A Survey of Ontario Family Practitioners on the Diagnostic Approach to Microcytosis

CONSENT FORM TO PARTICIPATE IN A RESEARCH STUDY

Study Title: A Survey of Ontario Family Practitioners on the Diagnostic Approach to Evaluation Microcytosis with or without Anemia

Principal Investigator:  Dr. Kevin Kuo, Phone: (416) 340-5233

Co-Investigators: Dr. David Esho, Dr. Hayley Merkeley

Contact Information: Hayley.Merkeley@uhn.ca.  Please note that communication via e-mail is not absolutely secure.  Thus, please do not communicate personal sensitive information via e-mail.

Dear Colleague,

You are being asked to take part in a research study consisting of a survey. Please read the information about the study presented in this form. The form includes details on this survey that you should know before you decide if you would like to take part. You should take as much time as you need to make your decision. You should ask the investigators to explain anything that you do not understand and make sure that all of your questions have been answered before completing this survey.  Participation in this study is voluntary.

Background: Thalassemia is an inherited disorder characterized by defective synthesis of α and β globins resulting in globin-chain imbalance and consequential ineffective erythropoiesis and chronic hemolysis.  Thalassemia prevalence is increasing in areas of North America with high immigration.   Thalassemia carriers are initially identified on the basis of erythrocyte microcytosis, which may or may not be associated with anemia. Microcytic anemia is the most common form of anemia, and is frequently observed in the outpatient setting.  Iron deficiency accounts for the majority of cases, but additional causes include α and β thalassemia.  The true prevalence of α and β thalassemia mutations in Ontario is unknown.

While distinct primary care guidelines for the diagnosis of iron deficiency and thalassemia carriers exist, there are no established guidelines for investigating newly diagnosed microcytosis with or without anemia. Therefore, the correct diagnosis of thalassemia relies upon primary care physicians recognizing microcytosis and ordering appropriate investigations.   We hope to identify decision-making factors as well as the breadth and sequence of diagnostic investigations in order to understand practice heterogeneity and potential areas for further education, with intent to optimize diagnostic accuracy and cost savings.

The purpose of this research study is to understand the diagnostic decision-making process and investigation of microcytosis amongst primary care providers in Ontario. 

You are being asked to participate in this survey because we value your expertise and experience with respect to the diagnostic work-up of red blood cell microcytosis in adult patients of reproductive age. 

Study Design:
We kindly ask that you complete, a brief, 15-item on-line questionnaire through Survey Monkey™, which is designed to take approximately 10 minutes to complete. Survey responses will then be statistically analysed and data may be utilized:

a)    To develop practice guidelines

b)   For research purposes including presentation or publication in medical literature
Risks of Participation:
The only potentially identifiable data we will collect are the first 3 digits of your primary practice postal code.  We will be using this information to assess whether survey responses reflect primary practice location.  We do not anticipate that postal code data will be able to be directly linked to individuals in the unexpected event that this information is released to an unauthorized party, but we will notify both participants and the UHN REB in case of an unauthorized disclosure.   In addition, we are requesting the location of your residency training in order to determine whether there are differences between practitioner responses based on location of training.

Data Collection and Storage:
Your participation is completely voluntary and your decision whether to participate will not be revealed to the investigators.  All data will be collected from the online survey website, to which only the investigators and study delegates will have password-protected access.  Each survey will be assigned a study identification number. The collected data will then be transferred to a password-protected and encrypted electronic database, which will be stored on the University Health Network (UHN) server to protect the information from theft, loss or unauthorized access.  Only the investigators and study delegates will have access to the data.

Confidentiality:
Your data will be shared as described in this consent form or as required by law. No personal information aside from the first 3 digits of your primary practice postal code and the location of your residency training will be collected.  The survey you will be consenting to is anonymous in nature. The data we collect from it cannot identify you. Because we are using an external service, (Survey Monkey), the service itself is aware of the IP Address of the computer you use to fill in the form. Additionally, there is no contract specific to UHN that controls the disposition of the information. The investigators will keep any personal information about you in a secure and confidential location for 10 years.

Remuneration: 
We appreciate that your time is valuable, and in exchange for your participation you will have the opportunity to be entered into a draw for a $200 CAD Amazon gift card.   If you would like to enter into the draw, please contact hayley.merkeley@uhn.ca directly.  Please note that communication via e-mail is not absolutely secure.  Thus, please do not communicated personal sensitive information via e-mail.

Questions About the Study:
By completing the survey, your consent is implied and you are agreeing to the use of your information as described above.  If you do not wish to have your information used please contact the study team.If you have any questions about your rights as a research participant or have concerns about this study, call the Chair of the University Health Network Research Ethics Board (UH N REB) or the Research Ethics office number at 416-581-7849. The REB is a group of people who oversee the ethical conduct of research studies. The UHN REB is not part of the study team. Everything that you discuss will be kept confidential. 

Thank-you for your consideration.  Should you have outstanding questions, please feel free to email: Hayley.Merkeley@uhn.ca.

 
Sincerely,

Hayley Merkeley MD, FRCPC
Clinical Fellow
Red Blood Cell Disorders Program
Division of Medical Oncology and Hematology
Department of Medicine, University Health Network

David M. T. Esho MD, CCFP
Family Physician
Toronto Western Family Health Team
Department of Family and Community Medicine, University Health Network

Kevin H. M. Kuo, MD, MSc, FRCPC
Clinical-Investigator and Staff Hematologist
Red Blood Cell Disorders Program
Therapeutic Apheresis Program
Division of Med

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* 1. Please enter your age (in years) in the text box below:

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* 2. Where did you complete your medical residency training (or internship if no residency training)?

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* 3. How many years have you been in medical practice (ie. since completion of internship and/or residency)

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* 4. Please list the first 3 alphanumeric digits of your primary practice postal code:

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* 5. What is your practice structure?
Choose all that apply:

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* 6. What would you estimate is the prevalence of microcytosis (with or without anemia) in your male and female patients of reproductive age (16-45 years)?

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* 7. From which sources do you seek resources about evaluating red blood cell microcytosis?
(Microcytosis is defined as mean red cell corpuscular volume [MCV] less than 80fL or lower limit of normal of reporting laboratory)

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* 8. When you see microcytosis with OR without anemia in male and female adult patients of reproductive age (16 to 45 years), which of the following do you include in your FIRST-TIER investigations? Choose all that apply:

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* 9. Which of the following considerations alter your FIRST-TIER investigations?
Choose all that apply:

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* 10. Assuming the patient has no chronic disease (eg. Systemic lupus erythematosus, Rheumatoid arthritis, Inflammatory bowel disease, chronic kidney disease, etc.), what are your SECOND-TIER investigations?

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* 11. Which of the following considerations alter your SECOND-TIER investigations?
Choose all that apply:

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* 12. Which of the following would influence a referral to an Internist/Hematologist/Other specialist to assess microcytosis with or without anemia?  Choose all that apply:

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* 13. What is the local availability of a Hematologist or other specialist physician (eg. Internist, Gastroenterologist, Medical Oncologist) for the diagnostic work-up of microcytosis?

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* 14. Are you interested in participating in a CME event about microcytosis?

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* 15. Based on your previous experiences, what format of CME events have you found most effective in achieving your learning goals?

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