Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
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Randomized Controlled Trial Comparative Study
Cost-effectiveness of trabectedin plus pegylated liposomal doxorubicin for the treatment of women with relapsed platinum-sensitive ovarian cancer in the UK: analysis based on the final survival data of the OVA-301 trial.
To estimate the cost-effectiveness of trabectedin plus pegylated liposomal doxorubicin (PLD) compared with PLD alone for the treatment of patients with relapsed platinum-sensitive ovarian cancer who are not expected to benefit from retreatment with platinum-based therapies based on the final survival data published in October 2012. ⋯ The analysis estimated a significant improvement in mean overall survival and incremental cost per QALY compared with that calculated in the original National Institute for Health and Clinical Excellence assessment, which was based on immature survival data.
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Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. ⋯ It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.
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We described previously the development of a set of quality indicators (QIs) of a childhood cancer system in Ontario, Canada. The purpose of this study was to determine the acceptability of the proposed set of QIs among stakeholders of the childhood cancer system. ⋯ Standardized implementation of the 20 pediatric cancer QIs endorsed by the multidisciplinary stakeholder panel will provide ongoing monitoring of various dimensions of system quality and the development of benchmarks over time, greatly augmenting the ability to identify needed system improvements across populations and jurisdictions.