Recommendations for Incorporating Patient-Reported Outcomes Into Clinical Comparative Effectiveness Research in Adult Oncology

被引：376

作者：

Basch, Ethan ^{[1
]}

Abernethy, Amy P. ^{[2
]}

Mullins, C. Daniel ^{[4
]}

Reeve, Bryce B. ^{[3
]}

Smith, Mary Lou ^{[6
]}

Coons, Stephen Joel ^{[7
]}

Sloan, Jeff ^{[8
]}

Wenzel, Keith

Chauhan, Cynthia

Eppard, Wayland ^{[9
]}

Frank, Elizabeth S. ^{[10
]}

Lipscomb, Joseph ^{[12
]}

Raymond, Stephen A. ^{[11
]}

Spencer, Merianne ^{[5
]}

Tunis, Sean ^{[5
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, Dept Med, Genitourinary Oncol Serv, Hlth Outcomes Res Grp,Dept Biostat, New York, NY 10065 USA

[2] Duke Univ, Durham, NC 27706 USA

[3] Univ N Carolina, Chapel Hill, NC USA

[4] Univ Maryland, College Pk, MD 20742 USA

[5] Ctr Med Technol Policy, Baltimore, MD USA

[6] Res Advocacy Network, Plano, TX USA

[7] Crit Path Inst, Tucson, AZ USA

[8] Mayo Clin, Rochester, MN 55905 USA

[9] Patient Advocacy Comm, N Cent Canc Treatment Grp, Rochester, MN USA

[10] Dana Farber Canc Inst, Boston, MA USA

[11] PHT Corp, Boston, MA USA

[12] Emory Univ, Atlanta, GA 30322 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2012年 / 30卷 / 34期

关键词：

QUALITY-OF-LIFE; RANDOMIZED CONTROLLED-TRIAL; CANCER CARE MONITOR; HEALTH; CHEMOTHERAPY; SYMPTOMS; COMMUNICATION; EQUIVALENCE; ASSESSMENTS; POINTS;

D O I：

10.1200/JCO.2012.42.5967

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Examining the patient's subjective experience in prospective clinical comparative effectiveness research (CER) of oncology treatments or process interventions is essential for informing decision making. Patient-reported outcome (PRO) measures are the standard tools for directly eliciting the patient experience. There are currently no widely accepted standards for developing or implementing PRO measures in CER. Recommendations for the design and implementation of PRO measures in CER were developed via a standardized process including multistakeholder interviews, a technical working group, and public comments. Key recommendations are to include assessment of patient-reported symptoms as well as health-related quality of life in all prospective clinical CER studies in adult oncology; to identify symptoms relevant to a particular study population and context based on literature review and/or qualitative and quantitative methods; to assure that PRO measures used are valid, reliable, and sensitive in a comparable population (measures particularly recommended include EORTC QLQ-C30, FACT, MDASI, PRO-CTCAE, and PROMIS); to collect PRO data electronically whenever possible; to employ methods that minimize missing patient reports and include a plan for analyzing and reporting missing PRO data; to report the proportion of responders and cumulative distribution of responses in addition to mean changes in scores; and to publish results of PRO analyses simultaneously with other clinical outcomes. Twelve core symptoms are recommended for consideration in studies in advanced or metastatic cancers. Adherence to methodologic standards for the selection, implementation, and analysis/reporting of PRO measures will lead to an understanding of the patient experience that informs better decisions by patients, providers, regulators, and payers. J Clin Oncol 30:4249-4255. (C) 2012 by American Society of Clinical Oncology

引用

页码：4249 / 4255

页数：7

共 31 条

[1] Improving Health Care Efficiency and Quality Using Tablet Personal Computers to Collect Research-Quality, Patient-Reported Data [J].

Abernethy, Amy P. ;

Herndon, James E., II ;

Wheeler, Jane L. ;

Patwardhan, Meenal ;

Shaw, Heather ;

Lyerly, H. Kim ;

Weinfurt, Kevin .

HEALTH SERVICES RESEARCH, 2008, 43 (06) :1975-1991

[2] Feasibility and Acceptability to Patients of a Longitudinal System for Evaluating Cancer-Related Symptoms and Quality of Life: Pilot Study of an e/Tablet Data-Collection System in Academic Oncology [J].

Abernethy, Amy P. ;

Herndon, James E. ;

Wheeler, Jane L. ;

Day, Jeannette M. ;

Hood, Linda ;

Patwardhan, Meenal ;

Shaw, Heather ;

Lyerly, Herbert Kim .

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT, 2009, 37 (06) :1027-1038

[3]

American Cancer Society, 2015 goals of the American Cancer Society

[4]

[Anonymous], 2002, QUAL LIFE RES, V11, P193

[5]

[Anonymous], PAT REP OUTC MEAS IN

[6]

[Anonymous], NIH PUBL

[7] Patient online self-reporting of toxicity symptoms during chemotherapy [J].

Basch, E ;

Artz, D ;

Dulko, D ;

Scher, K ;

Sabbatini, P ;

Hensley, M ;

Mitra, N ;

Speakman, J ;

McCabe, M ;

Schrag, D .

JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (15) :3552-3561

[8] Long-term toxicity monitoring via electronic patient-reported outcomes in patients receiving chemotherapy [J].

Basch, Ethan ;

Iasonos, Alexia ;

Barz, Allison ;

Culkin, Ann ;

Kris, Mark G. ;

Artz, David ;

Fearn, Paul ;

Speakman, John ;

Farquhar, Rena ;

Scher, Howard I. ;

McCabe, Mary ;

Schrag, Deborah .

JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (34) :5374-5380

[9] Methodological Standards and Patient-Centeredness in Comparative Effectiveness Research The PCORI Perspective [J].

Basch, Ethan ;

Aronson, Naomi ;

Berg, Alfred ;

Flum, David ;

Gabriel, Sherine ;

Goodman, Steven N. ;

Helfand, Mark ;

Ioannidis, John P. A. ;

Lauer, Michael ;

Meltzer, David ;

Mittman, Brian ;

Newhouse, Robin ;

Normand, Sharon-Lise ;

Schneeweiss, Sebastian ;

Slutsky, Jean ;

Tinetti, Mary ;

Yancy, Clyde .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2012, 307 (15) :1636-1640

[10] The Missing Voice of Patients in Drug-Safety Reporting [J].

Basch, Ethan .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (10) :865-869

← 1 2 3 4 →