. 2018 May 14;19:146. doi: 10.1186/s12891-018-2063-1

Table 4.

Lessons learned from discontinuation of the PACE Plus trial and corresponding recommendations for future research

Lessons learned	Recommendations for future research
• Even though treatment distribution follows legislation and works on paper, they may have issues in practice that affect patients. • Asking GPs to recruit incident cases during the first consultation seems unlikely to be successful considering the current workload in general practice. • Attempting to answer several research questions at once not only requires more patients but is also more complicated to explain to GPs and potential participants. • Interests and expectations of patients can collide with scientifically interesting questions in practice. • The number of available patients meeting inclusion criteria is easily overestimated (Lasagna’s Law). • Negative perception of trial treatment may influence participation of both GPs and patients.	• Keep treatment distribution as simple as possible and provide an attractive alternative to conventional therapy. • Try to answer your research question in prevalent cases or use alternative designs such as a trial within a cohort study. Take into account reimbursement of GPs in grant application and budgeting (especially if you do end up recruiting incident cases). • Choose your most important research question and design your trial to be as simple as possible. • Before starting a trial, ask a patient panel for their preferences and expectations of treatments and outcomes. Ask GPs if they know of any reservations about treatments you consider using. • Take Lasagna’s law into account when planning your trial. • Consider conducting a pilot trial and taking part in Mandatory Continuous Education.

Lessons learned

Recommendations for future research

• Even though treatment distribution follows legislation and works on paper, they may have issues in practice that affect patients.
• Asking GPs to recruit incident cases during the first consultation seems unlikely to be successful considering the current workload in general practice.
• Attempting to answer several research questions at once not only requires more patients but is also more complicated to explain to GPs and potential participants.
• Interests and expectations of patients can collide with scientifically interesting questions in practice.
• The number of available patients meeting inclusion criteria is easily overestimated (Lasagna’s Law).
• Negative perception of trial treatment may influence participation of both GPs and patients.

• Keep treatment distribution as simple as possible and provide an attractive alternative to conventional therapy.
• Try to answer your research question in prevalent cases or use alternative designs such as a trial within a cohort study. Take into account reimbursement of GPs in grant application and budgeting (especially if you do end up recruiting incident cases).
• Choose your most important research question and design your trial to be as simple as possible.
• Before starting a trial, ask a patient panel for their preferences and expectations of treatments and outcomes. Ask GPs if they know of any reservations about treatments you consider using.
• Take Lasagna’s law into account when planning your trial.
• Consider conducting a pilot trial and taking part in Mandatory Continuous Education.