Table 1.

Summary of the report back and discussion from the breakout groups.

Discrimination Topic	Specific Discrimination Topic	How Was the Discrimination Topic Addressed?
Determining differences when only non-inferiority trial evidence available	What general methods and procedures could be considered for determining differences (a) between groups; (b) response in a patient when only non-inferiority head-to-head trial data are available?	Assess assay sensitivity of treatment to active control and constancy of active control to placebo Use adjusted indirect methods for deriving indirect treatment comparison of treatment to placebo Use indirect estimates as one uses direct estimates for minimum detectable, minimum important, and major differences
Determining minimum detectable, minimum important, and major differences	What general methods and procedures could be considered for determining minimum detectable, minimum important, and major differences (a) between groups; (b) response in a patient?	Consider the “cube of discrimination” for looking at changes within patients and at differences between groups Anchor vs distribution based methods Consider contextual factors Importance of scaling method used and signal-to-noise ratio Determinations for improvement may not be same as for worsening Need for patient involvement
Determining the sensitivity to measure	What different “situations of interest” could be considered for assessing discrimination?	Consider in terms of providing examples for study designs and clinical practice for each situation in “cube of discrimination” Need for 2 RCT questioned
Determining a responder index	What general methods and procedures could be considered for determining a responder index?	Index must be sensitive to both improvement and worsening Standardization of the technique is needed in order to assess change
Practical checklist for discrimination	What items constitute a practical checklist for discrimination?	Filter 1 presentation best way but more examples recommended Basic principle for responsiveness — consider a clinical trial where there is a known treatment effect and then assess the change in the outcome Look for responsiveness first at group level then at individual level Anchor treatment effect to a PRO if want it to be understandable to patient COSMIN was not discussed in great detail and this must be more closely considered Role of effect size important

* How can the feasibility of a measure be made, taking into consideration aspects such as cost, burden, and interpretability? RCT: randomized controlled trial; PRO: patient reported outcomes; COSMIN: COnsensus-based standards for the selection of Health Measurement INstruments.