University Research Analysis: Antidepressant Medication and Pregnancy
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This report provides a critical appraisal of a retrospective cohort study examining the relationship between maternal antidepressant use and adverse pregnancy outcomes. The study, conducted by Hayes et al., analyzed data from 228,876 pregnancies within the Tennessee Medicaid program fr...
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Running head: RESEARCH ANALYSIS
Critical Appraisal of Research Paper
Name of the Student
Name of the University
Author Note
Critical Appraisal of Research Paper
Name of the Student
Name of the University
Author Note
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RESEARCH ANALYSIS
Research Question:
Population:
Pregnant Women
Intervention:
Antidepressant Medication
Comparison:
Use of Medication before or during
pregnancy
Outcome
Changes in Pregnancy Pattern
Critical Appraisal of Research Study
Study Design
The study conducted by Hayes et al. (1) employs a retrospective cohort study
design to conduct the research study and fulfill the objective of determining pregnancy
patters & outcomes with the use of antidepressant medications during pregnancy. Such type
of study design compares groups of individuals (here pregnant females), with a particular
outcome (pregnancy pattern changes). In this study design, the outcomes are known, and a
retrospective check is performed to determine what factors influenced the outcomes. This
study design benefits the researchers from this study by helping them to analyze large sample
size for the research study. However, in a retrospective study, it is difficult to include the case
of confounders that might have influenced the outcome other than the studied factor and thus,
deterring the reliability of the research findings.
Sample Analysis
The sample population selected for the research study composed of singleton
pregnancies among females aged between 15-44 years old. These subjects were enrolled in
the Tennessee Medicaid program for the year 1995 to 2007. Other inclusion criteria for the
selection of subjects were 180 days of continuous enrollment in the program before the LMP
(last menstrual period) and through 90 days post-delivery. These inclusion criteria ensure the
high relevance of the selected subjects to the research study. The research study is concerned
with evaluating the pregnancy outcomes and pattern changes when antidepressant
Research Question:
Population:
Pregnant Women
Intervention:
Antidepressant Medication
Comparison:
Use of Medication before or during
pregnancy
Outcome
Changes in Pregnancy Pattern
Critical Appraisal of Research Study
Study Design
The study conducted by Hayes et al. (1) employs a retrospective cohort study
design to conduct the research study and fulfill the objective of determining pregnancy
patters & outcomes with the use of antidepressant medications during pregnancy. Such type
of study design compares groups of individuals (here pregnant females), with a particular
outcome (pregnancy pattern changes). In this study design, the outcomes are known, and a
retrospective check is performed to determine what factors influenced the outcomes. This
study design benefits the researchers from this study by helping them to analyze large sample
size for the research study. However, in a retrospective study, it is difficult to include the case
of confounders that might have influenced the outcome other than the studied factor and thus,
deterring the reliability of the research findings.
Sample Analysis
The sample population selected for the research study composed of singleton
pregnancies among females aged between 15-44 years old. These subjects were enrolled in
the Tennessee Medicaid program for the year 1995 to 2007. Other inclusion criteria for the
selection of subjects were 180 days of continuous enrollment in the program before the LMP
(last menstrual period) and through 90 days post-delivery. These inclusion criteria ensure the
high relevance of the selected subjects to the research study. The research study is concerned
with evaluating the pregnancy outcomes and pattern changes when antidepressant

RESEARCH ANALYSIS
medications are administered, and it is apparent that the selected subjects for the research
study should include pregnant females.
Generalisability
The large sample size of 228,876 and their study over a period of 13 years highly
increases the overall generalisability of the research study (2). The differences in the
pregnancy period and depression assessment of the subjects were duly accounted for in the
study, and it can be concluded that the research findings are highly generalizable to a similar
population of subjects from all across the globe. Furthermore, the large sample size
comprised of pregnant women from all segments of the society, that is, White, Black, and
other, with residence in rural regions, standard metropolitan areas, or urban regions. This
significantly reduces the risk of low applicability of research findings to other relevant
populations, thus, effectively increasing the generalisability of the research findings (3).
Potential Bias
Analyzing the selection of the subjects and the method used to conduct the research
study, it can be determined that no potential bias has occurred during the selection. The
researchers obtained data of the subjects from the Medicaid database, and no bias was
observed if the subjects were compliant to the inclusion criteria for the research study.
Moreover, the data of the subjects were kept anonymous, and the birth certificates were
analyzed, which were developed for studying pregnancy outcomes and medication use in
pregnant women.
Research Findings
In the research study, the data indicate that 15% of the subject population was
prescribed antidepressants due to their history of getting affected by maternal depression. The
research study concludes that the majority of the subjects from the population comprising of
pregnant women discontinue the use of antidepressant medications before pregnancy or
medications are administered, and it is apparent that the selected subjects for the research
study should include pregnant females.
Generalisability
The large sample size of 228,876 and their study over a period of 13 years highly
increases the overall generalisability of the research study (2). The differences in the
pregnancy period and depression assessment of the subjects were duly accounted for in the
study, and it can be concluded that the research findings are highly generalizable to a similar
population of subjects from all across the globe. Furthermore, the large sample size
comprised of pregnant women from all segments of the society, that is, White, Black, and
other, with residence in rural regions, standard metropolitan areas, or urban regions. This
significantly reduces the risk of low applicability of research findings to other relevant
populations, thus, effectively increasing the generalisability of the research findings (3).
Potential Bias
Analyzing the selection of the subjects and the method used to conduct the research
study, it can be determined that no potential bias has occurred during the selection. The
researchers obtained data of the subjects from the Medicaid database, and no bias was
observed if the subjects were compliant to the inclusion criteria for the research study.
Moreover, the data of the subjects were kept anonymous, and the birth certificates were
analyzed, which were developed for studying pregnancy outcomes and medication use in
pregnant women.
Research Findings
In the research study, the data indicate that 15% of the subject population was
prescribed antidepressants due to their history of getting affected by maternal depression. The
research study concludes that the majority of the subjects from the population comprising of
pregnant women discontinue the use of antidepressant medications before pregnancy or

RESEARCH ANALYSIS
during their first trimester (1). The use of antidepressant medications in the second trimester
is associated with preterm birth, and the use of the medication in the third trimester is
associated with infant convulsions.
Reviewing and critically analyzing the selection of subjects and other aspects of
research methodologies, it is stated that the study design has high validity, which increases
the overall reliability of research findings (4). Agreeing to these points and keeping in mind
the high generalisability of the findings, the research study is marked to be of high clinical
importance and can be used as a reference for future studies.
during their first trimester (1). The use of antidepressant medications in the second trimester
is associated with preterm birth, and the use of the medication in the third trimester is
associated with infant convulsions.
Reviewing and critically analyzing the selection of subjects and other aspects of
research methodologies, it is stated that the study design has high validity, which increases
the overall reliability of research findings (4). Agreeing to these points and keeping in mind
the high generalisability of the findings, the research study is marked to be of high clinical
importance and can be used as a reference for future studies.
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RESEARCH ANALYSIS
References
1. Hayes RM, Wu P, Shelton RC, Cooper WO, Dupont WD, Mitchel E, Hartert TV.
Maternal antidepressant use and adverse outcomes: a cohort study of 228,876
pregnancies. American journal of obstetrics and gynecology. 2012 Jul 1;207(1):49-e1.
2. Murad MH, Katabi A, Benkhadra R, Montori VM. External validity, generalisability,
applicability and directness: a brief primer. BMJ evidence-based medicine. 2018 Feb
1;23(1):17.
3. Keast SL, Farmer K, Smith M, Nesser N, Harrison D. Prior authorization policies in
Medicaid programs: The importance of study design and analysis on findings and
outcomes from research. Research in Social and Administrative Pharmacy. 2016 Jan
1;12(1):154-63.
4. Curtis EA, Comiskey C, Dempsey O. Importance and use of correlational research.
Nurse Researcher. 2016 Jul 18;23(6).
References
1. Hayes RM, Wu P, Shelton RC, Cooper WO, Dupont WD, Mitchel E, Hartert TV.
Maternal antidepressant use and adverse outcomes: a cohort study of 228,876
pregnancies. American journal of obstetrics and gynecology. 2012 Jul 1;207(1):49-e1.
2. Murad MH, Katabi A, Benkhadra R, Montori VM. External validity, generalisability,
applicability and directness: a brief primer. BMJ evidence-based medicine. 2018 Feb
1;23(1):17.
3. Keast SL, Farmer K, Smith M, Nesser N, Harrison D. Prior authorization policies in
Medicaid programs: The importance of study design and analysis on findings and
outcomes from research. Research in Social and Administrative Pharmacy. 2016 Jan
1;12(1):154-63.
4. Curtis EA, Comiskey C, Dempsey O. Importance and use of correlational research.
Nurse Researcher. 2016 Jul 18;23(6).
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