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.
6.
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.
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