Since 2014
Register or electronic health records enriched randomized pragmatic trials: The future of clinical effectiveness and cost-effectiveness trials?
Nordic Journal of Health Economics
View Archive Info| Field | Value | |
| Title |
Register or electronic health records enriched randomized pragmatic trials: The future of clinical effectiveness and cost-effectiveness trials?
|
|
| Creator |
Ramsberg, Joakim; Department of Learning, Informatics, Management and Ethics, Medical Management Center, Karolinska Institutet, Stockholm, Sweden Neovius, Martin; Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden |
|
| Subject |
—
clinical trials, pragmatic trials, disease registries, electronic health records, costs I100, I190 |
|
| Description |
For many interventions in health care, there is limited information on efficacy, safety and cost-effectiveness even long after they have been implemented. To decide between treatments, the randomized controlled trial (RCT) provides the strongest evidence. This creates a problem because RCTs are very expensive, logistically challenging and generally cumbersome. Observational studies are inexpensive, but create weaker evidence. The pragmatic randomized trial, enriched with routinely collected register or electronic health record (EHR) data may be a solution to this dilemma since they are much less costly than traditional RCTs but create much stronger evidence than observational studies. Pragmatic randomized trials mean that patients in routine care are randomly allocated to alternative treatments. The outcome of the treatment is then followed up in existing registers with patient data. This means that it is possible to 1) follow patients in the normal care situation - unlike the often artificial situation in the traditional RCT, 2) that the costs are low, even for large studies and 3) that a broad spectrum of outcomes, including both health and economic outcomes, can be collected. Pragmatic randomized trials using register or EHR data in principle lend themselves well to health economic evaluations. We have identified a number of such trials in the literature. Very few, however, include economic outcomes.
|
|
| Publisher |
University of Oslo
|
|
| Contributor |
—
|
|
| Date |
2015-03-14
|
|
| Type |
info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion — |
|
| Format |
application/pdf
|
|
| Identifier |
https://www.journals.uio.no/index.php/NJHE/article/view/1386
10.5617/njhe.1386 |
|
| Source |
Nordic Journal of Health Economics; Vol 5, No 1 (2017): Special issue: The value of new technology; pp. 62-76
1892-9710 1892-9729 |
|
| Language |
eng
|
|
| Relation |
https://www.journals.uio.no/index.php/NJHE/article/view/1386/1275
|
|
| Rights |
Authors who publish with this journal agree to the following terms:Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal. Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
|
|