medical

Novel blood-sensing capsule ‘highly accurate’ in detecting upper GI bleeding

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Key takeaways:

  • The swallowed capsule detected the presence of blood with a sensitivity and specificity of 92.9% and 90.6%, respectively.
  • Positive and negative predictive values were 74.3% and 97.9%.

The PillSense System, a novel blood-sensing swallowed capsule device, safely detected blood in patients with clinically suspected upper gastrointestinal bleeding with a sensitivity of 92.9% and a specificity of 90.6%, data showed.

“[Esophagogastroduodenoscopy] is now considered the gold standard for diagnosing and treating [upper GI bleeding (UGIB)], although timely diagnosis and intervention can be challenging from a time, personnel and access perspective,” Karl Akiki, MD, a research fellow in the division of gastroenterology and hepatology at Mayo Clinic College of Medicine and Science, and colleagues wrote in Gastrointestinal Endoscopy. “Hence, an accurate, rapid, easy-to-interpret and noninvasive tool could assist in both diagnosing and offering guidance for clinical decision-making in scenarios of a suspected UGIB.”

The PillSense System, a novel blood-sensing swallowed capsule device, safely detected blood in patients with clinically suspected upper gastrointestinal bleeding.
Data derived from: Akiki K, et al. Gastrointest Endosc. 2023;doi:10.1016/j.gie.2023.11.051.

In an open-label, single-arm, comparative clinical trial, Akiki and colleagues evaluated the safety and efficacy of the PillSense System (EnteraSense Ltd.), an ingestible capsule that detects blood in the upper GI tract via an optical sensor and transmits data to an external receiver.

They enrolled 126 adults (mean age, 62.4 years; 59.5% men) with suspected UGIB at Mayo Clinic in Rochester between December 2021 and August 2022. Participants underwent esophagogastroduodenoscopy (EGD) within 4 hours of capsule administration and were monitored up to 21 days to confirm capsule passage.

According to results, 110 patients (87.3%) had confirmed capsule passage, with a mean transit time of 3.6 days. The capsule correctly detected the presence of blood in 26 out of 28 cases and the absence of blood in 87 out of 96 cases compared with EGD. The mean PillSense recording time was 6.71 minutes.

Further analysis demonstrated a sensitivity and specificity of 92.9% (95% CI, 76.5-99.1) and 90.6% (95% CI, 82.9-95.6), respectively, as well as positive and negative predictive values of 74.3% and 97.8%. The positive and negative likelihood ratios were 9.9 and 0.08.

Researchers reported no adverse events related to the PillSense System or capsule ingestion.

“Our study demonstrates that a novel blood-sensing swallowed capsule device provides highly accurate and rapid detection of UGIB,” Akiki and colleagues concluded. “The device was simple to deploy, results were easy to interpret and the capsule passed safely through the GI tract in all patients that completed the study.”

They continued: “The PillSense System may assist in efficiently diagnosing UGIB with the goal of improving patient outcomes and may ultimately alter the diagnostic and treatment approach for patients with a suspected UGIB.”

Parkinson’s Disease: How Accurate Is Primary Care Diagnosis?

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TOPLINE:

General practitioners (GPs) may benefit from interventions to improve recognition of Parkinson’s disease (PD) symptoms and refer patients to specialty care in a timely manner, but research in this area is sparse.

METHODOLOGY:

  • Investigators conducted a scoping review of studies assessing the diagnostic accuracy of PD in primary care, with the specialist diagnosis as the gold standard.
  • The review identified six eligible studies conducted in the United Kingdom, Singapore, Australia, United States, and Mexico among 716 patients with PD and 250 GPs.

TAKEAWAY:

  • Three studies assessed GPs’ knowledge in diagnosing PD and found gaps in early recognition of the condition and appropriate management.
  • A study on diagnostic delays found that the first clinician patient consulted for symptoms was most commonly a GP (40%); the average time to diagnosis was almost 2 years, and in 32.1% of patients, misdiagnosis was the reason for the delay.
  • A study conducted in North Wales found that only about half of general practice patients receiving anti-Parkinson medication (53%) had a correct diagnosis of probable PD.
  • Finally, a study conducted in London and Kent found that compared with specialists, GPs had a lower sensitivity (73.5% vs 93.5%) but a higher specificity (79.1% vs 64.5%) in diagnosing PD; however, the study had methodological issues leading to bias.

IN PRACTICE:

“There is [a] dearth of well-designed studies that assess the diagnostic accuracy of GPs when managing individuals with PD. This scientific gap has become more obvious after the introduction of NICE guidance, especially in the UK health care system,” the authors wrote. Knowledge-based interventions “can potentially lead to earlier identification of PD by GPs resulting in faster initiation of treatments and offering other appropriate support to patients, overall culminating in improved quality of care for individuals.”

SOURCE:

The study was led by Adnan Z. Khan, MBBS, MA, MRCP, MSc, University of Exeter, Exeter, UK, and was published online on December 22 in the British Journal of General Practice.

LIMITATIONS:

Limitations include differences across healthcare systems in the boundary between primary and secondary care, possible exclusion of some studies based on alternate PD referral processes, and variation in the categorisation of clinicians by specialty.