Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions

Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions

Lead Principal Investigator: Heather Kaplan, MD, MS

Organization: Cincinnati Children’s Hospital Medical Center

Purpose: To use N-of-1 trials to answer patient-derived questions about inflammatory bowel disease and atrial fibrillation.

Funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PPRND-1507-31321).

Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions

Lead Principal Investigator: Heather Kaplan, MD, MS

Organization: Cincinnati Children’s Hospital Medical Center

Purpose: To use N-of-1 trials to answer patient-derived questions about inflammatory bowel disease and atrial fibrillation.

Funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PPRND-1507-31321).

Overview

This demonstration project includes two significant aims (one for ImproveCareNow and one for Health eHeart Alliance)
• Aim 1: ImproveCareNow – Inflammatory Bowel Disease N-of-1
• Aim 2: Health eHeart Alliance – Atrial Fibrillation N-of-1
Aim 1: Study Naming contest
• ImproveCareNow community members suggested 11 study names
• An online voting was held to select final study name, and over 100 community members voted
Aim 2: Designed atrial fibrillation trigger survey to assess
possible triggers

• Worked with patient partners to design survey
• Survey sent to patient partner organizations/groups resulting in over 800 surveys completed to date

who's involved?

sites

Two participating Networks: ImproveCareNow and Health eHeart Alliance

how we're making a difference

After the completion of a trial, patients will receive personalized results directly on the app or during a conversation with their clinician
Applies a powerful experimental method (N-of-1 trials) in two very different diseases, demonstrating broad applicability of a currently underutilized research approach
Use of custom-configured mHealth technology to capture patient-reported outcomes, validated surveys, and real-time study progress