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Early detection of clinically significant prostate cancer: protocol summary and statistical analysis plan for the ProScreen randomised trial

Por: Nevalainen · J. · Raitanen · J. · Natunen · K. · Kilpeläinen · T. · Rannikko · A. · Tammela · T. · Auvinen · A.
Introduction

Evidence on the effectiveness of prostate cancer screening based on prostate-specific antigen is inconclusive and suggests a questionable balance between benefits and harms due to overdiagnosis, and complications from biopsies and overtreatment. However, diagnostic accuracy studies have shown that detection of clinically insignificant prostate cancer can be reduced by MRI combined with targeted biopsies.

The aim of the paper is to describe the analysis of the ProScreen randomised trial to assess the performance of the novel screening algorithm in terms of the primary outcome, prostate cancer mortality and secondary outcomes as intermediate indicators of screening benefits and harms of screening.

Methods

The trial aims to recruit at least 111 000 men to achieve sufficient statistical power for the primary outcome. Men will be allocated in a 1:3 ratio to the screening and control arms. Interim analysis is planned at 10 years of follow-up, and the final analysis at 15 years. Difference between the trial arms in prostate cancer mortality will be assessed by Gray’s test using intention-to-screen analysis of randomised men. Secondary outcomes will be the incidence of prostate cancer by disease aggressiveness, progression to advanced prostate cancer, death due to any cause and cost-effectiveness of screening.

Ethics and dissemination

The trial protocol was reviewed by the ethical committee of the Helsinki University Hospital (2910/2017). Results will be disseminated through publications in international peer-reviewed journals and at scientific meetings.

Trial registration number

NCT03423303

Cost volume profit analysis for full paying patient services in Malaysia: A study protocol

by Malindawati Mohd Fadzil, Sharifa Ezat Wan Puteh, Azimatun Noor Aizuddin, Zafar Ahmed, Nor Asiah Muhamad, Abdul Aziz Harith

Dual practice within public hospitals, characterised by the concurrent provision of public and private healthcare services within public hospitals, has become a widespread phenomenon. With the participation of selected public hospitals, dual practice within public hospitals, also known as Full Paying Patient services, was an initiative the Ministry of Health Malaysia took in 2007 to retain senior specialist physicians in Malaysia. The revenue generated from the Full Paying Patient services aims to provide an avenue for public sector specialists to supplement their incomes while alleviating the Government’s burden of subsidising healthcare for financially capable individuals. However, the effectiveness of Full Paying Patient services in recouping service delivery costs and yielding a profit is still uncertain after 16 years of implementation. This study is designed to evaluate the impact of Full Paying Patient inpatient services volume, revenue, and cost on profit versus loss at selected hospitals from 2017 to 2020. From the perspective of healthcare providers, we plan to perform a cost volume profit analysis. This analysis enables us to determine the break-even point, at which total revenues match total costs, along with no-loss and no-profit thresholds for Full Paying Patient services. This study has the potential to provide insights into how variations in service volume, cost, and pricing impact healthcare providers’ profitability. It also offers critical financial information regarding the volume of services required to reach the break-even point. A comprehensive understanding of service volume, cost and pricing is imperative for making informed decisions to fulfil the objectives and ensure the sustainability of the FPP services.
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