Progress towards an OECD reporting framework for transcriptomics and metabolomics in regulatory toxicology.

Omics methodologies are widely used in toxicological research to understand modes and mechanisms of toxicity. Increasingly, these methodologies are being applied to questions of regulatory interest such as molecular point-of-departure derivation and chemical grouping/read-across. Despite its value, widespread regulatory acceptance of omics data has not yet occurred. Barriers to the routine application of omics data in regulatory decision making have been: 1) lack of transparency for data processing methods used to convert raw data into an interpretable list of observations; and 2) lack of standardization in reporting to ensure that omics data, associated metadata and the methodologies used to generate results are available for review by stakeholders, including regulators. Thus, in 2017, the Organisation for Economic Co-operation and Development (OECD) Extended Advisory Group on Molecular Screening and Toxicogenomics (EAGMST) launched a project to develop guidance for the reporting of omics data aimed at fostering further regulatory use. Here, we report on the ongoing development of the first formal reporting framework describing the processing and analysis of both transcriptomic and metabolomic data for regulatory toxicology. We introduce the modular structure, content, harmonization and strategy for trialling this reporting framework prior to its publication by the OECD.

Characteristics of patients who had a stroke not initially identified during emergency prehospital assessment: a systematic review.

BACKGROUND: Around 25% of patients who had a stroke do not present with typical 'face, arm, speech' symptoms at onset, and are challenging for emergency medical services (EMS) to identify. The aim of this systematic review was to identify the characteristics of acute stroke presentations associated with inaccurate EMS identification (false negatives). METHOD: We performed a systematic search of MEDLINE, EMBASE, CINAHL and PubMed from 1995 to August 2020 using key terms: stroke, EMS, paramedics, identification and assessment. Studies included: patients who had a stroke or patient records; ≥18 years; any stroke type; prehospital assessment undertaken by health professionals including paramedics or technicians; data reported on prehospital diagnostic accuracy and/or presenting symptoms. Data were extracted and study quality assessed by two researchers using the Quality Assessment of Diagnostic Accuracy Studies V.2 tool. RESULTS: Of 845 studies initially identified, 21 observational studies met the inclusion criteria. Of the 6934 stroke and Transient Ischaemic Attack patients included, there were 1774 (26%) false negative patients (range from 4 (2%) to 247 (52%)). Commonly documented symptoms in false negative cases were speech problems (n=107; 13%-28%), nausea/vomiting (n=94; 8%-38%), dizziness (n=86; 23%-27%), changes in mental status (n=51; 8%-25%) and visual disturbance/impairment (n=43; 13%-28%). CONCLUSION: Speech problems and posterior circulation symptoms were the most commonly documented symptoms among stroke presentations that were not correctly identified by EMS (false negatives). However, the addition of further symptoms to stroke screening tools requires valuation of subsequent sensitivity and specificity, training needs and possible overuse of high priority resources.

Healthcare practitioners' views and experiences of barriers and facilitators to weight management interventions for adults with intellectual disabilities.

BACKGROUND: Obesity is common in adults with intellectual disabilities, yet little is known about how weight management interventions are provided for this population. METHODS: Semi-structured interviews were held with 14 healthcare practitioners involved in weight management interventions in an English county. A study topic guide was developed to elicit practitioners' views and experiences of barriers and facilitators to weight management for adults with intellectual disabilities. Responses were analysed using thematic analysis. RESULTS: Several barriers are involved in weight management for people with intellectual disabilities including communication challenges, general practitioners' lack of knowledge and awareness of weight management services, inconsistencies in caring support, resource constraints, wider external circumstances surrounding the individuals and motivational issues. Facilitators include reasonable adjustments to existing weight management services. However, there is a need for specialist weight management provision for people with intellectual disabilities. CONCLUSIONS: This study provides suggestions for future research, policy and practice consideration.

Stroke knowledge and awareness: an integrative review of the evidence.

BACKGROUND: the recognition of stroke symptoms by the public and activation of the emergency medical services (EMS) are the most important factors in instigating pre-hospital stroke care. Studies have suggested that poor recognition of the warning signs of stroke is the main cause of delay in accessing the EMS. METHODS: an integrative review of published studies about stroke knowledge and awareness was performed by searching online bibliographic databases, using keywords, from 1966 to 2008. Studies were included in the review if they focussed on risk factors, signs and symptoms, action and information. Each study was reviewed by two researchers (SJ and MJ). RESULTS: we identified 169 studies of which 39 were included in the review. The ability to name one risk factor for stroke varied between studies, ranging from 18% to 94% when asked open-ended questions and from 42% to 97% when asked closed questions. The ability to name one symptom ranged from 25% to 72% when asked open-ended questions and from 95% to 100% when asked closed questions. When asked what action people would take if they thought they were having a stroke, between 53% and 98% replied that they would call the EMS. People generally obtained information about stroke from family and friends. Older members of the population, ethnic minority groups and those with lower levels of education had consistently poor levels of stroke knowledge. CONCLUSIONS: generally, levels of knowledge about recognising and preventing stroke were poor. Nevertheless, most participants stated they would contact the EMS at the onset of stroke symptoms.