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How OR Can Help

Protocol Review

Protocol design is the most difficult aspect of clinical research, and inadequate design is the major reason studies fail. Often these failures could have been prevented by simple protocol modifications. Outcomes Research thus provides complementary review of investigator-initiated clinical research protocols. In consultation with the investigator, members of the Department of Outcomes Research will identify potential strengths weakness of proposed studies. We will then suggest protocol modifications that can strengthen the study. In almost all cases, we can suggest modifications that are inexpensive and easy to implement, but nonetheless substantially improve proposed projects.

Services Provided

A major goal of the Outcomes Research Department is to facilitate research throughout the Division of Anesthesia, Critical Care, and Comprehensive Pain Management. As time permits, we will also support investigators in other divisions and institutes. Although can help with investigator-initiated and sponsored projects. Assistance will be provided by experienced faculty, with the goal of turning rough ideas into workable studies.

At the initial meeting, we will evaluate proposed projects and make an evaluation of how to proceed. Possibilities include recommending that the project be abandoned, help transforming the proposed study into one with a stronger design, or a recommendation to continue with the original plan. Nearly always, we recommend continuing the project, but make suggestions that strengthen the design.

We are pleased to offer the following services:

Protocol design review

Investigators are free to select the services they wish, ranging from assistance with every aspect of a study to help with statistical analysis of a completed project.

Collaborative Agreement

Outcomes Research we will not accept every proposal. Instead, we will "adopt" projects: 1) to which we are likely to make a significant contribution; and, 2) that show sufficient promise of producing important scientific results.

Many projects presented to the Department will not be funded. We will thus work with investigators to develop formal protocols that can be submitted as grant applications. However, lack of funding will not preclude assistance from members of the Department.

Initiating Contact

If you are interested in the services provided by the Department of Outcomes Research, please contact either Dan Sessler or Andrea Kurz:

Daniel I. Sessler, M.D.
Professor and Chair
Department of Outcomes Research
The Cleveland Clinic
9500 Euclid Ave — P77
Cleveland, OH 44195
Tel: 216-444-4900
Fax: 216-444-6135
email: DS@OR.org

Andrea M. Kurz, M.D.
Vice-chair
Department of Outcomes Research
The Cleveland Clinic
9500 Euclid Ave — P77
Cleveland, OH 44195
Tel: 216-445-9924
email: AK@OR.org