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Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology
No full textAnalytical verification and validation of immunohistochemical tests and their equipment are common practice for today’s anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent authority regarding licensing of medical laboratories) performed in 2016, demonstrated a significant inter laboratory variation in validation procedures of immunohistochemical tests among Belgian laboratories. These results suggests the unavailability of practical information upon the approach to verification and validation of these tests. The existing Belgian Practice Guideline for implementation of a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and additionally to prepare the laboratories for the EU — IVD revised regulations (IVDR).
This paper describes Belgian recommendations for verification and validation of immunohistochemical tests prior to implementation, for ongoing validation and for revalidation. For each type of test (according to the IVDR classification and the origin) and its intended use (purpose), it addresses how to perform analytical verification/validation by recommending: (i) the number of cases in the validation set, (ii) the performance characteristics to be evaluated, (iii) the objective acceptance criteria, (iv) the evaluation method for the obtained results and (v) how and when to revalidate. A literature study and a risk analysis taking into account the majority of variables regarding verification/validation of methods have been performed, resulting in an expert consensus recommendation that is a compromise between achievability, affordability and patient safety. This new consensus recommendation has been incorporated in the aforementioned ISO15189:2012 based Practice Guideline.</p
A multidisciplinary Delphi consensus to define evidence-based quality indicators for diabetic foot ulcer care.
No full textBackground: Valid measures to assess quality of care delivered to patients with diabetes suffering from diabetic foot ulcer (DFU) are scarce. This study aimed to achieve consensus on relevant and feasible quality indicators (QIs) among stakeholders involved in DFU care, and was conducted as the second part of a Belgian quality indicator selection study that sought to identify QIs for DFU care.
Methods: A stakeholder panel, including caregivers from primary care and specialized disciplines active in diabetic foot care as well as a patient organization representative, was recruited. By using the RAND/UCLA Appropriateness Method, stakeholders were asked to rate a list of 42 candidate evidence-based indicators for appropriateness through a 9-point Likert scale. QIs were classified based on the median ratings and the disagreement index, calculated by the inter-percentile range adjusted for symmetry.
Results: At the end of a 3-phase process, 17 QIs were judged as appropriate. Among them, five were not previously described, covering the following topics: integration of wound care specialty in the multidisciplinary team, systematic evaluation of the nutritional status of the patient, administration of Low Density Lipoprotein (LDL)-cholesterol lowering medication and protocolized care (implementation of care and prevention management protocols).
Conclusions: The identified evidence-based QIs provide an assessment tool to evaluate and monitor quality of care delivered to DFU patients. Future research should focus on their complementarity with the existing QIs and their implementation in clinical practice.</p
PARERE: a network for discussing the regulatory need and relevance of new testing methods and approaches
No full textFood for thought: Reinforced learning and recall of physical activity calorie equivalent (PACE) and numerical calorie content in an associative learning task
No full textTowards facilitated interpretation of shotgun metagenomics long-read sequencing data analyzed with KMA for the detection of bacterial pathogens and their antimicrobial resistance genes
No full textEthical approval for controlled human infectious model clinical trial protocols - A workshop report.
No full textControlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop “Ethical Approval for CHIM Clinical Trial Protocols”, which took place on May 30-31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteria for CHIM and the role(s) of CHIM in pharmaceutical development. The discussions led to several recommendations, including continued assurance that routine ethical requirements are met, assurance that participants are well-informed, and that preparation of study documents must be both ethically and scientifically sound from an early stage. Study applications must clearly state the rationale for the challenge compared to alternative study designs. ECs need to have clear guidance and procedures for evaluating social value and assessing third-party risks. Among other things, public trust in research requires minimisation of harm to healthy volunteers and third-party risk. Other important considerations include appropriate stakeholder engagement, public education, and access to health care for participants after the study.</p
