Enhancing the Availability of Electronic Health Records for Secondary Purposes – A Case Study

Due to the sensitive nature of patient data, the secondary use of electronic health records (EHR) is restricted in scientific research and product development. Such restrictions pursue to preserve the privacy of respective patients by limiting the availability and variety of sensitive patient data. Current limitations do not correspond with the actual needs requested by the potential secondary users. In this thesis, the secondary use of Finnish and Swedish EHR data is explored for the purpose of enhancing the availability of such data for clinical research and product development. Involved EHR-related procedures and technologies are analysed to identify the issues limiting the secondary use of patient data. Successful secondary use of patient data increases the data value. To explore the identified circumstances, a case study of potential secondary users and use intentions regarding EHR data was carried out in Finland and Sweden. The data collection for the conducted case study was performed using semi-structured interviews. In total, 14 Finnish and Swedish experts representing scientific research, health management, and business were interviewed. The motivation for the corresponding interviews was to evaluate the protection of EHR data used for secondary purposes. The efficiency of implemented procedures and technologies was analysed in terms of data availability and privacy preserving. The results of the conducted case study show that the factors affecting EHR availability are divided to three categories: management of patient data, preservation of patients' privacy, and potential secondary users. Identified issues regarding data management included laborious and inconsistent data request procedures and the role and effect of external service providers. Based on the study findings, two secondary use approaches enabling the secondary use of EHR data are identified: data alteration and protected processing environment. Data alteration increases the availability of relevant EHR data, further decreasing the value of such data. Protected processing approach restricts the amount of potential users and use intentions while providing more valuable data content.

In search of information systems value : a case study of the EHR benefits realisation efforts of three Swedish hospitals.

The Swedish public health care organisation could very well be undergoing its most significant change since its specialisation during the late 19th and early 20th century. At the heart of this change is a move from using manual patient journals to electronic health records (EHR). EHR are complex integrated organisational wide information systems (IS) that promise great benefits and value as well as presenting great challenges to the organisation. The Swedish public health care is not the first organisation to implement integrated IS, and by no means alone in their quest for realising the potential benefits and value that it has to offer. As organisations invest in IS they embark on a journey of value-creation and capture. A journey where a costbased approach towards their IS-investments is replaced with a value-centric focus, and where the main challenges lie in the practical day-to-day task of finding ways to intertwine technology, people and business processes. This has however proven to be a problematic task. The problematic situation arises from a shift of perspective regarding how to manage IS in order to gain value. This is a shift from technology delivery to benefits delivery; from an ISimplementation plan to a change management plan. The shift gives rise to challenges related to the inability of IS and the elusiveness of value. As a response to these challenges the field of IS-benefits management has emerged offering a framework and a process in order to better understand and formalise benefits realisation activities. In this thesis the benefits realisation efforts of three Swedish hospitals within the same county council are studied. The thesis focuses on the participants of benefits analysis projects; their perceptions, judgments, negotiations and descriptions of potential benefits. The purpose is to address the process where organisations seek to identify which potential IS-benefits to pursue and realise, this in order to better understand what affects the process, so that realisation actions of potential IS-benefits could be supported. A qualitative case study research design is adopted and provides a framework for sample selection, data collection, and data analysis. It also provides a framework for discussions of validity, reliability and generalizability. Findings displayed a benefits fluctuation, which showed that participants’ perception of what constituted potential benefits and value changed throughout the formal benefits management process. Issues like structure, knowledge, expectation and experience affected perception differently, and this in the end changed the amount and composition of potential benefits and value. Five dimensions of benefits judgment were identified and used by participants when finding accommodations of potential benefits and value to pursue. Identified dimensions affected participants’ perceptions, which in turn affected the amount and composition of potential benefits. During the formal benefits management process participants shifted between judgment dimensions. These movements emerged through debates and interactions between participants. Judgments based on what was perceived as expected due to one’s role and perceived best for the organisation as a whole were the two dominant benefits judgment dimensions. A benefits negotiation was identified. Negotiations were divided into two main categories, rational and irrational, depending on participants’ drive when initiating and participating in negotiations. In each category three different types of negotiations were identified having different characteristics and generating different outcomes. There was also a benefits negotiation process identified that displayed management challenges corresponding to its five phases. A discrepancy was also found between how IS-benefits are spoken of and how actions of IS benefits realisation are understood. This was a discrepancy between an evaluation and a realisation focus towards IS value creation. An evaluation focus described IS-benefits as well-defined and measurable effects and a realisation focus spoke of establishing and managing an on-going place of value creation. The notion of valuescape was introduced in order to describe and support the understanding of IS value creation. Valuescape corresponded to a realisation focus and outlined a value configuration consisting of activities, logic, structure, drivers and role of IS.

Market Potential of Northwest Russia for Telemedicine Applications

The level of health care in Russia is mostly still below the western standards, but lately it has been developing quite positively. Many ICT solutions (telemedicine applications) have been developed for health care in Finland, but since the domestic market is so small, it’s necessary to expand to foreign markets to make the Finnish R&D projects more profitable. Telemedicine applications are not yet widely used in Russia, but since the health care system is going through fast changes, leapfrog effects can be expected and new modern applications and technologies will be implemented. This will open numerous business opportunities for Finnish technology developers. This thesis aims to be the first evaluation of the market and form an outlook of the health care system and telemedicine applications already utilized in Russia. The results of this study can be used for focusing further research ultimately aiming at technology implementation. The study showed that there is potential for many types of telemedicine solutions, e.g. electronic patient records and home monitoring systems; providing that further research in this field is needed.

Market Potential of Northwest Russia for Telemedicine Applications

The level of health care in Russia is mostly still below the western standards, but lately it has been developing quite positively. Many ICT solutions (telemedicine applications) have been developed for health care in Finland, but since the domestic market is so small, it’s necessary to expand to foreign markets to make the Finnish R&D projects more profitable. Telemedicine applications are not yet widely used in Russia, but since the health care system is going through fast changes, leapfrog effects can be expected and new modern applications and technologies will be implemented. This will open numerous business opportunities for Finnish technology developers. This thesis aims to be the first evaluation of the market and form an outlook of the health care system and telemedicine applications already utilized in Russia. The results of this study can be used for focusing further research ultimately aiming at technology implementation. The study showed that there is potential for many types of telemedicine solutions, e.g. electronic patient records and home monitoring systems; providing that further research in this field is needed.

Interoperability for IoT Health Systems Using HL7 Standard

Internet of Things or IoT is revolutionizing the world we are living in, similarly the way Internet and the web did few decades ago. It is changing how we interact with the things surrounding us. Electronic health and remote patient monitoring are the ways of utilizing these technological improvements towards the healthcare. There are many applications of IoT in eHealth such as, it will open the gate to provide healthcare to the remote areas of the world, where healthcare through traditional hospital systems cannot be provided. To connect these new eHealth IoT systems with the existing healthcare information systems, we can use the existing interoperability standards commonly used in healthcare information systems. In this thesis we implemented an eHealth IoT system based on Health Level 7 interoperability standard for continuous data transmission. There is not much previous work done in implementing the HL7 for continuous sensor data transmission. Some of the previous work was limited to sensors which are not continuous in nature and some of it is only theatrical architecture. This thesis aims to prove that it is possible to implement an eHealth IoT system by using sensors which require continues data transmission, such as respiratory sensors, and to connect it with the existing eHealth information system semantically by using HL7 interoperability standard. This system will be beneficial in implementing eHealth IoT systems for those patients, who requires continuous healthcare personal monitoring. This includes elderly people and patients, whose health need to be monitored constantly. To implement the architecture, HL7 v2.5 is selected due to its ease of implementation and low size. We selected some open source technologies because of their open licenses and large developer community. We will also review the most efficient technology available in every layer of eHealth IoT system and will propose an efficient system.

Delivery of European Cross-Border Health Care and the Relevance and Effects of EU Regulations and Judicial Processes with Reference to Delivery of Drugs and Blood Donor Information Material.

Valtion rajat ylittävät terveyspalvelut Euroopan unionissa sekä Euroopan unionin säädösten merkitys ja vaikutus erityisesti lääkejakeluun ja verenluovuttajille jaettavaan tiedotusaineistoon Valtion rajat ylittävä terveydenhuolto on suuren kiinnostuksen kohteena Euroopan unionissa. Resurssien hyödyntäminen parhaalla mahdollisella tavalla ja tiedon keskittäminen ovat tarpeen terveydenhuollon kustannusten alati noustessa. Terveydenhuoltopalvelut kuuluvat Euroopan sisämarkkinoiden vapaan liikkuvuuden piiriin. Euroopan unionilla ei ole kuitenkaan toimivaltaa säädellä terveydenhuoltojärjestelmiä, vaan sen mahdollisuudet ovat enimmäkseen kansanterveyden edistämisessä ja suojelussa, myös muilla toimialueilla kuin terveydenhuollossa. Tutkimuksen tavoitteena oli tutkia Euroopan unionin säädösten vaikutusta terveydenhuoltosektoriin, erityisesti valtion rajat ylittäviin terveydenhuoltopalveluihin. Erityiskohteena olivat lääkemääräyksen toimittaminen toisen Euroopan unionin jäsenmaan apteekista, resepti-lääkkeiden maahantuonti omaan henkilökohtaiseen käyttöön, sähköisen lääkemääräyksen käyttö kansallisesti ja mahdollisuudet sen käyttöön eri jäsenmaiden välillä, online-apteekkien soveltuvuus Euroopan unionin sisämarkkinoille sekä verenluovuttajille jaettavan tiedotusaineiston yhtenäistämistarve Euroopan unionin alueella. Tutkimuksen osa-alueiden aineisto koottiin vuosina 1999–2003, jolloin Euroopan unioniin kuului 15 jäsenmaata. Apteekit toimittivat useimmiten myös ei-kansalliset, toisessa Euroopan unionin jäsenmaassa annetut lääkemääräykset. Kaikki jäsenmaat rajoittivat lääkemääräyksen vaativien lääkkeiden maahantuontia. Rajoituksia oli maahantuontimäärissä ja -tavoissa. Lisäksi sairasvakuutuskorvausten saaminen ulkomailla lunastetuista reseptilääkkeistä oli hankalaa. Sähköiset lääkemääräykset olivat käytössä vain kahdessa maassa, mutta useissa maissa suunniteltiin niiden kokeilua. Standardit ja käyttöjärjestelmät olivat erilaisia eri maissa. Euroopan unionin alueelle on perustettu online-apteekkeja, joiden toiminta on kuitenkin vaatimatonta. Verenluovuttajille annettava tiedotusaineisto ei missään maassa täyttänyt veridirektiivin vaatimuksia. Tutkimuksen tulokset osoittivat kansallisten käytäntöjen eroavaisuuksien rajoittavan valtion rajat ylittäviä terveydenhuoltopalveluita. Vaikka Euroopan unionin tavoitteena ei ole yhtenäistää terveydenhuoltojärjestelmiä, on tarpeen arvioida uudelleen unionin ja jäsenmaiden välistä työnjakoa. Kansalliset terveydenhuoltojärjestelmät eivät ole erillään Euroopan sisämarkkinoista, jotka merkittävästi vaikuttavat terveydenhuoltoon.

Machine Learning and Clinical Text. Supporting Health Information Flow

Fluent health information flow is critical for clinical decision-making. However, a considerable part of this information is free-form text and inabilities to utilize it create risks to patient safety and cost-­effective hospital administration. Methods for automated processing of clinical text are emerging. The aim in this doctoral dissertation is to study machine learning and clinical text in order to support health information flow.First, by analyzing the content of authentic patient records, the aim is to specify clinical needs in order to guide the development of machine learning applications.The contributions are a model of the ideal information flow,a model of the problems and challenges in reality, and a road map for the technology development. Second, by developing applications for practical cases,the aim is to concretize ways to support health information flow. Altogether five machine learning applications for three practical cases are described: The first two applications are binary classification and regression related to the practical case of topic labeling and relevance ranking.The third and fourth application are supervised and unsupervised multi-class classification for the practical case of topic segmentation and labeling.These four applications are tested with Finnish intensive care patient records.The fifth application is multi-label classification for the practical task of diagnosis coding. It is tested with English radiology reports.The performance of all these applications is promising. Third, the aim is to study how the quality of machine learning applications can be reliably evaluated.The associations between performance evaluation measures and methods are addressed,and a new hold-out method is introduced.This method contributes not only to processing time but also to the evaluation diversity and quality. The main conclusion is that developing machine learning applications for text requires interdisciplinary, international collaboration. Practical cases are very different, and hence the development must begin from genuine user needs and domain expertise. The technological expertise must cover linguistics,machine learning, and information systems. Finally, the methods must be evaluated both statistically and through authentic user-feedback.

Carbohydrate intake in children - associations with dietary intakes, growth, serum lipids,and dental health. The STRIP Project

This study is part of the STRIP study, which is a long-term, randomized controlled trial, designed to decrease the exposure of children in the intervention group (n=540) to known risk factors of atherosclerosis. The main focus of the intervention was the quality of dietary fat. The control group (n=522) did not receive any individualized counselling. Food consumption was evaluated with food records, and blood samples were drawn and growth was measured regularly for all participating children from 13 months to 9 years. A subsample of 66 children participated in a dental health survey. The number of studies on children’s carbohydrate intake, especially fibre intake, is insufficient. The current international recommendations for fibre intake in children are based on average assumptions and data extrapolated from intakes in adults and intake recommendations for adults. Finnish nutrition recommendations lack strict recommendations for dietary fibre in children. Due to fibre’s high bulk volume, excessive dietary fibre is considered to decrease energy density and hence it may have an adverse effect on growth. If fats are reduced from the diet, the low-fat diet may become high in sucrose. Therefore, especially in the STRIP study, it is important to determine the use of fibre and sucrose in children and possible associations with growth and nutrition as well as dental health. The results of the present study indicate that a high fibre intake does not displace energy or disturb growth in children and that children with high fibre intake have better quality of diet than those with low fibre intake. Additionally, dietary fibre intake associated inversely with serum cholesterol concentration. Other carbohydrates also affected serum lipid levels as well, since total carbohydrates, sucrose, and fructose increased serum triglyceride concentration. Total carbohydrate intake reduced HDL cholesterol concentration only in children with apoE3 or apoE4 phenotype. Over the period from the 1970s to the 1990s the dental health of children in Finland has substantially improved despite an increase in sucrose intake. The improvement was thought to be due to improved dental hygiene and the use of fluorine. However, during the past twenty years improvement in dental health has stopped. The present study showed that high long-term sugar intake increases risk of caries in children. High intake of sugar had also negative effects on the diet of children, because it worsens dietary quality by displacing essential nutrients. Furthermore, the quality of dietary fat was worse in children with high sucrose intake. In this study the children’s high sucrose intake was not associated with overweight, but interestingly, it associated inversely with growth.

Health-related quality of life in school children: validation of instrument, child self assessment, parent-proxy assessment and school nursing documentation of health check-ups

The aims of this study were to validate an international Health-Related Quality of Life (HRQL) instrument, to describe child self and parent-proxy assessed HRQL at child age 10 to 12 and to compare child self assessments with parent-proxy assessments and school nursing documentation. The study is part of the Schools on the Move –research project. In phase one, a cross-cultural translation and validation process was performed to develop a Finnish version of Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0). The process included a two-way translation, cognitive interviews (children n=7, parents n=5) and a survey (children n=1097, parents n=999). In phase two, baseline and follow-up surveys (children n=986, parents n=710) were conducted to describe and compare the child self and parent-proxy assessed HRQL in school children between the ages 10 and 12. Phase three included two separate data, school nurse documented patient records (children n=270) and a survey (children n=986). The relation between child self assessed HRQL and school nursing documentation was evaluated. Validity and reliability of the Finnish version of PedsQL™ 4.0 was good (Child Self Report α=0.91, Parent-Proxy Report α=0.88). Children reported lower HRQL scores at the emotional (mean 76/80) than the physical (mean 85/89) health domains and significantly lower scores at the age of 10 than 12 (dMean=4, p=<0.001). Agreement between child self and parent-proxy assessment was fragile (r=0,4, p=<0.001) but increased as the child grew from age 10 to 12 years. At health check-ups, school nurses documented frequently children’s physical health, such as growth (97%) and posture (98/99%) but seldom emotional issues, such as mood (2/7%). The PedsQLTM 4.0 is a valid instrument to assess HRQL in Finnish school children although future research is recommended. Children’s emotional wellbeing needs future attention. HRQL scores increase during ages between childhood and adolescence. Concordance between child self and parent-proxy assessed HRQL is low. School nursing documentation, related to child health check-ups, is not in line with child self assessed HRQL and emotional issues need more attention.

Libyan breast cancer: Health services and biology. Diagnosis delay and prognostic value of DNA pploidy, S-phase fraction, and Ki-67 and Bcl-2 immunohistochemistry

The aim of this study was to investigate the diagnosis delay and its impact on the stage of disease. The study also evaluated a nuclear DNA content, immunohistochemical expression of Ki-67 and bcl-2, and the correlation of these biological features with the clinicopathological features and patient outcome. 200 Libyan women, diagnosed during 2008–2009 were interviewed about the period from the first symptoms to the final histological diagnosis of breast cancer. Also retrospective preclinical and clinical data were collected from medical records on a form (questionnaire) in association with the interview. Tumor material of the patients was collected and nuclear DNA content analysed using DNA image cytometry. The expression of Ki-67 and bcl-2 were assessed using immunohistochemistry (IHC). The studies described in this thesis show that the median of diagnosis time for women with breast cancer was 7.5 months and 56% of patients were diagnosed within a period longer than 6 months. Inappropriate reassurance that the lump was benign was an important reason for prolongation of the diagnosis time. Diagnosis delay was also associated with initial breast symptom(s) that did not include a lump, old age, illiteracy, and history of benign fibrocystic disease. The patients who showed diagnosis delay had bigger tumour size (p<0.0001), positive lymph nodes (p<0.0001), and high incidence of late clinical stages (p<0.0001). Biologically, 82.7% of tumors were aneuploid and 17.3% were diploid. The median SPF of tumors was 11% while the median positivity of Ki-67 was 27.5%. High Ki-67 expression was found in 76% of patients, and high SPF values in 56% of patients. Positive bcl-2 expression was found in 62.4% of tumors. 72.2% of the bcl-2 positive samples were ER-positive. Patients who had tumor with DNA aneuploidy, high proliferative activity and negative bcl-2 expression were associated with a high grade of malignancy and short survival. The SPF value is useful cell proliferation marker in assessing prognosis, and the decision cut point of 11% for SPF in the Libyan material was clearly significant (p<0.0001). Bcl-2 is a powerful prognosticator and an independent predictor of breast cancer outcome in the Libyan material (p<0.0001). Libyan breast cancer was investigated in these studies from two different aspects: health services and biology. The results show that diagnosis delay is a very serious problem in Libya and is associated with complex interactions between many factors leading to advanced stages, and potentially to high mortality. Cytometric DNA variables, proliferative markers (Ki-67 and SPF), and oncoprotein bcl-2 negativity reflect the aggressive behavior of Libyan breast cancer and could be used with traditional factors to predict the outcome of individual patients, and to select appropriate therapy.

Yleislääkärin vastaanottotapahtuma - näkökulmia laatuun

Tutkimuksen tavoitteena oli tutkia yleislääkärin vastaanottotapahtuman laadun eri ulottuvuuksia, erityisesti lääkärin ja potilaan arvioita vastaanottotapahtuman laadusta, sekä verrata näitä arvioita keskenään. Lisäksi tarkoituksena oli tutkia palkkausjärjestelmän yhteyttä laatuun sekä löytää sopivia välineitä yleislääkärin vastaanottotapahtuman laadun arviointiin. Tutkimuksessa käytettiin triangulaatiota sekä materiaalien, tutkijoiden että menetelmien osalta. Materiaali koostui kyselylomakkeista (2191 vastaanottotapahtumaa, 2167 lääkärin lomaketta ja 1777 potilaan lomaketta), potilasasiakirjoista (n=175) ja vastaanottotapahtumien videoinneista (n=20). Analyysissä käytettiin sekä kvantitatiivisia että kvalitatiivisia menetelmiä. Laatu koostuu tässä tutkimuksessa tieteellisteknisestä/ammatillisesta osaamisesta, vuorovaikutustaidoista ja taloudellisesta laadusta. Kaikki osatekijät olivat kyselylomaketutkimuksen perusteella varsin hyviä, ja potilaat arvioivat laadun kaikki osatekijät paremmiksi kuin lääkärit. Potilaiden selviytyminen ja voimaantuminen vastaanottotapahtuman jälkeen oli parempaa, mikäli he pitivät vuorovaikutuksen laatua hyvänä ja lääkäriä omalääkärinään. Kyselylomaketutkimus antoi laadusta kuitenkin positiivisemman kuvan kuin tutkijoiden potilasasiakirjojen ja videointien avulla tekemät arviot. Potilasasiakirjat oli laadittu puutteellisesti ja potilasasiakirjajärjestelmät vaikuttivat postilaisasiakirjojen laatuun. Tutkijoiden arvioimana lääkäreiden vuorovaikutustaidot olivat keskimäärin tyydyttävät. Lääkärin virkaehtosopimus ei näyttänyt vaikuttavan potilaan kokemaan laatuun, mutta väestövastuulääkärit kokivat sekä oman työnsä ammatillisen laadun että vuorovaikutustaitonsa paremmaksi kuin muut lääkärit. Väestövastuuterveyskeskuksissa myös hoidon jatkuvuus ja potilaan valinnanvapaus näyttivät toteutuvan muita terveyskeskuksia paremmin. Yleislääkärin työn laadun arviointiin tarvitaan useita menetelmiä. Potilasasiakirjajärjestelmien tulisi olla helppokäyttöisiä, interaktiivisia ja tietoa automaattisesti kerääviä, jotta niistä saataisiin luotettavaa tietoa laadun arvioimiseksi. Lääkärin työn itsearviointia on edelleen tutkittava ja kehitettävä.

Skannausratkaisun ja yleisarkiston käyttöönotto potilasasiakirjojen käsittelyyn terveydenhuollossa

Julkinen terveydenhuolto on muutoksen ja monien haasteiden edessä, kun palveluiden kysyntä ja laatuvaatimukset kasvavat. Julkisen sektorin taloudellinen tilanne aiheuttaa paineita kustannusten pienentämiseksi ja toimintojen keskittämiseen. Muutoksista huolimatta terveydenhuollon henkilökunnalla tulee olla mahdollisimman helppo ja nopea pääsy potilasta koskeviin ajantasaisiin ja olennaisiin tietoihin. Tämä diplomityö tarkastelee tietojärjestelmän käyttöönottoprosessia, paperisten potilasasiakirjojen digitalisointia ja niiden hyödyntämistä hoitoprosessissa. Tutkimuksessa esitellään paperilähetteiden käsittely, skannausratkaisun käyttöönotto ja integrointi HUS:n XDS-yleisarkistoon. Tutkimuksen teoreettinen viitekehys koostuu käyttöönottoprosessista ja siihen liittyvistä haasteista, onnistumiseen vaikuttavista tekijöistä sekä onnistumiseen mittaamiseen käytettävissä olevista malleista ja mittareista. Tietojärjestelmän käyttöönoton onnistumiseen vaikutti erityisesti ennakkosuunnittelu ja muutosvastarinnan ymmärtäminen. Tietojärjestelmän käyttöönotossa havaittiin, että muutos hyväksytään käyttäjien osalta, kun se vastaa käyttäjien todelliseen tarpeeseen. Erityisesti lähetteiden käsittely sähköisessä muodossa koettiin hyödylliseksi ja tarpeelliseksi, koska tämä mahdollisti potilastietojen saatavuuden paikasta ja ajasta riippumatta ja tuki potilaan hoitoprosessia. Käyttöönotossa havaittiin, että skannausprosessi ei voi olla samanlainen kaikkialla, koska eri yksiköissä tapahtuva skannaus voi olla potilaskeskeistä tai asiakirjatyyppien mukaan tai kompeksista ja suuriin määriin perustuvaa.