Description
For this assignment, you will be assigned an article from the peer-reviewed literature that describes an epidemiological study. You will use that article to complete a Critically Assessed Study Article FORM, in which you will provide a summary of the study by explaining the following:
Study purpose (This should be a full sentence. Remember, anytime you use the authors’ words, you must use quotation marks.)
Study design (What study design that is the focus of this exercise??)
Describe the source of the data and the study sample
Primary measure (Sometimes there will be more than 1 primary measure. However, for the purposes of this assignment, choose just the one that you believe is most important and explain why you made that choice. Remember that for our purposes, a measure is the construct (such as glycemic control, or depression, or tuberculosis) that we are measuring, NOT the instrument (such as a PDQ-9) or lab test (such as the HbA1C test) used to measure it.)
Statistical Test used for the primary measure (It should be Odds Ratio). (If it is something else, then you need to contact your instructor.)
Complete the 2×2 table using only the data from the study for the primary measure you were assigned. You will insert the appropriate numbers into the 2×2 table that was used in the study to arrive at the crude (unadjusted) OR reported. (The 2×2 table can be found in the 9th chapter of the textbook, page 254.)
Calculation of the crude (unadjusted) OR. You will put the numbers from the 2×2 table you constructed into the OR formula to show how the resulting OR was derived. (This formula can be found in the 9th chapter of the textbook on page 253.) All of the articles that were chosen for this assignment were chosen because they do report the crude (unadjusted) OR for your assigned variables somewhere in the article so you are able to check your table and calculations to ensure that you have come up with the correct number.
Interpretation of the measure of association for this study. You will explain how the above measure of association is interpreted for this study. The textbook helps you understand how to interpret the OR results.
Discussion of the advantages of using case-control designs. (You can get this from your book.)
Discussion of the limitations of using case-control designs. (You can get this from your book.)
Discussion of bias (information and selection biases) and confounding for this particular study. (See example provided.)
Description of any methods used in the study for minimizing bias and confounding, or methods that could have been used, but weren’t. (See example provided.)
There is an example article and completed form available to you in the Case Study module. You must examine that as a model for the one you will complete for your assigned article. Using this model is the best way for you to understand what is expected of your for this assignment.
IMPORTANT NOTES
1. The DUE date for this assignment is Sunday, March 10th. However, if you want to spend your Spring Break working on it, I will allow you to submit it up to Sunday, March 17th, without penalty. After March 17th, it will NOT be accepted!
2. As you know, your scores on your competencies do not impact your grades. However, your grades can impact the scoring on you competencies. Below is the criteria being used to score your L3. Analytical Thinking competency:
My criteria for awarding a “1”: I use your Individual Epidemiology Case Study and your Group Term Project scores – if you score at least a 70, but less than an 85, you will be awarded a “1” (basic level). Anything less than an 70, receives a “0”. A “0” or a “1” means that you did not meet the target level for this competency for this course.
My criteria for awarding a “2”: If you score at least an 85, but less than an 95, you will be awarded a “2” (intermediate level) and will have met the target for this competency for this course.
My criteria for awarding a “3”: There are some similarities between the intermediate and advanced level of this competency, but it really has to do with the complexity of the analysis being conducted by the student. Most students in this class do achieve the basic/intermediate level, but it will be fairly rare for a student to achieve the advanced level during this course. I will be using the same assignments as stated above – if the average of these assignments is at least a 95 or above, you will be awarded a “3” (advanced level) and will have exceeded the target for this competency for this course.
View Rubric
Epidemiology Study Assessment Rubric
Epidemiology Study Assessment Rubric
Criteria Ratings Pts
Followed Instructions (those given here, elsewhere in the course, and via Canvas announcements and emails), Used Correct Grammar and Terminology
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15 to >7.5 pts
Excellent to Average
7.5 to >0 pts
Below Average
/ 15 pts
Form Heading Correct
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5 to >2.5 pts
Excellent to Average
2.5 to >0 pts
Below Average
/ 5 pts
Purpose of Study
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5 to >3 pts
Excellent to Average
3 to >0 pts
Below Average
/ 5 pts
Study Design
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10 to >5 pts
Excellent to Average
5 to >0 pts
Below Average
/ 10 pts
Study Sample
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10 to >5 pts
Excellent to Average
5 to >0 pts
Below Average
/ 10 pts
Primary Measures
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10 to >5 pts
Excellent to Average
5 to >0 pts
Below Average
/ 10 pts
Statistical Test(s) Used
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10 to >5 pts
Excellent to Average
5 to >0 pts
Below Average
/ 10 pts
2×2 Table
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5 to >3 pts
Excellent to Average
3 to >0 pts
Below Average
/ 5 pts
Calculation
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5 to >3 pts
Excellent to Average
3 to >0 pts
Below Average
/ 5 pts
Interpretation
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5 to >2.5 pts
Excellent to Average
2.5 to >0 pts
Below Average
/ 5 pts
Bias
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10 to >5 pts
Excellent to Average
5 to >0 pts
Below Average
/ 10 pts
Strengths & Limitations of Design
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10 to >5 pts
Excellent to Average
5 to >0 pts
Below Average
/ 10 pts
This criterion is linked to a Learning OutcomeL3. ANALYTICAL THINKING
view longer description
threshold: 3
3 pts
Advanced L3.4 Develops Complex Plans or Analyses. Identifies multiple elements of a problem and breaks down each of those elements in detail, showing causal relationships between them; Peels back multiple layers of a problem; Uses several analytical techniques to identify potential solutions and weigh the value of each.
2 pts
Intermediate L3.2 Identifies Basic Relationships. Identifies the cause-and-effect relationship between two aspects of a situation; Separates situations into two parts: pro and con; Sorts out a list of tasks in order of importance. L3.3 Recognizes Multiple Relationships Makes multiple causal links: several potential causes of events, several consequences of actions, or multiple-part chain of events (A leads to B leads to C leads to D); Analyzes relationships among several parts of a problem or situation (e.g., anticipates obstacles and thinks ahead about next steps, in detail, with multiple steps).
1 pts
Basic L3.1 Breaks Down Problems. Breaks problems into simple lists of tasks or activities without assigning values; lists items with no particular order or set of priorities.
Total Points: 0
Unformatted Attachment Preview
Medicine
®
Observational Study
OPEN
Analysis of dental amalgam fillings on primary
Sjögren’s syndrome
A population-based case-control study in Taiwan
∗
Kun-Huang Chen, PhDa,b, Hui-Chieh Yu, DDS, PhDc, Yu-Chao Chang, DDS, PhDc,d,
Abstract
Downloaded from http://journals.lww.com/md-journal by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 03/04/2022
Primary Sjören’s syndrome (pSS) is an autoimmune disease characterized by the inflammatory infiltrate and progressive dysfunction
of salivary glands. Dental amalgam with mercury has been raised the public concerns regarding its purported mercury toxicity from
dental amalgam to possible systemic inflammatory and immune reactions.
In this study, a nationwide population-based database was employed to investigate the association of amalgam filling (AMF) and
the risk of pSS. A retrospective case-control study was sourced from the Taiwanese National Health Insurance Research Database
(NHIRD) from 2000 to 2013. Case and control groups were matched by sex, age, urbanization level, monthly income, and
comorbidities using the propensity score method with a 1:1 ratio. In this study, 5848 cases and 5848 controls were included.
The results demonstrated no statistically significant differences between AMF and pSS (odds ratio [OR]: 0.974, 95% confidence
interval [CI] = 0.904–1.049). In addition, pSS was also not associated with AMF for women (OR: 0.743, 95% CI = 0.552–1.000) and
men (OR: 1.006, 95% CI = 0.670–1.509), respectively.
Taken together, evidence demonstrated that the association of AMF and pSS was inconsistent from this robust register databank.
Abbreviations: AMF = amalgam filling, CIs = confidence intervals, ICD-9-CM = International Classification of Diseases, ninth
revision, Clinical Modification, LHID = Longitudinal Health Insurance Database, NHI = national health insurance, NHIRD = national
health insurance research database, OR = odds ratio, pSS = primary Sjören’s syndrome, SS = Sjören’s syndrome.
Keywords: dental amalgam fillings, national health insurance research database, primary Sjören’s syndrome, Taiwan
Sjögren syndrome (SS) is a chronic, inflammatory, and systemic
autoimmune disease manifested by the dryness of mouth and
eyes.[4] Primary Sjögren syndrome (pSS) occurs alone with no
other rheumatologic disease.[5] People who have other rheumatologic diseases such as systemic lupus erythematous or
rheumatoid arthritis were recognized as secondary SS. The exact
etiology and pathogenesis of pSS still remains unknown, the
genetic predisposition, environmental triggers, autoantibodies,
and pathological injury, are proposed to associate with pSS.[6]
Elevated antinuclear antibodies, autoantibodies anti-Ro/SSA and
anti-La/SSB, are common in patients with SS.[7]
Previously, mercury exposure was found to evoke antinuclear
antibodies positivity among females of reproductive age.[8] In
addition, a review article reported that SS patients exposed to
mercury were usually accompanying with Type IV allergy.[9] The
exposure to mercury was frequently linked to dental restorations.
However, little is known about the impact of amalgam filling
(AMF) on pSS. Therefore, the authors analyzed the risk of AMF
for pSS from the National Health Insurance Research Database
(NHIRD) by case control design in Taiwanese population.
1. Introduction
It has been a long time that dental amalgam has been used for
caries restoration. Dental amalgam is composed of silver alloys
and mercury. Previous studies have reported that mercury vapor
could be released for dental amalgam.[1,2] For the public health
concern, to ban, phase-out, or phase down of dental amalgam is
still under monitor and discussion.[3]
Editor: Maya Saranathan.
The authors have no conflicts of interests to disclose.
The datasets generated during and/or analyzed during the current study are
available from the corresponding author on reasonable request.
a
The College of Management and Design, Ming Chi University of Technology,
New Taipei, Taiwan, b Department of Artificial Intelligence, CTBC Business
School, Tainan, Taiwan, c School of Dentistry, Chung Shan Medical University,
Taichung, Taiwan, d Department of Dentistry, Chung Shan Medical University
Hospital, Taichung, Taiwan.
∗
Correspondence: Yu-Chao Chang, School of Dentistry, Chung Shan Medical
University, 110, Sec. 1, Chien-Kuo N. Rd., Taichung, Taiwan
(e-mail: [email protected]).
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
This is an open access article distributed under the terms of the Creative
Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is
permissible to download, share, remix, transform, and buildup the work provided
it is properly cited. The work cannot be used commercially without permission
from the journal.
2. Methods
2.1. Data source
The Longitudinal Health Insurance Database (LHID) 2010 was
used for this case control study. This research database includes
the details of all medical services utilized by the enrollees. The
codes of disease diagnoses and treatment procedures are based on
International Classification of Diseases, ninth revision, Clinical
Modification (ICD-9-CM). Under surveillance by Bureau of
How to cite this article: Chen KH, Yu HC, Chang YC. Analysis of dental amalgam
fillings on primary Sjögren’s syndrome: a population-based case-control study in
Taiwan. Medicine 2021;100:47(e28031).
Received: 14 October 2020 / Received in final form: 2 June 2021 / Accepted: 11
November 2021
http://dx.doi.org/10.1097/MD.0000000000028031
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Chen et al. Medicine (2021) 100:47
Medicine
Potential confounders were including sex, age, urbanization
level, socioeconomic status, and comorbidities. Diabetes mellitus
(ICD-9-CM 250), hypertension (ICD-9-CM 401–405), hyperlipidemia (ICD-9-CM 272), coronary artery disease (ICD-9-CM
410–414), stroke (ICD-9-CM 430–438), alcoholism (ICD-9-CM
291, 303, 305.00–305.03, 571.1, 571.2, 571.3, 790.3, A215 and
V11.3), obesity (ICD-9-CM 278), and tobacco use disorder
(ICD-9-CM 305.1, 491.0, 491.2, 492.8, 496, 523.6, 649.0,
989.84, and V15.82) are recognized as comorbid diseases. We
conditionally selected comparison subjects from the general
population matched by sex, age, urbanization level, socioeconomic status, and comorbidities using the propensity score
method at a 1:1 ratio for each case (Fig. 1).
National Health Insurance (NHI), the validation of LHID 2010
data is associated with public confidence. Many studies have been
published form NHIRD represented the epidemiological profiles
of Taiwanese population.[10–12] This study was approved by the
institutional review board of Chung Shan Medical University
Hospital (CSMUH No. CS2-17086).
2.2. Study design
The flow chart of this case control study is shown in Figure 1.
According to the European classification criteria for Sjögren
syndrome in 2002,[13] subjects who had at least three consensus
diagnoses ICD-9-CM 710.2 were identified as pSS. In addition,
patients with history of pSS, age less than 18 years old,
incomplete medical records, or missing data were excluded.
Moreover, we also excluded patients with autoimmune diseases
such as systemic lupus erythematous (ICD-9-CM 710.0),
dermatomyositis (ICD-9-CM 710.3), polymyositis (ICD-9-CM
710.4), rheumatoid arthritis (ICD-9-CM 714), and ankylosing
spondylitis (ICD-9-CM 720.0) to ensure the validity of the pSS
diagnoses. The comparison subjects were selected from the
random sample of general population.
2.3. AMF exposure assessment
The individuals with AMF from LHID 2010 were validated by NHI
treatment codes for health insurance reimbursement qualification.
Subjects who received AMF with NHI treatment codes 89001C,
89002C, 89003C, 89101C, 89102C, and 89103C were captured as
the exposed group. As shown in Figure 1, potentially confounding
factors were also identified and categorized.
Outpatient between 2000-2013 from NHIRD of a subdatasets of one million for the year 2010
Exclusion criteria:
1. Missing data
2. ICD-9-CM 710.0
3. ICD-9-CM 714
4. ICD-9-CM 720.0
5. ICD -9-CM 710.4
6. ICD-9-CM 710.3
N=781,566
Selected criteria for primary Sjögren syndrome
(pSS) by ICD-9-CM diagnosis code (710.2)
pSS (-)
N=775,581
pSS (+)
N=5,985
Matched (1:1) by age、gender、urbanization、
monthly income, alcoholism, coronary artery
disease, diabetes mellitus, hyperlipidemia,
hypertension, obesity, and tobacco use disorder
pSS (+)
N=5,848
pSS (-)
N=5,848
Selected criteria 89001, 89002,
89003, 89101, 89101, 89102
Amalgam filling (+)
pSS (+)
Amalgam filling (+)
pSS (-)
Amalgam filling (-)
pSS (+)
Amalgam filling (-)
pSS (-)
N= 3,282
N= 3,324
N= 2,566
N=2,524
Figure 1. Flow chart used for selection of cases from the Longitudinal Health Insurance Database 2010.
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Chen et al. Medicine (2021) 100:47
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Table 1
Demographic characteristics of selected subjects in this study.
Total (N = 11,696)
Population
Age
Age groups
18–29
30–39
40–49
50–59
60–69
70–79
>80
Gender
Female
Male
Urbanization
Urban
Suburban
Rural
Comorbid diseases
Alcoholism
Coronary artery disease
Diabetes mellitus
Hyperlipidemia
Hypertension
Obesity
Tobacco use disorder
Monthly income
NT$ 40,000
pSS (n = 5848)
%
Population
58.27 ± 17.23
Non-pSS (n = 5848)
%
Population
58.32 ± 16.94
%
58.21 ± 17.5
P value
.234
.168
656
1282
1635
2372
2367
1997
1387
5.61%
10.96%
13.98%
20.28%
20.24%
17.07%
11.86%
306
640
817
1193
1208
1015
669
5.23%
10.94%
13.97%
20.40%
20.66%
17.36%
11.44%
350
642
818
1179
1159
982
718
5.98%
10.98%
13.99%
20.16%
19.82%
16.79%
12.28%
8456
3240
72.30%
27.70%
4223
1625
72.21%
27.79%
4233
1615
72.38%
27.62%
7252
3535
909
62.00%
30.22%
7.77%
3590
1816
442
61.39%
31.05%
7.56%
3662
1719
467
62.62%
29.39%
7.99%
99
2468
797
422
5791
15
2732
0.85%
21.10%
6.81%
3.61%
49.51%
0.13%
23.36%
52
1239
405
216
2880
7
1371
0.89%
21.19%
6.93%
3.69%
49.25%
0.12%
23.44%
47
1229
392
206
2911
8
1361
0.80%
21.02%
6.70%
3.52%
49.78%
0.14%
23.27%
8891
1860
945
76.02%
15.90%
8.08%
4434
952
462
75.82%
16.28%
7.90%
4457
908
483
76.21%
15.53%
8.26%
.868
.499
.597
.810
.669
.798
.250
.801
.879
.994
pSS = primary Sjögren syndrome.
2.4. Statistical analysis
female to male ratio was about 2.6:1. Demographic characteristics, including age, gender, urbanization, region, monthly
income, and comorbidities, were not significantly different
between the cases and control groups.
As shown in Table 2, no statistically significant between AMF
and pSS (adjusted OR: 0.974, 95% CI = 0.904–1.049) was
observed. In addition, pSS was not associated with AMF
regardless of gender (Tables 3 and 4).
The adjusted OR of AMF for female pSS patients was 0.937
(95% CI = 0.858– 1.024) compared with non-AMF. Individuals.
The adjusted OR of AMF for male pSS patients was 1.085 (95%
CI = 0.943–1.249) for non-AMF subjects.
All statistical analyses were performed using SPSS version 18 for
Windows (SPSS, Chicago, IL, USA). Statistical analyses were
performed using Student t test for continuous variables and the
Chi-Squared test for categorical variables. The odds ratio (OR)
between case and control groups was analyzed by the ChiSquared test. A multivariate logistic regression model was
performed for subgroup analysis. All results are presented as ORs
and 95% confidence intervals (CIs). Adjustments were made for
age, gender, income, region, and comorbidities. Statistical
significance was set at P < .05.
3. Results
4. Discussion
As shown in Table 1, we identified 5848 newly diagnosed
patients with pSS as cases and 5848 matched non-pSS patients
from general population as controls. The mean age was 58.32 ±
16.94 years for cases and 58.21 ± 17.5 years for controls. The
To the best of our knowledge, this case-control study is the first to
use nationwide, population-based longitudinal administrative
data to examine the association between AMF and pSS. The
Table 2
Odds ratio for amalgam filling of those with a diagnosis of primary Sjögren syndrome.
pSS (n = 5848)
AMF
Non-AMF
OR (95% CI)
Adjusted OR (95% CI)
Non-pSS (n = 5848)
No. of patients
%
No. of patients
%
3282
2566
56.12%
43.88%
3324
2524
56.84%
43.16%
0.971 (0.903–1.045)
0.974 (0.904–1.049)
1.00
1.00
AMF = amalgam filling, CI = confidence interval, OR = odds ratio, pSS = primary Sjögren syndrome. Adjustment by age, gender, urbanization, monthly income, and comorbidities.
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Chen et al. Medicine (2021) 100:47
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Table 3
Odds ratio for females with a diagnosis of primary Sjögren syndrome with amalgam filling.
Female (n = 8,487)
pSS (n = 4249)
AMF
Non-AMF
OR (95% CI)
Adjusted OR (95% CI)
Non-pSS (n = 4238)
No. of patients
%
No. of patients
%
2379
1844
55.99%
43.40%
2459
1774
58.02%
41.86%
0.931 (0.854–1.015)
0.937 (0.858–1.024)
1.00
1.00
AMF = amalgam filling, CI = confidence interval, OR = odds ratio, pSS = primary Sjögren syndrome. Adjustment by age, gender, urbanization, monthly income, and comorbidities.
Table 4
Odds ratio for males with a diagnosis of primary Sjögren syndrome with amalgam filling.
Male (n = 3227)
pSS (n = 1608)
AMF
Non-AMF
OR (95% CI)
Adjusted OR (95% CI)
Non-pSS (n = 1619)
No. of patients
%
No. of patients
%
903
722
56.16%
44.90%
865
750
53.43%
46.32%
1.084 (0.944–1.245)
1.085 (0.943–1.249)
1.00
1.00
AMF = amalgam filling, CI = confidence interval, OR = odds ratio, pSS = primary Sjögren syndrome. Adjustment by age, gender, urbanization, monthly income, and comorbidities.
findings show that people with AMF were not at a higher risk of
pSS in Taiwanese population.
Contrarily, some reports suggested possible links between
dental amalgam exposure and Sjögren’s syndrome could be via
systemic autoimmune and inflammatory reactions.[14–16] However, these studies without appropriate control groups may result
in the inconsistent linking mercury toxicity from dental amalgam
to cause pSS. As the NHIRD represents the whole population, the
use of health insurance claims could minimize recall bias typical
of case–control studies and enhance clinical significance.
Dysfunction of salivary glands is the main symptom in pSS
patients. Studies have shown that pSS patients face a high risk
of developing dental caries due to xerostomia.[17,18] Recently,
Chuang et al[19] reported that the risk of dental caries was
significantly higher in patients with pSS from Taiwanese NHIRD.
Taken together, it could be explained that SS is associated with
high risk of caries, therefore, amalgam is a material of choice for
people with high susceptibility to dental caries.
In Taiwan, SS is one of the catastrophic illness covered under
the NHI program. However, patients with minor manifestations
of dry mouth and eye might not have a catastrophic illness
certificate of SS. In this study, only patients with at least three
consensus diagnoses (ICD-9-CM 710.0) were captured. Diagnosed pSS patients before a history of AMF were also excluded.
Moreover, to ensure the accurate diagnosis of pSS, patients who
had systemic lupus erythematous, dermatomyositis, polymyositis, rheumatoid arthritis, and ankylosing spondylitis were
excluded. The validity of the AMF was also identified by
treatment codes of the NHI system for health insurance
reimbursement qualification. Therefore, the results of this
nationwide registry-based study could have significance meaningful.
However, there are some possible limitations to the current
study. First, the lack of laboratory data is an inherent limitation
of the NHIRD. Second, information on individual behaviors,
lifestyle factors, and the subtypes of SS are unavailable from the
database. Third, NHIRD does not provide data on other teeth
metal restorations. Fourth, it is hard to monitor the actual
mercury vapor leached form amalgam restoration. Whether
mercury in the etiology of pSS occurrence released by amalgam
cannot be directly obtained in this study. The evaluation of
changes of mercury level in blood or saliva from newly restored
amalgam is required to verify the cause relationship. Finally, the
weakness of propensity matching methodology nature which
does not account for unmeasured confounders in this study
should be taken into consideration. In addition, this is a casecontrol study, and the effect of AMF on pSS over time could not
be estimated, a cohort study design is required in the future.[20]
5. Conclusions
This population-based case-control study preliminarily proposed
that AMF was not associated with pSS. However, approximately
50% of dental amalgam is elemental mercury by weight, it is still
a public concern for continuing use of dental amalgam or not.
Thus, the cause-effect relationship and pathophysiology are still
necessary to further investigations.
Author contributions
Formal analysis: Kun-Huang Chen.
Investigation: Kun-Huang Chen.
Methodology: Kun-Huang Chen, Hui-Chieh Yu.
Supervision: Hui-Chieh Yu, Yu-Chao Chang.
Validation: Yu-Chao Chang.
Writing – review & editing: Yu-Chao Chang.
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5
Critical Assessment of Study Article
Student Reviewer:
Title:
Authors:
Journal:
Publication Date:
Purpose of study:
Study design1:
Data source and/or Sample:
Primary measure:
Test used – Odds Ratio/Risk Ratio?:
Complete the below 2x2 table with the appropriate data from the study article that produced the
results:
Epidemiology 2x2 Table
Disease/Condition
Status
Yes
No
Total
Exposure
Status
Yes
No
Total
Calculation used with the above numbers that produced the resulting OR or RR:
Explain how the above measure of association is interpreted for this (case-control) study?
1
*The authors should state the study design. If they do not specifically state that this is a case-control or cohort
design, you can look at the definition in your Caron (2nd Ed.) textbook. The description of a case-control study
starts on page 252 and the cohort description starts on page 255.
Advantages of using a case-control study:
Limitations of using a case-control study:
There are two general categories of bias discussed in Chapter 9 of your textbook: information bias
(which includes recall bias, interviewer/abstractor bias, and prevarication bias) and selection bias.
Identify and discuss the plausibility of these biases for this study:
Describe methods the authors used to minimize bias and confounding. If there were none (not very
likely, but possible), what are some ways that they could have minimized the problems of bias and
confounding? (Chapter 9 discusses techniques for minimizing both categories of bias and confounding.):
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