TABLE 3.
HARPER table of contents
| 1. Title Page |
| 2. Abstract |
| 3. Amendments and updates |
| 4. Timeline |
| Table 1 Milestones and Timeline |
| 5. Rationale and background |
| 6. Research question and objectives |
| Table 2 Primary and secondary research questions and objective |
| 7. Research methods |
| 7.1. Study design |
| 7.2. Study design diagram |
| 7.3. Setting |
| 7.3.1 Context and rationale for definition of time 0 (and other primary time anchors) for entry to the study population |
| Table 3 Operational Definition of Time 0 (index date) and other primary time anchors |
| 7.3.2 Context and rationale for study inclusion criteria: |
| Table 4. Operational Definitions of Inclusion Criteria |
| 7.3.3 Context and rationale for study exclusion criteria |
| Table 5. Operational Definitions of Exclusion Criteria |
| 7.4. Variables |
| 7.4.1 Context and rationale for exposure(s) of interest |
| Table 6. Operational Definitions of Exposure |
| 7.4.2 Context and rationale for outcome(s) of interest |
| Table 7. Operational Definitions of Outcome |
| 7.4.3 Context and rationale for follow up |
| Table 8. Operational Definitions of Follow Up |
| 7.4.4 Context and rationale for covariates (confounding variables and effect modifiers, e.g. risk factors, comorbidities, comedications) |
| Table 9. Operational Definitions of Covariates |
| 7.5. Data analysis |
| 7.5.1 Context and rationale for analysis plan |
| Table 10. Primary, secondary, and subgroup analysis specification |
| Table 11. Sensitivity analyses – rationale, strengths and limitations |
| 7.6. Data sources |
| 7.6.1 Context and rationale for data sources |
| Table 12. Metadata about data sources and software |
| 7.7. Data management |
| 7.8. Quality control |
| 7.9. Study size and feasibility |
| Table 13. Power and sample size |
| 8. Limitation of the methods |
| 9. Protection of human subjects |
| 10. Reporting of adverse events |
| 11. References |
| 12. Appendices |