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Development of a repository of individual participant data from randomized controlled trials of therapists delivered interventions for low back pain
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Hee, Siew Wan, Dritsaki, Melina, Willis, Adrian, Underwood, Martin and Patel, Shilpa (2017) Development of a repository of individual participant data from randomized controlled trials of therapists delivered interventions for low back pain. European Journal of Pain, 21 (5). pp. 815-826. doi:10.1002/ejp.984
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Official URL: http://doi.org/10.1002/ejp.984
Abstract
Background
Individual patient data (IPD) meta-analysis of existing randomised controlled trials (RCTs) is a promising approach to achieving sufficient statistical power to identify sub-groups. We created a repository of IPD from multiple low back pain (LBP) RCTs to facilitate a study of treatment moderators. Due to sparse heterogeneous data, the repository needed to be robust and flexible to accommodate millions of data points prior to any subsequent analysis.
Methods
We systematically identified RCTs of therapist delivered intervention for inclusion to the repository. Some were obtained through project publicity. We requested both individual items and aggregate scores of all baseline characteristics and outcomes for all available time points. The repository is made up of a hybrid database: entity-attribute-value and relational database which is capable of storing sparse heterogeneous datasets. We developed a bespoke software program to extract, transform and upload the shared data.
Results
There were 20 datasets with more than 3 million data points from 9328 participants. All trials collected covariates and outcomes data at baseline and follow-ups. The bespoke standardised repository is flexible to accommodate millions of data points without compromising data integrity. Data are easily retrieved for analysis using standard statistical programs.
Conclusions
The bespoke hybrid repository is complex to implement and to query but its flexibility in supporting datasets with varying sets of responses and outcomes with different data types is a worthy trade off. The large standardised LBP dataset is also an important resource useable by other LBP researchers.
| Item Type: | Journal Article | ||||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RD Surgery |
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Backache, Medical records -- Databases, Clinical trials | ||||||||
| Journal or Publication Title: | European Journal of Pain | ||||||||
| Publisher: | Elsevier Ltd. | ||||||||
| ISSN: | 1090-3801 | ||||||||
| Official Date: | May 2017 | ||||||||
| Dates: |
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| Date of first compliant deposit: | 21 June 2017 | ||||||||
| Volume: | 21 | ||||||||
| Number: | 5 | ||||||||
| Page Range: | pp. 815-826 | ||||||||
| DOI: | 10.1002/ejp.984 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Open Access | ||||||||
| Funder: | National Institute for Health Research (Great Britain). Applied Research Programme (ARP NIHR) | ||||||||
| Grant number: | RP-PG-0608-10076 |
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