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Different Types of Epidemiologic Studies
Kamran Yazdani, MD MPH Department of Epidemiology and Biostatistics School of Public Health
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CASP Critical Appraisal Skills Programme http://www. phru. nhs
CASP Critical Appraisal Skills Programme (Appraisal Tools)
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CASP Major Points: Is the Objective CLEAR?
Is the Method (Design & Analysis) APPROPRIATE? Dealing with: Selection Bias Information Bias Confounding Chance error Reporting (Analysis, Results) Interpreting (Association, Causation) Generalizability Consistency, Coherence SCREENING
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http://www.strobe-statement.org/Checklist.html (Checklists)
STROBE STrengthening the Reporting of OBservational studies in Epidemiology (Checklists)
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Epidemiology The study of the distribution and determinants of health-related states or events in specified populations, and the application of this study to control of health problems.
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Aim of epidemiological studies
To determine distribution of disease Descriptive Studies To examine determinants of a disease To judge whether a given exposure causes or prevents disease Analytical Studies
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انواع مطالعات توصيفي: با هدف بررسي و توصيف يك وضعيت بدون آنكه قصد بررسي يك رابطه (آزمون فرضيه) را داشته باشيم تحليلي: با هدف بررسي يك رابطه ، اختلاف يا ارتباط (آزمون فرضيه) صورت مي پذيرد
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Epidemiologic Design Strategies
Descriptive studies case reports, case-series, cross-sectional Analytical studies Observational studies Cross-sectional Case-control studies Cohort studies Intervention studies Clinical trials Field trials Community trials Experimental (animals) Diagnostic Tests studies or Process Research
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انواع مطالعات توصيفي تحليلي مشاهده اي گزارش مورد گزارش موارد كوهورت
مداخله اي گزارش مورد گزارش موارد كوهورت كارآزمايي باليني اكولوژيك مورد شاهدي كارآزمايي ميداني مقطعي كارآزمايي اجتماعي
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Advantages of Case Reports and Case series
Allows for the description of new disease processes. Allows for the description of outcomes associated with rare diseases or rare features of any disease. To formulate hypotheses of the association
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Disadvantages/Limitations of Case Report & Case Series
Impossible to determine disease frequency. Cannot establish causality between exposures or risk factors and disease outcome.
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Case Report example In 1961, a published case report of a 40 year-old woman who developed pulmonary embolism after beginning use oral contraceptive
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Case Series example In Los Angeles, five young homosexuals men, previously healthy, were diagnosed with pneumocyst cariini pneumonia in a 6-month period (80-81)
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Case Series example RESULTS: Twelve patients with histopathologically confirmed tumours detected after extraction of teeth were studied. There were 11 males and one female giving a male to female ratio of 11:1. They ranged in age from years with a mean age of 53 years. Pain and swelling were the most common presenting complaints. The mandible was more often involved seven (58.3%) cases while five (41.7%) cases occurred in the maxilla. Squamous cell carcinoma (in 9 cases) was the most common malignant neoplasm among these patients.
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Cross-sectional studies
Cross-Sectional Studies measure existing disease and current exposure levels. They provide some indication of the relationship between the disease and exposure or non-exposure
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Cross Sectional Studies (contd)
Sample without knowledge of Exposure or Disease Sample at one point in time Mostly prevalence studies/surveys
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Cross Sectional Studies
(Advantages) Good design for hypothesis generation Can estimate overall and specific disease prevalence and sometimes rates Can estimate exposure proportions in the population Can study multiple exposures or multiple outcomes or diseases
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Cross Sectional Studies
(Advantages) Relatively easy, quick and inexpensive!!! Best suited to studying permanent factors (breed, sex, blood-type) to deal with TEMPORALITY. Often good first step for new study issue
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Cross Sectional Studies
(Disadvantages) Impractical for rare diseases Not a useful type of study for establishing causal relationships Confounding is difficult to control Problems with temporal sequence of data hard to decide when disease was actually acquired miss diseases still in latent period recall of previous exposure may be faulty
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Cross Sectional Studies
Disease Status Yes No Total Exposure Status Yes a b a +b No c d c +d a +c b +d N
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Cross Sectional Studies
Depression Yes No Total Yes 3 87 90 low SES No 14 75 89 17 162 179
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Cross Sectional Studies
Points need concern: Sampling Protocol (Quality Assurance & Control) Appropriate Analysis Appropriate and Fair Interpretation
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Randomized Clinical Trials
Population Outcome Inclu & Exclu New Treatment Improved Not improved Participants (Randomization) Comparison treatment Improved Not improved
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Randomized Clinical Trials
Cure Total Yes No A 13 87 100 Treatment 75 100 B 25 38 162 200
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Cohort / Follow-up Studies
Study population (Non-diseased) Exposed Non-exposed Disease + Disease -
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Cohort study, at a glance
Case control Cohort Study group Diseased/ healthy Exposed/ unexposed Measure of effect OR, AR Risk, RR,OR.AR temporal Hard to establish Easy to establish multiple exposures outcomes time Short Long cost inexpensive Expensive Population size small Large Information bias exposure Outcome Best when D rare E frequent E rare D frequent Problems Control selection Exposure information Unexposed selection change over time
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جدول توافقي در مطالعهي كوهورت
Disease Status Yes No Total n1 Exposure Status Yes a b a +b No c d c +d n2 a +c b +d N
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آيا مطالعه كوهورت هميشه تحليلي است؟
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مطالعه كوهورت ـ انواع زمان حال مواجهه پي آمد مواجهه پي آمد مواجهه
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Prospective vs. retrospective Cohort Studies
Prospective Cohort Studies Time consuming, expensive More valid information on exposure Measurements on potential confounders Retrospective Cohort Studies Quick, cheap Appropriate to examine outcome with long latency periods Admission to exposure data Difficult to obtain information of exposure Risk of confounding
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چه موقع مطالعه كوهورت مناسبتر است؟
شواهدي موجود باشد LOSS TO FOLLOW UP را بتوانيم كنترل كنيم مدت پي گيري نسبتاً كوتاه باشد بتوانيم كوهورت تاريخي انجام دهيم مواجهه نادر باشد
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Selection of the Exposed Population
Sample of the general population: Geographically area, special age groups, birth cohorts (Framingham Study) A group that is easy to identify: Nurses health study Special population (often occupational epidemiology): Rare and special exposure
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Selection of the Comparison Population
Internal Control Group Exposed and non-exposed in the same Study population (Framingham study, Nurses health study) Minimise the differences between exposed and non-exposed External Control Group Chosen in another group, another cohort (Occupational epidemiology: Asbestosis vs. cotton workers) The General Population
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Bias Selection bias: Information bias
Non-representativeness (unequal in e+ & e-) Non-response during data collection Losses to follow up Healthy worker effect Information bias Misclassification on exposure Misclassification on event
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CASP questions
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Case-control study Exposed Cases Non-exposed Study Population Exposed
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Direction exposure outcome
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Applications Diseases with long latency period
For best use of time and money The best for rare diseases & useful for prevalent diseases Mutiple exposures
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Case-control study, at a glance
Cohort Study group Diseased/ healthy Exposed/ unexposed Measure of effect OR, AR Risk, RR,OR.AR temporal Hard to establish Easy to establish multiple exposures outcomes time Short Long cost inexpensive Expensive Population size small Large Information bias exposure Outcome Best when D rare E frequent E rare D frequent Problems Control selection Exposure information Unexposed selection change over time
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BIASes Selection Information
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Selection of cases Case definition is more important than other studies: Strict diagnostic criteria (high degree of caseness) Homogenous diseases (one well-defined outcome or health-related state)
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Selection of cases Sources of cases
Population Hospital (available, better dx, low inf bias, high sel bias) Registry … Are the cases representative of total population or a fraction of it?
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Selection of cases Incident vs. Prevalent
Selection & Information BIASes
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Selection of controls Study base Deconfounding Comparable accuracy
Sel bias Deconfounding confounding Comparable accuracy Info bias
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Selection of controls سوال:
آيا مي توان براي يك گروه بيمار كه از بيمارستان انتخاب شده اند، گروه كنترل را از جامعه گرفت؟
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Types of controls Population controls Hospital controls
Friend, RDD, neighbor controls Hospital controls Similar disease as controls
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Hospital controls Similar study base Similar quality of information
Convenience
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Population controls Tax lists, vote lists, telephone directories,…
RDD: Selection bias due to higher ses., families with more than phone lines and family size
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Matching
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Ratio of controls to cases
Statistical considerations (increasing power) Unsuitable for very low or very high powers under equal sizes
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Ratio of controls to cases
Control to case ratio: up to 4-fold: case cont 1: 1: 1: 1: 1:
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جدول توافقي در مطالعهي
مورد ـ شاهدي Disease Status Yes No Total Exposure Status Yes a b a +b No c d c +d a +c n1 b +d n2 N
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CASP questions
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مقايسه RR و OR در مطالعه كوهورت OR مي تواند برآورد خوبي از RR باشد اگر: بيماري بروز بالايي نداشته باشد در مطالعه مورد شاهدي OR مي تواند برآورد خوبي از RR باشد اگر: موردها نماينده بيماران جامعه باشند شاهدها نماينده سالمهاي جامعه باشند
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Comparing cohort and case control
Study group Diseased/ healthy Exposed/ unexposed Measure of effect OR, AR Risk, RR,OR.AR temporal Hard to establish Easy to establish multiple exposures outcomes time Short Long cost inexpensive Expensive Population size small Large Information bias exposure Outcome Best when D rare E frequent E rare D frequent Problems Control selection Exposure information Unexposed selection change over time
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Intuition and Logic in Research
Dominant Mental Activity Intuition Feeling Judgement Experience Analysis Experiment Clinical trials Cohort Study Hi Case-control Study Cross-sectional Study Control over variance Case Report Case Series Qualitative Research Lo Potential for Misinterpretation Lo Hi
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