Second Opinion in Spinal Surgery Indications: Cost-Effectiveness Evaluation

The present study could provide benefits to all aspects of treatment approaches involved in patients with low back pain: for the entire medical community by presenting better information about the actual surgical indications for patients with low back pain; for health insurers and in general, who can spend their investments in really effective areas, and especially for patients, who will receive appropriate treatments for their conditions.

190 patients with indication of surgical treatment will be enrolled for this clinical trial and will be advised to receive a second opinion at Hospital Israelite Albert Einstein (HIAE).

Both assessments (with orthopedic physicians) will be compared, and when consensus is reached about diagnostic hypotheses and treatment, patients will be referred for conservative or surgical treatment. Any disagreements will be resolved by a committee of spine surgeons (four orthopedists and four neurosurgeons with more than 15 years of experience).

When the treatment chosen for the first medical care (two consultations of the orthopedic surgeons) is the conservative treatment, patients will be referred to consultations in the rehabilitation center. When surgical treatment is indicated, the patient will be referred to one of the eight surgeons of the spinal committee.

All patients will have the freedom of choice to decide to participate in the study guided by the second opinion service or perform the recommended treatment in the first hospital in which they were treated.

Sample size: For the calculation of the sample size estimate, we considered data presented in the study by van der Roer et al. (2006), in which the mean score obtained by the EuroQol instrument in pre-treatment patients was 0.70 in chronic patients, with standard deviation of 0.19. Assuming that the correlation between the measurements obtained at the two main moments of comparison (baseline and after 10 weeks of treatment) is of the order of 0.5 and that the minimally relevant difference between the two moments is 0.07, we estimate that 90 patients should be considered in the conservative treatment group. Assuming that of the patients who use the second opinion service about 55% will perform surgical procedures in the service, we estimate that 100 patients should be included in this group. Sample size estimates were performed with the statistical package STATA version 10.0, considering 90% power and 5% level of significance.

Inclusion criteria

• Patients with surgery indication (referred by the health care provider) for the treatment of degenerative diseases of the lumbar spine (basically: intervertebral disc disease, degenerative spondylolisthesis, lumbar canal stenosis, facet low back pain and lumbar instability);
• no contraindication to general anesthesia or any physiotherapeutic procedure;
• able to understand Portuguese language and after acceptance of a written consent.

Exclusion criteria

• Patients with:

• spinal fractures;
• scoliosis greater than 20 degrees;
• congenital deformities;
• spinal tumors;
• confirmed or suspected pregnancy;
• history of previous surgery in the spine; and,
• unable to participate in the follow-up (due to inability to read or complete the required forms).