scholarly journals Effect of Neoadjuvant Chemoradiotherapy on Health-Related Quality of Life in Esophageal or Junctional Cancer: Results From the Randomized CROSS Trial

2018 ◽  
Vol 36 (3) ◽  
pp. 268-275 ◽  
Author(s):  
Bo Jan Noordman ◽  
Mathilde G.E. Verdam ◽  
Sjoerd M. Lagarde ◽  
Maarten C.C.M. Hulshof ◽  
Pieter van Hagen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Neoadjuvant Chemoradiotherapy ◽  
Health Related Quality ◽  
End Points ◽  
Treatment Groups ◽  
Cohen’S D ◽  
Related Quality ◽  
Health Related ◽  
Cohen's D

Purpose To compare pre-agreed health-related quality of life (HRQOL) domains in patients with esophageal or junctional cancer who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery or surgery alone. Secondary aims were to examine the effect of nCRT on HRQOL before surgery and the effect of surgery on HRQOL. Patients and Methods Patients were randomly assigned to nCRT (carboplatin plus paclitaxel with concurrent 41.4-Gy radiotherapy) followed by surgery or surgery alone. HRQOL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 (QLQ-C30) and –Oesophageal Cancer Module (QLQ-OES24) questionnaires pretreatment and at 3, 6, 9, and 12 months postoperatively. The nCRT group also received preoperative questionnaires. Physical functioning (PF; QLQ-C30) and eating problems (EA; QLQ-OES24) were chosen as predefined primary end points. Predefined secondary end points were global QOL (GQOL; QLQ-C30), fatigue (FA; QLQ-C30), and emotional problems (EM; QLQ-OES24). Results A total of 363 patients were analyzed. No statistically significant differences in postoperative HRQOL were found between treatment groups. In the nCRT group, PF, EA, GQOL, FA, and EM scores deteriorated 1 week after nCRT (Cohen’s d: −0.93, P < .001; 0.47, P < .001; −0.84, P < .001; 1.45, P < .001; and 0.32, P = .001, respectively). In both treatment groups, all end points declined 3 months postoperatively compared with baseline (Cohen’s d: −1.00, 0.33, −0.47, −0.34, and 0.33, respectively; all P < .001), followed by a continuous gradual improvement. EA, GQOL, and EM were restored to baseline levels during follow-up, whereas PF and FA remained impaired 1 year postoperatively (Cohen’s d: 0.52 and −0.53, respectively; both P < .001). Conclusion Although HRQOL declined during nCRT, no effect of nCRT was apparent on postoperative HRQOL compared with surgery alone. In addition to the improvement in survival, these findings support the view that nCRT according to the Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study–regimen can be regarded as a standard of care.

scholarly journals In-Treatment Changes in Quality of Life-Related Variables in Therapeutic Communities for Cocaine Abusers: Are These Changes Associated with Clinical Outcomes?

2021 ◽  
Vol 18 (14) ◽  
pp. 7442
Author(s):  
Francisco González-Saiz ◽  
Esperanza Vergara-Moragues
Keyword(s):  
Quality Of Life ◽  
Treatment Outcomes ◽  
Beck Depression Inventory ◽  
Drug Abusers ◽  
Health Related Quality ◽  
Cohen’S D ◽  
Related Quality ◽  
Health Related ◽  
Cohen's D

Background: Few studies have explored changes in quality of life during the first three months of admission to a therapeutic community for addictions. The objective of this study was to determine the relationship between these changes and treatment outcomes at discharge. Methods: We undertook a prospective longitudinal study of 142 cocaine-dependent patients treated at a therapeutics community. All of these patients reached the 3-month evaluation and were subsequently followed until discharge. All participants completed the following measures: Health-Related Quality of Life for Drug Abusers Test; Beck Depression Inventory; State–Trait Anxiety Inventory; Opiate Treatment Index; Dual Diagnosis and Discharge Checklist. Results: At the 3-month assessment, scores on the Health-Related Quality of Life for Drug Abusers Test had increased significantly (Cohen’s d: 0.92), while scores on the Opiate Treatment Index (Cohen’s d: 0.86) and Beck Depression Inventory (Cohen’s d: 0.20) scales both decreased significantly. A higher proportion of the patients considered to have achieved “clinically relevant” treatment outcomes at discharge versus those without clinically relevant outcomes were considered “recovered” according to the Reliable Change Index. Conclusions: An improvement in quality of life-related variables from baseline to the 3-month assessment was associated with better outcomes at discharge from the therapeutic community. The findings of this study may help us to optimise therapeutic interventions.

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.

Effect of APF530 on health-related quality of life (QOL) and other chemotherapy-induced nausea and vomiting (CINV) end points: Phase III MAGIC trial.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e21666-e21666 ◽  
Author(s):  
Ian Schnadig ◽  
Eduardo Braun ◽  
Michael Mosier ◽  
Robert B. Geller ◽  
Lee Steven Schwartzberg
Keyword(s):  
Quality Of Life ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Health Related Quality ◽  
End Points ◽  
Related Quality ◽  
Health Related

scholarly journals Anxiety and Health-Related Quality of Life Among Patients With Low–Tumor Burden Non-Hodgkin Lymphoma Randomly Assigned to Two Different Rituximab Dosing Regimens: Results From ECOG Trial E4402 (RESORT)

2015 ◽  
Vol 33 (7) ◽  
pp. 740-748 ◽  
Author(s):  
Lynne I. Wagner ◽  
Fengmin Zhao ◽  
Fangxin Hong ◽  
Michael E. Williams ◽  
Randy D. Gascoyne ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Coping Style ◽  
Avoidant Coping ◽  
Random Assignment ◽  
Health Related Quality ◽  
End Points ◽  
General Anxiety ◽  
Related Quality ◽  
Health Related

Purpose The purpose of this study was to compare illness-related anxiety among participants in the Rituximab Extended Schedule or Retreatment Trial (RESORT) randomly assigned to maintenance rituximab (MR) versus rituximab re-treatment (RR). A secondary objective was to examine whether the superiority of MR versus RR on anxiety depended on illness-related coping style. Patients and Methods Patients (N = 253) completed patient-reported outcome (PRO) measures at random assignment to MR or RR (baseline); at 3, 6, 12, 24, 36, and 48 months after random assignment; and at rituximab failure. PRO measures assessed illness-related anxiety and coping style, and secondary end points including general anxiety, worry and interference with emotional well-being, depression, and health-related quality of life (HRQoL). Patients were classified as using an active or avoidant illness-related coping style. Independent sample t tests and linear mixed-effects models were used to identify treatment arm differences on PRO end points and differences based on coping style. Results Illness-related anxiety was comparable between treatment arms at all time points (P > .05), regardless of coping style (active or avoidant). Illness-related anxiety and general anxiety significantly decreased over time on both arms. HRQoL scores were relatively stable and did not change significantly from baseline for both arms. An avoidant coping style was associated with significantly higher anxiety (18% and 13% exceeded clinical cutoff points at baseline and 6 months, respectively) and poorer HRQoL compared with an active coping style (P < .001), regardless of treatment arm assignment. Conclusion Surveillance until RR at progression was not associated with increased anxiety compared with MR, regardless of coping style. Avoidant coping was associated with higher anxiety and poorer HRQoL.

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.

Double-Blind, Placebo-Controlled Study of Quality of Life, Hematologic End Points, and Safety of Weekly Epoetin Alfa in Children With Cancer Receiving Myelosuppressive Chemotherapy

2006 ◽  
Vol 24 (22) ◽  
pp. 3583-3589 ◽  
Author(s):  
Bassem I. Razzouk ◽  
Jeffrey D. Hord ◽  
Marilyn Hockenberry ◽  
Pamela S. Hinds ◽  
James Feusner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Study ◽  
Epoetin Alfa ◽  
Health Related Quality ◽  
Children With Cancer ◽  
Myelosuppressive Chemotherapy ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related

Purpose To evaluate the effects of once-weekly epoetin alfa (EPO) on health-related quality of life (HRQOL), hemoglobin (Hb), transfusions, and tolerability in children with cancer. Methods Anemic patients 5 years to 18 years of age receiving myelosuppressive chemotherapy for nonmyeloid malignancies, excluding brain tumors, received intravenous EPO 600 units/kg to 900 units/kg or placebo once-weekly for 16 weeks. Patients and parents completed the pediatric health-related quality-of-life generic scales (GS) and cancer-specific scales (CS). Results One hundred eleven patients received EPO and 111 patients received placebo. Mean final values for GS total score (P = .763 among patients; P = .219 among parents) and CS domain scores (P ≥ .238; P ≥ .081, respectively) were not significantly different between treatment groups. EPO-treated patients had greater increases in Hb overall (P = .002) and were more likely to be transfusion free after 4 weeks (38.7% v 22.5%; P = .010). Change in Hb was correlated with change in PedsQL-GCS total score in the EPO group (r = 0.242; P = .018), but was not in the placebo group (r = 0.086; P = .430). Adverse events were comparable between treatment groups. Conclusion This study confirmed the tolerability and hematologic benefits of once-weekly EPO in children with cancer. No significant difference in HRQOL was detected between treatment groups, but a significant positive correlation was observed between Hb changes and HRQOL changes in the EPO group. Additional studies are warranted to assess HRQOL when anemia is managed optimally in children with cancer.

The Italian Spine Youth Quality of Life questionnaire measures health-related quality of life of adolescents with spinal deformities better than the reference standard, the Scoliosis Research Society 22 questionnaire

2019 ◽  
Vol 33 (8) ◽  
pp. 1404-1415 ◽  
Author(s):  
Antonio Caronni ◽  
Sabrina Donzelli ◽  
Fabio Zaina ◽  
Stefano Negrini
Keyword(s):  
Quality Of Life ◽  
Research Society ◽  
Spinal Deformities ◽  
Scoliosis Research Society ◽  
Cohen’S D ◽  
Related Quality ◽  
Health Related ◽  
Cohen's D ◽  
Better Than

Objective: To compare the validity of the Italian Spine Youth Quality of Life (ISYQOL) questionnaire with that of the Scoliosis Research Society 22 (SRS22) questionnaire, the criterion standard for health-related quality of life (HRQOL) measurement in adolescents with spinal deformities. Design: Cross-sectional study. Setting: Outpatient clinic. Subjects: Consecutive adolescents (10–18 years; 541 wearing brace) affected by idiopathic scoliosis (642 females, 100 males) or hyperkyphosis (87 females, 109 males). Interventions: NA. Main measures: The Spearman’s correlation coefficient (rho) between ISYQOL and SRS22 was used to assess ISYQOL concurrent validity. Sex, age, severity, bracing, trunk appearance and deformity type were assessed for known-groups validity. Cohen’s d quantified between-groups differences. Multiple linear regression exploring the effect of sex, age, body mass index (BMI), severity, bone age, trunk appearance, physiotherapy, bracing and sport on HRQOL of scoliosis patients was used to assess concurrent validity further. Results: Satisfactory correlations were found between ISYQOL and SRS22 (scoliosis, rho = 0.71; kyphosis, rho = 0.56). Known-groups validity analysis showed that ISYQOL detects all the between-groups differences detected by SRS22 and a males-females difference undetected by SRS22. ISYQOL Cohen’s d was larger than SRS22 Cohen’s d in three between-groups comparisons and similar in the others. Brace, sport and scoliosis severity were independently related to ISYQOL (linear regression: R2 = 0.23; p < 0.001). Brace, sport and physiotherapy were related to SRS22 ( R2 = 0.17). Conclusions: ISYQOL showed high validity when used to measure HRQOL in adolescents with spinal deformities. Moreover, ISYQOL performs better than SRS22, having better known-groups validity and (contrary to SRS22) detecting the impact of disease severity on HRQOL.

Health-related quality of life in women and men with type 2 diabetes: a comparison across treatment groups

2015 ◽  
Vol 29 (2) ◽  
pp. 203-211 ◽  
Author(s):  
M. Schunk ◽  
P. Reitmeir ◽  
S. Schipf ◽  
H. Völzke ◽  
C. Meisinger ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Health Related Quality ◽  
Treatment Groups ◽  
Related Quality ◽  
Health Related

scholarly journals Prospective comparison of the impact of robotic-assisted laparoscopic radical prostatectomy versus open radical prostatectomy on health-related quality of life and decision regret

2014 ◽  
Vol 8 (1-2) ◽  
pp. 68 ◽  
Author(s):  
Barbara Joyce Davison ◽  
Andrew Matthew ◽  
Abbie M. Gardner
Keyword(s):  
Quality Of Life ◽  
Radical Prostatectomy ◽  
Sexual Function ◽  
Health Related Quality ◽  
Treatment Groups ◽  
Decision Regret ◽  
Open Radical Prostatectomy ◽  
Related Quality ◽  
Health Related

Introduction: There is no conclusive evidence that the roboticassisted laparoscopic radical prostatectomy (RARP) is superior to conventional open radical prostatectomy (ORP) when it comes to recovery of urinary and sexual function, and that the former surgical option results in less decision regret.Methods: Patients scheduled for both surgical procedures were surveyed prior to surgery, and then again at 6 and 12 months following treatment using the sexual and urinary modules of the Expanded Prostate Cancer Index Composite (EPIC) measure. Decision regret was measured at 12 months. Propensity score regression adjustment was used to account for differences between treatment groups by summarizing all covariate information into a single probability and to simulate randomization.Results: At 12 months, urinary summary scores approached baseline levels, while urinary bother scores had returned to baseline. Sexual summary and bother mean scores decreased by about half of what they were at baseline for both treatment groups at 6 and 12 months. No significant differences in the groups’ sexual summary and bother domains were identified at either 6 or 12 months. Both groups’ scores for decision regret were low. Moderate correlations (r2 range -0.333 to -0.368) were between current levels of urinary and sexual function and decision regret at 12 months.Conclusion: The results of our study found no significant difference in health-related quality of life outcomes based on surgical procedure at 12 months. Moreover, patients in both groups reported low levels of decision regret at 12 months. Further multi-site prospective studies are required to address this study’s limitations.

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