Sabanovic, Hana;
Pauling, John D;
Baron, Murray;
Clemens, Laurence;
Del Galdo, Francesco;
Denton, Christopher P;
Distler, Oliver;
... Ross, Laura; + view all
(2025)
'Am I doing this right?' Physician perceptions of the global assessment in clinical trials of systemic sclerosis.
Rheumatology
, Article keaf377. 10.1093/rheumatology/keaf377.
(In press).
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Abstract
OBJECTIVES: Physician global assessments (PhyGAs) are commonly performed in randomised controlled trials (RCTs) in systemic sclerosis (SSc). However, there is no single PhyGA applied across RCTs. We performed an exploratory qualitative study to explore perceptions of the PhyGA, its role in RCTs and how physicians perform their own assessment. METHODS: Participants with expertise in the clinical assessment and research of SSc were invited to participate. Participants were asked to define disease constructs of activity, damage, severity and overall health, how they perform a PhyGA and their perception of what a PhyGA should assess. Interview transcripts were analysed using deductive and inductive thematic analysis. RESULTS: Eighteen rheumatologists and one patient research partner were interviewed. Four major themes were identified: i) Physician uncertainty; ii) Variation in the conduct of a PhyGA; iii) Physician efforts to improve PhyGA consistency; iv) Utility of a PhyGA. Most participants felt a PhyGA should assess changeable aspects of SSc, commonly conceived of as disease activity. There was considerable uncertainty about the optimal method to identify disease activity. Participants were uncertain about their own methods of performing a PhyGA and variability in the application of the instrument was identified. Despite these limitations, physicians generally agreed the PhyGA is useful and can assess unquantifiable aspects of SSc. CONCLUSION: We identified significant heterogeneity in the approach to PhyGAs in SSc. This variation was considered a limitation of the PhyGA. Overall, a PhyGA was viewed as a useful instrument that can aid the assessment of treatment response in RCTs.
| Type: | Article |
|---|---|
| Title: | 'Am I doing this right?' Physician perceptions of the global assessment in clinical trials of systemic sclerosis |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/rheumatology/keaf377 |
| Publisher version: | https://doi.org/10.1093/rheumatology/keaf377 |
| Language: | English |
| Additional information: | Copyright © The Author(s) 2025. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
| Keywords: | Systemic sclerosis, clinical trials, global assessment, outcome measures, physician assessment |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10211657 |
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