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Real-Time Monitoring of Healthcare Interventions in Routine Care: Effectiveness and Safety of Newly Introduced Medicines
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiovascular epidemiology. (Kardiologi)ORCID iD: 0000-0001-7998-6017
2016 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Before market authorization of new medicines, their efficacy and safety are evaluated using randomized controlled trials. While there is no doubt about the scientific value of randomized trials, they are usually conducted in selected populations with questionable generalizability to routine care. 

In the digital data revolution era, with healthcare data growing at an unprecedented rate, drug monitoring in routine care is still highly under-utilized. Although many countries have access to data on prescription drugs at the individual level in ambulatory care, such data are often missing for hospitals. This is a growing problem considering the clear trend towards more new and expensive drugs administered in the hospital setting. The aim of this thesis was therefore to develop methods for extracting data on drug use from a hospital-based electronic health record system and further to build and evaluate models for real-time monitoring of effectiveness and safety of new drugs in routine care using data from electronic health records and regional and national health care registers.

Using the developed techniques, we were able to demonstrate drug use and health service utilization for inflammatory bowel disease and to evaluate the comparative effectiveness and safety of antiarrhythmic drugs.

With a rapidly evolving drug development, it is important to optimize the evaluation of effectiveness, safety and health economic value of new medicines in routine care. We believe that the models described in this thesis could contribute to fulfil this need.

Place, publisher, year, edition, pages
Uppsala: Uppsala University, 2016. , 76 p.
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1260
Keyword [en]
Electronic Health Records, Comparative Effectiveness Research, Comparative Safety Research, Sequential drug monitoring, propensity score, real-world data, infliximab, TNF-inhibitors, dronedarone, amiodarone, flecainide
National Category
Public Health, Global Health, Social Medicine and Epidemiology Public Health, Global Health, Social Medicine and Epidemiology
Research subject
Pharmacoepidemiology
Identifiers
URN: urn:nbn:se:uu:diva-304324ISBN: 978-91-554-9707-1OAI: oai:DiVA.org:uu-304324DiVA: diva2:1015130
Public defence
2016-11-19, Rudbeckssalen, Dag Hammarskjölds väg 20, Uppsala, 09:15 (English)
Opponent
Supervisors
Available from: 2016-10-26 Created: 2016-10-04 Last updated: 2016-11-02
List of papers
1. Extraction of Electronic Health Record Data in a Hospital Setting: Comparison of Automatic and Semi-Automatic Methods Using Anti-TNF Therapy as Model
Open this publication in new window or tab >>Extraction of Electronic Health Record Data in a Hospital Setting: Comparison of Automatic and Semi-Automatic Methods Using Anti-TNF Therapy as Model
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2013 (English)In: Basic & Clinical Pharmacology & Toxicology, ISSN 1742-7835, E-ISSN 1742-7843, Vol. 112, no 6, 392-400 p.Article in journal (Refereed) Published
Abstract [en]

There is limited experience and methods for extractions of drug therapy data from electronic health records (EHR) in the hospital setting. We have therefore developed and evaluated completeness and consistency of an automatic versus a semi-automatic extraction procedure applied on prescribing and administration of the TNF inhibitor infliximab using a hospital EHR system in Karolinska University Hospital, Sweden. Using two different extraction methods (automatic and semi-automatic), all administered infusions of infliximab between 2007 and 2010 were extracted from a database linked to the EHR system. Extracted data included encrypted personal identity number (PIN), date of birth, sex, time of prescription/administration, healthcare units, prescribed/administered dose and time of admission/discharge. The primary diagnosis (ICD-10) for the treatment with infliximab was extracted by linking infliximab infusions to their corresponding treatment episode. A total of 13,590 infusions of infliximab were administered during the period of 2007 to 2010. Of those were 13,531 (99.6%) possible to link to a corresponding treatment episode, and a primary diagnosis was extracted for 13,530 infusions. Information on encrypted PIN, date of birth, time of prescription/administration, time of admission/discharge and healthcare unit was complete. Information about sex was missing in one patient only. Calculable information about dosage was extracted for 13,300 (98.3%) of all linked infusions. This methodological study showed the potential to extract drug therapy data in a hospital setting. The semi-automatic procedure produced an almost complete pattern of demographics, diagnoses and dosages for the treatment with infliximab.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-202351 (URN)10.1111/bcpt.12055 (DOI)000319212100004 ()
Available from: 2013-06-24 Created: 2013-06-24 Last updated: 2016-10-04Bibliographically approved
2. Healthcare Utilisation and Drug Treatment in a Large Cohort of Patients with Inflammatory Bowel Disease
Open this publication in new window or tab >>Healthcare Utilisation and Drug Treatment in a Large Cohort of Patients with Inflammatory Bowel Disease
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2016 (English)In: Journal of Crohn's & Colitis, ISSN 1873-9946, E-ISSN 1876-4479, Vol. 10, no 5, 556-565 p.Article in journal (Refereed) Published
Abstract [en]

Crohn's disease [CD] and ulcerative colitis [UC] are chronic diseases associated with a substantial utilisation of healthcare resources. We aimed to estimate the prevalence of inflammatory bowel disease [IBD], CD, and UC and to describe and compare healthcare utilisation and drug treatment in CD and UC patients. This was a cross-sectional study of all patients with a recorded IBD diagnosis in Stockholm County, Sweden. Data on outpatient visits, hospitalisations, surgeries, and drug treatment during 2013 were analysed. A total of 13 916 patients with IBD were identified, corresponding to an overall IBD prevalence of 0.65% [CD 0.27%, UC 0.35%, inflammatory bowel disease unclassified 0.04%]; 49% of all IBD patients were treated with IBD-related drugs. Only 3.6% of the patients received high-dose corticosteroids, whereas 32.4% were treated with aminosalicylates [CD 21.2%, UC 41.0%, p < 0.0001]. More CD patients were treated with biologicals compared with UC patients [CD 9.6%, UC 2.9%, p < 0.0001] and surgery was significantly more common among CD patients [CD 3.0%, UC 0.8%, p < 0.0001]. This study indicates that patients with CD are the group with the highest medical needs. Patients with CD utilised significantly more healthcare resources [including outpatient visits, hospitalisations, and surgeries] than UC patients. Twice as many CD patients received immunomodulators compared with UC patients and CD patients were treated with biologicals three times more often. These results highlight that CD remains a challenge and further efforts are needed to improve care in these patients.

Keyword
Inflammatory bowel disease, healthcare utilisation, drug treatment
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-298688 (URN)10.1093/ecco-jcc/jjv243 (DOI)000376391100008 ()26733406 (PubMedID)
Available from: 2016-07-07 Created: 2016-07-06 Last updated: 2016-10-04Bibliographically approved
3. An Automatized Model for Sequential Monitoring of Effectiveness of New Drugs using Dronedarone as Example
Open this publication in new window or tab >>An Automatized Model for Sequential Monitoring of Effectiveness of New Drugs using Dronedarone as Example
(English)Manuscript (preprint) (Other academic)
Keyword
comparative effectiveness research, comparative safety research, propensity score, dronedarone, flecainide, sequential monitoring
National Category
Cardiac and Cardiovascular Systems
Research subject
Pharmacoepidemiology
Identifiers
urn:nbn:se:uu:diva-304322 (URN)
Available from: 2016-10-04 Created: 2016-10-04 Last updated: 2016-10-10
4. Dronedarone and Hepatic Toxicity? A Model for Evaluation of Post-Marketing Safety of Drugs in Routine Care
Open this publication in new window or tab >>Dronedarone and Hepatic Toxicity? A Model for Evaluation of Post-Marketing Safety of Drugs in Routine Care
(English)Manuscript (preprint) (Other academic)
Keyword
dronedarone, amidoarone, safety, propensity score, liver enzyme
National Category
Cardiac and Cardiovascular Systems
Research subject
Pharmacoepidemiology
Identifiers
urn:nbn:se:uu:diva-304323 (URN)
Available from: 2016-10-04 Created: 2016-10-04 Last updated: 2016-10-10

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