The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

Kawaguchi, Takashi; Azuma, Kanako; Sano, Motohiko; Kim, Soan; Kawahara, Yosuke; Sano, Yoko; Shimodaira, Tomohide; Ishibashi, Keiichiro; Miyaji, Tempei; Basch, Ethan; Yamaguchi, Takuhiro

doi:10.1186/s41687-017-0022-5

Journal of Patient-Reported Outcomes

Table 6 Standardized response mean in Cohort B (n = 100)

From: The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

	Overall Quality of Life			Physical State			Emotional State
	Improved	No change	Worse	Improved	No change	Worse	Improved	No change	Worse
Anxiety
Frequency	−0.11	−0.06	−0.30	0.00	−0.02	−0.37	0.35	0.05	−0.72
Severity	0.15	0.02	−0.25	0.27	0.10	−0.36	0.35	0.10	−0.53
Interference	0.00	−0.17	−0.21	0.12	−0.06	−0.30	0.54	−0.05	−0.50
Constipation
Severity	−0.13	0.10	−0.36	0.00	0.19	−0.47	−0.13	−0.05	−0.24
Decreased appetite
Severity	0.15	−0.11	−0.29	0.38	0.02	−0.36	0.15	−0.14	−0.31
Interference	0.24	−0.15	−0.25	0.67	0.06	−0.39	0.24	−0.09	−0.39
Dry mouth
Severity	0.36	0.19	−0.23	0.18	0.22	−0.27	0.35	−0.02	−0.04
Fatigue, tiredness, or lack of energy
Severity	−0.28	−0.10	−0.26	−0.10	−0.14	−0.23	0.20	−0.10	−0.37
Interference	0.00	0.00	−0.47	0.12	0.02	−0.44	0.35	−0.07	−0.58
Insomnia
Severity	−0.23	−0.05	−0.10	−0.07	−0.09	−0.10	0.00	−0.06	−0.16
Interference	0.00	−0.18	0.02	0.14	−0.15	0.00	0.20	0.00	−0.22
Loose or watery stools (diarrhea)
Frequency	0.06	−0.14	0.02	−0.49	−0.07	0.00	0.47	−0.12	−0.07
Mouth or throat sores
Severity	0.00	0.20	−0.21	0.12	0.17	−0.20	0.00	0.17	−0.26
Interference	−0.35	0.03	−0.38	−0.12	−0.09	−0.27	−0.35	−0.03	−0.36
Nausea
Frequency	−0.35	−0.20	−0.39	−0.18	−0.13	−0.49	−0.35	−0.19	−0.50
Severity	−0.54	−0.24	−0.32	−0.27		−0.33	−0.54	−0.19	−0.42
Numbness or tingling in your hands or feet
Severity	–	−0.04	0.03	–	0.03	−0.05	−0.35	0.00	0.04
Interference	−0.35	−0.17	−0.17	−0.33	−0.16	−0.22		−0.14	−0.30
Pain
Frequency	0.77	0.14	−0.02	0.39	0.24	−0.02	0.23	0.23	−0.15
Severity	1.20	0.06	−0.10	0.30	0.16	−0.10	0.00	0.10	−0.68
Interference	0.35	0.00	−0.13	0.00	0.11	−0.17	−0.20	0.14	−0.30
Sad or unhappy feeling
Frequency	0.00	−0.20	−0.34	−0.33	−0.19	−0.32	0.28	−0.11	−0.59
Severity	0.20	0.23	−0.19	0.18	0.16	−0.15	0.35	0.26	−0.32
Interference	0.20	0.20	−0.29	0.18	0.23	−0.32	0.35	0.17	−0.39
Shortness of breath
Severity	0.36	0.09	−0.45	0.50	0.04	−0.38	0.35	−0.10	−0.38
Interference	0.36	−0.08	−0.54	0.47	−0.04	−0.53	0.35	−0.19	−0.53
Vomiting
Frequency	−0.36	0.05	−0.27	0.33	−0.14	−0.22	−0.35	−0.03	−0.46
Severity	–	−0.06	−0.32	–	−0.15	−0.24	–	−0.04	−0.54
Arm or leg swelling
Frequency	0.00	−0.07	−0.30	0.20	−0.05	−0.29	−0.47	0.05	−0.40
Severity	0.00	0.05	−0.35	0.11	0.00	−0.31	−0.41	0.18	−0.51
Interference	0.00	0.00	−0.31	0.00	0.00	−0.30	−0.20	0.00	−0.33
Hair loss
Amount	−0.32	0.17	−0.08	−0.93	0.03	0.05	−0.13	0.14	−0.19
Headache
Frequency	0.00	−0.02	−0.22	0.36	−0.10	−0.09	−0.66	−0.05	−0.06
Severity	−0.20	0.02	−0.30	0.10	−0.07	−0.15	−0.72	−0.04	−0.13
Interference	−0.20	−0.08	−0.40	0.66	−0.14	−0.31	−0.35	0.12	−0.39
Problems with concentration
Severity	−0.51	−0.08	−0.35	0.25	−0.12	−0.36	−0.41	−0.13	−0.35
Interference	−0.20	−0.11	−0.32	0.23	−0.11	−0.33	0.20	−0.10	−0.46
Problems with tasting food or drink
Severity	−0.36	0.02	−0.36	0.18	0.03	−0.35	0.15	−0.12	−0.33

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