The cost-benefit analysis of Transforaminal Lumbar Interbody Fusion in the Indian Scenario

Aims & objectives (hypotheses if applicable):

To assess and compare the improvement in Oswestry Disability Index (ODI) scores per 50,000 rupees spent, between insured and uninsured patients undergoing lumbar decompression and fusion spine surgeries.

Hypotheses- There is no difference in improvement in ODI scores for every 50,000 rupees spent between insured and uninsured patients.

Justification for study (whether of national significance with rationale):

Currently, outcomes following spine surgery are measured using post-operative patient reported outcome measures, namely ODI and Numerical Rating Scale (NRS) Score. This study aims to compare the cost-effectiveness of care by evaluating the percentage improvement in ODI scores per 50,000 spent by insured and uninsured patients. By analysing outcomes in relation to expenditure, we aim to assess the value of care delivered and identify any difference in improvement of ODI between the insured and uninsured populations.

INCLUSION CRITERIA:

1. Adult patients aged between 18 and 65 years of either sex.

2. ASA I and ASA II undergoing general anaesthesia for elective posterior lumbar interbody fusion spine surgeries.

EXCLUSION CRITERIA:

1. Patient refusal.

2. Body mass index more than 35

3. Patients with severe cardiac, coronary, renal, hepatic, cerebral diseases and peripheral vascular diseases.

4. Patients coming for emergency / revision surgeries.

5. Pregnancy.

Neuromuscular disorder.

7. Neurological or any other postoperative complications

 Detailed description of procedure / processes:

Following institutional ethics committee clearance, this prospective observational study will be conducted after obtaining CTRI number, over the course of 1 year.

After written informed consent is obtained, all cases will be preoperatively evaluated for presence or absence of insurance. Information regarding patients’ histories, physical examination, and preoperative imaging will be obtained. Baseline patient demographic variables, investigations, in addition to number of lumbar vertebral levels to be fused will be noted. The preoperative Quality of recovery 15-item questionnaire (QoR-15) scores, ODI score and NRS score will be recorded at admission.

The primary drivers of cost are supply cost and personnel cost.

To determine personnel cost, we will identify the exact personnel types who will be involved in each surgical episode. These include- surgeon , anaesthesiologist , nursing staff and technicians. After determining the annual salary associated with each of these personnel types, we will calculate the per-minute wage for each personnel type. This per-minute wage was then multiplied by the total minutes spent by each of the personnel types in the OR. This will comprise the total personnel cost.

To calculate supply cost, we will identify the following: implant-related surgical supplies, such as screws, plates, biologic tissue, and grafts; consumables, such as sterile towels, gauze, and bipolar forceps; intraoperatively utilized medications, including all anaesthesia related costs for items and agents used; surgical tray sterilization, as determined by number of trays opened and their associated sterilization cost. We will also calculate the indirect costs, including turnover cost (defined as cost associated with replacement of personnel from 1 case to the next) and overhead cost (the cost associated with use of the operating room, itself).

Post surgery, Quality of recovery 15-item questionnaire (QoR-15) scores, ODI score , Satisfaction score and NRS score will be recorded at discharge and at 6 months postoperatively during the follow up.

  Outcome measures:

Primary outcomes to be measured:

Comparing the OVI/ ODI score improvement per 50,000 rupees between the two groups at 6 months postoperatively.

Secondary outcomes measured:

Comparing difference in QoR-15 score, NRS scores and Satisfaction scores at discharge and at 6 months after surgery, between the two groups. It will be done via telephonic follow-up.