Introduction 

Letter of Information and Consent to Participate in a Research Study

Study Title:
Evaluating the effectiveness of a trainee-focused multimodal educational module on the management of iron deficiency anemia

Study Team
Principal Investigator:
Michelle Sholzberg, MD
-        Department of Medicine, Division of Hematology
-        St. Michaels hospital, 30 Bond street, Toronto, ON M5B 1W8
-        Phone: (416) 864-5128 (9am-5pm) 
-        Michelle.Sholzberg@unityhealth.to

Co-Investigators:
Moussa Abdulghaffar, MD
-        General Internal Medicine Resident, University of Toronto
-        m.abdulghaffar@mail.utoronto.ca
Eric Tseng, MD
-        Department of Medicine
-        Eric.Tseng@unityhealth.to

Study Sponsor:
University of Toronto, General Internal Medicine Program

Study Funding:
No funding required
 
Conflict of Interest Statement:
The principal investigator, co-investigators, and research staff do not have any conflicts of interest, financial or otherwise, related to this study or its outcome.

Student Project Declaration:
This study is a student project conducted by Moussa Abdulghaffar, a resident at St. Michael’s Hospital as part of the general internal medicine residency program requirements at University of Toronto. This study is supervised by Dr. Michelle Sholzberg, an Assistant Professor at the University of Toronto, Clinical Hematologist, Division Head of Hematology-Oncology and the Medical Director of the coagulation Laboratory at St. Michael’s Hospital.

Introduction
You are being asked to consider participating in this research study because your input is very valuable in understanding the knowledge level regarding management of iron deficiency among postgraduate trainees, and we are aiming to provide you with practical and evidence-based knowledge on the optimal diagnosis and management of iron deficiency.

All research is voluntary – you do not have to participate and you can withdraw at any time.

Before agreeing to take part in this study, it is important that you read the information in this research consent form. It includes details we think you need to know in order to decide if you wish to take part in this study. If you have any questions, ask a study team member.

If you choose to participate in this study, you will need to choose the “I consent to participate in this study” answer in the first question in this Letter of Information and Consent form. You should not provide consent until you are sure you understand the information.

1.     Background and Purpose of the Study
It is estimated that over one-quarter of the world population has anemia, with more than half resulting from iron deficiency. In addition to anemia, iron deficiency itself is associated with diminished energy, quality of life, cognitive function, and work productivity. Moreover, iron deficiency is frequently associated with several serious medical conditions, including heart failure, chronic kidney disease and inflammatory bowel disease, and is associated with increased risk of hospitalization and mortality. Although the prevalence of iron deficiency anemia has decreased over the past years in industrialized countries, the global burden continues to be significant.

Treatment of iron deficiency involves finding and correcting the underlying cause and choosing a suitable iron replacement therapy. The majority of patients with iron deficiency should be investigated and treated as it is associated with risk of organ damage and progression of or to anemia.
Many physicians have concerns about the use of IV iron products, such as Venofer®, likely because older formulations were frequently associated with severe infusion hypersensitivity reactions. Over the past years, newer formulations of parenteral iron therapies with improved adverse event profiles have become available and there is evidence to support intravenous (IV) iron being superior, in both efficacy and safety, to oral iron in many clinical situations, including heart failure, chronic kidney disease, inflammatory bowel disease, and pregnancy. Despite this, oral iron therapy continues to be viewed as first-line therapy in settings where the use of IV iron may be preferable. There is also evidence that amongst hospitalized patients, anemia does not get adequately investigated and etiology specific treatment is not provided, especially in elderly patients with multiple comorbidities.

Encouragingly, there is evidence that physician participation in continuing medical education activities, such us workshops and online modules, has resulted in better care of iron deficiency anemia.

The aim of this scholarly activity is to develop an interactive education module targeting resident physicians that provides practical and evidence-based knowledge on the treatment of iron deficiency and the appropriate use of IV iron, and then evaluate the impact of this module on postgraduate trainee knowledge. 

2.     Study Design and Duration
Study Design
This is an educational research study.

Participant Population and Study Enrollment
This study will include 40 participants. The participants are postgraduate trainees who are currently specializing in various programs (i.e. internal medicine, subspecialties of internal medicine, emergency medicine, family medicine, obstetrics and gynecology, surgery) at the University of Toronto in all years of training.

Study Duration
Overall, this study will run for about 5 months. Your involvement in this study will involve completing a pre-module quiz, followed by reviewing a website about iron deficiency, and then repeating the quiz. Each quiz will take 15 minutes to complete and reviewing the website should take approximately 15 minutes to review. You will then be asked to repeat the same quiz after 2 months, which will take approximately 15 minutes to complete, to assess knowledge sustainability.

3.     Description of Research Activities
Research Questionnaires and Surveys
You will be asked to complete a quiz before, immediately after, and 2 months after reviewing an educational module about iron deficiency, which will be provided in the format of a website. The quiz will ask about your specialty program, postgraduate year level as well as general questions regarding the pathophysiology of iron deficiency, diagnosis, and management. The scores of the quiz are anonymous. They will only be used to evaluate the educational module, and will not impact your academic evaluations.

The educational module is a website that has been created the research team members that contains information on the causes of iron deficiency and aspects involved in the treatment of iron deficiency, including available formulations of iron replacement, adverse effects associated with the use of oral and IV iron, and preferred routes of administration in certain conditions.

Access to the quizzes, educational module, and the gift card will be provided to you through a link that will be sent by email, including a follow-up email to provide access to the quiz performed 2 months after reviewing the website. 
You must complete the quizzes; however, you can skip questions that you do not wish to answer and answering each question is not mandatory. We would appreciate you completing the questions to the best of your ability. If you have any questions or concerns while answering these questions, please talk to a study team member.

4.     Description of Study Visits
The iron deficiency website and the quizzes will be provided to you online, and can be completed from any location. The quizzes will be conducted through the website SurveyMonkey and each will take approximately 15 minutes to complete. The iron deficiency module will be a website that we have created to provide information about this topic, and will take you approximately 15 minutes to review. The same quiz will be provided after 2 months, and will also take approximately 15 minutes to complete.

5.     Participant Responsibilities
If you decide to take part in this study, it is important that you remember to:
·       Read through the educational module
·       Complete the pre- and post- module quizzes
·       Complete the quiz again after 2 months of completing the module
 
6.     Potential risks
There is no anticipated risk to you for participation in this study. You may feel uncomfortable taking a quiz, and after completion of the quiz, you will receive a test score. This score is intended to evaluate the module’s effectiveness, and is not aimed at evaluating you, nor will it impact your academic evaluation.

7.     Potential Benefits
There may be no direct benefit to you for participation in this study. The educational module may provide you with practical and evidence-based knowledge on the optimal diagnosis and management of iron deficiency.

8.     Privacy and Confidentiality of Your Personally Identifying Information and Study Data
This section describes how your personally identifying information and study data will be accessed, disclosed, and stored during this study. All persons involved in this study are committed to respecting your privacy. Other than the individuals or groups described in this section, no persons will have access to your personally identifying information without your consent, unless required by law.

Personally identifying information is any information that could be used to identify you; this includes your name and address.

Study data is information that is generated by and/or collected for a study that has been stripped of personally identifying information.

Anonymous Study
This is an anonymous study.  This means that no information that could be used to identify you is being accessed or collected as part of this study and we will not be using or analyzing your data in a way that could identify you.

Use of Email for Research
We will only use your email to ask for your participation and to provide with access to the educational module and quizzes. We will not ask you to provide your email, or any other personal identifying information, when completing the quizzes.  Your email will be stored for 2 months in the secure email address of the co-investigator, so that a follow-up email with the link for the quiz and gift card can be provided to you. After the follow-up email is sent, the research investigators will delete your email address.
There are common risks of using email to communicate:
·       Information travels electronically and is not secure in the way a phone call or regular mail would be.
·       If someone sees these emails, they may know that you are a participant in this study or see the health information included in the email.
9.     ONLINE SURVEYS, and THIRD PARTY WEBSITES
The online pre- and post-module quizzes are hosted by the American company SurveyMonkey. The following information will be collected by SurveyMonkey: specialty program, postgraduate year level, and the quiz responses and score. SurveyMonkey currently stores survey data in the United States and may be subject to U.S. laws, such as the USA PATRIOT Act, which allows authorities to access the records of internet service providers. If you choose to participate in this quiz, you understand that your responses to the survey questions and the IP address may be accessed outside of Canada. The security and privacy policy for SurveyMonkey can be found at the following link: https://www.surveymonkey.com/mp/policy/privacy-policy/.

10.     Storage and Retention of Your Personally Identifying Information and Study Data
PERSONALLY IDENTIFYING INFORMATION STORAGE AND RETENTION
All personally identifying data used in this study will be securely stored. The emails of the potential participants will be provided by the different specialty programs administration to the co-investigator, Moussa Abdulghaffar, through a University of Toronto secure email account. Once the recruitment period is complete, the email list will be deleted and will not be stored, nor used in the study. The emails of the study participants will be stored for 2 months, so that a follow-up email with a link to the quiz and gift card can be sent. Once this email is sent, the participants’ email addresses will be deleted.

Study Data Storage and Retention
As a reminder, study data is information that is generated by or collected for a study that has been stripped of personally identifying information.

Study data will be securely stored at Unity Health Toronto. Study data may also be transferred outside of Unity Health Toronto and shared with others for purposes related to the conduct of this study. The data submitted in the quizzes, including the specialty, postgraduate year, quiz responses, and test scores will be stored on SurveyMonkey, but will be deleted immediately after the data collection period ends, and stored on the secured Unity Health internal server. The data on the Unity Health Toronto internal server will be kept for as long as required by Unity Health Toronto policy (currently 5 years after this study ends), at which point any documents with personally identifying information will be destroyed.

Study data may be kept indefinitely and may be used for other research or analyses by the study investigators and the study sponsor.
 
Individual level study data may also be made available to scientific journals, their reviewers, other researchers inside or outside of Unity Health Toronto, or the public.

11.     Study Results and Study Registration
Results
The results of this study may be presented at a scientific conference or published in a scientific journal. If you are interested in obtaining the results of this study, you can contact the study team. We estimate that the results of this study will be available in 2 years.

You will never be personally identified in any publication, report, or presentation that may come from this study.

12.     Potential Costs and Reimbursement
There are no costs to you for participation in this study. After completing the post-module quiz 2 months after reviewing the educational module, you will be provided with a $10 Tim Hortons ® gift card as a thank you for your participation via email.

If you withdraw from this study before completing it, you will not receive compensation for the parts of the study that you have completed.
13.     Participation and Withdrawal
Participation in this Study
Your participation in this study is voluntary. If you choose not to participate, there will be no impact to the medical care received at, employment at, or other relationship with Unity Health Toronto  or University of Toronto now or in the future for you or your family.

Withdrawal from this study
If you choose to take part in this study, you can change your mind without giving a reason, and you may withdraw from this study at any time without any effect on the medical care, employment or other relationship you or your family have at or with Unity Health Toronto or University of Toronto.

This study may be terminated by the study investigators or by the study sponsor at any time for any reason.
 
Continued collection and use of your data after withdrawal
If you withdraw or are withdrawn from this study, no more data about you will be collected.
 
Because this is an anonymous study, we will not be able to withdraw any data that you have already provided because we do not know which information belongs to you.

14.     New Information About this Study
We may make changes to this study as it progresses. We may also learn new things about this study that you may need to know. Some of the new information or changes might affect your decision to continue taking part in this study. You will be notified about any new or changed information in a timely manner and we will ask you if you consent to remain in this study. You may be asked to review a new consent form at that time, through the website, SurveyMonkey.

15.     Research Ethics Board Contact
If you have any questions regarding your rights as a research participant, you may contact the Unity Health Toronto Research Ethics Board Office at 416-864-6060 ext. 42557 during business hours (9:00am to 5:00pm).

Unity Health Toronto is a health network that includes Providence Healthcare, St. Joseph’s Health Centre, and St. Michael’s Hospital.

16.     Study Contacts
If at any time during this study you have questions about the study or the research activities, you should contact the Principal Investigator, Moussa Abdulghaffar, at (647) 390-0160 (9am-5pm).

17.     Documentation of Informed Consent
Study Title: Evaluating the effectiveness of a trainee-focused multimodal educational module on the management of iron deficiency anemia.

Participant Statement of Consent
By agreeing to participate in this study, I acknowledge that:
·       This research study has been explained to me, and my questions have been answered to my satisfaction.
·       I know that I have the right not to participate and the right to withdraw from this study without affecting the medical care received at, employment at, or other relationship with Unity Health or the University of Toronto now or in the future for me or my family.
·       The potential risks and benefits (if any) of participating in this study have been explained to me.
·       I have been told that I have not waived my legal rights nor released the study investigator, study sponsor, or involved institutions from their legal and professional responsibilities.
·       I know that I may ask, now or in the future, any questions I have about this study.
·       I have been told that information about me and my participation in this study will be kept confidential and that no personally identifying information will be disclosed without my permission unless required by law.
·       I have been given suffi

Question Title

* 1. Do you provide consent to participate in this study?

T