TRUE KNEE INSTITUTE
Research concept template
Planning resource. Formal Institute study submissions are not yet open.
Do not include patient-level records or identifying information.

WORKING TITLE:
RESEARCH QUESTION:
WHY THIS QUESTION MATTERS TO PATIENTS:
EXISTING EVIDENCE AND THE GAP:
PROPOSED STUDY DESIGN:
POPULATION, SETTING, AND INCLUSION/EXCLUSION CRITERIA:
COMPARISON GROUP, IF APPLICABLE:
PRIMARY OUTCOME AND TIME POINT:
SECONDARY OUTCOMES:
PROPOSED MEASURES AND THEIR VALIDATION:
DATA SOURCES AND FEASIBILITY:
SAMPLE SIZE RATIONALE:
FOLLOW-UP AND MISSING DATA:
POTENTIAL CONFOUNDERS AND ANALYSIS PLAN:
CONSENT, OVERSIGHT, AND DATA ACCESS REQUIREMENTS:
PATIENT INPUT:
FUNDING AND CONFLICTS OF INTEREST:
PROPOSED COLLABORATORS:
PUBLICATION AND AGGREGATE REPORTING PLAN:
UNRESOLVED QUESTIONS:

This template is not ethics approval, a registry enrollment form, or an
accepted study protocol. Establish appropriate oversight before research begins.