We observed a lack of consistency in the application of methods for computing MID or MCID for generic and disease-specific HRQoL measures .
The anchor-based method yields conservative estimates of MID or MCID , compared to the distribution-based method .
OBJECTIVES The objective of the study was to assess the usability of minimal important difference ( MID ) and minimal clinical ly important difference ( MCID ) for measuring meaningful changes in disease-specific and generic health-related quality -of-life ( HRQoL ) outcomes in patient-centered care .
What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592.
To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer ( NSCLC ) , we set out to determine a clinical ly meaningful change ( CMC ) on the Lung Cancer Subscale ( LCS ) and the Trial Outcome Index ( TOI ) of the Functional Assessment of Cancer Therapy-Lung ( FACT-L ) question naire . We used data from Eastern Cooperative Oncology Group study 5592 ( E5592 ) , a r and omized trial comparing three chemotherapeutic regimens in 599 advanced NSCLC patients . Patients completed the FACT-L at baseline ( pretreatment ) , 6 weeks , 12 weeks , and 6 months . Comparing across baseline performance status ( 0 vs. 1 ) , prior weight loss ( < 5 % vs. > or = 5 % ) , and primary disease symptoms ( < or = 1 vs. > 1 ) , LCS and TOI score differences ranged from 2.4 to 3.6 and 6.5 to 9.2 , respectively ( all Ps < .001 ) . Mean improvement in LCS score from baseline to 12 weeks was 2.4 points in patients who had responded to treatment versus 0.0 points in patients who had progressive disease . Twelve-week LCS change scores for patients progressing early were 3.1 points worse than those of patients progressing later ( mean = -1.2 vs.1.9 , respectively ) . Similarly , the average TOI change score from baseline to 12 weeks was -6.1 for patients who had progressive disease versus -0.8 points for patients who had responded to treatment . Twelve-week TOI change scores for patients progressing early ( mean = -8.1 ) were 5.7 points worse than those of patients progressing later ( mean = -8.1 vs. -2.4 , respectively ) . Analyses assuming nonr and om missing data result ed in slightly larger differences . Clinical ly relevant change scores were estimated as two to three points for the LCS and five to seven points for the TOI , setting upper limits for minimal CMCs . These values were comparable to suggested distribution-based criteria of a minimally important difference . These results support use of a two to three point change in the LCS and five to six point change on the TOI of the FACT-L as a CMC , and offer practical direction for inclusion of important patient-based endpoints in lung cancer clinical trials
We observed a lack of consistency in the application of methods for computing MID or MCID for generic and disease-specific HRQoL measures .
The anchor-based method yields conservative estimates of MID or MCID , compared to the distribution-based method .
OBJECTIVES The objective of the study was to assess the usability of minimal important difference ( MID ) and minimal clinical ly important difference ( MCID ) for measuring meaningful changes in disease-specific and generic health-related quality -of-life ( HRQoL ) outcomes in patient-centered care .