Conceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpoints.
| Title: | Conceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpoints. |
|---|---|
| Authors: | Trigg A; Medical Affairs Statistics, Bayer plc, Reading, UK. andrew.trigg@bayer.com.; Ayasse ND; Clinical Outcome Assessment Program, Critical Path Institute, Tucson, AZ, USA.; Coon CD; Clinical Outcome Assessment Program, Critical Path Institute, Tucson, AZ, USA. |
| Source: | Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation [Qual Life Res] 2025 Jan; Vol. 34 (1), pp. 151-160. Date of Electronic Publication: 2024 Oct 09. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Springer Netherlands Country of Publication: Netherlands NLM ID: 9210257 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2649 (Electronic) Linking ISSN: 09629343 NLM ISO Abbreviation: Qual Life Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2005- : Netherlands : Springer Netherlands; Original Publication: Oxford, UK : Rapid Communications of Oxford, Ltd, c1992- |
| MeSH Terms: | Outcome Assessment, Health Care*/methods ; Quality of Life*; Humans ; Randomized Controlled Trials as Topic |
| Abstract: | Purpose: Determining if group-level differences in health outcomes are meaningful has recently been neglected in favour of determining if individuals have experienced a meaningful change. We explore interpretation of a meaningful between-group difference (MBGD) in clinical outcome assessment scores, primarily in the context of randomized clinical trials.; Methods: We constructed a series of possible 'viewpoints' on how to conceptualize MBGD thresholds. Each viewpoint is discussed critically in terms of potential advantages and disadvantages, with simulated data to facilitate their consideration.; Results: Five viewpoints are presented and discussed. The first considers whether thresholds for meaningful within-individual change over time can be equally applied at the group-level, which is shown to be untenable. Viewpoints 2-4 consider what would have to be observed in treatment groups to conclude a meaningful between-group difference has occurred, framed in terms of the proportion of patients perceiving that they had meaningfully improved. The final viewpoint considers an alternative framework where stakeholders are directly questioned on the meaningfulness of varying magnitudes of between-group differences. The choice of a single threshold versus general interpretative guidelines is discussed.; Conclusion: There does not appear to be a single method with clear face validity for determining MBGD thresholds. Additionally, the notion that such thresholds can be purely data-driven is challenged, where a degree of subjective stakeholder judgement is likely required. Areas for future research are proposed, to move towards robust method development.; (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.) |
| Competing Interests: | Declarations. Ethics approval: Not applicable for this commentary article. Competing interests: The authors have no relevant financial or non-financial interests to disclose in relation to this manuscript. |
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| Contributed Indexing: | Keywords: COA; MCID; MID; Meaningful change; PRO |
| Entry Date(s): | Date Created: 20241009 Date Completed: 20250424 Latest Revision: 20250515 |
| Update Code: | 20260130 |
| DOI: | 10.1007/s11136-024-03798-7 |
| PMID: | 39384724 |
| Database: | MEDLINE |
Journal Article