Study Information sheet
Study title: The extent of the treatment and prosthodontics rehabilitation for acquired head and neck defects in South Africa
Dear Sir/Madam
Thank you for taking time to go through this study information sheet. I am Dr Matshediso Mothopi-Peri, and I am a postgraduate student at the University of the Witwatersrand, studying towards a degree in Doctor of Philosophy (PhD) in Maxillo Facial and Oral Surgery. The main aim of this study is to establish the number of the surgical procedures and maxillofacial prosthodontic rehabilitation procedures that are performed in the head and neck region in South Africa and to determine the barriers that clinicians and dental technicians/technologists face whilst managing these patients or giving laboratory technical support.
I am inviting you to take part in this study as one of the professionals in the 6 groups of important role players: Ear Nose and Throat surgeons, Maxillofacial and Oral surgeons, Ophthalmologists, Plastic and Reconstructive surgeons, Prosthodontists and Dental technicians/technologists.
The study is a survey-based study, and it involves responding to an online questionnaire which can be accessed by a QR code or a link which will be sent to an email or to a WhatsApp messaging platform. Please note that the questionnaire is anonymous as there is no personal identifiable information that will be shared or published. Participation in this study is voluntary and there are no penalties for refusing to participate or for withdrawing from the study. If a participant decides to withdraw from the study (which can be done at any time), the data that have already been collected will be immediately destroyed unless the participant gives consent for it to be retained. There is no direct benefit to the participants or reimbursement for taking part in the study. There are no known risks for taking part in this study.
If you agree to take part in this study, you will be requested to complete a 10- 15 minute online questionnaire. Engaging in the online process will imply that you have consented to take part in the study. Confidentiality will be ensured in the study by the following measures: Only myself, and my supervisors (Professors Risimati Rikhotso and Peter Owen) will have access to the data during the study period. Data will be securely stored in a password protected computer for the duration of the study and for a period of two years post publication or for six years if there is no publication. Data will not be given to third parties.
The output of this study is anticipated to provide information which will guide the establishment of better treatment protocols and or guidelines for patients with acquired head and neck defects, leading to improved treatment outcomes for both patients and clinicians. The study results may be published. The summary of the results will be given to participants upon request.
This study has been approved by the Human Research Ethics Committee (Medical) of the University of the Witwatersrand, Johannesburg ("Committee"). The study's ethics approval number is MED24-03-464. A principal function of this Committee is to safeguard the rights and dignity of all human subjects who agree to participate in a research project and the integrity of the research.
If you have any concern over the way the study is being conducted, please contact the Chairperson of this Committee who is Professor Paul Ruff, who may be contacted via any one member of the secretariat. The telephone numbers for the Committee secretariat are 011 717 2700/1234/2656/1252 and the email addresses are Zanele.Ndlovu@wits.ac.za, Rhulani.Mukansi@wits.ac.za, Mapula.Ramaila@wits.ac.za and Iain.Burns@wits.ac.za
Should you need further information regarding this study, please feel free to contact me on the below contact details:
Email: 9610423R@students.wits.ac.za
Mobile number: 076 215 0952
Thank you for reading this information leaflet and for showing interest in this study.