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Table 1 Recruitment issues with the trial

From: Baseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST)

Issue

Explanation

Result/response

Insufficient sites recruited.

Primary Care Trusts refused to fund excess treatments costs, perceiving that some drugs, especially atorvastatin, would be too expensive. This was in spite of atorvastatin becoming generic midway through the trial.

Failure to recruit 30 hospital sites in start-up phase.

Insufficient patients recruited

Insufficient sites recruited.

Failure to recruit 600 patients in start-up phase, this precluding moving onto the main phase. The patient target was reduced to 100.

 

Some sites only identified screen-negative patients (Table 2).

Protocol amended to allow inclusion of posterior circulation strokes.

 

Exclusion criteria limited some recruitment; see screen failures (Table 2).

 
 

Follow-up of patients every 6 months meant that sites reached steady state of follow-up and, to maintain recruitment in other trials, ceased recruiting further patients into PODCAST.

 
  1. This table follows the format used for the MRC ENOS trial