- Published
- Updated
Writing a target number in a PMCF plan does not establish that valid follow-up can achieve it. Access to users, existing records and assessment time determine feasibility. Do not derive the target solely from device sales.
Define the assessment
Map potential use through eligible users, invitation, agreement and completed assessment. Show the assumption and information source at each step. Site workload, permissions and data quality may impose different limits from sales or distribution figures.
Worked example
For example, a team assumes that a thousand distributed devices will easily generate a hundred follow-ups. A pilot finds missing contact routes and a need for an additional assessment visit. The team examines access, burden and timing before revising the plan. Enrolling unsuitable users or treating incomplete forms as complete is not an acceptable way to protect the target.
Practical checks
- Estimate reaching intended users separately from completing valid assessments.
- Pilot site capacity using actual task time and available source records.
- Regularly compare observed progress with assumptions and examine reasons for divergence.
Decision and limitations
The accepted plan should justify expected losses and alternative collection approaches. Poor feasibility does not make the clinical question less important. Escalate changes to method, scope or timing for authorised review; do not silently reduce evidence quality to preserve a target.
Frequently asked questions
- Does distribution count equal an eligible sample?
- No. Eligibility, access, permission and completed assessment are separate stages.
- Is adding sites the only answer to slow progress?
- Understand the bottleneck first. More sites may not resolve an access or method problem.