The rationale for a spine registry

Röder, Christoph; Müller, Urs; Aebi, Max

doi:10.1007/s00586-005-1050-z

Cited by 38 publications

(25 citation statements)

References 30 publications

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“…2,4,24 With the proper design and implementation rigor, registries provide the potential to create reliable and expeditious access to outcomes data such as patient satisfaction, pain, disability, quality of life, and cost-effectiveness. 27 National and international spine registries have been created to assess both outcome and economic impacts of health care delivery.…”

Section: Discussionmentioning

confidence: 99%

“…1,18,25,27 While not an alternative to a randomized controlled trial, prospectively organized registries are more feasible and closer to daily clinical situations. 24 Furthermore, prospective registries measure quality and effectiveness on real-world patient populations in realworld health care delivery settings that are not limited, constrained, and ultimately biased by the inherent artificial research setting and structure criteria of a clinical trial. It is for these reasons that registries may represent the "next disruptive technology" in clinical research.…”

Section: Discussionmentioning

confidence: 99%

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

Parker¹,

Asher

Godil³

et al. 2015

FOC

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OBJECT 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. METHODS 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. RESULTS 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 < 0.0001) and ODI (r = 0.70; p < 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. CONCLUSIONS 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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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

Parker¹,

Asher

Godil³

et al. 2015

FOC

View full text Add to dashboard Cite

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“…Observational studies are well-suited for investigating potential connections between clinical care and patient outcome, as the statistical models can adjust for confounders such as coexisting conditions. 10,11 This not only increases the relevance of such studies, but also provides a more accurate representation of the actual clinical setting. Observational studies are more relevant for determining the efficacy of the real world treatment protocols as opposed to the effectiveness of a single intervention in an idealized clinical setting(s).…”

Section: Development Of Rhscir and Its Impact On Sci Research And Carementioning

confidence: 96%

The Rick Hansen Spinal Cord Injury Registry (RHSCIR): a national patient-registry

et al. 2011

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Study design: Development of a prospective patient registry. Objective: To develop a patient registry for persons with traumatic spinal cord injuries (SCI), which can be used to answer research questions and improve patient outcomes. Setting: Nine provinces in Canada. Methods: The Rick Hansen Spinal Cord Injury Registry (RHSCIR) is part of the Translational Research Program of the Rick Hansen Institute. The launch of RHSCIR in 2004 heralded the initiation of the first nation-wide SCI patient registry within Canada. Currently, RHSCIR is being implemented in 14 cities located in 9 provinces, and there are over 1500 individuals who have sustained an acute traumatic SCI registered to date. Data are captured from the pre-hospital, acute and rehabilitation phases of care, and participants are followed in the community at 1, 2, 5 and then every 5 years post-injury. Results: During the development of RHSCIR, there were many challenges that were overcome in selecting data elements, establishing the governance structure, and creating a patient privacy and confidentiality framework across multiple provincial jurisdictions. The benefits of implementing a national registry are now being realized. The collection of an internationally standardized set of clinical information is helping inform clinicians of beneficial interventions and encouraging a shift towards evidence-based practices. Furthermore, through RHSCIR, a network is forming amongst SCI clinicians and researchers, which is fostering new collaborations and the launch of multi-center clinical trials. Conclusions: For networks that are establishing SCI registries, the experiences and lessons learned in the development of RHSCIR may provide useful insights and guidance.

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“…As compared with a randomized controlled trial (RCT), prospective longitudinal registries are more feasible and may more closely reflect daily clinical situations, as they measure real-world care and are not artificially constrained by research settings, strict inclusion/exclusion criteria, and loss of patients not consenting to participate in clinical trial. 20 Patients with lumbar spondylosis are typically given a 6-to 8-week trial of nonoperative treatment including narcotic and nonnarcotic medications, muscle relaxants, steroid injections, and physical therapy. While the majority of patients will improve with nonoperative management, those who do not are offered the option of undergoing spinal surgery.…”

mentioning

confidence: 99%

Two-year comprehensive medical management of degenerative lumbar spine disease (lumbar spondylolisthesis, stenosis, or disc herniation): a value analysis of cost, pain, disability, and quality of life

Parker

Godil

Mendenhall³

et al. 2014

SPI

101

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Object Current health care reform calls for a reduction of procedures and treatments that are less effective, more costly, and of little value (high cost/low quality). The authors assessed the 2-year cost and effectiveness of comprehensive medical management for lumbar spondylolisthesis, stenosis, and herniation by utilizing a prospective single-center multidisciplinary spine center registry in a real-world practice setting. Methods Analysis was performed on a prospective longitudinal quality of life spine registry. Patients with lumbar spondylolisthesis (n = 50), stenosis (n = 50), and disc herniation (n = 50) who had symptoms persisting after 6 weeks of medical management and who were eligible for surgical treatment were entered into a prospective registry after deciding on nonsurgical treatment. In all cases, comprehensive medical management included spinal steroid injections, physical therapy, muscle relaxants, antiinflammatory medication, and narcotic oral agents. Two-year patient-reported outcomes, back-related medical resource utilization, and occupational work-day losses were prospectively collected and used to calculate Medicare fee–based direct and indirect costs from the payer and societal perspectives. The maximum health gain associated with medical management was defined as the improvement in pain, disability, and quality of life experienced after 2 years of medical treatment or at the time a patient decided to cross over to surgery. Results The maximum health gain in back pain, leg pain, disability, quality of life, depression, and general health state did not achieve statistical significance by 2 years of medical management, except for pain and disability in patients with disc herniation and back pain in patients with lumbar stenosis. Eighteen patients (36%) with spondylolisthesis, 11 (22%) with stenosis, and 17 (34%) with disc herniation eventually required surgical management due to lack of improvement. The 2-year improvement did not achieve a minimum clinically important difference in any outcome measure. The mean 2-year total cost (direct plus indirect) of medical management was $6606 for spondylolisthesis, $7747 for stenosis, and $7097 for herniation. Conclusions In an institution-wide, prospective, longitudinal quality of life registry that measures cost and effectiveness of all spine care provided, comprehensive medical management did not result in sustained improvement in pain, disability, or quality of life for patients with surgically eligible degenerative lumbar spondylolisthesis, stenosis, or disc herniation. From both the societal and payer perspective, continued medical management of patients with these lumbar pathologies in whom 6 weeks of conservative therapy failed was of minimal value given its lack of health utility and effectiveness and its health care costs. The findings from this real-world practice setting may more accurately reflect the true value and effectiveness of nonoperative care in surgically eligible patient populations.

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The rationale for a spine registry

Cited by 38 publications

References 30 publications

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

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

The Rick Hansen Spinal Cord Injury Registry (RHSCIR): a national patient-registry

Two-year comprehensive medical management of degenerative lumbar spine disease (lumbar spondylolisthesis, stenosis, or disc herniation): a value analysis of cost, pain, disability, and quality of life

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