Use of anchor based receiver operating characteristics to evaluate clinical response of an adjunctive device used in successful surgical therapy.
4 affiliations
- 1William Beaumont University Hospital, Royal Oak, MI, USA.
- 2OrthoCarolina Spine Center, Charlotte, NC, USA.
- 3Fziomed, Inc., San Luis Obispo, CA, USA.
- 4Biomedical Statistical Consulting LLC, Philadelphia, PA, USA.
Abstract
Clinical trials designed to identify additional clinical benefit from an adjuvant added to typically successful surgical procedure, e.g., lumbar discectomy to treat sciatica, can be challenged by the size of the remaining primary outcome variable (e.g., reduction in leg pain score) available for further improvement. Patients who are high responders to treatment can be identified by receiver operating characteristic (ROC) analysis when patient satisfaction, obtained from a patient-reported outcome (PRO) questionnaire, is used to anchor the ROC analysis. ROC analysis provides a within-study method to assess clinical metrics. Utility of anchor-based ROC analysis is illustrated here using two published clinical trials that used similar protocols to measure ipsilateral leg and lower back pain (LBP) following lumbar decompression surgery to evaluate a commercially available adjuvant, dual-polymer gel (Oxiplex, Fziomed, Inc., San Luis Obispo, CA, USA). Both studies were FDA authorized, prospective, randomized, double-blind, multi-center trials reporting Level 1 evidence. Participants with unilateral herniation at L4-L5 or L5-S1 with severe leg pain [>68 mm on 100 mm visual analog scale (VAS); >62 on Lumbar Spine Outcome Questionnaire (LSOQ) and LBP >50 mm on VAS Scale; >63 on LSOQ scale] with radiological evidence of nerve root compression, underwent initial, single-level, partial, lumbar discectomy. Participants were randomized to surgery plus dual-polymer gel (Treatment) or surgery alone (Control). Ipsilateral leg pain scores (VAS and LSOQ) were obtained via PRO before and 6 months after surgery. Patient satisfaction at 6 months was determined from responses to the Satisfaction Global Assessment PRO (Fischgrund study) and Satisfaction (Rhyne study) domain of the LSOQ score. Anchor-based ROC analysis in both studies showed an increased number of patients in the Treatment groups compared to the Controls for both the Rhyne and Fischgrund studies who were high responders to surgery (12.8%, 12.5%, respectively). Anchor-based ROC analysis identified similar cohorts of patients in the two studies with meaningful clinical benefits following use of the adjuvant. ROC analysis is a robust and reliable statistical methodology that can identify high responders within heterogeneous populations and enable assessment of patient responses to adjuvant therapies associated with efficacious primary treatments in complex clinical trials.
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BibTeX
@article{fischgrund2026anchor,
title = {{Use of anchor based receiver operating characteristics to evaluate clinical response of an adjunctive device used in successful surgical therapy.}},
author = {Jeffrey Fischgrund and Alfred Rhyne and Ronald Haynes and David Maislin and Stephanie Cortese and Andrea Limon and Alex Breno and Gere diZerega},
journal = {Journal of spine surgery (Hong Kong)},
year = {2026},
month = sep,
doi = {10.21037/jss-2026-0127},
url = {https://europepmc.org/article/MED/42996632},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Use of anchor based receiver operating characteristics to evaluate clinical response of an adjunctive device used in successful surgical therapy.
AU - Jeffrey Fischgrund
AU - Alfred Rhyne
AU - Ronald Haynes
AU - David Maislin
AU - Stephanie Cortese
AU - Andrea Limon
AU - Alex Breno
AU - Gere diZerega
PY - 2026
DA - 2026/09/29
JO - Journal of spine surgery (Hong Kong)
DO - 10.21037/jss-2026-0127
UR - https://europepmc.org/article/MED/42996632
AB - Clinical trials designed to identify additional clinical benefit from an adjuvant added to typically successful surgical procedure, e.g., lumbar discectomy to treat sciatica, can be challenged by the size of the remaining primary outcome variable (e.g., reduction in leg pain score) available for further improvement. Patients who are high responders to treatment can be identified by receiver operating characteristic (ROC) analysis when patient satisfaction, obtained from a patient-reported outcome (PRO) questionnaire, is used to anchor the ROC analysis. ROC analysis provides a within-study method to assess clinical metrics. Utility of anchor-based ROC analysis is illustrated here using two published clinical trials that used similar protocols to measure ipsilateral leg and lower back pain (LBP) following lumbar decompression surgery to evaluate a commercially available adjuvant, dual-polymer gel (Oxiplex, Fziomed, Inc., San Luis Obispo, CA, USA). Both studies were FDA authorized, prospective, randomized, double-blind, multi-center trials reporting Level 1 evidence. Participants with unilateral herniation at L4-L5 or L5-S1 with severe leg pain [>68 mm on 100 mm visual analog scale (VAS); >62 on Lumbar Spine Outcome Questionnaire (LSOQ) and LBP >50 mm on VAS Scale; >63 on LSOQ scale] with radiological evidence of nerve root compression, underwent initial, single-level, partial, lumbar discectomy. Participants were randomized to surgery plus dual-polymer gel (Treatment) or surgery alone (Control). Ipsilateral leg pain scores (VAS and LSOQ) were obtained via PRO before and 6 months after surgery. Patient satisfaction at 6 months was determined from responses to the Satisfaction Global Assessment PRO (Fischgrund study) and Satisfaction (Rhyne study) domain of the LSOQ score. Anchor-based ROC analysis in both studies showed an increased number of patients in the Treatment groups compared to the Controls for both the Rhyne and Fischgrund studies who were high responders to surgery (12.8%, 12.5%, respectively). Anchor-based ROC analysis identified similar cohorts of patients in the two studies with meaningful clinical benefits following use of the adjuvant. ROC analysis is a robust and reliable statistical methodology that can identify high responders within heterogeneous populations and enable assessment of patient responses to adjuvant therapies associated with efficacious primary treatments in complex clinical trials.
SN - 2414-469X
SN - 2414-4630
ER -