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July 2022: Access Relevant Diagnostics Scientific Publications

In July 2022, we have identified the following access relevant scientific publications that caught our attention from the (digital) diagnostics perspective. Check them out:

Clinical value:

1.       Prostate health index (PHI) as a reliable biomarker for prostate cancer: a systematic review and meta-analysis

Researchers of the study performed a systematic review and meta-analysis for assessing the diagnostic performance of PHI for PCa and for detecting clinically significant PCa (csPCa). They conclude that PHI has a high accuracy for detecting PCa and discriminating between aggressive and non-aggressive PCa. Thus, it could be useful as a biomarker in predicting patients harbouring more aggressive cancer and guiding biopsy decisions.

2.       Systematic evidence-based review: The application of noninvasive prenatal screening using cell-free DNA in general-risk pregnancies

This systematic evidence review evaluates Noninvasive prenatal screening (NIPS) performance in a general-risk population. Use of NIPS reduced diagnostic tests by 31% to 79%. Conclusions regarding psychosocial outcomes could not be drawn owing to lack of data.

3.       The impact of digital interventions on antimicrobial stewardship in hospitals: a qualitative synthesis of systematic reviews

The study provides a systematic overview and synthesis of evidence on the effectiveness of digital interventions to improve antimicrobial prescribing and monitoring in hospitals. It supports that digital interventions reduce antimicrobial use and improve antimicrobial appropriateness in hospitals, but no firm conclusions can be drawn about the degree to which different types of digital interventions achieve these outcomes.

4.       The Interdisciplinary Diagnosis of Rare Diseases-Results of the Translate-NAMSE Project

Patients with rare diseases often undergo a diagnostic odyssey that can last many years until the diagnosis is definitively established. To improve the diagnosis and treatment of these patients, the German National Task Force for Patients With Rare Diseases (NAMSE) has recommended the creation of Rare Disease Centers (RDCs). A diagnostic evaluation with the aid of interdisciplinary case conferences and the opportunity for exome analysis can be of benefit to people with rare diseases who have not received a definitive diagnosis in a standard care setting. Further improvement of the diagnosis rate can come from whole-genome analysis and from the introduction of an international registry.

5.       Johns Hopkins sepsis alert tool reduced patient deaths, studies find

Three studies published in Nature by researchers at Johns Hopkins University and machine learning startup Bayesian Health found that a sepsis early detection tool reduced relative deaths from sepsis by 18.2%. Sepsis is a life-threatening response to an infection that is estimated to cause about a third of hospital deaths, according to the Centers for Disease Control and Prevention.

6.       Clinical decision support systems to guide healthcare providers on HIV testing

The study aimed to understand the impact of clinical decision support systems (CDSSs) on improving HIV testing and diagnosis. CDSSs improve HIV testing and may, potentially, improve diagnosis. The data support the broader study of CDSSs in low- and high prevalent HIV settings to determine their precise impact on UNAIDS goals to reach universal HIV testing and treatment coverage.

7.       Applications of Liquid Biopsies in Non-Small-Cell Lung Cancer

This review addresses various aspects of the use of liquid biopsy with an emphasis on ctDNA as a biomarker in NSCLC patients.

8.       Applications of Circulating Tumor Cells and Circulating Tumor DNA in Precision Oncology for Breast Cancers

This review focuses on our current understanding of circulating tumor biomarkers, especially in breast cancer, and the scope of novel sequencing technologies and diagnostic methods for better prognostication and patient stratification to improve patient outcomes.

9.       Challenges Related to the Use of Next-Generation Sequencing for the Optimization of Drug Therapy

The study illustrates current challenges and discuss future directions toward the clinical implementation of NGS to inform genotype-guided decision-making.

  

Cost-effectiveness, HTA, pricing:

10.   Assessing, Pricing and Funding Point-of-Care Diagnostic Tests for Community-Acquired Acute Respiratory Tract Infections-Overview of Policies Applied in 17 European Countries

The study investigated these policies for this group of devices applied in the outpatient setting in Europe. Given low levels of regulation and few incentives, the study findings suggest room for strengthening pricing and funding policies of community-acquired acute respiratory tract infections (CA-ARTI) diagnostics to contribute to increased acceptance and use of these point-of-care tests.

11.   Cost-Effectiveness of a Core Antigen-Based Rapid Diagnostic Test for Hepatitis C

The study evaluated the performance and cost-effectiveness of a theoretical core antigen (cAg) RDT for HCV viremia confirmation, which requires fewer resources. It found that a cAg-based RDT for HCV could improve the diagnosis rate and result in cost savings. Such a test could have a substantial impact on the feasibility and cost of HCV elimination.

12.   Costs of Next-Generation Sequencing Assays in Non-Small Cell Lung Cancer: A Micro-Costing Study

The study aimed to determine the costs of NGS assays for NSCLC diagnostics. Its results could help inform decisions to select a robust platform for NSCLC diagnostics from fine needle aspirates, and future economic evaluations of the NGS platforms to guide treatment selections for NSCLC patients

 

Healthcare systems, utilization, coverage:

 13.   Biomarkers for Systemic Therapy in Metastatic Breast Cancer: ASCO Guideline Update

The study proposes an update of the ASCO biomarkers to guide systemic therapy for metastatic breast cancer (MBC) guideline. 19 studies were identified that inform the evidence base. A number of recommendations is provided.

14.   There's an app for that, but nobody's using it: Insights on improving patient access and adherence to digital therapeutics in Germany

This study seeks to explore healthcare stakeholders' roles and potential for fostering patient access and adherence to evidence-based digital therapeutics and thereby improve health outcomes from the perspective of digital therapeutics developers and distributors. Healthcare professionals were found to have the greatest potential to promote both access and patient adherence to digital therapeutics, followed by health insurers, pharmaceutical companies, and patients themselves.

15.   Lack of consensus among healthcare professionals at a large academic medical center on the use of exome sequencing for prenatal diagnosis

The aim of this study was to evaluate the medical community's attitude toward the clinical utility and use of exome sequencing for prenatal diagnosis and to address differences in attitudes and responses by type of practitioner, level of training, and years passed since last full-time training. Attitude toward the use of prenatal ES statistically differed (p < 0.05) by type of participant and level of training. This study shows a lack of consensus among the medical community regarding the clinical utility and indications for prenatal ES.