scholarly journals Impact of Pembrolizumab Versus Chemotherapy as Second-Line Therapy for Advanced Esophageal Cancer on Health-Related Quality of Life in KEYNOTE-181

2021 ◽  
Author(s):  
Antoine Adenis ◽  
Amit S. Kulkarni ◽  
Gustavo C. Girotto ◽  
Christelle de la Fouchardiere ◽  
Helene Senellart ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Second Line ◽  
Health Related Quality ◽  
Advanced Esophageal Cancer ◽  
Second Line Therapy ◽  
Treatment Groups ◽  
Line Therapy ◽  
Related Quality ◽  
Health Related

PURPOSE In the phase III KEYNOTE-181 study ( NCT02564263 ) of patients with advanced esophageal cancer (EC), pembrolizumab monotherapy prolonged overall survival versus chemotherapy as second-line therapy in patients with programmed death ligand 1 combined positive score (CPS) ≥ 10. We present the results of the prespecified health-related quality-of-life (HRQoL) analyses of the squamous cell carcinoma (SCC), CPS ≥ 10, and CPS ≥ 10 SCC populations. PATIENTS AND METHODS HRQoL was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), EORTC QLQ EC questionnaire (OES18), and EuroQol 5-dimension questionnaire (EQ-5D). Data were analyzed in patients who received ≥ 1 dose of study treatment and completed ≥ 1 HRQoL assessment. Key analyses included baseline to week 9 least squares mean change in global health status/quality of life, functional or symptom subscales, and time to deterioration (≥ 10-point deterioration) for specific subscales. RESULTS The HRQoL population included 387 patients with SCC. Compliance and completion rates for all three questionnaires were similar in both treatment groups at baseline and week 9. No clinically meaningful differences in global health status/quality of life scores were observed between treatment groups from baseline to week 9 (least squares mean difference, 2.80; 95% CI, –1.48 to 7.08); patients in both treatment groups generally exhibited stable functioning and symptom scores of the QLQ-C30 and QLQ-OES18 from baseline to week 9. Time to deterioration for pain (hazard ratio [HR], 1.22; 95% CI, 0.79 to 1.89), reflux (HR, 2.38; 95% CI, 1.33 to 4.25), and dysphagia (HR, 1.53; 95% CI, 1.02 to 2.31) subscales were similar between treatment groups. These findings were generally similar in the CPS ≥ 10 (n = 218) and CPS ≥ 10 SCC (n = 166) subgroups. CONCLUSION In patients with advanced EC, pembrolizumab monotherapy and chemotherapy maintained HRQoL in patients with SCC, CPS ≥ 10, and CPS ≥ 10 SCC.

scholarly journals The effect of self-management on the health-related quality of life in hypertensive patients in Xiamen, China

2020 ◽  
Author(s):  
Yanbing Zeng ◽  
Chenxi Lin ◽  
Fan Chen ◽  
Ya Fang
Keyword(s):  
Quality Of Life ◽  
Medication Adherence ◽  
Self Management ◽  
Average Score ◽  
Health Related Quality ◽  
Hypertensive Patients ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related

Abstract Background: A low HRQOL can be a risk factor for future cardiovascular events in patients with hypertension. Therefore, HRQOL should receive attention and be improved in the treatment of hypertension. The purpose of this study was to investigate if the association between treatment groups and Health-Related Quality of Life (HRQOL) of hypertension mediated by self-management, and to determine which factors of hypertension self-management influenced HRQOL. Methods: Hypertensive patients were selected by multi-stage stratified samping from “1+1+N” Physicians intervention (PI) group and the conventional management (CM) group in 5 communities of Xiamen, China. Patients were cross-sectionally assessed by validated self-reports using self-management Behavior Rating Scale and Quality of Life Instruments for Hypertension. A structural equation modeling (SEM) and a path analytic model were used to assess if the association between treatment groups and HRQOL was mediated by self-management. Results: A total of 1207 patients were included, of whom 48.55% were in the PI group. The average score of the HRQOL scale was 86.68, and the average score of the PI group was higher than the CM group (87.35 vs 86.04, respectively). Similar findings were observed for the self-management scale, in which the average score of the PI group was higher than the CM group (76.32 vs 72.00, respectively). Patients in the PI group had higher levels of self-management compared to the CM group except for management of emotion. SEM showed that the association between treatment groups and HRQOL was significantly mediated by self-management (a*b, 95% confidence intervals CI: 0.02,0.07) and that the single mediator (self-management) model explained 76.67% of the intervention effect. In the multivariable mediation model, the association between treatment groups and HRQOL was significantly mediated by management of medication adherence, sport and diet.Conclusions: The findings presented good evidence supporting that treatment groups are linked to HRQOL of hypertension via self-management. Specifically, management of medication adherence, sport, diet, and emotion are important for improving HRQOL.

scholarly journals Health-Related Quality of Life as Measured by the 12-Item Short-Form Survey Among Adults With Community-Acquired Bacterial Pneumonia who Received Either Lefamulin or Moxifloxacin in 2 Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials

2020 ◽  
Vol 7 (6) ◽  
Author(s):  
Thomas P Lodise ◽  
Sam Colman ◽  
Elizabeth Alexander ◽  
Daniel S Stein ◽  
David Fitts ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Bacterial Pneumonia ◽  
Short Form ◽  
The United States ◽  
Phase Iii ◽  
Health Related Quality ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related

Abstract Background Interest in patient-reported outcomes (PROs) as part of benefit–risk assessment for new drug approvals is increasing. Lefamulin is the first intravenous (IV) and oral pleuromutilin antibiotic for treatment of adults with community-acquired bacterial pneumonia (CABP). Assessment of health-related quality of life (HRQoL) was prospectively incorporated in its CABP trials (Lefamulin Evaluation Against Pneumonia [LEAP] 1 and 2) via the 12-Item Short-Form Survey (SF-12), a widely used PRO that measures general health status in 8 domains. Methods HRQoL was evaluated by SF-12 at baseline and test of cure (TOC; 5–10 days after the last study drug dose) in patients who received lefamulin or moxifloxacin in LEAP 1 (IV/oral treatment) and LEAP 2 (oral-only treatment). SF-12 outcomes included the 8 domains, physical component and mental component summary scores, and the Short-Form Six-Dimension health utility score. Results Analysis included 1215 patients (lefamulin: n = 607; moxifloxacin: n = 608). At baseline, all mean SF-12 scores in both treatment groups were well below the United States reference mean. Clinically meaningful and significant improvements from baseline to TOC were observed in all SF-12 scores. No significant differences in mean score improvements from baseline to TOC between treatment groups were observed. SF-12 score improvements at TOC across predefined subgroups were comparable between treatment groups. Conclusions Results indicate that adults with CABP experienced comparable HRQoL improvements with lefamulin relative to moxifloxacin, and treatment with either agent resulted in returns to population norm HRQoL levels. These data suggest that lefamulin is a potential alternative to moxifloxacin for treatment of adults with CABP.

scholarly journals Health-related quality of life in patients with chronic myeloid leukemia receiving first-line therapy with nilotinib

Cancer ◽  
2018 ◽  
Vol 124 (10) ◽  
pp. 2228-2237 ◽  
Author(s):  
Fabio Efficace ◽  
Fausto Castagnetti ◽  
Bruno Martino ◽  
Massimo Breccia ◽  
Mariella D'Adda ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Health Related Quality ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Related Quality ◽  
Health Related

scholarly journals Effect on health-related quality of life of the X-Bolt dynamic plating system versus the sliding hip screw for the fixation of trochanteric fractures of the hip in adults: the WHiTE Four randomized clinical trial

2021 ◽  
pp. 1-8
Author(s):  
Xavier L. Griffin ◽  
Juul Achten ◽  
Heather Marie O'Connor ◽  
Jonathan A. Cook ◽  
Matt L. Costa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hip Fracture ◽  
Health Related Quality ◽  
Sliding Hip Screw ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related ◽  
Hip Screw ◽  
Secondary Outcomes

Aims Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. Methods We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures. Results Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar. Conclusion Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported.

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