VICTR CTSA Biostatistics Group Meetings

2015 Jan 14

Attending:

• VICTR biostat support guideline: http://biostat.mc.vanderbilt.edu/VICTRBiostatPolicies
• Annual CTSA progress report, section of Design, Biostatistics and Research Ethics (1-3 pages). Reporting period is February 1, 2014 to January 31, 2015. Submit by February 16, 2015
  • Need everyone's input on their CTSA related publications
  • Need Ethics update
  • Teaching
  • Statistical method
• Translational Science 2015, abstract submission deadline January 20, 2015
• Recent approved vouchers after new guideline
  • Rice, Allergy/Pulmonary
  • DeAgostino, medical student
  • Arnold, Peds Emergency Medicine
  • Sakwe, MMC
  • Assad, Allergy/Pulmonary
  • Bosompem, Pathology,Microbiology,Immun

2013 Aug 14

Attending: Wang, Harrell, Yu, Byrne, guests Linda Stewart and Linda Wilson

• Discussed query from Stacy about BCC charges that are up to one year old
• Queries asked for detailed information after such information was already provided in a detailed response
• Queries assumed that work done to satisfy specific aims on the VICTR renewal needs special justification
• Issue with non-!VICTR biostatisticians getting vouchers, coming out of general VICTR biostat budget
• Discussed latest rdw analyses

2013 Jul 10

Attending: Harrell, Nian, Yu, Wang, Byrne, Nwosu

• Updated on vouchers
• Update on BCC
• Discussed basic science studios and how to assign statisticians
• Discussed whether expensive feasibility studies are worth funding

2013 Jun 12

Attending: Seth Martin, Audrey Carvajal, Harrell, Byrne, Nwosu, Wang, Nian

• Seth and Audrey discussed meeting with VICTR business team
• Stacy West is requesting more details in billing
• Pre-application, meetings, clinics, general categories
• Need category, PI name, type of work - used for Anesthesiology collaboration plan
• Challenge with lack of specified fields for this in CORES
• Need to clarify what level of detail is needed for vouchers; need to pay a bit more attention to the "general" category
  • Be sure to use VR # if it exists

2013 Mar 13

Attending: Harrell, Byrne, Wang, Nian, Nwosu

• CTSA staff effort
  • Wide variation in voucher requests over time
  • Effort needed for personalized medicine VICTR grants
• REDCap survey on Biostatistics Clinics for Clinics paper
• Instant voucher and development analysis session

2013 Feb 13

Attending: Nwosu, Harrell, Byrne, Wang, Nian

• Annual progress report is due on Feb 28. Plans for the coming years:
  • Continue the research on how predictive modeling is currently used in aiding physician decision making using the hospital computer system and expand VICTR research to make this work more evidence-based and rigorous.
  • Promote the application of the innovative study designs and adaptive designs into future VICTR studies and try to publish a paper on it.
  • Develop a matrix that can measure the quality of science over time to demonstrate the outcome of statistical involvement. Try to make a check list to give a score from 0 to 10 evaluating the statistical aspect of the proposal. The association between the score and the outcome will be assessed. research on research goal)
  • Use StarBRITE database to follow 5-year outcomes of the VICTR studies.
  • Create a series of teaching videos for the investigators.
  • Write a paper describing the Biostatistics Clinic structure for other interested CTSAs to use as a guide for implementing their own Clinics.
  • Use RedCAP surveys to assess and improve Biostatistics Clinic using regularly collected metrics. Part of our record keeping will also include taking wiki notes in real time during clinics for every investigator. The information recorded is the name and department of the investigator, very brief summary of the question, and the statisticians' recommendations. This helps us keep records of clinic use and is also helpful for the investigators to come back an refer to. We are also expanding clinics to help investigators navigate VICTR resources by educating them about what is available and estimating the amount of money needed for specific biostatistics support requests.
  • Institute a Morbidity and Methodology Conference (Harrell).
  • Expand on the collaboration with Vanderbilt's Health & Wellness group (Byrne).
  • Publish a paper on how we developed and incorporated innovative study design methods and adaptive designs into VICTR protocols (Goal 2, Yu and Alvarez).
  • Pilot an institutional research climate assessment as a means of evaluating the effects of ethics education and consultation (Heitman).
  • Fully implement the Instant Voucher program.
• CTSA meeting 2013
• Taking BCC projects when CTSA work load is low
• Voucher paper
• Dan's pressure ulcer proposal was funded by VICTR; Dan is interested in incorporating Bayesian design
• Mentioned new ad hoc clinic committee and grad student recommendations
• Discussed recent requests for voucher support that were requested to go to other statisticians
• Need to insure that VICTR MS biostatisticians can do a significant amount of non-voucher work such as advancing our long-term goals
• Dan discussed a study design issue in predicting risk of pressure ulcers; predictive model in StarPanel
  • Dedicated person to round
  • Pressure ulcers underdocumented in chart; peson rounding could increase reporting, which would bias against intervention group (re: coded information in chart or influencing bedside nurse to do so)
  • There are independent observers for a quarterly report; may look at 400 persons and find 20 with pressure ulcers
  • May be no way around an independent blinded assessor; need to know that all patients randomized to be intervened on were intervened

2012 Dec 12

Attending: Nwosu, Harrell, Wang, Yu, Nian

• Problem with "generic" charges, much of it from manuscript finish-up (revision) work
• Investigators hesitating to get letters of support from their home Division
• New policy: Ascertain the goal of the project. If it is to write or finish a manuscript, the minimum funding request will be $4000, i.e., the home Division will have to back at least $1000. We need to make it clear to the investigator that if the total manuscript work before final acceptance does not require 40 hours of work, the unspent time will not be charged to the home Division.
  • Some estimates, for complex analyses, will exceed $4000 up front
• Need a system involving Seth where statistician can bill to a voucher on an as-needed piecemeal basis and someone in the business office will keep track of when the first $2000 has been spent and then divide each incremental amount into two halves for billing from two accounts
  • Need to keep track of total charged to each account and tell statistician to stop work once the original limit is exceeded
    • If a limit is exceeded, investigator will have to have his/her home Division agree to pay for all of the additional work or will have to request supplemental VICTR funds before any work can proceed
• Instant Vouchers: Need to clarify is there a way around having individual charge codes set up before work is done; would be nice to have a "instant voucher basket" for charging
  • Or do we want a new category "instant post-clinic assistance" IPCA?
• Need to clarify yearly budget for BCC
• VICTR-sponsored RFAs: Not appropriate to instantly pay for, using VICTR biostat funds, development of internal grant proposals to VICTR. Investigators will have to obtain a developmental voucher in advance to obtain this assistance
  • Developmental voucher does not count against the one/year limit
    • May need to re-visit the exclusion of the $500 from cost-share formula

2012 Oct 10

Attending: Nian, Nwosu, Yu, Harrell, Byrne

• Discussed poster for town hall session in Light Hall Nov. 27
  • Suggestion to add support for larger VICTR studies and specialized biostatistical support requiring specialty expertise (e.g., proteomics, genomics); assistance to hospital operations/Pharmacy residents
  • Need to track outcomes of large outlays
• What kind of outcome metrics are being tracked by C4 that pertain to biostat?
• Use of non-!VICTR biostatisticians in BCC
  • How to handle K awards? What biostat support is reasonable to put in a K application?
    • Gordon may want to do this with an up-front match from home dept.
• Uncertainty about investigators who have contract with BCC also applying for VICTR support
  • Assign smaller projects (20 - 40h) to VICTR
  • Consider restarting Collaboration Plan with Pharmacy, perhaps with Pharmacy paying for senior biostatistician and VICTR funding BCC charges for MS biostatistician and when those funds run out Pharmacy pays for MS biostat time; make part of the goal to teach the residents research methodology
• Chang discussed the adaptive design group - working on a Phase I/II studies; looking for a real study
  • Need to be in a position to persuade investigators to use the new designs
  • Need to be able to account for time spent by Hui and Sam, e.g. simulation work
  • Can we charge to general VICTR code?

2012 Sep 12

Attending: Byrne, Wang, Nian, Yu, Nwosu

• Discussed about the VICTR biostat meeting summary
  • Work done before study is approved: what about the developmental work?
  • Instant voucher: should be <$1500 for less than 12 hours of work
• VICTR review turnaround time
  • Biostat has done a good job
  • Talked about a biostat voucher which took around 10 days to approve
• Need publications for the next CTSA renewal
  • Studio
  • Voucher
  • Clinics
  • Adaptive designs
• Adaptive design fits well under CTSA environment
  • Sam, Hui, and Li can start learning to prepare
  • How to allocate percent effort

2012 Jul 11

Attending: Byrne, Harrell, Nian, Wang, Nwosu

• Discussed implantable defibrillator voucher - analyses are fairly complex
• Still need data on various VICTR bottlenecks; may relate to decline in voucher requests
• Instant vouchers: need a safe way to bill, hopefully not needing to bill under one investigator
  • Let's be on the lookout during Mon. - Thurs. clinics for candidates for instant vouchers
• Clinic attendance
• Clinic sponsorship

2012 May 9

Attending: Harrell, Wang, Nian, Byrne, Yu

• Problems occurring because of making $2000 voucher estimates too often
• Much better to overestimate and to not charge the investigator's department as much as feared
• If project involves submitting a paper, add to original estimate the cost of re-analysis and re-writing after referee critiques received
• Need to be proactive in finding out if a project will lead to a paper
• Count meetings to understand the project, data cleaning, analysis file creation, analysis, reporting, meeting with investigators, assisting with writing, checking writing, dealing with referee comments, re-analysis, re-writing, resubmission of manuscript
• Almost no vouchers expected to lead to a paper should be for <= $2000
• What if we charged a very low rate for even the first hour of assistance, then have the rate increase to current rates after 20 hours?
• Alternative: Get letter from chief up front saying if the work goes over $2000 the division pre-approves coverage of 1/2 up to $10000
• Need to make a sheet to put in clinic areas informing non-!VICTR statisticians of the 5th and 6th bullet points (above)
• Discussed how VICTR should interact with hospital readmission trial

2012 April ?

Attending: Byrne, Yu

• How to make the VICTR work more rewarding to careers

2012 Mar 14

Attending: Byrne, Harrell, Wang, Yu

• Rocket
• Studio paper was accepted in Academic Medicine
• Another paper is being started on vouchers
• Voucher workload: Li has 10 active
• Jill Pulley asked for help with CTSA survey - relates to how the various CTSAs count CTSA support and output
• Li has instituted a system to alert the biostatisticians to which applications they reviewed are being discussed at the upcoming SRC meeting
• Let's start tracking whether or not a biostatistician's input was evident in the submission
  • Start with CTSAactivities - add text such as "biostatistician involved:Y or N"
• Dan reported on a problem protocol review - plan was ill-specified with too many ways to measure outcomes and stress levels; is a nebulous question a waste of time and resources? When in doubt be rigorous. Ask "what would constitute a failed or negative result?".
  • There is an important role for pre-specified statistical analysis plans

2012 Feb 8

Attending: Yu, Nian, Wang, Byrne

• Discussed a voucher request (VR3027).
  • Suggested to apply for $4000, but PI has difficulty to get department support
  • PI removed biostat request and serves the statistician himself
  • What about research quality?
• Studio paper has been accepted by Academic Medicine
• Think about papers we can write, like clinics, vouchers, CRC workshops, review process
• Help to have more adaptive designs in the future

VICTR CTSA Biostatistics Group Meetings

2012 Jan 11

Attending: Yu, Nian, Wang, Harrell, Byrne, Seth Martin

• Discussed MMC
  • Consider asking Drs Agboto and Poland to attend all studios for MMC investigators
  • Consider having more required biomedical research training
• Seth discussed the need for a better process for split-payment vouchers
  • Split billing is cumbersome
  • For now until the number of vouchers > $2000 grows, biostatisticians will alternate charges to two cost centers in 1/2 hour increments when the first $2000 is spent
  • Investigators can see money left by logging into StarBrite so billing needs to be speedy
• Terri Edwards and Lesa Black could not attend; will re-invite to discuss review process bottlenecks and how we can help
• Discussed Ken Monahan process
  • Need a way to flag proposals that have been in review for more than 2 months
  • Consider adding more statistician identification information in the StarBrite application so that reviewers would know there is stat backup
  • Can StarBrite give a report of delayed reviews?
• Voucher requests are down
  • Is cost-sharing related to this?
  • Need to get the word out to investigators that this is available
• Li's time: hard to hourly bill for everything, especially meetings and answering various investigator questions. 30% as % effort?
  • How to fund clinic attendance?
  • Instant vouchers post clinic - for smallest, narrow-focus projects; Extension of clinic, perhaps best done as part of 30% effort
• Planning for SCTS meeting in DC in April
• Talk about CTSA renewal summary statement next time

2011 Dec 14

Attending: Chang, Li, Dan, Frank

• Discussed EAB meeting
  • Did not bring up waiting time and research on research
• Discussed personnel support
  • In the future think of funding a graduate student
• Need to follow through on Meharry projects/studios
  • Consider inviting MMC faculty sit in on VU studios
  • Can also make more use of biostat clinics
  • Responsiveness of MMC biostat to MMC requests needs to be sped up
• 75d waiting time from StarBrite submission to SRC presentation: opportunity for improvement
  • Are all the reviews done in parallel
  • What is the average time from StarBrite submission to notification of reviewers that the proposal is ready to review?
  • What investigator delays are there?
    • What is the time between end of round 1 and start of round 2 reviews?
  • Why does it take 6w for a biostat-only request > $2000? Should only take 2w as an expedited SRC review.
  • Analyze the 5 most delayed applications
  • Invite Terri Edwards and Lesa Black to our next meeting
  • Goal to present metrics at VICTR OC meetings
• How to handle split vouchers - from VICTR and investigator's chief; only correct to bill VICTR first when still in the first $2000
  • Need to enhance software to handle this; talk to Seth Martin; another approach is to give a refund back to dept.

2011 November 9

• Attending: Dan, Chang, Li, Hui, JoAnn
• Discussed workload
• Discussed estimating amount for VICTR biostat support requests
• Need to find out whether researchers with the collaboration plan are allowed to apply for biostat support through VICTR

2011 October 12

• Attending: Terri, JoAnn, Frank, Li, Hui, Dan, Chang
• Frank has been sharing some of BERD's strategies with the Comparative Effectiveness Research group.
• Discussed different study designs for health services research intervention studies.
• Discussed estimating number of hours/funds for CTSA biostatistics requests. Emphasised that the estimate should be for the entire project, not only an initial phase.
• For situations where an investigator is planning on more than one paper or grant, direct them to talk to Frank to set up a collaboration plan with Department of Biostatistics.
• We will develop a wiki page to record our Department policies regarding our work on VICTR Biostatistics support requests. After this is set up, we may put it on StarBrite.
• Proposed a policy to require the mentor to attend the clinic for VICTR purposes and at least the first statistics meeting. This would apply to residents and fellows.
• Concern over low investigator attendance at clinics (mainly at Thursday clinic).
• Encourage statisticians at clinics to not to dominate the hour and to also focus on listening to the investigator and allowing other statisticians to provide input.
• Discussed benefits of having a designated moderator at all clinics.

2011 Sep 14

• Attending: Frank, Dan, Chang, Terri, JoAnn, Hui, Li
• Discussed current workload
  • Terri is leading the revision of the work flowchart; she has filled up the Friday workshop to end of year; Veida Elliot will take over workshop coordination
  • Hui could take 2 vouchers
  • Reviews are starting to pick up with Chang; capacity for vouchers
  • Li has 6 active vouchers + 2 developmental vouchers
  • JoAnn has 2 non-active vouchers; may be able to take another
  • Dan is reviewing protocols, taking part in studios, teaching MCSI
• Teaching modules and short courses
  • Terri has been evaluating Webex vs. GoToMeeting
  • http://khanacademy.org
  • Some combination of in-person short course and prerecorded material is probably best
• Consider contributing to http://ctspedia.org, especially graphics from CDISC datasets
• Need breakdown of time spent in each phase of VICTR review/resource requests; where are the bottlenecks?
  • We could volunteer to graph the data
• Need to keep vouchers moving
  • Can tell investigators that you have a window of opportunity that is about to close
  • Make sure they know that you cannot work efficiently with long delays between project steps; also teach how to efficiently publish papers
  • May be a good idea to be more picky about requiring the mentor to be present at meetings with the biostatisticians

2011 August 10

• Attending: Frank, Dan, Chang, Li, Hui, JoAnn
• How to handle repeat customers
• VICTR does not cover biostats help on a separate grant that did not budget for biostats help on the original main aims.
• Need to prospectively screen investigators seeking biostats money through VICTR to make sure this is not the case
• We can support this type of study with VICTR biostats personnel, but the investigator must pay 100%, and we will bill through BCC.
• Discussed workflow including attending clinics with investigators.
• Note taking during clinics is very important for VICTR.
• May encourage investigators seeking VICTR funds to attend on Monday, Wednesday, or Thursday, so that a VICTR biostatistician will be there. If they go to Tuesday or Friday, they may end up having to get the blessing of an additional set of statisticians.
• Discussed protocol review for pilot studies. This is an advantage of using precision to guide sample size calculations.
• If they need to do a pilot to estimate variability, they need to have at least 45.
• They need to at least include how well they can estimate the variance, even if it is low.
• How long does it take from the time the pre-review is completed until the SRC sees it.
• Goal of less than 4 days for a pre-review.
• If investigators come back later after their funds are exhausted, we can help them only if it would require less than one hour of work. If it requires more, they need to apply for more funds.
• Be sure to ask VICTR applicants if the goal is to write a manuscript, how many manuscripts. If they want more than one, they need to get on the collaboration plan.
• Gordon is considering Frank's idea of using VICTR time to do long-term projects handled through VICTR.
• Look a khanacademy.org. These are made using a graphics tablet.
• Go to ctspedia.org.

13Jul11

Attending: Dan Byrne, Terri Scott, Hui Nian, JoAnn Alvarez, Li Wang

• TS - Trouble getting Friday workshops. Need to get the workshops video tapped. Contact Jill and Mike S. about who will do this. Need to make it much more teacher-friendly. Tie this into our certificate program and pre-biostatistics.
• Discuss protocol turnaround time.
• Need to give JoAnn and others access to the protocols before SRC.
• Do vouchers expire after a specific period if there is money remaining.
• TS - Discuss with Frank not being coauthor on paper with Joseph Hall
• Discuss making a policy on advance notice known at voucher application time. Ideas: x working days to review/edit a manuscript, and opportunity to discuss any changes made to the statistician's edits. Early involvement of mentor?

8Jun11

Attending: Frank Harrell, Dan Byrne, Terri Scott, Hui Nian, JoAnn Alvarez

• Discussed grant writing/editing/figures/references process
• May want to put all references in http://zotero.org; works nicely with BibTeX
• Advantages of using Sweave as sometimes labels inside figures need to be changed during the editing process
• Need to discuss version control, how to get collaborators to edit our documents
• Final section was edited by Gordon Bernard to meet page limits; end result was tight, and read well
• Need to find out what is happening with the boot camp, how to design/format the Pre-Biostatistics course, when to use in-person vs. recorded vs. on-demand web modules vs. webinars
• What about the certificate program?
• Is there value in more often presenting interactive demonstrations of what statisticians do with data?
• Assignment: find the best example you can find of an online statistics module; also look at ggplot2 interactive

1Nov10

Attending: Chang Yu, Frank Harrell, Dan Byrne, Laurie Lebo, Lesa Black, Terri Edwards, Sharee Small

• Demonstrated the biostat wiki, the CTSA grant proposal page, ctspedia.org
• ctspedia.org may have a large role in the CTSA Coordinating Center
• Lesa discussed issue with pre-reviews when PIs request biostat support and are requested to attend a biostat clinic
  • Some are failing pre-review even after everything is deemed OK at clinic
  • Need clinic review to be considered a "final" pre-review including the cost estimate
  • Sharee is looking for the existence of a stat plan/sample size justification before biostatisticians see the application
• Proposed steps:
  1. Tell investigators who are preparing to come to clinic the names of the VICTR biostatisticians
  2. Have the investigator confirm that the pre-review statistician will attend the day the investigator attends
  3. When the clinic discussion starts, the investigator should make sure that someone is taking notes on the wiki notes page for that day, and the investigator should leave the clinic with the link to the notes for her/him
  4. The URL link to the clinic notes (not the notes themselves) should be included in the StarBrite application
  5. Clinic personnel need to be certain to include the name of the VICTR pre-review biostatistician who attended the clinic, in the notes for the study in question
  6. Occasionally the pre-review statistician and the investigator will not be able to schedule a mutually agreeable clinic time to meet; in that case a separate meeting can be scheduled
  7. Pre-review statistician may need to consult with an expert statistician in a specialty area

1Oct10

Attending: Yu, Byrne, Scott, Alvarez

• JoAnn Alvarez will be joining CTSA for 25%
• Discussed the coordinating center grant
• Proposed conducting a REDCap Survey of the 59 PI of the existing CTSAs and asking 2 questions: What is your biggest CTSA success initiative that you think should be reproduced at other CTSA? What is your biggest CTSA challenge that you would like to learn how others have solved?

Collect best practices

• CTSpedia - teaching, best practices
• CTSA Health Risk Assessment
• Conduct a national survey of what the taxpayers want regarding medical research.
• Coordinate the JSM ACTS meeting
• Discussed the 5-year renewal due June 2011
• Terri estimated that she spends 10% of her time on vouchers; Chang 5%
• Mentioned keeping turnaround time for reviews to <1 week

3Sep10

Attending: Wang, Yu, Harrell, Scott, Martin

• Seth demonstrated some features of the Cores reporting system
• Decided to do timekeeping for another month (September)
• Discussed problem collaboration
  • PI's journals are accepting unpowerful and often invalid analyses
  • Problems with percentiles, z-scores, and dichotomization

2July10

Attending: Wang, Byrne, Harrell, Blakemore,Scott, Martin

• Seth Martin presented Cores time tracking for new BCC work for vouchers
• Discussed new operating procedures in CTSA topic

4June10

Attending:Wang, Byrne, Harrell, Blakemore, Ding, CTSA admin core

Note: invited the VICTR team from 2525.

How to improve the voucher process.

How to shorten the prereview times, while increasing the level of science.

Planning for the CTSA renewal

An overview of how investigators can obtain biostatistical support at Vanderbilt - collaboration plan, clinics, vouchers, SRC. And how we can communicate this.

Metrics and reports to assess whether we are improving quality.

Who are our 57 biostatisticians and what are their areas of expertise.

The Biostatistical Collaboration Center (BCC) and how it works.

VICTR PR for the Biostatistics Department flat screen monitor in the S hallway.

7May10

Attending: Phillips, Scott, Harrell, Blakemore,Yu, Byrne

• Francis Collins visit
• IAB meeting: will discuss catalyst vs. hand-holding approach; concentrate on junior researchers?
• Should we continue to meet with junior researchers when their mentors are not present?
• Need to work with VICTR central to recognize that voucher funding needs to be there for all phases of the work, including for example work caused dealing with referee comments on a manuscript
  • Bring up at VICTR Ops Committee
• With the new system with cost-matching, should we extend current vouchers more often, not requiring new voucher requests?
  • What happens when the initial voucher is not "used up" and the investigator comes back later?
• Should VICTR cover DSMB work after a design voucher is issued? This should probably be a separate voucher.
• Need to get two points across to investigators at the outset:
  • It's REALLY $2000 and can run out
  • After the $2000 is used up, cost-sharing kicks in immediately. Investigator may need to get pre-approval for this cost-sharing.
• Problematic requests for last minute grant proposal help from Divisions not covered by collaboration plans
• Possibly consider, instead of # vouchers/yr/investigator, the number of VICTR $ per year ($2000 + VICTR half of match)
• Can we get some of the yearly surplus?
• What are the trends in VICTR pre-review times (not just biostat)?
• Need to push clinic attendance more strongly in first pre-review
  • What about a "pre-voucher" for 6 hours for developing the initial stat plan for the proposal to SRC?
  • Should there be a checklist and a process the investigator should go through before VICTR submission?
  • Is this an opportunity for reducing review time by shifting biostat-related time to pre-submission?
• Retrospective review of protocols submitted to GCRC a few years ago
  • Propose to VICTR that new submissions from investigators getting GCRC funding provide a brief outcome report of their previous funding (e.g., last 2 funded projects with funding date before 3 years from now)
    • Outcomes: patient recruitment, final sample size vs. initial plan, publication, grant proposal, grant award, great ideas
    • Could check a random sample of data from the reports

16Apr10

Attending: Blakemore, Scott, Harrell, Yu, Wang

• VICTR changes (see 17Mar10 meeting below)
  • Need to figure out whether initial voucher estimate is all-inclusive
  • May need clarification on multiple vouchers per investigator
  • May be good to have investigator get approval from her division up front for payment of 1/2 beyond $2000
  • New recharge center approach to voucher work
    • can pull in any biostatistician in the department; all will charge by the hour
    • need to figure out how the initial 20 hours or so can be done by non-VICTR biostatisticians
  • $2000 will be "spent" by salary categories used in the recharge center
• Activity and time tracking
  • dbconnect will need to be extended, including initializing vouchers (PI name, award date, total award, project name, estimated close date or time limit); need to get cumulative amounts spent at a glance
• SCTS meeting de-briefing
• BERD face-to-face meeting de-briefing

17Mar10

Attending: Jennifer Adams, Gordon Bernard, Donna Bock, WJ Cunningham, Terri Edwards, Frank Harrell, Seth Martin, Susan Meyn, Linda Stewart and Cheryl Wiggins

Topics

• Percent effort (VICTR FTE) was estimated for the following primary activities:
• Clinics (.05 FTE); it was noted that CTSA is the single biggest sponsor.
• Teaching and Design Studios (.10 FTE) Gail Mayo's teaching activities and CRC Friday workshops were mentioned. The CRC workshop is led by Terri Scott frequently and Sharon Phillips occasionally; it provides basic instruction (analysis, research design) for research staff (0.5 FTE). Design Studios probably require .05 FTE effort.
• Scientific Review Committee (SRC) protocol review (1.35 FTE). It was decided that on July 1 2010, VICTR will fund the first $2000 of vouchers with the investigator's department/division paying for half of the remaining work up to a cap of $25000 for VICTR + divisional costs combined. Vouchers include the bulk of the work and are estimated at 1.5 FTE.

Seminars were mentioned as another CTSA activity, e.g., Gordon and Frank's Morbidity and Methodology seminar.

It was noted that there is biostatistical review of all projects including vouchers and that clinics often serve as a pre-review.

Meharry Medical College Collaboration The importance of providing biostatistical support to Meharry colleagues was noted. Frank Harrell and Vincent Agboto have initiated and share a web site to coordinate VU/MMC CTSA Biostatistics overflow activities. Susan Meyn mentioned that vouchers can be enabled for Meharry workload.

Specialist “non-VICTR biostatistician” Requests Exceptions for specialists are granted, but, ideally, CTSA-funded biostatistician time should be used first. A big part of the specialist activity is proteomics. SRC pilot activities ($4K) include non-VICTR faculty/staff especially Yu Shyr and his team. Reasons for these requests are: 1) area of specialization (proteomics, mass spectrometry, genomics, pharmacologic PK, imaging, etc, 2) overflow and 3) Investigator request following establishing rapport with a particular biostatistician. It was noted that the CTSA Core is full of generalists.

Discussion regarding negative incentives for departments not participating in the collaboration plan ensued i.e., Department of Medicine and Section of Surgical Sciences.

Actions:

• It will be necessary to track hours carefully. Susan M will provide training for Biostatistics staff on new CORES hourly tracking system.
• The current Biostatistics core budget is personnel only. The CTSA budget will be restructured to shift to the Biostatistics Collaboration Center core charge model effective 7/1/10. Rebudgeting to the core will involve shifting all staff biostatisticians support and “certain” faculty.
• When vouchers are assigned to non-VICTR biostatisticians, they are to be billed through BCC.
• Fixed support (all non-voucher time, including studios, clinics, admin, review, etc.) will remain in VICTR and all other support will be channeled through the BCC.

12Mar10

Attending: Byrne, Phillips, Yu, Wang, Scott, Blakemore

The 5-year renewal report is due June 2011. Below are the goals that we wrote in the initial CTSA grant and the plans for the coming year. We need to agree upon the plans and in the next year use the monthly meetings to make sure we are making progress toward these goals. For the report we will need more diagrams, graphs, etc. to make the report less dense.

Everyone should review the "Draft review criteria for competing renewal applications":

http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/competing_renewals.asp

And also the fact sheet on this page.

NCRR has a 2009-2013 Strategic Plan listed here:

http://www.ncrr.nih.gov/strategic_plan/

http://www.ncrr.nih.gov/strategic_plan/online_version/full.asp

We need to decide if we are going to request more FTEs for biostatistics.

Dan is helping Bob and Italo write a paper on the Studios.

We need to document how we have helped to support Meharry. We could invite Russ to one of our Biostat meetings and give him a tour of our department.

We need to make sure biostatistics is not responsible for slowing down the review process.

Discuss the meeting in April, posters, funding.

What are our achievements in the first 5 years of the CTSA?

What impact have we had on the quality and extent of clinical and translational science at Vanderbilt and within the local and regional communities?

Dan worked with Terri Edwards, Tara Helmer and Lynda Lane today to create the 2009 CTSA publication list, poster, and graph. The following search terms were used in PubMed:

(RR000095[GR] OR RR-000095[GR] OR RR024975[GR] OR RR-024975[GR]) Limits: Publication Date from 2009/01/01 to 2009/12/31

Vanderbilt NOT (RR000095[GR] OR RR-000095[GR] OR RR024975[GR] OR RR-024975[GR]) Limits: Publication Date from 2009/01/01 to 2009/12/31

Goals of Component Program:

1. Improve research quality and rigor by broadly implementing and making available a wide range of supportive resources for new and experienced investigators, through the entire research process and in support of the SRC process.

2. Develop and incorporate innovative study design methods to improve efficiency, ethics, and impact. Expand novel methods of interaction with industry and other external collaborators and partners.

3. Improve biostatistical, methodological, and ethics-related training. Expand innovative methods of teaching modern biostatistics; develop feedback mechanisms to update the curricula and course material with the VICTR experience. Implement an innovative MS and PhD biostatistics program.

4. Research the research process to strengthen the infrastructure by supporting the VICTR Program Evaluator (Dr. Len Bickman) in analyzing outcomes data generated by VICTR as an experiment to assess research efficiency, collaborative facilitation, promotion of efficient translational research, and identification of best research practices that could be translated to other institutions.

5. Provide an integrated bioethics and biostatistics model to provide early review, assessment and, where needed, intervention to facilitate highest quality translational research.

f. Plans for the Coming Year:

1. Publish a paper on the Studio process (Goal 1, Byrne).

2. Evaluate the biostatistical input for VICTR research and Biostatistics Clinics using a REDCap survey (Blakemore).

3. Create a RedCAP database of protocol follow-up to assess 5-year outcomes (Blakemore).

4. Publish a paper on how modern methods of sample size justification can improve efficiency and ethics of clinical research (Wang).

5. Publish a paper on "research on research" (Goal 4, Blakemore).

6. Publish a paper on how improving ethical aspects of research improves efficiency of research and the success of clinical investigators (Goal 5, Heitman).

7. Institute a Morbidity and Methodology Conference (Harrell).

8. Build a collaboration with Vanderbilt's Health & Wellness group (Byrne).

9. Publish a paper on VICTR-supported training (Goal 3, Scott).

10. Publish a paper on how we developed and incorporated innovative study design methods into VICTR protocols (Goal 2, Yu).

11. Pilot an institutional research climate assessment as a means of evaluating the effects of ethics education and consultation (Heitman).

15Jan10

Attending: Scott, Phillips, Harrell, Blakemore, Byrne

• Terri is organizing a session on responsible conduct of research for the CRC workshop
  • Liz has recommended a 4-day course at Indiana University May 18-21
  • We can see if there is VICTR funding to send a few people
• Terri is renewing CME credit for the workshop by submitting a new application
  • Needs to determine the sponsoring department
• Evaluations are now being requested from attendees
• Several sessions are scheduled from a variety of speakers including in computer literacy
• Carl Hornung will be visiting from U. Louisville a week from today to work on a presentation on biostatistics education for SCTS/ACTR
• REDCap clinic is thriving
• Need to start work on a national BERD REDCap database
• Sharon will be preparing for the winding down of biostat support from Surgical Sciences
  • A log of actual hours spent per investigator will be extremely helpful in putting VICTR resources vs. the current Surgical Sciences resources into context

18Dec09

Attending: Scott, Byrne, Harrell, Yu, Phillips, Wang, Blakemore

• Late-breaking news on faulty analysis in personalized medicine: http://www.e-publications.org/ims/submission/index.php/AOAS/user/submissionFile/5816?confirm=cfad51b7
  • See article in http://cancerletter.com/tcl-newsletter/35CL36_24BR08.pdf
• We have many opportunities in helping to put personalized medicine research on a firmer footing
• What procedure is being used to check responses to biostat pre-review for adequacy?
  • Time for 2nd review may be a bit short (< 1 week); if need more time, ask for it
• Power vs. precision as basis for sample size calculations
  • Example: Recent proposal aimed at showing difference between two measurement methods is within 10%
• Issues with use of small pilot studies to estimate SD to use in power calculations
  • n=24 required to ensure a multiplicative margin of error less than 2 at 0.95 level (2-sided)
  • What is good statistical practice? One could present a range of sample sizes or use 0.75 one-sided CI for sigma, for example.
  • We are having many cases where a researcher needs the SD of a difference but only has the SD of a single measurement
• Good news from CTSA External Advisory Board
  • Asked how cores work together
• Our renewal is June 2011; be planning publications
  • Some publication and outcome data collection are being considered
• A satisfaction survey of our customers may be in order; be collecting testimonials
  • Need to determine where in the process people should be surveyed
• Frank and Chang attended the CER kiickoff meeting on 12/14. The KFC is still forming its mission and vision statements, put the committee in place.

20Nov09

Attending: Byrne, Harrell

• April CTSA (SCTS) meeting in DC - Harrell, Byrne, Wang, Yu will attend.
• Poster - Dana - Overview of how the CTSA Biostatistics Group Supports VICTR
• Poster - Li - How sample size and power consultations improves the success of projects
• Poster - Terri - VICTR training
• Poster - Chang - I can present a poster on themes like: 1) enhanced CTSA support results in publications; or 2) CTSA study-motivated statistical methods research. Probably go with the first one.
• May be best to make posters for VU use for now as it may be too late for submission to SCTS
• Chang is representing us at the CTSA consortum evaluation task force. Are there others we should be more active in?
  • Perhaps new BERD groups: imact and reproducible research/good stat practice
• Online web training with Mike Stein
• Expanding the grant prereview studios - list of NIH study section members.
• Supplement for interim monitoring.
• REDCap Survey training on Dec 3rd at 9 am.
• Contribution to the consortium and CTSpedia.
• External Advisory Board 30 minutes - need ideas for content?
• Annual report
• Renewal plan
• Prepare wish list for CRC equipment carry forward $251,001
• Research on Research - IAP, need more ideas.
• We need to create something of value that we can show others - papers, posters, software, etc.

11Sep09

Attending: Wang, Yu, Harrell, Scott, Blakemore, Phillips

• Industry protocols
• Discussed consult on BMI, triglycerides, HDL, diabetes, and metabolic syndrome in adolescents; need for more fucused questions, perhaps at another clinic
  • Problem with the use of percentiles of BMI; probably best to adjust for age in some fashion
  • BMI may be defective, i.e., a "normal" may be at idea weight at every age but have their BMI change over time
• Discussed the need to be on the lookout for opportunities to assist with research related to the H1N1 epidemic

21Aug09

Attending: Lane, Clayton, Shyr, Harrell, Maron, Yu, Heitman, Wang, Bernard, Phillips, Blume

Special biostat-ethics clinic for David Maron's cardiovascular treatment clinical trial

17Jul09

Attending: Yu, Wang, Phillips, Harrell, Scott, Byrne

• Brief discussion on pre-reviews
  • Check for clinic notes
  • Need to make sure that Meharry investigators are fully documenting study designs and sample size methods in CTSA proposals
  • Hope that Vincent can attend these meetings once/month
• Need to better advertise clinics, Friday workshops, etc.
• Authorship issue related to a voucher
  • Referred to ManuscriptPolicies
• Meeting coming up about voucher payments
• Studios continue to be successful
• Can search PubMed for RR000095 or RR-000095 or RR024975 to monitor VICTR grant citations
• Upcoming pre-JSM meeting of CTSA statisticians

19Jun09

Attending: Wang, Blakemore, Yu, Harrell, Scott, Phillips

• Welcomed Dana to the group
• Need to let Shraddha know about Dana
• Need to update review randomization list and its allocation ratios
• Dana will rotated in at 0.1 effort share (Li and Chang will run the program); Chang, Frank, and Dan will assist Dana with reviews initially
• Update on WISDOM trial
• Update on BERD esp. importance of 1-1 work with investigators (part of the impact group)
  • Also: online resources (http://ctspedia.org), minding the gap, good stat practice, eval task force
• Discussed protocols from Meharry Medical College

15May09

Attending: Phillips, Wang, Yu, Harrell, Scott, Xu, Byrne

• Supplement grant on interim monitoring
• Scope of voucher requests
  • NOT for funded projects (grants, contracts)
  • Priority to design
  • Priority to trans-department high-profile high-impact projects
  • Can request voucher request data from VICTR
  • Need to do excellent time or task tracking and measuring supply and demand
  • Need to note completion of vouchers; can keep a voucher open all of the time wasn't used
  • Should VICTR ask home departments to pay any matching funds, as a governor on the system?
• Crohn's disease reviews
• Internal Advisory Committee

14Apr09

Attending: Phillips, Wang, Yu, Harrell

• Crohn's disease applications and SRC
• Supplement grant brainstorming

23Jan08

Attending: Donahue, Harrell, Wang, Yu

• Report out from 2 VICTR meetings
• Discussed activity tracking
• Discussed Meharry Biostatistics coordination
• Discussed protocol assignment and completion tracking
  • Expand status of reviews to include the following; consider using EDITTABLE plug-in
    • assigned/completed/in process (?)
    • Design problems noted: none/minor/moderate/severe
    • Analysis plan problems noted: none/minor/moderate/severe
    • Recommendation: accept/studio/clinic/resubmission after revisions
• Contribution to VICTR brochure; incorporate some text from proposal aims

13Feb08

Attending: Donahue, Harrell, Yu, Wang

• Reviewed brochure; will add two access points - clinics and applying for support through VICTR
• Discussed the fact that we are not supposed to provide help unless the investigator applied through VICTR, was approved, and we get a notion of the scope of work
• Need to determine how time scope is estimated and is quoted to the applicant
• Any investigator who is not ready to apply to VICTR who does not already have biostatistics support through the collaboration plan only has clinics as a recourse
• Be prepared for providing grant proposal assistance
• Frank reported on yesterday's teleconference with NIH BERD committee on electronic resources
• Problem with expedited reviews getting serious biostat concerns and still being approved
  • Helped by getting reviews done by the Wednesday after Friday notification
• Bayesian Biostatistics Conference at MD Anderson: 7 Biostatistics members attended, learned a lot about adaptive design; met with Vincent Agboto, MMC director of biostatistics
• Frank reported on successful teleconference with outside statistical center after review that raised some concerns
• Possibility of requesting additional funds for IT development, linked to RedCap

27Feb08

Attending: Donahue, Harrell, Yu, Wang, Agboto

• Noted that Quick Links in StarBrite referred investigators directly to Biostatistics. Changed the twiki page to tell them to apply for resources through StarBrite.
• Ask Paul Harris to change link to Quick Links to list Biostatistics up front.
• Brochure needs to be consistent with this
• Vincent talked about CTSA activities at Meharry. There are active awareness/educational processes going on to make investigators aware of the resources. Investigators will go through StarBrite to request support through a voucher. For the present, a database at Meharry is used to note requests. Until Vincent recruits more biostatisticians, some help may be obtained (through StarBrite).
• Rafe asked whether an MS biostatistician who is 1/2 VU 1/2 Meharry would be a good idea.
• We need to be ready for grant proposal assistance requests. Frank has told Jill that we will be available for grant development requiring short- and medium-term collaboration. Longer development phases need to be covered by the Collaboration Plan.

12Mar08

Attending: Harrell, Yu, Wang, Byrne

• Discussed recruiting and how to handle gap when Rafe's departure
• Li will take over protocols assigned to Rafe for review, with the other three biostatisticians helping often
• Would be helpful to add a checklist of protocol problems to avoid
• We need to be diligent in recording major analysis or protocol issues in our review status table
• Format CTSA twiki activities to match the progress report template to make the next progress report easier
• Bring up to ethicists the possibility of doing prospective reviews in April or May.
• Updates from CTSA Operations Committee meeting 11Mar08
  • Think of biostat/ethics needs for funding from year one funds
    • Think about software that will help the infrastructure
    • Jeff Horner may be able to help, extended RecCap more for R
  • Think of more ways to reach out to MMC and other institutions
• Do we want one replacement for Rafe or two, splitting the effort?
• Lei might work with CTSA until 1Jul08
  • May be some applications for analysis of EEG and sleep data; Paul Harris and Dan have worked on this before
• Get CTSA grant number in papers we participate in if the participation was even somewhat related to CTSA
• We need to start making progress in research on research
  • Dan will look at outcomes of some past protocols especially with regard to publishing papers
    • StarBrite could track outcomes of research; would have a bigger impact if requests for future CTSA resources were denied if outcomes of previous investments were not reported
  • Frank offered to do a live extreme collaboration during a GCRC workshop or clinic
  • Continue to think about publications we would want to write, including common flaws in protocols; a valuable paper would be on our joint work with ethicists
• Training in responsible conduct of research would be beneficial to all statisticians (also refer to ASA code of ethics)
• Upcoming biostat/ethics clinic for sports medicine

26Mar08

Attending: Yu, Byrne, Harrell, Wang, Xu, Agboto

• Welcomed Lei Xu to the group
• Need to rotate Lei and Li into the protocol review assignment table
• Lei and Li might bring rough drafts of reviews to clinics for comments and assistance
• Need to clarify why and where the short review (or pre-review) are placed on VCAMP, on topic CTSAreview; investigator needs to see comments as early as possible, on the VCAMP web page
• Demonstration of RedCap protocol review database

09Apr08

Attending: Wang, Yu, Byrne, Harrell, Xu, Agboto

Report from 1Apr08 CTSA BERD Teleconference on Evaluation

* Dave DeMets put together a attached spreadsheet. We need to review.

• The plan is to have 6 major categories of evaluation:
  • Consultations and Collaborations
  • Grants
  • Protocols
  • Publications
  • New Methods
  • Education
• Within each of these categories the workgroup will define specific metrics.
• A few items that we need to discuss at our next CTSA Biostat meeting:
• We need to demonstrate how we have leveraged our CTSA money to accomplish more, improved efficiency and increased our impact.
• We need to document how we have expanded to reach out to other departments, schools, and parts of Vanderbilt.
• It will be very important to get collaborators to include the CTSA grant number on all publications that result from our CTSA-supported work. We can include the following as a footer in our emails or just send to collaborators.
• Publications that result from VICTR support should reference the grant. A final reprint should also be sent to the VICTR-CRC office so the publication may be incorporated into our files and bibliography as required by the NIH. The following manuscript citation is suggested: "Supported in part by Vanderbilt CTSA grant 1 UL1 RR024975 from NCRR/NIH"
• We need to create a list of essential variables that should be recorded in most studies and put this into the base RedCAP default system (e.g. weight).
• We need to review the RedCAP protocol review form and move it to next level.
• Update twiki into the progress report format and keep up-to-date.
  • To avoid duplication, some material might be INCLUDE{}'d from other pages
• Discuss the paper we will write regarding CTSA.
• We need to try the RedCAP survey.
• VUspace.
• Recommend biostatisticians for CTSA External Advisory Board.
• Plan ways to use the CTSA consortium to fix something that was a duplication of effort.
• We need to make sure 100% of protocols have a formal biostat review.

Other Business

• Discussed being ready to deal with problem investigators if there are any
• Discussed time expectation for reviewing a protocol and whether you can do an adequate review without delving into the background material (e.g., references)
• When reviewing a protocol/statistical analysis plan from a coordinating center of a multi-center study, we still need to do a full statistical review. This may result in better stat plans for future studies from that group, and hopefully, for the current study.
• We are starting to review pilot study proposals; we need to make sure we have reviewed all of them
• Remember that most proposals not asking for biostatistics support still need concrete hypotheses and sample size justifications

23Apr08

Attending: Dan Byrne, Li Wang, Jeff Horner, Chang Yu, Lei Xu.

• Internal Advisory Meeting
• Protocol review - need to ensure that 100% of protocols in SRC folder have a biostats review.
• RedCap covariates - discuss spreadsheet.
• Research on Research Project - discuss questions and variables.
• Need to encourage our collaborators to apply for pilot and other CTSA resources soon.
• Job satisfaction and workload.
• Need to line up CRC workshops and speakers.
• Review CTSA goals and aims to assess progress.
• CTSA wiki for the consortium - Spreadsheet from Hell.
• Studios
• Vouchers
• Discuss publications demonstrating we have accomplished one of the aims.
• Progress report format on twiki - need to keep updating.
• Prepare for Cody Hamilton, July 1, 2008.
• Wish list - equipment, books, etc.
• Jeff Horner is working with Paul Harris too add features to Redcap using Hmisc and describe.

14May08

Attending: Byrne, Harrell, Xu, Wang

• The CTSA biostatisticians’ workgroup has an evaluation task force with monthly teleconferences.
  • The attached spreadsheet was put together by Dave DeMets to summarize the outcome measures from the various CTSAs.
  • See the “Measures” tab. (We will give them an update about our metrics.) This spreadsheet will give you an idea about what other CTSAs are measuring.
  • The group decided to categorize these into 6 major areas. See top of the BERD Evaluation outline document.
  • The plan is to write definitions for these outcomes.
  • The idea is that we define the appropriate metrics rather than having NCRR impose metrics they think up on us.
  • Scott Zeger, chair of biostats at Hopkins, is the leader of this workgroup and is very effective.
  • There is talk about adding a 7th major area = Contribution to the consortium.
  • Scott’s suggestion for next steps is to develop ways that we can share ideas about how we leverage our time and effort to positively influence the greatest number of researchers with our existing resources. How can we maximize our impact? The idea is that each of us has some techniques that we use for maximizing our impact. We want to find a way to share these best practices with the other CTSAs. * We need to capture much if not most of these metrics through the normal workflow processes. How can we accomplish this?
• Frank and Dan talked about the last BERD online resources teleconference
  • Central online teaching resources vs. links to resources at all CTSA sites
  • Updating http://wikipedia.org with stat definitions
• Discussed an interesting pilot study analysis of blood sample deterioration, with multiple blood analyses by patient; discussed summary measure approach, serial data parametric analysis, and having an observer write down the time until deterioration for each patient then do a simple one-sample confidence interval

27May08

Attending: Byrne, Yu, Harrell, Xu, Wang

• Should we change how protocol reviews are scheduled? Current method is working pretty well with occasional very heavy weeks for one reviewer
• Need to define 2 objectives for next year for CTSA Biostats, e.g.
  • Raising the level of science with more comprehensive protocol reviews
  • Rejecting at least 20% of submissions, many of these outright rejections
  • VICTR Grand Rounds; constructive review of published papers, emphasizing that there are other alternatives, not just right and wrong approaches; discuss alternative designs also
    • Want to do this only on articles published by non-VU reseachers?
• Need to get the message out that multi-center protocols based outside VU still need to have their scientific act together
• Use NCRR mission statement in wording these objectives
• Equipment ordered
• Workshop speakers needed for Friday
• Graphics core? Have a puzzler-type contest?

25Jun08

Attending: Byrne, Yu, Harrell, Xu, Wang, Horner

• Jeffrey gave a demo of the new Rapache Redcap extension
• Frank discussed budget issues and supplemental application from online resources task force related to central BERD twiki
• Use the following in our goals and objectives: "The CTSA program enables researchers to provide new treatments more efficiently and quickly to patients."
• Discuss proposing new metric: 5 best stories/discoveries; we need a way to capture these in an ongoing way; perhaps a checklist might help
• Equipment: bought anatomical model + books, laptops, software; smartboards should be coming
• Future wish list
• Protocol review: we need to be firm about sloppy or incomplete work and be clear on rejecting inadequate plans
• Vacation coverage
• Li Wang - Mentoring plan
• Li Wang - Green card
• IAP evaluation plan
• Redcap standard variables; need version control or repository

For next meeting:

• Expand teaching
• Paper with Nancy Brown
• Next progress report
• Upcoming conferences
• Recruiting and Ben S.
• Poster contest
• CRC workshops
• Studios and vouchers
• Clinical research solicitation feedback meeting
• Vanderbilt HRA
• Research on research process

23July08

Attending:Xu, Wang, Agboto

• We discussed issues related to protocol review process: Per Vikki's suggestion: "We suggest an approval" is too strong as it sounds like we are approving the protocol when we are only approving the stat part. We would suggest we just make a statement that it ready for agenda or hold for agenda.
• We discussed statistical issues of our current projects.

27Aug08

Attending: Yu, Byrne, Saville, Xu, Harrell, Shraddha Nigaveker, Wang, Phillips

• Introduced Shraddha from VICTR Research Support Services, supporting SRC
  • Goal is to have new version of StarBrite in 3-6 months
  • Demonstrated the RedCap implementation that will bridge the new StarBrite implementation
• Discussed vouchers; will be discussed at faculty meeting
• Lei talked about an old voucher she was working on which is highly problematic
• Sharon updated us on Surgical Sciences
• Frank talked about possible sequential monitoring of selected studies

10Sept08

Attending: Yu, Byrne, Wang, Phillips, Xu

• Chang discussed an ED project of n=20 + 80 pilot with inadequate sample size justification.
• Terri will join 20%
• 99% power $40,000.
• Need to ID the biostatistician on the protocol page 1.
• Help Lei find PIs to get publications.
• Need to redo the protocol assignment Lei decreased.
• Update on evaluation task force teleconference 7/29/08.
• Define the 7th major evaluation area and submit?
• Review the attachment "BERD Evaluation Guidelines V3.doc"
• Use CTSA as seed money to leverage more money and support.
• Show the leveraging you have done with grants and department collaboration support.
• Function as catalysts.
• The CTSA cannot do all of the biostatistical work. Need to recruit new faculty and staff for the collaboration plan. The CTSA biostatisticians can help identify needs and sell other departments on the collaboration plan.
• The CTSA activity is bigger than the funded part. This is important so that we can spend time doing more than "billable hours" working on specific protocols.
• We need to keep track of our CTSA work but not billable hours.
• We need to try a CTSA collaborator satisfaction survey using Paul Harris' RedCap survey tool or StarBRITE. The survey needs to be short and the cover letter needs to be carefully written. See consortium twiki. Consider sending every 6 months.
• Build the infrastructure to improve efficiency.

22Oct08

Attending: Yu, Byrne, Wang, Phillips, Xu, Harrell

• Discussed testing of new version of Dupont-Plummer PS software; possible request from Bill for CTSA support for testing/proofreading
  • Frank will alert the Online Resources CTSA consortium about this
  • Also consider web applications: how much trouble would it be to convert PS to an R web app?
• Voucher procedures
  • Requests not involving already-collected data (favored; planning process with early biostat involvement): voucher can be approved quickly; for selected applications recommend a clinic for jump-starting the project and exposing other statisticians to interesting brainstorming sessions
  • Requests involving already collected data: scrutinize more closely, require a clinic before voucher is officially submitted
    • Clinic will determine if dataset is appropriate for the intended purpose, and estimate the statistician time required; one or more CTSA biostatisticians will have to be present and will require coordination
    • For surgical research proposals emphasis is on appropriateness of dataset (and readiness for analysis)
• Status of open biostat vouchers
  • 9 approved, $0 spent; 6 went to Sharon where no $0 really involved. One was stopped due to attempt to change the scope of the project. System needs to add a close date and a current status category (not started, in progress, completed, stopped due to investigator attempting to change scope from what was approved). Need to also add a field for total hours worked to date.
• Tracking of utilization of CTSA-paid personnel
  • Possible categories: protocol review, planning studies and analyses (including meeting with investigator), data analysis, CTSA operations (mainly attending meetings), manuscript review/writing, studio, clinic attendance
  • Captured time spent in each category to the nearest 10 min. chunks, e.g. one month every 6 months; alternative is to do retrospective calculations if activity log is complete or can be completed; do for Nov 2008
  • Be better at documenting activities on twiki page
• Issue of suggesting fixes to problems detected in protocol review; mainly fix simple problems as we go, otherwise emphasize clinics and studios or resubmission
• Should requests for study design and study analysis be separated? Depends on complexity; discuss further next time

12Nov08

Attending: Yu, Byrne, Wang, Phillips, Xu.

• Discussed:
• Packets at the SRC. Li will print copies for the biostatistics group.
• A role we can play in making sure investigators work with their collaboration biostatistician.
• Protocols without sample size justification.
• BERD meeting next week; Frank will attend.
• Research on the research process.

10Dec08

Attending: Harrell, Phillips, Byrne, Wang, Yu, Xu

• Terri Scott will join the group in January; discussed involving her in data analysis and the Friday workshop
• Should the CRC Research Skills Workshop be renamed VICTR Research Skills Workshop? Dan will talk to Paul, Jill, Gordon, David R. about this.
• Li and group are meeting to finalize the list of "!RedCap essential variables"
• The group doing this found a great web site explaining how to prepare data for National Death Index inquiries; it includes suggested coding for gender and race
• Should lab data be included in the project?
• Report on BERD
  • Frank attended 2nd day; 1st day was for newly added CTSA members
  • Frank presented what is in the main content of our twiki site
  • There was discussion about the lack of visibility of biostatistics in the new CTSA strategic aims document
  • We need to emphasize aspects of biostat that need to be nationally coordinated
    • Gordon is interested in good statistical practice as an organizing principle
    • Also discussed credentialing of statisticians & reproducible research
  • Web computing tools are one area to emphasize as well as CTSpedia
• The #1 priority voted was development of the next generation of biostatisticians
• RedCap data cleaning module unveiled by Rob Taylor

14Jan09

Attending: Harrell, Phillips, Byrne, Wang, Yu, Xu

• Terri will focus on stat analysis consultations, teaching, and coordinating the Friday skills workshop
• Others will help Terri find speakers and will volunteer to present
• Anyone knowing of a session that would be of special interest to biostatisticians should contact Frank to send an e-mail to everyone
• Voucher charge rate ($100/hr 20 hrs total biostatistician time for a $2000 voucher) and training people who use voucher
  • Will need to keep track of time for each project
  • Created template under CTSAactivities
• Covariate project update
• Make sure to include CTSA grant number in publication (RR024975)
• Development of public relations
  • Doing video like Department of medicine
• This Friday's CRC Research Skills Workshop: “Vanderbilt's Synthetic Derivative Project: De-Identified Medical Record Data For Research Utilization”

20Feb09

Attending:Byrne, Wang, Xu, Harrell, Scott, Phillips, Yu, Agboto

• Clinic sponsorship and attendance
  • Will add a sign-in sheet for Thursday clinics
  • CTSA biostatisticians will come on average once/week
• Publications and 2 numbers needed for CTSA progress report. PMID and _ ?
• Last year’s progress report and what we need to update
• Flowchart on StarBRITE of the proper channels for CTSA Biostat requests
• Potential capacity of CTSA biostatistics
• Ways that we can help with the CTSA goals and keep the PI satisfied with biostats
• Updating the task list
• Attendance at SRC meeting: in the future we may want a rotation schedule but it will be good to attend when a protocol you reviewed is discussed

Mar09

Attending: Wang, Phillips, Xu, Byrne, Harrell, Scott, Yu, Agboto

• Problem with inconsistent powers used in sample size calculations; biostat reviewers need to be consistent
  • Advantages to plotting the power curve
  • Showed short article by Andrew Vickers on http://medscape.com
  • Discussed effect sizes and standardized effect sizes (Cohen's)
• Rejections during pre-review for bad statistics/bad science
  • Make sure that pre-disapprovals are known to Chair of SRC
  • Let's talk to the research ethicists
• Dan discussed the need to build the next progress report as we go
  • Each person needs to collect a table of vouchers executed, or find a way for StarBrite to do this
  • Keep a list of major accomplishments under CTSAactivities by calendar year
    • look at CTSA goals, papers published, courses and workshops taught
• Use of VICTR funds for purchasing equipment
• We are getting many requests related to the NIH stimulus
• JSM will have a joint GCRC-CTSA statisticians meeting