The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)

Rationale: Assessment and reporting of long-term clinical follow-up after medical interventions is essential for transparency of medical care and its quality improvement. However follow-up adherence is a serious challenge in clinical trials. Taking the patient preference of the mode of follow-up into account is likely to enhance trial adherence, reduce withdrawals, and facilitate a longer follow-up duration. No data on patient preference of annual follow-up have been reported.

Objective: To investigate the patient preference of approach to obtain follow-up information after percutaneous coronary intervention (PCI)

Study design: Single-center, prospective, observational registry

Study population: All patients enrolled in the percutaneous coronary intervention studies TWENTE trial (a broad study population reflecting real-world PCI patients) and DUTCH PEERS trial (an all-comers population), who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

Intervention: All subjects will receive a questionnaire with questions regarding their preference with regards to the approach of acquiring follow-up information after PCI.

Main study endpoints:

• The primary endpoint is the patient preference on how to be approached for annual follow-up after PCI procedures.
• Secondary endpoints include

• least preferred approach of follow-up
• the preferred number of follow-up moments per year
• the from the patients' perspective maximum acceptable number of questions to be answered
• the assessment of potential relationships between the most and least preferred approach of assessment and patient age, gender urgency of PCI treatment, and history of previous revascularizations

Inclusion criteria

• All patients enrolled in the TWENTE trial and DUTCH PEERS trial (an all-comers population, who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

Exclusion criteria

• Patients who had withdrawn their consent for participation in the TWENTE and DUTCH PEERS trials, respectively. Patients who passed away during follow-up could obviously not be approached for further questioning.