Ophthalmology Study Design Worksheet #6
Cross-sectional (Prevalence) Study
Cross-sectional (Prevalence) Study. An observational study that identifies individuals with and without the condition being studied at the same time (synonymous with prevalence study). May or may not be population based.
Manuscript #: __________________
(For Office Use)		  
First Author's Name: ______________________________________________________
Manuscript Title: ______________________________________________________  
Heading Descriptor Yes/No Page/¶ N/A Comments
Title: 1. Manuscript content clarified within 135 character limit. ________ ________ ________ ________
Abstract: 2. Structured per Instructions For Authors. ________ ________ ________ ________
  3. Design identified as Cross-sectional Study. ________ ________ ________ ________
Introduction: 4. Statement/clarification of the research question/objectives. ________ ________ ________ ________
5. Population under study (controls and subjects) defined and issue(s) of interest clarified. ________ ________ ________ ________
  6. Background and significance as to why study was conducted. ________ ________ ________ ________
7. Brief review of pertinent literature. ________ ________ ________ ________
Methods: 8. Define the source of information (survey, record review). ________ ________ ________ ________
9. List inclusion and exclusion criteria for exposed and unexposed subjects (cases and controls) or refer to previous publications (applies to items #9-16). ________ ________ ________ ________
  10. Indicate time period used for identifying patients. ________ ________ ________ ________
  11. Clarify sample size determination (e.g., statistically or participants accrued over a specified time period); if statistically predetermined, elaborate in statistical methods section. ________ ________ ________ ________
  12. Indicate whether or not subjects were consecutive if not population-based. ________ ________ ________ ________
  13. Indicate if evaluators of subjective components of study were masked to other aspects of the status of the participants. ________ ________ ________ ________
14. IRB approval and informed consent obtained. ________ ________ ________ ________
  15. Describe relevant primary and secondary measurements and the time point(s) used for data recording when relevant. ________ ________ ________ ________
  16. Indicate how assessments/measurements were made and describe evaluators. ________ ________ ________ ________
  17. Describe any assessments undertaken for quality assurance purposes (e.g., test/retest of primary outcome measurements). ________ ________ ________ ________
  18. Describe efforts to ensure completeness of planned sampling. ________ ________ ________ ________

(Statistical Issues/Data Management)
19. Clarify any assumptions used in calculating sample size. ________ ________ ________ ________
  20. Indicate how data were extracted for analysis (e.g., chart review, or prospectively completed data forms). ________ ________ ________ ________
  21. Explain any patient exclusions from analysis. ________ ________ ________ ________
  22. Explain analytic method for all outcome analyses and identify specific software programs employed. ________ ________ ________ ________
  23. If applicable, note that statistical analyses take complex sampling designs into account. ________ ________ ________ ________
24. Describe how confounding was assessed and/or controlled. ________ ________ ________ ________
  25. If applicable, explain how missing data were handled in the analysis. ________ ________ ________ ________
Results: 26. Describe demographic characteristics and all variables of prognostic importance. ________ ________ ________ ________
  27. Summarize patient response rates and completeness of data collection. Clarify what follow-up, if any, was expected and the percentage of patients for which incomplete data or follow-up was obtained. ________ ________ ________ ________
  28. Compare completeness of data within each subgroup for each candidate risk factor of interest. ________ ________ ________ ________
29. Describe extent to which sampled study population is representative of target population. ________ ________ ________ ________
  30. Report results of other statistical comparisons made of the subgroups of candidate risk factors. ________ ________ ________ ________
  31. Provide both absolute numbers and percentages when feasible (e.g., 33 of 50, 66%). ________ ________ ________ ________
  32. Provide confidence intervals for prevalence estimates and P values for all major comparisons between subgroups. ________ ________ ________ ________
  33. Report assessment of confounding among the known and candidate risk factors. ________ ________ ________ ________
Discussion:
 34. Briefly summarize important study findings. ________ ________ ________ ________
  35. Interpret the study findings. ________ ________ ________ ________
  36. Discuss possible bias. ________ ________ ________ ________
  37. When applicable, discuss the biological plausibility of findings. ________ ________ ________ ________
  38. Contrast or compare study results to other studies. ________ ________ ________ ________
  39. Comment on generalizability of results and identify non-applicable patients. ________ ________ ________ ________
  40. Summarize study design limitations and weaknesses. ________ ________ ________ ________
  41. When indicated, summarize the applicability of results to clinical practice. ________ ________ ________ ________
  42. Comment on future desirable studies when indicated. ________ ________ ________ ________



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          Copyright © 2003 by the American Academy of Ophthalmology.