TY - JOUR
T1 - Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer
AU - Cella, David
AU - Rosenbloom, Sarah K.
AU - Beaumont, Jennifer L.
AU - Yount, Susan E.
AU - Paul, Diane
AU - Hampton, Debra
AU - Abernethy, Amy P.
AU - Jacobsen, Paul B.
AU - Syrjala, Karen
AU - Von Roenn, Jamie H.
PY - 2011/3/1
Y1 - 2011/3/1
N2 - Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/ pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.
AB - Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/ pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.
KW - Advanced cancer
KW - Health-related quality of life
KW - Measurement
KW - Patient-centered
KW - Symptom index
UR - http://www.scopus.com/inward/record.url?scp=79952675460&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79952675460&partnerID=8YFLogxK
U2 - 10.6004/jnccn.2011.0026
DO - 10.6004/jnccn.2011.0026
M3 - Review article
C2 - 21393439
AN - SCOPUS:79952675460
SN - 1540-1405
VL - 9
SP - 268
EP - 278
JO - JNCCN Journal of the National Comprehensive Cancer Network
JF - JNCCN Journal of the National Comprehensive Cancer Network
IS - 3
ER -
