Current medical research and opinion
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Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials. Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020. Results: A total of 189 trials are included in the study. ⋯ Study design characteristics: 71% of all studies were randomized, 5% of all studies were blinded, 18% of all studies were multicenter and 76% of all studies were single center. Conclusion: Although many COVID-19 studies include randomization in their design, the lack of additional double-blind and placebo-controlled elements in their designs result in a less robust evaluation of intervention safety and efficacy. Furthermore, similar or repeated research and small sample studies that have less promise in gains of new information have possibly led to a shortage of recruitable patients and become a barrier to the completion of large multicenter clinical trial studies.
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Multicenter Study
Epidemiology, management and costs of sepsis in Spain (2008-2017): a retrospective multicentre study.
Objective: To update the profile of patients attended with sepsis in specialised care centres in Spain, to analyse in-hospital mortality, disease management and costs between 2008 and 2017. Methods: Admission records registered between 1 January 2008 and 31 December 2017 obtained from a Spanish National hospital discharge database for public and private hospitals. Centres are responsible for data codification, evaluation and confidentiality. ⋯ Mean annual direct medical costs of specialised care over the study period were €6664 and €8084 per patient in patients with sepsis without and with organ dysfunction, respectively, and €11,359 per patient in those with septic shock. Conclusions: The social and economic burden of sepsis in Spain continues to grow (incidence, total costs). Despite its general decreasing trend, CFR remains elevated, thus, patients could benefit from further research and protocol revision.
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Observational Study
Cost of cystectomy-related complications in patients with bladder cancer in the United States.
Aims: To describe healthcare utilization and cost associated with the short-term and long-term complications of cystectomy among commercially insured bladder cancer patients in the United States. Materials and methods: This retrospective, observational cohort study evaluated adults with bladder cancer receiving a transurethral resection of bladder tumor followed by a partial or radical cystectomy procedure using U. S. administrative claims from the 2005-2015 IBM MarketScan Commercial and Medicare Supplemental databases. ⋯ In the long-term period, PPPM complication-related healthcare costs were $544 [$2580] for partial cystectomy and $1619 [$7874] for radical cystectomy. Conclusions: Cystectomy-related complications, especially with radical cystectomy, present a substantial financial burden to patients and payers immediately after surgery as well as in the long term. Targeted interventions which improve clinical outcomes but reduce substantial costs associated with cystectomy for bladder cancer are needed.
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Meta Analysis Comparative Study
The importance of considering differences in study and patient characteristics before undertaking indirect treatment comparisons: a case study of siponimod for secondary progressive multiple sclerosis.
Background: Indirect treatment comparisons (ITCs) provide valuable evidence on comparative efficacy where head-to-head clinical trials do not exist; however, differences in patient populations may introduce bias. Therefore, it is essential to assess between-trial heterogeneity to determine the suitability of synthesizing ITC results. We provide an illustrative case study in multiple sclerosis (MS) where we assess the feasibility of conducting ITCs between siponimod and interferon beta-1b (IFN β-1b) and between siponimod and ocrelizumab. ⋯ ITCs were not feasible between siponimod and ocrelizumab because study designs and patient populations were too dissimilar to conduct a reliable ITC. Conclusions: This study highlights the importance of conducting a detailed feasibility assessment before undertaking ITCs to illuminate when excessive between-trial heterogeneity would cause biased results. MAIC was performed for siponimod and IFN β-1b in the absence of a head-to-head trial and was considered a more valid approach than a traditional ITC to examine comparative effectiveness.
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Randomized Controlled Trial
Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.
Objective: To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Methods: Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. ⋯ Conclusion: Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.