Pragmatic Clinical Trials

Evidence-based medicine relies on rigorous scientific studies to compare the effectiveness of treatments or procedures. The best clinical trials to inform medical decision making are large-scale, population-based studies, such as the 10-year, 11-state SPORT study that compared the effects of surgery vs. non-operative care for the three most common back conditions that lead people to seek surgery. The SPORT results have provided physicians and patients with new, objective information they can use to make their treatment decisions. TDI’s Pragmatic Clinical Trials Unit is dedicated to designing and facilitating similar trials that enhance patients’ ability to make a truly informed choice about their medical care.

The mission of TDI’s Pragmatic Clinical Trials unit is to develop, perform, and/or coordinate clinical trials that:

1) evaluate products or processes designed to aid patients’ informed choice;

2) assess patients’ preferences, values, and/or expectations and the role of these factors in treatment outcome;

3) seek to define or refine the key evidence base needed by patients making preference sensitive decisions; or

4) that deal with the national agenda of comparative effectiveness and how this information is transmitted to patients and their physicians.

SPORT Lumbar Intervertebral Disk Herniation and Back Pain
SPINE, 2008;33: 428-35 Cost-Effectiveness of Spinal Surgery: The Jury's Out
Annals of Internal Medicine, December 16, 2008;149, No. 12: 901-904 Design of the Spine Patient Outcomes Research Trial
SPINE, 2002;27, No. 12: 1361-72 Surgical Treatment of Spinal Stenosis with and without Degenerative Spondylotheisis: Cost-Effectiveness after 2 years
Annals of Internal Medicine, December 16, 2008;149: 845-54 Surgical versus Nonsurgical Therapy for Lumbar Spinal Stenosis
The New England Journal of Medicine, February 21, 2008;358, No. 8: 794-801 The Tortoise and the Hare: Is There a Place in Spine Surgery for Randomized Trials
SPINE, 1999;24, No. 23: 2548-9 United States' Trends and Regional Variations in Lumbar Spine Surgery: 1992-2003
SPINE, 2006;31, No. 23: 2707-14

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