Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

Devlin, Nancy; Herdman, Michael; Pavesi, Marco; Phung, De; Naidoo, Shevani; Beer, Tomasz M.; Tombal, Bertrand; Loriot, Yohann; Ivanescu, Cristina; Parli, Teresa; Balk, Mark; Holmström, Stefan

doi:10.1186/s12955-017-0704-y

Cited by 26 publications

(31 citation statements)

References 34 publications

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“…We chose Set 1 because the authors used the EQ-5D-5 L version to evaluate the health-related quality of life of individuals with diabetes, a chronic disease that we incorporated in our data set (Set 3). We chose Set 2 for two reasons: (i) in their study, Devlin et al [14] used the EQ-5D-3 L version, which is the case also in our study (Set 3); (ii) Devlin et al evaluated in their clinical trial the positive impact of medical treatment on the quality of life of patients. Devlin et al data set (Set 2) enabled us to test the effectiveness of the Improved RIDIT method to evaluate the health quality of life in clinical trials.…”

Section: Data Collectionmentioning

confidence: 99%

“…We also tested the Improved RIDIT method on the health-related quality of life data obtained through the EQ-5D-3 L version administered by Devlin et al [14]. In contrast to Mateo et al [23] analyzing the effect of Table 2 False positive rate detected by the Improved RIDIT and MWW relative to nominal α = 0.05 using simulation under the null hypothesis.…”

Section: Data Setmentioning

confidence: 99%

“…It was developed for estimating utility scores based on population preferences for the different health states. It is used in observational studies to evaluate health-related quality of life in patients with different pathologies [1][2][3][4][5], to estimate normative values of health states or so called score utilities in different populations [6][7][8][9][10][11][12] and in clinical trials to describe treatment efficacy [13,14].…”

Section: Introductionmentioning

confidence: 99%

“…Measurement on the 5 distinct dimensions of the EQ-5D can also be informative in order to determine which dimensions of the EQ-5D are affected by disease or improved by treatment. Some studies [1,2,4,14] have compared the impact of a treatment or disease on the quality of life by comparing the frequencies of "level 1" obtained from the two samples for each of the five dimensions. A chi-square test is often used to compare these frequencies.…”

Section: Introductionmentioning

confidence: 99%

“…A chi-square test is often used to compare these frequencies. For example, in a clinical trial, the positive impact of treatment on the health status of patients is significant if the frequency of the "level 1" corresponding to "no problems" is observed to be higher after treatment [14]. Health-related quality of life studies using the EQ-5D generate outcome ordinal data that are interpreted as categories ordered by severity.…”

Section: Introductionmentioning

confidence: 99%

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Improved RIDIT statistic approach provides more intuitive and informative interpretation of EQ-5D data

Marfak

Youlyouz-Marfak

Achhab

et al. 2020

Health Qual Life Outcomes

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Background: EQ-5D is generic measure of health-related quality of life. Studies using EQ-5D generate ordinal data that are interpreted as categories ordered by severity. New analytic approaches taking into account the ordinal nature of the health dimension severity and leading to a better interpretation of EQ-5D data are needed to better elucidate differences in health-related quality of life. We propose utilizing the Improved RIDIT statistical method to analyze EQ-5D outcomes. Methods: 556 Moroccan participants aged over 18 years representing four chronic diseases: back pain (n = 158), renal insufficiency (n = 56), diabetes (n = 82) or hypertension (n = 80) and healthy subjects (n = 180). All participants received the two EQ-5D versions. Two other published data sets were included. The first was extracted from a diabetic Spain study and the second was extracted from a clinical trial study. The Improved RIDIT analyses were carried out using an R statistic program we developed. Results: Applying the Improved RIDIT on the EQ-5D data allowed estimating for the first time the ordinal odds, the Absolute Risk Reduction (ARR) or the Absolute Risk Increase (ARI) and the Number Needed to Treat. The ARI values estimated for Moroccan patients showed that (i) hypertension increased anxiety/depression by 66% and reduced mobility by 65%; (ii) back pain increased pain/discomfort by 69%; (iii) renal insufficiency impacts mobility (ARI = 57%, odds ordinal = 9.95) and usual activities (ARI = 44%, odds ordinal = 6.41) and (iv) diabetes acts only on anxiety/depression (ARI = 50%, odds ordinal = 4.8). Also, we demonstrated that the approach works well in clinical trials. Conclusions: Improved RIDIT provides more intuitive and informative interpretation of the EQ-5D data by (1) taking into account the level severity; estimating (2) the odds ordinal, (3) the ARR/ARI and the NNT; (4) analyzing the five dimensions of the EQ-5D separately, which gives clinical teams more precision in understanding the treatment/ pathology impacts on the health status and completes the EQ-5D data analysis based on score utilities.

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Section: Data Collectionmentioning

confidence: 99%

Section: Data Setmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Improved RIDIT statistic approach provides more intuitive and informative interpretation of EQ-5D data

Marfak

Youlyouz-Marfak

Achhab

et al. 2020

Health Qual Life Outcomes

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Association of Second-generation Antiandrogens With Depression Among Patients With Prostate Cancer

et al. 2021

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Key Points Question Are second-generation antiandrogens (AAs) associated with increased risk of depression among older men diagnosed with prostate cancer? Findings In this cohort study of 30 069 men aged 66 years and older, there was a statistically significant 2-fold increase in depression among patients treated with second-generation AA compared with traditional forms of hormone therapy (HT) and no HT. Meaning These findings suggest that use of second-generation AAs is associated with a clinically significant increased risk of depression when compared with traditional HT alone or no HT.

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Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient‐reported outcomes in randomized controlled trials to support clinical decision‐making

Hemelrijck

Sparano

Moris³

et al. 2020

Cancer Medicine

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Background Given the growing importance of patient‐reported outcomes (PROs) as part of “big data” in improving patient care, there is a need to provide a state‐of‐the‐art picture of the added value of using PROs in prostate cancer (PCa) randomized controlled trials (RCTs). We aimed to synthetize the most recent high‐quality PRO evidence‐based knowledge from PCa RCTs and to examine whether quality of PRO reporting in PCa research improved over time. Methods We conducted a systematic literature search using PubMed, from April 2012 until February 2019. For benchmarking purposes, we also included RCTs identified in our previously published review of RCTs (2004‐2012). Methodology for study identification and evaluation followed standardized criteria and a predefined data extraction form was used to abstract information. PRO quality of the studies was evaluated using the International Society of Quality of Life Research (ISOQOL) recommended criteria. Results A total of 55 new RCTs were published between April 2012 and February 2019. About 24 (43.6%) RCTs were found to be of high‐quality regarding PRO assessments. Of these, 13 (54.2%) have been reported in the most recent European Association of Urology (EAU) PCa Guidelines. Overall QoL and sexual, urinary, and bowel function were the most commonly reported PROs. FACT‐P, EPIC‐26, and EORTC QLQ‐C30 and/or its module PR25 were most frequently used as measurement tools. An overall improvement in the completeness of PRO reporting was noted over time. Conclusion Many PRO trials are currently not included in the EAU guidelines. Our findings suggest that there has to be a better consensus on the use of PRO data for PCa patients, which will then be reflected in the PCa Guidelines and future data collection. Homogeneity in PROs collection and measurement tools will in turn enable “big data” Consortia to increase the patients’ voice in clinical research.

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Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

Cited by 26 publications

References 34 publications

Improved RIDIT statistic approach provides more intuitive and informative interpretation of EQ-5D data

Improved RIDIT statistic approach provides more intuitive and informative interpretation of EQ-5D data

Association of Second-generation Antiandrogens With Depression Among Patients With Prostate Cancer

Harnessing the patient voice in prostate cancer research: Systematic review on the use of patient‐reported outcomes in randomized controlled trials to support clinical decision‐making

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