Define the source of information (survey, record review); (2) List inclusion and exclusion criteria for exposed and unexposed subjects (cases and controls) or refer to previous publications; (3) Indicate time period used for identifying patients; (4) Indicate whether or not subjects were consecutive if not population-based; (5) Indicate if evaluators of subjective components of study were masked to other aspects of the status of the participants; (6) Describe any assessments undertaken for quality assurance purposes (e.g., test/retest of primary outcome measurements); (7) Explain any patient exclusions from analysis; (8) Describe how confounding was assessed and/or controlled; (9) If applicable, explain how missing data were handled in the analysis; (10) Summarize patient response rates and completeness of data collection; (11) Clarify what follow-up, if any, was expected and the percentage of patients for which incomplete data or follow-up was obtained. |