PSG Retrospective Datamining
The Parkinson Study Group (PSG) has funding available for investigators seeking initial support for Parkinson disease research. Candidates propose a hypothesis driven, one year research plan for a retrospective datamining research project in Parkinson disease using PSG databases. Funds have been provided by the Parkinson’s Disease Foundation to the PSG to support retrospective datamining projects. See investigators who have been awarded, below.
PSG Mentored Clinical Research Award
Parkinson Study Group: Mentored Clinical Research Award for new investigators in patient-oriented research in Parkinson’s disease and related disorders
The Mentored Clinical Research Award (MCRA) for new investigators is funded by a grant from the Parkinson’s Disease Foundation (PDF) to the Parkinson Study Group (PSG). The purpose of this grant is to support a new investigator for a 1 year project in patient oriented research in Parkinsons disease or other parkinsonian disorders under the mentorship of an experienced investigator. The goal of the Award is to provide funding for an investigator with the potential to become an independent researcher. Appropriate applicants for the MCRA are clinicians and scientists who are within 5 years of having completed formal training. The applicant must identify an appropriate mentor or mentors with extensive research experience. Either the applicant or the mentor must be a member of the PSG.
Discovering and Validating Biomarkers in Parkinson Disease: Utilizing PSG DATATOP Biospecimens
This program is in collaboration with The Michael J. Fox Foundation to support the identification and validation of novel biomarkers through use of the DATATOP biospecimen and clinical data resource. The DATATOP (Deprenyl And Tocopherol Antioxidative Therapy Of Parkinsonism) intervention trial, conducted by the PSG in the late 1980s, also collected serum, cerebrospinal fluid, urine and DNA from trial participants to be banked for subsequent analyses. The biologic specimens paired with the clinical data from this study are a unique resource for identifying and verifying objective markers that change with clinical features of Parkinson disease.
Click here to download additional details of the DATATOP trial.
Since 2011, 7 investigators have received funding and requests for proposals are ongoing. (Click here to read more.)
The NIH PROMIS Project and Parkinson’s Disease Common Data Elements
The NIH PROMIS Project – High Quality Patient-Reported Outcome Measures
The NIH PROMIS Roadmap-initiated project has transformed the field of patient-reported outcomes (PROs) PROMIS approaches health from a domain, rather than a disease perspective, so that it is uniquely positioned to precisely measure PROs related to physical, mental and social well-being across diverse medical conditions. PROMIS has been adopted for use by numerous NIH grantees as well as the CDC and DOD.
The first NIH funding phase of PROMIS began in 2004. The second phase, which began in 2009, expanded the PROMIS Network to its current configuration of 12 research sites and 3 coordinating centers. The goal has been to develop and standardize tools to efficiently measure PROs in both adult and pediatric subjects in clinical research and care, as well as large-scale, national surveys. Today, PROMIS instruments boast over 3,000 registered users, 800 active PRO research protocols, and over 6.5 million patient responses! There are even greater implications for the future as PROMIS enjoys international support. Over 40 adult and child item banks or scales are currently available while more are under development and will be released soon. Click here to download a PDF of the Instrument Library.
PROMIS is the first major attempt to bring Item Response Theory (IRT) and Computer-Adaptive Testing (CAT) into biomedical research and clinical care. Both have been the research foundation in educational testing for decades. Based on rigorously conducted qualitative and quantitative studies, a domain-specific set of items is transformed into an item bank of “questions.” Although some item banks (e.g. adult physical function) contain as many as 124 items, subjects do not reply to all the questions. Rather with CAT, the computer algorithm selects subsequent items based on subjects’ initial responses. Thus, respondent burden is kept to a minimum. In addition to the CATs, there are two other PROMIS instrument types: short forms and profiles. See a CAT demo here.
The PROMIS Technology Center is an online research management tool that enables creation of study-specific websites to securely capture patient data. The study-specific PRO instruments can be administered to patients through a range of mediums (e.g. paper, computer, smart phone, computer, interactive voice response) and encompass all people regardless of literacy, language, physical function or life course.
Parkinson’s Disease Common Data Elements
The National Institute of Neurological Disorders and Stroke (NINDS) recently assembled an external working group of nearly 70 international experts to develop the Parkinson’s disease Common Data Elements (CDEs). Content standards, including data dictionaries and case report forms (CRFs), have been developed to enable clinical investigators to systematically collect, analyze, and share data across the research community.
The PD CDEs are now publically available for use! To access the materials, go to http://www.commondataelements.ninds.nih.gov/, click on Standards ⇨ Parkinson’s disease ⇨ Data Standards, then click on the domain name to view the CRF modules/guidelines.