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Study designs. Wilfried Karmaus Reproductive Epidemiology EPI 824. Five basic study designs. Descriptive study Cross-sectional study Longitudinal study and intervention trial Case-control study Aggregative study (ecological study). Descriptive Studies (1).
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Study designs Wilfried Karmaus Reproductive Epidemiology EPI 824
Five basic study designs • Descriptive study • Cross-sectional study • Longitudinal study and intervention trial • Case-control study • Aggregative study (ecological study)
Descriptive Studies (1) • Descriptive studies examine the distribution of disease in a defined population. • Based on existing mortality or morbidity statistics, such as hospital discharge data. • Examine patterns of health outcome by age, gender or ethnicity, for specified time period or geographical areas. • Estimates the incidence or prevalence of the disease: • Life time prevalence • Period prevalence • Point prevalence
Descriptive Studies (2) • Do not formally evaluate the association between exposure and health outcome, although they can be helpful in assessing the possibility that an association exists. • Descriptive data are used to examine patters of health outcome by: • Place • Time • Person
Flow of knowledge and its application Assumptions: knowledge about the appropriate time window of exposure & effect randomized clinical or intervention trials analytical observational studies observational studies
Cross-sectional study Begin of the study Measure/Classify and Compare Risk/Factor (+) Free of Disease/Outcome Risk/Factor (-) Study population Risk/Factor (+) Have Disease/Outcome Risk/Factor (-)
Longitudinal study & intervention trials Begin of the study Measure/Classify the exposure Free of Disease/Outcome Risk/Factor (+) Have Disease/Outcome Disease-free at the beginning Study population Free of Disease/Outcome Risk/Factor (-) Have Disease/Outcome Change the exposurein an intervention trial Measure and compare the disease frequency
Case-control studies (case comparison, case referent) Caseness = starting point of case-control studies (medical care) not exposed Cases exposed Measure and compare the EXPOSURE frequency not exposed Controls exposed No estimates of incidence or prevalence
Aggregative Study (ecological study) Mean of a variable Mean of a variable =aggregated data =aggregated data Association?
Imagine some hypothesis for reproductive health outcomes (see below) and then develop some designs • Plurality • Pregnancy outcome: stillbirth, live birth, induced abortion, miscarriage, ectopic pregnancy • Gender of the offspring • Number of children • Fetal growth (ultrasound) • breech / cephalic delivery • birth weight, size, head circumference • placental markers • malformations • retinopathy of prematurity • fibroids, neoplasm • genital and breast development (Tanner stages) • sperm count / motility • AFP, etc. • pregnancy test • male and female hormone profiles • age at menarche • age at menopause • age at first intercourse • interval between menarche and first intercourse • age at first marriage • cycle length, duration of menstruation • gestational age • LMP (date of last menstrual period before conception) • Time to pregnancy (TTP) • Periods of unprotected intercourse not leading to pregnancy (PUNP) • Contraceptive use • Planning a baby • Frequency of sexual intercourse • Number and gender of partners • Use of fertility services • Gravidity, Parity • Male or female infertility