Hello, I need some help with my assignment. Analysis of one research article.I would like the help of the same person who helped me previously(it was theorder Id 69623).I need toustify why I am choosing this study design in the context of controlling for threats to internal validity. I need to be sure to indicate what data needs to be collected. Total 1-2 pages. Please let me know.
Unit 9 Assignment 1: Legal Drinking Age - Study Design Suppose that advocacy actions are underway to return the legal drinking age in your state to 18. If it were to become law, there are several potential outcomes that could be studied related to this, most of which would require a quasi-experimental approach. Choose one of the possible outcomes and design a quasi-experimental study to examine the effect of the proposed legislation on your selected outcome based on the article you found. Justify why you are choosing this design in the context of controlling for threats to internal validity. Be sure to indicate what data needs to be collected (identifying dependent and independent variables), the composition of the sample, how data would be collected, and how data might be analyzed. Reference: Mamluk, L., Jones, T, Ijaz, S., Edwards, H., Savovic, J., Leach, V., … Zuccolo, L. (2020). Evidence of detrimental effects of prenatal alcohol exposure on offspring birthweight and neurodevelopment from a systematic review of quasi-experimental studies. International Journal of Epidemiology. dx.doi.org/10.1093/ije/dyz272, hdl.handle.net/1765/125252 OP-IJEJ190280 1..24 Original article Evidence of detrimental effects of prenatal alcohol exposure on offspring birthweight and neurodevelopment from a systematic review of quasi-experimental studies Loubaba Mamluk ,1,2,3* Timothy Jones,2,3 Sharea Ijaz,2,3 Hannah B Edwards,2,3 Jelena Savovi�c,2,3 Verity Leach,2,3 Theresa HM Moore,2,3 Stephanie von Hinke,4 Sarah J Lewis,2 Jenny L Donovan,2,3 Deborah A Lawlor,1,2,3,5 George Davey Smith ,1,2,5 Abigail Fraser1,2,5 and Luisa Zuccolo1,2 1MRC Integrative Epidemiology Unit, Department of Population Health Sciences, University of Bristol, Bristol, UK, 2Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK, 3NIHR ARC West, University Hospitals Bristol NHS Foundation Trust, Bristol, UK, 4Department of Economics, School of Economics, Finance and Management, University of Bristol, Bristol, UK and 5NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, University of Bristol, Bristol, UK *Corresponding author. NIHR Applied Research Collaboration (ARC) West, University Hospitals Bristol NHS Foundation Trust, 9th Floor, Whitefriars, Lewins Mead, Bristol BS1 2NT, UK. E-mail:
[email protected] Editorial decision 25 November 2019; Accepted 8 January 2020 Abstract Background: Systematic reviews of prenatal alcohol exposure effects generally only in- clude conventional observational studies. However, estimates from such studies are prone to confounding and other biases. Objectives: To systematically review the evidence on the effects of prenatal alcohol ex- posure from randomized controlled trials (RCTs) and observational designs using alter- native analytical approaches to improve causal inference. Search strategy: Medline, Embase, Web of Science, PsychINFO from inception to 21 June 2018. Manual searches of reference lists of retrieved papers. Selection criteria: RCTs of interventions to stop/reduce drinking in pregnancy and obser- vational studies using alternative analytical methods (quasi-experimental studies e.g. Mendelian randomization and natural experiments, negative control comparisons) to de- termine the causal effects of prenatal alcohol exposure on pregnancy and longer-term offspring outcomes in human studies. Data collection and analysis: One reviewer extracted data and another checked extracted data. Risk of bias was assessed using customized risk of bias tools. A narrative synthesis of findings was carried out and a meta-analysis for one outcome. VC The Author(s) 2020. Published by Oxford University Press on behalf of the International Epidemiological Association. 1 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. IEA International Epidemiological Association International Journal of Epidemiology, 2020, 1–24 doi: 10.1093/ije/dyz272 Original article D ow nloaded from https://academ ic.oup.com /ije/advance-article-abstract/doi/10.1093/ije/dyz272/5716483 by guest on 13 M arch 2020 http://orcid.org/0000-0003-3558-6892 http://orcid.org/0000-0002-1407-8314 https://academic.oup.com/ Main results: Twenty-three studies were included, representing five types of study de- sign, including 1 RCT, 9 Mendelian randomization and 7 natural experiment studies, and reporting on over 30 outcomes. One study design–outcome combination included enough independent results to meta-analyse. Based on evidence from several studies, we found a likely causal detrimental role of prenatal alcohol exposure on cognitive out- comes, and weaker evidence for a role in low birthweight. Conclusion: None of the included studies was judged to be at low risk of bias in all domains, results should therefore be interpreted with caution. Systematic review registration: This study is registered with PROSPERO, registration number CRD42015015941 Key words: Alcohol, pregnancy, prenatal alcohol exposure, systematic review, quasi-experimental studies, nega- tive control, Mendelian randomization, causal inference, neurodevelopment, FASD Introduction The effects of prenatal alcohol consumption have typically been studied using standard analytical approaches in ob- servational studies.1 Systematic reviews have used these types of studies to determine the effects of prenatal alcohol exposure on several outcomes with a wide range and vary- ing definition of alcohol intake including low-moderate to binge drinking. Outcomes such as central auditory disor- ders in children,2 orofacial clefts,3 speech and language4 and several birth outcomes including low birthweight, pre- term birth and small for gestational age1,5,6 have been in- vestigated. These have led to varying results from systematic reviews: an increased risk of detrimental out- comes at very heavy drinking levels,1,2 inconsistent evi- dence regarding effects of moderate, heavy, or binge drinking (5þ drinks on any occasion),3 inconsistent effects from low-moderate alcohol consumption (up to 83 g/ week)5 and some evidence that even light prenatal alcohol consumption is associated with harmful birth outcomes (up to 32 g/week).6 However, estimates from such studies are prone to the effects of: (i) confounding by socio- demographic characteristics (age, ethnicity, education, socio-economic position) and behavioural factors (smoking and substance use) and (ii) measurement error, namely under-reporting of alcohol intake and/or recall bias. Therefore, the direction and size of any potential causal relationships cannot be determined without bias. In recent decades, novel analytical approaches have been increasingly applied to data from observational stud- ies in order to improve causal inference when assessing po- tential effects of prenatal alcohol exposure. These approaches include Mendelian randomization (MR),7 family-based designs such as paternal or sibling compari- son studies8 and natural experiments.9 Their respective strengths and limitations are outlined in Box 1. We conducted a systematic review of human studies that used experimental data [randomized controlled trials (RCTs)] or alternative analytical methods to improve causal inference applied to observational data, in order to deter- mine the causal effects of maternal alcohol consumption in pregnancy on offspring outcomes at birth and later in life. Additionally, as is being recognised elsewhere,11–13 it is im- portant in public health and in epidemiology to include work from other disciplines in order to avoid missing im- portant contributions to the literature. We therefore present a co-citation analysis to evaluate whether studies of alcohol Key Messages • Systematic reviews of prenatal alcohol exposure effects generally only include conventional observational studies. However, estimates from such studies are prone to confounding and other biases. • We conducted a comprehensive systematic review of experimental human data and alternative analytical approaches to improve causal inference based on observational data. • We also developed customized risk of bias tools for Mendelian randomization, natural experiments and parental and sibling comparison, and applied them to studies with these designs. • Our results showed a likely causal detrimental role of prenatal alcohol exposure on cognitive outcomes, and weaker evidence for a decrease in birthweight, confirming results from conventional observational studies. • Guidance should continue to advise abstention from alcohol in pregnancy. 2 International Journal of Epidemiology, 2020, Vol. 0, No. 0 D ow nloaded from https://academ ic.oup.com /ije/advance-article-abstract/doi/10.1093/ije/dyz272/5716483 by guest on 13 M arch 2020 B o x 1 . O u tl in e o f a lt e rn a ti v e a n a ly ti c a l a p p ro a c h e s (a d a p te d fr o m 1 0 ) C a u sa l in fe re n ce a p p ro a ch D e fi n it io n B ia se s a d d re ss e d S tr e n g th s L im it a ti o n s R a n d o m iz e d co n - tr o ll e d tr ia l (R C T ) S u b je ct s a re ra n d o m ly a ll o ca te d to e it h e r e x - p o su re o r co n tr o l g ro u p s w it h a ss u m p ti o n th a t th e re is n o d if fe re n ce b e tw e e n th e tw o g ro u p s e x ce p t fo r th e in te rv e n ti o n th e y a re re ce iv in g C o n fo u n d in g , re v e rs e ca u sa li ty , se - le ct io n b ia s, lo ss -t o -f o ll o w u p b ia s (u si n g in te n ti o n -t o -t re a t a n a ly si s) , m e a su re m e n t e rr o r G o ld st a n d a rd fo r e st im a ti n g ca u sa l e ff e ct s. A n y e ff e ct is v e ry li ke ly to b e ca u sa l if st u d y h a s la rg e n u m b e r a n d tr ia l is re li a b ly p e rf o rm e d G e n e ra li za b il it y m a y b e q u e st io n a b le ; im - p o ss ib le o r u n e th ic a l to ra n d o m iz e to ce rt a in e x p o su re s; ca n b e e x p e n si v e M e n d e li a n ra n d o m i- za ti o n (M R ) M R is th e u se o f a g e n e ti c v a ri a n t ro b u st ly a s- so ci a te d w it h a n e x p o su re /r is k fa ct o r o f in - te re st a s a n in st ru