Effect of diabetes on patient-reported outcome measures at one year after laminoplasty for cervical spondylotic myelopathy

ethics

A prospective spine surgery registry was started at eight institutions in the greater Tokyo metropolitan area, after obtaining approval from the Clinical Research Support Center of the University of Tokyo Hospital (10,335-(3)) and the institutional review boards of all participating hospitals ie, The University of Tokyo Hospital, Japanese Red Cross Medical Center, Yokohama Rosai Hospital, Kanto Rosai Hospital, Japan Community Health-care Organization Tokyo Shinjuku Medical Center, Toranomon Hospital, Japanese Red Cross Saitama Hospital, and Japanese Red Cross Musashino Hospital. The present study was carried out in accordance with the relevant guidelines and regulations/ethical principles of the Declaration of Helsinki. The authors have obtained informed consent form with opt-out method from patients.

patients

The authors evaluated a consecutive cohort of patients who were diagnosed with CSM and underwent posterior cervical decompression at 11 different institutions between April 2017 and October 2019. Diagnosis was made by board-certified spine surgeons based on neurological examinations as well as MRI or myelography evaluations ( existence of the effacement of subarachnoid space with spinal cord compression). The study’s inclusion criteria were as follows: symptomatic CSM (at least one clinical sign of myelopathy), surgical level between C3 and C7, evidence of cervical spinal cord compression on magnetic resonance imaging or cervical myelogram-computed tomography, and no previous cervical spine surgery . The study’s exclusion criteria were as follows: diagnosis of posterior longitudinal ligament ossification, spinal tumors, trauma, or infectious diseases; aged younger than 18 years; emergency surgery; surgery involving the thoracic spine; and fixation surgery.

Patient data collection

Data on the clinical characteristics of the patients, including age, sex, body mass index, current smoking history, American Society of Anesthesiologists (ASA) classification, and medical history, were retrospectively collected. Preoperative laboratory data were assessed. Patients with a fasting blood glucose level of 126 mg/dL and glycated hemoglobin (HbA1c) levels of 6.5% or those previously diagnosed with diabetes by a diabetes specialist were considered to have diabetes15. Diabetes specialists at each hospital were able to sufficiently control the blood sugar levels of patients diagnosed with diabetes throughout the immediate perioperative period. Blood glucose levels were checked four times a day, and a sliding scale insulin coverage was adopted to avoid perioperative hyperglycemia until the patient’s food intake stabilized. Surgical factors, including operative time and estimated blood loss, were registered. Surgeons in charge were asked to report all intraoperative complications, including nerve root damage and dural tear, and postoperative complications within 30 days after surgery.

Patient-reported outcome measures

At baseline and one year after surgery, all patients were asked to answer a booklet of questionnaires, including the Japanese version of the (1) Numerical Rating Scale (NRS), (2) the Short Form-12 Physical Component Summary (PCS), (3) Mental Component Summary (MCS), (4) Euro quality of life 5-dimension (EQ-5D)-3L to assess health-related quality of life16(5) Neck Disability Index (NDI) to assess pain-associated disability, and (6) Core Outcome Measures Index (COMI)-Neck17. The NRS measures the intensity of pain over the preceding 4 weeks; the scores range from 0 (no pain at all) to 10 (worst pain imaginable). To evaluate the diabetic effect on axial pain and residual radiculopathy, the authors analyzed the following five NRS domains; neck, arm, hand, leg, and foot pain. Each corresponding body part had been discussed in previous reports18. To determine treatment satisfaction, a 7-point Likert scale was used, wherein the patients were asked to answer whether they were satisfied with the treatment, with possible answers of “very satisfied,” “satisfied,” “somewhat satisfied,” “neither ,” “dissatisfied,” “somewhat dissatisfied,” and “very dissatisfied”17.

Statistical analysis

Baseline demographic and clinical characteristics in the diabetic and nondiabetic groups were compared using the Chi-square test for categorical variables and student’s t– test for continuous variables. The Student’s t-test was used to examine intergroup differences with respect to pre- and postoperative NRS, PCS, MCS, EQ-5D, NDI, and COMI-Neck scores. For further evaluation of the difference in each outcome score, the authors calculated the adjusted p values ​​by inverse probability weighting method after calculating propensity scores based on seven variables (age, sex, BMI, smoking status, ASA class, operative time, and estimated blood loss) as per a previous report12:19. The correlations between diabetes-related factors (preoperative HbA1c level and fasting blood sugar) and postoperative outcomes was measured using Spearman’s rank correlation coefficients. We defined the correlation as the value of ρ > 0.40 with p value < 0.05. All data analyzes were performed using SPSS version 21.0 statistical software (SPSS, Inc., Chicago, IL, USA).

The sample size for this study was calculated using G*Power version 3.1. With an approximately 20–25% prevalence of diabetes as reported in a previous prospectively collected database10,13,20a total sample size of at least 200 patients was required with a power of > 0.8, significance level of P< 0.05, and effect size of < 0.2.

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