Evaluation of the Psychotropic Medication Algorithm for Fetal Alcohol Spectrum Disorder
Principle Investigator
Dr. Mansfield Mela
Department of Psychiatry, College of Medicine, University of Saskatchewan
Phone: 306-844-1316
Email: mam865@mail.usask.ca
Research Coordinator
Monique Reboe-Benjamin, MSc, MPhil
Department of Psychiatry, College of Medicine, University of Saskatchewan
Phone: 306-844-1335
Email: mpr795@usask.ca
Purpose
Dr. Mela and a team of 12 multidisciplinary international experts have spent over 2 years developing a decision-tree style medication algorithm to guide prescribers as they see patients with Fetal Alcohol Spectrum Disorder/Neurobehavioral Disorder Associated with Prenatal Alcohol Exposure (FASD/ND-PAE). This algorithm is the first-ever treatment recommendation for psychotropic medications for FASD/ND-PAE. It is based on all available evidence (albeit very limited), which was consolidated in a recently published systematic review (Mela M, Okpalauwaekwe U, Anderson T, Eng J, Nomani S, Ahmed A, Barr AM. The utility of psychotropic drugs on patients with Fetal Alcohol Spectrum Disorder (FASD): a systematic review. Psychiatry and Clinical Psychopharmacology. 2018:1-10). From there, the algorithm was developed by considering the evidence and incorporating the clinical perspective of the expert panel. Now that the algorithm is developed, it needs to be evaluated to understand the effectiveness and allow for improvements for future iterations.
Participating
This survey is to be completed by prescribers who are using the medication algorithm with their patients. If you choose to participate, you will be asked to complete questions requesting brief information about you as a clinician, the patient with whom you used the algorithm, and the outcomes of the algorithm use. Since we are requesting information about the outcome of using the algorithm, we ask that you complete the survey only after sufficient time has passed to observe the effects of using the algorithm with your patient. The information you provide about yourself and your patient will all be non-identifiable data.
Participation in this survey is voluntary. You can decide not to participate at any time by closing your browser without clicking the “Submit” button at the end of the survey. You can choose to skip (not answer) any questions with which you don’t feel comfortable. Any answers you provide will only be collected if you click "Submit" at the end of the survey. Since the survey is not collecting identifying information, once it is submitted it cannot be removed. There are no known risks to participating in this survey; however, as with any online related activity the risk of breach of confidentiality of the data that has been collected is always possible.
The survey is hosted by JotForm, a secure online survey tool. Data collected by JotForm is stored safely on servers located in both Germany (Europe) and the United States. For any data stored by Jotform on German servers, the data will be transferred from Germany to Canada, and the data may be subject to investigation by European Union (EU) authorities during the transfer as per the EU General Data Protection Regulation data sharing legislation. For more information please visit JotForm’s privacy policy at https://www.jotform.com/privacy/.
The information gathered from the surveys will be used to better understand the effectiveness of the algorithm and feedback from users. This research will be used to develop the next iteration of the algorithm, based on the data collected.
Reminder: This survey is only meant to collect non-identifiable information. Please do not enter data that would identify you or your patient in any way.
Privacy
We will use the responses from the survey to write reports, manuscripts and presentations. In these formats, we will never include anything that would allow people to know who you are, as we will not have collected any identifying information. If we report something from the survey, we may report profession and experience (i.e. Pediatricians working with individuals with FASD for over 5 years).
Any information we keep on a computer will only be seen by people who are working on the study. It will need a password to be opened. We will do everything we can to make sure it is kept private. If any paper information is generated it will be kept in a locked filing cabinet in the Research Coordinator’s office in Ellis Hall. The information we use for the study will be kept for 5 years post publication. After 5 years, the electronic data will be deleted using a program that does not permit recovery. If any paper information is generated, it will be shredded.
Other Information
There are no known conflicts of interest.
Once we write our reports, you are welcome to read them. If you want a copy, please email: mpr795@usask.ca
This project was reviewed on ethical grounds by the U of S Behavioural Research Ethics Board. Any questions regarding your rights as a participant may be addressed to the Research Ethics Office toll free at 1-888-966-2975 or ethics.office@usask.ca.