Karunanayake, Aranjan Lionel
Solomon-Moore, Emma
Coghill, Nikki
Article History
Received: 27 March 2022
Accepted: 29 October 2022
First Online: 15 November 2022
Declarations
:
: Ethical approval for the study was obtained by Research Ethics Approval Committee for Health at the University of Bath, United Kingdom (<i>REACH reference number</i>: EP 20/21 037). In addition, permission was obtained by the medical centre management committee in Sri Lanka to conduct the study. Patients will not be subjected to any painful or harmful procedures. Prior to recruitment, all potential participants will receive written information about the nature and purpose of the study and each participant will be requested to sign an informed consent form. Participants will be reassured that they can withdraw from the study at any point in time without giving any reason and that it will not have any effect on their treatment course. A model consent form is provided.The hard and soft copies of the data obtained through the course of study will be anonymised and will be kept in a locked cabinet and password-protected encrypted computer files. The results published from this study will be in the form of data for the whole group. After the study is completed, the data will be protected and stored for a period of ten years.
: Model consent forms have been attached.
: The authors declare no competing interests.