The screen log: a tool for monitoring critical care clinical research activity

Introduction

Clinical research relevant to the care of critically ill patients has been ongoing for decades. Sponsors of research projects monitor site performance by providing a screen log (SL) which contains a record of enrolled patients (multicentre, uni-project in scope). The present study was undertaken to evaluate the utility of a unicentre, multi-project SL.

Design

Prospective evaluation of an SL for monitoring critical care clinical research activities in a Canadian tertiary care academic medical centre.

Methods

Consecutive patients admitted over a 2 year period to the Medical Surgical ICU were screened for eligibility into 3 protocols. Patients were defined as follows: 1. Eligible: met all inclusion criteria; 2. Excluded: study specific exclusion criteria; or prognosis was considered hopeless; or were enrolled in another study; or no consent; or missed; 3. Truly eligible: [eligible]-[met no exclusions + hopeless prognosis + enrolled in other protocol]; 4. Enrolled: consent obtained and patient randomized; 5. Recruitment efficiency: number of patients enrolled / number truly eligible.

Results

54 patients/month were screened for a total of 1292 admissions. Table 1 presents screening and recruitment summary for 3 protocols in progress over varying lengths of time within the 2 year period of SL evaluation.

Conclusion

100% screening with data entry into a SL database provides a quantitative description of enrolled patients into multiple clinical trials, the number not randomized and the reasons for non-randomization. The SL provides a method of accountability of research activity and identifies potential problems such as poor consent rates and missed patients. The SL provides the ability to evaluate recruitment strategies and recruitment efficiency over time. Short-term feasibility screening for projects may also occur.

Table 1