OBJECTIVES:

INTREPID was a pragmatic clinical trial, which assessed the effectiveness of single-inhaler triple therapy (fluticasone furoate/umeclidinium/vilanterol) in the treatment of COPD. An exploratory objective of the study was to use linked routine English healthcare data to assess the validity and practicality of future pragmatic trials using this as a method to ascertain healthcare resource utilisation (HCRU) outcomes.

METHODS:

Linked secondary care medical record data were obtained from English INTREPID participants who consented to linkage to the Hospital Episode Statistics (HES) database. HCRU was summarised during the 12 months prior to index (baseline), and for up to 6 months post-index (follow-up) to assess face validity of the data.

RESULTS:

629 patients consented to data linkage. During baseline, 72 patients had an inpatient admission for COPD (mean 1.61 [SD: ±1.03]) and during follow-up, 42 patients had a COPD-related inpatient admission (mean 1.29 [SD: ±0.46]). 67 patients (mean 1.58 [SD: ±0.87]) and 40 patients (mean 1.23 [SD: ±0.42]), during baseline and follow-up, respectively, had unplanned admissions. Mean length of stay was 4.60 days (SD: ±2.57) and 4.43 days (SD: ±3.08), respectively, during baseline and follow-up.

In total, 66 patients and 41 patients during baseline and follow-up, respectively, had COPD A&E attendances (baseline mean: 1.45 [SD: ±1.0]) vs. follow-up mean: 1.32 [SD: ±0.61]); 100% and 80% were unplanned COPD-related A&E attendances.

Overall, 441 patients and 357 patients, during baseline and follow-up, respectively, had all-cause outpatient attendances (baseline mean: 6.05 [SD: ± 6.35] vs. follow-up mean: 3.5 [SD: ±3.41]).

CONCLUSIONS:

Linked HCRU data were available for INTREPID patients with greater granularity than data generally available from prospectively collected patient recall of HCRU in pragmatic studies. Future studies should consider the benefits of using linked routine hospital data alongside prospectively collected data in pragmatic trials in routine practice in England.

Funding: GSK (study 206854)