PMID- 16603063 OWN - NLM STAT- MEDLINE DCOM- 20060801 LR - 20231103 IS - 1465-993X (Electronic) IS - 1465-9921 (Print) IS - 1465-9921 (Linking) VI - 7 IP - 1 DP - 2006 Apr 7 TI - Health status measurement in COPD: the minimal clinically important difference of the clinical COPD questionnaire. PG - 62 AB - BACKGROUND: Patient-reported outcomes (PRO) questionnaires are being increasingly used in COPD clinical studies. The challenge facing investigators is to determine what change is significant, ie what is the minimal clinically important difference (MCID). This study aimed to identify the MCID for the clinical COPD questionnaire (CCQ) in terms of patient referencing, criterion referencing, and by the standard error of measurement (SEM). METHODS: Patients were > or = 40 years of age, diagnosed with COPD, had a smoking history of >10 pack-years, and were participating in a randomized, controlled clinical trial comparing intravenous and oral prednisolone in patients admitted with an acute exacerbation of COPD. The CCQ was completed on Days 1-7 and 42. A Global Rating of Change (GRC) assessment was taken to establish the MCID by patient referencing. For criterion referencing, health events during a period of 1 year after Day 42 were included in this analysis. RESULTS: 210 patients were recruited, 168 completed the CCQ questionnaire on Day 42. The MCID of the CCQ total score, as indicated by patient referencing in terms of the GRC, was 0.44. The MCID of the CCQ in terms of criterion referencing for the major outcomes was 0.39, and calculation of the SEM resulted in a value of 0.21. CONCLUSION: This investigation, which is the first to determine the MCID of a PRO questionnaire via more than one approach, indicates that the MCID of the CCQ total score is 0.4. FAU - Kocks, J W H AU - Kocks JW AD - Department of General Practice University Medical Center Groningen, The Netherlands. FAU - Tuinenga, M G AU - Tuinenga MG FAU - Uil, S M AU - Uil SM FAU - van den Berg, J W K AU - van den Berg JW FAU - Stahl, E AU - Stahl E FAU - van der Molen, T AU - van der Molen T LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20060407 PL - England TA - Respir Res JT - Respiratory research JID - 101090633 RN - 0 (Anti-Inflammatory Agents) RN - 9PHQ9Y1OLM (Prednisolone) SB - IM MH - Administration, Oral MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Inflammatory Agents/administration & dosage/therapeutic use MH - Disease Progression MH - Endpoint Determination MH - *Health Status MH - Health Status Indicators MH - Humans MH - Injections, Intravenous MH - Middle Aged MH - Prednisolone/administration & dosage/therapeutic use MH - Pulmonary Disease, Chronic Obstructive/complications/drug therapy/*physiopathology MH - Reference Values MH - *Surveys and Questionnaires MH - Time Factors MH - Treatment Outcome PMC - PMC1508149 EDAT- 2006/04/11 09:00 MHDA- 2006/08/02 09:00 PMCR- 2006/04/07 CRDT- 2006/04/11 09:00 PHST- 2005/10/11 00:00 [received] PHST- 2006/04/07 00:00 [accepted] PHST- 2006/04/11 09:00 [pubmed] PHST- 2006/08/02 09:00 [medline] PHST- 2006/04/11 09:00 [entrez] PHST- 2006/04/07 00:00 [pmc-release] AID - 1465-9921-7-62 [pii] AID - 10.1186/1465-9921-7-62 [doi] PST - epublish SO - Respir Res. 2006 Apr 7;7(1):62. doi: 10.1186/1465-9921-7-62.