The assessment of complications after spine surgery: time for a paradigm shift?

BACKGROUND CONTEXT: Recent years have witnessed a shift in the assessment of spine surgical outcomes with a greater focus on the patient's perspective. However, this approach has not been widely extended to the assessment of complications. PURPOSE: The present study sought to quantify the patient-rated impact/severity of complications of spine surgery and directly compare the incidences of surgeon-rated and patient-reported complications. STUDY DESIGN: Prospective study of patients undergoing surgery for painful degenerative lumbar disorders, being operated in the Spine Center of an orthopedic hospital. PATIENT SAMPLE: A total of 2,303 patients (mean [standard deviation] age, 61.9 [15.1] years; 1,136 [49.3%] women and 1,167 [50.7%] men). PATIENTS: Core Outcome Measures Index, self-rated complications, bothersomeness of complications, global treatment outcome, and satisfaction. Surgeons: Spine Tango surgery and follow-up documentation forms registering surgical details and complications. METHODS: PATIENTS completed questionnaires before and 3 months after surgery. Surgeons documented complications before discharge and at the first postoperative follow-up, 6 to 12 weeks after surgery. RESULTS: In total, 615 out of 2,303 (27%) patients reported complications, with "bothersomeness" ratings of 1%, not at all; 22%, slightly; 26%, moderately; 34%, very; and 17%, extremely bothersome. PATIENTS most commonly reported sensory disturbances (35% of those reporting a complication) or ongoing/new pain (27%) followed by wound healing problems (11%) and motor disturbances (8%). The surgeons documented complications in 19% of patients. There was a minimal overlap regarding the presence or absence of complications in any given patient. CONCLUSIONS: Most complications reported by the patient are perceived to be at least moderately bothersome and are, hence, not inconsequential. Surgeons reported lower complication rates than the patients did, and there was only moderate agreement between the ratings of the two. As with treatment outcome, complications and their severity should be assessed from both the patient's and the surgeon's perspectives.

Ratings of global outcome at the first post-operative assessment after spinal surgery: how often do the surgeon and patient agree?

Patient-orientated questionnaires are becoming increasingly popular in the assessment of outcome and are considered to provide a less biased assessment of the surgical result than traditional surgeon-based ratings. The present study sought to quantify the level of agreement between patients' and doctors' global outcome ratings after spine surgery. 1,113 German-speaking patients (59.0 +/- 16.6 years; 643 F, 470 M) who had undergone spine surgery rated the global outcome of the operation 3 months later, using a 5-point scale: operation helped a lot, helped, helped only little, didn't help, made things worse. They also rated pain, function, quality-of-life and disability, using the Core Outcome Measures Index (COMI), and their satisfaction with treatment (5-point scale). The surgeon completed a SSE Spine Tango Follow-up form, blind to the patient's evaluation, rating the outcome with the McNab criteria as excellent, good, fair, and poor. The data were compared, in terms of (1) the correlation between surgeons' and patients' ratings and (2) the proportions of identical ratings, where the doctor's "excellent" was considered equivalent to the patient's "operation helped a lot", "good" to "operation helped", "fair" to "operation helped only little" and "poor" to "operation didn't help/made things worse". There was a significant correlation (Spearman Rho = 0.57, p < 0.0001) between the surgeons' and patients' ratings. Their ratings were identical in 51.2% of the cases; the surgeon gave better ratings than the patient ("overrated") in 25.6% cases and worse ratings ("underrated") in 23.2% cases. There were significant differences between the six surgeons in the degree to which their ratings matched those of the patients, with senior surgeons "overrating" significantly more often than junior surgeons (p < 0.001). "Overrating" was significantly more prevalent for patients with a poor self-rated outcome (measured as global outcome, COMI score, or satisfaction with treatment; each p < 0.001). In a multivariate model controlling for age and gender, "low satisfaction with treatment" and "being a senior surgeon" were the most significant unique predictors of surgeon "overrating" (p < 0.0001; adjusted R (2) = 0.21). Factors with no unique significant influence included comorbidity (ASA score), first time versus repeat surgery, one-level versus multilevel surgery. In conclusion, approximately half of the patient's perceptions of outcome after spine surgery were identical to those of the surgeon. Generally, where discrepancies arose, there was a tendency for the surgeon to be slightly more optimistic than the patient, and more so in relation to patients who themselves declared a poor outcome. This highlights the potential bias in outcome studies that rely solely on surgeon ratings of outcome and indicates the importance of collecting data from both the patient and the surgeon, in order to provide a balanced view of the outcome of spine surgery.

Outcome assessment in low back pain: how low can you go?

The present study examined the psychometric characteristics of a "core-set" of six individual questions (on pain, function, symptom-specific well-being, work disability, social disability and satisfaction) for use in low back pain (LBP) outcome assessment. A questionnaire booklet was administered to 277 German-speaking LBP patients with a range of common diagnoses, before and 6 months after surgical (N=187) or conservative (N=90) treatment. The core-set items were embedded in the booklet alongside validated 'reference' questionnaires: Likert scales for back/leg pain; Roland and Morris disability scale; WHO Quality of Life scale; Psychological General Well-Being Index. A further 45 patients with chronic LBP completed the booklet twice in 1-2 weeks. The minimal reliability (similar to Cronbach's alpha) for each core item was 0.42-0.78, increasing to 0.84 for a composite index score comprising all items plus an additional question on general well-being ('quality of life'). Floor or ceiling effects of 20-50% were observed for some items before surgery (function, symptom-specific well-being) and some items after it (disability, function). The intraclass correlation coefficient (ICC) ("test-retest reliability") was moderate to excellent (ICC, 0.67-0.95) for the individual core items and excellent (ICC, 0.91) for the composite index score. With the exception of "symptom-specific well-being", the correlations between each core item and its corresponding reference questionnaire ("validity") were between 0.61 and 0.79. Both the composite index and the individual items differentiated (P<0.001) between the severity of the back problem in surgical and conservative patients (validity). The composite index score had an effect size (sensitivity to change) of 0.95, which was larger than most of the reference questionnaires (0.47-1.01); for individual core items, the effect sizes were 0.52-0.87. The core items provide a simple, practical, reliable, valid and sensitive assessment of outcome in LBP patients. We recommend the widespread and consistent use of the core-set items and their composite score index to promote standardisation of outcome measurements in clinical trials, multicentre studies, routine quality management and surgical registry systems.