Identify one strength of the study design

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Reference no: EM133477613

For this activity, you will watch two videos and completea worksheet. The videos will provide background information on the autism and vaccine controversy, and you will use the worksheet to design a study to examine the relationship between vaccinations and autism.

I. Background Information: In 1998, Andrew Wakefield, a former medical doctor, published a study claiming the measles, mumps and rubella vaccine (MMR vaccine) caused autism in children. Since its publication, a large number of different types of studies in different countries and with different investigators have shown no association between the MMR vaccine and autism. An investigation into Wakefield's work uncovered a number of ethical offenses committed by Wakefield.

You can learn more about the Wakefield study and the problems with his work in these videos:

Khan Academy: Vaccines and the Autism Myth-Part 1

Khan Academy: Vaccines and the Autism Myth-Part 2

II. Worksheet

Directions: Understanding study design, including strengths and limitations, is the foundation for accurately interpreting an overall BODY of research, which is how public health policy and practice are developed. Please read the public health problem and study proposal below and answer questions 1-6.

Public Health Problem: You are working for a non-profit public health agency that conducts research and delivers health education to the local community. Recently, your community has voiced concern over rumors and media highlights that suggest vaccination could cause autism. Physicians and healthcare workers are continuing to encourage vaccination; however, the public is demanding answers following the recent media attention surrounding this issue. Furthermore, you have noticed an increase in the incidence of measles in this community suggesting that this is a time-sensitive issue. Your organization has been tasked with designing and conducting an epidemiologic study to further explore the association between the MMR vaccine and autism. Your co-worker has left a proposed study summary on your desk for your review and feedback.

Study Proposal: To assess the association between the MMR vaccine and autism spectrum disorder (ASD), we propose to conduct the following epidemiologic study. Eligible participants will include children 12-15 months of age who have yet to receive the first dose of the MMR vaccine (age when children should receive the vaccination according to the Center for Disease Control and Prevention). Twenty children will be recruited from Happy Hearts, a daycare program in a community that is known to have a high socioeconomic status (SES). The children will be randomized into an intervention group or a control group using an online statistical computing web program to generate the randomization schedule. The intervention group (n=10) will receive the MMR vaccine. Those in the control group will receive a salt water placebo "vaccine" with no active agent (n=10). Parents will be notified of their child's dose assignment (vaccine vs placebo) and be asked to inform the study team about any unusual side effects or symptoms experienced by their children. A list of 20 common symptoms will be provided for reference, but they will also be encouraged to report additional, unlisted symptoms. Parents will complete follow-up surveys at 3-months, 6-months and 12-months post-dose and asked questions such as "do you believe your child is suffering from autism?" Furthermore, children will meet with a trained study-appointed physician 12-months post-dose for a comprehensive clinical evaluation. During this visit, the physician will determine whether the child will receive an autism diagnosis. The physician will be blinded to children's vaccine status. The association between MMR vaccine status and autism diagnosis status will be determined by using findings from the vaccine group and the placebo group at 12-months post-dose.

Question 1: Identify the type of study design being proposed. If this is an intervention study, indicate whether it is blinded, single-blinded or double blinded. If this is a cohort study, indicate whether it is prospective or retrospective.

Question 2: Identify one strength of the study design. Why is this a strength?

Question 3: Identify two weaknesses in the study design. Why are these weaknesses?

Reference no: EM133477613

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