Institutional Review Board, Hospital for Special Surgery
December 13, 2012
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
The term ‘low back pain’ evokes a vivid and dreaded clinical picture of pain, physical disability, loss of valued activities, psychological distress, and decreased quality of life. A large proportion of patients seek surgical treatment after unsuccessfully trying multiple other modalities and a sizable proportion of these patients undergo repeat surgery. Because of their complex course, patients who undergo surgery have perhaps the most pressing expectations, which may or may not be reasonable given the severity and refractoriness of their condition. Although expectations are among the most salient patient-centered variables for spine surgery patients, ironically they are among the least studied variables.
Using new validated methods derived from our studies of patients’ experiences with spine surgery, it is now possible to systematically and rigorously measure patients’ expectations of spine surgery and to gauge the effectiveness of interventions to affect expectations. Therefore, among 320 patients scheduled for lumbar spine surgery, the primary aim of this clustered RCT is to compare the effectiveness of an existing educational class addressing immediate perioperative care (standard-class) to the standard-class class plus an additional educational module addressing long-term expectations of surgery (enhanced-class). Before and after their assigned class, patients will complete a valid and reliable patient-derived Lumbar Spine Surgery Expectations Survey measuring expectations for symptoms, function, and psychological well-being. The primary aim is to measure the within-patient change in pre- to- post-class survey scores, for which a clinically relevant difference has been defined. Surgeons also will complete the survey for each patient, and a secondary aim is to assess the effectiveness of the intervention in achieving concordance in expectations within the patient-surgeon pair. Finally, two years after surgery patients will complete a follow-up version of the survey and a secondary aim is to measure fulfillment of expectations and ascertain whether fulfillment is associated with greater concordance between patients and surgeons. For all objectives the outcomes will be the comparison between the standard-class and the enhanced-class groups using quantitative analytical methods including generalized estimating equations accounting for clustering and clinical characteristics and concordance correlation coefficients.
This project focuses on patients’ expectations of a common and costly medical intervention for which there is great controversy about treatment effectiveness and health care dollar value. Our considerable multidisciplinary expertise in studying orthopedic expectations coupled with our large and diverse patient population will ensure that our study generates novel and relevant results that will influence the definition of outcome of lumbar spine surgery.
Patients will be eligible if they:
· are scheduled for elective lumbar spine surgery;
· speak English;
· are well enough to complete surveys during an interview; and
· have access to a telephone for follow-up.
Patients will be excluded if they:
· have cognitive deficits; and cannot provide informed consent
Carol A. Mancuso, MD