Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan...
Transcript of Julie Pepe, Biostatistician - Florida Hospital | Hospitals ... · PDF file2 Grants Regina Tan...
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GrantsRegina Tan
Budget Memo Memo dated August 12, 2014 sent to the Research Department Leadership as
a reminder that FH Research Services requires a FULL grant budget to be included in all research grant proposal applications.
A Budget Preparation Guide details certain direct costs that should be kept in mind in preparing a budget. Budget must reasonably reflect FH scope of work.
Any application which includes cost sharing1, whether mandatory or voluntary, must include a Cost Sharing Approval Form signed by the Department Administrator/Director committing the funds and by Research Services. 1 Cost Sharing is the financial support contributed by FH to externally funded
projects.
Invoicing In an effort to have a consistent way of invoicing as it pertains to Grants,
Research Services will work with the Research Departments, Research Finance, and Research Accounting to centralize this function.
Grants Team
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Coggins, Sasha [email protected]
Shields, Leerin [email protected]
Dickstein, Stephanie [email protected]
Tan, Regina [email protected]
Grants Administration
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Grants AdministrationDepartment/Institute/Centers Pre-Award Post-Award
(Non-Financial)Post-Award(Financial)
Cancer Research & Development Stephanie Dickstein Stephanie Dickstein Sasha CogginsCardiovascular Regina Tan Regina Tan Sasha CogginsChildren's Research Regina Tan Regina Tan Sasha CogginsEndoscopy Stephanie Dickstein Stephanie Dickstein Sasha CogginsGlobal Robotics Regina Tan Regina Tan Sasha CogginsGME Stephanie Dickstein Stephanie Dickstein Sasha CogginsNeuroscience Regina Tan Regina Tan Sasha CogginsNicholson Center Regina Tan Regina Tan Sasha CogginsNursing Leerin Shields Leerin Shields Sasha CogginsOrthopaedics Stephanie Dickstein Stephanie Dickstein Sasha CogginsSurgery/ISA Stephanie Dickstein Stephanie Dickstein Sasha CogginsThrombosis Leerin Shields Leerin Shields Sasha CogginsTransplant Leerin Shields Leerin Shields Sasha CogginsTRI-MD Leerin Shields Leerin Shields Sasha CogginsUrology Leerin Shields Leerin Shields Sasha CogginsWomen's Health (OB, GYN, Breast, and Fertility) Stephanie Dickstein Stephanie Dickstein Sasha Coggins
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IRBJanice Turchin
• Reportable New Information• Not sure if an item/issue needs reported?
• Patient missed appointment • Safety Reports• Adverse events
• Important to involve PI• PI responsibilities – PI Forum
• Moving forward • New Forms Review• Engaging PI’s
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Educational activity – to include CME’s
Mandatory for all investigators (regardless of credentials)
Working on dates/locations for January 2015
Anticipate one (1) hour including time allotted for Q/A
Post-session (immediately following Forum) available for those who want to learn more – Non-obligatory
RSVP required / IRB soliciting contact information
Investigator Forum Coming Soon
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ORAMichelle Dolske
• New Processes• Case Study – BIG CHANGE
• Now defined as 1, 2, or 3 cases• Must be submitted to ORA prior to submitting to external
entity• Scholarly Work – NEW SERVICE• De-identified Data Sets – NEW SERVICE
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Case Studies
Researcher submits Reviews Prep
to Research Request to IRB
Researcher identifies
cases from his/her
clinical work (and
obtains Authorization
from patient, if
possible)
Researcher needs to
identify cases from
medical record search
Researcher would like to write a
Case Study (defined as up to 3 cases)
IRB Approves
Reviews Prep
to Research
Researcher reviews medical
records to identify cases for
inclusion
Researcher submits case study
to ORA
ORA Review
· De-identification of data or
Authorization signed by patient
· Compliant with FH P&Ps and SOPs
· If needed, contracts are in place
Researcher submits for
presentation and/or publication
ORA approves
case study
Researcher prepares case study
No corrections needed
Corrections or
additional
Information
needed
Case Study or Case Report: The analysis and
report of 1, 2, or 3 patients. A Case Study is generally
prepared for the purposes of illustrating some points in the
care of a patient, to educate, and/or to formulate new
research questions. A case study, by virtue of its publication
or presentation at a meeting, contributes to generalizable
knowledge, albeit at a low level of evidence. The following
types of cases may be worthy of reporting:
· Uncommon observations or practices
· Report of a new condition, treatment and follow up
· Report of a treatment not previously reported for a
known condition
· Report of atypical response to treatment
· Report of a familial condition with a proposed mode of
inheritance
· A new theory
· Questions regarding a new theory
· Unusual combination of conditions or events that cause
confusion
· Adverse responses to therapies
· Personal Impact
· Unique aspects of practice not previously reported
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ScholarlyWork
Researcher submits Reviews Prep
to Research Request to IRB
Researcher identifies
cases from his/her
clinical work (and
obtains Authorization
from patient, if
possible)
Researcher needs to
identify cases from
medical record search
Researcher would like to write a
Scholarly Work (such as book chapter) that includes patient information
IRB Approves
Reviews Prep
to Research
Researcher reviews medical
records to identify cases for
inclusion in scholarly work
Researcher submits scholarly
work to ORA
ORA Review
· De-identification of data or
Authorization signed by patient
· Compliant with FH P&Ps and SOPs
· If needed, contracts are in place
Researcher submits for
presentation and/or publication
ORA certifies scholarly
work is HIPAA compliant
Researcher prepares scholarly
work
No corrections needed
Corrections or
additional
Information
needed
Scholarly Activity Requiring Review: Demonstration of scholarship can be established with many
activities. Only activities that include patient information or
images require review. Examples include:
· Writing book chapters or articles
· Presentation at seminars, workshops, or educational
conferences
· Platform or poster presentation at national and
regional meetings
· Platform or poster presentation of clinical topics at
educational conferences and programs
· Community seminars
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De-identifiedData Set
Researcher is obtaining de-identified
data set from Florida Hospital
Researcher would like to use a
de-identified data set for a
research study.
Researcher would like to conduct a
Research Study using a
De-identified Data Set
Data set is provided
by an entity that
requires a Data Use
Agreement (DUA)
Researcher is obtaining de-identified
data set outside of Florida Hospital.
Researcher identifies who is creating
data set (cannot be researcher).
Data set is sent to the ORA
Data set is
provided by an
entity that does
not require a DUA
ORA biostatistician or designee reviews
data set. The Expert Determination
Method or the Safe Harbor Method are
used to satisfy the HIPAA Privacy Rule’s
de-identification standard.
ORA certifies data set
meets HIPAA de-identification
standard
Data set is sent to
researcher to begin study
Researcher works
with ORA to obtain
DUA
Information or
decision-making
needed from
Researcher
No additional
information
needed
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Dr. Rodricks
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the color theme of your choice. You can also create your own color theme.
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Florida Hospital is ranked the #1 hospital in the state of Florida and #26 nationally for Neurology and Neurosurgery by U.S.
News & World Report for 2014-15. It is also the number one hospital nationally for Neurology volume with greater than 10,000
inpatient visits in 2013. In November 2010, our hospital changed the Neurocritical Care (NCC) staffing to a partially closed
model, which required patients to be managed by an intensivist. Previously, the intensivist management was optional. Few
studies have examined the effect of an intensivist in an NCC unit1,2,3. The purpose of this study was to identify both patient and
economic benefits of a new requirement for mandatory intensivist management upon admittance into the NCC unit.
Primary Objective: To show that mandatory intensivist management in an NCC unit decreases NCC length of stay (LOS). This
was accomplished by retrospectively comparing LOS for patients admitted into the NCC unit during the 12 months before and
the 12 months after the new staffing model.
Secondary Objectives: 1) To show that mandatory intensivist management maintains excellent patient outcomes and benefits
the community by decreasing service line closure rates. This was accomplished by comparing Acute Physiology and Chronic
Health Evaluation III (APACHE III) scores, the emergency transfer center (ETC) decline rates, mortality and discharge disposition
during the two time periods. 2) To show that mandatory intensivist management has a positive economic benefit through
decreased resource utilization.
Background
Methods
Results Continued
Implementation of mandatory intensivist management in the NCC unit statistically improved NCC length of stay. This
improvement was maintained throughout the entire hospital stay. The percentage of patients that were declined for NCC
admission due to a closed service line decreased significantly. With improved resource utilization an increased number of
patients were able to be treated, which has significant benefits to the community. There were no statistically significant
differences in mortality, APACHE III Scores or discharge disposition. This data supports the implementation of mandatory
intensivist management in an NCC unit.
References 1. Knopf, L., Staff, I., Gomes, J., McCullough, L. Impact of a Neurointensivist on Outcomes in Critically Ill Stroke Patients. Neurocrit Care 2012; 16:63-71.
2. Josephson, S.A., Douglas, V. C., Lawton, M.T., English, J.D. Smith, W. S., Ko, N. U. Improvement in intensive care unit outcomes in patients with subarachnoid hemorrhage after initiation of
neurointensivist co-management. J. Neurosurg 2010; 112:626-630.
3. Varelas, P. N., Eastwood, D., Yun, H. J., Spanaki, M. V., Bey, L. H., Kessaris, C., Gennarelli, T. A. Impact of a neurointensivist on outcomes in patients with head trauma treated in a
neurosciences intensive care unit. J Neurosurg 2006; 104:713-719.
Results
Special thanks to
• Dr. Julie Pepe, Biostatistician, FH Office of Research Administration
• The APACHE team especially, Cheryl Williams, Critical Care Services & Tess Mendoza, Outcomes Coordinator
• The Financial Services Team especially, Rossitza Kassabova, Finance Director, FH Orlando Cardiovascular &
Neuroscience SBUs & Amy Montevilla, Financial Analyst, FH PFS
A retrospective review comparing 1,551 patients admitted to the NCC unit from November 1, 2009-October 31, 2010 with 1,702
patients admitted from January 1, 2011-December 31, 2011 was performed. This included examining LOS, APACHE III scores,
service line decline rates for the unit, mortality and discharge disposition. The percentage of patients managed by an intensivist
during each of the two time periods was analyzed based off of the Patient Financial Services (PFS) database. The secondary
objective data was in summary form, except for financial values. Summary measures, such as mortality and ETC closure rates
were obtained from monthly reports for the NCC unit. Individual financial data was collected based on direct cost and analyzed.
1Florida Hospital Orlando, Neurocritical Care, Orlando, FL, United States; 2Florida State University, College of Medicine, Orlando, FL, United States; 3Florida Hospital Orlando, Neuroscience Research Institute, Orlando, FL, United States; 4University of Central Florida, College of Medicine, Orlando, FL, United States
Rodricks, M.B.1,2, Napolitano, S. E.3, Anderson, G. A.3, Basignani, C.3,4, Tuppeny, M.1
Mandatory Intensivist Management Decreases Length of Stay and Allows for an Increase in Admissions to a Neurocritical Care Unit
Acknowledgements
Prior to the new staffing model, 51.47% of patients were managed by an intensivist. That number rose to 97.60% after
implementation of mandatory intensivist management. APACHE III scores were comparable between the two time periods,
indicating that acuity levels were unchanged. NCC LOS was reduced from 4.6 days to 3.7 days, (p<0.001). This difference was
maintained for the entire hospitalization, 9.8 days vs. 8.7, (p<0.001). The number of NCC admissions per month increased, 129
patients per month vs. 142 patients per month (p=0.017). The percentage of patients that were declined admission due to a
closed service line decreased from 12.36% to 5.66%, (p=0.020). Mortality rates remained below national predicted values and
discharge disposition remained unchanged. Direct hospital cost with an NCC stay was statistically more expensive in 2010 than
in 2011, $4146.55 vs. $3736.55 (p=0.017).
772
1709 1500
1751
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Nov 2009-Oct 2010 Jan-Dec 2011
Patients Seen by anIntensivist
Total Patients4.6
3.7
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
Nov 2009-Oct 2010 Jan- Dec 2011
Average NCC LOS in Days Patients managed by an Intensivist
Limitations
Conclusion
129
142
120
125
130
135
140
145
Nov 2009-Oct 2010 Jan-Dec 2011
Average Number of Patients per Month
Based on patient consults provided by PFS; p<0.001 Based on the monthly averages provided by APACHE III Data; p<0.001
Study Limitations: Data collected was performed retrospectively and analyzed from two different sources: APACHE III and PFS.
APACHE III analyzed patients based off of admissions and PFS analyzed patients based off of discharge. Both datasets examined
the same set of patients, but there was a difference in the number of patients that were grouped in the pre-and post
categories, 1551/1702 (APACHE III) vs. 1500/1751 (PFS).
Statistical Limitations: With only 12 months in each time period for APACHE III and ETC data, analysis may be limited to visual
comparison, but non-parametric analysis may be appropriate.
12.36%
5.66%
0.00%
5.00%
10.00%
15.00%
Nov 2009-Oct 2010 Jan-Dec 2011
ETC Percent of Patients Declined
Based on the APACHE III monthly averages; p=0.017
Based on the monthly averages provided by Emergency Transfer Center; p=0.020
Contact Information
Michael Rodricks, MD
Critical Care Specialists
2501 North Orange Avenue, Suite 401
Orlando, FL 32804
4,161.55
3,767.55
3400
3600
3800
4000
4200
2010 2011
Direct Cost
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43.42 42.5
4343.5
4444.5
4545.5
Nov 2009- Oct 2010 Jan-Dec 2011
APACHE III Scores
APACHE III scores were based on APACHE III monthly averages not statistically significant
Florida Hospital is ranked 26th nationally in Neurology and Neurosurgery by U.S. News & World Report.
51.47% 97.60%
Based on PFS data for each patient; p=0.017 Not adjusted for hospital LOS or for inflation
8.5 7.17
0
2
4
6
8
10
Nov 2009-Oct 2010 Jan-Dec 2011
Average Morality
Numerical difference based on APACHE III monthly averages not statistically significant
National Predicted Average
65
29.7 5.3
65.3
30.7 4
0
20
40
60
80
Good Bad Other
Discharge Disposition
Good=Home, Self-Care, Home Health Service, Rehab, Against Medical Advice Bad=SNF, Expired, Hospice, Hospice Medical Facility
Based on PFS data for each patient
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Research LegalViki Prescott
Improvements to policies related to Legal
• Revisions to hospital admissions documents being finalized, and similar form for ancillaries• HIPAA authorization for use of PHI and tissue for future research • Set stage for streamlined approval for use of tissue/fluids for
research• Policies and procedures related to these changes coming in a couple
of months• Date for roll-out of new patient forms soon
• Invention disclosure process coming in fall for things that may be patentable• Process: Complete Invention Disclosure online form and submit
through the site. Submitter will receive confirmation email. Review process is under development now.
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Research LegalViki Prescott
• Improvements in processes and workflow• New software tool for Legal project tracking
implemented July 22, 2014• Read access available by research department, upon
request
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Dual Enrollment Obtaining lab documents from FH lab COI Forms Recruitment of Employees IRBnet Tagging
Additional ORA Topics:
The practice of study participants participating in more than one clinical research study simultaneously or enroll in a single clinical investigation multiple times (for example the same trial at different sites).
Dual Enrollment
Some study subjects may not realize it is a problem unless they are specifically asked about their study participation and educated.
Others may hope to benefit from either: Increased compensation Additional healthcare
as a result of their study participation.
Why do Subjects Dual Enroll?
“FDA strongly discourages these practices as enrollment in more than one clinical investigation could increase risks to subjects… and confound the results of the clinical investigations.”
Excerpt from “FDA Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors; Draft Guidance, July, 2014”
FDA Speaks on the Subject of Dual enrollment
Increases risk to the subject. Potential exposure to more than one investigational
product simultaneously Safety profiles not yet well understood Potential drug or device interactions
Increases difficulty in understanding all the potential risks and proposed benefits
Increased time and demands of multiple protocols May harm the integrity of the study data and
confound study results
The Problems with Dual Enrollment
Information Gathering Type of trial, Investigational product,
interfering study activities, length of participation
Principal Investigator Determination Is it safe for the subject to participate in both
protocols in the opinion of the PI, and could is jeopardize the results?
Documentation
Your subject answered “Yes” Now what?
The FH Laboratory has a separate website outside of InSite: www.flhosplab.com/
All lab certification documents necessary for your regulatory binder are accessible here for all campuses
You still have to request the appropriate Lab Director’s CV as those are not included on the website.
You may request via the contact form on the website, or contact Linda Valdes via email.
Lab Certification Documents
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Recruitment of EmployeesP&P 400.120 SOP 400.120A
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Updated COI Form
Available NOW!
IRBnetMaking the MOST out of Tags
3 Easy Steps!!!1. Develop tag schema for you or your department2. Create tags in IRBnet3. Apply tags to your departmental projects
Step 1: Develop Tag Schema Creating and Managing Tags in IRBNet is a great
way to organize projects and be able to see what is going on with a project without clicking in packages.
Tags can be created to show a process flow from initial receipt of regulatory documents through the life of the project.
Take time to develop your tagging schema before you dive in. Get your team to brainstorm how the team currently functions and how you would like to improve functioning with the use of a robust tagging system.
Step 1: Develop schema (continued)
Tags can be categorized to suit many needs. Examples: Delineate actions to be taken on the project Delineate pending or completed items Assign staff to tasks on a project Characterization of study (e.g., sponsor, type of study –
drug, device) Use color coding schema for “stages” of task:
Need – Dark Pink Received from sponsor – Light Pink Submitted – Light Yellow Pending – Light Green Approved – Dark Green
Externally Sponsored --- Examples of Tags Site Feasibility form needed Site Feasibility form received Site Feasibility form submitted Site selection pending Site selected RRA needed RRA completed by dept RRA submitted without signatures RRA pending signatures RRA complete and submitted
CDA needed CDA received from sponsor CDA submitted to ORA for legal review
CDA approved and pending signatures CDA fully executed
Protocol needed Protocol received from sponsor Protocol submitted for review by MD Protocol pending acceptance by MD Protocol accepted by MD
CTA needed CTA received from sponsor CTA submitted to ORA for legal review
CTA approved and pending signatures CTA fully executed
Budget-Sponsor needed Budget-Sponsor received Budget-Sponsor under review by dept
Budget-Sponsor pending negotiation by dept Budget-Sponsor accepted by dept
Budget-ORA needed Budget-ORA completed by dept Budget-ORA submitted to ORA for review Budget-ORA under review Budget-ORA approved
1572 needed 1572 completed by dept 1572 submitted to MDs for completion 1572 pending MD signatures 1572 submitted to sponsor
Financial Disclosure needed Financial Disclosure completed by dept
Financial Disclosure submitted to MDs for completion
Financial Disclosure pending MD signatures
Financial Disclosures submitted to sponsor
IRB other documents needed from sponsor
IRB other documents received from sponsor IRB project submitted to IRB IRB project pending approval IRB approved
Consent needed Consent received from sponsor Consent modified for IRB and matching contract Consent pending sponsor approval Consent approved by sponsor
IB needed IB received from sponsor
eCRF training needed eCRF training scheduled eCRF training initiated eCRF training pending for all team members eCRF training completed
SIV needed SIV scheduled SIV pending SIV completed IP Drug needed IP Drug shipped IP Drug received IP Device needed IP Device shipped IP Device received
ORA Institutional Clearance needed ORA Institutional Clearance – all documents submitted ORA Institutional Clearance pending ORA Institutional Clearance
received Regulatory staff assigned REG – Jill REG – Mary REG – REG - CRC assigned CRC – Bob CRC – Jan CRC – Pam CRC - Sue IRB to be used IRB - FH IRB – WIRB IRB – Quorum IRB - CIRB Sponsor Sponsor Merck Sponsor GSK Sponsor Medtronic Sponsor Covidien Study Type Phase I/II Phase III Phase IV Registry Study Status Status – project in development Status – IRB/ORA approved Status – Open Status - Closed Records (study) location of… Records onsite Records Iron Mountain
Step 2: Create Tags
1. Type in tag name
2. Select tag color
3. Create a new tag!
1 2
3
Step 3: Apply Tags To tag a project click on the icon next to the
Study Title.
Step 3: Apply Tags (continued) A box will come up with Add and Remove Tags.
Once tags have been created there are 2 options for the type of Tag:
Step 3: Apply Tags by clicking on:
Personal Tags only you can view
the tag
Shared Tags any team member
with access to the project can view the tag
Sorting by Tags When multiple projects
appear on the “My Projects” list, it can be beneficial to sort the projects by tag.
You can sort by any tag by clicking the drop down box and selecting the tag you would like to search by.
Hit enter, and the projects with that tag will be listed.
Modifying Tags Changing the Tag Name
Click on the Tag name and modify in the box Delete the Tag
CAUTION!!! To delete a tag simply click on the t at the right-
sided end of the row (next to the Tag Color). Once you hit “delete,” you will receive a message “Remove
from all projects and delete tag?” If you click “OK,” the tag will be removed from all projects
currently tagged with this tag
Tag Pointers Reminder: Take time to develop your tagging schema before
you dive in. Get your team to brainstorm how the team currently functions and how you would like to improve functioning with the use of a robust tagging system.
When Creating Tags, keep the tag name short as it may be cut off from view when added to the project if the tag name is long
You can see the whole tag name by hovering over it. Remember if you Delete a Tag, it is removed from all projects
that currently have that tag in use People who have been granted access to the project can see the
tags. The IRB, ORA, and FH Grants cannot see the tags placed on projects!!
Feel free to use as many tags as you need. There is no limit! Happy Tagging!!!
36
Orthopedic Research will be giving an oral presentation at the upcoming AAOS (American Academy of Orthopedic Surgeons) Conference in Las Vegas (March 2015). Patella Fracture Fixation Using a Load-Bearing Cable System.
Thrombosis Research has 2 papers accepted for publication: Peerschke, EIB, Castellone, DD, Stroobants, AK and Francis, JL.
Reference Range Determination for whole blood aggregation using the Multiplate® analyzer. American Journal of Clinical Pathology 2014 (in press).
Amirkhosravi A, Boulaftali Y, Robles-Carrillo L, Meyer T, McKenzie SE, Francis JL, Bergmeier W. CalDAG-GEFI deficiency protects mice from FcγRIIa-mediated thrombotic thrombocytopenia induced by CD40L and β2-GPI immune complexes. J Thromb Haemost. 2014 (in press).
Research Recognition
IRB RemindersRenewals / Study Closures
Must be received well in advance of IRB Study Expiration Date 30 days per IRB letter There may be issues that need addressed before Review
Study Closures must be submitted before Study Expiration Date
Failure to do so = Non-Compliance
Sponsors contacting IRB Looking Forward – Restrictions / Continuing Non-Compliance
IRB Classes – On-Line Calendar
38
Steven Smith, MDChief Scientific Officer
39
Thank you for your attendance at Research Matters!
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