Putting the Meaning Into Meaningful Change Research
Abstract PurposeMethods for deriving clinically meaningful change thresholds have advanced considerably in recent years, however, key questions remain about what the identified change score actually means for an individual patient or group of patient. This is particularly important in the case of ClinROs where the translation from clinically meaningful change to patient-relevance in daily living is not clear. This paper provides case studies from an Industry perspective, where we have addressed this challenge using varied approaches. We have explored meaningful change at both the group and individual level.MethodsWe provide several case studies to illustrate different approaches to understanding and communicating a meaningful outcome on a ClinRO. These include alternative methods for interpreting group-level MCIDs, and several examples of linking ClinRO items to patient-relevant real-world concepts e.g. through exit interviews, translation of ClinRO items into patient-friendly concepts, and use of the Rasch model to equate ClinRO items to real-world functional measures.ResultsEach case study provides unique learning opportunities. For example, contextualising group-level differences, converting MCIDs into other metrics like numbers needed to treat and responder deltas supports interpretation of clinical meaning, especially for clinicians. For interpreting individual-level meaningful change, exit interviews and the development of patient-friendly versions of ClinROs provide a means of linking clinician-focused content to real-world functional outcomes in a meaningful way for patients. Finally, the Rasch model can help predict probable item scores on a ClinRO associated with the threshold at which a function is gained or lost.ConclusionWhile methods for deriving meaningful change thresholds have evolved, there remains a significant challenge in communicating what observed changes mean to the patient, a challenge which is further complicated in ClinROs. These case studies showcase novel approaches to addressing this challenge and may provide a useful addition to the COA scientist’s toolbox.