Observational studies: Cohort and case-control studies
Open accessAbstract
Observational studies constitute an important category of study designs. To address some investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct. Instead, observational studies may be the next best method of addressing these types of questions. Well-designed observational studies have been shown to provide results similar to those of randomized controlled trials, challenging the belief that observational studies are second rate. Cohort studies and case-control studies are two primary types of observational studies that aid in evaluating associations between diseases and exposures. In this review article, the authors describe these study designs and methodologic issues, and provide examples from the plastic surgery literature.
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- Premisecitation
For some investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct.
“To address some investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct.”
- Also stated in: § Abstract · plain
“However, RCT methodology, which was first developed for drug trials, can be difficult to conduct for surgical investigations.3”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [3] Chung KC Burns PB A guide to planning and executing a surgical randomized controlled trial J. Hand Surg. [Am] 2008 33 407 412 18343300 source
Not checked in the free run.
- Also stated in: § Abstract · plain
- Premisereasoning
Cross-sectional studies cannot assess a cause-and-effect relationship because the temporal relationship between disease occurrence and exposure cannot be established.
“Because the temporal relationship between disease occurrence and exposure cannot be established, cross-sectional studies cannot assess the cause and effect relationship.”
Quote in the paperSubstantial claim - Premisecitation
In a retrospective review of 224 pedicled TRAM flaps in 200 patients over 10 years, obese patients had a significantly higher incidence of donor site complications, multiple flap complications, and partial flap necrosis than normal or overweight patients.
“The findings revealed that obese patients had a significantly higher incidence of donor site complications, multiple flap complications, and partial flap necrosis than normal or overweight patients.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [11] Spear SL Ducic I Cuoco F Effect of obesity on flap and donor-site complications in pedicled TRAM flap breast reconstruction Plast. Reconstr. Surg 2007 119 788 795 17312479
Not checked in the free run.
- Premisereasoning
Case-control studies are well suited to investigate rare outcomes or outcomes with a long latency period because subjects are selected by their outcome status.
“Case-control studies are well suited to investigate rare outcomes or outcomes with a long latency period because subjects are selected from the outset by their outcome status.”
Quote in the paperSubstantial claim - Premisecitation
Maternal cigarette smoking during pregnancy was significantly associated with cleft lip/palate in newborns (adjusted OR 1.34, 95% CI 1.36-1.76).
“A significant relationship with maternal cigarette smoking and cleft lip/palate in the newborn was reported in this study (adjusted OR 1.34, 95% CI 1.36-1.76).18”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] Chung KC Kowalski CP Kim HM Maternal cigarette smoking during pregnancy and the risk of having a child with cleft lip/palate Plast. Reconstr. Surg 2000 105 485 491 10697150 source
Not checked in the free run.
- Premisenone given
If too many subjects are lost to follow-up, the internal validity of a cohort study is reduced.
“If too many subjects are loss to follow-up, the internal validity of the study is reduced.”
Quote in the paperSubstantial claim - Premisereasoning
Cohort studies are particularly advantageous for examining rare exposures because subjects are selected by their exposure status.
“Cohort studies are particularly advantageous for examining rare exposures because subjects are selected by their exposure status.”
Quote in the paperNot a substantial claim - Premisecitation
Well-designed observational studies have been shown to produce results comparable to those of randomized controlled trials.
“Well-designed observational studies have been shown to provide results similar to randomized controlled trials, challenging the belief that observational studies are second-rate.”
- Also stated in: § Abstract · plain
“However, recent work has challenged this notion, showing comparable results between observational studies and RCTs.4, 5”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [4] Benson K Hartz AJ A comparison of observational studies and randomized, controlled trials N. Engl. J. Med 2000 342 1878 1886 10861324 source
Not checked in the free run.
- cites [5] Concato J Shah N Horwitz RI Randomized, controlled trials, observational studies, and the hierarchy of research designs N. Engl. J. Med 2000 342 1887 1892 10861325 PMC1557642 source
Not checked in the free run.
- Also stated in: § Abstract · plain
- Premisecitation
A critical characteristic of subject selection in cohort studies is that both the exposed and unexposed groups be selected from the same source population.
“A critical characteristic of subject selection is to have both the exposed and unexposed groups be selected from the same source population (Figure 4).9”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [9] Elwood M Critical Appraisal of Epidemiological Studies and Clinical Trials 2007 1 570 Oxford University Press Oxford 3rd Ed
Not checked in the free run.
- Classified as probably not a substantial claim. 5
- May combine two claims. 10
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationA 22-item STROBE checklist was generated to enhance the reporting of observational studies across disciplines.
“Thus a 22-item checklist was generated to enhance the reporting of observational studies across disciplines.25,26”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [25] von Elm E Altman DG Egger M The strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies J. Clin. Epidemiol 2008 61 344 349 18313558 source
Not checked in the free run.
- cites [26] von Elm E Altman DG Egger M The strengthening the reporting of observational studies in epidemiology (STROBE) statement: Guidelines for reporting observational studies Lancet 2007 370 1453 1457 18064739 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationCase-series are descriptive studies following one small group of subjects and lack a control group.
“Contrasting with epidemiological cohort studies, case-series are descriptive studies following one small group of subjects.”
- Also stated in: § Study Design · plain
“Usually the cases are obtained from the authors' experiences, generally involve a small number of patients, and more importantly, lack a control group.12”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [12] Jenicek M Foundations of Evidence-Based Medicine 2003 1 542 Parthenon Pub. Group Boca Raton
Not checked in the free run.
- Also stated in: § Study Design · plain
May combine two claims.
PremisecitationMatching is used to ensure comparability between cases and controls and reduces variability and systematic differences due to background variables not of interest to the investigator.
“Matching is a method used in an attempt to ensure comparability between cases and controls and reduces variability and systematic differences due to background variables that are not of interest to the investigator.8”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [8] Everitt BS Palmer CR Encyclopaedic Companion to Medical Statistics 2005 Hodder Arnold London
Not checked in the free run.
May combine two claims.
PremisecitationBecause exposure is identified before the outcome, cohort studies have a temporal framework that allows assessment of causality and gives them the potential to provide the strongest scientific evidence.
“Because exposure is identified before the outcome, cohort studies have a temporal framework to assess causality and thus have the potential to provide the strongest scientific evidence.8”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [8] Everitt BS Palmer CR Encyclopaedic Companion to Medical Statistics 2005 Hodder Arnold London
Not checked in the free run.
May combine two claims.
PremisereasoningRecall bias, interviewer bias, or reliance on the completeness or accuracy of recorded information decrease the internal validity of a case-control investigation.
“These biases decrease the internal validity of the investigation and should be carefully addressed and reduced in the study design.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationIn a case-control study of congenital microtia, adverse maternal health was among the main risk factors, specifically maternal disease during pregnancy (OR 5.89, 95% CI 2.36-14.72), maternal toxicity exposure during pregnancy (OR 4.76, 95% CI 1.66-13.68), and living near air-pollution industries (OR 7.00, 95% CI 2.09-23.47).
“The authors concluded that adverse maternal health was among the main risk factors for congenital microtia, specifically maternal disease during pregnancy (OR 5.89, 95% CI 2.36-14.72), maternal toxicity exposure during pregnancy (OR 4.76, 95% CI 1.66-13.68), and resident area, such as living near industries associated with air pollution (OR 7.00, 95% CI 2.09-23.47).16”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [16] Zhang QG Zhang J Yu P Environmental and genetic factors associated with congenital microtia: A case-control study in Jiangsu, China, 2004 to 2007 Plast. Reconstr. Surg 2009 124 1157 1164 19935299 source
Not checked in the free run.
Classified as probably not a substantial claim.
InterpretationreasoningIn the plastic surgery literature, retrospective cohort studies are better indicated than prospective cohort studies because they are timelier and less expensive.
“Instead, retrospective cohort studies are better indicated given the timeliness and inexpensive nature of the study design.”
Quote in the paperSubstantial claimMay combine two claims.
PremisereasoningIn case-control studies, cases and controls should stem from the same source population, and the validity of the study depends on the comparability of the two groups.
“An important principle is that the distribution of exposure should be the same among cases and controls; in other words, both cases and controls should stem from the same source population.”
- Also stated in: § Methodological Issues · plain
“Because the validity of the study depends upon the comparability of these two groups, cases and controls should otherwise meet the same inclusion criteria in the study.”
Quote in the paperSubstantial claim- Also stated in: § Methodological Issues · plain
May combine two claims.
PremisereasoningDisadvantages of cohort studies include the need for a large sample size and a potentially long follow-up duration, which make the design costly.
“Disadvantages include the need for a large sample size and the potentially long follow-up duration of the study design resulting in a costly endeavor.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationCompared with cohort studies, case-control studies are quick, relatively inexpensive, require fewer subjects, and allow multiple exposures or risk factors to be assessed for one outcome.
“Thus in comparison to cohort studies, case-control studies are quick, relatively inexpensive to implement, require comparatively fewer subjects, and allow for multiple exposures or risk factors to be assessed for one outcome (Table 4).2,9”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [2] Hulley SB Cummings SR Browner WS Designing Clinical Research: An Epidemiologic Approach 2001 1 336 Lippincott Williams & Wilkins Philadelphia 2nd Ed
Not checked in the free run.
- cites [9] Elwood M Critical Appraisal of Epidemiological Studies and Clinical Trials 2007 1 570 Oxford University Press Oxford 3rd Ed
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationLoss to follow-up should not exceed 20% of the sample.
“A general rule of thumb requires that the loss to follow-up rate not exceed 20% of the sample.6”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [6] Merril RM Timmreck TC Introduction to Epidemiology 2006 1 342 Jones and Bartlett Publishers Mississauga, Ontario 4th Ed
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisereasoningOf the STROBE checklist items, 18 are common to all three types of observational studies and 4 are specific to each of the three study designs.
“In fact, 18 of the checklist items are common to all three types of observational studies, and 4 items are specific to each of the 3 specific study designs.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationSelecting multiple controls per case increases the statistical power of an investigation by increasing the sample size, and precision may improve with up to about three or four controls per case.
“This method increases the “statistical power” of the investigation by increasing the sample size. The precision of the findings may improve by having up to about three or four controls per case.21-23”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [21] Ury HK Efficiency of case-control studies with multiple controls per case: Continuous or dichotomous data Biometrics 1975 31 643 649 1100136 source
Not checked in the free run.
- cites [22] Bruce N Pope D Stanistreet D Quantitative Methods for Health Research 2008 1 529 John Wiley & Sons, Ltd West Sussex, England
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [23] Woodward M Epidemiology: Study Design and Data Analysis 2005 1 849 Chapman & Hall/CRC London 2nd Ed
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The influence of recall or information bias was thought to be minimal due to the prospective design.
“The influence of recall or information bias was thought to be minimal due to the prospective design [49].”
From The Modified A-DIVA Scale as a Predictive Tool for Prospective Identification of Adult Patients at Risk of a Difficult Intravenous Access: A Multicenter Validation Study (2019) · cites this paper as [49]
The Cohort Study > Study Design section says prospective studies can use tailored data-collection methods and may collect more complete exposure data. The Case-Control Studies > Methodological Issues section describes recall and information-quality problems with retrospective exposure assessment. These passages support the rationale, but they do not establish that recall or information bias was minimal in the citing authors’ particular study. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Adjusted odds ratio lies outside its reported confidence interval
MinorThe reported point estimate of 1.34 is below the lower bound of its reported 95% confidence interval, 1.36.
“adjusted OR 1.34”
“95% CI 1.36-1.76”
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“In addition, this current study was carried out according to the STROBE statement [26,49].”
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- Authors
- Song, J. W., & Chung, K. C.
- Affiliations
- Michigan Medicine (US)
- Venue
- Plastic and Reconstructive Surgery
- Published
- 2010-12
- Volume
- 126
- Issue
- 6
- Pages
- 2234-2242
- ISSN
- 0032-1052 (ISSN-L)
- PMC
- PMC2998589
- OpenAlex
- W2033465810
- Semantic Scholar
- ee4ce5ab25a1825e160dd212939027f214345425
- Cited by
- 948
- References
- 32
- Citations by year
- 2026: 58 · 2025: 113 · 2024: 115 · 2023: 106 · 2022: 75 · 2021: 104 · 2020: 85 · 2019: 76 · 2018: 63 · 2017: 46 · 2016: 52 · 2015: 38 · 2014: 6 · 2013: 5 · 2012: 2
- FWCI
- 2.18
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Plastic & Reconstructive Surgery (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (K24AR053120, F32AR058105)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Health Sciences › Health Professions › Health Information Management › Methodologies in Health Research and Practice
- Keywords
- observational study design, cohort studies, case-control study, plastic surgery research, exposure-disease association
- MeSH terms
- Humans, Prospective Studies, Retrospective Studies, Cohort Studies, Bias, Case-Control Studies, Randomized Controlled Trials as Topic, Evidence-Based Medicine, Plastic Surgery Procedures
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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