Towards a More Simplified Approach for Evaluating Strength of Evidence in Health Technology Assessments.

It is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of a new medical device prior to the widespread adoption of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. Even though dozens of organizations perform HTAs, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA. Thus, there are considerable discrepancies in the methodologies among HTAs such that the same device with the same underlying clinical evidence is often endorsed by one agency but not another, leading to inconsistencies in healthcare coverage policy decisions. Here, we propose a more simplified and unified approach for summarizing clinical effectiveness and safety outcomes for HTAs. We developed a short, semi-quantitative scoring tool that can be used to provide an overall evaluation of evidence strength in HTAs consisting of five categories: (a) the number of randomized controlled trials (RCTs) that have been performed using the technology, (b) the risk of bias among RCTs, (c) the effect size observed for the key effectiveness outcome, (d) the effect size observed for the key safety outcome, and (e) the generalizability of outcomes observed in RCTs to those observed in real-world clinical use. Utilization of this simplified semi-quantitative framework may simplify the HTA process and improve the consistency of the resulting recommendations.

Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis.

BACKGROUND: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations. OBJECTIVE: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level. METHODS: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States. Baseline and follow-up visits collected demographics, clinical, and radiographic status. The primary endpoint was a measure of composite clinical success 24 months postoperatively. For this current 36-month analysis, composite clinical success was calculated using analogous methods. RESULTS: Composite clinical success at 36 months was achieved by 62.2% among 196 coflex Interlaminar Stabilization patients and 48.9% among 94 fusion patients (difference = 13.3%, 95% confidence interval, 1.1%-25.5%, P = .03). Bayesian posterior probabilities for noninferiority (margin = -10%) and superiority of cofle Interlaminar Stabilization vs fusion were >0.999 and 0.984, respectively. Substantial and comparable improvements were observed in both groups for patient-reported outcomes, although the percentage with a clinically significant improvement (≥15) in the Oswestry Disability Index seemed larger for the coflex Interlaminar Stabilization group relative to the fusion group (P = .008). Radiographic measurements maintained index level and adjacent level range of motion in coflex Interlaminar Stabilization patients, although range of motion at the level superior to fusion was significantly increased (P = .005). CONCLUSION: Coflex Interlaminar Stabilization for stenosis is proven to be effective and durable at improving overall composite clinical success without altering normal spinal kinematic motion at the index level of decompression or adjacent levels. ABBREVIATIONS: CCS, composite clinical successCEC, clinical events committeeFDA, Food and Drug AdministrationIDE, investigational device exemptionILS, Coflex Interlaminar StabilizationODI, Oswestry Disability IndexSF-12, Short-Form 12VAS, visual analogue scalesZCQ, Zurich Claudication Questionnaire.

Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial.

INTRODUCTION: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. METHODS: This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. RESULTS: At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. CONCLUSION: Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels. LEVEL OF EVIDENCE AND ETHICAL STATEMENTS: This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.

Therapeutic sustainability and durability of coflex interlaminar stabilization after decompression for lumbar spinal stenosis: a four year assessment.

BACKGROUND: Approved treatment modalities for the surgical management of lumbar spinal stenosis encompass a variety of direct and indirect methods of decompression, though all have varying degrees of limitations and morbidity which potentially limit the efficacy and durability of the treatment. The coflex(®) interlaminar stabilization implant (Paradigm Spine, New York, NY), examined under a United States Food and Drug Administration (US FDA) Investigational Device Exemption (IDE) clinical trial, is shown to have durable outcomes when compared to posterolateral fusion in the setting of post-decompression stabilization for stenotic patients. Other clinical and radiographic parameters, more indicative of durability, were also evaluated. The data collected from these parameters were used to expand the FDA composite clinical success (CCS) endpoint; thus, creating a more stringent Therapeutic Sustainability Endpoint (TSE). The TSE allows more precise calculation of the durability of interlaminar stabilization (ILS) when compared to the fusion control group. METHODS: A retrospective analysis of data generated from a prospective, randomized, level-1 trial that was conducted at 21 US sites was carried out. Three hundred forty-four per-protocol subjects were enrolled and randomized to ILS or fusion after decompression for lumbar stenosis with up to grade 1 degenerative spondylolisthesis. Clinical, safety, and radiographic data were collected and analyzed in both groups. Four-year outcomes were assessed, and the TSE was calculated for both cohorts. The clinical and radiographic factors thought to be associated with therapeutic sustainability were added to the CCS endpoints which were used for premarket approval (PMA). RESULTS: Success rate, comprised of no second intervention and an ODI improvement of ≥ 15 points, was 57.6% of ILS and 46.7% of fusion patients (p = 0.095). Adding lack of fusion in the ILS cohort and successful fusion in the fusion cohort showed a CCS of 42.7% and 33.3%, respectively. Finally, adding adjacent level success to both cohorts and maintenance of foraminal height in the coflex cohort showed a CCS of 36.6% and 25.6%, respectively. With additional follow-up to five years in the U.S. PMA study, these trends are expected to continue to show the superior therapeutic sustainability of ILS compared to posterolateral fusion after decompression for spinal stenosis. CONCLUSION: There are clear differences in both therapeutic sustainability and intended clinical effect of ILS compared to posterolateral fusion with pedicle screw fixation after decompression for spinal stenosis. There are CCS differences between coflex and fusion cohorts noted at four years post-op similar to the trends revealed in the two year data used for PMA approval. When therapeutic sustainability outcomes are added to the CCS, ILS is proven to be a sustainable treatment for stabilization of the vertebral motion segment after decompression for lumbar spinal stenosis.

Neuro-critical care skills training using a human patient simulator.

BACKGROUND: Neurosurgical trainees regularly encounter critical care situations. Traditionally, education was accomplished through lecture and experience. Increasingly, human patient simulators (HPS) are employed, allowing trainees to sharpen skills in a safe and realistic environment. We describe our experience using HPS in neurosurgical training. METHODS: We developed a critical care training program for residents and medical students using HPS. We used a hi-fidelity, lifelike Human Patient Simulator™ (HPS™) produced by Medical Education Technologies, Inc.™ to simulate realistic scenarios for trainee education. Topics included spinal shock, closed head injury, and cerebral vasospasm. A three-way evaluation model was employed to test validity, including pre- and post-exercise testing, survey feedback, and videotaped replay. The simulation exercises were conducted by a neuro-critical care attending, a senior neurosurgical resident, and a HPS technician. RESULTS: We currently have 29 participants. On a 20-point critical care multiple-choice exam for these participants, average improvement has been 4.5 points or 25%. In subgroup analysis, average improvement was 4.75 points (24%) amongst neurosurgery residents, 3.07 points (18%) amongst neurology residents, 7 points (38%) amongst general surgery residents, and 7 points (38%) amongst senior medical students. Post-exercise evaluations were overwhelmingly positive. CONCLUSIONS: Neurosurgical critical care education is important for safe and effective care for patients. Clinical experience and didactic lectures help trainees obtain a solid knowledge base, but do not provide the benefit for learning in a fail-safe environment. Through the use of HPS, we have enhanced the critical care education of our trainees.

Spinal epidural abscess associated with infliximab treatment for psoriatic arthritis. Case report.

Tumor necrosis factor-alpha inhibitors are used to treat numerous chronic inflammatory and rheumatological diseases, such as Crohn disease, rheumatoid arthritis, and psoriatic arthritis. Because the mechanism of these inhibitors is to decrease the body's inflammatory response, the primary complication of treatment is infection. The authors present the first case of a spinal epidural abscess in a patient receiving long-term infliximab therapy for severe psoriatic arthritis. Infliximab and its side-effect profile are discussed, along with other associated complications.

Minimally invasive transforaminal lumbar interbody fusion with unilateral pedicle screw fixation.

OBJECT: Posterior lumbar interbody fusion (PLIF) has been shown to be effective in the treatment of axial low-back pain. Minimally invasive spine surgery for arthrodesis has several advantages, including quicker patient recovery, less postoperative pain, and less destruction of adjacent tissue. The purpose of this paper is to evaluate the clinical outcomes after PLIF procedures in which unilateral pedicle screw fixation was used. METHODS: Prospective data were collected in 34 patients undergoing a one-level minimally invasive transforaminal lumbar interbody fusion (TLIF) in 2003. Conservative therapy, including physical therapy and aggressive multimodality pain management, had failed in all patients. Selection was based on magnetic resonance imaging studies demonstrating degenerative disc disease. All patients underwent a unilateral TLIF procedure in conjunction with posterior unilateral pedicle screw fixation. Twenty patients in whom the follow-up duration was longer than 6 months were included in this study. The follow-up duration in all patients ranged from 6 to 12 months. Seventeen (85%) of 20 patients had a good result, which was defined as a greater than 20-point reduction in the Oswestry Disability Index (ODI) score. The other three patients had no improvement. The mean preoperative ODI score of 57 improved to 25 after surgery (p < 0.005). In the 17 patients who demonstrated improvement, the mean ODI score improved from 57 to 18. The patients' visual analog scale pain scores improved from 8.3 to 1.4 (p < 0.005) after surgery. In patients who received Workers' Compensation, three (75%) of four improved. Follow-up computerized tomography scans were obtained in all 20 patients at 6 months. At that time, 13 of the patients demonstrated some degree of fusion, and no symptomatic pseudarthrosis was noted. CONCLUSIONS: Minimally invasive TLIF in conjunction with unilateral pedicle screw instrumentation is an effective treatment for axial low-back pain in appropriately selected patients.

Greater local recurrence occurs with "berry picking" than neck dissection in thyroid cancer.

Managing cervical lymph node metastases in well-differentiated thyroid cancer with either "berry picking" (BP) or anatomic neck dissection (AND) has not been shown to alter survival. Nevertheless local control of thyroid cancer is important. The purpose of this study is to determine whether the local recurrence rate of well-differentiated thyroid cancer is equivalent with BP versus AND. A retrospective analysis revealed 41 patients with well-differentiated thyroid cancer and cervical node metastases seen by a single surgeon from 1985 to 2002. A total of 83 initial and repeat neck operations were performed (nine BPs, 30 central neck dissections, and 44 modified radical neck dissections). Recurrence of cancer, intervention for recurrence, and complications of the BP and AND groups were evaluated. All nine (100%) patients undergoing a limited BP operation had local recurrence of cancer. Only three of the 32 (9%) patients undergoing an initial formal neck operation had local recurrence of tumor. The recurrences after BP (100%) were significantly greater than the recurrences after AND (9%) (P < 0.001). The incidence of surgical complications with BP and AND was not different. Six of 32 (19%) initial formal neck dissection patients and four of nine (44%) BP patients had surgical complications. We conclude that BP is associated with greater local recurrence of thyroid cancer. Patients with nodal metastases should be managed with ANDs.