Nuts and Bolts Symposium

September 11, 2009

Proposal Writing Workshop

Scientific Review Committee Panel

Goal: Promote credible research and develop research proposal writing skills for new investigators

Method: Discuss actual submissions to the SRC to illustrate best practices

Consider two versions of the proposal

Dr. Ben Dart Describe purpose of the study

Dr. Eric Gratias Find an identifiable hypothesis

Dr. Beth Choby Apply appropriate methods and design

Dr. Greg Heath Apply appropriate statistical techniques

Dr. Francis Fesmire Is it possible to reach an appropriate conclusion supported by results

A biomechanical evaluation of custom foot orthoses effects on extrinsic pressures around a hallux valgusdeformity

Thanks to the authors for allowing us to use this example

Initially submitted 3/2/09

Subsequent versions

Final version 8/17/09

Describe purpose of study

3/2/09 8/17/09

To determine whether a foot orthosis increases pressure over a bunion and therefore, may serve as conduit to increase pain

To determine whether a foot orthosis effects extrinsic contract pressures surrounding a hallux valgusdeformity

Find an identifiable hypothesis

3/2/09 8/17/09

Custom foot orthoses will increase footwear extrinsic pressures on bunion deformities

Custom foot orthoses will increase footwear pressures on bunion deformities

Appropriate method and design

3/2/09 8/17/09Pt will be fitted with a standard custom foot orthosis3 pressure transducers measure dorsal, medial & plantar pressuresWalk 10 meters then stand for measurementsControl, PSFL, PSSL, PSQLANOVA and Fisher’s PLSD method of comparison with 95% confidence interval

X-rayPt instructionsImpression protocolModification protocolFabrication protocolFirst pt fittingSensor attachmentTesting protocolTrimming protocolStatistical protocol

Applying statistical techniques

3/2/09 8/17/09

Pts meeting inclusion criteria will be identified & recruited. We will include 25 pts.

Results will be compared with one-way ANOVA and Fisher’s PLSD method of comparison using a confidence interval of 95%

A power analysis of 3 prelim test subjects shows we can expect avg SD of 4.938 psi coupled with means for each group of 4 orthotic status and 2 different shoes an effects size of 0.4696 was calculated. For two-way ANOVA with repeated measures given a 95% confidence interval and a power of 80% a sample size of 32 pts will be needed.

Is it possible to reach an appropriate conclusion supported by results

3/2/09 8/17/09

If extrinsic pressures are not increased, an orthosis may still be considered an acceptable alternative for conservative treatment of bunions

If extrinsic contact pressures are decreased, an orthosis may still be considered an acceptable application for conservative treatment of bunions. If pressure is increased by the orthosis, further clinical trials into the actual effectiveness of orthosis for conservative bunion treatment are needed.

Resources are availableResearch Resource List (http://www.utcomchatt.org/docs/Research20Resource20List.pdf)

SRC and IRB Deadlines (http://www.utcomchatt.org/subpage.php?pageId=499)

Proposal development consultation (Consultation Request Form to Greg Heath, DHSc, Gregory-Heath@utc.edu)

Questions? Comments?