Observational Studies

Author(s):  
Minou Djannatian ◽  
Clarissa Valim ◽  
Andre Brunoni ◽  
Felipe Fregni

This chapter on observational studies provides an understanding of the main concepts in epidemiology, introduces common study designs, such as cross-sectional, case-control, and cohort studies, and outlines their importance for clinical research. The hallmark of epidemiological research is that it observes unexposed and exposed individuals under “real-life conditions” without intervening itself. The chapter emphasizes the important role of bias and confounding in interpreting results from such studies and explains how bias and confounding can be controlled. It furthermore discusses specific aspects of sample size determination that are relevant to observational studies. The chapter concludes with a brief review of the special nature of surgical research.

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):  
Sam Ghebrehewet ◽  
Paul Cleary ◽  
Merav Kliner ◽  
Ewan Wilkinson

This chapter describes the different types of epidemiological studies that are used in health protection investigations. These include descriptive studies such as case reports, case series, cross-sectional studies, and analytical studies, particularly case-control and cohort studies. It provides a number of real-life examples illustrating these different types of investigation and their application in health protection practice. It also gives guidance on the type of study to use in different incidents or outbreaks, and on sample size determination. The limitations of the different study designs are described. The particular requirements of randomized controlled trials and systematic reviews, and their role in health protection are described. The roles of qualitative and operational studies are also outlined.


2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Zahra Aslani ◽  
Omid Sadeghi ◽  
Motahar Heidari-Beni ◽  
Hoda Zahedi ◽  
Fereshteh Baygi ◽  
...  

Abstract Context The association of dietary inflammatory index (DII®), as an index of inflammatory quality of diet, with cardiometabolic diseases (CMDs) and risk factors (CMRFs) has been inconsistent in previous studies. Objective The current systematic review and dose–response meta-analysis was performed to investigate the association of the DII score with CMDs and CMRFs. Data Sources All published observational studies (cohort, case–control and cross-sectional) using PubMed/Medline, Scopus, ISI Web of Science, and Google Scholar databases were retrieved from inception through November 2019. Data extraction Two reviewers independently extracted the data from included studies. Data analysis Pooled hazard ratio (HR) or odds ratio (OR) were calculated by using a random-effects model. Results Ten prospective cohort studies (total n = 291,968) with 31,069 CMDs-specific mortality, six prospective cohort studies (total n = 43,340) with 1311 CMDs-specific morbidity, two case–control studies with 2140 cases and 6246 controls and one cross-sectional study (total n = 15,613) with 1734 CMDs-specific morbidity were identified for CMDs. Meta-analyses of published observational studies demonstrated that the highest DII score category versus the lowest DII score category was associated with 29% increased risk of CMDs mortality (HR = 1.29; 95% confidence interval (CI) 1.18, 1.41). Moreover, there was a significant association between the DII score and risk of CMDs in cohort studies (HR = 1.35; 95% CI 1.13, 1.61) and non-cohort study (HR = 1.36; 95% CI 1.18, 1.57). We found a significant association between the DII score and metabolic syndrome (MetS) (OR: 1.13; 95% CI 1.03, 1.25), hyperglycemia and hypertension. None-linear dose response meta-analysis showed that there was a significant association between the DII score and risk of CMDs mortality (Pnonlinearity < 0.001). Moreover, evidence of none-linear association between the DII score and risk of CMDs was not observed (p-value = 0.1). Conclusions Adherence to pro-inflammatory diet was associated with increased risk of CMDs, mortality and MetS.


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.


2016 ◽  
Vol 46 (4) ◽  
pp. 242-252 ◽  
Author(s):  
Danfei Lou ◽  
Yuehua Li ◽  
Guoliang Yan ◽  
Jianhong Bu ◽  
Haihui Wang

Background: The association of soy product consumption with the relative risk of cardiovascular disease remains controversial. This meta-analysis aimed at investigating whether an association exists between soy consumption and the risk of stroke and coronary heart disease (CHD) in observational studies. Methods: A systematic search of the PubMed and EMBASE databases was performed for case-control and cohort studies that assessed soy consumption and the risk of stroke and CHD. Summary relative risks (SRRs) and 95% CIs were combined by using a random-effects model. Results: Of a total of 1,266 abstracts, 5 prospective cohort and 6 case-control studies met our inclusion criteria, and comprised 4,954 stroke and 7,616 CHD events. Based on the high vs. low analyses, combining cohort studies showed no association between soy intake and risk of stroke (SRR 0.92; 95% CI 0.70-1.10; Pheterogeneity = 0.236; I2 = 29.4%) or CHD (SRR 0.97; 95% CI 0.74-1.27; Pheterogeneity = 0.020; I2 = 62.7%), although a significantly inverse association between soy intake and the risk of stroke (SRR 0.54; 95% CI 0.34-0.87; Pheterogeneity = 0.001; I2 = 79.3%) and CHD (SRR 0.66; 95% CI 0.56-0.77; Pheterogeneity = 0.421; I2 = 0) was observed in case-control studies. No association between soy isoflavone intake and the risk of stroke and CHD was identified. Conclusion: There was limited evidence to indicate that soy consumption was inversely associated with the risk of stroke and CHD, although further studies, with prospective designs that use validated questionnaires and control for important confounders, are warranted.


2015 ◽  
Vol 114 (9) ◽  
pp. 1341-1359 ◽  
Author(s):  
Míriam Rodríguez-Monforte ◽  
Gemma Flores-Mateo ◽  
Emília Sánchez

AbstractEpidemiological studies show that diet is linked to the risk of developing CVD. The objective of this meta-analysis was to estimate the association between empirically derived dietary patterns and CVD. PubMed was searched for observational studies of data-driven dietary patterns that reported outcomes of cardiovascular events. The association between dietary patterns and CVD was estimated using a random-effects meta-analysis with 95 % CI. Totally, twenty-two observational studies met the inclusion criteria. The pooled relative risk (RR) for CVD, CHD and stroke in a comparison of the highest to the lowest category of prudent/healthy dietary patterns in cohort studies was 0·69 (95 % CI 0·60, 0·78; I2=0 %), 0·83 (95 % CI 0·75, 0·92; I2=44·6 %) and 0·86 (95 % CI 0·74, 1·01; I2=59·5 %), respectively. The pooled RR of CHD in a case–control comparison of the highest to the lowest category of prudent/healthy dietary patterns was 0·71 (95 % CI 0·63, 0·80; I2=0 %). The pooled RR for CVD, CHD and stroke in a comparison of the highest to the lowest category of western dietary patterns in cohort studies was 1·14 (95 % CI 0·92, 1·42; I2=56·9 %), 1·03 (95 % CI 0·90, 1·17; I2=59·4 %) and 1·05 (95 % CI 0·91, 1·22; I2=27·6 %), respectively; in case–control studies, there was evidence of increased CHD risk. Our results support the evidence of the prudent/healthy pattern as a protective factor for CVD.


2021 ◽  
pp. 1-10
Author(s):  
Jan P. Vandenbroucke ◽  
Erik Von Elm ◽  
Douglas G. Altman ◽  
Peter C. Gotzsche ◽  
Cynthia D. Mulrow ◽  
...  

Much medical research is observational. The reporting of observational studies is often of insufficient quality. Poor reporting hampers the assessment of the strengths and weaknesses of a study and the generalisability of its results. Taking into account empirical evidence and theoretical considerations, a group of methodologists, researchers, and editors developed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) recommendations to improve the quality of reporting of observational studies. The STROBE Statement consists of a checklist of 22 items, which relate to the title, abstract, introduction, methods, results and discussion sections of articles. Eighteen items are common to cohort studies, case-control studies and cross-sectional studies and four are specific to each of the three study designs. The STROBE Statement provides guidance to authors about how to improve the reporting of observational studies and facilitates critical appraisal and interpretation of studies by reviewers, journal editors and readers. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the STROBE Statement. The meaning and rationale for each checklist item are presented. For each item, one or several published examples and, where possible, references to relevant empirical studies and methodological literature are provided. Examples of useful flow diagrams are also included. The STROBE Statement, this document, and the associated Web site (http://www. strobe-statement.org/) should be helpful resources to improve reporting of observational research. This article is the reprint with Russian translation of the original that can be observed here: Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, et al. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med 2007;4(10):e297. doi:10.1371/journal.pmed.0040297


Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3594
Author(s):  
Emmanouela Sdona ◽  
Athina Vasiliki Georgakou ◽  
Sandra Ekström ◽  
Anna Bergström

A high intake of dietary fibre has been associated with a reduced risk of several chronic diseases. This study aimed to review the current evidence on dietary fibre in relation to asthma, rhinitis and lung function impairment. Electronic databases were searched in June 2021 for studies on the association between dietary fibre and asthma, rhinitis, chronic obstructive pulmonary disease (COPD) and lung function. Observational studies with cross-sectional, case–control or prospective designs were included. Studies on animals, case studies and intervention studies were excluded. The quality of the evidence from individual studies was evaluated using the RoB-NObs tool. The World Cancer Research Fund criteria were used to grade the strength of the evidence. Twenty studies were included in this systematic review, of which ten were cohort studies, eight cross-sectional and two case–control studies. Fibre intake during pregnancy or childhood was examined in three studies, while seventeen studies examined the intake during adulthood. There was probable evidence for an inverse association between dietary fibre and COPD and suggestive evidence for a positive association with lung function. However, the evidence regarding asthma and rhinitis was limited and inconsistent. Further research is needed on dietary fibre intake and asthma, rhinitis and lung function among adults and children.


2020 ◽  
Vol 34 (5) ◽  
pp. 703-714
Author(s):  
Xiaoping Gao ◽  
Mei Yin ◽  
Pei Yang ◽  
Xia Li ◽  
Lingling Di ◽  
...  

Background Controversies persist regarding whether exposure to cat or dog increases the risk of asthma and allergic rhinitis. Objective This meta-analysis aimed to assess the associations between exposure to cats or dogs and the development of asthma and allergic rhinitis. Methods A systematic review was performed to identify case-control and cohort studies before May 2019, evaluating the association between exposure to cats and dogs and the risk of asthma and rhinitis. The risk of bias was assessed using the Newcastle–Ottawa Scale. The odds ratios (ORs) and risk ratios (RRs) were pooled for case-control and cohort studies, respectively. Subgroup analyses were performed on prespecified study-level characteristics. Results The meta-analysis of 34 cohort studies showed a protective role of exposure to cats [RR: 0.88, 95% confidence interval (CI): 0.77–0.99] or dogs (RR: 0.85, 95% CI: 0.73–0.97) in the development of asthma. The subgroup analysis of birth cohort (RR: 0.74, 95% CI: 0.56–0.93) and children population (RR: 0.83, 95% CI: 0.70–0.96) also suggested a favorable role of exposure to dogs in the development of asthma. Pooled evidence from 13 case-control studies indicated no significant impact of cats (OR: 1.66, 95% CI: 0.39–2.94) and dogs (OR: 1.22, 95% CI: 0.92–1.52) on the development of asthma. A pooled analysis of five cohort studies showed a favorable effect of exposure to cats (RR: 0.60, 95% CI: 0.33–0.86) or dogs (RR: 0.68, 95% CI 0.44–0.90) on the development of allergic rhinitis. Conclusion The findings indicated a protective effect of exposure to cats and dogs, especially ownership, on the development of asthma and allergic rhinitis.


Blood ◽  
2010 ◽  
Vol 116 (16) ◽  
pp. 2897-2907 ◽  
Author(s):  
Jorge J. Castillo ◽  
Samir Dalia ◽  
Sheila K. Pascual

AbstractThe incidence of non-Hodgkin lymphoma (NHL) has increased steadily for the past few decades. Previous studies have suggested an association between blood transfusions and NHL. The main objective of this study was to evaluate this relationship with a meta-analysis of observational studies. A literature search was undertaken, looking for case-control and cohort studies evaluating the risk of developing NHL in persons who received allogeneic blood transfusions; 14 studies were included. Outcome was calculated and reported as relative risk (RR). Heterogeneity was assessed with Cochrane Q and I2 statistics. Dissemination bias was evaluated by funnel plot visualization and trim-and-fill analysis. Quality assessment was performed with the Newcastle-Ottawa scale. Our analysis showed a RR of developing NHL of 1.05 (95% CI, 0.89-1.25; P = .42) and 1.34 (95% CI, 1.15-1.55; P < .01) in case-control and cohort studies, respectively. When pooling all studies, RR was 1.2 (95% CI, 1.07-1.35; P < .01). In subset analysis, RR of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was 1.66 (95% CI, 1.08-2.56; P = .02). The RR of NHL was elevated in both men and women and in persons receiving transfusions either before or after 1992. Blood transfusions appear to increase the risk of developing NHL; however, the risk of CLL/SLL appears higher than for other NHL subtypes.


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