GIM Research Methods and Shared Resources Core Director of Operations, Tara Strigo (tara.strigo@duke.edu) Scientific co-director(s): Hayden Bosworth, PhD and Maren Olsen, PhD The General Internal Medicine (GIM) Research Methods and Shared Resources Core provides essential support for the conduct of clinical research at Duke University. The Core provides services to support the research and analysis needs of GIM faculty members and trainees to facilitate high quality study design grant submissions, and post-award study execution for studies focusing on health services and outcomes research studies being performed by faculty members and trainees within the Division. Why A Core is Needed: Faculty members and trainees in GIM have specialized needs in the performance of advanced health services and outcomes research studies that are not currently being met by other services offered at Duke. Prior to the development of this Core, Duke faculty members and trainees have had to arrange special agreements with the Veterans Affairs Center and other Centers outside of Duke to obtain many of these services. Establishment of the Core in GIM at Duke will provide these services directly to Duke GIM faculty members and trainees, facilitating their extremely high-quality work by providing a needed service. GIM faculty members and trainees needs are highly specialized and diverse. Faculty members and trainees perform research studies with a variety of designs (from population based surveys to focus groups to randomized controlled trials to large observational studies to economic analyses to organizational analyses of health care systems using quality improvement and implementation science methodologies). The core is designed to help faculty members and trainees identify and work with other superbly trained faculty members and trainees and staff with expertise in all of these domains and who can facilitate the design and conduct of rigorous research studies across this spectrum in GIM. How Services are Unique to Duke: Duke does not offer specialized services for GIM faculty and trainees who perform state-of-the-art analyses in health services and patient centered outcomes research. Faculty and trainees in the Division have specialized needs for analytic support relevant to health services and outcomes studies in chronic disease. The Core will identify these special needs for faculty and trainees and in providing consultative services on study design that can only be obtained through the Core at Duke. The Core Research Methods and Services Unit, which is a component of the Core services, is unique in that it will coordinate the hiring of staff with skills tailored to the successful conduct of health services and outcomes research studies in chronic disease. Coordination of the various experts available to provide advanced methods consultation has not previously been possible. The Core will facilitate this, 1
providing a central mechanism through which consultations can be sought out and obtained via a streamlined process. Our distinct Core services offer the following: Core Research Methods and Services Unit: Epidemiological, Biostatistical, and Qualitative analytic support for health services and outcomes research studies. Guidance and support to obtain appropriate research operational support. Research Methods Resource This resource hosts PhD and Masters trained experts in biostatistics or other related quantitative and qualitative disciplines who facilitate the conduct and analysis of clinical research, with an emphasis in these areas: Evaluation of health services effectiveness (e.g., clinical trials) Longitudinal observational studies Clinical epidemiological studies Implementation science and health system organization studies Qualitative analysis Health Economics Health Services Data Management a. Skills: PhD Biostatisticians with skills in the following areas: Longitudinal data analysis and complicated longitudinal data structures (including EHR outcomes) Multiple imputation of missing data Two-part models for semicontinuous longitudinal health data (e.g., expenditure and utilization outcomes) Cluster randomized trials Capture/recapture methods Simulation of complex data structures as it applies to health services Bayesian methods Spatial statistics Survival analysis as applied to chronic disease (e.g., kidney disease, hypertension, diabetes, arthritis); chronic disease prevention (smoking cessation, obesity, insomnia); mental health; palliative care; and, patient-provider communication. Masters Analysts with skills in the following areas: Statistical programming and data management in SAS, R, STATA, WinBugs and SUDAAN Implementing complicated statistical analyses in SAS, including propensity score matching, bootstrap resampling, mixed-effects models, and multiple imputation for continuous and binary data outcomes 2
Use of RedCap survey design and collection tools Design and use of project tracking tool Creating study summary reports Creating CONSORT study diagrams for both complex observational studies and randomized trials Writing analysis summaries for investigator team and for manuscript preparation Independent collaboration with MD fellows and PhD post-doctoral faculty and trainees b. Resources: Programming consultation for statistical programs (SAS, R, STATA, WinBugs, SUDAAN) Duke GIM virtual servers for central storage, backup, and analyses GIM storage and backup services with security standards Software licensing and updates IT desktop support for statistical software Research Services Personnel Resource This resource provides access to faculty and trainees and staff with expertise in the conduct of patient oriented clinical and health services research studies (single or multi-site). Emphasis is on resources needed for primary data collection. The Director is available to guide faculty and trainees regarding how to identify resources and staff to support health services and patient centered outcome research (PCOR) projects. The Core provides staff support for junior faculty and trainees who have limited needs in these areas. The Core also facilitates the sharing of expert staff across larger funded projects to enhance stability and support the sustained excellence of research resources employed for all GIM studies. The Core focuses on studies performing primary data collection in these areas: Trials of behavioral interventions Observational studies Qualitative studies The Core provides guidance regarding the following research needs: Protocol development and IRB approval Intervention development Study participant tracking Data collection, storage and management Hiring part time students or staff to support research Grant submission 3
How to Use the Research Methods and Shared Resources Core The GIM Research Methods and Shared Resources Core provides Coordinated Services to assist you with your research needs. Our goal is to streamline the process of obtaining services for your research teams and to help the Division with continuously expanding and contracting research programs which can threaten our most precious resource our well-trained expert staff colleagues. We anticipate there will be 4 primary types of help faculty members may need in using the Core. 1. Obtaining statistical support for studies both in the planning phases (preaward) and in the post-award phases. 2. Finding (and sharing effort on) research staff members with appropriate expertise to conduct certain types of studies. 3. Obtaining and understanding research regulations at Duke University (including the training investigators and staff are required to take) 4. Securing IT support for special project needs (e.g., extra server space or identifying appropriate research analysis servers) 5. Assistance with submitting and guiding applications through the IRB process This document provides guidance regarding how faculty and staff can utilize Core services as well as information on how to contribute to the Core through your inclusion of the Core in grant applications and awards. Where to get information (COMING SOON): Visit the GIM Research Methods and Shared Resources Core SharePoint site at: https://intranet.medschool.duke.edu/domcentral/meddivs/gim/sitepages/researc h%20methods%20and%20shared%20resources%20core.aspx. These documents will be updated regularly so please visit the site prior to each submission. On the SharePoint you will find this document along with the following: A. GIM Research Methods and Shared Resources Core_MOU for GIM Research Faculty This document requires your signature prior to using the Core for every submitted proposal through GIM. B. GIM Research Methods and Shared Resources Core_Request for Support Form You should complete this form prior to submitting a request to use Core services at least eight (8) weeks prior to your proposal due date and email it to tara.strigo@duke.edu (Eventually submit via REDCap.) C. GIM Research Methods and Shared Resources Core_Budget Justification You should include the required annual fees and language in your budget and justification. D. GIM Research Methods and Shared Resources Core_Facilities & Resources You should include this information in the facilities and 4
resources section in your proposal. E. Boilerplate Duke/GIM facilities and resources description as well as job descriptions for project staff (based on GIM standard) that you can edit for your proposal. The staff positions are the required titles by SOM for coordination of projects and activities and the Core can provide general guidance on which levels to choose based on your needs. Who to Contact: Tara Strigo (tara.strigo@duke.edu) or 919-668-4536 When to Contact: Pre-Award Contact us at least eight (8) weeks prior to your proposal due date to get on the schedule. Submit your draft budget and budget justification for review by Tara Strigo three (3) weeks prior to submission. Post-Award If Core fees were not included in original budget, contact Tara Strigo as soon as possible to discuss options. If Core fees were included in original budget, contact Tara Strigo as soon as you receive notification of award. Obtaining statistical support: Pre-Award We will help identify the types of positions and University salary and effort levels that are appropriate to put on your budget We will pay for pre-award consultation with a PhD biostatistician for statistical power calculations and consultation on study design. A PhD statistician will be assigned to you based on your needs as well as their expertise and time. You will be required to include the PhD statistician who worked on your pre-award in your budget as key personnel for the agreed upon effort. If a Master s level statistician is needed post-award, you will be required to include a TBN Master s level statistician at the annual rate of $75,000 (salary only) for the % effort agreed upon with the PhD statistician, in your pre-award budget. Post-Award We will facilitate your access to statistical or other research support (i.e., identify and contact appropriate personnel for your study) provided you have included core services in your budget. The Core does not provide support for actual personnel time in the post-award phase. You will be required to use the named PhD statistician included in your pre-award budget. In the event the named PhD statistician cannot work on your post-award, the Core will identify someone for you. 5
If you have not already identified a Master s level biostatistician for the post-award work, the Core will identify a Master s level statistician to work on your project with the PhD statistician you already included in your proposal. Finding (and sharing effort on) research staff members: The Core can assist you with identifying potential staff to work on your project. We will try to track funding levels on current GIM research staff for the potential of sharing staff across projects. We will also assist with hiring new staff across projects as needed by providing job descriptions and general guidance on projects staff needs. Annual charges to include in your budget: The below annual charges should be included in your budget and will be deducted by GIM at the beginning of each grant year. These charges take into account the direct effort and resources required to support all study activities in each year. Agreed upon charges will be in effect for the duration of each award. Because activities are directly related to the conduct of individual research projects, charges for these services are applied to the direct budgets of funded studies. The Division has provided a budget and budget justification for services, which the PI will include in their application. If the PI has not placed this on the budget, the costs of these services will be charged to grants utilizing these services in the post-award phase. If the PI decides to use services outside of GIM, they will contact Tara Strigo prior to the end of the budgeted year. Research Services Personnel Unit Computer, Analytic and <$200K 13 hours = $1,113 520 hours = $1,914 $200K-$299K 26 hours = $2,226 1,040 hours = $3,827 $300K-$399K 39 hours = $3,338 1,560 hours = $5,741 $400K-$500K 52 hours = $4,451 2,080 hours = $7,654 Server Unit ANNUAL CHARGES: $3,027 $6,053 $9,079 $12,105 Ø Core charges per year are dependent on your annual per year. Ø For an application exceeding $500K per year, contact Tara Strigo (tara.strigo@duke.edu) for Core charges. Ø For subcontracts with PI only effort, you are not required to use the Core. If GIM Staff and resources such as the GIM drives/server/it services are used in the subcontract, then Core charges must be included. 6