Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group.

Objectives: Uncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface.

Diversity in Health Informatics: Mentoring and Leadership.

Diversity, inclusion and interdisciplinary collaboration are drivers for healthcare innovation and adoption of new, technology-mediated services. The importance of diversity has been highlighted by the United Nations' in SDG5 "Achieve gender equality and empower all women and girls", to drive adoption of social and digital innovation. Women play an instrumental role in health care and are in position to bring about significant changes to support ongoing digitalization and transformation.

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study.

Purpose: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.

Novel protein interactions with endoglin and activin receptor-like kinase 1: potential role in vascular networks.

Endoglin and activin receptor-like kinase 1 are specialized transforming growth factor-beta (TGF-β) superfamily receptors, primarily expressed in endothelial cells. Mutations in the corresponding ENG or ACVRL1 genes lead to hereditary hemorrhagic telangiectasia (HHT1 and HHT2 respectively). To discover proteins interacting with endoglin, ACVRL1 and TGF-β receptor type 2 and involved in TGF-β signaling, we applied LUMIER, a high-throughput mammalian interactome mapping technology.

Early versus delayed implantation of a loop recorder in patients with unexplained syncope--effects on care pathway and diagnostic yield.

Background: This study looked to assess the care pathway and diagnostic yield in patients who received an implantable loop recorder (ILR) after an "initial phase of the diagnostic work-up" (initial work-up) or after a "full evaluation" of unexplained syncope.

Methods And Results: Physicians classified the timing of an ILR implant in 514 patients as either following an "initial work-up" (n=128; 25%) or "full evaluation" (n=386; 75%). Patients with an "initial work-up" underwent a median (IQ range) of 8 (6-14) tests prior to ILR implant compared to 14 (10-21) tests after "full evaluation" (p<0.

Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry.

Aims: To collect information on the use of the Reveal implantable loop recorder (ILR) in the patient care pathway and to investigate its effectiveness in the diagnosis of unexplained recurrent syncope in everyday clinical practice.

Methods And Results: Prospective, multicentre, observational study conducted in 2006-2009 in 10 European countries and Israel. Eligible patients had recurrent unexplained syncope or pre-syncope.

Multivalent recombinant proteins for probing functions of leucocyte surface proteins such as the CD200 receptor.

CD200 (OX2) is a membrane glycoprotein that interacts with a structurally related receptor (CD200R) involved in the regulation of macrophage function. The interaction is of low affinity (K(D) approximately 1 microm) but can be detected using CD200 displayed in a multivalent form on beads or with dimeric fusion proteins consisting of the extracellular region of CD200 and immunoglobulin Fc regions. We prepared putative pentamers and trimers of mouse CD200 with sequences from cartilage oligomeric matrix protein (COMP) and surfactant protein D (SP-D), respectively.

Analysis of leukocyte membrane protein interactions using protein microarrays.

Background: Protein microarrays represent an emerging class of proteomic tools to investigate multiple protein-protein interactions in parallel. A sufficient proportion of immobilized proteins must maintain an active conformation and an orientation that allows for the sensitive and specific detection of antibody and ligand binding. In order to establish protein array technology for the characterization of the weak interactions between leukocyte membrane proteins, we selected the human leukocyte membrane protein CD200 (OX2) and its cell surface receptor (hCD200R) as a model system.