Measuring the Quality of Life of Patients with Cancer

2014 ◽  
Vol 10 (01) ◽  
pp. 10
Author(s):  
Efstathios Zikos ◽  
Corneel Coens ◽  
John Bean ◽  
Divine Ediebah ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Meta Analysis ◽  
Randomised Clinical Trial ◽  
The United States ◽  
Prognostic Indicators ◽  
Patient Reported ◽  
Eortc Qlq

What is quality of life? Clinical trials have long been dominated by clinically based endpoints, but research has proved that health-related quality of life (HRQoL) can only be captured accurately by patients themselves using patient-reported outcomes (PROs). The United States Food and Drug Administration defines PROs as the measurement of any aspect of a patient’s health status that comes directly from the patient, that is, a measurement taken without interpretation of the patient’s responses by a physician or anyone else. The EORTC QLQ-C30 is the most widely cancer specific HRQoL questionnaire used for PROs in the world. Developed in 1991 by the EORTC Quality of Life Group, it has been translated into more than 60 languages and has over 40 developed or under development cancer-specific modules. One of the key challenges faced is pooling data and performing meta-analyses of the results of closed trials. The EORTC Patient Reported Outcomes and Behavioural Evidence (PROBE) team is dedicated to the meta-analysis of EORTC randomised clinical trial quality of life results. During the last 5 years, pooled data have revealed important results, such as prognostic indicators of survival, which have informed clinical practice. This research shows how the patient perspective in palliative and curative EORTC trials has been considered of major importance. The inclusion of patient perspective in drug development shows that a more comprehensive HRQoL assessment has taken place over time as better instruments have become available. As clinicians, regulatory bodies and industry acknowledge the value of the patient perspective, we expect that EORTC will continue including HRQoL endpoints where appropriate.

scholarly journals Patient-Reported Outcomes Following Total Knee Replacement in Patients <65 Years of Age—A Systematic Review and Meta-Analysis

2020 ◽  
Vol 9 (10) ◽  
pp. 3150
Author(s):  
Jason Trieu ◽  
Daniel J. Gould ◽  
Chris Schilling ◽  
Tim Spelman ◽  
Michelle M. Dowsey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Patient Reported Outcomes ◽  
Meta Analysis ◽  
Functional Decline ◽  
Older Individuals ◽  
Patient Reported ◽  
Related Quality ◽  
Total Knee

An increasing number of total knee replacements (TKRs) are being performed in response to the growing burden of osteoarthritis. Patients <65 years of age represent the fastest growing group of TKR recipients and are expected to account for an increasing number of primary and revision procedures. Concerns have been raised about the outcomes that can be expected by this age demographic who are more active, physically demanding, and have longer life expectancies compared to older TKR recipients. This systematic review and meta-analysis evaluated the effectiveness of TKR for osteoarthritis in patients <65 years of age, compared to older individuals. A systematic search of Embase and Medline was conducted to identify studies which examined patient-reported outcomes measured using disease-specific and generic health-related quality of life instruments. Ten studies met our inclusion criteria and were included in this review. These studies comprised 1747 TKRs performed between 1977 and 2014. In the meta-analysis of two prospective studies (288 TKRs), patients <65 years of age were able to attain large and clinically meaningful improvements in pain, function, and quality of life. One of these studies (61 TKRs) suggested that patients <55 years of age attained a larger degree of improvement compared to older individuals. Results into the second postoperative decade were less certain, with some data suggesting a high prevalence of pain and patterns of functional decline. Further research is required to investigate longer-term outcomes following TKR for osteoarthritis in younger patients.

scholarly journals Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non–Small-Cell Lung Cancer

2020 ◽  
Vol 38 (22) ◽  
pp. 2530-2542 ◽  
Author(s):  
Martin Reck ◽  
Thomas Wehler ◽  
Francisco Orlandi ◽  
Naoyuki Nogami ◽  
Carlo Barone ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Patient Reported Outcomes ◽  
Small Cell ◽  
Small Cell Lung ◽  
Patient Reported ◽  
Eortc Qlq ◽  
Nonsquamous Nsclc

PURPOSE Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non–small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC. METHODS Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13. RESULTS Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5% v 8.2%; ABCP, 48.6% v 21.2%; BCP, 44.7% v 11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly. CONCLUSION ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.

Patient-reported outcomes from a phase III multicenter, randomized, double-blind, placebo-controlled trial of gefitinib versus placebo in esophageal cancer progressing after chemotherapy: Cancer Oesophagus Gefitinib (COG).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 6-6
Author(s):  
Susan J. Dutton ◽  
Jane M. Blazeby ◽  
Russell D. Petty ◽  
Wasat Mansoor ◽  
Joyce Thompson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Esophageal Cancer ◽  
Patient Reported Outcomes ◽  
Predictive Biomarkers ◽  
Phase Iii ◽  
Patient Reported ◽  
Global Quality Of Life ◽  
Eortc Qlq

6 Background: There are no randomised trials of 2nd line chemotherapy for esophageal cancer. The phase III COG trial of gefitinib versus placebo in patients with esophageal cancer progressing after chemotherapy did not show significant overall survival (OS) benefit, however the trial incorporated patient reported outcomes (PRO) using validated tools. The PRO data are therefore critical to inform practice and the initial results are presented here. Methods: Adults with measurable/evaluable metastatic esophageal or types I/II junctional adeno or squamous cell carcinoma progressing after prior chemotherapy, with performance status 0-2 were randomised 1:1 to 500mg gefitinib (G) or placebo (P), treated until progression. Primary outcome: OS. Secondary outcomes include safety, PFS, PRO (assessed by EORTC QLQ-C30 and EORTC QLQ-OG25 at baseline 4, 8 and 12 weeks until progression) and predictive biomarkers. Pre-specified PRO domains were global quality of life, dysphagia, eating and odynophagia. Analysis by ANCOVA of change in PRO at 4 weeks adjusted for baseline. Results: 450 patients were recruited from 51 UK centres and no difference in OS was detected. There was evidence that PFS was better in the intervention arm (P 35 days, G 49 days; HR=0.795, 95%CI 0.66, 0.96, p=0.017). Questionnaire compliance rates were excellent at baseline (94%) and at 4 weeks (77%). Patients in the gefitinib arm reported significantly better social function (9.26; 95%CI 1.94 to 16.58; p=0.013) and significantly fewer problems with odynophagia (-8.61; 95%CI -14.49 to -2.73; p=0.004), constipation (-15.24; 95%CI -22.83 to -7.65; p=0.0001) and speech (-10.40; 95%CI -16.13 to -4.67; p=0.0004) than patients receiving placebo but more problems with diarrhoea (19.23; 95%CI 11.79 to 26.27; p<0.0001). All other PRO domains were similar between the two groups. Conclusions: Gefitinib did not improve overall survival in esophageal cancer patients after chemotherapy however there was significant PFS improvement and improvement in quality of life and palliation of symptoms albeit with an excess of diarrhoea. Clinical trial information: 29580179.

scholarly journals Acupuncture for Breast Cancer: A Systematic Review and Meta-Analysis of Patient-Reported Outcomes

2021 ◽  
Vol 11 ◽  
Author(s):  
Yuzhu Zhang ◽  
Yang Sun ◽  
Dongmei Li ◽  
Xiaoyuan Liu ◽  
Chen Fang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Systematic Review ◽  
Cancer Therapy ◽  
Functional Assessment ◽  
Patient Reported Outcomes ◽  
Meta Analysis ◽  
Hot Flashes ◽  
Patient Reported

AbstractThe present systematic review and meta-analysis was undertaken to evaluate the effects of acupuncture in women with breast cancer (BC), focusing on patient-reported outcomes (PROs).MethodsA comprehensive literature search was carried out for randomized controlled trials (RCTs) reporting PROs in BC patients with treatment-related symptoms after undergoing acupuncture for at least four weeks. Literature screening, data extraction, and risk bias assessment were independently carried out by two researchers.ResultsOut of the 2, 524 identified studies, 29 studies representing 33 articles were included in this meta-analysis. At the end of treatment (EOT), the acupuncture patients’ quality of life (QoL) was measured by the QLQ-C30 QoL subscale, the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), the Functional Assessment of Cancer Therapy–General/Breast (FACT-G/B), and the Menopause-Specific Quality of Life Questionnaire (MENQOL), which depicted a significant improvement. The use of acupuncture in BC patients lead to a considerable reduction in the scores of all subscales of the Brief Pain Inventory-Short Form (BPI-SF) and Visual Analog Scale (VAS) measuring pain. Moreover, patients treated with acupuncture were more likely to experience improvements in hot flashes scores, fatigue, sleep disturbance, and anxiety compared to those in the control group, while the improvements in depression were comparable across both groups. Long-term follow-up results were similar to the EOT results.ConclusionsCurrent evidence suggests that acupuncture might improve BC treatment-related symptoms measured with PROs including QoL, pain, fatigue, hot flashes, sleep disturbance and anxiety. However, a number of included studies report limited amounts of certain subgroup settings, thus more rigorous, well-designed and larger RCTs are needed to confirm our results.

scholarly journals Pain and Opioid Use in Patients with FLT3 Mutation-Positive Relapsed/Refractory AML: A Subanalysis of Patient-Reported Outcomes from the Admiral Trial

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 25-26
Author(s):  
David Cella ◽  
Ellen Ritchie ◽  
Arnaud Pigneux ◽  
Yoshinobu Kanda ◽  
Cristina Ivanescu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Board Of Directors ◽  
Research Funding ◽  
Patient Reported Outcomes ◽  
The United States ◽  
Opioid Use ◽  
Advisory Committees ◽  
Flt3 Mutation ◽  
Patient Reported

Background: Despite widespread interest in pain management and opioid use across the United States, information on pain and opioid utilization in patients with relapsed or refractory acute myeloid leukemia (R/R AML) is lacking. Better understanding of patient-reported outcomes (PROs) specific to pain could be used to identify strategies to improve the quality of life in patients with R/R AML. Aim/Objective: To describe pain and opioid use in patients with FLT3 mutation-positive (FLT3mut+)R/R AML receiving either gilteritinib or salvage chemotherapy (SC) using PRO data collected from the ADMIRAL study (NCT02421939). Methods: ADMIRAL was a phase 3, open-label, multicenter, active-controlled randomized study comparing the efficacy and safety of gilteritinib to SC in patients with FLT3mut+ R/R AML. Pain was assessed using selected items from the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu; GP4 item: "I have pain") and the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L; Pain/Discomfort domain). Data for these instruments were collected at baseline (BL), Day 1 of every treatment cycle, and end of treatment (EOT). A modified EOT (mEOT) was defined as the last PRO assessment before patient discontinuation, study data cut-off date, or patient death. Patients on high-intensity chemotherapy (HIC) were treated for up to two cycles depending on treatment response; as such, only changes from BL to Cycle 2 were evaluated. Opioid utilization, including percentage of patients using any opioid medication, specific medications, duration of use, and use by transfusion dependence, was also described. Analyses of the intention-to-treat population using analysis of covariance, including BL score, response to first-line AML therapy, and investigator-preselected SC as covariates, were conducted to estimate least squares mean (LSM) and compare the differences in pain question responses between treatment arms. Descriptive statistics were used to describe opioid utilization. Results: Of 371 eligible patients, 247 were randomized to gilteritinib and 124 to SC. The median age for both groups was 62 years and slightly more patients were female (gilteritinib, 53.0%; SC, 56.5%). Improvements at the mEOT from BL in the Fact-Leu GP4 item were observed in both gilteritinib (LSM -0.3) and SC (LSM -0.1). Scores also changed on the EQ-5D-5L at the mEOT from BL for both groups (gilteritinib, LSM 0.2; SC, LSM 0.3). No treatment differences were observed between gilteritinib vs SC on the change from BL to Cycle 2 or mEOT on the Fact-Leu GP4 item (LSM [95% CI] of -0.1 [-0.65, 0.38]; P=0.6016 and -0.2 [-0.53, 0.21]; P=0.3902, respectively) or on the EQ-5D-5L Pain/Discomfort domain (LSM [95% CI] of 0.2 [-0.21, 0.62]; P=0.3255 and -0.1 [-0.38, 0.23]; P=0.6288, respectively). During Cycles 1 and 2, no differences were identified between gilteritinib or SC on the percentage of patients using opioids (Cycle 1: 49.8% vs 55.6%; Cycle 2: 58.9% vs 62.7%, respectively) or the time-averaged duration of use (Cycle 1: 12.4 days vs 14.1 days; Cycle 2: 15.0 days vs 17.2 days, respectively). Patients on gilteritinib were less likely to use opioids during the first two cycles compared with patients on HIC, when stratified by chemotherapy intensity (Cycle 1: 49.0% vs 72.0%, P&lt;0.05; Cycle 2: 58.2% vs 74.1%, P&lt;0.05). Conversely, patients on gilteritinib were more likely to use opioids compared with patients on low-intensity chemotherapy during the first two cycles (Cycle 1: 51.0% vs 30.6%, P&lt;0.05; cycle 2: 60.0% vs 33.3%, P&lt;0.05). In patients using opioids across the first two cycles (Table), opioids used most frequently were oxycodone (Cycle 1: 45.3%; Cycle 2: 44.6%) and tramadol (Cycle 1: 43.2%; Cycle 2: 42.5%). In patients on gilteritinib, those dependent on transfusions were generally more likely to use opioids, and for more days (time-averaged) during each cycle than patients independent of transfusions. Conclusions: Patients with FLT3mut+ R/R AML receiving gilteritinib or SC demonstrated modest changes in responses to pain-related assessments at EOT compared with BL values. Opioids were used more frequently by patients receiving HIC regimens and transfusion-dependent patients receiving gilteritinib. These data suggest that treatments for FLT3mut+ R/R AML may impact opioid use; further study should be done to determine the relationships between these factors and their potential impact on overall quality of life. Disclosures Cella: DSI: Consultancy, Research Funding; Evidera: Consultancy; Ipsen: Consultancy, Research Funding; Mei Pharma: Consultancy; Oncoquest: Consultancy; ASAHI KASEI PHARMA CORP.: Consultancy; BMS: Consultancy, Research Funding; IDDI: Consultancy; Kiniksa: Consultancy; Novartis: Consultancy; Pfizer: Consultancy, Research Funding; Apellis: Consultancy; Alexion: Research Funding; Clovis: Research Funding; Janssen: Research Funding; Pled Pharma: Research Funding; PROMIS Health Org: Membership on an entity's Board of Directors or advisory committees, Other; BlueNote: Consultancy; Astellas: Consultancy, Honoraria; FACIT.org: Membership on an entity's Board of Directors or advisory committees, Other: President; Abbvie: Consultancy, Research Funding. Ritchie:Abbvie: Honoraria; Sierra Oncology: Honoraria; Novartis: Honoraria; Pfizer: Honoraria, Research Funding; Jazz pharmaceuticals: Honoraria, Research Funding; Incyte: Speakers Bureau. Kanda:Pfizer: Honoraria, Research Funding; Astellas Pharma: Honoraria, Research Funding; Janssen: Honoraria; Shionogi: Research Funding; Chugai Pharma: Honoraria, Research Funding; Otsuka: Honoraria, Research Funding; Celgene: Honoraria; Sumitomo Dainippon Pharma: Honoraria; Eisai: Honoraria, Research Funding; Novartis: Honoraria; Kyowa Kirin: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria; Takeda Pharmaceuticals: Honoraria; Alexion Pharmaceuticals: Honoraria; Shire: Honoraria; Daiichi Sankyo: Honoraria; Ono Pharmaceutical: Honoraria; Nippon Shinyaku: Honoraria, Research Funding; Mochida Pharmaceutical: Honoraria; Mundipharma: Honoraria; Sanofi: Honoraria, Research Funding; Meiji Seika Kaisha: Honoraria; Merck Sharp & Dohme: Honoraria. Ivanescu:Astellas: Other: IQVIA employee which is a contracted by Astellas. Pandya:Astellas Pharma, Inc.: Current Employment. Shah:Astellas: Current Employment.

scholarly journals QOLP-35. OUTCOMES AND CORRELATIONS BETWEEN LEGACY QUALITY OF LIFE MEASURES (EORTC-C30/EORTC-BN20) AND THE ELECTRONIC QUALITY OF LIFE MEASURING SYSTEM NIH-PROMIS IN GLIOBLASTOMA PATIENTS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi205-vi205
Author(s):  
Tobias Walbert ◽  
Lonni Schultz ◽  
James Snyder ◽  
Aarushi Suneja
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Correlation Coefficients ◽  
European Organization ◽  
P Values ◽  
Gi Symptoms ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Abstract BACKGROUND Health-related quality of life (QoL) and patient reported outcomes are essential to guide patient-care. The NIH sponsored electronic Patient-Reported Outcomes Measurement Information System (PROMIS) is well established in multiple cancers but not in Glioblastoma (GBM). The aim of this study was to analyze the association of the PROMIS measures with the European Organization for Research and Treatment of Cancer core instrument (EORTC-QLQ-C30) and the brain tumor specific EORTC QLQ-BN20 questionnaire (EORTC-BN20) in GBM patients. METHODS Newly diagnosed patients with GBM were enrolled prospectively to assess association between both tools. The PROMIS modules were selected to reflect the quality of life domains assessed in the EORTC- QLQ-C30 and EORTC-BN20 questionnaires. Pearson’s correlation coefficients were computed between the PROMIS and EORTC-C30/ EORTC-BN20 measures. Due to multiple responses over time, the p-values for the correlation coefficients were adjusted. Because of the large number of correlations computed and many with p-values less than 0.05, the magnitude of the correlation was considered. Correlations greater than 0.5 or less than -0.5 were consider to be “strong” associations, while correlations between 0.3 and 0.499 (or -0.3 and -0.499) were consider to be “moderate”. RESULTS 43 patients with 124 PROMIS/EORTC responses were included in this analysis. The PROMIS measures had strong associations with the QoL functioning and fatigue measures from the EORTC-C30 and future uncertainty, communication deficit, motor dysfunction, social satisfaction and drowsiness from the EORTC-BN20 (all p< 0.001 and correlation >0.5). CONCLUSIONS There are strong and moderate correlations in the majority of PROMIS assessments and the EORTC tools. The PROMIS toolkit may be used to assess core features of the EORTC surveys. GI symptoms, seizures and itchy skin do not correlate. Given the prior documented shorter assessment time, the PROMIS toolkit may be a feasible alternative to established legacy tools to assess QoL in GBM patients.

scholarly journals Symptoms and Association with Health Outcomes in Relapsing-Remitting Multiple Sclerosis: Results of a US Patient Survey

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Angela E. Williams ◽  
Jeffrey T. Vietri ◽  
Gina Isherwood ◽  
Armando Flor
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Patient Reported Outcomes ◽  
The United States ◽  
Symptom Clusters ◽  
Patient Reported ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background. A variety of symptoms have been reported, but the prevalence of specific symptoms in relapsing-remitting multiple sclerosis (RRMS), how they are related to one another, and their impact on patient reported outcomes is not well understood.Objective. To describe how symptoms of RRMS cooccur and their impact on patient-reported outcomes.Methods. Individuals who reported a physician diagnosis of RRMS in a large general health survey in the United States indicated the symptoms they experience because of RRMS and completed validated scales, including the work productivity and activity impairment questionnaire and either the SF-12v2 or SF-36v2. Symptom clusters were identified through hierarchical cluster analysis, and the relationship between clusters and outcomes was assessed through regression.Results. Fatigue, difficulty walking, and numbness were the most commonly reported symptoms. Seven symptom clusters were identified, and several were significantly related to patient reported outcomes. Pain, muscle spasms, and stiffness formed a cluster strongly related to physical quality of life; depression was strongly related to mental quality of life and cognitive difficulty was associated with work impairment.Conclusions. Symptoms in RRMS show a strong relationship with quality of life and should be taken into consideration in treatment decisions and evaluation of treatment success.

scholarly journals 1.5T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment

2020 ◽  
Author(s):  
Filippo Alongi ◽  
Michele Rigo ◽  
Vanessa Figlia ◽  
Francesco Cuccia ◽  
Niccolò Giaj-Levra ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Patient Reported Outcomes ◽  
Adaptive Strategy ◽  
Localized Prostate Cancer ◽  
Rectal Pain ◽  
Genitourinary Toxicity ◽  
Patient Reported ◽  
Eortc Qlq

Abstract Background Unity Elekta is a unique magnetic resonance (MR)-linac that conjugates a 1.5 Tesla MR unit with a 7 MV flattening filter free accelerator.A prospective observational study for the clinical use of Elekta Unity is currently ongoing in our department. Herein, we present our preliminary report on the feasibility, quality of life, and patient-reported outcomes measures (PROMs) for localized prostate cancer (PC) treated with stereotactic body radiotherapy (SBRT). Methods The SBRT protocol consisted of a 35 Gy schedule delivered in 5 fractions within two weeks. Toxicity and quality of life (QoL) were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v5.0, International Prostatic Symptoms Score (IPSS), ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires. Results Between October 2019 and January 2020, 25 patients with localized PC were recruited. The median age was 68 years (range, 54-82); 4 were low risk, 11 favorable intermediate risk (IR) and 10 unfavorable IR. Median iPSA was 6.8 ng/ml (range, 1-19), and 9 of these patients (36%) received concurrent androgen deprivation therapy. Median prostate volume was 36 cc (range, 20-61); median baseline IPSS was 5 (range, 0-10). Median time for fraction was 53 minutes (range, 34-86); adaptive strategy with daily critical structure and target re-contouring and daily replanning (adapt to shape) was performed in all cases. No grade ≥ 3 adverse event was observed, three patients (12%) reported grade 2 acute genitourinary toxicity (urinary frequency, urinary tract pain and urinary retention), while only one patient reported mild rectal pain. No relevant deteriorations were reported in PROMs. Conclusion To the best of our knowledge, this is the first experience reporting feasibility, clinician-reported outcome measurements, and PROMs for 1.5T MR-guided adaptive SBRT for localized prostate cancer. The preliminary data collected here report optimal safety and excellent tolerability, as also confirmed by PROMs questionnaires. Moreover, the data on technical feasibility and timing of online daily adapted planning and delivery are promising. More mature data are warranted.

scholarly journals Pruritus and Patient Reported Outcomes in Non-Dialysis CKD

2019 ◽  
Vol 14 (5) ◽  
pp. 673-681 ◽  
Author(s):  
Nidhi Sukul ◽  
Elodie Speyer ◽  
Charlotte Tu ◽  
Brian A. Bieber ◽  
Yun Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
United States ◽  
Mental Component Summary ◽  
Patient Reported Outcomes ◽  
Prevalence Ratio ◽  
The United States ◽  
Depression Symptoms ◽  
Ckd Stage ◽  
Patient Reported

Background and objectivesAmong patients on hemodialysis, pruritus has been associated with poorer mental and physical quality of life, sleep quality, depression, and mortality. We evaluated patients with nondialysis CKD to describe the prevalence of pruritus, identify associated factors, and investigate associations with patient-reported outcomes.Design, setting, participants, & measurementsUsing cross-sectional data from patient questionnaires in the CKD Outcomes and Practice Patterns Study (CKDopps), we asked patients with CKD stages 3–5 (nondialysis) from the United States, Brazil, and France to identify how much they were bothered by pruritus. Response options ranged from “not at all” to “extremely.” Log-Poisson regression, yielding prevalence ratios, was used to evaluate associations of moderate-to-extreme pruritus with patient characteristics, CKD stage, self-reported depression symptoms, and restless sleep. Mixed linear regression was used to examine associations between pruritus and physical and mental component summary scores, with lower scores indicating poorer quality of life.ResultsOf the 5658 CKDopps patients enrolled in the United States, Brazil, and France, 3780 (67%) answered the pruritus question. The prevalence of moderate-to-extreme pruritus was 24%, and more likely in older patients, women, and those with stage 5 CKD, lung disease, diabetes, and physician-diagnosed depression. In adjusted models, patients with moderate pruritus had physical and mental component summary scores 3.5 (95% confidence interval [95% CI], −4.6 to −2.3) and 2.3 (95% CI, −3.2 to −1.5) points lower, respectively, than patients without pruritus, and they also had a higher adjusted prevalence of patient-reported depression (prevalence ratio, 1.83; 95% CI, 1.58 to 2.11) and restless sleep (prevalence ratio, 1.69; 95% CI, 1.49 to 1.91) compared with patients without pruritus. These patient-reported outcomes were progressively worse with increasing severity of pruritus.ConclusionsOur findings demonstrate high prevalence of pruritus in nondialysis CKD, as well as strong associations of pruritus with poor health-related quality of life, self-reported depression symptoms, and self-reported poor sleep.

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