ADHD and Women’s Health
ADHD and Women’s Health
Subject information for participation in medical research
ADHD and Women’s Health Survey
Official title: Female ADHD: An international survey on experiences and health of women with ADHD
Introduction
Dear reader,
You have registered for the ADHD and Women’s Health Survey on our website.
With this letter, we would like to ask you to take part in a medical study. Participation is voluntary.
In this information sheet you can read about the medical study, what participation means for you, and what the pros and cons are. It is a lot of information. It is important for you to have all the information about this study, so you can make an informed decision to take part.
Please read the information and decide if you want to take part. If you want to take part, complete the Informed Consent form by clicking on “I have no questions and will participate” at the bottom of this page.
Ask your questions
You can make your decision based on the information in this information sheet. You might also find it helpful to:
- Ask any questions to the investigators who gave you this information: Maxime de Jong and Emma van Andel, femaleadhd@psyq.nl.
- Talk to your partner, family, or friends about this study.
- Ask any questions to the independent expert, Andreia Hazewinkel
- Read the information on government.nl/medical-research-information-for-human-subjects.
1. General information
PsyQ Expertise Center Adult ADHD, The Hague, The Netherlands has set up this study in collaboration with ADHD Europe. The investigators conduct the study in different countries. This study needs at least 3000 participants from different countries (e.g. United Kingdom, The Netherlands, Belgium, USA, France, Malta).
The Medical Ethics Review Committee Erasmus MC has approved this study.
2. What is the purpose of the study?
With this survey in women with AD(H)D, we would like to:
- Understand their overall experience of their health and diagnosis;
- Explore the links between AD(H)D and other health conditions;
- Identify barriers to diagnosis and sources of support;
- Identify what needs to be researched further and which interventions are needed.
3. What is the background of the study?
There is more and more awareness of AD(H)D in women, but research into AD(H)D is still mainly done in men. Also, most studies have focused on perspectives of caregivers, guardians, or health professionals, or relied on medical records - rather than asking people with AD(H)D themselves about their experiences. Important information may be missed this way. For this reason, we want to conduct a survey on AD(H)D and women’s health and provide the space for participants to offer their own perspectives and ideas for future research and/or treatments.
4. What happens during the study?
How long will the study take?
Filling out the survey will take about two times 25 minutes in the space of 1 week in total.
Step 1: are you eligible to take part?
First, we want to know if you are eligible to take part. The current survey is for:
- People with AD(H)D (both self-diagnosed and diagnosed by a health professional);
- People who identify as women;
- People aged 18 and above.
You cannot partake in this study if you are not able to read or understand this information letter or sign the consent form.
Can people still fill in the survey if they have ADD, not ADHD?
Yes. Attention Deficit Disorder (ADD), once considered a disorder in its own right, now falls under the “predominantly inattentive” subtype of attention deficit hyperactivity disorder (ADHD). People who consider themselves to have or were diagnosed with ADD are also eligible to complete the survey.
Step 2: study and measurements
We will email you an online questionnaire in two parts. The questions are about:
Part 1
- ADHD Diagnosis & Symptoms
- ADHD and Other Health Conditions
- Demographics
Part 2
- Menstrual Cycle
- Conflict Tactics & Romantic Relationships (optional)
- Sleep
In each section there is room to provide short answers (with check boxes) and long answers (by writing down own thoughts). You can take as much time as you like. The questionnaire can be saved and resumed later.
At the end are a few optional questions with space for personal input and feedback.
5. What agreements do we make with you?
We want the study to go well. That is why we want to make the following agreements with you:
You should contact the investigator in the following situations:
- You no longer wish to take part in the study.
- Your email address changes.
6. What side effects, adverse effects or discomforts could you experience?
Some questions might be confrontational or triggering. You are free to skip these questions if you like.
7. What are the pros and cons if you take part in the study?
Taking part in the study can have pros and cons. We will list them below. Think about this carefully and talk to other people about it if you feel that could be helpful.
You yourself do not directly benefit from taking part in this study. Participation does have these pros:
- You will contribute to the representation of women with AD(H)D in the scientific community.
- You will help the investigators to get more insight into the experiences and health of women with AD(H)D.
- Your input will help in the search for a better treatment for women with AD(H)D.
Taking part in the study can have these cons:
- The questionnaires and some questions of the survey can be confrontational and/or triggering.
- Taking part in the study will cost you time.
- You have to comply with the study agreements.
You do not wish to participate in the study?
It is up to you to decide if you wish to participate in the study. Do you not wish to participate? Then you do not have to fill out the Informed Consent form, nor do you have to fill out the survey.
8. When does the study end?
In these situations, the study will stop for you:
- You filled out all questionnaires of the survey.
- You want to stop participating in the study yourself. You can stop at any time. It is appreciated if you will let the investigator know. You do not have give a reason for why you want to stop.
- If one of the following parties decides that the study should end:
- PsyQ Expertise Center Adult ADHD
- The government, or
- The medical-ethical committee that approved this study.
What happens if you stop participating in the study?
The investigators use the data that have been collected up to the moment that you decide to stop participating in the study. The entire study ends when all the participants have finished.
9. What happens after the study has ended?
After the study has ended, the investigators will analyse the data from the survey. About one year after you took part in the study, the investigator will inform you about the most important results of the study.
Once the outcomes of the study have been measured and reported, we may be able to identify health risks associated with AD(H)D. We can then explore these in more detail and develop appropriate prevention and/or treatments for them. We would like to spread the findings amongst health policy makers and all others who are involved with care for women with AD(H)D. The suggestions provided by the women who complete the study will allow us to come up with new topics for further research.
10. What will happen with your data?
Are you taking part in the study? Then you also give your consent to collect, use, and store your data.
What data do we store?
We store these data:
- Your name
- Your gender
- Your email address
- Your phone number
- All other information we collect during the study
Why do we collect, use, and store your data?
Your name, email address, and phone number are only used to verify your identity. We collect, use, and store your data to answer the questions of this study and to be able to publish the results.
How do we protect your privacy?
To protect your privacy, we give a code to your data instead of using your name. Your data will be anonymous. We only put this code on your data. We keep the key to the code digitally in a safe place on the server of Parnassia Group Academy, of which PsyQ Expertise Center Adult ADHD, The Hague, The Netherlands is part. When we process your data, we always use only that code. Also, in reports and publications about the study, nobody will be able to see that it was about you.
Who can see your data?
Some people can see your name and other personal information without a code. These are people checking whether the investigators are carrying out the study properly and reliably. The following people can access your data:
- A controller hired by the Parnassia Group Academy, of which PsyQ Expertise Center Adult ADHD is part.
- National supervisory authorities.
These people will keep your information confidential. For access by these people we ask you to give your permission. The Inspectie Gezondheidszorg en Jeugd (IGJ) can access our data without permission.
For how long do we store your data?
We store your data on the server of Parnassia Group Academy, of which PsyQ Expertise Center Adult ADHD, The Hague, The Netherlands is part, for 15 years.
Can we use your data for other research?
Your data may also be important after this study for other medical research on AD(H)D in women. For this purpose, your data will be stored on the server of Parnassia Group Academy, of which PsyQ Expertise Center Adult ADHD, The Hague, The Netherlands is part. Please indicate in the consent form whether you agree with this. Do you not want to give your consent? Then you can still take part in this study.
Can you take back your consent for the use of your data?
You can take back your consent for the use of your data at any time. This applies both to the use in this study and to the use in future research. But please note: if you take back your consent, and the investigators have already collected data for research, they are still allowed to use this information. Do you want to take back your consent? Then contact the researchers at femaleadhd@psyq.nl
Do you want to know more about your privacy?
- Do you want to know more about your rights when processing personal data? Visit www.autoriteitpersoonsgegevens.nl.
- Do you have questions about your rights? Or do you have a complaint about the processing of your personal data? Please contact the person who is responsible for processing your personal data. For the present study, this is:
PsyQ Expertise Center Adult ADHD, The Hague, The Netherlands: see Contact Details below. - If you have any complaints about the processing of your personal data, we recommend that you first discuss them with the research team. You can also contact the Data Protection Officer of Parnassia Group Academy. Or you can file a complaint to the Dutch Data Protection Authority.
11. Will you receive compensation if you participate in the study?
You will not receive compensation for participation in this survey.
12. Are you insured during the study?
You are not additionally insured for this study. Because taking part in the study has no additional risks. That is why PsyQ is not obliged by the Ethical Committee of Erasmus MC to take out additional insurance.
13. Do you have any questions?
If you have any questions about the study, you can contact the research team. At the bottom of this page, you can click on “I have questions”. You can then choose who you would like to talk to and briefly describe your questions. The researchers will then contact you to answer your questions.
Do you have a complaint during the study? Discuss it with the investigators via femaleadhd@psyq.nl. If you prefer not to do so, please contact the Complaints committee or complaints officer of Parnassia Group (see Contact details below)
14. How do you give consent for the study?
You can first think carefully about this study. You can discuss it with your partner, family, or friends.
If you would like to participate, you can click on “I have no questions and will participate” at the bottom of this page. You will then go the page with the Informed Consent form.
Read this Informed Consent form and fill it out. By signing and sending this form you indicate that you have understood the information and consent to participating in the study.
After you have signed the Informed Consent form, the researchers will also sign this form. You will receive a copy of the fully signed form along with this information letter in a secure email.
Thank you for your time and attention.
Contact details for PsyQ Expertise Center Adult ADHD
Project leaders/first contact persons:
Maxime de Jong, physician-researcher/PhD student
Emma van Andel, senior researcher
PsyQ Expertise Center Adult ADHD
femaleadhd@psyq.nl
Principal investigator:
Prof. dr. Sandra Kooij
Psychiatrist
Head of PsyQ Expertise Center Adult ADHD
s.kooij@psyq.nl
Independent expert:
Andreia Hazewinkel
Psychiatrist
PsyQ ADHD Leiden
a.hazewinkel@psyq.nl
Complaints:
Complaints committee clients Parnassia Group, attn. Chair
Monsterseweg 93, 2553 RJ The Hague, The Netherlands
klachtencie.patientenHaaglanden@parnassiagroep.nl
+31 (0)88 357 0080 or +31 (0)88 357 0027
General complaints:
Complaints officer Parnassia Group, region Haaglanden
klachtenfunctionaris@parnassiagroep.nl
I have read this letter.
Do you have no (further) questions? Then click "I have no questions and will participate" below.
If you have any questions after reading this information, you can ask them before participating. Please note: this only applies to questions about this study. Click on "I have questions".