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Study Designs
Dr Pallavi Potdar
Associate Prof.,
Community Medicine
D.Y. Patil Medical College Kolhapur
• It is important to get results from experiment
but the most important is the process in
getting that results.
Study Designs?
Study Designs
Descriptive
•Case report
•Case series
•Ecological
•Cross sectional
Analytical
•Case-control
•Cohort studies
•Randomized
controlled trials
•Non-randomized
controlled trials
Observational Experimental
Case report
• Identifying an unusual feature of a disease.
• First clue in identification of new disease.
• Documents an interesting medical oddity.
BMJ Case Reports 2016;
Severe hyponatraemia associated with pre-eclampsia
Breffini Anglim1, Kirk Levins1, Neidin Bussmann2, Mendinaro Imcha1
+ Author Affiliations 1Limerick Maternity Hospital, Limerick, Ireland
Summary
Pre-eclampsia is a multisystem disorder with incidence rates ranging from 2%
to 5%. Hyponatraemia is a rare complication of pre-eclampsia. A 41-year-old,
para 0+1 in vitro fertilisation monochorionic diamniotic triplet pregnancy woman
presented at 25 weeks with dyspnoea and general malaise. Her antenatal course was
complicated by the diagnosis of intrauterine growth restriction in triplet one at 27 weeks
of gestation. At 27+3 weeks gestation, she was diagnosed as having pre-eclampsia.
Subsequent biochemical analysis demonstrated hyponatraemia
with serum sodium falling steadily to 117 mmol/L over the next
19 days. She was admitted to intensive care unit for stabilisation of fulminant pre-
eclampsia and severe hyponatraemia at 30+5 weeks of gestation. Hypertonic saline and
intravenous labetolol were administered prior to delivery by caesarean section. She
recovered well postdelivery with stabilisation of her blood pressure and normalisation of
her sodium level to 135 mmol/L. Awareness and frequent monitoring of
hyponatraemia should become an integral part of monitoring
women with pre-eclampsia.
Case series
• Also known as clinical series.
• Study that tracks subjects with a known
exposure, such as patients who have received
a similar treatment, or examines their medical
records for exposure and outcome.
Delayed care seeking for fatal pneumonia in
children aged under five years in Uganda: A
case-series study (WHO Bulletin 2008)
• Objective To review individual case histories of children who had died of
pneumonia in rural Uganda and to investigate why these children did not
survive.
• Methods This case-series study was done in Uganda, where 67000 people were
visited once every 3 months for population-based data and vital events. Children
aged 1–59 months from November 2005 to August 2007 were included. Verbal
and social autopsies were done to determine likely cause of death and care-
seeking actions.
• Findings Cause of death was assigned for 164 children, 27% with pneumonia. Of
the pneumonia deaths, half occurred in hospital and one-third at home.
Most first received drugs at home: 52% antimalarials and 27% antibiotics. Most
were taken for care outside the home, 36% of whom first went to public hospitals.
• Conclusion There was mistreatment with antimalarials, delays in seeking
care and likely low quality of care for children with fatal pneumonia. To
improve access to and quality of care, the feasibility and effect on mortality of
training community health workers and drug vendors in pneumonia and malaria
management with prepacked drugs should be tested.
• What is the difference between Case report &
Case series?
Ecological studies (Correlational study)
• Associations between exposures and
outcomes in populations rather than in
individuals.
• Use data that has already been collected.
• Quick and cheap to conduct.
• Prone to Ecological fallacy.
Cross-sectional studies
(Prevalence study)
• Simplest form of observational study.
• Observation of a defined population at a
single point of time or time interval.
Steps in cross-sectional studies
1) State the Objective
2) Define Study population
3) Define study setting
4) Specify study variables
5) Sample Size calculation
6) Describe sampling method
7) Data collection
8) Analysis
Prevalence of hypertension and its risk factors among
individuals attending outpatient department of rural
health training centre, Uttarakhand
INDIAN JOURNAL OF COMMUNITY HEALTH / VOL 26 / ISSUE NO 01 / JAN – MAR 2014
Abstract
Objectives: 1) To find out the prevalence of Hypertension in
study subjects 2) To identify the risk factors associated with
Hypertension. Materials and Methods: A Cross-sectional study
was carried out among 369 individuals of 30 years and above
attending Out Patient Department (OPD) in Rural Health Training
Centre (RHTC) under the Department of Community Medicine,
Government Medical College, Haldwani during June 2013-August
2013. A pretested predesigned questionnaire was used to collect
demographic data by interview technique .The blood pressure
was recorded and classified using JNC VII criteria to grade
hypertension.
Strengths of Cross-sectional Study
• Prevalence
• Fast/Inexpensive - no waiting!
• Associations can be studied.
Drawbacks of cross-sectional study
• Very little information about natural history of
disease.
• Incidence can not be calculated.
Plan a study …
1) To determine prevalence of anaemia among
pregnant women.
2) To study factors associated with anaemia in
pregnancy.
Analytical studies
1) Case control study (Retrospective studies)
2) Cohort study.
Steps in Case-control studies
1) Selection of cases
2) Selection of controls
3) Matching
4) Measurement of exposure
5) Analysis – Odds ratio (strength of association
between risk factor and outcome).
Case-Control Studies
Effect of potentially modifiable risk factors associated with
myocardial infarction in 52 countries ( INTERHEART
study): Case-control study
• Methods -Established a standardised case-control
study of acute myocardial infarction in 52 countries,
representing every inhabited continent. 15,152 cases
and 14,980 controls were enrolled.
• The relation of smoking, history of hypertension or
diabetes, waist/hip ratio, dietary patterns, physical
activity, consumption of alcohol, blood apolipoproteins
(Apo), and psychosocial factors to myocardial infarction
are reported here. Odds ratios and their 99% CIs for
the association of risk factors to myocardial infarction
were calculated.
Strengths of Case-control Study
• Relatively easy
• Rapid and inexpensive
• Establishes association (Odds ratio)
• Useful for generating hypotheses (multiple risk
factors can be explored)
Weakness of Case-control study
• Selection bias (appropriate controls)
• Recall bias.
• Incidence can not be calculated.
Cohort study
• What is cohort?
• Also called as…….
Steps in cohort study
1) Selection of study subjects.
2) Obtaining data on exposure.
3) Selection of comparison groups.
4) Follow up
5) Analysis
Cohort study
time
Exposure Study starts
Disease
occurrence
Prospective cohort study
time
ExposureStudy starts
Disease
occurrence
2009
2016
2005
2019 2032
2025
Retrospective cohort studies
Exposure
time
Disease
occurrence Study starts
20162001 2009
Strengths of cohort studies
• Incidence
• Can study multiple outcomes of a single
exposure.
• Dose-response ratios can be calculated.
Drawbacks of cohort studies
• Expensive
• Often need long follow-up period or a very large
population.
• Loss to follow-up can affect validity of findings.
Experimental Study Designs
• Randomized Controlled Trials (RCT)
• Non-randomized Controlled Trials
Steps in RCT
• Protocol
• Selection of reference and experimental
population.
• Informed consent
• Randomization
• Intervention
• Follow-up
• Assessment of outcome.
Blinding (masking)
• To reduce bias
• Single blind trial
• Double blind trial
• Triple blind trial
Crossover study
Randomised
Group 2
Group 2
Group 1
Group 1
Group 2
Group 2
Group 1
Group 1
Observed
Observed
Issues in RCT
• Ethical considerations
• Cost
• Attrition
RCT types
• Clinical trials
• Preventive trials
• Risk factor trials
• Cessation experiment
• Evaluation of health services
Example of RCT
RCT
• India’s first clinical trial to reduce hair loss in
cancer patients.
• To address hair loss after chemotherapy.
• Scalp cooling machine attached with two scalp
coolers.
( The Hindu Jan 19, 2017)
Non randomized controlled Trial
Types-
1) Uncontrolled trials
2) Natural experiments
3) Before and after comparison trials
Which study design do I choose?
1) Measuring incidence
2) Measuring disease burden (Prevalence)
3) Odd case
4) Comparing cases with others
5) Doing an intervention
Take home message
Carefully designed research strategies are
must to carry out any research activity.
Thank You

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Study designs

  • 1. Study Designs Dr Pallavi Potdar Associate Prof., Community Medicine D.Y. Patil Medical College Kolhapur
  • 2. • It is important to get results from experiment but the most important is the process in getting that results.
  • 4. Study Designs Descriptive •Case report •Case series •Ecological •Cross sectional Analytical •Case-control •Cohort studies •Randomized controlled trials •Non-randomized controlled trials Observational Experimental
  • 5. Case report • Identifying an unusual feature of a disease. • First clue in identification of new disease. • Documents an interesting medical oddity.
  • 6. BMJ Case Reports 2016; Severe hyponatraemia associated with pre-eclampsia Breffini Anglim1, Kirk Levins1, Neidin Bussmann2, Mendinaro Imcha1 + Author Affiliations 1Limerick Maternity Hospital, Limerick, Ireland Summary Pre-eclampsia is a multisystem disorder with incidence rates ranging from 2% to 5%. Hyponatraemia is a rare complication of pre-eclampsia. A 41-year-old, para 0+1 in vitro fertilisation monochorionic diamniotic triplet pregnancy woman presented at 25 weeks with dyspnoea and general malaise. Her antenatal course was complicated by the diagnosis of intrauterine growth restriction in triplet one at 27 weeks of gestation. At 27+3 weeks gestation, she was diagnosed as having pre-eclampsia. Subsequent biochemical analysis demonstrated hyponatraemia with serum sodium falling steadily to 117 mmol/L over the next 19 days. She was admitted to intensive care unit for stabilisation of fulminant pre- eclampsia and severe hyponatraemia at 30+5 weeks of gestation. Hypertonic saline and intravenous labetolol were administered prior to delivery by caesarean section. She recovered well postdelivery with stabilisation of her blood pressure and normalisation of her sodium level to 135 mmol/L. Awareness and frequent monitoring of hyponatraemia should become an integral part of monitoring women with pre-eclampsia.
  • 7. Case series • Also known as clinical series. • Study that tracks subjects with a known exposure, such as patients who have received a similar treatment, or examines their medical records for exposure and outcome.
  • 8. Delayed care seeking for fatal pneumonia in children aged under five years in Uganda: A case-series study (WHO Bulletin 2008) • Objective To review individual case histories of children who had died of pneumonia in rural Uganda and to investigate why these children did not survive. • Methods This case-series study was done in Uganda, where 67000 people were visited once every 3 months for population-based data and vital events. Children aged 1–59 months from November 2005 to August 2007 were included. Verbal and social autopsies were done to determine likely cause of death and care- seeking actions. • Findings Cause of death was assigned for 164 children, 27% with pneumonia. Of the pneumonia deaths, half occurred in hospital and one-third at home. Most first received drugs at home: 52% antimalarials and 27% antibiotics. Most were taken for care outside the home, 36% of whom first went to public hospitals. • Conclusion There was mistreatment with antimalarials, delays in seeking care and likely low quality of care for children with fatal pneumonia. To improve access to and quality of care, the feasibility and effect on mortality of training community health workers and drug vendors in pneumonia and malaria management with prepacked drugs should be tested.
  • 9. • What is the difference between Case report & Case series?
  • 10. Ecological studies (Correlational study) • Associations between exposures and outcomes in populations rather than in individuals. • Use data that has already been collected. • Quick and cheap to conduct. • Prone to Ecological fallacy.
  • 11. Cross-sectional studies (Prevalence study) • Simplest form of observational study. • Observation of a defined population at a single point of time or time interval.
  • 12. Steps in cross-sectional studies 1) State the Objective 2) Define Study population 3) Define study setting 4) Specify study variables 5) Sample Size calculation 6) Describe sampling method 7) Data collection 8) Analysis
  • 13. Prevalence of hypertension and its risk factors among individuals attending outpatient department of rural health training centre, Uttarakhand INDIAN JOURNAL OF COMMUNITY HEALTH / VOL 26 / ISSUE NO 01 / JAN – MAR 2014 Abstract Objectives: 1) To find out the prevalence of Hypertension in study subjects 2) To identify the risk factors associated with Hypertension. Materials and Methods: A Cross-sectional study was carried out among 369 individuals of 30 years and above attending Out Patient Department (OPD) in Rural Health Training Centre (RHTC) under the Department of Community Medicine, Government Medical College, Haldwani during June 2013-August 2013. A pretested predesigned questionnaire was used to collect demographic data by interview technique .The blood pressure was recorded and classified using JNC VII criteria to grade hypertension.
  • 14. Strengths of Cross-sectional Study • Prevalence • Fast/Inexpensive - no waiting! • Associations can be studied.
  • 15. Drawbacks of cross-sectional study • Very little information about natural history of disease. • Incidence can not be calculated.
  • 16. Plan a study … 1) To determine prevalence of anaemia among pregnant women. 2) To study factors associated with anaemia in pregnancy.
  • 17. Analytical studies 1) Case control study (Retrospective studies) 2) Cohort study.
  • 18. Steps in Case-control studies 1) Selection of cases 2) Selection of controls 3) Matching 4) Measurement of exposure 5) Analysis – Odds ratio (strength of association between risk factor and outcome).
  • 20. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries ( INTERHEART study): Case-control study • Methods -Established a standardised case-control study of acute myocardial infarction in 52 countries, representing every inhabited continent. 15,152 cases and 14,980 controls were enrolled. • The relation of smoking, history of hypertension or diabetes, waist/hip ratio, dietary patterns, physical activity, consumption of alcohol, blood apolipoproteins (Apo), and psychosocial factors to myocardial infarction are reported here. Odds ratios and their 99% CIs for the association of risk factors to myocardial infarction were calculated.
  • 21. Strengths of Case-control Study • Relatively easy • Rapid and inexpensive • Establishes association (Odds ratio) • Useful for generating hypotheses (multiple risk factors can be explored)
  • 22. Weakness of Case-control study • Selection bias (appropriate controls) • Recall bias. • Incidence can not be calculated.
  • 23. Cohort study • What is cohort? • Also called as…….
  • 24. Steps in cohort study 1) Selection of study subjects. 2) Obtaining data on exposure. 3) Selection of comparison groups. 4) Follow up 5) Analysis
  • 25.
  • 27.
  • 28.
  • 29. time Exposure Study starts Disease occurrence Prospective cohort study time ExposureStudy starts Disease occurrence 2009 2016 2005 2019 2032 2025
  • 31.
  • 32. Strengths of cohort studies • Incidence • Can study multiple outcomes of a single exposure. • Dose-response ratios can be calculated.
  • 33. Drawbacks of cohort studies • Expensive • Often need long follow-up period or a very large population. • Loss to follow-up can affect validity of findings.
  • 34. Experimental Study Designs • Randomized Controlled Trials (RCT) • Non-randomized Controlled Trials
  • 35.
  • 36. Steps in RCT • Protocol • Selection of reference and experimental population. • Informed consent • Randomization • Intervention • Follow-up • Assessment of outcome.
  • 37. Blinding (masking) • To reduce bias • Single blind trial • Double blind trial • Triple blind trial
  • 38. Crossover study Randomised Group 2 Group 2 Group 1 Group 1 Group 2 Group 2 Group 1 Group 1 Observed Observed
  • 39. Issues in RCT • Ethical considerations • Cost • Attrition
  • 40. RCT types • Clinical trials • Preventive trials • Risk factor trials • Cessation experiment • Evaluation of health services
  • 42. RCT • India’s first clinical trial to reduce hair loss in cancer patients. • To address hair loss after chemotherapy. • Scalp cooling machine attached with two scalp coolers. ( The Hindu Jan 19, 2017)
  • 43. Non randomized controlled Trial Types- 1) Uncontrolled trials 2) Natural experiments 3) Before and after comparison trials
  • 44. Which study design do I choose? 1) Measuring incidence 2) Measuring disease burden (Prevalence) 3) Odd case 4) Comparing cases with others 5) Doing an intervention
  • 45. Take home message Carefully designed research strategies are must to carry out any research activity.