scholarly journals A Systematic Review of Health‐Related Quality of Life Reporting in Ovarian Cancer Phase III Clinical Trials: Room to Improve

2017 ◽  
Vol 23 (2) ◽  
pp. 203-213 ◽  
Author(s):  
Michelle K. Wilson ◽  
Michael L. Friedlander ◽  
Florence Joly ◽  
Amit M. Oza
2007 ◽  
Vol 25 (32) ◽  
pp. 5082-5086 ◽  
Author(s):  
Andrew Bottomley ◽  
Neil K. Aaronson

Over recent decades, health-related quality of life (HRQOL) research has been increasingly integrated into cancer clinical trials. The purpose of this review is to examine the overall approach taken towards clinical trial–based HRQOL investigations within the European Organisation for Research and Treatment of Cancer (EORTC). This article reports a literature review of clinical trial–based HRQOL investigations and provides selective examples of HRQOL studies in phase III clinical trials in various disease sites. The findings of this review highlight that, historically, assessing HRQOL was a challenge. However, as EORTC has become more experienced in the assessment of HRQOL and has developed a portfolio of appropriate tools, HRQOL has become a more accepted end point in large-scale trials. The trials reviewed in this article show that, in general, HRQOL data do provide information that can both inform clinicians about the effectiveness of the treatments and also serve as an invaluable source of information for patients to make informed decisions regarding the treatment choice.


2014 ◽  
Vol 9 (1) ◽  
pp. 19 ◽  
Author(s):  
Heinz Reichmann ◽  
Pablo Martínez Martin ◽  
Fabrizio Stocchi ◽  
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◽  
...  

Health-related quality of life (HRQoL) used to be considered a secondary parameter in clinical trials of Parkinson’s disease (PD) and in routine clinical practice, but is now increasingly recognised as an important measure of patient status. A number of studies have shown that the severity of PD is strongly associated with poor HRQoL scores and that measuring HRQoL domains provides a valuable assessment of overall patient status. Current guidelines from the Movement Disorder Society Task Force and the European Parkinson’s Disease Association recommend the use of HRQoL measures in the diagnosis and monitoring of patients. The European Medicines Agency PD Guidelines, however, do not yet recommend the use of such indirect endpoints in clinical trials. A series of phase III and post-marketing studies evaluating the selective monoamine oxidase type B inhibitor, rasagiline in PD, including between 404 and 1,176 patients, showed that treatment with rasagiline leads to significant improvements in HRQoL parameters such as the Parkinson’s Disease Quality of Life questionnaire (PDQUALIF), the 39-Item Parkinson’s Disease Questionnaire (PDQ-39), the PDQ-8 and other HRQoL-related parameters. Other clinical trials have shown significant improvements in parameters including: Short-Form-36, EuroQuol 5D, PDQUALIF, PDQ-39 and HRQoL-related parameters in PD patients treated with dopamine agonists, selegiline, tocopherol or levodopa/carbidopa/entacapone or levodopa/carbidopa combinations. Experience gained with these instruments is likely to increase the attention paid to HRQoL in PD assessment and could improve diagnosis and monitoring of PD and may ultimately improve patient outcomes.


2019 ◽  
Vol 53 (6) ◽  
pp. 585-598 ◽  
Author(s):  
Nicole R. Aimée ◽  
Nailê Damé-Teixeira ◽  
Luana Severo Alves ◽  
Gabriel Á. Borges ◽  
Lyndie Foster Page ◽  
...  

This systematic review and meta-analysis were undertaken to assess the responsiveness of validated oral health-related quality of life (OHRQoL) questionnaires to dental caries interventions in children, adolescents, and young adults. Studies eligible were randomized clinical trials (RCTs), controlled clinical trials (CCTs), and prospective case series (PCS), which had OHRQoL questionnaires answered before and after caries intervention(s). The main outcome was improvement in OHRQoL mean scores following caries intervention. Twenty-six studies were selected for the quality assessment and 14 were selected for the meta-analysis. Most of the studies were PCS with a single group pretest and posttest study design (n = 19). Five studies were CCT and only 2 were RCT. The numbers of participants were 3,522 in the control group (baseline = 2,002; final = 1,520) and 5,917 in the test group (baseline = 3,102; final = 2,815). The age of the subjects ranged from 3 to 19 years. All studies showed significant improvement in OHRQoL following caries intervention. Most of nonrandomized studies (n = 15) had low or moderate risk of bias. The meta-analysis showed the effect of caries interventions (standardized weighted mean differences = –1.24; 95% CI: –1.68 to –0.81; p < 0.001). However, high heterogeneity between the studies was found. The Grading of Recommendations Assessment, Development and Evaluation approach classified the quality of evidence as very low and its strength weak. In conclusion, there is evidence that the OHRQoL of children and adolescents improved following caries intervention procedures, but the quality of the evidence was very low. In spite of that, caries interventions are highly recommended as abstaining from treatment is likely to result in a deterioration of OHRQoL.


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