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Concept: Standards


Many residents in Beijing use disposable face masks in an attempt to protect their health from high particulate matter (PM) concentrations. Retail masks may be certified to local or international standards, but their real-life performance may not confer the exposure reduction potential that is marketed. This study aimed to evaluate the effectiveness of a range of face masks that are commercially available in China.

Concepts: Electrochemistry, People's Republic of China, Pollution, Particulate, Smog, Standards, Air pollution, Dust


OBJECTIVE: To determine whether the knowledge contained in a rich corpus of local terms mapped to LOINC (Logical Observation Identifiers Names and Codes) could be leveraged to help map local terms from other institutions. METHODS: We developed two models to test our hypothesis. The first based on supervised machine learning was created using Apache’s OpenNLP Maxent and the second based on information retrieval was created using Apache’s Lucene. The models were validated by a random subsampling method that was repeated 20 times and that used 80/20 splits for training and testing, respectively. We also evaluated the performance of these models on all laboratory terms from three test institutions. RESULTS: For the 20 iterations used for validation of our 80/20 splits Maxent and Lucene ranked the correct LOINC code first for between 70.5% and 71.4% and between 63.7% and 65.0% of local terms, respectively. For all laboratory terms from the three test institutions Maxent ranked the correct LOINC code first for between 73.5% and 84.6% (mean 78.9%) of local terms, whereas Lucene’s performance was between 66.5% and 76.6% (mean 71.9%). Using a cut-off score of 0.46 Maxent always ranked the correct LOINC code first for over 57% of local terms. CONCLUSIONS: This study showed that a rich corpus of local terms mapped to LOINC contains collective knowledge that can help map terms from other institutions. Using freely available software tools, we developed a data-driven automated approach that operates on term descriptions from existing mappings in the corpus. Accurate and efficient automated mapping methods can help to accelerate adoption of vocabulary standards and promote widespread health information exchange.

Concepts: Scientific method, Validation, Map, Standard, Standards, Information retrieval, Supervised learning, LOINC


The clinical hemostasis laboratory is a complex testing arena which employs numerous coagulation assays and spans several different test methodologies. Adding further complexity, these test results are expressed in a wide variety of unique units (concentration, activity, time, percentage, and ratio). Unfortunately, many of these reference values are derived from a local plasma pool or manufacturer’s standards, as there are few established international standards. These three main issues complicate the validation and performance of the coagulation testing. Before an assay can be introduced into clinical use, both analytical and clinical performance parameters must be validated or verified using the standard validation procedures of the laboratory. This article summarizes the initial evaluation and validation processes of the coagulation laboratory, which sometimes can be difficult concepts to implement. A standardized validation protocol is described in this article and, if used, will help to objectively evaluate the assay performance and determine if it meets acceptable laboratory criteria.

Concepts: Coagulation, Validation, Complexity, Test method, Standardization, Standard, Standards, Verification


The importance of hemoglobin A2 (HbA2) as an indicator of the presence of β-thalassemia was established many years ago. However, clinical application of recommended HbA2 cut off values is often hampered due to poor equivalence of HbA2 results among methods and laboratories. Thus, the IFCC Standardization program for HbA2 was initiated in 2004 with the goal of achieving a complete reference system for this measurand. HbA2 standardization efforts are still in progress, including the development of a higher-order HbA2 reference measurement procedure and the preparation of a certified reference material in collaboration with the IRMM. Here, we review the past, present and future of HbA2 standardization and describe the current status of HbA2 testing.

Concepts: Present, Time, Future, Work in progress, The Current, Past, Certified reference materials, Standards


To truly achieve personalized medicine in oncology, it is critical to catalog and curate cancer sequence variants for their clinical relevance. The Somatic Working Group (WG) of the Clinical Genome Resource (ClinGen), in cooperation with ClinVar and multiple cancer variant curation stakeholders, has developed a consensus set of minimal variant level data (MVLD). MVLD is a framework of standardized data elements to curate cancer variants for clinical utility. With implementation of MVLD standards, and in a working partnership with ClinVar, we aim to streamline the somatic variant curation efforts in the community and reduce redundancy and time burden for the interpretation of cancer variants in clinical practice.

Concepts: Medicine, Clinical trial, Cancer, Oncology, Developed country, Standardization, Standards, Variant type


In resource-rich countries, bolus fluid expansion is routinely used for the treatment of poor perfusion and shock, but is less commonly used in many African settings. Controversial results from the recently completed FEAST (Fluid Expansion As Supportive Therapy) trial in African children have raised questions about the use of intravenous bolus fluid for the treatment of shock. Prior to the start of the trial, the Independent data monitoring committee (IDMC) developed stopping rules for the proof of benefit that bolus fluid resuscitation would bring. Although careful safety monitoring was put in place, there was less expectation that bolus fluid expansion would be harmful and differential stopping rules for harm were not formulated.In July 2010, two protocol amendments were agreed to increase the sample size from 2,880 to 3,600 children, and to increase bolus fluid administration. There was a non-significant trend against bolus treatment, but although the implications were discussed, the IDMC did not comment on the results, or on the amendments, in order to avoid inadvertent partial unblinding of the study.In January 2011, the trial was stopped for futility, as the combined intervention arms had significantly higher mortality (relative risk 1.46, 95% CI 1.13 to 1.90, P = 0.004) than the control arm. The stopping rule for proof of benefit was not achieved, and the IDMC stopped the trial with a lower level of significance (P = 0.01) due to futility and an increased risk of mortality from bolus fluid expansion in children enrolled in the trial. The basis for this decision was that the local standard of care was not to use bolus fluid for the care of children with shock in these African countries, and this was a different standard of care to that used in the UK. These decisions emphasize two important principles: firstly, the IDMC should avoid inadvertent unblinding of the trial by commenting on amendments, and secondly, when considering stopping a trial, the IDMC should be guided by the local standard of care rather than standards of care in other parts of the world.

Concepts: Intravenous therapy, United States Constitution, Standards, Jury, Duty of care, Reasonable person


Despite standardization in disease assessments and curative interventions for childhood cancer, palliative assessments and psychosocial interventions remain diverse and disparate.

Concepts: Cancer, Oncology, Chemotherapy, Palliative care, Standardization, Standards, Nursing specialties


When her mother is hurt, a health care executive finds that the standardized care she championed isn’t always appropriate.

Concepts: Health care, Medical ethics, Standards, Mika Nakashima


With ever-increasing amounts of metabolomics data produced each year, there is an even greater need to disseminate data and knowledge produced in a standard and reproducible way. To assist with this a general purpose, open source metabolomics repository, MetaboLights, was launched in 2012. To promote a community standard, initially culminated as metabolomics standards initiative (MSI), COordination of Standards in MetabOlomicS (COSMOS) was introduced. COSMOS aims to link life science e-infrastructures within the worldwide metabolomics community as well as develop and maintain open source exchange formats for raw and processed data, ensuring better flow of metabolomics information.

Concepts: Scientific method, Life, Standardization, Standard, Standards, Open source


In 2008 the Australian Government introduced a national reform agenda to increase organ and tissue donation. Australia continues to perform poorly by international standards on measures of organ procurement, however. This paper outlines three proposals to improve donation rates and considers the empirical evidence available for each. A number of ethical objections frequently given to resist such proposals are also addressed. Firstly, it is recommended that Australia implement an ‘opt-out’ system of organ donation. Secondly, the existing veto rules should be changed to better protect the wishes of those who wish to donate. Finally, a numer of incentives should be offered to increase donation rates; these could include incentives of financial value, but also non-financial incentives such as prioritisation for the receipt of organs for previous donors.

Concepts: Economics, Skin, Organ transplant, Australia, Standards, Finance, Donation, Government of Australia