49 research outputs found
Blockchain's potential to improve clinical trials-an essay by Leeza Osipenko
No full textThere’s more to this tamperproof technology than bitcoin. It could be used to improve the administration of clinical trials, ensuring transparency and yielding better quality data, writes Leeza Osipenk
The Locked-down: we need more than headline statistics to understand the impact of Covid-19
No full textFor governments and individuals much of our understanding of the Covid-19 pandemic has been mediated through metrics of cases and deaths and shaped by heartbreaking personal stories. In this post, Leeza Osipenko argues that such metrics only scratch the surface of the impact of the Covid-19 pandemic and makes the case for more expansive data collection to understand how Covid-19 is reshaping society
sj-docx-1-smo-10.1177_20503121221074480 – Supplemental material for The early impact of the global lockdown on post-secondary students and staff: A global, descriptive study
No full textSupplemental material, sj-docx-1-smo-10.1177_20503121221074480 for The early impact of the global lockdown on post-secondary students and staff: A global, descriptive study by Behdin Nowrouzi-Kia, Leeza Osipenko, Parvin Eftekhar, Nasih Othman, Sultan Alotaibi, Alexandra M Schuster, Hae Sun Suh and Andrea Duncan in SAGE Open Medicine</p
A new fetal RHD genotyping test : costs and benefits of mass testing to target antenatal anti-D prophylaxis in England and Wales
No full textBackground
Postnatal and antenatal anti-D prophylaxis have dramatically reduced maternal sensitisations and cases of rhesus disease in babies born to women with RhD negative blood group. Recent scientific advances mean that non-invasive prenatal diagnosis (NIPD), based on the presence of cell-free fetal DNA in maternal plasma, could be used to target prophylaxis on "at risk" pregnancies where the fetus is RhD positive. This paper provides the first assessment of cost-effectiveness of NIPD-targeted prophylaxis compared to current policies.
Methods
We conducted an economic analysis of NIPD implementation in England and Wales. Two scenarios were considered. Scenario 1 assumed that NIPD will be only used to target antenatal prophylaxis with serology tests continuing to direct post-delivery prophylaxis. In Scenario 2, NIPD would also displace postnatal serology testing if an RhD negative fetus was identified. Costs were estimated from the provider's perspective for both scenarios together with a threshold royalty fee per test. Incremental costs were compared with clinical implications.
Results
The basic cost of an NIPD in-house test is £16.25 per sample (excluding royalty fee). The two-dose antenatal prophylaxis policy recommended by NICE is estimated to cost the NHS £3.37 million each year. The estimated threshold royalty fee is £2.18 and £8.83 for Scenarios 1 and 2 respectively. At a £2.00 royalty fee, mass NIPD testing would produce no saving for Scenario 1 and £507,154 per annum for Scenario 2. Incremental cost-effectiveness analysis indicates that, at a test sensitivity of 99.7% and this royalty fee, NIPD testing in Scenario 2 will generate one additional sensitisation for every £9,190 saved. If a single-dose prophylaxis policy were implemented nationally, as recently recommended by NICE, Scenario 2 savings would fall.
Conclusions
Currently, NIPD testing to target anti-D prophylaxis is unlikely to be sufficiently cost-effective to warrant its large scale introduction in England and Wales. Only minor savings are calculated and, balanced against this, the predicted increase in maternal sensitisations may be unacceptably high. Reliability of NIPD assays still needs to be demonstrated rigorously in different ethnic minority populations. First trimester testing is unlikely to alter this picture significantly although other emerging technologies may
Fetal RHD typing - is fetal RHD typing in all RhD negative women cost effective?
No full textFinning et al show that non-invasive detection of fetal RHD status can be performed in a high throughput laboratory with high sensitivit
Quality of Evidence submitted to NICE Technology Appraisals (2000-2020)
No full textThis file provides a data set on 409 Technology Appraisals (TAs) issued by NICE between March 2000 when TA1 was published and September 11, 2019 when TA 600 was published. For each of these TAs, there are analyses including a score for their Data Quality, QoL Data Quality, Quality of Submitted Evidence, Overall Quality of Evidence for decision, and Quality of Submitted RCTs. A legend is in the file's second tab
The Origin and Clinical Benefit of First-in-Class Drugs that entered the French market between 2008 and 2018
No full textThis file contains a data set of 135 First-in-class medicines that entered the French market between 2008 to 2018. For each drug we present data on provenance (inventor of the drug) and clinical benefit grading by Haute Autorité de Santé (HAS) and Prescrire. A legend on matching clinical grading scale can be found on tab 3 of the document
Provenance of 632 medicines that entered the French market between 2008 and 2018
No full textThis file contains a data set of 632 medicines that entered the French market between 2008 to 2018. 529 drugs are single drugs and 103 are combination drugs. For each drug we present data on provenance (inventor of the drug) and sources of referencing our searches for drug origin
Provenance, Added Clinical Benefit and Therapeutic Area of 632 medicines that entered the French market between 2008 and 2018
No full textThis file contains a data set of 632 medicines that entered the French market between 2008 to 2018. 529 medicines are single drugs and 103 are combination medicines. For each drug we present data on provenance (inventor of the drug) and sources referencing our searches for origins of each medicine. We also present added clinical benefit data for all 632 medicines based on HAS and Prescrire matched grading scale as well as therapeutic area of each medicinal product in which the clinical benefit grading was sourced (highest clinical benefit grading attained by the product in the indication based on Prescrire grading). The file also contains data on the medicines approved by the FDA in the United State
