Last updated on April 2018

Swiss Paediatric Airway Cohort


Brief description of study

The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via annual questionnaires to families, monthly mobile phone symptom scores, and data from follow-up visits.

Currently, 350 patients from four major hospitals (Bern, Zurich, Basel and Lucerne) have been enrolled, but other clinics and practices will join and the investigators aim for at least 3000 patients.

SPAC will provide real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies.

Detailed Study Description

Background

Many studies have investigated the epidemiology of asthma in childhood, but most were based on data from the general population gathered either in cross-sectional or longitudinal surveys in schoolchildren.

Objectives

The Swiss Paediatric Airway Cohort (SPAC) was set up in 2017 as a large, longitudinal database that is representative of children and adolescents visiting physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory symptoms. It will constitute a national research platform for studying healthcare provision, phenotypes and prognosis of these problems, and a sampling frame for conducting nested studies.

Methods

Recruitment and participation:

The SPAC study recruits patients aged 0-16 that are referred to a paediatric outpatient clinic for recurrent respiratory symptoms. Families receive a SPAC information package containing an invitation letter, study information leaflet, informed consent form, and questionnaire. Physicians introduce the study to them, answer questions, and collect informed consent forms. Completed questionnaires are brought by families to the clinics or sent directly by families to the SPAC study centre using a prepaid return envelope. Eligible patients have consultations in participating clinics regardless of their study participation. No tests are performed specifically for SPAC; examinations and tests are done only if clinically indicated or ordered by the referring physician. Examinations such as lung function, allergy, blood, or bronchial challenge tests are done using respective standard procedures in the clinics. SPAC research team members visit participating centres at regular intervals to collect data. One year after enrolment in SPAC, caregivers or patients who are 16 or older will receive a follow-up questionnaire by email, sms, or post.

Information collected:

Questionnaires

At baseline families complete a detailed questionnaire that includes sections on frequency, duration, severity, triggers, and history of upper and lower respiratory symptoms, and diagnoses, treatments, health behaviours, environmental factors, family history, and contact information.

The follow-up questionnaires are shorter and focus on symptoms, treatments, and important risk factors during the past 12 months. Postal addresses for mailing are obtained from hospital records and updated by contacting community registration offices, a procedure used successfully for other registries and cohort studies in Switzerland. Questionnaires are currently available in German, but will be translated into French and Italian.

Medical records:

Information obtained from medical records includes reasons for referral; anthropometric measures; results from the physical examination and diagnostic tests including pulmonary function, allergy, and blood tests; information about asthma control; and final diagnoses and prescribed treatments.

Linkage to routine data:

For specific analyses, probabilistic record linkage will be used to merge data from SPAC with routine datasets collected by the Swiss Federal Statistical Office.

Study database:

The SPAC 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.

Current status of the project:

The first four clinics began recruiting patients in 2017: Lucerne, Bern, Zurich, and Basel. Currently, 350 patients are enrolled in the SPAC study.

Funding

Setting up SPAC was funded by the Swiss National Science Foundation (SNF32003B_162820), and several local funding bodies including the Lung League of St. Gallen and the Allergiestiftung Ulrich Mller-Gierok.

Clinical Study Identifier: NCT03505216

Contact Investigators or Research Sites near you

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Claudia E Kuehni, Prof

Institute of Social and Preventive Medicine
Bern, Switzerland
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Recruitment Status: Open


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