International PCD (iPCD) Cohort and International PCD Registry: characteristics and methods
| iPCD Cohort | International PCD Registry | |
| Study design | Cohort study, collaborative dataset | Registry |
| Year founded | 2013 | 2014 |
| Inclusion criteria | National, collaborative or single-centre datasets of patients (any age) diagnosed and treated for PCD | National, collaborative or single-centre datasets of patients (any age) diagnosed and treated for PCD |
| National legal and ethical requirements met by participating centre | National legal and ethical requirements met by participating centre | |
| Both cross-sectional and longitudinal datasets accepted (longitudinal encouraged) | ||
| Patients with probable or confirmed PCD diagnosis who are treated as PCD in the participating centres, ranging from clinical presentation consistent with PCD to diagnosis established with several PCD diagnostic tests based on the European Respiratory Society diagnostic recommendations | Patients with a confirmed PCD diagnosis fulfilling the following diagnostic criteria: clinical presentation consistent with PCD and consistent findings specific for PCD by at least two methods (high-frequency video microscopy analysis, transmission electron microscopy, immunofluorescence microscopy and low nasal nitric oxide concentration/production or biallelic disease-causing mutations by genotyping) | |
| Written informed consent needed for prospective data, depending on national laws | Entering individual patients requires written informed consent by the patient or his/her legal guardian(s) | |
| Patients (2019) n | 3824 | 920 |
| Participating countries | Argentina, Australia, Belgium, Canada, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, Serbia, Spain, Switzerland, Turkey, UK, USA | Austria, Belgium, Canada, Cyprus, Denmark, France, Greece, Germany, Italy, Netherlands, Slovakia, Spain, Switzerland, Turkey, UK, USA |
| Prospective/retrospective | Retrospective and prospective | Prospective (and retrospective) |
| Type of data | Pseudo-anonymised | Pseudo-anonymised |
| ClinicalTrials.gov identifier | NCT03517865 | NCT02419365 |
| Database | REDCap database | Internet-based data entry system; will be transferred to REDCap October 2019 |
| Easy data import and export in several formats | Easy data import and export in several formats | |
| Each collaborator has access to own data | Each collaborator has access to own data | |
| Basic data set is monitored for completeness, further items are currently checked manually for plausibility by experts | ||
| Funding | EU-funded BESTCILIA project (FP7/2007–2013) under grant agreement 305404, Swiss National Science Foundation 320030_173044, Pro-Kartagener Foundation Milena Karvajal and institutional funding |
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| Host institution | Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland www.ispm.unibe.ch | University Hospital Muenster, Westphalian University of Muenster, Muenster, Germany www.ukm.de www.pcdregistry.eu |
| To contribute data | Contact: pcd@ispm.unibe.ch | Contact: PCDRegistry.eu@ukmuenster.de |
EU: European Union.