David Hui1, Omar Shamieh2, Carlos Eduardo Paiva3, Odai Khamash2, Pedro Emilio Perez-Cruz4, Jung Hye Kwon5, Mary Ann Muckaden6, Minjeong Park7, Joseph Arthur8, Eduardo Bruera8. 1. Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org. 2. Department of Palliative Care, King Hussein Cancer Center, Amman, Jordan. 3. Department of Medical Oncology, Barretos Cancer Hospital, Barretos, Brazil. 4. Departamento Medicina Interna, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. 5. Department of Medical Oncology, Kangdong Sacred Heart Hospital, Seoul, Republic of Korea. 6. Department of Palliative Care, Tata Memorial Center, Mumbai, India. 7. Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA. 8. Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Abstract
CONTEXT: The Edmonton Symptom Assessment System (ESAS) is one of the most commonly used symptom batteries in clinical practice and research. OBJECTIVES: We used the anchor-based approach to identify the minimal clinically important difference (MCID) for improvement and deterioration for ESAS physical, emotional, and total symptom distress scores. METHODS: In this multicenter prospective study, we asked patients with advanced cancer to complete their ESAS at the first clinic visit and at a second visit three weeks later. The anchor for MCID determination was Patient's Global Impression regarding their physical, emotional, and overall symptom burden ("better," "about the same," or "worse"). We identified the optimal sensitivity/specificity cutoffs for both improvement and deterioration for the three ESAS scores and also determined the within-patient changes. RESULTS: A total of 796 patients were enrolled from six centers. The ESAS scores had moderate responsiveness, with area under the receiver operating characteristic curve between 0.69 and 0.76. Using the sensitivity-specificity approach, the optimal cutoffs for ESAS physical, emotional, and total symptom distress scores were ≥3/60, ≥2/20, and ≥3/90 for improvement, and ≤-4/60, ≤-1/20, and ≤-4/90 for deterioration, respectively. These cutoffs had moderate sensitivities (59%-68%) and specificities (62%-80%). The within-patient change approach revealed the MCID cutoffs for improvement/deterioration to be 3/-4.3 for the physical score, 2.4/-1.8 for the emotional score, and 5.7/-2.9 for the total symptom distress score. CONCLUSION: We identified the MCIDs for physical, emotional, and total symptom distress scores, which have implications for interpretation of symptom response in clinical trials.
CONTEXT: The Edmonton Symptom Assessment System (ESAS) is one of the most commonly used symptom batteries in clinical practice and research. OBJECTIVES: We used the anchor-based approach to identify the minimal clinically important difference (MCID) for improvement and deterioration for ESAS physical, emotional, and total symptom distress scores. METHODS: In this multicenter prospective study, we asked patients with advanced cancer to complete their ESAS at the first clinic visit and at a second visit three weeks later. The anchor for MCID determination was Patient's Global Impression regarding their physical, emotional, and overall symptom burden ("better," "about the same," or "worse"). We identified the optimal sensitivity/specificity cutoffs for both improvement and deterioration for the three ESAS scores and also determined the within-patient changes. RESULTS: A total of 796 patients were enrolled from six centers. The ESAS scores had moderate responsiveness, with area under the receiver operating characteristic curve between 0.69 and 0.76. Using the sensitivity-specificity approach, the optimal cutoffs for ESAS physical, emotional, and total symptom distress scores were ≥3/60, ≥2/20, and ≥3/90 for improvement, and ≤-4/60, ≤-1/20, and ≤-4/90 for deterioration, respectively. These cutoffs had moderate sensitivities (59%-68%) and specificities (62%-80%). The within-patient change approach revealed the MCID cutoffs for improvement/deterioration to be 3/-4.3 for the physical score, 2.4/-1.8 for the emotional score, and 5.7/-2.9 for the total symptom distress score. CONCLUSION: We identified the MCIDs for physical, emotional, and total symptom distress scores, which have implications for interpretation of symptom response in clinical trials.
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