Changes in weight and weight-related quality of life in a multicentre, randomized trial of aripiprazole versus standard of care

2008 ◽  
Vol 23 (8) ◽  
pp. 561-566 ◽  
Author(s):  
Ronette L. Kolotkin ◽  
Patricia K. Corey-Lisle ◽  
Ross D. Crosby ◽  
Hong J. Kan ◽  
Robert D. McQuade
Keyword(s):  
Quality Of Life ◽  
Clinical Symptoms ◽  
Clinical Trial Data ◽  
Standard Of Care ◽  
Random Regression ◽  
Sexual Life ◽  
Baseline Body Mass Index ◽  
Meaningful Change ◽  
Related Quality

AbstractBackgroundThis is a secondary analysis of clinical trial data collected in 12 European countries. We examined changes in weight and weight-related quality of life among community patients with schizophrenia treated with aripiprazole (ARI) versus standard of care (SOC), consisting of other marketed atypical antipsychotics (olanzapine, quetiapine, and risperidone).MethodFive-hundred and fifty-five patients whose clinical symptoms were not optimally controlled and/or experienced tolerability problems with current medication were randomized to ARI (10–30 mg/day) or SOC. Weight and weight-related quality of life (using the IWQOL-Lite) were assessed at baseline, and weeks 8, 18 and 26. Random regression analysis across all time points using all available data was used to compare groups on changes in weight and IWQOL-Lite. Meaningful change from baseline was also assessed.ResultsParticipants were 59.7% male, with a mean age of 38.5 years (SD 10.9) and mean baseline body mass index of 27.2 (SD 5.1). ARI participants lost an average of 1.7% of baseline weight in comparison to a gain of 2.1% by SOC participants (p < 0.0001) at 26 weeks. ARI participants experienced significantly greater increases in physical function, self-esteem, sexual life, and IWQOL-Lite total score. At 26 weeks, 20.7% of ARI participants experienced meaningful improvements in IWQOL-Lite score, versus 13.5% of SOC participants. A clinically meaningful change in weight was also associated with a meaningful change in quality of life (p < 0.001). A potential limitation of this study was its funding by a pharmaceutical company.ConclusionsCompared to standard of care, patients with schizophrenia treated with aripiprazole experienced decreased weight and improved weight-related quality of life over 26 weeks. These changes were both statistically and clinically significant.

Superabsorbent Wound Dressing for Management of Patients With Moderate-to-Highly Exuding Chronic Leg Ulcers: An Early Stage Model-Based Benefit–Harm Assessment

2021 ◽  
pp. 153473462110093
Author(s):  
Vladica M. Velickovic ◽  
Jean P. Lembelembe ◽  
Francisco Cegri ◽  
Ivana Binic ◽  
Amr B. Abdelaziz ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Early Stage ◽  
Absolute Risk ◽  
Standard Of Care ◽  
Risk Difference ◽  
Wound Dressings ◽  
Leg Ulcers ◽  
Related Quality ◽  
Health Related

The aim of the research is to assess the benefit–harm of superabsorbent polymers wound dressings based on polyacrylate polymers (SAPs) compared with standard of care (SoC) dressing mix for patients with moderate-to-highly exuding hard-to-heal leg ulcers. The SoC dressings mix was composed of other superabsorbents in 29% of cases, antimicrobials 26%, foams 20%, alginates 5%, and other dressings 19% weighted according to their frequency. We have used the decision-analytic modeling method, Markov process, as an adequate analytical solution for medical prognosis. We have combined the systematic literature search to identify the most relevant inputs for the analysis, with available patient-level clinical data concerning benefits of superabsorbent to generate a robust prediction of patient-relevant outcomes, including healing rates and health-related quality of life. Besides, we have qualitatively described adverse events associated with those treatments. Our research indicates that SAPs when compared with SoC dressing mix in a patient with moderate-to-highly excluding leg ulcers are leading to an improved healing rate with an absolute risk difference of 2.20% in 6 months and a relative risk of 1.07 in favor of SAP dressings. The attributable fraction among those exposed to SAP dressings of 6.6%, meaning that 6.6% of the healed ulcers could be attributed to having had the SAP dressing treatment instead of the SoC dressing treatment. Besides, SAP dressings lead to improved quality of life measured as incremental quality-adjusted life weeks (QALWs) of 0.13 QALWs.

scholarly journals Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040

2020 ◽  
Author(s):  
Kevin J Harrington ◽  
Denis Soulières ◽  
Christophe Le Tourneau ◽  
Jose Dinis ◽  
Lisa F Licitra ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Standard Of Care ◽  
Neck Squamous Cell Carcinoma ◽  
Related Quality ◽  
Health Related

Abstract Background Head and neck squamous cell carcinoma (HNSCC) affects health-related quality of life (HRQoL); few treatments have demonstrated clinically meaningful HRQoL benefit. KEYNOTE-040 evaluated pembrolizumab vs standard of care (SOC) in patients with recurrent and/or metastatic HNSCC whose disease recurred or progressed after platinum-containing regimen. Methods Patients received pembrolizumab 200 mg or SOC (methotrexate, docetaxel, or cetuximab). Exploratory HRQoL analyses used European Organisation for Research and Treatment of Cancer (EORTC) 30 quality-of-life, EORTC 35-question quality-of-life head and neck cancer-specific module, and EuroQoL 5-dimensions questionnaires. Results The HRQoL population comprised 469 patients (pembrolizumab = 241, SOC = 228). HRQoL compliance for patients in the study at week 15 was 75.3% (116 of 154) for pembrolizumab and 74.6% (85 of 114) for SOC. The median time to deterioration in global health status (GHS) and QoL scores were 4.8 months with pembrolizumab and 2.8 months with SOC (hazard ratio = 0.79, 95% confidence interval [CI] = 0.59 to 1.05). At week 15, GHS / QoL scores were stable for pembrolizumab (least squares mean [LSM] = 0.39, 95% CI = –3.00 to 3.78) but worsened for SOC (LSM = −5.86, 95% CI = −9.68 to −2.04); the LSM between-group difference was 6.25 points (95% CI = 1.32 to 11.18; nominal 2-sided P = .01). A greater difference in the LSM for GHS / QoL score occurred with pembrolizumab vs docetaxel (10.23, 95% CI = 3.15 to 17.30) compared with pembrolizumab vs methotrexate (6.21, 95% CI = −4.57 to 16.99) or pembrolizumab vs cetuximab (−1.44, 95% CI = −11.43 to 8.56). Pembrolizumab-treated patients had stable functioning and symptoms at week 15, with no notable differences from SOC. Conclusions GHS / QoL scores were stable with pembrolizumab but declined with SOC in patients at week 15, supporting the clinically meaningful benefit of pembrolizumab in recurrent and/or metastatic HNSCC.

scholarly journals Patients’ Satisfaction and Oral Health-Related Quality of Life of Edentulous Patients Using Conventional Complete Dentures and Implant-Retained Overdentures in Saudi Arabia

2022 ◽  
Vol 19 (1) ◽  
pp. 557
Author(s):  
Salwa Omar Bajunaid ◽  
Abdullah S. Alshahrani ◽  
Ahad A. Aldosari ◽  
Atheer N. Almojel ◽  
Rehab S. Alanazi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oral Health ◽  
Standard Of Care ◽  
Strong Impact ◽  
Complete Dentures ◽  
Patients Satisfaction ◽  
Related Quality ◽  
Health Related ◽  
Edentulous Patients

The aim of this study was to compare patients’ satisfaction and quality of life (QoL) when using implant overdentures vs. conventional dentures. The QoL of Saudi patients who were provided mandibular implant-supported overdentures was assessed using a structured questionnaire. Overall satisfaction; ability to speak, eat, and chew food; comfort; esthetics; stability; and satisfaction of general oral health were measured. A total of 48.3% vs. 6.9% were, overall, very satisfied with their implant overdentures and conventional dentures, respectively. A total of 37.9% of the patients were very satisfied regarding speaking with their implant overdentures vs. 17.2% with conventional dentures. Furthermore, 41.4% were very comfortable with their implant overdentures vs. 5.2% were very comfortable using conventional dentures. However, only 15.5% were very satisfied with the esthetics of the conventional dentures compared to 43.1% being satisfied with implant overdentures. Only 1.7% were very satisfied with the stability of conventional dentures vs. 44.8% being satisfied using implant overdentures. About 8.6% of the candidates were very satisfied regarding chewing food with conventional dentures vs. 36.2% being very satisfied using implant overdentures. Approximately 10.3% were very satisfied with their general oral health using conventional dentures compared to 29.3% being very satisfied using implant overdentures. Mandibular implant overdentures had a strong impact on patients’ quality of life over conventional complete dentures and should be considered the minimum standard of care provided to completely edentulous patients.

Patient-reported diarrhea impact on physical functioning and quality of life in clinical trial data submitted to the U.S. Food and Drug Administration.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19105-e19105
Author(s):  
Ting-Yu Chen ◽  
Bellinda King-Kallimanis ◽  
Lyna Merzoug ◽  
Mallorie Fiero ◽  
Jennifer J Gao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial Data ◽  
Life Questionnaire ◽  
Double Blind ◽  
Patient Reported ◽  
Related Quality ◽  
Cancer Trials ◽  
And Function

e19105 Background: Patient-reported outcomes can provide symptom and function data that complement standard oncology endpoints. Frequently, trials will conclude there was no clinically meaningful detriment to health-related quality of life (HRQL) or function, even when notable toxicity is observed. It is possible that mean change from baseline analyses obscures meaningful change in subgroups experiencing symptomatic toxicity. In this study, we explore how patients’ response to a diarrhea item related to physical function (PF) and HRQL in trials submitted to US FDA. Methods: We analyzed 3 randomized, double-blind breast cancer trials (early to late line metastatic) where diarrhea was a more common AE-symptom in the treatment arm, but there was not a large detriment in the mean change from baseline for HRQL and PF. Trials included the EORTC Quality of Life Questionnaire (QLQ-C30), which captures patient-reported HRQL, symptoms, and functioning. Higher scores (range 0-100) indicate better functioning and HRQL. Symptoms were measured with a 4-point scale; not at all to very much. Descriptive statistics were used to analyze diarrhea, PF, and HRQL over time. Results: Patients reporting very much diarrhea at month 3 had worse PF and HRQL compared to patients reporting no diarrhea . The range of difference between patients who reported very much diarrhea and those with none was 8-18 points for PF across trials. For HRQL scores, the range was 13–17 points worse. This trend was also seen in the control arm and at other times. Conclusions: In this set of breast cancer trials with differences in diarrhea by arm, reporting “no meaningful difference in PF or HRQL between the arms” is insufficient and potentially misleading. A more informative interpretation is that an exploratory analysis of HRQL and PF did not show in the investigational arm; there was a greater proportion of patients reporting diarrhea on the treatment arm; and patients reporting more frequent diarrhea reported lower HRQL and PF compared to patients with no diarrhea, regardless of arm. [Table: see text]

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