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Mixed-Methods to Define Meaningful Change using Exit Interviewand Clinical Trial Data in Patients with Tenosynovial Giant Cell Tumor (TGCT).

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Title: Mixed-Methods to Define Meaningful Change using Exit Interviewand Clinical Trial Data in Patients with Tenosynovial Giant Cell Tumor (TGCT).
Authors: Gelhorn, Heather L. (AUTHOR), Cutts, Katelyn N. (AUTHOR), Harrow, Brooke (AUTHOR), Tait, Christopher (AUTHOR), Saunders, Amanda (AUTHOR), Fikre, Tsion (AUTHOR), Han, Yipin (AUTHOR), Zeringo, Nicholas A. (AUTHOR), Van De Sande, Michiel (AUTHOR), Tap, William (AUTHOR), Gelderblom, Hans (AUTHOR), Bernthal, Nicholas (AUTHOR)
Source: Quality of Life Research. Mar2026, Vol. 35 Issue 3, p1-13. 13p.
Subjects: Range of motion of joints, Patient reported outcome measures, Mixed methods research, Exit interviewing, Giant cell tumors, Health outcome assessment
Abstract: Background: Tenosynovial giant cell tumor (TGCT) is a locally aggressive neoplasm associated with limited range of motion (ROM), stiffness, joint damage, pain, and reduced physical functioning (PF). The MOTION Phase 3 trial (NCT05059262) was a randomized, placebo-controlled, double-blind study of vimseltinib among patients with TGCT. The objective of the current study was to define meaningful changes in clinical outcome assessments (COAs) measuring active ROM, PF, and stiffness using qualitative and quantitative data from patients in the MOTION trial. Methods: Embedded exit interviews with patients in MOTION were conducted to explore meaningful changes in Patient Global Impression of Change (PGIC) anchors, active ROM, Patient-Reported Outcomes Measurement Information System (PROMIS)–PF, and Worst Stiffness numeric rating scale (NRS). Anchor- and distribution-based analyses of the MOTION data, informed by the exit interviews, were used to define responder thresholds. Results: In the MOTION trial, 96/123 patients (78%) completed an exit interview. Most considered "minimally improved" responses for each question (PGIC-PF: 67%; PGIC-ROM 73%) as meaningful. Responder estimates ranged from 1.45 to 4.9 (PROMIS-PF), from 6.0 to 14.8 (active ROM), and from − 2.3 to − 0.5 (Stiffness). The cumulative distribution function curves show a clear separation between treatment groups at a wide range of values around the proposed thresholds. Conclusions: The responder definitions were at least a 3-point improvement for PROMIS-PF, a 10% improvement for active ROM, and a 2-point improvement for the Worst Stiffness NRS. Qualitative interviews facilitate integrating the patient perspective in the selection of anchors and defining meaningful change. [ABSTRACT FROM AUTHOR]
Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Mixed-Methods to Define Meaningful Change using Exit Interviewand Clinical Trial Data in Patients with Tenosynovial Giant Cell Tumor (TGCT).
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  Data: <searchLink fieldCode="AR" term="%22Gelhorn%2C+Heather+L%2E%22">Gelhorn, Heather L.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Cutts%2C+Katelyn+N%2E%22">Cutts, Katelyn N.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Harrow%2C+Brooke%22">Harrow, Brooke</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tait%2C+Christopher%22">Tait, Christopher</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Saunders%2C+Amanda%22">Saunders, Amanda</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fikre%2C+Tsion%22">Fikre, Tsion</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Han%2C+Yipin%22">Han, Yipin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zeringo%2C+Nicholas+A%2E%22">Zeringo, Nicholas A.</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Van+De+Sande%2C+Michiel%22">Van De Sande, Michiel</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Tap%2C+William%22">Tap, William</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gelderblom%2C+Hans%22">Gelderblom, Hans</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bernthal%2C+Nicholas%22">Bernthal, Nicholas</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Quality+of+Life+Research%22">Quality of Life Research</searchLink>. Mar2026, Vol. 35 Issue 3, p1-13. 13p.
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  Data: <searchLink fieldCode="DE" term="%22Range+of+motion+of+joints%22">Range of motion of joints</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+reported+outcome+measures%22">Patient reported outcome measures</searchLink><br /><searchLink fieldCode="DE" term="%22Mixed+methods+research%22">Mixed methods research</searchLink><br /><searchLink fieldCode="DE" term="%22Exit+interviewing%22">Exit interviewing</searchLink><br /><searchLink fieldCode="DE" term="%22Giant+cell+tumors%22">Giant cell tumors</searchLink><br /><searchLink fieldCode="DE" term="%22Health+outcome+assessment%22">Health outcome assessment</searchLink>
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  Data: Background: Tenosynovial giant cell tumor (TGCT) is a locally aggressive neoplasm associated with limited range of motion (ROM), stiffness, joint damage, pain, and reduced physical functioning (PF). The MOTION Phase 3 trial (NCT05059262) was a randomized, placebo-controlled, double-blind study of vimseltinib among patients with TGCT. The objective of the current study was to define meaningful changes in clinical outcome assessments (COAs) measuring active ROM, PF, and stiffness using qualitative and quantitative data from patients in the MOTION trial. Methods: Embedded exit interviews with patients in MOTION were conducted to explore meaningful changes in Patient Global Impression of Change (PGIC) anchors, active ROM, Patient-Reported Outcomes Measurement Information System (PROMIS)–PF, and Worst Stiffness numeric rating scale (NRS). Anchor- and distribution-based analyses of the MOTION data, informed by the exit interviews, were used to define responder thresholds. Results: In the MOTION trial, 96/123 patients (78%) completed an exit interview. Most considered "minimally improved" responses for each question (PGIC-PF: 67%; PGIC-ROM 73%) as meaningful. Responder estimates ranged from 1.45 to 4.9 (PROMIS-PF), from 6.0 to 14.8 (active ROM), and from − 2.3 to − 0.5 (Stiffness). The cumulative distribution function curves show a clear separation between treatment groups at a wide range of values around the proposed thresholds. Conclusions: The responder definitions were at least a 3-point improvement for PROMIS-PF, a 10% improvement for active ROM, and a 2-point improvement for the Worst Stiffness NRS. Qualitative interviews facilitate integrating the patient perspective in the selection of anchors and defining meaningful change. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Quality of Life Research is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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