Digital Analysis of Clinical Screening Criteria for a Rare Disease - Behcet's Disease.

The objective is to identify clinical screening criteria for a rare disease,- Behcet's disease and to analyse the digitally structured and unstructured components of the Identified Clinical criteria, build a clinical archetype using OpenEHR editor to be used by learning health support systems for clinical screening of the disease. Methods/Search Strategy: Literature search was conducted, 230 papers were screened, and finally 5 papers were retained, analysed and summarised. Digital Analysis of the clinical criteria was done and a sandardised clinical knowledge model of the same was built using OpenEHR editor, underpinned by OpenEHR international standards. Results The structured and unstructured components of the criteria analysed to be able to incorporate them in a learning health system to screen patients for Behcet's disease. SNOMED CT and Read codes were assigned to the structured componenets. Possible misdiagnosis were identified, along with their corresponding clinical terminology codes that can be incorporated in the Electronic Health Record systems. Conclusion: The identified clinical screening was digitally analysed which can be embedded into a clinical decision support system that can be plugged onto the primary care systems to give an alert to the clinicians if a patient needs to be screened for a rare disease, for e.g., Behcet's.

IT Evaluation of Foundation Healthcare Group NHS Vanguard programme: IT simultaneously an enabler and a rate limiting factor.

The goal of the Foundation Healthcare Group (FHG) Vanguard model was to develop a sustainable local hospital model between two National Health Service (NHS) Trusts (a London Teaching Hospital Trust and a District General Hospital Trust) that makes best use of scarce resources and can be replicated across the NHS, UK. The aim of this study was to evaluate the provision, use, and implementation of the IT infrastructure based on qualitative interviews focused mainly on the perspectives of the IT staff and the clinicians' perspectives. METHODS: In total, 24 interview transcripts, along with 'Acute Care Collaboration' questionnaire responses, were analyzed using a thematic framework for IT infrastructure, sharing themes across the vascular, pediatric, and cardiovascular strands of the FHG programme. RESULTS: Findings indicated that Skype for Business had been an innovative and helpful development widely available to be used between the two Trusts. Clinicians initially reported lack of IT support and infrastructure expected at the outset for a national Vanguard project but later appreciated that remote access to most clinical applications including scans between the two Trusts became operational. The Local Care Record (LCR), an IT project was perceived to have been delivered successfully in South London. Shared technology reduced patient traveling time by providing locally based shared care. CONCLUSION: Lesson learnt is that ensuring patient benefit and priorities is a strong driver to implementation and one needs to identify IT rate-limiting steps at an early stage and on a regular basis and then focus on rapid implementation of solutions. In fact, future work may also assess how the IT infrastructure developed by FHG vanguard project might have helped/boosted the 'digital health' practice during the COVID-19 times. Spreading and scaling-up innovations from the Vanguard sites was the aspiration and challenge for system leaders. After COVID-19, the use of IT is scaled up and now, the challenges in the use of IT are much less compared to the pre-COVID-19 time when this project was evaluated.

Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCT.

BACKGROUND: Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. OBJECTIVE: To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. DESIGN: This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. SETTING: A total of 44 English general practices. PARTICIPANTS: Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. INTERVENTIONS: (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed 'dose-by-age' amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. COMPARATOR: Immediate 'dose-by-age' oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. MAIN OUTCOME MEASURE: Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated 'no' or 'very slight' problem (without need for analgesia). METHODS: Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. RESULTS: Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4-9), 4 (3-7) and 4 (3-6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. LIMITATIONS: The over-riding weakness was the failure to recruit enough children. CONCLUSIONS: We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12873692 and EudraCT 2017-003635-10. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 67. See the NIHR Journals Library website for further project information.

Ear infections are common in childhood. Some are complicated by a burst eardrum, followed by discharge from the ear. The usual treatment for this is a short course of antibiotics taken by mouth. However, alternative treatment using antibiotic drops, or a 'wait and see' policy before starting antibiotics, would result in less antibiotic use and reduce the subsequent risk of antibiotic resistance, which is bad for both patients and the environment. This study set out to see if these alternative treatments were as effective as the usual treatment for children with ear discharge. Although ear infections are common, only one in six children develops ear discharge, so only a few children might be available to take part at each general practice. We planned to use an electronic recruitment system to help us to gather enough patients. The system [called the 'TRANSFoRm' (Translational Research and Patient Safety in Europe) platform] was designed to remind busy general practitioners and nurses about the study and take them through the recruitment process step by step, as well as to support trial processes. Although the TRANSFoRm platform had been developed and tested, it had not been used in general practices before. We were surprised to find that there were many technical problems in setting up the TRANSFoRm platform in general practices, and staff were too busy and/or did not have the skills to overcome the technical issues. As a result, recruiting patients was slow and the study was halted before we had enough children to answer the main research question. In total, we managed to get 44 general practices and 22 children, but this was not enough. We still think that this kind of research and electronic trial platforms are important. We have noted many system and technical issues that need to be solved to enable funders and researchers to use this recruitment approach in the future.

IT Evaluation of Foundation Healthcare Group Vanguard Project.

The aim of the Foundation Healthcare Group (FHG) Vanguard model was to develop a sustainable local hospital model between two National Health Service (NHS) Trusts (a London Teaching Hospital Trust and a District General Hospital Trust) that makes best use of scarce resources and can be replicated across the NHS, UK. The aim of this study was to evaluate the provision, use and implementation of the IT infrastructure; based on qualitative interviews and focused mainly on the perspectives of the IT staff and the clinicians' perspectives. In total 24 interview transcripts, along with 'Acute Care Collaboration' questionnaire responses, were analysed using a thematic framework for IT infrastructure, sharing themes across the vascular, paediatric and cardiovascular strands of the FHG programme. Findings indicated that Skype for Business had been an innovative and helpful development widely available to be used between the two Trusts. Clinicians initially reported lack of IT support and infrastructure expected at the outset for a national Vanguard project, but later appreciated that remote access to most clinical applications between the two Trusts became operational. The Local Care Record (LCR), an IT project was perceived to have been delivered successfully in South London. Shared technology reduced patient travelling time by providing locally based shared care. Spreading and scaling-up innovations from the Vanguard sites was the aspiration and challenge for system leaders.

Impact of patient access to their electronic health record: systematic review.

Patient access to their own electronic health records (EHRs) is likely to become an integral part of healthcare systems worldwide. It has the potential to decrease the healthcare provision costs, improve access to healthcare data, self-care, quality of care, and health and patient-centered outcomes. This systematic literature review is aimed at identifying the impact in terms of benefits and issues that have so far been demonstrated by providing patients access to their own EHRs, via providers' secure patient portals from primary healthcare centers and hospitals. Searches were conducted in PubMed, MEDLINE, CINHAL, and Google scholar. Over 2000 papers were screened and were filtered based on duplicates, then by reading the titles and finally based on their abstracts or full text. In total, 74 papers were retained, analyzed, and summarized. Papers were included if providing patient access to their own EHRs was the primary intervention used in the study and its impact or outcome was evaluated. The search technique used to identify relevant literature for this paper involved input from five experts. While findings from 54 of the 74 papers showed positive outcome or benefits of patient access to their EHRs via patient portals, 10 papers have highlighted concerns, 8 papers have highlighted both and 2 have highlighted absence of negative outcomes. The benefits range from re-assurance, reduced anxiety, positive impact on consultations, better doctor-patient relationship, increased awareness and adherence to medication, and improved patient outcomes (e.g., improving blood pressure and glycemic control in a range of study populations). In addition, patient access to their health information was found to improve self-reported levels of engagement or activation related to self-management, enhanced knowledge, and improve recovery scores, and organizational efficiencies in a tertiary level mental health care facility. However, three studies did not find any statistically significant effect of patient portals on health outcomes. The main concerns have been around security, privacy and confidentiality of the health records, and the anxiety it may cause amongst patients. This literature review identified some benefits, concerns, and attitudes demonstrated by providing patients' access to their own EHRs. This access is often part of government strategies when developing patient-centric self-management elements of a sustainable healthcare system. The findings of this review will give healthcare providers a framework to analyze the benefits offered by promoting patient access to EHRs and decide on the best approach for their own specialties and clinical setup. A robust cost-benefit evaluation of such initiatives along with its impact on major stakeholders within the healthcare system would be essential in understanding the overall impact of such initiatives. Implementation of patient access to their EHRs could help governments to appropriately prioritize the development or adoption of national standards, whilst taking care of local variations and fulfilling the healthcare needs of the population, e.g., UK Government is aiming to make full primary care records available online to every patient. Ultimately, increasing transparency and promoting personal responsibility are key elements of a sustainable healthcare system for future generations.

Feasibility of Using EN 13606 Clinical Archetypes for Defining Computable Phenotypes.

INTRODUCTION: Computable phenotypes are gaining importance as structured and reproducible method of using electronic health data to identify people with certain clinical conditions. A formal standard is not available for defining and formally representing phenotyping algorithms. In this paper, we have tried to build a formal representation of such phenotyping algorithm. METHODS: We built EN 13606 EHR standard for building clinical archetypes to represent the computable phenotyping algorithm for 'diagnosis of cardiac failure'. As part of this work, we created a set of new clinical archetypes for defining 'cardiac failure diagnosis'. The EN13606 editor called Object Dictionary Client was used which was in-house developed by University College London. We evaluated the ability of EN 13606 to provide clinical archetypes to define EHR phenotyping algorithms using the predefined desiderata for the purpose [Mo et al]. RESULTS: EN 13606 archetypes could represent phenotype components grouped and nested based on their logical meaning. It was possible to build the EHR phenotyping algorithm with the clinical elements and their interrelationships along with hierarchical structure and temporal criteria. But the specific mathematical calculation and temporal relations involved in the algorithm was difficult to incorporate. These will need to be coded and integrated within the clinical information system. These archetypes can be mapped for comparison with the openEHR models. Binding to external clinical terminology is fully supported. However, it does not satisfy all the desiderata defined by Mo et al. A possible way could be an approach using phenotype ontologies and its architectural representation integrated with ISO interoperability. CONCLUSION: The EN13606 archetypes can be used to define the phenotype algorithm that basically identifies patients by a set of clinical characteristics in their records. Phenotype representations defined in EN 13606 do not satisfy all the desiderata proposed by Mo et al. and thus currently has a limited ability to define the computable phenotyping algorithms. Further work is required to make the EN13606 standard to fully support the objective.

Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data.

OBJECTIVES: Integrating Electronic Health Record (EHR) systems into the field of clinical trials still contains several challenges and obstacles. Heterogeneous standards and specifications are used to represent healthcare and clinical trial information. Therefore, this work investigates the mapping and data interoperability between healthcare and research standards: EN13606 used for the EHRs and the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used for clinical research. METHODS: Based on the specifications of CDISC ODM 1.3.2 and EN13606, a mapping between the structure and components of both standards has been performed. Archetype Definition Language (ADL) forms built with the EN13606 editor were transformed to ODM XML and reviewed. As a proof of concept, clinical sample data has been transformed into ODM and imported into an electronic data capture system. Reverse transformation from ODM to ADL has also been performed and finally reviewed concerning map-ability. RESULTS: The mapping between EN13606 and CDISC ODM shows the similarities and differences between the components and overall record structure of the two standards. An EN13606 archetype corresponds with a group of items within CDISC ODM. Transformations of element names, descriptions, different languages, datatypes, cardinality, optionality, units, value range and terminology codes are possible from EN13606 to CDISC ODM and vice versa. CONCLUSION: It is feasible to map data elements between EN13606 and CDISC ODM and transformation of forms between ADL and ODM XML format is possible with only minor limitations. EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies. It is feasible to transform EHR data in the EN13606 form to ODM to transfer it into research database. The attempt to use EN13606 to build a study protocol (that was already built with CDISC ODM) also suggests the possibility of using EN13606 standard in place of CDISC ODM if needed to avoid transformations.

Establishment of Requirements and Methodology for the Development and Implementation of GreyMatters, a Memory Clinic Information System.

INTRODUCTION: The aim of the paper is to establish the requirements and methodology for the development process of GreyMatters, a memory clinic system, outlining the conceptual, practical, technical and ethical challenges, and the experiences of capturing clinical and research oriented data along with the implementation of the system. METHODS: The methodology for development of the information system involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. The standard Institute of Electrical and Electronics Engineers (IEEE) recommended approach for the specifications of software requirements was adopted. An electronic health record (EHR) standard, EN13606 was used, and clinical modelling was done through archetypes and the project complied with data protection and privacy legislation. RESULTS: The requirements for GreyMatters were established. Though the initial development was complex, the requirements, methodology and standards adopted made the construction, deployment, adoption and population of a memory clinic and research database feasible. The electronic patient data including the assessment scales provides a rich source of objective data for audits and research and to establish study feasibility and identify potential participants for the clinical trials. CONCLUSION: The establishment of requirements and methodology, addressing issues of data security and confidentiality, future data compatibility and interoperability and medico-legal aspects such as access controls and audit trails, led to a robust and useful system. The evaluation supports that the system is an acceptable tool for clinical, administrative, and research use and forms a useful part of the wider information architecture.

An Electronic Healthcare Record Server Implemented in PostgreSQL.

This paper describes the implementation of an Electronic Healthcare Record server inside a PostgreSQL relational database without dependency on any further middleware infrastructure. The five-part international standard for communicating healthcare records (ISO EN 13606) is used as the information basis for the design of the server. We describe some of the features that this standard demands that are provided by the server, and other areas where assumptions about the durability of communications or the presence of middleware lead to a poor fit. Finally, we discuss the use of the server in two real-world scenarios including a commercial application.

Development and evaluation of a memory clinic information system.

AIM: To describe the requirements, development and evaluation of a cognitive disorders and older persons' clinical and research application, outlining the conceptual and practical challenges. METHODS: A technology development methodology was used to develop a database of people being investigated for or diagnosed with cognitive disorders as well as their carers. The methodology involved phases of requirements gathering, modeling and prototype creation, and 'bench testing' the prototype with experts. RESULTS: This case study suggests that construction and population of a memory clinic and research database is feasible, but initial development is complex. Its utility can be evaluated to some extent and was found to be acceptable to most users. DISCUSSION AND CONCLUSIONS: The development of a system needs to take in account existing data collection methods and other information systems used. The GreyMatters system can be considered a supplementary or complementary health record that sits alongside the main Trust information system. Integrating data from multiple systems enhances utility to clinical and research users.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs.

OBJECTIVES: The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. METHODS: Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. RESULTS: The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. CONCLUSIONS: Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes.

Quality requirements for EHR archetypes.

The realisation of semantic interoperability, in which any EHR data may be communicated between heterogeneous systems and fully understood by computers as well as people on receipt, is a challenging goal. Despite the use of standardised generic models for the EHR and standard terminology systems, too much optionality and variability exists in how particular clinical entries may be represented. Clinical archetypes provide a means of defining how generic models should be shaped and bound to terminology for specific kinds of clinical data. However, these will only contribute to semantic interoperability if libraries of archetypes can be built up consistently. This requires the establishment of design principles, editorial and governance policies, and further research to develop ways for archetype authors to structure clinical data and to use terminology consistently. Drawing on several years of work within communities of practice developing archetypes and implementing systems from them, this paper presents quality requirements for the development of archetypes. Clinical engagement on a wide scale is also needed to help grow libraries of good quality archetypes that can be certified. Vendor and eHealth programme engagement is needed to validate such archetypes and achieve safe, meaningful exchange of EHR data between systems.

Developing a Dementia Research Registry: a descriptive case study from North Thames DeNDRoN and the EVIDEM programme.

AIM: To describe the development of a dementia research registry, outlining the conceptual, practical and ethical challenges, and to report initial experiences of recruiting people with dementia to it from primary and secondary care. BACKGROUND: Women, the oldest old and ethnic minorities have been under-represented in clinical trials in dementia. Such under-representation biases estimates of absolute effect, absolute harm and cost-effectiveness. Research on dementia should include patient populations that more exactly reflect the population at risk. One of the impediments to this is the lack of a suitable tool for identification of patients suitable for studies. CONSTRUCTION & CONTENTS: A technology development methodology was used to develop a registry of people with dementia and their carers. This involved phases of modelling and prototype creation, 'bench testing' the prototype with experts and then 'field testing' the refined prototype in exemplar sites. The evaluation of the field testing described here is based on a case study methodology. UTILITY: This case study suggests that construction and population of a dementia research registry is feasible, but initial development is complex because of the ethical and organisational difficulties. Recruitment from primary care is particularly costly in terms of staff time and only identifies a very small number of people with dementia who were not already known to specialist services. Recruiting people with dementia through secondary care is a resource intensive process that takes up to six months to complete. Identifying the components of a minimum dataset was easy but its usefulness for pre-screening potential research populations has yet to be established. Acceptance rates are very high in the first clinic to recruit to the registry, but this may reflect the efforts of registry 'champions'. DISCUSSION AND CONCLUSIONS: Easier recruitment may perpetuate potential selection biases and we are not yet able to assess the representativeness of the research-ready population recruited to the registry. The need to recruit from wider populations, through primary and social care, remains. The success of this registry will be measured by the proportion of people from it who are recruited to research projects, and its impact on overall accrual to studies.

Implementation of a query interface for a generic record server.

INTRODUCTION: This paper presents work to define a representation for clinical research queries that can be used for the design of generic interfaces to electronic healthcare record (EHR) systems. Given the increasing prevalence of EHR systems, with the potential to accumulate life-long health records, opportunities exist to analyse and mine these for new knowledge. This potential is presently limited by many factors, one of which is the challenge of extracting information from them in order to execute a research query. METHOD: There is limited pre-existing work on the generic specification of clinical queries. Sets of example queries were obtained from published studies and clinician reference groups. These were re-represented as structured logical expressions, from which a generalisable pattern (information model) was inferred. An iterative design and implementation approach was then pursued to refine the model and evaluate it. RESULTS: This paper presents a set of requirements for the generic representation of clinical research queries, and an information model to represent any arbitrary such query. A middleware component was implemented as an interface to an existing system that holds 20,000 anonymised cancer EHRs in order to validate the model. This component was interfaced in turn to a query design and results presentation tool developed by the Open University, to permit end user demonstrations and feedback as part of the evaluation. CONCLUSION: Although it is difficult to separate cleanly the evaluation of a theoretical model from its implementation, the empirical evaluation of the query-execution interface revealed that clinical queries of the kinds studied could all be represented and executed successfully. However, performance was a problem and this paper outlines some of the challenges faced in building generic components to handle specialised data structures on a large scale. The limitations of this work are also discussed. The work complements many years of European research and standardisation on the interoperable communication of electronic health records, by proposing a way in which one or more EHR systems might be queried in a standardised way.

The CLEF corpus: semantic annotation of clinical text.

The Clinical E-Science Framework (CLEF) project is building a framework for the capture, integration and presentation of clinical information: for clinical research, evidence-based health care and genotype-meets-phenotype informatics. A significant portion of the information required by such a framework originates as text, even in EHR-savvy organizations. CLEF uses Information Extraction (IE) to make this unstructured information available. An important part of IE is the identification of semantic entities and relationships. Typical approaches require human annotated documents to provide both evaluation standards and material for system development. CLEF has a corpus of clinical narratives, histopathology reports and imaging reports from 20 thousand patients. We describe the selection of a subset of this corpus for manual annotation of clinical entities and relationships. We describe an annotation methodology and report encouraging initial results of inter-annotator agreement. Comparisons are made between different text sub-genres, and between annotators with different skills.