Minimal Clinically Important Difference in the Physical, Emotional, and Total Symptom Distress Scores of the Edmonton Symptom Assessment System.
BACKGROUND
The Edmonton Symptom Assessment System (ESAS) is one of the most commonly used symptom batteries in clinical practice and research.


OBJECTIVE
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.


CONCLUSIONS
We identified the MCIDs for physical, emotional, and total symptom distress scores, which have implications for interpretation of symptom response in clinical trials.
Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.
David
D
Hui
Department of Palliative Care, King Hussein Cancer Center, Amman, Jordan.
Omar
O
Shamieh
Department of Medical Oncology, Barretos Cancer Hospital, Barretos, Brazil.
Carlos Eduardo
CE
Paiva
Department of Palliative Care, King Hussein Cancer Center, Amman, Jordan.
Odai
O
Khamash
Departamento Medicina Interna, Escuela de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.
Pedro Emilio
PE
Perez-Cruz
Department of Medical Oncology, Kangdong Sacred Heart Hospital, Seoul, Republic of Korea.
Jung Hye
JH
Kwon
Department of Palliative Care, Tata Memorial Center, Mumbai, India.
Mary Ann
MA
Muckaden
Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Minjeong
M
Park
Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Joseph
J
Arthur
Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, USA.
Eduardo
E
Bruera
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D000071081:Minimal Clinically Important Difference; D009369:Neoplasms / Q000175:diagnosis* / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D011446:Prospective Studies; D012372:ROC Curve; D012680:Sensitivity and Specificity; D063189:Symptom Assessment / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
Neoplasms; outcome measures; pain; sample size; sensitivity and specificity; symptom assessment