Study designs which can demonstrate and test causation

Author(s):  
Mark Elwood

This chapter presents study designs which can test and show causation. Cohort and intervention studies compare people exposed to an agent or intervention with those unexposed or less exposed. Case-control studies compare people affected by a disease or outcome with a control group of unaffected people or representing a total population. Surveys select a sample of people, not chosen by exposure or outcome. Cohort studies may be prospective or retrospective; case-control studies are retrospective; surveys are cross-sectional in time, but retrospective or prospective aspects can be added. In part two, strengths, weaknesses and applications of these designs are shown. Intervention trials, ideally randomised, are the prime method of assessing healthcare interventions; special types include crossover trials and community-based trials. Non-randomised trials are noted. The strengths and weaknesses of cohort studies, case-control studies, and surveys are shown.

Author(s):  
Tamsin Ford ◽  
Jayati Das-Munshi ◽  
Martin Prince

This chapter provides a brief overview for each of the main types of study design commonly used in psychiatric epidemiology. The chapter begins with a discussion of the importance of study design. This is followed by a section on classifying study design, including descriptive studies, ecological studies, cross-sectional surveys, cohort studies, case–control studies, intervention studies, and qualitative and mixed methods studies. The chapter concludes with a description of the basic steps which should be observed in the conduct of studies employing quantitative methodologies (including cross-sectional, cohort, and case–control studies), as well as discussing interviews/assessments, and data collection and processing.


F1000Research ◽  
2019 ◽  
Vol 7 ◽  
pp. 1725 ◽  
Author(s):  
Carl Heneghan ◽  
Jeffrey K. Aronson ◽  
Elizabeth Spencer ◽  
Bennett Holman ◽  
Kamal R. Mahtani ◽  
...  

Background: Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations. Methods: We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies. Results: We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4,209 were exposed to HPTs. Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%). Exposure to HPTs was associated with an increased risk of congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%); nervous system malformations  OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%); gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%); musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%); the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%). Conclusions: This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.


Author(s):  
Sadie Costello ◽  
Jennifer M. Cavallari ◽  
David H. Wegman ◽  
Marie S. O’Neill ◽  
Ellen A. Eisen

This chapter describes the basic principles of epidemiology, emphasizing the aspects most relevant to studies of health effects from occupational and environmental exposures. Numerous examples are provided of how epidemiology can be used to identify and quantify the relations between recent or long-term exposure and health outcomes, such as prevalence or incidence of disease, injury, or mortality. The chapter describes the common study designs, including cohort studies, case-control studies, and cross-sectional studies, with examples of their application. Key aspects of exposure assessment and characterizing and quantifying exposure, are described. The three types of bias in epidemiology, information, selection, and confounding, are defined as well as the healthy worker effect, a potential source of bias unique in occupational studies. Study designs and analytic methods that can reduce or eliminate specific types of bias are also described. Finally, the chapter provides guidance on how to interpret the results of studies, with an eye toward causal inference.


2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Hui Liu

Objective. Although the relative risk from a prospective cohort study is numerically approximate to the odds ratio from a case-control study for a low-probability event, a definite relationship between case-control and cohort studies cannot be confirmed. In this study, we established a different model to determine the relationship between case-control and cohort studies. Methods. Two analysis models (the cross-sectional model and multiple pathogenic factor model) were established. Incidences in both the exposure group and the nonexposure group in a cohort study were compared with the frequency of the observed factor in each group (diseased and nondiseased) in a case-control study. Results. The relationship between the results of a case-control study and a cohort study is as follows: Pe=Pd∗m/Pc∗1−m+Pd∗m; Pn=m∗1−Pd/1−Pc∗1−m−Pd∗m, where Pe and Pn represent the incidence in the exposed group and nonexposed group, respectively, from the cohort study, while Pd and Pc represent the observed frequencies in the disease group and the control group, respectively, for the case-control study; finally, m represents the incidence in the total population. Conclusions. There is a definite relationship between the results of case-control and cohort studies assessing the same exposure. The outcomes of case-control studies can be translated into cohort study data.


PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252844
Author(s):  
Po-Yueh Chen ◽  
Tzu-Ying Chen ◽  
Pin-Zhir Chao ◽  
Wen-Te Liu ◽  
Chyi-Huey Bai ◽  
...  

Background In recent population-based case-control studies, sleep apnea was significantly associated with a higher incidence (hazard ratio, 1.71) of vertigo and the risk of tinnitus was found to increase 1.36 times in patients with sleep apnea. The possibility that obstructive sleep apnea (OSA) might affect neurotological consequences was not noticed, until studies using polysomnography (PSG) for these patients. Objectives The purpose of this study was to investigate the relationship between vertigo and OSA. Methods The collected data among patients from May 1st, 2018 to October 31th, 2018 at Shuang Ho Hospital. Eligibility criteria included an age older than 20 years, a diagnosis of obstructive sleep apnea. The diagnosis of OSA was defined as an oxygen desaturation index of at least 5, was established with the use of polysomnographic examination at hospital. Patients were excluded from the study if they had head injury, brain tumour, headache history and hearing loss. Patients who had vertigo were labeled as Vertigo group. In the other hand, patients who had no dizziness were labeled as control group. 58 patients were in the Vertigo group, and 113 were in the control group. Results After PSG examination, 58 patients who had vertigo, were diagnosed OSA (29 males, average age = 57.07 years old, BMI = 26.64, RDI = 24.69, ESS = 8.65), and 24 patients of them (41.3%) were REM-related OSA. Meanwhile, in the control group, 113 patients had OSA (92male, average age = 49.66 years old, BMI = 26.06, RDI = 35.19, ESS = 11.43), and 18 patients of them (15.9%) were REM-related OSA (Table 1). Therefore, patient who had vertigo, would have higher proportion of REM OSA (P<0.001). Conclusions The vertigo patients have a higher rate of REM-related OSA, and the acceptance rate to CPAP use is low. Further research is needed to explore novel therapeutic approaches, or combination of currently available non-CPAP therapies, in patients with REM OSA.


F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1725 ◽  
Author(s):  
Carl Heneghan ◽  
Jeffrey K. Aronson ◽  
Elizabeth Spencer ◽  
Bennett Holman ◽  
Kamal R. Mahtani ◽  
...  

Background: Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations. Methods: We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies. Results: We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4209 were exposed to HPTs. Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%). Exposure to HPTs was associated with an increased risk of congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%); nervous system malformations  OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%); gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%); musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%); the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%). Conclusions: This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Meng-Han Shen ◽  
Chau Yee Ng ◽  
Kuo-Hsuan Chang ◽  
Ching-Chi Chi

Abstract Polyautoimmunity implicates that some autoimmune diseases share common etiopathogenesis. Some studies have reported an association between multiple sclerosis (MS) and vitiligo; meanwhile, other studies have failed to confirm this association. We performed a systemic review and meta-analysis to examine the association of MS with vitiligo. We searched the MEDLINE and Embase databases on March 8, 2020 for relevant case–control, cross-sectional, and cohort studies. The Newcastle–Ottawa Scale was used to evaluate the risk of bias of the included studies. Where applicable, we performed a meta-analysis to calculate the pooled odds ratio (OR) for case–control/cross-sectional studies and risk ratio for cohort studies with 95% confidence interval (CI). Our search identified 285 citations after removing duplicates. Six case–control studies with 12,930 study subjects met our inclusion criteria. Our meta-analysis found no significant association of MS with prevalent vitiligo (pooled OR 1.33; 95% CI 0.80‒2.22). Analysis of the pooled data failed to display any increase of prevalent vitiligo in MS patients compared with controls. Ethnic and genetic factors may play an important role for sporadically observed associations between MS and vitiligo. Future studies of this association should therefore consider stratification by ethnic or genetic factors.


2021 ◽  
pp. jnnp-2021-326405
Author(s):  
Jonathan P Rogers ◽  
Cameron J Watson ◽  
James Badenoch ◽  
Benjamin Cross ◽  
Matthew Butler ◽  
...  

There is accumulating evidence of the neurological and neuropsychiatric features of infection with SARS-CoV-2. In this systematic review and meta-analysis, we aimed to describe the characteristics of the early literature and estimate point prevalences for neurological and neuropsychiatric manifestations. We searched MEDLINE, Embase, PsycINFO and CINAHL up to 18 July 2020 for randomised controlled trials, cohort studies, case-control studies, cross-sectional studies and case series. Studies reporting prevalences of neurological or neuropsychiatric symptoms were synthesised into meta-analyses to estimate pooled prevalence. 13 292 records were screened by at least two authors to identify 215 included studies, of which there were 37 cohort studies, 15 case-control studies, 80 cross-sectional studies and 83 case series from 30 countries. 147 studies were included in the meta-analysis. The symptoms with the highest prevalence were anosmia (43.1% (95% CI 35.2% to 51.3%), n=15 975, 63 studies), weakness (40.0% (95% CI 27.9% to 53.5%), n=221, 3 studies), fatigue (37.8% (95% CI 31.6% to 44.4%), n=21 101, 67 studies), dysgeusia (37.2% (95% CI 29.8% to 45.3%), n=13 686, 52 studies), myalgia (25.1% (95% CI 19.8% to 31.3%), n=66 268, 76 studies), depression (23.0% (95% CI 11.8% to 40.2%), n=43 128, 10 studies), headache (20.7% (95% CI 16.1% to 26.1%), n=64 613, 84 studies), anxiety (15.9% (5.6% to 37.7%), n=42 566, 9 studies) and altered mental status (8.2% (95% CI 4.4% to 14.8%), n=49 326, 19 studies). Heterogeneity for most clinical manifestations was high. Neurological and neuropsychiatric symptoms of COVID-19 in the pandemic’s early phase are varied and common. The neurological and psychiatric academic communities should develop systems to facilitate high-quality methodologies, including more rapid examination of the longitudinal course of neuropsychiatric complications of newly emerging diseases and their relationship to neuroimaging and inflammatory biomarkers.


Author(s):  
Harman Chaudhry ◽  
Mohit Bhandari

ABSTRACT Clinical research fundamentally involves finding answers to questions. Next to asking important questions, determining what type of study design to use is arguably the most pivotal step for a researcher. In this article, we provide an overview of various clinical study designs, including case reports and series, case-control studies, observational cohort studies, randomized controlled trials and systematic reviews. We aim to elucidate the utility, advantages and drawbacks of these study designs in order to assist researchers in selecting the most valid design for their research question. How to cite this article Chaudhry H, Bhandari M. Research made Easy: Answering Important Questions with Valid Designs. J Postgrad Med Edu Res 2012;46(1):8-11


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