scholarly journals PCN457 THE SISAQOL INITIATIVE: ESTABLISHING INTERNATIONAL STANDARDS AND RECOMMENDATIONS FOR THE ANALYSIS OF PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE DATA IN ONCOLOGY RANDOMIZED CLINICAL TRIALS

2019 ◽  
Vol 22 ◽  
pp. S525
Author(s):  
L. Dorme ◽  
M. Pe ◽  
C. Coens ◽  
E.M. Basch ◽  
M. Calvert ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Randomized Clinical Trials ◽  
International Standards ◽  
Life Data ◽  
Patient Reported

scholarly journals Patient-Reported Outcomes in Clinical Trials Leading to Cancer Immunotherapy Drug Approvals From 2011 to 2018: A Systematic Review

2020 ◽  
Author(s):  
Houssein Safa ◽  
Monica Tamil ◽  
Philippe E Spiess ◽  
Brandon Manley ◽  
Julio Pow-Sang ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Cancer Immunotherapy ◽  
Patient Reported Outcomes ◽  
Randomized Clinical Trials ◽  
International Standards ◽  
Type I ◽  
Patient Centeredness ◽  
Patient Reported

Abstract Background Patient-reported outcomes (PROs) promote patient centeredness in clinical trials; however, in the field of rapidly emerging and clinically impressive immunotherapy, data on PROs are limited. Methods We systematically identified all immunotherapy approvals from 2011 through 2018 and assessed the analytic tools and reporting quality of associated PRO reports. For randomized clinical trials (RCTs), we developed a novel 24-point scoring scale: the PRO Endpoints Analysis Score based on 24 criteria derived from the recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. Results We assessed 44 trial publications supporting 42 immunotherapy approvals. PROs were published for 21 of the 44 (47.7%) trial publications. Twenty-three trials (52.3%) were RCTs and 21 (47.7%) pertained to single-arm trials. The median time between primary clinical outcomes publications and their corresponding secondary PRO publications was 19 months (interquartile range = 9-29 months). Of the 21 PRO reports, 4 (19.0%) reported a specific hypothesis, and most (85.7%) used descriptive statistics. Three (3 of 21 [14.3%]) studies performed a control for type I error. As for RCTs, 14 of 23 (60.9%) published PRO data, including 13 (56.5%) that published a secondary dedicated manuscript. One-half of these 14 trials scored less than 13 points on the 24-point PRO Endpoints Analysis Score. The mean score was 12.71 (range = 5-17, SD = 3.71), and none met all the recommendations of the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. Conclusions Suboptimal reporting of PROs occurs regularly in cancer immunotherapy trials. Increased efforts are needed to maximize the value of these data in cancer immunotherapy development and approval.

Correlation between patient-reported fatigue and hemoglobin (Hgb) levels in metastatic renal cell carcinoma (mRCC) patients (pts) receiving sunitinib (SU).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 418-418
Author(s):  
Mellar P. Davis ◽  
Ewa M. Matczak ◽  
Connie Chen ◽  
Beata Korytowsky ◽  
Helen Bhattacharyya ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Randomized Clinical Trials ◽  
Dosing Schedule ◽  
Patient Reported ◽  
The Relationship

418 Background: Low Hgb is linked with fatigue in cancer pts; however, the onset and severity of fatigue is multifactorial. The approved SU dosing schedule in mRCC is 4 weeks on treatment, 2 weeks off, and quality of life (QoL) when examined on day 28 is significantly worse than on day 1 of each cycle. The relationship between pt-reported fatigue and Hgb levels with SU in mRCC was investigated. Methods: Two randomized clinical trials of SU were combined to examine the pt-reported fatigue item from FKSI-15 which asks pts to indicate their level of fatigue on a 5-point Likert scale from 0=“not at all” to 4=“very much”. Data were collected at baseline (BL; cycle 1, day 1) and on days 28 and 42 of each 42-day cycle. For each visit, only pts who had data for both fatigue and Hgb at BL were included in the analysis. Results: 481 pts were included. Fatigue and Hgb levels at BL and over cycles 1–6 are shown in the table. Pts reported worse fatigue (higher score) at day 28 of each cycle than on day 42. Fatigue scores typically ranged from 1= “a little bit” to 2=“somewhat”. Changes in Hgb levels, however, were modest and opposite to fatigue changes i.e. were higher on day 28 of each cycle and lower on day 42. Findings were similar beyond cycle 6. Conclusions: Pts indicated less fatigue on day 42, after the 2-week break, than on day 28 of each cycle, consistent with previous overall QoL findings. Low Hgb is not associated with worse fatigue in mRCC pts receiving SU.This may be due to the multifactorial nature of fatigue. The ‘on’ and ‘off’ periods in intermittent dosing are important considerations of patients’ full experience of QoL. [Table: see text]

Compliance of subjects using electronic patient-reported outcomes (ePRO) in multinational prostate trials.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 232-232
Author(s):  
Susan M. Dallabrida
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Quality Data ◽  
Data Set ◽  
Patient Reported ◽  
Clinic Visits

232 Background: Patient Reported Outcomes (PRO) and electronic PRO (ePRO) are increasingly becoming an important aspect of cancer clinical trials and patient care, especially with regard to measuring drug efficacy, patient quality of life and drug safety. Subject compliance with completion of PRO/ePRO assessments is an important component for obtaining accurate and high-quality data when conducting clinical trials. It has been hypothesized that patient health status, length of time in a trial and country of origin, may affect compliance. Methods: To address this hypothesis, an operational analysis was conducted to assess oncology subject completion compliance of PRO reports using an electronic tablet to determine its suitability and performance in use. Toward this objective, the compliance of prostate cancer patients in completing three electronic questionnaires that were administered at clinic visits was evaluated. Subjects were asked to complete the Brief Pain Inventory – Short Form (BPI-SF) at every clinic visit. At some clinic visits, subjects were asked to additionally complete the Functional Assessment of Cancer Therapy – Prostate (FACT-P) and the Euro Quality of Life 5 Dimensions (EQ-5D). Questionnaires were completed electronically on the tablet. Percent completion was calculated as the number of questionnaires completed divided by the number of questionnaires expected, based on attended clinic visits compiled for this review and the administration schedule for the questionnaires. Results: This review draws on the experience of over 1,000 subjects from 21 countries, and describes the individual and overall compliance with the expected questionnaire completion, the variance between subsequent visits, and compliance by country. Conclusions: The collection of ePRO using a clinic-based tablet yielded a highly complete data set in prostate cancer subjects demonstrating that this is an effective and feasible approach for recording symptoms and quality of life assessments.

The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

2008 ◽  
Vol 26 (8) ◽  
pp. 1355-1363 ◽  
Author(s):  
Carolyn C. Gotay ◽  
Crissy T. Kawamoto ◽  
Andrew Bottomley ◽  
Fabio Efficace
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Prognostic Significance ◽  
Cancer Clinical Trials ◽  
Life Questionnaire ◽  
European Organization ◽  
Patient Reported ◽  
The Impact

Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials, have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs on patient survival after a cancer diagnosis within the context of clinical trials. Design Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions. Results In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P < .05) in multivariate analysis, with varying effect sizes. Studies of lung (n = 12) and breast cancer (n = 8) were most prevalent. The most commonly assessed PRO was quality of life, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 in 56% of studies. Clinical variables adjusted for included performance status (PS), treatment arm, stage, weight loss, and serum markers. Results indicated that PROs provide distinct prognostic information beyond standard clinical measures in cancer clinical trials. Conclusion PROs might be considered for stratification purposes in future trials, as they were often better predictors of survival than PS. Studies are needed to determine whether interventions that improve PROs also increase survival and to identify explanatory mechanisms through which PROs relate to survival.

scholarly journals Patient-Reported Outcomes and Survivorship in Radiation Oncology: Overcoming the Cons

2014 ◽  
Vol 32 (26) ◽  
pp. 2920-2927 ◽  
Author(s):  
Farzan Siddiqui ◽  
Arthur K. Liu ◽  
Deborah Watkins-Bruner ◽  
Benjamin Movsas
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Clinical Oncology ◽  
Cancer Survivorship ◽  
Web Sites ◽  
Radiation Oncology ◽  
Patient Reported Outcomes ◽  
Radiation Therapy Oncology Group ◽  
Patient Reported

Purpose Although patient-reported outcomes (PROs) have become a key component of clinical oncology trials, many challenges exist regarding their optimal application. The goal of this article is to methodically review these barriers and suggest strategies to overcome them. This review will primarily focus on radiation oncology examples, will address issues regarding the “why, how, and what” of PROs, and will provide strategies for difficult problems such as methods for reducing missing data. This review will also address cancer survivorship because it closely relates to PROs. Methods Key articles focusing on PROs, quality of life, and survivorship issues in oncology trials are highlighted, with an emphasis on radiation oncology clinical trials. Publications and Web sites of various governmental and regulatory agencies are also reviewed. Results The study of PROs in clinical oncology trials has become well established. There are guidelines provided by organizations such as the US Food and Drug Administration that clearly indicate the importance of and methodology for studying PROs. Clinical trials in oncology have repeatedly demonstrated the value of studying PROs and suggested ways to overcome some of the key challenges. The Radiation Therapy Oncology Group (RTOG) has led some of these efforts, and their contributions are highlighted. The current state of cancer survivorship guidelines is also discussed. Conclusion The study of PROs presents significant benefits in understanding and treating toxicities and enhancing quality of life; however, challenges remain. Strategies are presented to overcome these hurdles, which will ultimately improve cancer survivorship.

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