Classification of electronic health record–related patient safety incidents : Development and validation study

Publisher Copyright: © Sari Palojoki, Kaija Saranto, Elina Reponen, Noora Skants, Anne Vakkuri, Riikka Vuokko.Background: It is assumed that the implementation of health information technology introduces new vulnerabilities within a complex sociotechnical health care system, but no international consensus exists on a standardized format for enhancing the collection, analysis, and interpretation of technology-induced errors. Objective: This study aims to develop a classification for patient safety incident reporting associated with the use of mature electronic health records (EHRs). It also aims to validate the classification by using a data set of incidents during a 6-month period immediately after the implementation of a new EHR system. Methods: The starting point of the classification development was the Finnish Technology-Induced Error Risk Assessment Scale tool, based on research on commonly recognized error types. A multiprofessional research team used iterative tests on consensus building to develop a classification system. The final classification, with preliminary descriptions of classes, was validated by applying it to analyze EHR-related error incidents (n=428) during the implementation phase of a new EHR system and also to evaluate this classification’s characteristics and applicability for reporting incidents. Interrater agreement was applied. Results: The number of EHR-related patient safety incidents during the implementation period (n=501) was five-fold when compared with the preimplementation period (n=82). The literature identified new error types that were added to the emerging classification. Error types were adapted iteratively after several test rounds to develop a classification for reporting patient safety incidents in the clinical use of a high-maturity EHR system. Of the 427 classified patient safety incidents, interface problems accounted for 96 (22.5%) incident reports, usability problems for 73 (17.1%), documentation problems for 60 (14.1%), and clinical workflow problems for 33 (7.7%). Altogether, 20.8% (89/427) of reports were related to medication section problems, and downtime problems were rare (n=8). During the classification work, 14.8% (74/501) of reports of the original sample were rejected because of insufficient information, even though the reports were deemed to be related to EHRs. The interrater agreement during the blinded review was 97.7%. Conclusions: This study presents a new classification for EHR-related patient safety incidents applicable to mature EHRs. The number of EHR-related patient safety incidents during the implementation period may reflect patient safety challenges during the implementation of a new type of high-maturity EHR system. The results indicate that the types of errors previously identified in the literature change with the EHR development cycle.Peer reviewe

Vapaaehtoisen vaaratapahtumajärjestelmän kehittäminen korkean kehitysasteen potilastietojärjestelmissä

Vertaisarvioitu. English abstract.Peer reviewe

Vapaaehtoisen vaaratapahtumajärjestelmän kehittäminen korkean kehitysasteen potilastietojärjestelmissä

Vertaisarvioitu. English abstract.Peer reviewe

Postoperative pain as a risk factor for stiff knee following total knee arthroplasty and excellent patient-reported outcomes after manipulation under anesthesia

Background and purpose - Manipulation under anesthesia (MUA) is the first-choice treatment for stiffness following total knee arthroplasty (TKA) unresponsive to pain management and physiotherapy. Some of the predisposing factors and patient-reported outcome measures (PROMs) following MUA remain poorly studied. We retrospectively investigated the etiological risk factors and the outcomes of MUA. Patients and methods - 391 TKA patients from a randomized trial comparing the use of a tourniquet and anesthesia (spinal or general) were analyzed, and patients needing MUA were identified (MUA group). We evaluated in-hospital opioid consumption, Oxford Knee Score (OKS), range of motion (ROM), and pain assessed by the Brief Pain Inventory-short form with a 1-year follow-up. Results - 39 (10%) MUA patients were identified. The MUA patients were younger (60 years vs. 64 years, difference -4, 95% CI -6 to -1) and had higher postoperative oxycodone consumption (66 mg vs. 51 mg, median difference 11, CI 1-22) than the no-MUA patients. The proportion of MUA patients who contacted the emergency department within 3 months because of pain was larger than that of non-MUA patients (41% vs. 12%, OR 5, CI 3-10). At the 1-year follow-up, the ROM was improved by 39 degrees following MUA, but the total ROM was worse in the MUA group (115 degrees vs. 124 degrees, p < 0.001). No difference was found in the OKS between the MUA and no-MUA patients. Interpretation - Higher postoperative pain seems to predict MUA risk. MUA performed 3 months postoperatively offers substantial ROM improvement and comparable PROMs to no-MUA patients 1 year after TKA.Peer reviewe

Verityhjiön käytön vaikutus polven tekonivelleikkauksen tuloksiin: satunnaistettu tutkimus

English abstrac

Effects or anaesthesia method and tourniquet use on recovery following total knee arthroplasty : a randomised controlled study

Background: We investigated the effects of spinal and general anaesthesia and surgical tourniquet on acute pain and early recovery after total knee arthroplasty (TKA). Methods: Patients (n=413) were randomised to four parallel groups: spinal anaesthesia with or without tourniquet, and general anaesthesia with or without tourniquet. The primary outcome was patient-controlled i.v. oxycodone consumption over 24 postoperative hours. Results: Results from 395 subjects were analysed. Median i.v. oxycodone consumption did not differ between the four groups (spinal anaesthesia without [36.6 mg] and with tourniquet [38.0 mg], general anaesthesia without [42.3 mg] and with tourniquet [42.5 mg], P=0.42), between spinal (37.7 mg) and general anaesthesia (42.5 mg) groups (median difference -3.1, 95% confidence interval [CI] -7.4 to 1.2, P=0.15) and between tourniquet and no-tourniquet groups (40.0 vs 40.0 mg, median difference -0.8, CI -5.1 to 3.5, P=0.72). Vomiting incidence was higher with spinal than with general anaesthesia (21% [42/200] vs 13% [25/194], CI 1.05 to 3.1, P=0.034). The mean haemoglobin decrease was greater without than with tourniquet (-3.0 vs -2.5 g dl(-1), mean difference -0.48, CI -0.65 to -0.32, P Conclusions: For TKA, spinal and general anaesthesia with or without tourniquet did not differ in 24-h postoperative opioid consumption, pain management, blood transfusions, in-hospital complications, and length of hospital stay. Vomiting incidence was higher in the spinal than in the general anaesthesia group. Tourniquet use caused smaller decreases in haemoglobin levels.Peer reviewe

Validation of the Lean Healthcare Implementation Self-Assessment Instrument (LHISI) in the finnish healthcare context

Lean management is growing in popularity in the healthcare sector worldwide, yet healthcare organizations are struggling with assessing the maturity of their Lean implementation and monitoring its change over time. Most existing methods for such assessments are time consuming, require site visits by external consultants, and lack frontline involvement. The original Lean Healthcare Implementation Self-Assessment Instrument (LHISI) was developed by the Center for Lean Engagement and Research (CLEAR), University of California, Berkeley as a Lean principles-based survey instrument that avoids the above problems. We validated the original LHISI in the context of Finnish healthcare.Background Lean management is growing in popularity in the healthcare sector worldwide, yet healthcare organizations are struggling with assessing the maturity of their Lean implementation and monitoring its change over time. Most existing methods for such assessments are time consuming, require site visits by external consultants, and lack frontline involvement. The original Lean Healthcare Implementation Self-Assessment Instrument (LHISI) was developed by the Center for Lean Engagement and Research (CLEAR), University of California, Berkeley as a Lean principles-based survey instrument that avoids the above problems. We validated the original LHISI in the context of Finnish healthcare. Methods The original HISI survey was sent over a secure organizational email system to the over 26,000 employees of the Hospital District of Helsinki and Uusimaa in March 2020. The data were randomly split with one part used to carry out an exploratory factor analysis (EFA), and the other for testing the resulting model using confirmatory factor analysis (CFA). Results A total of 6073 employees responded to the LHISI survey, for an overall response rate of 23%. The results indicated that the 43 items used in the original LHISI can be reduced to 25 items, and these items measure a five-dimensional model of the progress of Lean implementation: leadership, commitment, standard work, communication, and daily management system. In comparison with a single-factor model, the fit measures for the 5-factor model were better: smaller X-2, larger comparative fit index (CFI), smaller root mean square error of approximation (RMSEA), and smaller standardized root mean square residual (SRMR). Conclusions The 25 item LHISI is valid and feasible to use in the context of Finnish healthcare. The LHISI allows the organization to self-monitor the progress of its Lean implementation and provides the leadership with actionable knowledge to guide the path towards Lean maturity across the organization. Our findings encourage further studies on the adoption and validation of the LHISI in healthcare organizations worldwide.Peer reviewe

Lääkärikouluttajan erityispätevyys on suuressa suosiossa

Lääkärikouluttajan erityispätevyyden saaneet kokevat hyötyneensä prosessista, vaikka pätevyyden tuoma arvostus ei näy työpaikalla. Teoreettisen pedagogisen koulutuksen saatavuus näyttää olevan pullonkaula

Alfa4- ja alfa5-ketjuja sisältävien laminiinien esiintyminen ja vaikutukset solujen kiinnittymiseen ihmisen suonten sisäpintaa verhoavassa endoteelissä ja syöpäkasvaimissa

Basement membranes are specialized sheets of extracellular matrix found in contact with epithelia, endothelia, and certain isolated cells. They support tissue architecture and regulate cell behaviour. Laminins are among the main constituents of basement membranes. Due to differences between laminin isoforms, laminins confer structural and functional diversity to basement membranes. The first aim of this study was to gain insights into the potential functions of the then least characterized laminins, alpha4 chain laminins, by evaluating their distribution in human tissues. We thus created a monoclonal antibody specific for laminin alpha4 chain. By immunohistochemistry, alpha4 chain laminins were primarily localized to basement membranes of blood vessel endothelia, skeletal, heart, and smooth muscle cells, nerves, and adipocytes. In addition, alpha4 chain laminins were found in the region of certain epithelial basement membranes in the epidermis, salivary gland, pancreas, esophagus, stomach, intestine, and kidney. Because of the consistent presence of alpha4 chain laminins in endothelial basement membranes of blood vessels, we evaluated the potential roles of endothelial laminins in blood vessels, lymphatic vessels, and carcinomas. Human endothelial cells produced alpha4 and alpha5 chain laminins. In quantitative and morphological adhesion assays, human endothelial cells barely adhered to alpha4 chain-containing laminin-411. The weak interaction of endothelial cells with laminin-411 appeared to be mediated by alpha6beta1 integrin. The alpha5 chain-containing laminin-511 promoted endothelial cell adhesion better than laminin-411, but it did not promote the formation of cell-extracellular matrix adhesion complexes. The adhesion of endothelial cells to laminin-511 appeared to be mediated by Lutheran glycoprotein together with beta1 and alphavbeta3 integrins. The results suggest that these laminins may induce a migratory phenotype in endothelial cells. In lymphatic capillaries, endothelial basement membranes showed immunoreactivity for laminin alpha4, beta1, beta2, and gamma1 chains, type IV and XVIII collagens, and nidogen-1. Considering the assumed inability of alpha4 chain laminins to polymerize and to promote basement membrane assembly, the findings may in part explain the incomplete basement membrane formation in these vessels. Lymphatic capillaries of ovarian carcinomas showed immunoreactivity also for laminin alpha5 chain and its receptor Lutheran glycoprotein, emphasizing a difference between normal and ovarian carcinoma lymphatic capillaries. In renal cell carcinomas, immunoreactivity for laminin alpha4 chain was found in stroma and basement membranes of blood vessels. In most tumours, immunoreactivity for laminin alpha4 chain was also observed in the basement membrane region of tumour cell islets. Renal carcinoma cells produced alpha4 chain laminins. Laminin-411 did not promote adhesion of renal carcinoma cells, but inhibited their adhesion to fibronectin. Renal carcinoma cells migrated more on laminin-411 than on fibronectin. The results suggest that alpha4 chain laminins have a counteradhesive function, and may thus have a role in detachment and invasion of renal carcinoma cells.Ihmisen kudokset koostuvat soluista ja soluväliaineesta. Tyvikalvot ovat soluväliaineen erilaistuneita osia, jotka sijaitsevat solukerrosten ja tiettyjen yksittäisten solujen välittömässä läheisyydessä. Tyvikalvot tukevat kudosten rakennetta ja vaikuttavat solujen toimintaan solujen pintareseptoreiden välityksellä. Laminiinit kuuluvat tyvikalvojen päärakenneosiin. Tämän tutkimuksen ensimmäisenä tavoitteena oli selvittää vähiten tunnettujen laminiinien, alfa4-ketjuja sisältävien laminiinien, esiintymistä ihmiskudoksissa. Tätä tarkoitusta varten kehitimme yhden solukloonin tuottaman vasta-aineen, joka tunnistaa ihmisen laminiini alfa4-ketjun. Tämän vasta-aineen ja immunohistokemiallisten menetelmien avulla totesimme, että alfa4-ketjua sisältäviä laminiineja on ihmisen verisuonten sisäpintaa verhoavan endoteelisolukerroksen, luuranko-, sydän- ja sileälihassolujen, sekä hermojen ja rasvasolujen tyvikalvoissa. Näitä laminiineja havaitsimme myös tiettyjen päällyskerrosten eli epiteelien tyvikalvoissa ihossa, sylkirauhasessa, haimassa, mahasuolikanavassa ja munuaisessa. Koska havaitsimme alfa4-ketjuja sisältäviä laminiineja erityisesti verisuonten endoteelien tyvikalvoissa, ryhdyimme selvittämään näiden laminiinien tehtäviä verisuonten ja imusuonten sisäpintaa verhoavassa endoteelissä ja syöpäkasvaimissa. Endoteelisolut eivät juurikaan kiinnittyneet alfa4-ketjuja sisältäviin laminiineihin. Endoteelisolujen ja alfa4-laminiinien välistä heikkoa vuorovaikutusta välittivät integriini alfa6beeta1-tyypin solujen pintareseptorit. Endoteelisolut kiinnittyivät paremmin endoteelien tyvikalvoissa myöskin sijaitseviin alfa5-ketjuja sisältäviin laminiineihin, mutta tämäkään vuorovaikutus ei johtanut voimakasta kiinnittymistä osoittavien kiinnittymisrakenteiden muodostumiseen. Endoteelisolujen ja alfa5-ketjuja sisältävien laminiinien vuorovaikutusta välittivät beeta1- ja alfavbeeta3-integriini- sekä luteraaniglykoproteiiniryhmään kuuluvat solujen pintareseptorit. Nämä tulokset viittaavat siihen, että endoteelin tyvikalvon laminiinit edistäisivät endoteelisolujen liikkumista. Imusuonien sisäpintaa verhoavan endoteelin välittömässä läheisyydessä havaitsimme alfa4, beeta1, beeta2 ja gamma1 laminiiniketjuja, tyypin IV ja XVIII kollageeneja, sekä nidogeeni-1:tä. Laminiineista ainoastaan alfa4-ketjuja sisältävien alatyyppien esiintyminen imusuonten endoteelien tyvikalvoissa voi selittää sen, minkä vuoksi imusuonissa tyvikalvo on rakenteeltaan katkonainen. Munasarjasyöpäkasvainten imusuonten endoteelien läheisyydessä havaitsimme myös alfa5-ketjuja sisältäviä laminiineja ja näiden reseptoreina toimivia luteraaniglykoproteiineja, mikä viittaa siihen, että terveiden kudosten ja syöpäkasvainten imusuonet ovat erilaiset. Munuaissyöpäkasvaimissa alfa4-ketjuja sisältäviä laminiineja löytyi suonten endoteelien tyvikalvoista, kasvaimen sidekudosta muistuttavasta osasta eli stroomasta sekä suurimmassa osassa kasvaimia myös kasvainsolusaarekkeiden ympäriltä. Totesimme munuaissyöpäsolujen tuottavan alfa4-ketjuja sisältäviä laminiineja. Nämä laminiinit eivät edistäneet munuaissyöpäsolujen kiinnittymistä, vaan estivät solujen kiinnittymisen fibronektiiniin, joka on yksi soluväliaineen tärkeimmistä solujen kiinnittymistä edistävistä proteiineista. Munuaissyöpäsolut käyttivät alfa4-ketjuja sisältäviä laminiineja liikkumisalustanaan. Nämä tulokset viittaavat siihen, että alfa4-ketjuja sisältävät laminiinit vähentäisivät solujen kiinnittymistä ja lisäisivät niiden liikkumista, ja voisivat siten vaikuttaa kasvainsolujen irtoamiseen alkuperäisestä sijainnistaan ja liikkumiseen elimistössä