Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel

Ghogawala, Zoher; Schwartz, J. Sanford; Benzel, Edward C.; Magge, Subu N.; Coumans, Jean Valery; Harrington, J. Fred; Gelbs, Jared Craig; Whitmore, Robert G.; Butler, William E.; Barker, Fred G.

doi:10.1097/sla.0000000000001483

Cited by 11 publications

(9 citation statements)

References 17 publications

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“…Panel results of suitability for randomization were shared with each eligible patient, an approach that has resulted in increased rates of patient consent to randomization (eFigure 1 in Supplement 3). Clinical equipoise was defined as not met when either (1) 80% or more of panel members chose either ventral or dorsal surgery or (2) a simple majority voted against randomization.…”

Section: Methodsmentioning

confidence: 99%

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy

Ghogawala

Terrin

Dunbar

et al. 2021

JAMA

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IMPORTANCE Cervical spondylotic myelopathy is the most common cause of spinal cord dysfunction worldwide. It remains unknown whether a ventral or dorsal surgical approach provides the best results.OBJECTIVE To determine whether a ventral surgical approach compared with a dorsal surgical approach for treatment of cervical spondylotic myelopathy improves patient-reported physical functioning at 1 year. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of patients aged 45 to 80 years with multilevel cervical spondylotic myelopathy enrolled at 15 large North American hospitals from April 1, 2014, to March 30, 2018; final follow-up was April 15, 2020.INTERVENTIONS Patients were randomized to undergo ventral surgery (n = 63) or dorsal surgery (n = 100). Ventral surgery involved anterior cervical disk removal and instrumented fusion. Dorsal surgery involved laminectomy with instrumented fusion or open-door laminoplasty. Type of dorsal surgery (fusion or laminoplasty) was at surgeon's discretion. MAIN OUTCOMES AND MEASURES The primary outcome was 1-year change in the Short Form 36 physical component summary (SF-36 PCS) score (range, 0 [worst] to 100 [best]; minimum clinically important difference = 5). Secondary outcomes included 1-year change in modified Japanese Orthopaedic Association scale score, complications, work status, sagittal vertical axis, health resource utilization, and 1-and 2-year changes in the Neck Disability Index and the EuroQol 5 Dimensions score.RESULTS Among 163 patients who were randomized (mean age, 62 years; 80 [49%] women), 155 (95%) completed the trial at 1 year (80% at 2 years). All patients had surgery, but 5 patients did not receive their allocated surgery (ventral: n = 1; dorsal: n = 4). One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) (estimated mean difference, 0.3; 95% CI, −2.6 to 3.1; P = .86). Of 7 prespecified secondary outcomes, 6 showed no significant difference. Rates of complications in the ventral and dorsal surgery groups, respectively, were 48% vs 24% (difference, 24%; 95% CI, 8.7%-38.5%; P = .002) and included dysphagia (41% vs 0%), new neurological deficit (2% vs 9%), reoperations (6% vs 4%), and readmissions within 30 days (0% vs 7%).CONCLUSIONS AND RELEVANCE Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral surgical approach did not significantly improve patient-reported physical functioning at 1 year compared with outcomes after a dorsal surgical approach.

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Section: Methodsmentioning

confidence: 99%

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy

Ghogawala

Terrin

Dunbar

et al. 2021

JAMA

Self Cite

120

128

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“…However, consensus was still reached in this large, diverse group of neurosurgical oncologists on a number of questions about SpTR for GBMs in speci c anatomical regions. This encourages further use of the "wisdom of the crowd" approach to inform decisions regarding patient care where no one treatment has been conclusively proven superior [32,34].…”

Section: Discussionmentioning

confidence: 99%

“…For each of the ten anatomically distinct GBM cases, survey respondents reviewed MR images and categorized the eloquence of the tumor's location, indicated whether it would be reasonable to randomize it to SpTR or GTR, and identi ed their personal treatment plan and any adjunct perioperative techniques they would use (Supplement). Consensus on each case's eloquence, equipoise, or treatment plan was de ned as at least 70% agreement among the respondents, following past conventions [32,33].…”

Section: Survey Distribution and Data Collectionmentioning

confidence: 99%

A consensus definition of supratotal resection for anatomically distinct primary glioblastoma: an AANS/CNS Section on Tumors survey of neurosurgical oncologists

et al. 2022

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Supratotal resection (SpTR) of glioblastoma may be associated with improved survival, but published results have varied in part from lack of consensus on the de nition and appropriate use of SpTR. A previous small survey of neurosurgical oncologists with expertise performing SpTR found resection 1-2 cm beyond contrast enhancement was an acceptable de nition and glioblastoma involving the right frontal and bilateral anterior temporal lobes were considered most amenable to SpTR. The general neurosurgical oncology community has not yet con rmed the practicality of this de nition. MethodsSeventy-six general neurosurgical oncology members of the AANS/CNS Tumor Section were surveyed using a crowdsourcing approach. Participants were presented with 11 de nitions of SpTR and rated each de nition's appropriateness. Participants additionally reviewed magnetic resonance imaging for 10 anatomically distinct glioblastomas and assessed the tumor location's eloquence, perceived equipoise of enrolling patients in a randomized trial comparing gross total to SpTR, and their personal treatment plans. ResultsFifty-two neurosurgeons (73.2%) agreed that resection 1-2 cm beyond contrast enhancement was an acceptable de nition for SpTR. Cases were divided into three anatomically distinct groups by perceived equipoise between gross total and SpTR. The best clinical trial candidates were right anterior temporal (n=58, 76.3%) and right frontal (n=55, 73.3%) glioblastomas. ConclusionSupport exists within the neurosurgical oncology community to adopt the proposed consensus de nition of SpTR of glioblastoma and to treat right anterior temporal and right frontal glioblastomas using SpTR.A smaller proportion of general neurosurgical oncologists than SpTR experts consider SpTR feasible in the left anterior temporal lobe.

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“…SLIP II will include an international expert panel review by experienced orthopedic and neurological spine surgeons (Table). 14,15 Each patient's lumbar MRI (sagittal and key axial images and flexion and extension radiographs) will be uploaded into a web-based platform and reviewed with plans to share the reviews with patients in real time (Figure 2). Figure 2 shows the importance of defining the patient population using radiographic data.…”

Section: Slip Ii-opportunities and Future Directionsmentioning

confidence: 99%

Achieving Optimal Outcome for Degenerative Lumbar Spondylolisthesis

et al. 2017

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Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel

Abstract: Patients provided with an expert panel's assessment of their own suitability for randomization were twice as likely to agree to randomization compared with patients receiving only their own surgeon's recommendation.

Cited by 11 publications

References 17 publications

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy

A consensus definition of supratotal resection for anatomically distinct primary glioblastoma: an AANS/CNS Section on Tumors survey of neurosurgical oncologists

Achieving Optimal Outcome for Degenerative Lumbar Spondylolisthesis

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