Understanding the Genetic Widespread Recruitment Initiative

The Widespread Recruitment Initiative (WRI) is an internet-based recruitment tool that allows potential PPMI participants to be screened, consented and provided with LRRK2 genetic testing without having to visit a PPMI site.  The purpose of the WRI is to identify and screen individuals at increased risk of a LRRK2 mutation, who  may be willing and eligible to participate in the PPMI study.  The WRI is an English language resource. The goals of the WRI are to ease the burden for sites of large scale testing and allow PPMI to reach a wide audience of new potential participants.

The process begins with outreach efforts directing the public to visit www.michaeljfox.org/ppmi/genetics to learn more about the genetic screening phase of PPMI.  Individuals meeting initial screening criteria are directed to the PPMI website of the Genetic Coordination Core (GCC) at Indiana University to review and agree to the terms of an Informed Consent (IC) form and to complete screening questions.  Those who are unable to access the website are directed to call the GCC (1-888-830-6299) to request paper copies.

Anyone with questions about the IC or screening forms can contact the GCC study coordinator (1-888-830-6299) to have their questions answered. Upon receipt of the forms, the study coordinator will contact the subject to inform them of whether or not they qualify for the genetic screening.  If an individual indicates that they have already undergone genetic testing, they are asked to send a copy of the test results to the GCC for verification. When a positive test result is verified, the individual is referred directly to a PPMI site to learn more about the study.

Individuals who are not eligible to participate in the screening portion of the study are informed that they may be contacted regarding potential participation in other phases of PPMI. Individuals who are eligible to participate in the screening portion of the study are contacted by the GCC study coordinator to confirm the positive screening questions and the subject?s willingness to provide a saliva sample for genetic testing. After verifying the subject?s eligibility, the GCC mails the subject an at-home saliva collection kit. This kit is identified by a kit identification number.  It does not have any identifiable information. At the testing laboratory, DNA is extracted from the saliva sample and screened for the LRRK2 mutation.  Any remaining DNA is stored for future use.

The testing laboratory sends genetic test results to  the Indiana University GCC. The GCC genetic counselor contacts the participant to review the results of the genetic testing.  She provides the participant with a written summary of their test results and of the genetic counseling session.

Individuals found to have the LRRK2 mutation are offered a referral to the most convenient PPMI study site to learn more about PPMI. Subjects who do not carry the LRRK2 mutation are referred to Fox Trial Finder to learn about other research opportunities.

To date, 705 individuals have consented and qualified to receive a saliva kit. Saliva kits have been sent to 691 individuals. The GCC has received saliva kits back from 543 individuals and has received LRRK2 testing results for 501 of these individuals.  Of the individuals who have been screened through the WRI, 11.2% carry a LRRK2 mutation. The rate is higher among those who have a diagnosis of Parkinson disease (12.6%) and lower among those who are unaffected (9.8%).  This Widespread Recruitment Initiative has been well received and has proven to be a very effective means to screen large numbers of individuals for a LRRK2 mutation.