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24th April 2024
Patients with suspected inflammatory bowel disease (IBD) could avoid unnecessary colonoscopy tests and speed up diagnosis by using multiple home testing kits, a new study has found.
Researchers from the University of Birmingham, UK, have developed a unique testing protocol to improve IBD referral triage by combining a new 13-point symptom checker with the results of multiple faecal calprotectin (FCP) tests.
Obtaining a second FCP result prevented patients from undergoing unnecessary colonoscopies. The findings could reduce the need for expensive and intrusive investigations, speed up diagnosis for many IBD patients, and support self-diagnosis to secondary care. This would, in turn, reduce the burden on primary care.
The study, published in the journal Frontline Gastroenterology, is the first in the UK to prospectively examine the symptoms of IBD and levels of faecal calprotectin (FCP) from the onset of the condition.
Patients with IBD, including Crohn’s disease and ulcerative colitis, often have a long wait until diagnosis, and the researchers note that the current testing system is under immense strain. Diagnostic delays for IBD can result in adverse outcomes for patients.
The two-year study, which took place between January 2021 and August 2023, involved 767 participants. Over half of those who took part (n=423, 55%) were diagnosed with IBD: 208 with Crohn’s disease and 215 with ulcerative colitis.
A 13-point symptom history was taken prediagnosis, and clinical indices such as repeat FCP were collected prospectively.
The most common symptoms, which were not always easily distinguished from non-IBD symptoms, were abdominal pain (84%), looser stools (84%) and fatigue (79%) for Crohn’s disease and per-rectal bleeding (94%), urgency of stools (82%), and looser stools (81%) for ulcerative colitis.
The researchers found blood in the stools and weight loss to be the strongest predictors of IBD. The results showed that a person with blood in their stools was over four times more likely than those without to have Crohn’s disease (based on a measurement of an odds ratio (OR) of 4.38 with a 95% confidence interval and a range of 2.40 to 7.98) and over three times more likely to have weight loss (OR 3.39; 2.14–5.38).
Patients diagnosed with ulcerative colitis were 33 times more likely to experience blood in their stools and over two times more likely to have weight loss (OR 33.68; 15.47–73.33 and OR 2.33; 1.37–4.00, respectively).
Serial FCP measurements were found to be more useful than a single test for predicting IBD accurately.
Two FCP measurements, where one is greater than 100 µg/g and the other greater than 200 µg/g, were shown to be associated with the diagnosis of IBD. However, a second result, ≥220 µg/g, when considered alone and regardless of the first result, was more accurate at predicting IBD.
Some patients with elevated FCP levels and were suspected of having IBD were re-tested and showed a reduction in levels since the first measurement, indicating the initial elevated levels of FCP were not due to IBD.
Using the findings, the researchers have developed a rapid-access pathway for suspected IBD patients outside of the urgent ‘two-week wait’ criteria, with patients triaged by utilising a combination of FCP results and symptom history.
The researchers suggest that the results from home FCP testing can be coupled with a review of symptoms to form the foundation of effective self-referral pathways. Based on the study findings, patients with two FCPs >200 µg/g could be streamed directly to colonoscopy, while those with two FCPs >100 µg/g could be reviewed in clinic.
A second result ≥220 µg/g is deemed more accurate than dual-result thresholds and can indicate that a patient should be referred directly for a colonoscopy. The researchers observed that only 20% of patients had two samples submitted before referral to secondary care.
Dr Peter Rimmer, academic clinical lecturer in gastroenterology at the University of Birmingham’s National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC) and corresponding author of the study said: ‘Using a comprehensive 13-point symptom checker and multiple FCP tests, we have been able to identify much more accurately patients who had IBD and other diseases.
‘The rollout of this protocol could reduce the time taken to get a diagnosis and start treatment for IBDs as much more of the screening and testing can be done through primary care. The sensitivity of multiple FCP tests can be used to flag those patients who urgently need referral into secondary care.’
The researchers hope the study will improve referral triage for IBD patients and open new care pathways for them. A large follow-up study will explore the latter.
Efficiencies in the diagnosis of Barrett’s oesophagus have also recently been identified with a successful pilot project using a capsule sponge test found to reduce the need for invasive endoscopy.
6th April 2023
In a systemic review and meta-analysis, Canadian researchers found that the performance of an artificial intelligence (AI) model for the diagnosis of hip fractures was comparable with that of expert radiologists and surgeons.
Artificial intelligence (AI) models being increasing used for a range of healthcare applications, although the evidence for a beneficial effect on clinician diagnostic performance is spare. In contrast, models based on deep learning algorithms offer some promise for diagnostic purposes with findings to date suggesting that the diagnostic performance of such systems are equivalent to that of health-care professionals. With hip fractures associated with a huge morbidity and mortality, how useful is an AI model (AIM) for the automatic identification and classification of hip fractures and how does this compare with clinicians were the questions addressed by researchers in the current study.
The team performed a systematic review of the literature and included studies that involved the development of machine learning models for the diagnosis of hip fractures from hip or pelvic radiographs or to predict any postoperative patient outcome following hip fracture surgery. The team examined the diagnostic accuracy of an AIM in comparison to expert clinicians and used the areas under the curve (AUC) for postoperative outcome prediction such as mortality between traditional statistical models and that developed by the machine learning models.
AI model and hip fracture diagnosis
A total of 39 studies were included, of which 46.2% used an AIM to diagnose hip fractures on plain radiographs and 53.8% used an AIM to predict patient outcomes following hip fracture surgery.
When compared with clinicians, the odds ratio for diagnostic error of the AI models was 0.79 (95% CI, 0.48 – 1.31 p = 0.36) for hip fracture radiographs. In other words, although the analysis favoured an AIM, statistically, models were no better than clinicians. In addition, the mean sensitivity for the model was 89.3% and the specificity 87.5% and the F1 score (which that assesses the model’s accuracy) was 0.90 (range 0 to 1.0).
For post-operative predictions, e.g., such as mortality, the mean AUC was 0.84 with AI models and 0.79 for alternative controls and therefore not significantly different (p = 0.09).
The authors concluded that while promising for the diagnosis of hip fractures, the performance of AI models was comparable with that of expert radiologists and surgeons, adding that AI outcome prediction appears to provide no substantial benefit over traditional multivariable predictive statistics.
Citation
Lex JR et al. Artificial Intelligence for Hip Fracture Detection and Outcome Prediction: A Systematic Review and Meta-analysis. JAMA Netw Open 2023
13th February 2023
A team of UK researchers have developed a novel prostate cancer (PaC) screening test based on measurement of five chromosome conformations that were originally detected in association with advanced PaC and which, together with the prostate specific antigen (PSA) test, has a high degree of accuracy for detecting the cancer.
Prostate cancer is the second most common cancer in men and in 2020, there were just over 1.4 million new cases worldwide. Further investigations for suspected PaC are based on the results of a PSA test and the threshold has conventionally been set at 3 to 4 to differentiate between ‘normal’ and ‘abnormal’ although cancer can be present at lower PSA levels. However, while other tests have been developed, these all generally have a low positive predictive value. While imaging modalities have shown promise as screening tests, the recent PROSTAGRAM study which compared PSA test, MRI and ultrasound, found that all provided a similar level of accuracy for detecting PaC.
In the current study, researchers developed an assay based on specific chromosome conformation changes in certain genes in the blood of men with PaC. Using samples from the PROSTAGRAM study, which included men diagnosed with PaC and control patients, the team set out to establish whether their novel assay (EpiSwitch) in combination with a PSA test could improve the accuracy of PaC diagnosis.
Novel prostate cancer test performance
Samples from 109 men (88 control and 21 with PaC) were analysed. Based on a PSA cut-off level of 3 ng/mL, the test had an accuracy of 79%. The EpiSwitch test alone had an accuracy of only 64% but when the EpiSwitch test was combined with the PSA test, the accuracy was 94%.
The researchers reported that using the EpiSwitch test and the PSA level taken as a continuous variable, there was a high positive predictive (92%) and negative predictive value (94%) for the diagnosis of PaC. Although the study was based on a relatively small number of patient samples, the authors called for further studies to examine the value of the test in larger patient samples.
Citation
Pchejetski D et al. Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers 2023
4th October 2021
The research, which was conducted across multiple hospitals in Spain, compared data from the first year of the COVID-19 pandemic with data from the previous year. Of 1385 cases of CRC diagnosed over the two-year period, almost two thirds (868 cases, 62.7%) were diagnosed in the pre-pandemic year from 24,860 colonoscopies. By contrast, only 517 cases (37.3%) were diagnosed during the pandemic, which also saw a 27% drop in the number of colonoscopies performed, to 17,337
Those who were diagnosed with CRC between 15 March 2020 and 28 February 2021 were also older than in the pre-pandemic year, had more frequent symptoms, a greater number of complications and presented at a more advanced disease stage.
Experts say the fall is a consequence of the suspension of screening programmes and the postponement of non-urgent colonoscopy investigations during the pandemic. Fewer cancers were identified by CRC screening in the pandemic period, with just 22 (4.3%) cases found in comparison to 182 (21%) in the pre-pandemic year. During the pandemic, more patients were diagnosed through symptoms (81.2% of diagnoses) compared with the pre-pandemic year (69%).
Dr María José Domper Arnal, from the Service of Digestive Diseases, University Clinic Hospital and the Aragón Health Research Institute (IIS Aragón) in Zaragoza, Spain, and lead author of the study, commented “These are very worrying findings indeed – cases of colorectal cancer undoubtedly went undiagnosed during the pandemic. Not only were there fewer diagnoses, but those diagnosed tended to be at a later stage and suffering from more serious symptoms.”
There was a significant increase in the number of patients being diagnosed with serious complications – a sign of late-stage disease – with an increase in symptoms such as bowel perforation, abscesses, bowel obstruction and bleeding requiring hospital admission. These cases made up 10.6% pre-pandemic and 14.7% during the pandemic. The number of stage IV cancers being diagnosed rose during the pandemic year, with stage IV cases making up 19.9% of cases, in comparison to 15.9% in the previous year.
“Although these figures are across a population of 1.3 million in Spain, it’s highly likely that the same drop in diagnoses would have happened elsewhere across the globe where screening was stopped and surgeries postponed, especially in countries that were heavily impacted by COVID-19”, explained Dr Arnal.
“Colorectal cancer is often curable if it’s caught at an early stage. Our concern is that we’re losing the opportunity to diagnose patients at this early stage, and this will have a knock-on effect on patient outcomes and survival. We are likely to see this fall out for years to come.”
Source
Impact of the COVID-19 pandemic in the diagnosis and characteristics of colorectal cancer patients, presented at UEG Week Virtual 2021
11th June 2021
Acute myocarditis (aMC) has many different causes but the prevalence is unclear because the condition has similar clinical symptoms to an acute myocardial infarction (aMI). Although the diagnosis of myocarditis can be confirmed with cardiac magnetic resonance imaging, this technique is not always available. However, one approach to resolve the diagnosis involves the use of microRNAs (miRNAs), which are small, non-coding RNAs that play an important role in gene expression. Several miRNAs have been identified in the infarcted heart and this led a team from the Vascular Pathophysiology Area, Madrid, to try and identify a unique miRNA which could be used to distinguish between myocarditis and myocardial infarction. The team focused on circulating T cells, in particular T helper 17 (Th17) cells, which were confirmed as being a characteristic of myocardial injury in the acute phase of myocarditis. They performed a miRNA microarray analysis and quantitative polymerase chain reaction (qPCR) assays in Th17 cells after experimentally inducing myocarditis and myocardial infarction in mice to identify unique biomarkers.
Findings
The researchers identified the miRNA, mmu-miR-721, produced by Th17 cells in mice which was only produced in response to either autoimmune or viral myocarditis and which was absent from those with aMI. Using four patient cohorts with myocarditis, they subsequently identified a human homologue to mmu-miR-721, termed has-miR-Chr8:96. The researchers found that plasma levels of has-miR-Chr8:96 were considerably higher among myocarditis patients compared to both those with a myocardial infarction and in healthy controls. The area under the receiver-operating characteristics curve for has-miR-Chr8:96 was 0.927 (i.e., 92.7%) for distinguishing between aMC and aMI and this diagnostic value was retained even after adjusting for age, ejection fraction, and serum troponin levels.
Although the authors accepted that more work is needed to validate this biomarker in other cardiac disorders such as dilated cardiomyopathy, their preliminary findings suggest that raised plasma levels of has-miR-Chr8:96 are unique to those with myocarditis and have sufficient discriminatory power from myocardial infarction.
Citation
Blanco-Dominguez R et al. A Novel Circulating MicroRNA for the Detection of Acute Myocarditis. N Engl J Med 2021;384:2014-27
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