Turning Clinical practice into Scholarship: Even without funding!

Turning Clinical practice into Scholarship:Even without funding! Michele T. Pato, M.D. Associate Dean Academic Scholarship Professor of Psychiatry-Keck SOM-USC Center for Psychiatric and Molecular Genetics (adapted with permission,9/4/03, from “Doing Research on a Shoestring Budget- M. Dewan, E. Silberman, M.T. Pato)

Why Publish and/or Do Research? • Satisfies your own curiosity • Advances the field • Improves patient care • Advances your own career • Gains you respect among peers & colleagues • A break from the routine-Burn Out prevention! • Gives your parents,kids (and chair) something to brag about! Pato1999inHandbkPsychEd:Kay,SilbermanPessar,APPI,DC

Where do ideas come from? EXPERIENCE!!!! • Patients • Things that go right • Things that go wrong, Side effects • The “unexpected” • Literature • New findings • Metanalysis • Review articles • Philosophical articles • Colleagues (MD, Nurse,Psychologist,SW), students and friends • At meetings • On rounds • Over dinner,At the coffee pot Pato1999inHandbkPsychEd:Kay,SilbermanPessar,APPI,DC

Research is good clinical care • Turning a notion into research : ASKING A QUESTION YOU CAN ANSWER WITH THE RESOURCES AT YOUR DISPOSAL

Things you’ll need • A question to answer • A sample of subjects • Something to measure • A way to measure it • A way to summarize and analyze your measurements • A way to disperse you findings Pato1999HandbkPsychEdKaySilbermanPessarAPPI DC

Things you’ll need-Elaborated • A question to answer- A null hypothesis-(The “So what” test) • A sample of subjects-(Generalizability) • Something to measure • an Outcome variable (dependent variable) • Predictor variable (independent variables) • A way to control interference (inclusion and exclusion criteria) • A way to measure it • Rating scales, • Instrumentation-biologic, physical • Outcomes and surveys • A way to summarize and analyze your measurements (statistics)(S. Glantz- Primer Biostatistics) • How many “subjects” do I need to say something significant- (POWER) • A way to disperse you findings-(Publications+Grants) Pato1999HandbkPsychEdKaySilbermanPessarAPPI DC

Ways to contribute to Your Field! • Teaching-Self, Students, Colleagues (CME)-see online below • Publishing- In the literature • Letters to the editor- “n of 1” studies • Case reports • Literature review • Questionaire studies • Chart review • Think pieces • Open clinical trials • Hypothesis driven studies • Case-control+Cohort study, Randomized clinical trials, Biologic studies • “Publishing- On line” • Entrez-PubMed: http://www.ncbi.nlm.nih.gov/PubMed • AAMC education tools- MedEdPortal and IIME( Institute for Improving Medical Education) Pato1999HandbkPsychEdKaySilbermanPessarAPPI DC

More on AAMC sites (Association American Medical Colleges) • MedEdPORTAL-MedEdPORTAL is a Web-based tool that promotes collaboration across disciplines and institutions by facilitating the exchange of peer reviewed educational materials, knowledge, and solutions. The overall goal of MedEdPORTAL is to serve as a central repository of high quality educational materials such as PowerPoint presentations, assessment materials, virtual patient cases, and faculty development materials. • Institute for Improving Medical Education-  IIME- The AAMC established the IIME to respond to concerns about the quality of U.S. medical education. The institute convenes expert panels to: provide guidance on innovative approaches to educate doctors; develop grant programs to provide support for development and implementation of innovations in education; develop and disseminates position papers; organizes policy forums to focus attention on specific issues; and build coalitions of organizations willing to work toward change.

Entering the Scientific Domain • “ an individual’s knowledge properly enters the domain of science only after it is presented to others in such a fashion that they can independently judge its validity” • Importance of skepticism in science On Being a Scientist1995NAS

Why publish? • Reporting new scientific findings • To warn or inform others of your experience • Allows evaluation of results • Places results in perspective against work in field • Allows for replication of your work • Credits other scientists:both co-authors+ others in the field who have influenced work • Establishes who is accepting responsibility for the work

Jacob , 1988 The Statue Within, Basic Books Inc, NY, NY • “Scientific writing transforms and formalizes research” • Scientific writing “substitute(s) an orderly train of concepts and experiments for a jumble of disordered efforts… In short writing a paper is to substitute order for disorder and agitation that animate life in the laboratory.” Macrina2000ScientificIntegrityc1

A good hypothesis should be: • Internally consistent • Provide accurate experimental predictions • Unify disparate observations • Have simplicity and elegance On Being a Scientist1995NAS

Using informed consent in Clinical setting • Consider running your clinical practice from the beginning with a request to your patients to use clinical data in their chart for research in a conscientious, confidential, and ethical way. • To monitor your own practices • To improve your care of patients • To contribute to the literature in your specialty ( all possible things to publish/report !!) • HIPAA- Health Insurance Portability and Accountability Act

Using Scholarship in becoming a Clinical Scholar? • Criteria:“Focus of Research is on application of clinical science to clinical care” • National reputation with innovation in clinically important research. • “Evidence that there is a theme of expertise”-could be broader than tenure track faculty • “evidence of Excellence in SCHOLARSHIP and in one of two other areas (Teaching or Service) • As with Tenure track this appointment must be granted at the university (UCAPT) level as the medical school level.

Using Scholarship in becoming a clinical scholar? • Demonstration of Scholarship includes: • “Research that is widely recognized as making an impact in a specific area of medicine or science” • “Continued productivity as first or senior author of important articles in high quality peer reviewed journals” • “Success in obtaining peer reviewed funding especially from governmental agencies.” • More flexibility of Recognition and Funding for Clinical Scholar versus Tenure but excellence still required.

Using Scholarship in theClinical Educator track • This non-tenure track still recognizes excellence but in the practice of Teaching and Leadership in major educational programs. Excellence includes: • Didactic + clinical teaching evals • Gaining educational grants • Receipt local + national awards and recognition • Production + “publication” teaching materials and methods - ie: SCHOLARSHIP

FYI information • New Faculty and Staff Orientation Guide:http://capsnet.usc.edu/ProfessionalDevelopment/OrientationGuide/documents/NEO2006.pdf • Faculty Handbookhttp://policies.usc.edu/facultyhandbook/ • Dental faculty promotion info is: http://www.usc.edu/hsc/dental/dfa/documents.htm • IRB- Internal Review Board http://www.usc.edu/academe/faculty/research/ethical_conduct/ • HIPAA-Health Insurance PortabilityAccountability Act:http://www.usc.edu/admin/compliance/hipaa.html

More to come • Talk about specifics of • Getting support without funding • Writing for publication in small groups • Informed consent

Getting started without funding WHAT ARE YOU GOING TO STUDY? • What do you need? • Personnel- • To do assessment • To enter data • To analyze data • To Do clerical work • Equipment • Supplies • Lab tests • Subject payment

Sources of Personnel without funding • Secretaries • Students • PhD candidates - esp. psychologists • Residents • Med students • Colleagues- MD, Nurse,Psychologist,SW • Volunteers • Research assistants on other projects • So you only pay for the time you need

Non-Monetary payment-Bartering • Co-Authorship - paper or grant • No cost Piggyback on another study • (just agree to do the IRB … paperwork) • Analyze existing data • Offer to teach in exchange for support • Offer to do more clinical work in exchange for support* ( but you have to make the time) • Offer to help someone else in exchange • Exchanging technical skills

Small sources of money-Befriend grant/research staff • Seed money-( can be memorial award) • Departmental • Medical school • Undergraduate med ed • Graduate med ed • Junior faculty awards • Pharmaceutical companies-instead of pizza • Foundation grants • NARSAD(scz/dep), RWJ(hsrd), McArthur award(mood), Scottish Rite (psychosis),National organizations-OCD, Dep, ADAA… • NIH- small grants, first awards, • Become a co-investigator or consultant

Getting it into print!! • Choosing the right journal • Writer’s block- getting started • Reviews and rejections

Getting it into print!! • Choosing the right journal • What do they usually publish • Following instructions • Choosing the right length- • Generalizability • Scientific merit

The purposes of allocating credit • Acknowledges work of others • Directs the reader toward additional sources • Acknowledges conflict with other results • Provides support for views expressed • Places paper in broader scientific context On Being a Scientist1995NAS

Senior author and/orFirst author*? • Assumes responsibility for: • Validity of entire body of work* • Facilitating communication among co-authors • Describing role + contribution each co-author • Logistics of manuscript submission • Distribution of reprints • Response to peer review comments * • Meeting requests to share material • Responding to queries about the work * • Retention and storage of data

Writing and Reviewing: Having good friends and enemies! • Writer’s block- getting started • Get something down. • Polish the apple later • Read it aloud • Have others read it-friends and enemies • Rejection and review • Routine - 2% of publications accepted initially but 20-40% accepted on resubmission. • Reviewers often don’t agree • One study 585 comments 42x agreed (Fiske and Fogg, 1985 Am Psychologist, 45,591-598) • Remember reviewers are people just like you! • They’re not always right! • They don’t always get it!

Common review criteria • Try to be non-adversarial instead help author & editor • Evaluating the MERIT • Clear statement of problem • Appropriate literature citations • Scientific merit and originality

Review criteria con’t • Techniques and preparation • Research designs and techniques appropriate • Description and methods detailed enough to replicate • Is data presently clearly and effectively • Are interpretations sound,logical,& clearly worded • Is manuscript easy to read, grammatically correct • Read title and abstract last!! • DO THEY ADEQUATELY AND ACCURATELY REFLECT THE WORK?

Informed consent A Necessary part of any Human Subject Research

Informed consent is a process not a signature! And the process is ongoing for the entire course of the research AND Doctor-patient relationship

Key elements of Informed Consent Facilitating a Free and Informed choice • That it is research and what the research entails • Risks and discomfort • Benefits • Alternative treatments • Confidentiality • Compensation • Who to contact with questions • Participation is Voluntary

Problems with Informed Consent • Limited by ability of patient to understand especially with regard to medical literacy • Understanding the consent form seems Inversely related to IT’S LENGTH! • Average form written for 8th grade reading level but average literacy of population is 5th grade level.

Waiving requirements for Informed Consent • Even a waiver of written consent must be run through the IRB • Studies that have no more than minimal risk of harm and no individual identifiers • Examples include: • Observational studies • Some CQI studies • Some chart review studies • The rule of thumb is run everything by the IRB first by phone and/or writing before beginning

A Final Thought YOU CAN’T WIN THE LOTTERY IF YOU DON’T BUY A TICKET!!!

For more information • About: Tenure, Clinical Scholarship and promotion email me: mpato@usc.edu

Turning Clinical practice into Scholarship: Even without funding!