Affiliation:
1. University of Liverpool
Abstract
Abstract
Background:
Healthcare systems data (HSD) has the potential to optimize efficiency of randomized controlled trials (RCTs), by decreasing trial specific data demands. Therefore, use of HSD in trials is expected to increase. In 2019, it was estimated that 47% of NIHR funded trials were planning to use HSD. We aim to understand the extent and nature of its current use and its evolution over time.
Methods:
We identified a cohort of RCTs within the NIHR Journals Library that commenced after 2019 and were described as being in progress at 6th June 2022. Details on the source and use of HSD were extracted from eligible RCTs. The use of HSD was categorised according to whether it was used as the sole data source for outcomes and whether the outcomes were primary or secondary. HSD is often insufficient for patient reported outcomes (PROs). We aimed to determine methods used by trialists for collecting PRO data alongside HSD.
Results:
Of the 84 eligible studies, 52 (62%) used HSD, and 79 (94%) collected PROs. The number of RCTs using HSD for at least one outcome was 28 (54%) with 24 of these using HSD as the sole data source for at least one outcome.
The number of studies using HSD for primary and secondary outcomes were 10 (20%) and 21 (40%) respectively. The sources of HSD were National Health Service (NHS) Digital 37 (79%), patient registries 7 (29%), primary care 5 (21%), The Office for National Statistics (ONS) 3 (13%), and other 2 (8%).
PROs were collected for 92% of the trials using HSD. Methods for collection of PROs included in-person 26 (54%), online 22 (46%), postal 18 (38%), phone 14 (29%), app 2 (4%).
Conclusions:
HSD is being used in around two thirds of the studies but cannot yet be used to support PRO data collection within the cohort we examined. Comparison with an earlier cohort demonstrates an increase in the number of RCTs planning to use HSD.
Publisher
Research Square Platform LLC
Cited by
1 articles.
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