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Having an Impact in a Multi- Disciplinary Setting Janice Derr, Ph.D. I am speaking as a private citizen and not as an official FDA representative. The.

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Presentation on theme: "Having an Impact in a Multi- Disciplinary Setting Janice Derr, Ph.D. I am speaking as a private citizen and not as an official FDA representative. The."— Presentation transcript:

1 Having an Impact in a Multi- Disciplinary Setting Janice Derr, Ph.D. I am speaking as a private citizen and not as an official FDA representative. The statements I am about to make reflect my personal opinions and are not necessarily supported or endorsed by FDA.

2 Having an Impact uFor Statisticians, Methodologists, Epidemiologists, … uWhat Does “Having an Impact” Mean? uTypical Challenges uPractical Approaches

3 Having an Impact Tale #1  An investigator came to my office asking for sample size requirements  I could never get a clear picture of the overall situation  She put my questions aside, all she wanted was “the number”  After I finally coughed up a number for her she never got back to me  I admit I did not try very hard to follow up with her either  My impression is that the number was too large

4 Having an Impact Tale #2  I was working as a biostatistician for a large grant  The primary analyses specified in our grant were not significant  In the exploratory analyses, the intervention effects were significant  The investigator asked me to help draft a manuscript based only on the exploratory results  I explained the difference between exploratory analyses and confirmatory analyses  After a long series of discussions, I finally persuaded her and we agreed to report both the primary analysis results and the exploratory analysis results.

5 What Does “Having an Impact” Mean? uPromoting good statistical practices uPromoting statistical thinking uContributing to the goals of the organization uContributing to the development of research methodology uOther ideas?

6 Tale #1: Lack of Involvement Limits Impact The statistician: uEncountered resistance to her questions (why?) uProvided an answer that probably didn’t satisfy anybody

7 Tale #2: Involved Statistician Has an Impact The statistician: uSupported the overall research objectives uExplained his concerns and consequences in the context of the study conclusions uSuggested an alternative approach uMaintained a collaborative relationship with the team

8 What does it take for a statistician to have an impact in a multi-disiplinary setting? uStatistical Expertise uNon-Statistical Skills uVision of Broad Role Impact Involvement

9 Challenges to Having an Impact They didn’t appreciate all of my hard work on their problem. They didn’t understand how my work addresses their questions. Clients from this field seem to think they can just ignore the statistical evidence and make arbitrary decisions. Her solutions don’t look very realistic.. We don’t understand the report or the relevance of her input. Statisticians don’t give us answers that we can use. We’ll just make a decision based on what we’ve always done in the past. StatisticianClient

10 Challenges to Having an Impact 1.Role of the statistician 2.Communication skills 3.Strategic issues

11 Challenge #1: Role of the Statistician uNarrow uBroad “Helping clients think through their scientific goals, working out details of study design and implementation, and figuring out how to display and interpret results are major tasks. In fact, refining a good idea for a research study into concrete specific aims and study design is one of the most challenging parts of doing research, and something with which an experienced statistician can be a great help.” Kevin Cain, The Statistical Consultant, Fall, 2006

12 Practical Approaches uGraduate student education in statistics/methodology needs to include full involvement in actual projects uPracticing statisticians: Evaluate the level of your involvement in projects

13 Challenge #2: Communication Skills Asking Good Questions Talking About Statistics

14 Practical Approach: Improve Your Skills 1. “So, what is your target population?” 3. “Well, you mentioned this forty thousand. Now is that undergraduate students on their own or is it graduates and undergraduates?” 5. “OK, so are you able to get a random probability sample of this target population?” 2. “Uh, you mean the people we want to find out about?” 4. “Well, it’s graduates and undergraduates...” 6.“A what?”

15 Use Closed Probes for Specific Information uHow many nursing homes are in the database? uCan you conduct interviews in person instead of over the phone? uDid each surgeon evaluate the records of all 202 patients for risk of complications? uCan you obtain a matching set of records for patients who did not use antidepressants?

16 Use Open Probes for General Information uWhy do you need a seven-year reference period for recalling product purchases? uHow does a surgeon express the risk of complications in the abdominal aneurism surgery? uHow would clinicians view each of the outcomes related to incontinence in the nursing home patients? uWhat other factors might influence a patient’s insulin dosage over the 14-year reference period?

17 Use Concrete Paraphrase To Confirm Your Understanding My understanding is that … uas a diabetic patient ages he tends to use a larger dose of insulin. uwe could develop a plan to conduct an in-person interview with fewer subjects but with a greater response rate. uclinicians view the use of a catheter as a separate outcome not related to incontinence. uthe computer program was developed independently of the surgeons who evaluated the patients’ records.

18 G G E E N N E E R R A A L L S S P P E E C C I I F F I I C C REQUEST FOR INFORMATION OPEN QUESTION CONCRETE PARAPHRASE CLOSED PROBE CONCRETE PARAPHRASE S S P P E E C C I I F F I I C C G G E E N N E E R R A A L L CLOSED PROBE CONCRETE PARAPHRASE REQUEST FOR INFORMATION CONCRETE PARAPHRASE OPEN QUESTION Asking Good Questions

19 Talking About Statistics Video examples of good and poor communication skills

20 Talking About Statistics uBe prepared to communicate statistical information in a variety of different ways uBe attuned to your client to pick up clues about his/her learning preferences (visual, auditory, kinesthetic) uAdapt your discussion accordingly, on the spot!

21 Challenge #3: Strategic Issues uClients not aware of benefits of collaboration uLack of previous collaborative experiences uClient discipline does not have a tradition of involving statisticians uInstitutional barriers uLimited resources uPosition of statistician in the organization

22 Practical Approaches uProvide talks, short courses to clients uInvite clients and statisticians to discuss common methodological concerns uIdentify clients who can serve as role models to their colleagues for collaboration and innovation uDiscuss with clients how to minimize institutional barriers

23 Having an Impact in a Multi-Disciplinary Setting “In my opinion, statisticians can help facilitate effective collaborative relationships with clinical researchers by being proactive in being included in research teams from the inceptions of projects. In all situations, asking the questions needed to gain a clear understanding of the research and related clinical issues should be considered a prerequisite to providing assistance. … Collaborative relationships could be further enhanced by training statisticians in consultative approaches and methods along with real-world practice providing consultation in a variety of settings. ” Janet Powell, The Statistical Consultant, Fall, 2006


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