Table 1.
Requirements for Conducting High-Quality Epidemiology Studies.
| Category | # | Requirement |
|---|---|---|
| Objectives and Study Plans | 1 | Clearly state study objectives |
| 2 | Review ethical guidelines for human research | |
| 3 | Create and follow an a priori study protocol | |
| 4 | Write and follow a Standard Operating Procedure (SOP) | |
| 5 | Write and follow a quality assurance plan | |
| 6 | Describe all deviations from study protocol | |
| 7 | Provide dates of study initiation and completion | |
| 8 | Document roles and responsibilities of all staff | |
| Study Design | 1 | Report study design and setting (e.g., date, location) |
| 2a | Document participant selection process and participant inclusion/exclusion criteria | |
| 2b | Use consistent participant recruitment methods to ensure that baseline differences between groups are minimized | |
| 3 | Report participant characteristics (e.g., age, sex) | |
| 4a | Report study size | |
| 4b | Use a sufficient study size so that estimates are not subject to a large degree of imprecision | |
| 4c | Conduct and report study power analysis | |
| 5 | Blind outcome assessors to exposure status | |
| 6a | Report participation rate/attrition | |
| 6b | Maintain similar attrition rate across groups | |
| 6c | Minimize loss to follow-up/ensure a high response rate | |
| 6d | Discuss the potential for selection bias | |
| 7a | Provide detailed discussion of comparison groups | |
| 7b | Ensure that comparison groups are similar to cases/exposed subjects | |
| Exposure Characterization | 1 | Choose exposure metric in outcome-relevant time window |
| 2 | Report exposure levels and units of measurement | |
| 3 | Use a measurement that is sensitive, valid, and applied consistently a | |
| 4 | Assess exposure independent of outcome | |
| 5 | Assess and report the potential for exposure measurement error/misclassification | |
| 6 | Report the stability and storage of biological samples, as applicable | |
| 7 | Describe QA/QC procedures, limits of detection or quantification, standards recovery, measures of repeatability, and investigation and prevention of contamination through appropriate use of blanks | |
| 8 | Ensure that there are a sufficient number of samples (to be statistically meaningful for the investigation) or, in the instance of a single sample, evidence that errors are negligible | |
| Outcome Assessment Methods | 1a | Provide detailed statistical methods |
| 1b | Use appropriate statistical techniques | |
| 1c | Document all calculations and analyses | |
| 2 | Report all data sources (including raw data upon request of regulator) | |
| 3 | Report data measurement methods | |
| 4 | Perform and report QA/QC methods for outcome measurement | |
| 5 | Provide collection date and signature of person entering data | |
| 6a | Use validated outcome assessment methods | |
| 6b | Discuss potential for outcome misclassification | |
| 7a | Identify sources of bias and confounding a priori based on hypothesis being tested | |
| 7b | Report how confounding and bias are addressed | |
| 7c | Control for co-exposures | |
| 7d | Reduce possibility for bias through design b | |
| Study Results | 1a | Report the results of all measured outcomes and adjusted and unadjusted analyses (i.e., complete outcome reporting) |
| 1b | Report the results of sensitivity, subgroup, or other analyses | |
| Discussion | 1 | Report study limitations |
| 2 | Provide an interpretation of results | |
| 3 | Discuss issues of generalizability | |
| 4a | Report the funding source/provide a Conflict of Interest statement | |
| 4b | Discuss whether the funding source affected design or interpretation | |
| 5 | Discuss other sources of bias |
# = Numbering for the list of requirements in each category; QA/QC = Quality Assurance/Quality Control; a That is, use well-established, validated, quantitative exposure assessment methods at the individual level, with as little measurement error as possible; b for example, through statistical methods or sensitivity analyses.