Point of care tests for sexually transmitted infections (STIs)

A number of clinical/disease areas have been prioritised by the Technology Strategy Board (TSB) and Department of Health (DH) for the DIIA Innovation Platform. To support commissioning of technology development for detection of sexually transmitted infections (STIs) in humans, a scoping review has been undertaken to help identify the specific requirements for new diagnostic test development and likely economic payback for point of care (POC) tests for STIs in the UK

Point of care tests for hospital-acquired infections (HAIs) : economic analysis report

A number of clinical/disease areas have been prioritised by the Technology Strategy Board (TSB) and Department of Health (DH) for the DIIA Innovation Platform. To support commissioning of technology development for detection of hospital acquired infections (HAIs) in humans, a scoping review has been undertaken to help identify the specific requirements for new diagnostic test development and likely economic payback for point of care (POC) tests for HAIs in the UK. This report presents economic analysis findings for the following HAIs: - Methicillin-resistant Staphylococcus aureus (MRSA) - Clostridium difficile (C. difficile) - Extended-spectrum beta-lactamase (ESBL) infections

The Locked-down: we need more than headline statistics to understand the impact of Covid-19

For 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

Point of care tests for tuberculosis (TB) : economic analysis report

A number of clinical/disease areas have been prioritised by the TSB and DH for the DIIA Innovation Platform. To support commissioning of technology developments in the area of tuberculosis detection in humans, a scoping review has been undertaken to help identify the specific requirements for new diagnostic test development and likely payback in the area of point of care (POC) tuberculosis tests in the UK. There has been a gradual rise in the number of tuberculosis (TB) cases observed in the UK over the last 20 years, with a 4.2% rise in 2009 giving an overall 9,040 TB cases diagnosed or 15 cases per 100,000 population [1]. The aims of this economic review are to identify available information on the following for tuberculosis (TB): - economic burden of disease in the UK; - current NHS cost of TB detection and cost of treating identified TB cases; - evidence on cost-effectiveness of current tests for detection of active and latent TB infection; and - estimates of the economic benefits which new POC tests might provide in the UK

Blockchain's potential to improve clinical trials-an essay by Leeza Osipenko

There’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

Emerging prenatal genetic tests : developing a health technology assessment (HTA) framework for informed decision-making

Delphi Process In preparation for the first Delphi exercise, a list of questions was produced from the academic literature, webbased sources and interviews with experts. These questions were structured into broad dimensions and a draft questionnaire piloted. A final list of 73 questions formed the basis of the first Delphi survey. Participants were asked to grade the perceived importance of each question for inclusion in HTA reports on new prenatal genetic tests (4 = Essential; 3 = Desirable, but not essential; 2 = Useful but should not be required; 1 = Of little/ no importance; 0 = I have no basis for judgement). Secondly, they were asked to indicate whether a question should be addressed during test development or whether the question could be addressed later once the technology is ready for implementation. Finally, Panel members were encouraged to identify any other questions which appeared to be missing from the initial list. For copy of questionnaire, see Annex 1: Delphi Round 1 Questionnaire. Respondents were also asked to provide personal details to give some indication of their HTA experience and specialist expertise. Analysis of responses demonstrated that SAFE Delphi panel members represent a highly experienced, multidisciplinary international group of experts with the knowledge required to define which key questions should be addressed in HTA reports on new prenatal genetic tests. Delphi Responses Responses were received from 77/90 (86%) of Panel members. These were analysed with a cut-off of 75% (±3%) applied as an indicator of Panel consensus for all questions. Thus, any question which three out of four respondents rated as essential or desirable was retained, whilst those not achieving this level of agreement were provisionally excluded. In addition, mean scores were also calculated (excluding 0 = I have no basis for judgement) for each question. A mean score >3.25 ± 0.05 was taken as an indication that the Panel had identified a particular question as being of the highest priority to address in HTA

A review of evidence on non-invasive prenatal diagnosis (NIPD) : tests for fetal RHD genotype

This report concentrates on three main areas. First and foremost, we set the background context for RhD NIPD in prenatal care. While the methodology chapter describes how the literature review was carried out and how additional information was collected, the second chapter provides an overview of the key issues associated with pregnancy of RhD negative women. We present background information based on publications from 1997 to 2006 which describe the genetic condition and its prevalence (RhD negativity) in populations, as well as the frequency of cases of sensitisation and HDN (haemolytic disease of the newborn). We also discuss current service provision for RhD negative women in a number of European countries and look at how the NIPD test might be set within current service contexts

Provenance and clinical benefit of medicines introduced to the French market, 2008 to 2018

IMPORTANCE Both the commercial sector and academia play a vital role in medicine development. Ongoing debates exist on their contribution and the value of medicinal products entering the market. OBJECTIVE To identify the provenance and clinical benefit of medicines that entered the French market between 2008 and 2018. DESIGN AND SETTING In this cross-sectional study, the provenance of each medicine in the French market was established via a review of multiple sources documenting at least 2 matching findings per product. The clinical benefit was assigned using the matched scale developed from the Prescrire and Haute Autorité de Santé (HAS) gradings. The χ2 test was used to analyze the proportions and frequencies of medicines graded by Prescrire and HAS by origin, therapeutic category, and clinical benefit. MAIN OUTCOMES AND MEASURES The origins and therapeutic categories of medicines. Clinical benefit based on Prescrire and HAS grading. Concordance of Prescrire and HAS grading. RESULTS Of the 632 medicines that entered the French market between 2008 and 2018, 464 originated (73%) in the commercial sector, and 168 originated (27%) in the academic setting or in collaboration with commercial enterprises. Prescrire graded psychotropic agents (13/14 [93%]), whereas HAS graded respiratory agents (24/25 [96%]) as the highest percentage of medicines that provided no added benefit. Prescrire graded 360 medicines (77.6%) that originated in the industry and 108 medicines (64.3%) that originated in the academic setting (P = .001) to have no added clinical benefit. HAS assigned such grading to 331 ([71.3%] industry) vs 104 ([61.9%] academia) (P = .02). Based on the Prescrire grading, academia invented more medicines delivering some added benefit 57 (33.9%) vs 98 (21.1%) invented by industry (P = .001). HAS grading on some added benefit 51 ([30.4%] academia) vs 121 ([26.1%] industry) did not reach statistical significance (P = .29). However, HAS grading on substantial added clinical benefit reached statistical significance in favor of academia (13 [7.7%] vs 12 [2.6%] in the industry; P = .003), whereas Prescrire grading did not (1.8% academia vs 1.3% industry; P = .64). CONCLUSIONS AND RELEVANCE More than 70% of medicines that entered the French market during the 10-year period originated in the commercial sector. Although most medicines were not graded as providing clinical benefit, medicines originating in the academic setting were more likely to be graded as conferring clinical benefit than those originating in the commercial setting

Assessment of devices, diagnostics and digital technologies: a review of NICE medical technologies guidance

Background: The Medical Technologies Evaluation Programme (MTEP) of NICE in England aims to evaluate medical devices that are deemed to be cost-saving or cost-neutral and produce medical technology guidance (MTG) to encourage their adoption. Objective: To review the MTGs since MTEP’s inception in 2009 until February 2017. Methods: One researcher assessed all published MTGs and extracted data on the clinical and economic evidence supporting each technology. The NICE Committee’s decision outcome for each assessment was also recorded. A qualitative analysis was performed on technologies that were not supported for adoption to identify the main drivers of the decision. Results: 31 MTGs were reviewed. The committee fully supported the medical devices in 14 MTGs, 11 were partially supported and 6 not-supported. 58% of the MTGs had no RCT data available and the main source of evidence came from non-experimental studies. There was no statistically significant difference in the average number of RCTs and non-experimental studies between the fully supported, partially supported and not supported technologies. Whilst all the fully supported MTGs demonstrated cost-saving results only 50% of the not-supported MTGs did. The sponsor estimated a higher average cost-saving than the EAC in most of cases (20/31). The qualitative evaluation suggests that the main drivers for negative decisions were the quantity or quality of studies, and cost incurring results in the economic evaluation. Conclusions: The main drivers of the decision-making process are the quality and quantity of the submitted evidence supporting the technologies, as well as the economic evaluation results