Exciting, selected scientific publications from the world of (digital) diagnostics from market access, health care systems, policy, and clinical value perspectives.
Healthcare systems, utilization, coverage, reimbursement
1. Antibiotic Decision-Making in the ICU
This review summarizes the evidence to help guide antibiotic decision-making in the ICU. Authors focus on 1) deciding if to start antibiotics, 2) choosing the spectrum of the empiric agents to use, and 3) de-escalating the chosen empiric antibiotics. The authors provide a perspective on the role of machine learning and artificial intelligence models for clinical decision support systems that can be incorporated seamlessly into clinical practice to improve the antibiotic selection process and, more importantly, current, and future patients' outcomes.
Changes in healthcare use before cancer diagnosis could signal opportunities for quicker detection, but systematic appreciation of such evidence is lacking. The authors reviewed studies examining pre-diagnostic changes in healthcare utilization (e.g., rates of GP or hospital consultations, prescriptions, or diagnostic tests) among patients subsequently diagnosed with cancer. Across twenty-eight studies, changes in healthcare use were observable at least six months pre-diagnosis for many common cancers, and potentially even earlier for colorectal cancer, multiple myeloma, and brain tumors. Early changes were also identified for brain and colon cancer sub-sites.
3. The dawn of digital public health in Europe: Implications for public health policy and practice
Representatives of the European Public Health Association's (EUPHA) Digital Health Section, reflect on the current state of DPH, share their understanding at the European level, and determine how the application of DPH has developed during the COVID-19 pandemic. Authors also discuss the opportunities, challenges, and implications of the increasing digitalization of public health in Europe.
The landscape of payment for genetic testing has been changing, with an increase in the number of laboratories offering testing, larger panel offerings, and lower prices. To determine the influence of payer coverage and out-of-pocket costs on the ordering of NGS panel tests for hereditary cancer in diverse settings, the authors conducted semi-structured interviews with providers who conduct genetic counseling and order next-generation sequencing (NGS) panels purposefully recruited from 11 safety-net clinics and academic medical centers (AMCs) in California and North Carolina, states with diverse populations and divergent Medicaid expansion policies.
Clinical value
1. Advances in point-of-care platforms for traumatic brain injury: recent developments in diagnostics
This review includes a deep dive into the latest advances in chemical, mechanical, electrical, and optical sensing systems that hold promise for TBI-POC diagnostic testing platforms. It also focuses on the performance of these proposed biosensors compared to biofluid-based orthodox diagnostic techniques in terms of sensitivity, specificity, and limits of detection. Finally, it examines commercialized TBI-POCs present in the market, the challenges associated with them, and the future directions and prospects of these technologies and the field.
2. Managing sepsis in the era of precision medicine: challenges and opportunities
This review highlights recent advances in the diagnosis and treatment of sepsis of bacterial origin using precision medicine approaches including rapid diagnostic tests, predictive biomarkers, genomic methods, rapid antimicrobial susceptibility testing, and monitoring cell mediated immunity. Challenges and directions for future research are also discussed.
Multicancer screening is a promising approach to improving the detection of preclinical disease, but current technologies have limited ability to identify precursor or early-stage lesions, and approaches for developing the evidentiary chain are unclear. Frameworks to enable development and evaluation from discovery through evidence of clinical effectiveness are discussed.
This expert review offers an analysis of these systems science frontiers with a view to future applications at the intersection of digital health and personalized medicine, or put in other words, signaling the rise of "digital personalized medicine."
Cost-effectiveness, HTA, real-world data
This review compares digital health technologies and artificial intelligence with traditional health care technologies, review existing health technology assessment frameworks, and discuss challenges and opportunities related to cardiovascular digital health technologies and artificial intelligence health technology assessment, Digital health, Digital public health, public health, Digital transformations
This paper provides an in-depth discussion of distinct features of DHIs and how they might impact the design, measurement, analysis and reporting of cost-effectiveness analysis conducted alongside both randomized and non-randomized studies. These include aspects related to choose of comparator, costs and benefits assessment, study perspective and type of economic analysis.
3. Defining a Core Data Set for the Economic Evaluation of Precision Oncology
Literature review of economic evaluations of next-generation sequencing technologies, a common application of precision oncology, published between 2005 and 2018. The authors developed a preliminary core data set for informal expert feedback.
This paper assesses the diagnostic and economic value of next-generation sequencing (NGS) versus single-gene testing, and of liquid biopsy (LBx) versus tissue biopsy (TBx) in non-small-cell lung cancer biomarker testing through literature review.
This review examines current regulatory practices in relation to IVD product development and discusses the use of CDSS in assisting clinicians to retrieve, filter, and analyze patient data in support of complex decisions regarding diagnosis and treatment. The review then explores how utilizing RWD could augment regulatory body understanding of test performance, clinical outcomes, and benefit-risk profiles, and how RWD could be leveraged to augment CDSS and improve safety, quality, and efficiency of health care practices.