Analysis and interpretation of results based on patient-reported outcomes

被引:47
作者
Sloan, Jeff A. [1 ]
Dueck, Amylou C. [1 ]
Erickson, Pennifer A. [2 ,3 ]
Guess, Harry [4 ]
Revicki, Dennis A. [6 ]
Santanello, Nancy C. [5 ]
Sloan, Jeff A. [1 ]
机构
[1] Mayo Clin, Dept Hlth Sci Res, 200 1st St SW, Rochester, MN 55905 USA
[2] Penn State Univ, Hershey Med Sch, Dept Biobehav Hlth, State Coll, PA USA
[3] Penn State Univ, Hershey Med Sch, Dept Hlth Evaluat Sci, State Coll, PA USA
[4] Univ N Carolina, Sch Publ Hlth, Dept Epidemiol, Chapel Hill, NC USA
[5] Merck Res Labs, West Point, PA USA
[6] United BioSource Corp, Ctr Hlth Outcomes Res, Bethesda, MD USA
关键词
clinical significance; minimally important difference; missing data; patient-reported outcomes; statistical analysis;
D O I
10.1111/j.1524-4733.2007.00273.x
中图分类号
F [经济];
学科分类号
02 ;
摘要
This article is part of a series of manuscripts dealing with the incorporation of patient-reported outcomes (PROs) into clinical trials. The issues dealt with in this manuscript concern the common pitfalls to avoid in statistical analysis and interpretation of PROs. Specifically, the questions addressed by this manuscript involve the analysis pitfalls with PRO data in clinical trials and how can they be avoided (e.g.,missing data, multiplicity, null results etc.). The manuscript provides key literature for existing resources and proposes new guidelines.
引用
收藏
页码:S106 / S115
页数:10
相关论文
共 45 条
[1]   Handling missing data [J].
不详 .
CURRENT PROBLEMS IN CANCER, 2005, 29 (06) :317-325
[2]   Presenting longitudinal data [J].
不详 .
CURRENT PROBLEMS IN CANCER, 2005, 29 (06) :296-305
[3]  
[Anonymous], 2005, Assessing Quality of Life in Clinical Trials: Methods and Practice
[4]  
Brown H., 1999, Applied mixed models in medicine
[5]   Accounting for deaths in longitudinal studies using the SF-36 - The performance of the physical component scale of the short form 36-item health survey and the PCTD [J].
Diehr, P ;
Patrick, DL ;
McDonell, MB ;
Fihn, SD .
MEDICAL CARE, 2003, 41 (09) :1065-1073
[6]   Transforming self-rated health and the SF-36 scales to include death and improve interpretability [J].
Diehr, P ;
Patrick, DL ;
Spertus, J ;
Kiefe, CI ;
McDonell, M ;
Fihn, SD .
MEDICAL CARE, 2001, 39 (07) :670-680
[7]   Learnincy to live with missing quality-of-life data in advanced-stage disease trials [J].
Donaldson, GW ;
Moinpour, CM .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (30) :7380-7384
[8]   A primer on the use of modern missing-data methods in psychosomatic medicine research [J].
Enders, Craig K. .
PSYCHOSOMATIC MEDICINE, 2006, 68 (03) :427-436
[9]  
Fairclough D, 2005, Assessing Quality of Life in Clinical Trials: Methods and Practice, V2nd
[10]  
Fairclough DL, 1997, STAT MED, V16, P1197, DOI 10.1002/(SICI)1097-0258(19970615)16:11<1197::AID-SIM531>3.0.CO