MedTech-related health technology assessments from NIHR in February 2022

The National Institute for Health Research (NIHR) funds valuable independent research for health and social care decision-makers in England. Reports from the Health Technology Assessment (HTA) Programme are published in the NIHR HTA Journal and inform NICE guidance.

In February 2022, six MedTech-related assessments were published in the NIHR HTA Journal:

• Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and meta-analysis were conducted to evaluate the performance of novel biomarkers for detecting acute kidney injury and the prediction of other relevant clinical outcomes. The following novel biomarkers were considered: NephroCheck® (Astute Medical), ARCHITECT® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories), and urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S) immunoassays. It was concluded that current evidence is insufficient to fully appraise the role and economic value of these biomarkers and determine whether or not they provide cost-effective improvements in the clinical outcomes of acute kidney injury patients;
• Non-invasive testing for early detection of neovascular macular degeneration in unaffected second eyes of older adults based on multicentre, prospective, cohort, comparative diagnostic accuracy study (EDNA) in monitoring setting for up to 3 years. It was concluded that optical coherence tomography was the most accurate non-invasive test in diagnosing neovascular age-related macular degeneration in the second eye of older adults;
• A multidomain decision support tool to prevent falls in older people based on a multicentre, cluster, parallel, randomized controlled trial (FinCH). The objectives were to evaluate the clinical effectiveness and cost-effectiveness of the Guide to Action for falls prevention in Care Homes (GtACH) program. It was shown that  GtACH program significantly reduced the falls rate in care homes without restricting residents' activity levels or increasing their dependency and was cost-effective at current thresholds in the NHS;
• Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilization is based on a pragmatic, multicenter, superiority, open-label, parallel-group, individually randomized controlled trial and the systematic review. This trial and the subsequent systematic review found no evidence that performing endometrial scratch in the mid-luteal phase in women undergoing their first IVF cycle significantly improves the live birth rate, although the procedure was well-tolerated and safe. So, an endometrial scratch was not recommended in this population;
• Moulded cast compared with K-wire fixation after manipulation of an acute dorsally displaced distal radius fracture based on the pragmatic, superiority, multicenter, randomized controlled trial with a health economic evaluation (DRAFFT 2). It was concluded that surgical fixation with K-wires is not superior to moulded casting, as measured by the Patient-Rated Wrist Evaluation score. However, one in eight participants treated in a moulded cast required surgery for loss of fracture reduction in the first six weeks. After a successful closed reduction, clinicians may consider a moulded cast as a safe and cost-effective alternative to surgical fixation with K-wires;
• A rapid intrapartum test for group B Streptococcus to reduce antibiotic usage in mothers with risk factors based on the unblinded cluster randomized controlled trial (GBS2) with a nested test accuracy study, an economic evaluation, and a microbiology sub-study. The accuracy of the GeneXpert® Dx IV GBS rapid testing system (Cepheid) was compared with the standard of selective enrichment culture in diagnosing maternal group B Streptococcus colonization. It was concluded that the rapid test is accurate; however, using it for women with risk factors for their baby developing group B Streptococcus infection does not reduce antibiotic usage in mothers, although it does in babies. Value for money is uncertain and depends on what costs are included.

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