Future mental health care may include diagnosis via brain scan and computer algorithm

 Most of modern medicine has physical tests or objective techniques to define much of what ails us. Yet, there is currently no blood or genetic test, or impartial procedure that can definitively diagnose a mental illness, and certainly none to distinguish between different psychiatric disorders with similar symptoms. Experts are combining machine learning with brain imaging tools to redefine the standard for diagnosing mental illnesses.

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New NICE Diagnostics guidance [DG33] Biomarker tests to help diagnose preterm labour in women with intact membranes

New NICE Diagnostics guidance [DG33] Biomarker tests to help diagnose preterm labour in women with intact membranes


Published date: July 2018  Next review: July 2021


Evidence-based recommendations on biomarker tests to help diagnose preterm labour in women with intact membranes. The tests are Actim Partus, PartoSure and the Rapid fetal fibronectin (fFN) 10Q Cassette Kit (at thresholds other than 50 nanograms/millilitre).


For full guidance
 https://www.nice.org.uk/guidance/dg33

New NICE Diagnostics guidance DG32 Adjunctive colposcopy technologies for assessing suspected cervical abnormalities

NICE Diagnostics guidance [DG32] Adjunctive colposcopy technologies for assessing suspected cervical abnormalities: the DYSIS colposcope with DYSISmap and the ZedScan I.
Published date: April 2018. Next review: April 2021                


This guidance replaces the NICE diagnostics guidance on adjunctive colposcopy technologies for examination of the uterine cervix – DySIS and the Niris Imaging System (DG4) and the NICE medtech innovation briefing on ZedScan as an adjunct to colposcopy in women with suspected cervical intra‑epithelial neoplasia (MIB20).


Read full guidance at: https://www.nice.org.uk/guidance/dg32

Slow growing mycobacteria: procedure for testing heater cooler units

This protocol provides guidance on how best to perform and process environmental water and air sampling, from heater-cooler units and environments where these units are in operation, in order to recover slow growing mycobacterial species.


The environmental samples referred to in this document are:

• water samples from heater-cooler units (used in cardiopulmonary bypass surgery)
• air samples in environments where heater cooler units are in operation (in support of cardiopulmonary bypass surgery)

From Public Health England

NIHR Signal New screening pathway could help to identify a rare, single-gene form of diabetes

A screening pathway using blood and urine tests followed by two genetic (DNA) tests identified all people with a rare subtype of diabetes called monogenic diabetes. The screening pathway performed better than current practice based on age at diagnosis and family history which misses 63%. It is, therefore, a useful approach for ruling out this form of diabetes and probably cheaper overall than offering every young person with diabetes DNA testing.


Monogenic diabetes, caused by a mutation in a single gene can be misdiagnosed as type 1 diabetes, leading to unnecessary insulin treatment. Those recruited for this study were 98% white and tested at an average of 14 years after diagnosis.


From the NIHR Dissemination Centre

Signal Single urine samples are just as good as 24-hour collections for diagnosing pre-eclampsia

The urine spot albumin-creatinine ratio (which is done on a single, on-the-spot sample) reliably identified 99% of pregnant women with high blood pressure who went on to develop severe pre-eclampsia. The spot protein-creatinine ratio, as currently recommended by NICE, was slightly less sensitive identifying over 90% of women. Both spot tests were good value for money.


Nearly 1,000 women, suspected of having pre-eclampsia, took part in this NIHR-funded study, in 36 UK obstetric units. They had high blood pressure and protein detected in their urine (by dipstick) beyond 20 weeks of pregnancy. The study compared the diagnostic accuracy of newer ways of ‘spot’ testing a single sample of urine for predicting severe pre-eclampsia with traditional tests on a urine sample taken over 24-hours.


From the NIHR Dissemination Centre

Plasma EGFR mutation tests for adults with locally advanced or metastatic non-small-cell lung cancer [MIB 137}

New:  Medtech innovation briefing


Epidermal growth factor receptor (EGFR) mutation tests are in vitro diagnostic (IVD) tests used to help identify adults with non-small-cell lung cancer (NSCLC) suitable for treatment with EGFR tyrosine kinase inhibitors (EGFR‑TKIs). The presence of specific EGFR mutations show how effective treatment with EGFR‑TKIs will be. As a result, the test is useful for oncologists for deciding personalised treatment options.


EGFR mutations occur in EGFR exons 18–21 and mutations in exons 18, 19 and 21 and indicate suitability for treatment with EGFR‑TKIs. Mutations in exon 20 (with the exception of a few mutations) show the tumours are EGFR‑TKI resistant and not suitable for treatment with EGFR‑TKIs.

Point-of-care creatinine tests before contrast-enhanced imaging [MIB 136]

New:  Medtech innovation briefing


POC creatinine tests allow rapid measurements of creatinine levels using very small samples of whole blood, serum, plasma or a combination of these. The devices used for these tests are either handheld or table-top and need blood from either finger-prick or venous/arterial samples. The method of analysis can vary with some devices using test cartridges and some using test strips.


The focus of this briefing is POC creatinine testing to assess kidney function in people who are scheduled to have contrast-enhanced imaging. Testing is important because contrast materials such as iodine or gadolinium can cause kidney injury, particularly in high-risk patients and those with known kidney dysfunction. If patients do not have a recent creatinine measurement, their imaging may be cancelled and rescheduled. Alternatively, they may have unenhanced imaging – which is less reliable – or the planned contrast agent may be given, risking kidney injury. Current practice varies; a recent UK survey estimated that up to 20% of hospitals only check creatinine levels before imaging in people known to be at high risk of kidney injury (Harris et al. 2016).

MammaTyper in vitro diagnostic test for determining breast cancer subtypes [MIB 135]

New:  Medtech innovation briefing


The MammaTyper (BioNTech Diagnostics GmbH) test is a molecular in vitro diagnostic test for the relative gene expression quantification of the genes ERBB2, ESR1, PGR and MKI67 in human breast cancer tissue. It is used as a diagnostic test on biopsy samples of invasive breast cancer tissue from surgical resection or pre-operative core needle biopsies. The test is based on reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR). MammaTyper classifies breast cancer into 4 subtypes that have different treatments according to St Gallen (2017) guidelines:

• Luminal A-like (oestrogen receptor [ER]-positive and generally human epidermal growth receptor 2 [HER2]-negative); treated with endocrine therapy.
• Luminal B-like subdivided according to the ERBB2 expression into:
  
  • luminal B-like (ER-negative and HER2-positive); treated with anti-HER2 therapy and chemotherapy
  • luminal B-like (ER-positive and generally HER2-negative); treated with endocrine therapy.
  
  
• HER2-positive (non-luminal); treated with anti-HER2 therapy and chemotherapy.
• Triple-negative (generally ER, progesterone receptor [PR]- and HER2-negative); treated with chemotherapy.

Next-generation sequencing panel for solid tumour cancers in children [MIB133]

New:  Medtech innovation briefing

The next-generation sequencing (NGS)-based panel for solid tumour cancers in children is an in-house laboratory test, not a commercial product. It was developed at the Centre for Molecular Pathology at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust and validated in-house for clinical application, following the standardised framework published by Mattocks et al. (2010).

NHS Performance Statistics - January 2018

Combined Performance Summary

• Urgent and emergency care – Accident and Emergency, NHS111, Ambulances, Delayed Transfers of Care 
• Planned care – Referral to Treatment, Diagnostics, Mixed Sex Accommodation, NHS Continuing Healthcare and NHS-funded Nursing Care, Patient Reported Outcome Measures 
• Cancer - Cancer Waiting Times, Cancer Registrations, Cancer Emergency Presentations, Cancer Survival Estimates 
• Mental Health - Early Intervention in Psychosis, Out of Area Placements, Children and Young People with an Eating Disorder, Contacts and Referrals, Improving Access to Psychological Therapies

Point-of-care and home faecal calprotectin tests for monitoring treatment response in inflammatory bowel disease [MIB132]

New medtech innovation briefing from NICE:

Elevated faecal calprotectin (FC) is a marker of intestinal inflammation, including that caused by inflammatory bowel disease (IBD). NICE diagnostics guidance recommends FC testing for the diagnosis of IBD; this briefing summarises the available information on the use of FC to monitor treatment response in patients with IBD.

There are 3 types of FC test available: point of care (used by healthcare professionals), home use (used by patients or carers) and laboratory (used by laboratory scientists). This briefing includes only point‑of‑care and home‑use tests because laboratory tests are widely available in the NHS, although their usage varies.

Survey of Dermatologists and Venereologists Shows Varying Approach to Penile Biopsies

J Clin Aesthet Dermatol. 2017;10(10):26–27

Objective. To determine frequency of use and safety of epinephrine containing local anesthesia among dermatologists in the United Kingdom and venereologists undertaking penile biopsy.

Conclusion. Use of epinephrine-containing local anesthesia is common among physicians in the United Kingdom undertaking penile biopsies. Despite this, no episodes of necrosis were observed. While further investigation is still required, it is likely that use of epinephrine-containing local anesthesia is safe for local penile injection.

UHCW Research: Aaron Wernham and Tang Ngee Shim

Tests in secondary care to identify people at high risk of ovarian cancer [DG321

New: Diagnostic Guidance

Evidence-based recommendations on tests in secondary care to identify people at high risk of ovarian cancer. The tests are the IOTA ADNEX model, Overa (MIA2G), RMI I (at thresholds other than 250), ROMA and IOTA Simple Rules.

There is currently not enough evidence to recommend the routine adoption of the IOTA ADNEX model, Overa (MIA2G), RMI I (at thresholds other than 200 or 250), ROMA or IOTA Simple Rules in secondary care in the NHS to help decide whether to refer people with suspected ovarian cancer to a specialist multidisciplinary team (MDT).

GDm-Health for people with gestational diabetes [MIB131]

New:  Medtech innovation briefing from NICE:

GDm‑Health (Oxford University NHS Foundation Trust and The University of Oxford) comprises 2 parts: a patient-facing mobile app, which is downloaded to the patient's mobile device, and a secure clinician-facing website designed to allow remote blood glucose monitoring.

The mobile app is available for iOS and Android operating systems. The app downloads data from the user's blood glucose meter (through Bluetooth or near-field communication [NFC]). It then automatically sends these blood glucose measurements to the secure website through wifi or a mobile internet connection. The user may also enter notes alongside the measurements, such as explanations of unusually high readings, and these are also sent to the website.

Combined Performance Summary - October 2017

This publication from NHS England summarises the data around NHS performance for October 2017. It contains a summary of the monthly performance statistics on:

• NHS 111
• ambulance quality indicators
• A&E attendances and emergency admissions
• waiting times for diagnostic tests, referral to treatment for consultant-led elective care and cancer services;
• delayed transfers of care; and
• early intervention in psychosis

HTG EdgeSeq ALKPlus Assay EU for ALK status testing in non-small-cell lung cancer [MIB128]

New: Medtech innovation briefing from NICE:

HTG EdgeSeq ALKPlus Assay EU (HTG Molecular Diagnostics) is an in vitro diagnostic assay which is designed to identify the ALK status of NSCLC. It is a next-generation sequencing (NGS)-based assay that works with the company's HTG EdgeSeq analyser. The test is only compatible with Illumina MiSeq and MiSeqDx systems. The test is done on stored formalin-fixed, paraffin-embedded (FFPE) lung tumour specimens.

The test differs from current methods of ALK status testing in that it automatically generates a report on ALK status. The report is presented in a way that needs no special training or experience to understand.

NIHR Signal Placing wet gauze on babies’ tummies speeds up urine collection

Almost a third of infants managed to urinate within five minutes after a painless, cheap technique that stimulates the skin, compared with 12% of infants observed only, as is standard practice.

The ‘Quick-Wee’ method involved rubbing the babies’ abdomens gently with gauze soaked in cold saline before collecting urine. This trial was carried out with 354 babies aged one to 11 months in one Australian paediatrics emergency room.

NICE guidelines recommend non-invasive ‘clean catch’ collection if possible but this can be difficult, especially in young children. They estimate that 20 minutes of staff time can be needed to obtain a sample. Hospital paediatrics settings and primary care may want to try this promising, cheap and safe technique.

There was no difference in rates of contamination and it may reduce the number of babies who need to go on to the less desirable collection by pad samples or invasive techniques.

From the NIHR Dissemination Centre

Detecting Eating Psychopathology in Female Athletes by Asking About Exercise: Use of the Compulsive Exercise Test

Use of the Compulsive Exercise Test. Eur. Eat. Disorders Rev., 25: 618–624. doi: 10.1002/erv.2561.

The present study assessed the suitability of the Compulsive Exercise Test (athlete version; CET-A) for identifying female athletes with clinically significant features related to or comparable with eating psychopathology. Three hundred and sixty-one female athletes (including 12 with a clinically diagnosed eating disorder) completed the Eating Disorders Examination Questionnaire and the CET-A. Receiver operating curve analysis was employed to identify a cut-off value on the CET-A, which could indicate clinically significant features related to or comparable with eating psychopathology among female athletes. The analysis demonstrated that a CET-A score of 10 successfully discriminated female athletes with a current eating disorder. The results suggest that the CET-A may be a suitable tool for detecting eating psychopathology in female athletes. Additional longitudinal research is needed to evaluate the predictive value of the CET-A.

UHCW Research: Caroline Meyer

Combined Performance Summary - August 2017

This publication from NHS England summarises the data around NHS performance for August 2017. It contains a summary of the monthly performance statistics on:

• NHS 111
• ambulance quality indicators
• A&E attendances and emergency admissions
• waiting times for diagnostic tests, referral to treatment for consultant-led elective care and cancer services;
• delayed transfers of care; and
• early intervention in psychosis