Developing a conformance methodology for clinically-defined medical record headings:a preliminary report.

Background: The Professional Records Standards Body for health and social care (PRSB) was formed in 2013 to develop and assure professional standards for the content and structure of patient records across all care disciplines in the UK. Although the PRSB work is aimed at Electronic Health Record (EHR) adoption and interoperability to support continuity of care, the current technical guidance is limited and ambiguous. Objectives: This project was initiated as a proof-ofconcept to demonstrate whether, and if so, how, conformance methods can be developed based on the professional standards. Methods: An expert group was convened, comprising clinical and technical representatives. A constrained data set was defined for an outpatient letter, using the subset of outpatient headings that are also present in the ep-SOS patient summary. A mind map was produced for the main sections and sub-sections. An openEHR archetype model was produced as the basis for creating HL7 and IHE implementation artefacts. Results: Several issues about data definition and representation were identified when attempting to map the outpatient headings to the epSOS patient summary, partly due to the difference between process and static viewpoints. Mind maps have been a simple and helpful way to visualize the logical information model and expose and resolve disagreements about which headings are purely for human navigation and which, if any, have intrinsic meaning. Conclusions: Conformance testing is feasible but nontrivial. In contrast to traditional standards-development timescales, PRSB needs an agile standards development process with EHR vendor and integrator collaboration to ensure implementability and widespread adoption. This will require significant clinical and technical resources

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Intervening Role of Sustainability Practices in the Nexuses of Responsible Leadership and Environmental, Task, and Contextual Performance

Purpose: The current study assessed the function of responsible leadership in the banking industry using the stakeholder theory. The current study also looks into the connection between responsible leadership and task, contextual, and environmental performance. Methodology: The banking industry's 389 branch employees, including branch managers, business development officers, general banking officers, branch operation managers, cash officers, and relationship managers, were surveyed using a survey questionnaire approach to gather data. Mplus was used to analyze the data using the structural equation modeling method. Findings: The study's findings showed that ethical leadership had a direct influence on a firm's environmental (0.204), task (0.365), and contextual performance (0.188), as well as indirect effects through varied sustainability policies. Implications: it implies the significance of sustainable policies concerning responsible leadership and a company's success. The current study is a pioneering effort that added to the body of knowledge on the relationship between organizational tasks, contextual performance, and environmental performance in Pakistan's banking industry. It also evaluated the role of sustainability strategies in the interim

How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium

Data dictionaries for clinical trials are often created manually, with data structures and controlled vocabularies specific for a trial or family of trials within a sponsor&rsquo;s portfolio. Microsoft Excel is commonly used to capture the representation of data dictionary items but has limited functionality for this purpose. The conect4children (c4c) network is piloting the Direcht clinical data modelling tool to model their Cross Cutting Paediatric Data Dictionary (CCPDD) in a more formalised way. The first pilot had the key objective of testing whether a clinical data modelling tool could be used to represent data items from the CCPDD. The key objective of the second pilot is to establish whether a small team with little or no experience of clinical data modelling can use Direcht to expand the CCPDD. Clinical modelling is the process of structuring clinical data so it can be understood by computer systems and humans. The model contains all of the elements that are needed to define the data item. Results from the pilots show that Direcht creates a structured environment to build data items into models that fit into the larger CCPDD. Models can be represented as an HTML document, mind map, or exported in various formats for import into a computer system. Challenges identified over the course of both pilots are being addressed with c4c partners and external stakeholders

How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium

Data dictionaries for clinical trials are often created manually, with data structures and controlled vocabularies specific for a trial or family of trials within a sponsor’s portfolio. Microsoft Excel is commonly used to capture the representation of data dictionary items but has limited functionality for this purpose. The conect4children (c4c) network is piloting the Direcht clinical data modelling tool to model their Cross Cutting Paediatric Data Dictionary (CCPDD) in a more formalised way. The first pilot had the key objective of testing whether a clinical data modelling tool could be used to represent data items from the CCPDD. The key objective of the second pilot is to establish whether a small team with little or no experience of clinical data modelling can use Direcht to expand the CCPDD. Clinical modelling is the process of structuring clinical data so it can be understood by computer systems and humans. The model contains all of the elements that are needed to define the data item. Results from the pilots show that Direcht creates a structured environment to build data items into models that fit into the larger CCPDD. Models can be represented as an HTML document, mind map, or exported in various formats for import into a computer system. Challenges identified over the course of both pilots are being addressed with c4c partners and external stakeholders