Does patient satisfaction reflect quantitative pain and function measurements in cervical spine surgery?

Background: Context: Patient satisfaction with surgical treatment is a common qualitative metric used in FDA IDE clinical trials to assess treatment effectiveness. Often administered as a self‐assessed questionnaire, a measurement of patient satisfaction gives an important evaluation of treatments success from a patient's perspective. The extent to which patient satisfaction reflects more quantitative clinical outcome measures of pain and function has not been well characterized. Purpose: Here we examine data from an FDA IDE clinical trial of cervical total disc replacement (TDR) versus anterior cervical discectomy and fusion (ACDF) to determine whether patient satisfaction is related to subsequent surgeries, pain scores, function, and quality of life assessments at 5 years follow‐up. Study Design/Setting: An FDA IDE, randomized, prospective clinical trial was conducted across 24 sites in the U.S. Patient Sample: A total of 186 ACDF and 389 TDR patients treated at one or two contiguous levels were pooled. Outcome Measures: Patients were assessed for satisfaction, NDI, VAS neck pain, SF‐12PCS/MCS scores, and subsequent surgery rate through 60 months. Methods: A satisfaction questionnaire prompted patients to answer if they were "very satisfied," "somewhat satisfied," "somewhat dissatisfied," or "very dissatisfied" with their treatment. ANOVA with Tukey's test for multiple comparisons and Chi‐square test were used to determine significant differences between clinical outcomes of patients in the four satisfaction categories. Results: Data was available for 512 patients at 60 months with 437 patients as "very satisfied," 50 patients as "somewhat satisfied," 16 patients as "somewhat dissatisfied," and 9 patients as "very dissatisfied." Patient satisfaction was significantly associated with patient outcomes for NDI, VAS neck pain, and SF‐12 MCS/PCS scores. Mean NDI was 15.12 ± 15.98 for the very satisfied, 36.62 ± 17.53 for somewhat satisfied, 38.25 ± 18.94 for somewhat dissatisfied, and 57.56 ± 21.42 for very dissatisfied patients. Mean VAS neck pain score was 15.19 ± 22.70 for very satisfied, 47.14 ± 29.64 for somewhat satisfied, 59.06 ± 30.45 for somewhat dissatisfied, and 64.67 ± 29.57 for very dissatisfied patients. The mean SF‐12 MCS score was 52.17 ± 9.59, 45.74 ± 12.63, 46.62 ± 14.21 and 38.64 ± 12.12 for the very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied patients, respectively. Similarly, the mean SF‐12 PCS score was 48.16 ± 10.59, 37.46 ± 9.19, 34.29 ± 5.45 and 29.72 ± 8.48 for the very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied patients, respectively. The secondary surgery rate was significantly different across groups with 5.03%, 6.00%, 31.25% and 22.22% of very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied patients requiring surgeries, respectively (p < 0.0001). Patients that were very satisfied at 60 months demonstrated a significantly higher SF‐12 MCS score at baseline than patients that were not classified as very satisfied (42.77 ± 11.77 vs. 39.74 ± 11.95, p = 0.0424). No significance was found in baseline NDI, VAS or SF‐12 PCS scores between satisfaction groups. Conclusion: The significance differences in NDI, VAS and SF‐12 scores between satisfaction groups suggest that a qualitative measurement of patient satisfaction accurately reflects quantitative measurements of patient pain, function and quality of life. Additionally, results indicate that a significant relationship may exist between postoperative patient satisfaction and preoperative patient mental health.