Quality of Life Assessments in the Development and Clinical Trials of New Antipsychotics: Pharmaceutical Industry Perspective

Author(s):  
Raimund Buller ◽  
Christophe Sapin
2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.


Author(s):  
E F Juniper ◽  
P R Johnston ◽  
C M Borkhoff ◽  
G H Guyatt ◽  
L P Boulet ◽  
...  

2021 ◽  
pp. 1-8
Author(s):  
Alexander Pantelyat ◽  
Lenora Higginbotham ◽  
Liana Rosenthal ◽  
Diane Lanham ◽  
Vanessa Nesspor ◽  
...  

<b><i>Introduction:</i></b> There is growing interest in using patient-reported outcomes as end points in clinical trials, such as the progressive supranuclear palsy quality of life (PSP-QoL) scale. However, this tool has not been widely validated and its correlation with validated motor scales has not been explored. To evaluate the potential utility of using PSP-QoL as an outcome, it is important to examine its relationship with a standard scale used to evaluate neurologic parameters, such as the PSP Rating Scale. <b><i>Methods:</i></b> PSP-QoL and PSP Rating Scale scores were gathered from 60 clinically diagnosed PSP patients, including patients with Richardson syndrome PSP (PSP-RS, <i>n</i> = 43) and those with non-RS PSP variants (<i>n</i> = 17). Linear regression analysis adjusted for age, sex, and disease duration was used to evaluate the cross-sectional relationship between the total and subscale scores of the 2 instruments. <b><i>Results:</i></b> Among 60 PSP patients, there was a significant correlation between total PSP-QoL and PSP Rating Scale scores. The physical and mentation subscales of each instrument also demonstrated significant correlations. Comparisons among PSP subtypes indicated that worsening PSP-QoL Total and Physical subscale scores correlated with worsening PSP Rating Scale gait subscale scores more strongly for the non-RS PSP variants than for PSP-RS. <b><i>Discussion:</i></b> There is a significant association between the total scores and many of the subscale scores of the PSP-QoL and the PSP Rating Scale. Additionally, the relationship between these measures may differ for PSP-RS and non-RS variants. These findings suggest that the PSP-QoL may be useful in clinical trials as a patient-reported outcome measure. Large prospective multicenter studies utilizing the PSP-QoL are necessary to examine its relationship to disease evolution and changes in the PSP Rating Scale.


2004 ◽  
Vol 15 (5) ◽  
pp. 491-499
Author(s):  
Sati Mazumdar ◽  
Mary Amanda Dew ◽  
Patricia R. Houck ◽  
Charles F. Reynolds

2017 ◽  
Vol 52 (1) ◽  
pp. 24-38 ◽  
Author(s):  
Daniel J Brownstein ◽  
Estela Salagre ◽  
Cristiano Köhler ◽  
Brendon Stubbs ◽  
João Vian ◽  
...  

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