worksheet5

Ophthalmology Study Design Worksheet #5
Case-control Study

Case-control Study. An observational, usually retrospective study that begins by identifying individuals with a disease (cases) for comparison to individuals without a disease (controls or reference group), in which research proceeds from effect to cause.

(Worksheet modified from Lichtenstein MJ, Mulrow CD, Elwood PC. Guidelines for reading case-control studies. J Chron Dis 1987;40:893-903.)

Manuscript #: __________________ (For Office Use)
First Author's Name: ______________________________________________________
Manuscript Title: ______________________________________________________

Heading	Descriptor	Yes/No	Page/¶	N/A	Comments
Title:	1. Contents of manuscript clearly identified within 135 character limit.	________	________	________	________
Abstract:	2. Structured per Instructions for Authors.	________	________	________	________
	3. Design identified as Case-control Study.	________	________	________	________
Introduction:	4. Background for why study was conducted.	________	________	________	________
	5. Brief review of pertinent literature.	________	________	________	________
	6. Statement of research question.	________	________	________	________
Methods:	7. Definition and source of cases.	________	________	________	________
	8. Diagnostic procedures to identify cases.	________	________	________	________
	9. Exclusion criteria for cases.	________	________	________	________
	10. Information on whether cases are incident or prevalent.	________	________	________	________
	11. Definition and source of controls.	________	________	________	________
	12. Time period used for identifying patients.	________	________	________	________
	13. Statement whether cases and controls underwent same diagnostic procedures.	________	________	________	________
	14. Exclusion criteria for controls.	________	________	________	________
	15. Information on matching procedures, if used.	________	________	________	________
	16. Explain how exposure variables were defined and ascertained.	________	________	________	________
	17. Information on methods of data collection (interview, questionnaire, record review).	________	________	________	________
	18. Information on masking of observers to case/control status when obtaining exposure history.	________	________	________	________
	19. Verify IRB permission for research, record review, interviews, etc.	________	________	________	________
	20. Description of sample size calculation/assumptions.	________	________	________	________
	21. Description of analytic methods/software.	________	________	________	________
	22. Information on methods for dealing with confounding variables.	________	________	________	________
Results:	23. Information on exposure (duration, intensity).	________	________	________	________
	24. Statement of response/ non response rate.	________	________	________	________
	25. Presentation of adjusted analyses, if used.	________	________	________	________
	26. If both eyes of each patient were studied, indicate whether they were analyzed separately or averaged or methods used for correlated data.	________	________	________	________
	27. Presentation of relative risk and confidence limits.	________	________	________	________
Discussion:	28. Statement of conclusions derived from data.	________	________	________	________
	29. Compare and contrast results with previous studies.	________	________	________	________
	30. Discuss possible confounding variables and study design limitations.	________	________	________	________
	31. Information on investigation of possible sources of bias.	________	________	________	________
	32. Discuss biological plausibility of study results.	________	________	________	________
	33. Discuss applicability and generalizability of results to clinical care if appropriate.	________	________	________	________
	34. Comment on need for future studies when indicated.	________	________	________	________
Form completed by: ________________________________________