Patient-reported outcomes 3 months after spine surgery: is it an accurate predictor of 12-month outcome in real-world registry platforms?

Abstract

<jats:sec> <jats:title>OBJECT</jats:title> <jats:p>The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care.</jats:p></jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months.</jats:p></jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p &lt; 0.0001) and ODI (r = 0.70; p &lt; 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity.</jats:p></jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.</jats:p></jats:sec>

Impact of surgery on pain, disability, and quality of life of patients with degenerative lumbar disease: Brazilian data

“…As the study developed, however, overlapping of different pathologic subtypes in the same patient became so frequent as to justify studying the group as a whole. A tendency to combine data for the different types of DLD for such analyses has also been observed in other recent publications [12][13][14] .…”

“…The MCID for the SF-36 pain component was reached by 73.2% of the patients in the satisfaction group 5, and by 63.7% of the patients in the group 4+5. It should be noted that the use of the SF-36 pain component to evaluate treatment results is not widespread in the literature; most often, the reported scores are based on the visual analogue scale (VAS) 21,22,9,23,8 and numerical rating scale (NRS) 13,24,7,10,12 . However, a few authors have recently been opting for the SF-36 pain component 25 .…”

“…In other studies where preoperative ODI scores were assessed, some reports included higher scores than the ones reported here 24,26,27 , whereas other reports were closer to our results 12,14 . Some authors described the improvement in disability based on the percentage of the patients reaching the MCID for ODI 6,13 , while others took into consideration the average variation of the disability score 12,28,8,27 .The percentage improvement for our Table 3. Comparison between the satisfied and dissatisfied groups using the scores of the Oswestry Disability Index (ODI), and physical component summary (PCS), mental component summary (MCS) and Pain constructs of the SF-36.…”

“…All DLD patients for whom preoperative and postoperative ( from six to 12 months after surgery) data were available were included in our analysis. ODI scores were estimated following the original recommendations 13 . SF-36 scores were grouped in three constructs: physical component summary (PCS), mental component summary (MCS), and pain (PAIN) 16,17 .…”

“…However, the patients often present different clinical conditions at the same time, including disc herniation and stenosis, stenosis in one level and spondylolisthesis in another, and so on. Recently, studies evaluating the results of surgery for DDL analyzing all patients as a single set have been published, an approach that seems realistic 12,13,14 .…”