The State of the Science in Patient-Reported Outcomes for Patients with Lung Cancer

2020 ◽  
Vol 41 (03) ◽  
pp. 377-385
Author(s):  
Canhua Xiao ◽  
Newton Hurst ◽  
Benjamin Movsas
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Treatment Effectiveness ◽  
Clinical Decision ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
Cancer Type ◽  
Patient Reported ◽  
State Of The Science

AbstractTraditionally, clinicians have assumed the primary responsibility for evaluating disease- and treatment-related outcomes. In the past few decades, however, a series of recommendations and standards promulgated by professional societies and regulatory agencies have resulted in increased use of patient-reported outcome (PRO) measures in cancer clinical trials. PROs, such as quality of life (QOL) measures, are important in establishing overall treatment effectiveness in cancer clinical trials, and they can inform clinical decision making. This article discusses the current state of the science in PRO research for patients with lung cancer, the cancer type with the highest incidence rate and the lowest survival rate worldwide. The discussion focuses on (1) PRO and survival; (2) electronic PRO reporting and interventions; (3) PROs and immunotherapy; (4) PRO, biomarkers, and precision health; (5) key issues in applying PROs in clinical trials; and (6) future directions for research.

Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials—Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?

2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.

scholarly journals PCN129 A DATABASE REVIEW OF PATIENT-REPORTED OUTCOME STUDIES IN EORTC CANCER CLINICAL TRIALS

2010 ◽  
Vol 13 (7) ◽  
pp. A276
Author(s):  
A Bottomley ◽  
C Quinten ◽  
M Mauer ◽  
M Taphoorn ◽  
HH Flechtner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcome ◽  
Outcome Studies ◽  
Cancer Clinical Trials ◽  
Patient Reported

scholarly journals Patients and clinicians define symptom levels and meaningful change for PROMIS pain interference and fatigue in RA using bookmarking

Rheumatology ◽  
2021 ◽  
Author(s):  
Clifton O Bingham ◽  
Alessandra L Butanis ◽  
Ana Maria Orbai ◽  
Michelle Jones ◽  
Victoria Ruffing ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
Outcome Measurement ◽  
Clinical Decision ◽  
Patient Reported Outcome ◽  
Pain Interference ◽  
Measurement Information ◽  
Meaningful Change ◽  
External Anchor ◽  
New Information ◽  
Patient Reported

Abstract Objectives Using patient-reported outcomes to inform clinical decision-making depends on knowing how to interpret scores. Patient-Reported Outcome Measurement Information System® (PROMIS®) instruments are increasingly used in rheumatology research and care, but there is little information available to guide interpretation of scores. We sought to identify thresholds and meaningful change for PROMIS Pain Interference and Fatigue scores from the perspective of RA patients and clinicians. Methods We developed patient vignettes using the PROMIS item banks representing a continuum of Pain Interference and Fatigue levels. During a series of face-to-face ‘bookmarking’ sessions, patients and clinicians identified thresholds for mild, moderate and severe levels of symptoms and identified change deemed meaningful for making treatment decisions. Results In general, patients selected higher cut points to demarcate thresholds than clinicians. Patients and clinicians generally identified changes of 5–10 points as representing meaningful change. The thresholds and meaningful change scores of patients were grounded in their lived experiences having RA, approach to self-management, and the impacts on function, roles and social participation. Conclusion Results offer new information about how both patients and clinicians view RA symptoms and functional impacts. Results suggest that patients and providers may use different strategies to define and interpret RA symptoms, and select different thresholds when describing symptoms as mild, moderate or severe. The magnitude of symptom change selected by patients and clinicians as being clinically meaningful in interpreting treatment efficacy and loss of response may be greater than levels determined by external anchor and statistical methods.

Non-English language validation of patient-reported outcome measures in cancer clinical trials

2020 ◽  
Vol 28 (6) ◽  
pp. 2503-2505 ◽  
Author(s):  
Stephen R. Grant ◽  
Sonal S. Noticewala ◽  
Walker Mainwaring ◽  
Timothy A. Lin ◽  
Austin B. Miller ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
English Language ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Cancer Clinical Trials ◽  
Patient Reported

Funding Patient-Reported Outcomes in Cancer Clinical Trials

2007 ◽  
Vol 25 (32) ◽  
pp. 5100-5105 ◽  
Author(s):  
Carol M. Moinpour ◽  
Andrea M. Denicoff ◽  
Deborah Watkins Bruner ◽  
Alice B. Kornblith ◽  
Stephanie R. Land ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Trial Data ◽  
Patient Reported Outcome ◽  
National Institutes Of Health ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Funding Sources ◽  
Community Clinical Oncology Program ◽  
Patient Reported ◽  
Cost Components

We surveyed four cooperative groups to identify current funding sources for the collection and analysis effort associated with the inclusion of patient-reported outcome (PRO) data in cancer clinical trials. Survey questions included what proportion of staff effort was funded through the Cancer Therapy Evaluation Program (CTEP) and the Community Clinical Oncology Program (CCOP) grants. In addition, the groups were asked to what extent outside funding was solicited to cover an underfunded PRO effort (eg, the pharmaceutical industry, foundations, or National Institutes of Health grants). All four groups noted the challenge of making limited resources cover a number of trial responsibilities. PRO effort is usually bundled with effort required for all clinical trial data. There is variation in the use of the CTEP and CCOP grants to fund PRO research. The groups differed with respect to both the types and amount of outside funding used. This survey focused on funding sources for the conduct of PRO research in cooperative group trials; it did not assess the specific cost components associated with collecting and analyzing these data. In general, the costs for conducting PRO research have been bundled with other study costs because in most cases, the PRO has been considered an integral component of the trial. However, these data also suggest that PRO research has required the use of outside funding sources in the four surveyed cooperative groups and that PRO economic issues require attention if we are to continue the inclusion of these outcomes in cancer clinical trials.

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