12/10/2014 Disclosures None of the faculty, planners, speakers, providers nor CME committee have any relevant financial relationships with commercial interest Organizing and Participating There is no commercial support for this CME activity in a Research Project NOVEMBER 18, 2014 David D. Lo, MD, PhD Distinguished Professor, Biomedical Sciences Senior Associate Dean, Research UCR School of Medicine Introduction to This Series Today’s Discussion • Our initial series will have four topics: • Organizing and Participating in a Research Project • Asking Research Questions in a Clinical Setting • Getting involved in research questions at any level • How does scientific method apply in the clinic • Organizing and Participating in a Research Project • Getting involved in research questions at any level • Today we will discuss research settings at UCR and UCR SOM • It Doesn’t Count Until It’s Reported: Presenting, Publishing and ways you can get involved and Grant Writing • Effective communication of scientific questions and • We will also have a discussion on experimental design answers to all audiences issues, especially logical fallacies • Research Ethics (Why do we do research?), and IRB approval • Human curiosity, the motivations to do research, and ways to guide proper conduct of research Visiting a Foreign Culture: Visiting a Foreign Culture: The Biomedical Research Laboratory The Biomedical Research Laboratory • Travel broadens the mind: Learn a new language and culture! • Travel broadens the mind: Learn a new language and culture! • How does Biomedical research compare to clinical practice? • How does Biomedical research compare to clinical practice? • We wear Personal Protective Equipment (PPE): • We wear Personal Protective Equipment (PPE): Or depending on the safety level… 1 12/10/2014 Visiting a Foreign Culture: How is the conventional research lab different The Biomedical Research Laboratory from the usual clinical practice? Clinical Research • How is the conventional research lab similar to the • Work product: Patient care • Research papers – publish or usual clinical practice? perish! • Hierarchy: Leadership down to specialized staff • Business model: Revenue from • Investigator-initiated Grant patient visits, procedures Awards (NIH, Industry) • Management of staff at different levels • Job security, advancement: • Publications, grants, service, • Sophisticated (and expensive) equipment Clinical work, GME, Board invited seminars, committees, • Choices in investment certification conference organization, (teach) • Teaching: Medical students, • Postdocs, Graduate students, • Administrative infrastructure: pay the bills, Residents Undergrad (mostly pre- compliance • Train the next generation of meds!!) CLINICANS • The emphasis is on training RESEARCHERS So the emphasis is different So What Occupies Faculty Actual Time Sidebar: versus Faculty Preoccupation? Why the preoccupation with grants? • NIH Funding has not been on a good trend lately • After a doubling of funding from the late 1990s to 2003, NIH funding has essentially undergone an “undoubling” • What does this do to • Research and FUNDING, especially FUNDING research motivations • In some institutions, faculty salary depends on extramural or incentives? research funds, so the pressure can be intense Back to Research: Assisting in a clinical study or clinical trial if your clinical Types of Research Settings site is involved in the study • At UCR and UCR SOM, you do not have to initiate your own • Clinical studies are often performed at multiple sites. At each study to be involved in research. You may be able to work site, patients must be recruited, enrollment criteria are use to with researchers in at least three different settings: decide who can be entered into a study, and then the subjects are followed • Assisting in a clinical study or clinical trial if your clinical site is • Studies may be supported by drug companies or can be involved in the study funded by agencies such as the NIH (investigator-initiated) • Working with basic biomedical researchers by providing • Strict rules govern the performance of these studies to access to clinical biopsy specimens protect the patients as well as insure the quality of the data • Collaborating with a UCR social sciences researcher by generated in the study helping provide access to clinical populations for a study • Some studies involve medical interventions or drugs, so there can be risk to the subjects, and so close monitoring is involved • Training of medical staff is essential to be certain that protocols are strictly followed 2 12/10/2014 Working with basic Biomedical researchers by providing Collaborating with a UCR social sciences researcher by access to clinical biopsy specimens helping provide access to clinical populations • Biomedical Sciences research labs generally do research with • Several social sciences faculty at UCR are working on various animal models of disease (mainly mouse models, but also rats, aspects of clinical medicine, including topics on doctor-patient non-human primates, etc.) Predictions made in animal models interactions, to resource management and outcomes require confirmation using clinical samples • Examples: • Examples: • A Psychology faculty researcher has been studying affective • In a study on cytokine production and macrophage behavior among cancer patients. How is behavior influenced activation in a mouse model of parasite infection, one of by anticipation of a potentially life-changing diagnosis? our faculty worked with a doctor in Africa to supply serum samples from patients including control and parasite • A faculty researcher in Economics has been studying the infected patients. They found that infected serum value of committing significant resources to neonatal intensive contained higher levels of a specific cytokine. care units. Are the resources optimally utilized, and is there evidence that it has a beneficial effect on birth outcomes? • In a study on the effects of intestinal inflammation and epithelium barrier function, intestinal biopsy samples from • A faculty researcher in Political Sciences studies the role of the control and IBD patients will be needed to confirm the internet in patient access to correct health information effects seen in a mouse model of colitis. Example: Surgical Communication Surgical Communication (cont.) (Kate Sweeny, UCR Psychology) • Important but rarely studied (most research in • One earlier study audio-recorded conversations primary care). with surgeons (orthopedics and general). • Particularly difficult due to complex and technical • Surgeons did most of the talking discussions about procedures, risks, etc. • Few open-ended questions • Focused on biomedical (not psychosocial) • Patients generally dissatisfied with surgeons’ • Good start, but some limitations… communication in outpatient setting (1 study). • ≈90% White/Non-Hispanic, all English fluent • Brevity of conversation • Most patients had seen surgeon before • Lack of opportunity for participation in decisions • Unusually long conversations (M = 13 min.) Questions Questions • How do patients feel about their surgical care? • What predicts surgical outcomes? • Satisfaction, adherence intentions • Adherence, success, satisfaction • Predictors related to condition and care • Predictors related to condition and • Are there disparities in patients’ experiences? • Predictors related to patients’ state of mind • Predictors related to • Are there disparities in patients’ outcomes following surgery? • Predictors related to 3 12/10/2014 Still Other Alternatives, for example: Summary Bioengineering Senior Design • Experiences with surgical care are a function of… • Students in the last year of the undergraduate bioengineering • Demographic differences (disparities…?) program work in small groups (4-5 each) to design, prototype, and test a project over the academic year • Their health condition (severity, general health) • Past projects have included: • The surgeon’s style of care (emotions, control, • A pediatric laparoscopic surgical respect, comprehension, conversational goals) simulator for duodenal atresia • The patient’s state of mind (hope, satisfaction) • The Diaper Detective (won 3rd place in NIH DEBUT, • Up next: Recordings of patient-surgeon interactions! https://www.youtube.com/watch?v=VzFio1Wfwe0 ) • Characteristics of surgical communication • Groups are strongly encouraged to enter both the BME Start • Communication about expectations and NIH DEBUT competitions, which value clinically motivated projects with potential business value Additional note: see how physicians can be • At least two meetings with a group per academic quarter involved at multiple points in this kind of study • Please contact [email protected] Still More Alternatives, for example: SOM LACE PIP Example SOM LACE Practice Improvement Project Example of • UCR SOM Medical Students first three years includes an student project outpatient contact experience • As part of this experience, students also develop projects with volunteer clinical faculty to improve a specific aspect of clinical practice: Practice Improvement Project (PIP) • Projects may include any aspect of clinical practice from diagnostic methods, patient interaction, etc. • Projects are proposed with implementation plan, and evaluation of outcomes • Students do a PIP project each year • Contact: Michael Nduati ([email protected]) What If You Want To Try Your Own Idea? Steps To Starting A Research Project • Is “Protected Time” required?