Clinical Research Methodology 2: Observational Clinical Research
@article{Sessler2015ClinicalRM, title={Clinical Research Methodology 2: Observational Clinical Research}, author={Daniel I. Sessler and Peter B. Imrey}, journal={Anesthesia \& Analgesia}, year={2015}, volume={121}, pages={1043–1051} }
Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation—in addition to errors of chance. Confounding can be statistically…
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References
SHOWING 1-10 OF 29 REFERENCES
Randomized, controlled trials, observational studies, and the hierarchy of research designs.
- MedicineThe New England journal of medicine
- 2000
The results of well-designed observational studies (with either a cohort or a case-control design) do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.
- MedicinePreventive medicine
- 2007
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study, resulting in a checklist of 22 items that relate to the title, abstract, introduction, methods, results, and discussion sections of articles.
Comparison of evidence of treatment effects in randomized and nonrandomized studies.
- PsychologyJAMA
- 2001
Despite good correlation between randomized trials and nonrandomized studies-in particular, prospective studies-discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common.
Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies
- Medicine, PsychologyCanadian Medical Association Journal
- 2006
Evidence from randomized trials is compared with that from epidemiologic studies to determine whether they give different estimates of risk for important harms of medical interventions, and nonrandomized studies are often conservative in estimating absolute risks of harms.
Randomized versus historical controls for clinical trials.
- Medicine, BiologyThe American journal of medicine
- 1982
Case reports and case series from Lancet had significant impact on medical literature.
- MedicineJournal of clinical epidemiology
- 2005
A comparison of observational studies and randomized, controlled trials.
- Medicine, PsychologyThe New England journal of medicine
- 2000
Propensity score methods gave similar results to traditional regression modeling in observational studies: a systematic review.
- Medicine, PsychologyJournal of clinical epidemiology
- 2005
A clinician's guide for conducting randomized trials in individual patients.
- MedicineCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne
- 1988
The practical approach presented in this paper allows clinicians to conduct their own N of 1 RCTs and suggests formal statistical analysis may be helpful for interpreting the results.
Meta-analysis of well-designed nonrandomized comparative studies of surgical procedures is as good as randomized controlled trials.
- MedicineJournal of clinical epidemiology
- 2010