Using postal randomization to replace telephone randomization had no significant effect on recruitment of patients

Area of Science:

• Clinical Trials
• Primary Care Research
• Health Services Research

Background:

• Recruitment is a critical challenge in clinical trials.
• Randomization methods can influence trial efficiency and patient participation.
• Primary care settings present unique logistical hurdles for trial recruitment.

Purpose of the Study:

• To evaluate the impact of postal randomization on patient recruitment rates in a primary care randomized trial.
• To compare the effectiveness of postal versus telephone randomization for patient recruitment.

Main Methods:

• A randomized trial in primary care settings across the United Kingdom.
• Initial recruitment utilized a telephone randomization service.
• Modified procedure involved postal submission of baseline materials for randomization.

Main Results:

• Of 647 invited practices, 45% (130/288) joined with telephone randomization and 43% (155/359) with postal randomization.
• Postal randomization resulted in a non-significant 14% reduction in patient recruitment.
• Increased number of general practitioners and decreased practice distance from hospitals positively correlated with recruitment.

Conclusions:

• Postal randomization did not significantly affect patient recruitment in this primary care trial.
• Factors such as practice size and geographical location play a role in recruitment success.
• Further research may explore optimized strategies for postal randomization in clinical trials.