Thomas M Atkinson, Angela M Stover, Daniel F Storfer, Rebecca M Saracino, Thomas A D'Agostino, Denise Pergolizzi, Konstantina Matsoukas, Yuelin Li, Ethan Basch
{"title":"癌症临床试验中患者报告的身体功能测量方法。","authors":"Thomas M Atkinson, Angela M Stover, Daniel F Storfer, Rebecca M Saracino, Thomas A D'Agostino, Denise Pergolizzi, Konstantina Matsoukas, Yuelin Li, Ethan Basch","doi":"10.1093/epirev/mxx008","DOIUrl":null,"url":null,"abstract":"<p><p>Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.</p>","PeriodicalId":50510,"journal":{"name":"Epidemiologic Reviews","volume":"39 1","pages":"59-70"},"PeriodicalIF":5.2000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5858035/pdf/mxx008.pdf","citationCount":"0","resultStr":"{\"title\":\"Patient-Reported Physical Function Measures in Cancer Clinical Trials.\",\"authors\":\"Thomas M Atkinson, Angela M Stover, Daniel F Storfer, Rebecca M Saracino, Thomas A D'Agostino, Denise Pergolizzi, Konstantina Matsoukas, Yuelin Li, Ethan Basch\",\"doi\":\"10.1093/epirev/mxx008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.</p>\",\"PeriodicalId\":50510,\"journal\":{\"name\":\"Epidemiologic Reviews\",\"volume\":\"39 1\",\"pages\":\"59-70\"},\"PeriodicalIF\":5.2000,\"publicationDate\":\"2017-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5858035/pdf/mxx008.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Epidemiologic Reviews\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/epirev/mxx008\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Epidemiologic Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/epirev/mxx008","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH","Score":null,"Total":0}
Patient-Reported Physical Function Measures in Cancer Clinical Trials.
Patient-reported outcomes (PROs) are increasingly used to monitor treatment-related symptoms and physical function decrements in cancer clinical trials. As more patients enter survivorship, it is important to capture PRO physical function throughout trials to help restore pretreatment levels of function. We completed a systematic review of PRO physical function measures used in cancer clinical trials and evaluated their psychometric properties on the basis of guidelines from the US Food and Drug Administration. Five databases were searched through October 2015: PubMed/MEDLINE, EMBASE, CINAHL (Cumulative Index of Nursing and Allied Health Literature), Health and Psychosocial Instruments, and Cochrane. From an initial total of 10,233 articles, we identified 108 trials that captured PRO physical function. Within these trials, approximately 67% used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and 25% used the Medical Outcomes Study Short Form 36. Both the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and Medical Outcomes Study Short Form 36 instruments generically satisfy most Food and Drug Administration requirements, although neither sought direct patient input as part of item development. The newer Patient-Reported Outcomes Measurement Information System physical function short form may be a brief, viable alternative. Clinicians should carefully consider the psychometric properties of these measures when incorporating PRO instrumentation into clinical trial design to provide a more comprehensive understanding of patient function.
期刊介绍:
Epidemiologic Reviews is a leading review journal in public health. Published once a year, issues collect review articles on a particular subject. Recent issues have focused on The Obesity Epidemic, Epidemiologic Research on Health Disparities, and Epidemiologic Approaches to Global Health.