Design element | Operational considerations | Researcher considerations | Compromise |
---|---|---|---|
Study population | |||
Patient screening | No systematic pre-diabetes screening in place, just weight management referral system | Need to screen patients at risk for pre-diabetes | Use weight management referral system and add pre-diabetes screening |
Study design | |||
Primary goal | Answer operational questions in real-time | Answer research questions over time | Answer both; program implemented on more rapid timeline and preliminary data used to make operational decisions |
Group assignment | By site; pre-post | Randomization | Systematic assignment |
Control group | Usual care | Control group | Usual care as control group |
Resources | • Infrastructure • Separate funding • Leadership • Dissemination | • Research staff • Research funding • Program evaluation | Share resources |
QI vs research | |||
Ethics review | IRB and informed consent not necessary for QI | IRB and informed consent required for research | IRB and informed consent for evaluation components only |
Funding sources | Clinical funds for QI components | Research funds for evaluation components | Maintain separate funding sources for QI vs research; funding sources were pieced together over time |
Outcome assessment | |||
Timeline | Need for rapid results | Need time for study design, proposal review, and data analysis | Provide preliminary results prior to final outcomes |