Table 2 FIRST enrolment and follow-up enhancement strategies
Before the study begins | At screening | At baseline | During the study | For participants who are difficult to contact |
|---|---|---|---|---|
• Formally train clinical research coordinators on how to reduce loss to follow-up | • Let participants know what information will be collected and how their information will be used | • Obtain several personal contacts on a locator form, including friend or family and employment contacts to assist in locating participants later | • Provide participant with a choice of email, phone, and/or clinic visits for convenience | • Repeatedly search for updated information or try previously disconnected phone numbers |
• Ensure the survey area is private and comfortable | • Let participants know that the study might help other patients in similar situations to enhance their motivation to participate | • Ensure each locator form is signed by the participant to ensure a thorough understanding and to give written consent to contact listed individuals | • Be flexible on scheduling in-clinic visits to allow for scheduling issues to be resolved | • Search local phone directories, contact alternate contacts, try to contact patients from a different phone number or at a different time of day |
• Develop a locator protocol to guide efforts to locate patients for follow-up visits | • Be explicit with the participant about the follow-up procedures including providing specific information to the participant about when to expect contact from the study staff, how often, and what type of contact (email, in-person, telephone, etc.) | • Ensure informed consent is conducted in an appropriate manner, including using examples and explanations that are accessible to a lay audience | • Ensure participants can easily contact the study staff by providing them with materials on which the study toll-free number was printed, such as business cards, appointments cards, brochures, or study promotional materials | • Hold regular staff meetings to brainstorm ideas about how to find some of the participants who are the most difficult. This will also increase staff motivation for locating hard-to-find participants |
• Routinely verify contact information | ||||
• Study personnel will log all attempts to contact each participant and the outcome of each attempt | ||||
• The methods centre will conduct random site audits to verify that all precautions are being taken to secure data | ||||
• The methods centre will conduct extensive data entry audits and verifications, weekly data reports, recruitment reports, and contact tracking reports |