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Basheal M. Agrawal, Nathaniel P. Brooks and Daniel K. Resnick

Object

Given the pragmatic difficulties in developing randomized controlled trials in patients with disorders of the spine, the Wisconsin Spine Outcome Group has adopted the use of a prospective registry design to perform comparative effectiveness research on treatments for degenerative lumbar disorders. The goal of the Wisconsin Spine Outcome Study–Pilot (WISPOS-P) was to establish a Web-based, Health Insurance Portability and Accountability Act–compliant registry and to implement a patient registration paradigm that demonstrates at least 80% compliance in collecting pre- and posttreatment data in patients with lumbar disorders, regardless of the treatment they receive. The primary outcome measures were the percentage of patients with lumbar spine disorders who completed a Web-based survey preappointment, and at 1 and 3 months postappointment; the percentage of patients receiving a physician-assigned diagnosis in the registry; and the success of electronic data transition from the Web-based interface to a locally controlled registry.

Methods

The WISPOS-P uses a prospective, diagnosis-based registry design. A universally accessible and secure Internet-based data management platform was created that accrues self-entered patient data on validated disability indices, including the visual analog pain scale, Oswestry Disability Index (ODI), and the 36-Item Short Form Health Survey questionnaire. Data were obtained on patients, preappointment and at 1 and 3 months postappointment, regardless of the treatment rendered. A physician-entered diagnosis was assigned to each patient for data stratification.

Results

One hundred patients were invited into the WISPOS-P; 90 patients participated, and 10 withdrew for various reasons. Eighty-eight of 90 patients were assigned a diagnosis by the evaluating physician. Preliminary and qualitative assessment of the data shows that the major difference between patients who withdrew from the study and those who participated was the number of days between study invitation and clinic appointment (median 11 vs 20.5 days, respectively). In evaluating patients by mode of survey completion, the 2 largest groups were those who completed their intake forms electronically before their clinic appointment and those who used the paper format. The median age of patients electronically completing this survey was 14.34 years younger than those using the paper format. A significantly higher proportion of patients who completed their forms electronically had listed an email address. The 3 major diagnoses were disc disease (32 patients), stenosis (24 patients), and nonsurgical pain of spinal origin (14 patients). Patients with stenosis were older than those in the other 2 groups. Patients with nonsurgical pain of spinal origin had lower ODI scores compared with the other 2 groups.

Conclusions

A diagnosis-based registry design is effective in collecting pretreatment data for patients with lumbar disorders. When stratified by diagnosis, comparative effectiveness analyses can be performed to identify optimum treatments for lumbar disorders given individual patient characteristics. The WISPOS-P has established a mechanism and proof of principle for the participation of patients in an outcomes registry.

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Khoi D. Than, Jill N. Curran, Daniel K. Resnick, Christopher I. Shaffrey, Zoher Ghogawala and Praveen V. Mummaneni

-Item Short-Form Health Survey). 6 A secondary outcome was the percentage of patients who completed all outcome assessments during the 1-year study period at each site as well as the overall study-wide compliance in obtaining patient-reported outcome assessments. It was expected that all sites would have at least an 80% compliance rate for the completion of all outcome questionnaires during the 1-year study period. Patients completed 1 disease-specific outcome measure, the Oswestry Disability Index (ODI) 4 ; 1 general health-related quality of life measure, the

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Zoher Ghogawala, Daniel K. Resnick, William C. Watters III, Praveen V. Mummaneni, Andrew T. Dailey, Tanvir F. Choudhri, Jason C. Eck, Alok Sharan, Michael W. Groff, Jeffrey C. Wang, Sanjay S. Dhall and Michael G. Kaiser

Recommendations There is no evidence that conflicts with the previous recommendations published in the original version of the “Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine.” Grade B It is recommended that when assessing functional outcome in patients treated for low-back pain due to degenerative disease, a reliable, valid, and responsive outcomes instrument, such as the disease-specific Oswestry Disability Index (ODI), be used (Level II evidence). It is recommended that when assessing general

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Robert G. Whitmore, Jill N. Curran, Zarina S. Ali, Praveen V. Mummaneni, Christopher I. Shaffrey, Robert F. Heary, Michael G. Kaiser, Anthony L. Asher, Neil R. Malhotra, Joseph S. Cheng, John Hurlbert, Justin S. Smith, Subu N. Magge, Michael P. Steinmetz, Daniel K. Resnick and Zoher Ghogawala

demonstrated that lumbar discectomy and lumbar spinal fusion for degenerative lumbar spondylolisthesis were effective in improving QOL using validated general and disease-specific outcome instruments, the 36-item Short-Form Health Survey (SF-36), Oswestry Disability Index (ODI), and a visual analog scale (VAS). 9 Collection of patient-reported outcomes data in NeuroPoint-SD required dedicated research personnel at multiple institutions, data management and analysis experts, and was associated with significant costs. One of the major drivers of cost, as well as the

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Zoher Ghogawala, Daniel K. Resnick, Steven D. Glassman, James Dziura, Christopher I. Shaffrey and Praveen V. Mummaneni

imaging) or not. This study did not detect any difference in the treatment arms using the Oswestry Disability Index (ODI) as the primary outcome measure. The SLIP trial, on the other hand, was a smaller study that focused upon a homogeneous population of patients with nonmobile single-level Grade I spondylolisthesis. Figures 1 and 2 illustrate the importance of defining the patient population using radiographic data. The patient in Fig. 1 has single-level spondylolisthesis with stenosis and was included in the SLIP study. The images in Fig. 2 are from a

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Zoher Ghogawala, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Tanya Logvinenko, Neil R. Malhotra, Stephen J. Dante, R. John Hurlbert, Andrea F. Douglas, Subu N. Magge, Praveen V. Mummaneni, Joseph S. Cheng, Justin S. Smith, Michael G. Kaiser, Khalid M. Abbed, Daniel M. Sciubba and Daniel K. Resnick

the 1-year study period. Patients completed 1 disease-specific outcome measure, the Oswestry Disability Index (ODI), 4 1 general health-related quality of life measure, the norm-based SF-36, 8 and the visual analog scale (VAS) 6 for back pain preoperatively and at 1, 3, 6, and 12 months postoperatively. Return to work and complication assessments were completed by an independent study coordinator at each site. Complications included all major adverse events (death, myocardial infarction, pulmonary embolus, infection, CSF leakage, new neurological deficit [such

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Praveen V. Mummaneni, Robert G. Whitmore, Jill N. Curran, John E. Ziewacz, Rishi Wadhwa, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Joseph S. Cheng, R. John Hurlbert, Andrea F. Douglas, Justin S. Smith, Neil R. Malhotra, Stephen J. Dante, Subu N. Magge, Michael G. Kaiser, Khalid M. Abbed, Daniel K. Resnick and Zoher Ghogawala

lower back surgical procedures: lumbar discectomy and lumbar spinal fusion for spondylolisthesis. 14 At 30 days, lumbar discectomy and single-level fusion procedures were associated with significant improvements in Oswestry Disability Index (ODI), visual analog scale, and 36-Item Short Form Health Survey (SF-36) scores (p = 0.0002) that persisted over the 1-year follow-up period (p < 0.0001). 14 The purpose of this analysis was to determine the cost-effectiveness from a societal perspective of lumbar discectomy and single-level lumbar fusion by using the

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Jason C. Eck, Alok Sharan, Daniel K. Resnick, William C. Watters III, Zoher Ghogawala, Andrew T. Dailey, Praveen V. Mummaneni, Michael W. Groff, Jeffrey C. Wang, Tanvir F. Choudhri, Sanjay S. Dhall and Michael G. Kaiser

following lumbar spine fusion. Limitations of this study included a small sample size & lack of quantitative & validated clinical outcomes measures. * AAOS = American Academy of Orthopaedic Suregeons; ALIF = anterior lumbar interbody fusion; DDD = degenerative disc disease; FRA = femoral ring allograft; JOA = Japanese Orthopaedic Association; MODEMS = Musculoskeletal Outcomes Data Evaluation and Management System; ODI = Oswestry Disability Index; pts = patients; VAS = visual analog scale. Scientific Foundation The use of discography for the diagnosis of lumbar

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Daniel K. Resnick, Tanvir F. Choudhri, Andrew T. Dailey, Michael W. Groff, Larry Khoo, Paul G. Matz, Praveen Mummaneni, William C. Watters III, Jeffrey Wang, Beverly C. Walters and Mark N. Hadley

differentiate treated patients from conservatively managed controls. In comparing techniques thought to be more equivalent (such as different types of efficacious treatments), larger numbers of cases are required to demonstrate a difference between groups. Researchers are cautioned that in the context of small sample size, the absence of a statistically significant benefit does not necessarily indicate the absence of a clinically relevant benefit. Abbreviations used in this paper GFS = General Function Scale ; ODI = Oswestry Disability Index

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Jason C. Eck, Alok Sharan, Zoher Ghogawala, Daniel K. Resnick, William C. Watters III, Praveen V. Mummaneni, Andrew T. Dailey, Tanvir F. Choudhri, Michael W. Groff, Jeffrey C. Wang, Sanjay S. Dhall and Michael G. Kaiser

lumbar interbody fusion; AP = anteroposterior; JOA = Japanese Orthopaedic Association; LBP = low-back pain; NASS = North American Spine Society; NS = not significant; ODI = Oswestry Disability Index; PT = physical therapy; pts = patients; SF-36 = 36-Item Short Form Health Survey; VAS = visual analog scale. Scientific Foundation A review of the Cochrane database failed to identify a randomized, controlled trial investigating the utility of lumbar fusion for the treatment of low-back pain due to spondylosis. 19 Two subsequent randomized trials were summarized in