Introduction

There is potential for a paradigm shift from a biopsy- to a serology-based diagnosis of coeliac disease in selected adults. However, it remains unknown if this approach would be acceptable to patients. We aimed to explore patients’ views and preferences regarding the no-biopsy approach for coeliac disease diagnosis.

Aims & Methods

We developed a discrete choice experiment survey containing 12 different scenarios with 2 possible alternatives (endoscopy & biopsy or serology), to estimate patient preferences. The scenarios were based on 5 attributes: risk of false positive results, risk of missed diagnosis, waiting time to start treatment, risk of complications, discomfort, or pain. Patient preferences and the relative importance of the attributes were estimated using a mixed logit model.

Results

In total, 385 people (70.6% female, 98.2% white) completed the survey. Respondents preferred a serology-based diagnosis over endoscopy and duodenal biopsies (59% vs 41%, β coefficient = 1.88, p <0.001). Diagnostic test accuracy (p<0.001), shorter waiting time to start treatment (p<0.001), and discomfort levels during the procedure (p<0.001) were the most important attributes to respondents. The risk of complications, including perforation and bleeding, did not significantly influence respondents' choices. Respondents with previous endoscopy experience were more willing to undergo endoscopy compared with those who never had one.

Conclusion

The no-biopsy approach to diagnosing coeliac disease is acceptable and preferred by patients over endoscopy and biopsy. Our findings highlight the importance of patient-centred care and shared decision-making in guiding diagnostic strategies for optimal patient outcomes.

Introduction

Recent evidence supports diagnosing coeliac disease without biopsy in patients with significantly elevated tissue transglutaminase (IgA-tTG) antibodies. However, the implementation of this no-biopsy approach relies on accurate and consistent serological testing across laboratories. In this nationwide survey, we aimed to evaluate the availability and variability of coeliac disease testing across the United Kingdom.

Aims & Methods

We conducted a cross-sectional telephone survey of biomedical scientists and laboratory managers from NHS trusts and health boards across England, Wales, Scotland, and Northern Ireland. Data collected included assay types, reporting methods, upper limit of normal (ULN) thresholds, turnaround times, total IgA testing, the availability of anti-endomysial antibodies (EMA),

Results

A total of 356 sites were approached, with a 96% response rate (n=342). Of responding sites, 177 performed coeliac serology tests in-house, while 165 transferred samples externally. Among sites performing tests, 12 different tTG assays were identified, with considerable variability in ULN thresholds ranging from 3 to 30 IU/mL, even within laboratories using the same assays. The median turnaround time for IgA-tTG results was 7 days (range 1–21 days). Only 43% of laboratories routinely measured total IgA when IgA-tTG was requested. EMA testing was available in 83% of laboratories.

Conclusion

Significant variability exists in coeliac serology testing across UK laboratories which poses a challenge for the implementation of the no-biopsy approach in clinical practice. Efforts to standardise serological testing are urgently needed. Until such standardisation is achieved, local assay validation remains critical.

Disclosure

MGS and HAP received speaker fees from Thermo Fisher.