242 7 Chapter 7 Ethics approval and consent to participate The cognitive interview study and the FitKnip study were cleared for ethics by the Medical Ethical Review Committee of the Leiden University Medical Centre (No. 19 – 078 and No. P20.001, respectively). All methods were carried out in accordance with relevant guidelines and regulations. Informed consent to participate in the study was obtained from all participants. Consent for publication Not applicable Availability of data and materials Individual de-identified participant data supporting findings of study 1 are available from corresponding author on reasonable request. The raw data that support the findings of study 2 are available from the FitKnip study but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of the FitKnip study investigators at the Leiden University Medical Centre (fitknip@lumc.nl) Competing interests The authors declare that they have no competing interests Funding The study was partly funded by the National eHealth Living Lab (NeLL), the Netherlands. RHO was funded in part through a National Health and Medical Research Council (NHMRC) of Australia Principal Research Fellowship (APP1155125). Authors contribution CP and EM conceptualized and designed the study. CP, EM and LK contributed to the translation. CP coordinated data collection and the overall process. CP analysed the data. MF provided statistical advice and support. CP wrote the manuscript and EM and MF and MF provided feedback at each version of the manuscript. LK and NC provided advice in multiple stages of the research. EM, MF, NC, RHO and LK critically reviewed the paper. All authors gave input to the manuscript and approved the last version. Acknowledgements We thank all participants involved in the cognitive interviewing study and the participants of the FitKnip study. We thank the FitKnip investigators (Leiden University Medical Centre) for sharing their data. We gratefully acknowledge the contribution of Annette Rush (licensed translator) and Maria Sherwood (University of Leiden) for their help with the forward and backward translation. We thank Kimberly de Jong (University of Leiden) for her assistance in data collection and Janneke Korst (Leiden University
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