よむ、つかう、まなぶ。
参考資料14 高齢者がん医療Ｑ＆Ａ総論（厚生労働科学研究「高齢者がん診療指針策定に必要な基盤整備に関する研究」） (198 ページ)
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文献
1)
Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med.
2010;362:865-869
2)
Administration USDoHaHSFaD. Guidance for Industry Patient-Reported Outcome
Measures: Use in Medical Product Development to Support Labeling Claims 2009
3)
Basch E et al. Development of the National Cancer Institute's patient-reported outco
mes version of the common terminology criteria for adverse events (PRO-CTCAE). J
Natl Cancer Inst. 2014;106
4)
Miyaji T et al．Japanese translation and linguistic validation of the US National
CancerInstitute's Patient-Reported Outcomes version of the Common Terminology
Criteria for Adverse Events (PRO-CTCAE). J Patient Rep Outcomes.2017;1:8
5)
Kawaguchi T et al．The Japanese version of the National Cancer Institute's patientreported outcomes version of the common terminology criteria for adverse events
(PRO-CTCAE): The psychometric validation and discordance between clinician and
patient assessments ofadverse events. J Patient Rep Outcomes. 2017;2:2
6)
NCI. PRO-CTAETM. 2017
https://healthcaredelivery.cancer.gov/pro-ctcae/pro-ctcae_japanese.pdf.
7)
USDoHaH Services. FDA Administration. Guidance for Industry Electronic SourceDat
a in Clinical Investigations. 2013
190
1)
Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med.
2010;362:865-869
2)
Administration USDoHaHSFaD. Guidance for Industry Patient-Reported Outcome
Measures: Use in Medical Product Development to Support Labeling Claims 2009
3)
Basch E et al. Development of the National Cancer Institute's patient-reported outco
mes version of the common terminology criteria for adverse events (PRO-CTCAE). J
Natl Cancer Inst. 2014;106
4)
Miyaji T et al．Japanese translation and linguistic validation of the US National
CancerInstitute's Patient-Reported Outcomes version of the Common Terminology
Criteria for Adverse Events (PRO-CTCAE). J Patient Rep Outcomes.2017;1:8
5)
Kawaguchi T et al．The Japanese version of the National Cancer Institute's patientreported outcomes version of the common terminology criteria for adverse events
(PRO-CTCAE): The psychometric validation and discordance between clinician and
patient assessments ofadverse events. J Patient Rep Outcomes. 2017;2:2
6)
NCI. PRO-CTAETM. 2017
https://healthcaredelivery.cancer.gov/pro-ctcae/pro-ctcae_japanese.pdf.
7)
USDoHaH Services. FDA Administration. Guidance for Industry Electronic SourceDat
a in Clinical Investigations. 2013
190