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Background <p>Fatigue significantly impacts quality of life in lymphoma patients. Multiple patient-reported fatigue measures are used in lymphoma research, including FACIT-Fatigue and PROMIS Fatigue instruments, but direct comparisons of their responsiveness and ability to detect individual-level change in this population are lacking. This study evaluated the responsiveness and sensitivity to individual-level change of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue measures (4a, 7a, and 13a), and NFLyMSI-18 Lymphoma Symptom Index in patients with lymphoma.</p> Methodology <p>In a prospective observational study, 102 lymphoma patients at an academic cancer center completed FACIT‑Fatigue, PROMIS Fatigue 4a, 7a, and 13a, and NFLymSI‑18 at baseline and again at 3 months (<i>n</i> = 89). Responsiveness was evaluated using standardized response means (SRMs) for patients classified as improved or worsened via clinical anchors: Patient Global Rating of Change, Patient Global Rating of Severity, Patient Global Rating of Severity Interference, and PRO-CTCAE severity and interference fatigue items. Individual-level change was evaluated using Reliable Change Index (RCI) and Likely Change Index (LCI).</p> Results <p>SRM magnitudes varied by anchor and direction of change. For improvement, FACIT-Fatigue and NFLymSI-18 showed consistent responsiveness (SRMs 0.67–1.01 and 0.62–0.89, respectively), while PROMIS measures showed more variability (SRMs 0.31–1.58). For worsening, PROMIS measures, particularly 4a and 13a, demonstrated larger SRMs (0.75–1.71) than FACIT-Fatigue (0.73–1.24) or NFLymSI-18 (0.57–0.84) for most anchors. LCI analyses identified reliable improvement in 31.5% of patients using FACIT-Fatigue and 24.7–33.7% with PROMIS, and reliable worsening in 24.7% using FACIT-Fatigue and 23.6–34.8% using PROMIS measures.</p> Conclusions <p>Among lymphoma patients, FACIT-Fatigue and PROMIS Fatigue measures are responsive to meaningful change, with somewhat differing magnitude estimates across anchors and direction of change. These findings support planning for the use and interpretation of these fatigue measures in future clinical trials.</p>

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Measuring group‑ and individual‑level change of FACIT- fatigue, NFLymSI-18 and PROMIS fatigue measures (4a, 7a and 13a) in lymphoma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月19日

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  • Maja Kuharic,
  • Kimberly A. Webster,
  • Anne R. Zola,
  • Maria E. Corona,
  • Elijah A. Patten,
  • Reem Karmali,
  • Leo Gordon,
  • Shuo Ma,
  • John D. Peipert,
  • David Cella

摘要

Background

Fatigue significantly impacts quality of life in lymphoma patients. Multiple patient-reported fatigue measures are used in lymphoma research, including FACIT-Fatigue and PROMIS Fatigue instruments, but direct comparisons of their responsiveness and ability to detect individual-level change in this population are lacking. This study evaluated the responsiveness and sensitivity to individual-level change of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue measures (4a, 7a, and 13a), and NFLyMSI-18 Lymphoma Symptom Index in patients with lymphoma.

Methodology

In a prospective observational study, 102 lymphoma patients at an academic cancer center completed FACIT‑Fatigue, PROMIS Fatigue 4a, 7a, and 13a, and NFLymSI‑18 at baseline and again at 3 months (n = 89). Responsiveness was evaluated using standardized response means (SRMs) for patients classified as improved or worsened via clinical anchors: Patient Global Rating of Change, Patient Global Rating of Severity, Patient Global Rating of Severity Interference, and PRO-CTCAE severity and interference fatigue items. Individual-level change was evaluated using Reliable Change Index (RCI) and Likely Change Index (LCI).

Results

SRM magnitudes varied by anchor and direction of change. For improvement, FACIT-Fatigue and NFLymSI-18 showed consistent responsiveness (SRMs 0.67–1.01 and 0.62–0.89, respectively), while PROMIS measures showed more variability (SRMs 0.31–1.58). For worsening, PROMIS measures, particularly 4a and 13a, demonstrated larger SRMs (0.75–1.71) than FACIT-Fatigue (0.73–1.24) or NFLymSI-18 (0.57–0.84) for most anchors. LCI analyses identified reliable improvement in 31.5% of patients using FACIT-Fatigue and 24.7–33.7% with PROMIS, and reliable worsening in 24.7% using FACIT-Fatigue and 23.6–34.8% using PROMIS measures.

Conclusions

Among lymphoma patients, FACIT-Fatigue and PROMIS Fatigue measures are responsive to meaningful change, with somewhat differing magnitude estimates across anchors and direction of change. These findings support planning for the use and interpretation of these fatigue measures in future clinical trials.