Preliminary Exploration of Main Elements for Systematic Classification Development:Case Study of Patient Safety Incidents

Publisher Copyright: © 2022 JMIR Publications Inc.. All Rights Reserved.Background: Currently, there is no holistic theoretical approach available for guiding classification development. On the basis of our recent classification development research in the area of patient safety in health information technology, this focus area would benefit from a more systematic approach. Although some valuable theoretical and methodological approaches have been presented, classification development literature typically is limited to methodological development in a specific domain or is practically oriented. Objective: The main purposes of this study are to fill the methodological gap in classification development research by exploring possible elements of systematic development based on previous literature and to promote sustainable and well-grounded classification outcomes by identifying a set of recommended elements. Specifically, the aim is to answer the following question: what are the main elements for systematic classification development based on research evidence and our use case? Methods: This study applied a qualitative research approach. On the basis of previous literature, preliminary elements for classification development were specified, as follows: defining a concept model, documenting the development process, incorporating multidisciplinary expertise, validating results, and maintaining the classification. The elements were compiled as guiding principles for the research process and tested in the case of patient safety incidents (n=501). Results: The results illustrate classification development based on the chosen elements, with 4 examples of technology-induced errors. Examples from the use case regard usability, system downtime, clinical workflow, and medication section problems. The study results confirm and thus suggest that a more comprehensive and theory-based systematic approach promotes well-grounded classification work by enhancing transparency and possibilities for assessing the development process. Conclusions: We recommend further testing the preliminary main elements presented in this study. The research presented herein could serve as a basis for future work. Our recently developed classification and the use case presented here serve as examples. Data retrieved from, for example, other type of electronic health records and use contexts could refine and validate the suggested methodological approach.Peer reviewe

Reporting medical device safety incidents to regulatory authorities : An analysis and classification of technology-induced errors

The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting.Peer reviewe

The European cross-border health data exchange : Focus on clinically relevant data

Publisher Copyright: © 2021 European Federation for Medical Informatics (EFMI) and IOS Press. All rights reserved.The eHealth Digital Service Infrastructure (eHDSI) is an infrastructure ensuring the continuity of care for European citizens while they are travelling abroad in the EU. We present the Finnish readiness of implementing datasets of diagnosis, vaccinations and medication summary in a case study, and discuss challenges emerging from the national perspective. International harmonized standards are a key element in the smooth development of European information exchange.Peer reviewe

Harmonization of Finnish vaccination data

Publisher Copyright: © 2021 European Federation for Medical Informatics (EFMI) and IOS Press. All rights reserved.Vaccination information is needed at individual and at population levels, as it is an important part of public health measures. In Finland, a vaccination data structure has been developed for centralized information services that include patient access to information. Harmonization of data with national vaccination registry is ongoing. New requirements for vaccination certificates have emerged because of COVID-19 pandemic. We explore, what is the readiness of Finnish development of vaccination data structures and what can be learned from Finnish harmonization efforts in order to accomplish required level of interoperability.Peer reviewe

Electronic Health Record-Related Safety Concerns : A Cross-Sectional Survey of Electronic Health Record Users

Background: The rapid expansion in the use of electronic health records (EHR) has increased the number of medical errors originating in health information systems (HIS). The sociotechnical approach helps in understanding risks in the development, implementation, and use of EHR and health information technology (HIT) while accounting for complex interactions of technology within the health care system. Objective: This study addresses two important questions: (1) "which of the common EHR error types are associated with perceived high-and extreme-risk severity ratings among EHR users?", and (2) "which variables are associated with high-and extreme-risk severity ratings?" Methods: This study was a quantitative, non-experimental, descriptive study of EHR users. We conducted a cross-sectional web-based questionnaire study at the largest hospital district in Finland. Statistical tests included the reliability of the summative scales tested with Cronbach's alpha. Logistic regression served to assess the association of the independent variables to each of the eight risk factors examined. Results: A total of 2864 eligible respondents provided the final data. Almost half of the respondents reported a high level of risk related to the error type "extended EHR unavailability". The lowest overall risk level was associated with "selecting incorrectly from a list of items". In multivariate analyses, profession and clinical unit proved to be the strongest predictors for high perceived risk. Physicians perceived risk levels to be the highest (P<.001 in six of eight error types), while emergency departments, operating rooms, and procedure units were associated with higher perceived risk levels (P<.001 in four of eight error types). Previous participation in eLearning courses on EHR-use was associated with lower risk for some of the risk factors. Conclusions: Based on a large number of Finnish EHR users in hospitals, this study indicates that HIT safety hazards should be taken very seriously, particularly in operating rooms, procedure units, emergency departments, and intensive care units/critical care units. Health care organizations should use proactive and systematic assessments of EHR risks before harmful events occur. An EHR training program should be compulsory for all EHR users in order to address EHR safety concerns resulting from the failure to use HIT appropriately.Peer reviewe

Health information systems´ usability-related use errors in patient safety incidents

Health information systems contain usability issues that cause use errors, which may pose a risk to patient safety. The aim of this study was to identify what kind of usability issues in information systems cause use errors that lead to patient safety incidents. Patient safety incidents reported into an incident reporting system in a Finnish hospital district during the year 2014 (n=2500) were analyzed from the perspectives of usability and use errors. An inductive content analysis was carried out in order to gather information about the usability issues that may have led to a use error, thus causing patient safety incidents. The results showed that the main usability issues are the distribution of information into multiple views, identification problems with the selected patient, and basic daily tasks' reliance on users' memory. The results show that the relationship between usability, use errors, and patient safety should be understood and considered in the health information system design.Terveydenhuollon tietojärjestelmissä esiintyy käyttövirheisiin johtavia käytettävyysongelmia, mikä saattaa aiheuttaa riskin potilasturvallisuudelle. Tämän tutkimuksen tarkoituksena oli tunnistaa, millaiset tietojärjestelmän käytettävyysongelmat aiheuttavat käyttövirheitä, jotka johtavat vaaratapahtumaan. Tutkimuksessa analysoitiin yhdessä sairaanhoitopiirissä vuonna 2014 vaaratapahtumajärjestelmään raportoituja tapahtumia (n=2500) käytettävyyden ja käyttövirheiden näkökulmasta. Aineiston induktiivisella sisällönanalyysillä kerättiin tietoa käytettävyysongelmista, jotka ovat johtaneet käyttövirheeseen ja siten aiheuttaneet vaaratapahtuman. Tulokset osoittivat merkittävimmiksi käytettävyysongelmiksi tiedon jakautumisen usealle näkymälle, valitun potilaan tunnistamisen ongelmat, sekä päivittäisten perustoimintojen suorittamisen jättämisen käyttäjän muistin varaan. Tulokset osoittavat, että käytettävyyden, käyttövirheiden ja potilasturvallisuuden väliset suhteet tulisi ymmärtää ja huomioida terveydenhuollon tietojärjestelmien suunnittelussa

An analysis of electronic health record-related patient safety incidents

The aim of this study was to analyse electronic health record-related patient safety incidents in the patient safety incident reporting database in fully digital hospitals in Finland. We compare Finnish data to similar international data and discuss their content with regard to the literature. We analysed the types of electronic health record-related patient safety incidents that occurred at 23 hospitals during a 2-year period. A procedure of taxonomy mapping served to allow comparisons. This study represents a rare examination of patient safety risks in a fully digital environment. The proportion of electronic health record-related incidents was markedly higher in our study than in previous studies with similar data. Human-computer interaction problems were the most frequently reported. The results show the possibility of error arising from the complex interaction between clinicians and computers.Peer reviewe

Sosiaali- ja terveydenhuollon kokonaisarkkitehtuurin kypsyysmallivertailu: näkökulmia kansalliseen ohjaukseen

In the social and health care sector, results of enterprise architecture (EA) have not been extensively assessed even though the method has been utilized for almost two decades. The aim of the study is to examine and compare some of the key maturity models and their application of EA. Based on the literature, the study was grounded on the assumption that increasing the maturity of the EA benefits steering of the public administration. The method of the narrative literature review was applied. The study produced a comparison of maturity assessment models EAMM, DyAMM, MIT CISR, and SAMM. Additionally, the evaluation components of DyAMM and SAMM were examined. Results indicate that the maturity assessment of EA has been examined to a small extent. The weakness of the theoretical foundation challenges the EA development and its maturity assessment. The dimensions identified in the theoretical models could be applied more widely in order to make more effective use of the EA in its role of the steering support in public administration. The development of maturity assessment models requires further research, in which the theoretical examination is accompanied by testing the model with real data. In this way, models can be developed evidence-based and not just on the terms of individual projects. By these means, the models would provide a reliable and target-specific assessment to improve steering in public administration.Sosiaali- ja terveydenhuollon alueella kokonaisarkkitehtuurin (KA) tuloksia ei ole vielä laajasti arvioitu, vaikka menetelmää on sovellettu jo lähes parin vuosikymmen ajan. Tässä tutkimuksessa tarkastellaan tiettyjä keskeisiä kokonaisarkkitehtuurin kypsyysmalleja. Tutkimuksen lähtökohtana oli olettamus, että KA-kypsyyden kasvu parantaa julkishallinnon ohjausta. Tutkimusmenetelmänä käytettiin kuvailevaa kirjallisuuskatsausta. Tutkimus tuotti vertailun neljästä kypsyysmallista: EAMM, DyAMM, MIT CISR ja SAMM. Lisäksi tarkasteltiin kahden mallin, DyAMM ja SAMM arviointipiirteitä. Tämän tutkimuksen tulokset osoittavat, että KA-kypsyysmalleja on tutkittu vähän. Teoreettisen perustan heikkous onkin haaste KA-kehittämiselle ja kypsyysarvioinnille. Malleissa tunnistettuja ulottuvuuksia voitaisiin kuitenkin hyödyntää tehokkaammin julkishallinnon KA-ohjauksessa. Kypsyysmallien kehittäminen edellyttäisi jatkotutkimusta, jossa teoreettinen tutkimus yhdistettäisiin mallien testaamiseen tapausaineistolla. Malleja tulisi kehittää tutkimusnäyttöön perustuen eikä pelkästään yksittäisten hankkeiden perusteella. Tällä tavalla kypsyysmallit tuottaisivat luotettavaa ja paremmin kohteeseen soveltuvaa arviointia myös julkishallinnossa ja sen ohjauksessa

Vapaaehtoisen vaaratapahtumajärjestelmän kehittäminen korkean kehitysasteen potilastietojärjestelmissä

Vertaisarvioitu. English abstract.Peer reviewe

Vapaaehtoisen vaaratapahtumajärjestelmän kehittäminen korkean kehitysasteen potilastietojärjestelmissä

Vertaisarvioitu. English abstract.Peer reviewe