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Real-Time Monitoring of Healthcare Interventions in Routine Care: Effectiveness and Safety of Newly Introduced Medicines
Uppsala universitet, Medicinska och farmaceutiska vetenskapsområdet, Medicinska fakulteten, Institutionen för medicinska vetenskaper, Kardiovaskulär epidemiologi. (Kardiologi)ORCID-id: 0000-0001-7998-6017
2016 (Engelska)Doktorsavhandling, sammanläggning (Övrigt vetenskapligt)
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.

Ort, förlag, år, upplaga, sidor
Uppsala: Uppsala University, 2016. , 76 s.
Serie
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1260
Nyckelord [en]
Electronic Health Records, Comparative Effectiveness Research, Comparative Safety Research, Sequential drug monitoring, propensity score, real-world data, infliximab, TNF-inhibitors, dronedarone, amiodarone, flecainide
Nationell ämneskategori
Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi
Forskningsämne
Farmakoepidemiologi
Identifikatorer
URN: urn:nbn:se:uu:diva-304324ISBN: 978-91-554-9707-1 (tryckt)OAI: oai:DiVA.org:uu-304324DiVA: diva2:1015130
Disputation
2016-11-19, Rudbeckssalen, Dag Hammarskjölds väg 20, Uppsala, 09:15 (Engelska)
Opponent
Handledare
Tillgänglig från: 2016-10-26 Skapad: 2016-10-04 Senast uppdaterad: 2016-11-02
Delarbeten
1. Extraction of Electronic Health Record Data in a Hospital Setting: Comparison of Automatic and Semi-Automatic Methods Using Anti-TNF Therapy as Model
Öppna denna publikation i ny flik eller fönster >>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 (Engelska)Ingår i: Basic & Clinical Pharmacology & Toxicology, ISSN 1742-7835, E-ISSN 1742-7843, Vol. 112, nr 6, 392-400 s.Artikel i tidskrift (Refereegranskat) 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.

Nationell ämneskategori
Medicin och hälsovetenskap
Identifikatorer
urn:nbn:se:uu:diva-202351 (URN)10.1111/bcpt.12055 (DOI)000319212100004 ()
Tillgänglig från: 2013-06-24 Skapad: 2013-06-24 Senast uppdaterad: 2017-12-06Bibliografiskt granskad
2. Healthcare Utilisation and Drug Treatment in a Large Cohort of Patients with Inflammatory Bowel Disease
Öppna denna publikation i ny flik eller fönster >>Healthcare Utilisation and Drug Treatment in a Large Cohort of Patients with Inflammatory Bowel Disease
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2016 (Engelska)Ingår i: Journal of Crohn's & Colitis, ISSN 1873-9946, E-ISSN 1876-4479, Vol. 10, nr 5, 556-565 s.Artikel i tidskrift (Refereegranskat) 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.

Nyckelord
Inflammatory bowel disease, healthcare utilisation, drug treatment
Nationell ämneskategori
Medicin och hälsovetenskap
Identifikatorer
urn:nbn:se:uu:diva-298688 (URN)10.1093/ecco-jcc/jjv243 (DOI)000376391100008 ()26733406 (PubMedID)
Tillgänglig från: 2016-07-07 Skapad: 2016-07-06 Senast uppdaterad: 2017-11-28Bibliografiskt granskad
3. An Automatized Model for Sequential Monitoring of Effectiveness of New Drugs using Dronedarone as Example
Öppna denna publikation i ny flik eller fönster >>An Automatized Model for Sequential Monitoring of Effectiveness of New Drugs using Dronedarone as Example
(Engelska)Manuskript (preprint) (Övrigt vetenskapligt)
Nyckelord
comparative effectiveness research, comparative safety research, propensity score, dronedarone, flecainide, sequential monitoring
Nationell ämneskategori
Kardiologi
Forskningsämne
Farmakoepidemiologi
Identifikatorer
urn:nbn:se:uu:diva-304322 (URN)
Tillgänglig från: 2016-10-04 Skapad: 2016-10-04 Senast uppdaterad: 2016-10-10
4. Dronedarone and Hepatic Toxicity? A Model for Evaluation of Post-Marketing Safety of Drugs in Routine Care
Öppna denna publikation i ny flik eller fönster >>Dronedarone and Hepatic Toxicity? A Model for Evaluation of Post-Marketing Safety of Drugs in Routine Care
(Engelska)Manuskript (preprint) (Övrigt vetenskapligt)
Nyckelord
dronedarone, amidoarone, safety, propensity score, liver enzyme
Nationell ämneskategori
Kardiologi
Forskningsämne
Farmakoepidemiologi
Identifikatorer
urn:nbn:se:uu:diva-304323 (URN)
Tillgänglig från: 2016-10-04 Skapad: 2016-10-04 Senast uppdaterad: 2016-10-10

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