Short-Term Neck Pain After Posterior Foraminotomy Compared with Anterior Discectomy with Fusion for Cervical Foraminal Radiculopathy: A Secondary Analysis of the FACET Randomized Controlled Trial.

BACKGROUND: Short-term neck pain after posterior cervical foraminotomy (posterior surgery) compared with anterior cervical discectomy with fusion (anterior surgery) treating cervical radiculopathy has only been assessed once, retrospectively, to our knowledge. The aim of this study was to prospectively evaluate the course of neck pain for 6 weeks after both treatments. METHODS: This is a secondary analysis of the multicenter Foraminotomy ACDF Cost-Effectiveness Trial (FACET), conducted from January 2016 to May 2020. Of 389 patients who had single-level, 1-sided cervical radiculopathy and were screened for eligibility, 265 were randomly assigned to undergo posterior surgery (n = 132) or anterior surgery (n = 133). The primary outcome of the present analysis was neck pain, assessed weekly for 6 weeks using the visual analog scale (VAS), on a scale of 0 to 100. The secondary outcomes were arm pain, neck disability, work ability, quality of life, treatment satisfaction, motor and sensory changes, and hospital length of stay. Data were analyzed with mixed model analysis in intention-to-treat samples using 2-sided 95% confidence intervals (CIs). RESULTS: In the first postoperative week, the mean VAS for neck pain was 56.2 mm (95% CI, 51.7 to 60.8 mm) after posterior surgery and 46.7 mm (95% CI, 42.2 to 51.2 mm) after anterior surgery. The mean between-group difference was 9.5 mm (95% CI, 3.3 to 15.7 mm), which gradually decreased to 2.3 mm (95% CI, -3.6 to 8.1 mm) at postoperative week 6. As of postoperative week 5, there was no significant difference between groups. Responder analyses confirmed this result. Secondary outcomes showed small differences between groups. CONCLUSIONS: Insight into the course of neck pain during the first 6 weeks after posterior compared with anterior surgery is provided. Despite initially more neck pain after posterior surgery, patients swiftly improved and, as of postoperative week 5, results similar to those after anterior surgery were observed. Our findings should enable improved patient counseling and enhanced shared decision-making between physicians and patients with cervical radiculopathy, where more neck pain in the first postoperative weeks should be balanced against the benefits of posterior surgery. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year: The FACET Randomized Clinical Trial.

Importance: The choice between posterior cervical foraminotomy (posterior surgery) and anterior cervical discectomy with fusion (anterior surgery) for cervical foraminal radiculopathy remains controversial. Objective: To investigate the noninferiority of posterior vs anterior surgery in patients with cervical foraminal radiculopathy with regard to clinical outcomes after 1 year. Design, Setting, and Participants: This multicenter investigator-blinded noninferiority randomized clinical trial was conducted from January 2016 to May 2020 with a total follow-up of 2 years. Patients were included from 9 hospitals in the Netherlands. Of 389 adult patients with 1-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomized (132 to posterior and 133 to anterior), 15 were lost to follow-up and 228 were included in the 1-year analysis (110 in posterior and 118 in anterior). Interventions: Patients were randomly assigned 1:1 to posterior foraminotomy or anterior cervical discectomy with fusion. Main Outcomes and Measures: Primary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%). Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with 2-proportion z tests at 1-sided .05 significance levels with Bonferroni corrections. Results: Among 265 included patients, the mean (SD) age was 51.2 (8.3) years; 133 patients (50%) were female and 132 (50%) were male. Patients were randomly assigned to posterior (132) or anterior (133) surgery. The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, -0.11 percentage points; 1-sided 95% CI, -0.01) and the between-group difference in arm pain was -2.8 (1-sided 95% CI, -9.4) at 1-year follow-up, indicating noninferiority of posterior surgery. Decrease in arm pain had a between-group difference of 3.4 (1-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had 2-sided 95% CIs clustered around 0 with small between-group differences. Conclusions and Relevance: In this randomized clinical trial, posterior surgery was noninferior to anterior surgery for patients with cervical radiculopathy regarding success rate and arm pain at 1 year. Decrease in arm pain and secondary outcomes had small between-group differences. These results may be used to enhance shared decision-making. Trial Registration: Netherlands Trial Register Identifier: NTR5536.

Cognitive biases, environmental, patient and personal factors associated with critical care decision making: A scoping review.

PURPOSE: Cognitive biases and factors affecting decision making in critical care can potentially lead to life-threatening errors. We aimed to examine the existing evidence on the influence of cognitive biases and factors on decision making in critical care. MATERIALS AND METHODS: We conducted a scoping review by searching MEDLINE for articles from 2004 to November 2020. We included studies conducted in physicians that described cognitive biases or factors associated with decision making. During the study process we decided on the method to summarize the evidence, and based on the obtained studies a descriptive summary of findings was the best fit. RESULTS: Thirty heterogenous studies were included. Four main biases or factors were observed, e.g. cognitive biases, personal factors, environmental factors, and patient factors. Six (20%) studies reported biases associated with decision making comprising omission-, status quo-, implicit-, explicit-, outcome-, and overconfidence bias. Nineteen (63%) studies described personal factors, twenty-two (73%) studies described environmental factors, and sixteen (53%) studies described patient factors. CONCLUSIONS: The current evidence on cognitive biases and factors is heterogenous, but shows they influence clinical decision. Future studies should investigate the prevalence of cognitive biases and factors in clinical practice and their impact on clinical outcomes.

Surgical Interventions for Cervical Radiculopathy without Myelopathy: A Systematic Review and Meta-Analysis.

BACKGROUND: The effectiveness of surgical interventions for cervical degenerative disorders has been investigated in multiple systematic reviews. Differences in study population (e.g., patients with myelopathy and/or radiculopathy) were often neglected. Therefore, the objective of this study was to investigate the effectiveness of surgical interventions for patients with symptoms of cervical radiculopathy without myelopathy by conducting a systematic review and meta-analysis based on randomized controlled trials (RCTs). METHODS: A comprehensive systematic search was conducted in MEDLINE, Embase, and CENTRAL (Cochrane Central Register of Controlled Trials) to identify RCTs that investigated the effectiveness of surgical interventions using an anterior or posterior approach compared with other interventions for patients with pure cervical radiculopathy. Outcomes were success rates (Odom criteria, similar rating scales, or percentage of patients who improved), complication and reoperation rates, work status, disability (Neck Disability Index), and pain (arm and neck). The Cochrane risk-of-bias tool was used to assess the likelihood of the risk of bias. A random-effects model was used. Heterogeneity among study results (I2 ≥ 50% or p < 0.05) was explored by conducting subgroup analyses. Funnel plots were used to assess the likelihood of publication bias. RESULTS: A total of 21 RCTs were included, comprising 1,567 patients. For all outcomes, among all surgical techniques, only 1 pooled estimate showed a significant effect on success rate, which was in favor of anterior cervical discectomy with fusion compared with anterior cervical discectomy without an intervertebral spacer (p = 0.02; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.77 to 0.98). Complication rates were higher when autologous bone graft from the iliac crest was used as an intervertebral spacer (p < 0.01; RR = 3.40; 95% CI = 1.56 to 7.43), related to donor-site morbidity. CONCLUSIONS: This meta-analysis demonstrated consistent results regarding clinical outcome for pure cervical radiculopathy among all studied interventions. Complication and reoperation rates were also similar, with the exception of higher complication rates in patients in whom autologous bone grafts were used. On the basis of clinical outcome and safety, there is no superior surgical intervention for pure cervical radiculopathy. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.