BACKGROUND: Precision public health (PPH) can maximize impact by targeting surveillance and interventions by temporal, spatial, and epidemiological characteristics. Although rapid diagnostic tests (RDTs) have enabled ubiquitous point-of-care testing in low-resource settings, their impact has been less than anticipated, owing in part to lack of features to streamline data capture and analysis.
OBJECTIVE: We aimed to transform the RDT into a tool for PPH by defining information and data axioms and an information utilization index (IUI); identifying design features to maximize the IUI; and producing open guidelines (OGs) for modular RDT features that enable links with digital health tools to create an RDT-OG system.
METHODS: We reviewed published papers and conducted a survey with experts or users of RDTs in the sectors of technology, manufacturing, and deployment to define features and axioms for information utilization. We developed an IUI, ranging from 0% to 100%, and calculated this index for 33 World Health Organization-prequalified RDTs. RDT-OG specifications were developed to maximize the IUI; the feasibility and specifications were assessed through developing malaria and COVID-19 RDTs based on OGs for use in Kenya and Indonesia.
RESULTS: The survey respondents (n=33) included 16 researchers, 7 technologists, 3 manufacturers, 2 doctors or nurses, and 5 other users. They were most concerned about the proper use of RDTs (30/33, 91%), their interpretation (28/33, 85%), and reliability (26/33, 79%), and were confident that smartphone-based RDT readers could address some reliability concerns (28/33, 85%), and that readers were more important for complex or multiplex RDTs (33/33, 100%). The IUI of prequalified RDTs ranged from 13% to 75% (median 33%). In contrast, the IUI for an RDT-OG prototype was 91%. The RDT open guideline system that was developed was shown to be feasible by (1) creating a reference RDT-OG prototype; (2) implementing its features and capabilities on a smartphone RDT reader, cloud information system, and Fast Healthcare Interoperability Resources; and (3) analyzing the potential public health impact of RDT-OG integration with laboratory, surveillance, and vital statistics systems.
CONCLUSIONS: Policy makers and manufacturers can define, adopt, and synergize with RDT-OGs and digital health initiatives. The RDT-OG approach could enable real-time diagnostic and epidemiological monitoring with adaptive interventions to facilitate control or elimination of current and emerging diseases through PPH.

OBJECTIVE: This aimed to develop a blueprint for an effective community pharmacy Hepatitis C virus (HCV) testing service by producing a consensus statement.
METHODS: This was a modified Delphi process.
METHODS: We recruited a heterogenous panel of experts (who had been involved in the setup or delivery of a community pharmacy HCV testing service) by purposive and chain referral methods. We had three rounds of a modified Delphi process. The first was a series of questions with free text responses and was analysed using thematic analysis, and the second and third were statements for the respondents to rate using a 7-point Likert scale. Consensus was predefined in a published protocol, and the results were reviewed by a public and patient involvement panel before the statement was finalised.
RESULTS: We had 24 participants, including community and hospital-based pharmacists, local pharmaceutical committee members, charity representatives (Hepatitis C Trust), local clinical service lead, nurse specialists and doctors. The response rate of the first, second and third rounds were 100%, 96% and 88%, respectively. After the third round, we had 60 statements that reached consensus. We discussed the accepted statements with a patient and public involvement group. We used these statements to produce the I-COPTIC statement and a graphical summary.
CONCLUSIONS: We developed a blueprint for the design of a gold standard community pharmacy HCV testing service. We believe this will support the successful implementation of community pharmacy testing for HCV. Community pharmacy testing is an important service to help achieve and maintain HCV elimination.

Developmental toxicology is a constantly evolving research field which needs to attend to a complex underlying regulatory network. In order to ensure human health and environmental safety, new substances have to be tested for toxic effects on reproduction and development, before being commercialized. Traditional in vivo mammalian models represent the intricacy of human development and provide more adequately an assessment of the interaction of chemical compounds with the reproductive system. However, in the last years, the directives are to reduce the use of vertebrate animals, promoting their use only as a last resort. Consequently, the interest on the development and validation of alternative tests, able to cover the various aspects of the reproductive cycle, has significantly increased. Reproductive toxicity is probably the most difficult endpoint to be replaced by alternative assays, since it should provide information on mechanism interactions essential for female and male fertility and also knowledge on the animal development during the first phases of its life cycle. This complexity explains the slow progress in implementing alternative models for reproductive toxicity safety assays. Alternative test models may be based on in vitro systems and nonmammalian animal models. Many biological processes have been successfully addressed using in vitro models, opening the possibility to study the interference of teratogenic compounds. Their validation and implementation have lagged behind, in part because of difficulties in establishing their predictability. Nevertheless, the advance toward the process of validation is crucial to replace and reduce the use of living animals. Based on the present state of the art, it is not probable that such testing strategies will completely replace the need to assess reproductive toxicity in vivo in the near future, but they will contribute to reduce animal tests and will provide important information. In this chapter, the approved guidelines for standard methods and alternative methods, according to their regulatory and scientific status, are enumerated and briefly described.

Globally, people living with the Human Immunodeficiency Virus (HIV) are over-represented in incarcerated populations. The current study aimed to provide a national (Australian) snapshot of current HIV prison policies against the United Nations\' (UN) 15 key HIV interventions for prisons. Publicly available policies, reports, and data were obtained, and interviews were conducted with prison health staff in five of eight Australian jurisdictions. We rated whether policies were compliant, partially compliant, or not compliant to the UN interventions and assigned an overall grade (A to E, where A = most compliant and E = least compliant) for each jurisdiction. Three jurisdictions received a B grade, three received a C grade, and two were not assessed due to insufficient data. In all jurisdictions HIV policies fell short of full compliance to most UN interventions. Prison-based needle and syringe programs and initiatives beyond education to reduce HIV transmission from body modification procedures (eg, tattooing) were absent in all jurisdictions. No condom programme existed in one jurisdiction and access issues were reported in others. Opioid substitution therapy, and peer-education access varied across and within most jurisdictions. Findings indicate that more action is required to meet the UN recommended interventions for HIV prevention in prisons.

BACKGROUND: Incorporating emerging knowledge into Emergency Medical Service (EMS) competency assessments is critical to reflect current evidence-based out-of-hospital care. However, a standardized approach is needed to incorporate new evidence into EMS competency assessments because of the rapid pace of knowledge generation.
OBJECTIVE: The objective was to develop a framework to evaluate and integrate new source material into EMS competency assessments.
METHODS: The National Registry of Emergency Medical Technicians (National Registry) and the Prehospital Guidelines Consortium (PGC) convened a panel of experts. A Delphi method, consisting of virtual meetings and electronic surveys, was used to develop a Table of Evidence matrix that defines sources of EMS evidence. In Round One, participants listed all potential sources of evidence available to inform EMS education. In Round Two, participants categorized these sources into: (a) levels of evidence quality; and (b) type of source material. In Round Three, the panel revised a proposed Table of Evidence. Finally, in Round Four, participants provided recommendations on how each source should be incorporated into competency assessments depending on type and quality. Descriptive statistics were calculated with qualitative analyses conducted by two independent reviewers and a third arbitrator.
RESULTS: In Round One, 24 sources of evidence were identified. In Round Two, these were classified into high- (n = 4), medium- (n = 15), and low-quality (n = 5) of evidence, followed by categorization by purpose into providing recommendations (n = 10), primary research (n = 7), and educational content (n = 7). In Round Three, the Table of Evidence was revised based on participant feedback. In Round Four, the panel developed a tiered system of evidence integration from immediate incorporation of high-quality sources to more stringent requirements for lower-quality sources.
CONCLUSIONS: The Table of Evidence provides a framework for the rapid and standardized incorporation of new source material into EMS competency assessments. Future goals are to evaluate the application of the Table of Evidence framework in initial and continued competency assessments.

METHODS: Since the onset of COVID-19, several assays have been deployed for the diagnosis of SARS-CoV-2. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) published the first set of guidelines on SARS-CoV-2 in vitro diagnosis in February 2022. Because the COVID-19 landscape is rapidly evolving, the relevant ESCMID guidelines panel releases an update of the previously published recommendations on diagnostic testing for SARS-CoV-2. This update aims to delineate the best diagnostic approach for SARS-CoV-2 in different populations based on current evidence.
METHODS: An ESCMID COVID-19 guidelines task force was established by the ESCMID Executive Committee. A small group was established, half appointed by the chair, and the remaining selected with an open call. The panel met virtually once a week. For all decisions, a simple majority vote was used. A list of clinical questions using the population, intervention, comparison, and outcome (PICO) format was developed at the beginning of the process. For each PICO, 2 panel members performed a literature search focusing on systematic reviews with a third panellist involved in case of inconsistent results. The panel reassessed the PICOs previously defined as priority in the first set of guidelines and decided to address 49 PICO questions, because 6 of them were discarded as outdated/non-clinically relevant. The \'Grading of Recommendations Assessment, Development and Evaluation (GRADE)-adoption, adaptation, and de novo development of recommendations (ADOLOPMENT)\' evidence-to-decision framework was used to produce the guidelines.
UNASSIGNED: After literature search, we updated 16 PICO questions; these PICOs address the use of antigen-based assays among symptomatic and asymptomatic patients with different ages, COVID-19 severity status or risk for severe COVID-19, time since the onset of symptoms/contact with an infectious case, and finally, types of biomaterials used.

In recent years, immunotherapy represented by immune checkpoint inhibitors programmed death 1 (PD-1) has made great progress in the treatment of esophageal cancer and is rewriting the global paradigm for the treatment of esophageal cancer. According to current data, only a small number of patients with esophageal cancer could benefit from immunotherapy. Therefore, it is a challenge to screen the potential beneficiaries of PD-1 inhibitors. Studies have shown that the expression level of programmed death-ligand 1 (PD-L1) in esophageal cancer is closely associated with the efficacy of PD-1 inhibitors, and PD-L1 is the most important predictive biomarker of the efficacy of PD-1 inhibitors. With the clinical application of different PD-1 inhibitors and PD-L1 protein expression detection platforms, clarifying the clinical significance and timing of detection of PD-L1 protein expression in esophageal cancer, and establishing a standardized PD-L1 testing procedure, are of great significance to improve the accuracy of detection and reduce the difference between laboratories, so as to maximize the therapeutic benefits for patients. This consensus was finally reached, based on the combination of literature, expert experience, and internal discussion and voting of committee members, to provide an accurate and reliable evidence for clinicians to make decisions.
近年来，以程序性死亡受体1(PD-1)免疫检查点抑制剂为代表的免疫治疗在食管癌治疗领域取得了巨大进展，并逐步改写着全球食管癌的治疗模式。但仅有部分食管癌患者能从免疫治疗中显著获益，因此如何筛选出PD-1抑制剂的潜在获益人群是目前面临的重要挑战。食管癌程序性死亡受体配体(PD-L1)蛋白表达水平与PD-1抑制剂疗效密切相关，是目前最重要的疗效预测标志物。随着不同PD-1抑制剂和PD-L1蛋白表达检测平台的临床应用，明确食管癌PD-L1蛋白表达检测的临床意义、检测时机、建立规范化和标准化检测流程有助于提高检测结果的准确性和降低室间差异性，使患者获益更大。结合相关文献、专家经验、委员会成员内部讨论和投票最终达成中国食管癌PD-L1蛋白表达检测临床病理专家共识，以期为临床医师决策提供准确可靠的依据。.

UNASSIGNED: The objectives were to elaborate new recommendations for the French Government taking into account the new epidemiological situation due to Omicron variant of SARS-CoV-2 virus and to maintain essential functions of the State through socioeconomic and health life.
UNASSIGNED: Two self-decision matrix were built for isolation (cases) and quarantine (contacts) and for citizen testing, respectively. The recommendations included in the two matrix were validated internally by experts and scientists from the scientist literature.
UNASSIGNED: A strategic breakdown into five phases corresponding to the possible phases of Omicron variants spread was built. Exceptional and transitory derogation for essential activities was proposed in fully vaccinated professionals. Suspension of quarantine period for fully vaccinated contacts and professionals was proposed with routine self-testing program.
UNASSIGNED: These new HCSP guidelines aims to preserve public health as a whole and to minimize the socioeconomic and health consequences linked to the emergence of the Omicron variant by making trade-offs/adaptations in dependent scientist contexts.
UNASSIGNED: HCSP scientists and experts were in charge of drafting the recommendations and promoting them to the Government for their application by regulatory decree voted by law.

This 2022 European Atherosclerosis Society lipoprotein(a) [Lp(a)] consensus statement updates evidence for the role of Lp(a) in atherosclerotic cardiovascular disease (ASCVD) and aortic valve stenosis, provides clinical guidance for testing and treating elevated Lp(a) levels, and considers its inclusion in global risk estimation. Epidemiologic and genetic studies involving hundreds of thousands of individuals strongly support a causal and continuous association between Lp(a) concentration and cardiovascular outcomes in different ethnicities; elevated Lp(a) is a risk factor even at very low levels of low-density lipoprotein cholesterol. High Lp(a) is associated with both microcalcification and macrocalcification of the aortic valve. Current findings do not support Lp(a) as a risk factor for venous thrombotic events and impaired fibrinolysis. Very low Lp(a) levels may associate with increased risk of diabetes mellitus meriting further study. Lp(a) has pro-inflammatory and pro-atherosclerotic properties, which may partly relate to the oxidized phospholipids carried by Lp(a). This panel recommends testing Lp(a) concentration at least once in adults; cascade testing has potential value in familial hypercholesterolaemia, or with family or personal history of (very) high Lp(a) or premature ASCVD. Without specific Lp(a)-lowering therapies, early intensive risk factor management is recommended, targeted according to global cardiovascular risk and Lp(a) level. Lipoprotein apheresis is an option for very high Lp(a) with progressive cardiovascular disease despite optimal management of risk factors. In conclusion, this statement reinforces evidence for Lp(a) as a causal risk factor for cardiovascular outcomes. Trials of specific Lp(a)-lowering treatments are critical to confirm clinical benefit for cardiovascular disease and aortic valve stenosis.

Haemochromatosis is characterised by elevated transferrin saturation (TSAT) and progressive iron loading that mainly affects the liver. Early diagnosis and treatment by phlebotomy can prevent cirrhosis, hepatocellular carcinoma, diabetes, arthropathy and other complications. In patients homozygous for p.Cys282Tyr in HFE, provisional iron overload based on serum iron parameters (TSAT >45% and ferritin >200 μg/L in females and TSAT >50% and ferritin >300 μg/L in males and postmenopausal women) is sufficient to diagnose haemochromatosis. In patients with high TSAT and elevated ferritin but other HFE genotypes, diagnosis requires the presence of hepatic iron overload on MRI or liver biopsy. The stage of liver fibrosis and other end-organ damage should be carefully assessed at diagnosis because they determine disease management. Patients with advanced fibrosis should be included in a screening programme for hepatocellular carcinoma. Treatment targets for phlebotomy are ferritin <50 μg/L during the induction phase and <100 μg/L during the maintenance phase.