,
van den Beld, Maaike J. C. http://orcid.org/0000-0001-8720-8434
Warmelink, Esther
Friedrich, Alexander W.
Reubsaet, Frans A. G.
Schipper, Maarten
de Boer, Richard F.
Notermans, Daan W.
Petrignani, Mariska W. F.
van Zanten, Evert
Rossen, John W. A.
Friesema, Ingrid H. M.
Kooistra-Smid, A. M. D. ( Mirjam)
Funding for this research was provided by:
Dutch National Institute for Public Health for local public health services (Not applicable)
Article History
Received: 6 September 2019
Accepted: 25 November 2019
First Online: 9 December 2019
Ethics approval and consent to participate
: Patients were informed about the study and subjected to a single survey during a telephone interview to collect clinical and epidemiological data. To increase the response rate in order to obtain sufficient statistical power in a reasonable inclusion period, verbal informed consents were obtained from the patients before and after the telephone interview; these consents were digitally registered. One of the parents or guardians was asked to participate in the survey in case of minors. The medical ethics review board (METC) in Utrecht, the Netherlands, stated that this study design was not subject to “medical research with human subjects” laws (protocol number 15–414/C). Data collection of patients took place in 2016 and 2017 and complied with the Dutch Personal Data Protection Act. Data handling complied with the EU General Data Protection Regulation, which was operative from May 2018. The IBESS-study was registered as observational study under number 23481 in the Dutch Trial Register.
: Not applicable.
: The authors declare that they have no competing interests.