Molen, Thys

N1 - Elsevier deal

PY - 2019/12/1

Y1 - 2019/12/1

N2 - Objectives: Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD). Study Design and Setting: Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor- and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative for Obstructive Lung Disease (GOLD) classification, comorbidities, and baseline health status. Results: In total, 658 patients were included with 2,299 change score measurements. MCID estimates for improvement and deterioration ranged for all subgroups 0.50–6.30 (CAT), 0.10–0.84 (CCQ), and 0.33–12.86 (SGRQ). Larger MCID estimates for improvement and smaller ones for deterioration were noted in patients with worse baseline health status, females, elderly, GOLD I/II patients, and patients with less comorbidities. Estimates from PR were larger. Conclusion: Baseline health status and setting affected MCID estimates of COPD health status questionnaires. Patterns were observed for gender, age, spirometry classification, and comorbidity levels. These outcomes would advocate the need for tailored MCIDs.

AB - Objectives: Minimal clinically important differences (MCIDs) are used as fixed numbers in the interpretation of clinical trials. Little is known about its dynamics. This study aims to explore the impact of baseline score, study setting, and patient characteristics on health status MCIDs in chronic obstructive pulmonary disease (COPD). Study Design and Setting: Baseline and follow-up data on the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ), and St. George's Respiratory Questionnaire (SGRQ) were retrospectively analyzed from pulmonary rehabilitation (PR) and routine clinical practice (RCP). Anchor- and distribution-based MCID estimates were calculated and tested between settings, gender, age, Global initiative for Obstructive Lung Disease (GOLD) classification, comorbidities, and baseline health status. Results: In total, 658 patients were included with 2,299 change score measurements. MCID estimates for improvement and deterioration ranged for all subgroups 0.50–6.30 (CAT), 0.10–0.84 (CCQ), and 0.33–12.86 (SGRQ). Larger MCID estimates for improvement and smaller ones for deterioration were noted in patients with worse baseline health status, females, elderly, GOLD I/II patients, and patients with less comorbidities. Estimates from PR were larger. Conclusion: Baseline health status and setting affected MCID estimates of COPD health status questionnaires. Patterns were observed for gender, age, spirometry classification, and comorbidity levels. These outcomes would advocate the need for tailored MCIDs.

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KW - COPD Assessment Test (CAT)

KW - Health status

KW - Minimal clinically important difference (MCID)

KW - St. George's Respiratory Questionnaire (SGRQ)

KW - Chronic obstructive pulmonary disease (COPD)

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JO - Journal of clinical epidemiology

JF - Journal of clinical epidemiology

SN - 0895-4356

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