Patient-reported outcome and quality of life research policy: Japan Clinical Oncology Group (JCOG) policy

被引：2

作者：

Ishiki, Hiroto ^{[1
]}

Kikawa, Yuichiro ^{[2
]}

Terada, Mitsumi ^{[3
]}

Mizusawa, Junki ^{[4
]}

Honda, Michitaka ^{[5
]}

Iwatani, Tsuguo ^{[6
,7
]}

Mizutani, Tomonori ^{[8
]}

Mori, Keita ^{[9
]}

Nakamura, Naoki ^{[10
]}

Miyaji, Tempei ^{[11
]}

Yamaguchi, Takuhiro ^{[12
]}

Ando, Masahiko ^{[13
]}

Nakamura, Kenichi ^{[14
]}

Fukuda, Haruhiko ^{[4
]}

Kiyota, Naomi ^{[15
]}

机构：

[1] Natl Canc Ctr, Dept Palliat Med, Tokyo, Japan

[2] Kansai Med Univ, Dept Breast Surg, Osaka, Japan

[3] Natl Canc Ctr, Dept Int Clin Dev, Tokyo, Japan

[4] Natl Canc Ctr, Japan Clin Oncol Grp JCOG Data Ctr, Tokyo, Japan

[5] Fukushima Med Univ, Dept Minimally Invas Surg & Med Oncol, Fukushima, Japan

[6] Okayama Univ Hosp, Dept Breast Surg, Okayama, Japan

[7] Okayama Univ Hosp, Dept Endocrine Surg, Okayama, Japan

[8] Kyorin Univ, Dept Med Oncol, Fac Med, Tokyo, Japan

[9] Shizuoka Canc Ctr, Clin Res Ctr, Dept Biostat, Shizuoka, Japan

[10] St Marianna Univ, Dept Radiat Oncol, Sch Med, Kawasaki, Japan

[11] Natl Canc Ctr, Inst Canc Control, Div Support Care Survivorship & Translat Res, Tokyo, Japan

[12] Tohoku Univ, Div Biostat, Grad Sch Med, Sendai, Japan

[13] Univ Hosp, Dept Adv Med, Nagoya, Japan

[14] Natl Canc Ctr, JCOG Data Ctr, Operat Off, Tokyo, Japan

[15] Kobe Univ Hosp, Dept Med Oncol & Hematol, Ctr Canc, Kobe, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2023年 / 53卷 / 03期

关键词：

JCOG; patient-reported outcome; health-related quality of life; quality of life; endpoint; study design; END-POINTS; ESOPHAGEAL CANCER; BONE METASTASES; TRIALS; RECOMMENDATIONS; RADIOTHERAPY; RADIATION; DYSPHAGIA; SINGLE;

D O I：

10.1093/jjco/hyad007

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Assessments of patient-reported outcomes and health-related quality of life in cancer clinical trials have been increasingly emphasized recently because patient and public involvement in cancer treatment development has been promoted by regulatory authorities and academic societies. To assess patient experiences during and after cancer treatment, there is interest in implementing patient-reported outcome and health-related quality of life assessments into cancer clinical trials. The Japan Clinical Oncology Group quality of life ad hoc committee previously created a version of the Quality of Life Assessment Policy in 2006. Recently, there has been increasing demand from Japan Clinical Oncology Group researchers to assess patient-reported outcome/health-related quality of life in clinical trials. Although guidelines are available regarding planning and reporting clinical trials that include patient-reported outcome/health-related quality of life as an endpoint, there are still issues regarding the lack of consensus on standardized methods for analysing and interpreting the results. Hence, it was considered necessary to reorganize the Japan Clinical Oncology Group patient-reported outcome/quality of life research committee and to revise the former patient-reported outcome/quality of life research policy to promote patient-reported outcome/health-related quality of life research in future Japan Clinical Oncology Group trials. The purpose of this Japan Clinical Oncology Group patient-reported outcome/quality of life research policy is to define patient-reported outcome/health-related quality of life research and provide guidelines for including patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials. This policy defines patient-reported outcome and health-related quality of life research and provides guidelines for implementing patient-reported outcome/health-related quality of life as an endpoint in Japan Clinical Oncology Group trials.

引用

页码：195 / 202

页数：8

共 50 条

[1] Geriatric Research Policy: Japan Clinical Oncology Group (JCOG) policy
Mizutani, Tomonori
Nakamura, Kenichi
Fukuda, Haruhiko
Ogawa, Asao
Hamaguchi, Tetsuya
Nagashima, Fumio
[J]. JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2019, 49 (10) : 901 - 909
[2] Japan Clinical Oncology Group (JCOG)
Shimoyama, M
Fukuda, H
Saijo, N
Yamaguchi, N
[J]. JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 1998, 28 (03) : 158 - 162
[3] Clinical Trial Methodology for Geriatric Oncology - JCOG Geriatric Research Policy
Nakamura, Kenichi
[J]. ANNALS OF ONCOLOGY, 2016, 27
[4] Patient-Reported Outcome Measures in Clinical Research
Weinfurt, Kevin P.
Reeve, Bryce B.
[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2022, 328 (05): : 472 - 473
[5] The use of patient-reported outcome and experience measures for health policy purposes: A scoping review in oncology
Minvielle, E.
Fierobe, A.
Fourcade, A.
Ferrua, M.
di Palma, M.
Scott, F.
Mir, O.
[J]. HEALTH POLICY, 2023, 129
[6] Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology
Efficace, Fabio
Horneber, Markus
Lejeune, Stephane
Van Dam, Frits
Leering, Suzanne
Rottmann, Michael
Aaronson, Neil K.
[J]. JOURNAL OF CLINICAL EPIDEMIOLOGY, 2006, 59 (12) : 1257 - 1265
[7] Investigating the quality of patient-reported outcome research in complementary and alternative medicine interventions in oncology
Efficace, F.
Horneber, M.
Lejeune, S.
Van Dam, F.
Aaronson, N.
[J]. PSYCHO-ONCOLOGY, 2006, 15 (02) : S233 - S233
[8] Electronic patient-reported outcome systems in oncology clinical practice
不详
[J]. CA-A CANCER JOURNAL FOR CLINICIANS, 2012, 62 (05) : 336 - 347
[9] Quality of life: A patient-reported outcome worth monitoring
Winkler, Marion F.
[J]. JOURNAL OF PARENTERAL AND ENTERAL NUTRITION, 2021, 45 (05) : 860 - 861
[10] Health-related quality of life and patient-reported outcome measurement in Head and Neck Oncology
Kanatas, Anastasios
Rogers, Simon N.
[J]. FRONTIERS OF ORAL AND MAXILLOFACIAL MEDICINE, 2023, 5

← 1 2 3 4 5 →