The EPICD-PCD is hosted at the Institute of Social and Preventive Medicine (ISPM) at the
University of Bern, Switzerland. Research is performed in close collaboration with all
data contributors. This study aims to characterise ENT disease in PCD patients and its
association with lower respiratory disease, and to identify determinants of its
prognosis.
The investigators aim to:
Assess the prevalence and severity of sinonasal and otologic symptoms and the
frequency and range of signs and physiological findings assessed during standardised
ENT physical examination, and describe differences by age;
Study the association of sinonasal and otologic disease with lower respiratory
disease in PCD patients;
Identify determinants of disease course and prognosis of sinonasal and otologic
disease in PCD patients.
Study design:
The EPIC-PCD is a prospective observational clinical cohort study, set up as a
multinational multi-centre study. It is embedded into routine patient care of
participating reference centres for PCD and patients will keep being managed according to
local procedures and guidelines.
Patients with PCD are followed regularly at each centre, at 3-month to 6-month intervals.
Each patient undergoes a detailed ENT sinonasal and otologic examination by ENT
specialists, at minimum once a year, during a programmed follow-up visit. Additional ENT
examinations are performed if indicated during in-between follow-up visits. Patients will
not be subjected to additional invasive measurements solely for the purposes of the
study.
What information is collected:
The study collect clinical data from patients assessment at regular consultations at the
outpatient clinics.
For the collection of clinical data, participating centres will use FOLLOW-PCD, a
disease-specific form for standardised prospective data collection during routine
clinical follow-up of PCD patients.
Study database:
The EPIC-PCD database is web-based, using the Research Electronic Data Capture (REDCap)
platform developed at Vanderbilt University. REDCap is widely used in academic research
and allows data entry and extraction in various formats.
How to participate:
Centres that wish to participate to the project and contribute data can contact the
EPIC-PCD managing centre to sign a data delivery agreement. They then will receive a
password to access the online software REDCap and they will be able to enter their data
directly. They can also upload follow-up data or add additional patients at a later time
point.
Funding:
The setting up of the EPIC-PCD (salaries, consumables and equipment) was funded by the
Swiss National Science Foundation. Data collection and management at each site was funded
according to local arrangements. Most participating researchers and data contributors
participate in the European Respiratory Society Clinical Research collaboration "Better
Evidence to Advance Therapeutic options for PCD" (BEAT-PCD)
(https://beat-pcd.squarespace.com/). Infrastructure is provided for free by the
University of Bern, where the data are pooled and stored.