Using Multiple Anchor- and Distribution-Based Estimates to Evaluate Clinically Meaningful Change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) Instrument

Abstract

We combined patient-reported estimates, physician-reported estimates, and distribution-based estimates to derive MIDs for HRQL outcomes from the FACT-BRM. These results will enable interpretation of treatment group effects in a clinical trial setting, and they can be used to estimate sample size or power when designing future studies.

Assessing methods to specify the target difference for a randomised controlled trial: DELTA (Difference ELicitation in TriAls) review

“…change would be considered substantial rather than minimal if > 0.6 SDs). This was also the case in two studies by Yost and colleagues, one excluding anchor estimates for which the SES was > 0.8 SDs 395 and the other excluding anchor estimates for which the SES was not within the 0.2-0.5 SD range. 396 Some studies, in which a combination of methods were used to evaluate important change, also calculated other metrics that could have been used as part of the process but were not (e.g.…”

The minimal clinically important difference in the Gastrointestinal Quality-of-Life Index after cholecystectomy

“…First, global ratings of change require patients to compare their symptoms, emotions, physical functions, and social functions retrospectively before and after cholecystectomy surgery, and these retrospective self-reports are known to be subject to recall bias [15]. Health researchers have proposed prospective anchors that merit further study [16].…”

Psychometric evaluation of the functional assessment of HIV Infection (FAHI) questionnaire and its usefulness in clinical trials

“…In addition, the MID of the EQ-5D index [42] and thermometer [43] scores were used as anchors to define the MID of the FAHI questionnaire: Spearman correlation coefficients were calculated between EQ-5D and FAHI change in scores, and simple linear regressions of the change in the FAHI scores according to the change in the EQ-5D scores were undertaken to obtain the equation linking the score to the anchor (in the DUET trials only). Moderate correlations between the anchor and the score ([0.3) are recommended to reliably interpret the results [44].…”