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Authors
Gal, Roxanne
Monninkhof, Evelyn M.
van Gils, Carla H.
Groenwold, Rolf H. H.
Elias, Sjoerd G.
van den Bongard, Desirée H. J. G.
Peeters, Petra H. M.
Verkooijen, Helena M.
May, Anne M. https://orcid.org/0000-0003-0643-3790
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Funding
Funding for this research was provided by:
ZonMw (016.156.050)
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Article History
Received: 8 April 2021
Accepted: 8 August 2021
First Online: 24 August 2021
Declarations
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: The authors declare no potential conflicts of interest.
: This study was conducted according to the principles of the Declaration of Helsinki (Forteleza, October 2013: ) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The study has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht (15-166/D).
: Within the TwiCs design, a stage-informed consent procedure is applied []. In the first stage, at cohort entry, patients are asked for consent to participate in the cohort study (collection of medical and patient reported outcomes) and for consent to be randomized for future intervention studies within the cohort. Next, patients who are randomly selected for the intervention group in a RCT within the cohort are asked for consent to participate in the intervention study.
