Dear Parent, We are writing to ask for your participation in a survey about the medical support that you received before and after the birth of your child with Down syndrome. This study, which entails only a brief questionnaire, is designed to improve the medical care given to future parents who are expecting a child with Down syndrome. Both mothers and fathers are encouraged to participate in this research. Each parent should complete a separate survey. Rarely researched are parents' perceptions, feelings, and recommendations about the medical support they received around their child's birth. Think back to the time when you were expecting your child. Could your medical provider have done something different? The purpose of this study is to gather your thoughts and input so that future parents can receive more helpful support. This research study has been reviewed and approved as protocol 2020P001055 by Partners Human Research Committee on January 8, 2021. On the next page of this survey, you will find more specific information and a Q&A about the nature of the study. If you have any questions regarding this survey, please do not hesitate to contact us at jartal@mgh.harvard.edu, bskotko@mgh.harvard.edu, or (617) 643-3196. We would be grateful to receive your survey responses within four weeks.Thank you, in advance, for your thoughtful consideration of this project. Having siblings with Down syndrome, ourselves, we very much look forward to hearing from you. Sincerely, Jonathan M. Artal Research Assistant Massachusetts General Hospital Down Syndrome Program Brian G. Skotko, M.D., M.P.P. Associate Professor of Pediatrics, Harvard Medical School Emma Campbell Endowed Chair on Down Syndrome, Massachusetts General Hospital
Study Title: Parental Perceptions of How Physicians Communicate Prenatal and Postnatal Diagnoses of Down Syndrome: A Retrospective Survey 2003-Present.
Principal Investigator: Brian G. Skotko, M.D., M.P.P.
Informational Q&A for Study Participants
What is the research study's goal? This research study will investigate whether, since 2003, there have been any improvements in the medical support that parents receive following a child's diagnosis of Down syndrome. We will investigate how physicians deliver the diagnosis and how parents respond to the news. Our primary aim is to identify strategies to improve medical support for parents whose children receive diagnoses of Down syndrome.
Who designed this study? This study was created by a team of researchers at Massachusetts General Hospital, which is sponsoring the study. The study's principal investigator is Brian Skotko, M.D., M.P.P., who chairs the hospital's Down Syndrome Program and is an Associate Professor of Pediatrics at Harvard Medical School.
What is involved? We are asking each parent to complete a brief online survey, which we expect to take 15-20 minutes per person. Not all questions will apply to you, but should you choose to complete the survey, you will be asked questions about diagnostic tests prior to the birth of your child, your family's decision to continue the pregnancy, and the support that you received from your medical staff before and after the birth of your child. At the end of the survey, you will have an opportunity to list your recommendations, if any, for how to improve the medical support that parents receive. The responses you provide in this survey will constitute the only data the study team will collect. At all times, your responses will remain confidential.
What happens if I do not complete the survey? Your participation is completely voluntary, and your refusal to participate will involve no consequences. Deciding not to participate will not affect medical care you receive at Massachusetts General Hospital or its affiliates, nor will it affect any benefits you have a right to receive. Similarly, deciding not to participate will not affect your membership in any Down syndrome organization with which we have partnered for this study.
What are the risks and possible discomforts? Some survey questions will address topics or events that might be sensitive in nature. While questions may evoke feelings of sadness or pain, you may choose not to respond to any question.
What are the benefits to me? While there are no direct benefits to you or remuneration for completing the survey, your responses will inform future research, policy, and advocacy that will affect the medical care that the Down syndrome community receives.
How is my privacy being protected? We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice and does not describe all details of this requirement. During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.
We will store all data we collect in a password-controlled folder behind hospital firewalls. We will aggregate all data so that it will be impossible to determine your identity from your responses. Your de-identified information will not be used or shared with other researchers and will not be used in clinical care. The risk of a confidentiality data breach is very small.
Who can I contact if I have questions about the study? If you have any questions regarding this survey, please do not hesitate to contact us. You may reach Jonathan Artal, a member of the research team, at jartal@mgh.harvard.edu, or Brian Skotko, M.D., M.P.P., the principal investigator, at bskotko@mgh.harvard.edu or (617) 643-3196. If you'd like to speak to someone not involved in this research about your rights as a research subject, or any concerns or complaints you may have about the research, contact the Partners Human Research Committee at (857) 282-1900.
I AGREE TO PARTICIPATE IN THIS RESEARCH:
Yes
No
How are you related to the person with Down syndrome?
Biological Mother
Stepmother
Foster or Adopted Mother
Biological Father
Stepfather
Foster or Adopted Father
Other
What is your gender identity?
Man
Woman
Transgender Man
Transgender Woman
Genderqueer/Gender Non-conforming
Biological sex of your child with Down syndrome:
Male Female
How old were you when you had your child with Down syndrome?
In what year was your child with Down syndrome born?
What is the first letter of your child's first name?
What is the first letter of your child's last name?
What is the numerical day of the month on which your child was born?
Did your family receive any prenatal testing prior to the birth of your child?
Yes No
Which of the following prenatal screening tests did you pursue? Select all that apply.
Did you have a "noninvasive prenatal screen" that indicated an enhanced risk of having a child with Down syndrome?
Yes No
Do you remember which of the following NIPS tests you chose?
MaterniT-21-PLUS (Integrated Genetics/Sequenom)
Harmony (Roche)
QNatal (Quest)
Panorama (Natera)
Determine 10 (Lab Genomics)
Prequel (Myriad) -- Previously, Prelude (Counsyl)
Informed Prenatal Test (NxGen)
PathGroup NIPS (PathGroup)
ClariTest (Bio Reference)
Innatal (Progenity)
I don't remember which test I chose.
Did you have an amniocentesis and/or CVS to detect Down syndrome?
I received the results of the amniocentesis/CVS in person.
Yes No
If you were married or with your partner at the time, did your physician give the results in the presence of both persons?
Yes No
I had an amniocentesis/CVS because of the results from the prenatal screening bloodwork (not NIPS).
Yes No
I had an amniocentesis/CVS because of the results from the "noninvasive prenatal screen" (NIPS).
Yes No
I had an amniocentesis/CVS because of the results from ultrasound findings.
Yes No
I had an amniocentesis/CVS because of my or my partner's age.
Yes No
Other reasons why you had an amniocentesis/CVS?
How could the amniocentesis/CVS process have been better?
Were you given any printed or digital materials on Down syndrome prior to the birth of your child?
Yes No
What printed or digital materials were you given on Down syndrome?
What types of printed or digital materials do you wish you would have received--but didn't--after receiving a prenatal screening, NIPS, or amniocentesis/CVS result of Down syndrome?
Did any other factor play an important role in your decision to continue the pregnancy?
Yes No
Date of birth of the biological mother (MM/DD/YY):
Date of birth of the biological father (MM/DD/YY):
Are you of Hispanic or Latino origin or descent?
Yes
No
White or Caucasian
Black or African American
Asian
Native American or American Indian
Hawaiian or Pacific Islander
More than one race
What is the highest level of your education?
didn't graduate from 8th grade
graduated from 8th grade
graduated from high school
graduated from college
received master's degree
received doctorate degree
What is your religious affiliation?
Buddhist Catholic Hindu Jewish Mormon Muslim Protestant Sikh Other No religion
What is your religious affiliation?
What is the total combined income of your household?
In what state, district, or territory did you receive medical care for your pregnancy?
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District Of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
In what state, district, or territory do you reside now?
Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District Of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming
(Optionally, to prevent future emails asking you to complete this survey.) What is your email address?
1. What, if anything, did your physician, genetic counselor, nurse, or medical staff member do that angered you?
2. What, if anything, did your physician, genetic counselor, nurse, or medical staff member do that helped you the most?
3. If your family received prenatal care, how could it have been better? Please list your recommendations.
Please use this space to describe or list anything else about your prenatal care, pregnancy, and/or postnatal care that you deem important, either positive or negative. Are there any incidents or stories that you would like to share?