Panel stacking is a threat to consensus statement validity.

Consensus statements can be very influential in medicine and public health. Some of these statements use systematic evidence synthesis but others fail on this front. Many consensus statements use panels of experts to deduce perceived consensus through Delphi processes. We argue that stacking of panel members toward one particular position or narrative is a major threat, especially in absence of systematic evidence review. Stacking may involve financial conflicts of interest, but nonfinancial conflicts of strong advocacy can also cause major bias. Given their emerging importance, we describe here how such consensus statements may be misleading, by analyzing in depth a recent high-impact Delphi consensus statement on COVID-19 recommendations as a case example. We demonstrate that many of the selected panel members and at least 35% of the core panel members had advocated toward COVID-19 elimination (Zero-COVID) during the pandemic and were leading members of aggressive advocacy groups. These advocacy conflicts were not declared in the Delphi consensus publication, with rare exceptions. Therefore, we propose that consensus statements should always require rigorous evidence synthesis and maximal transparency on potential biases toward advocacy or lobbyist groups to be valid. While advocacy can have many important functions, its biased impact on consensus panels should be carefully avoided.

Differences in gross motor and fine motor outcomes for toddlers after early complex cardiac surgery.

OBJECTIVES: To determine whether gross motor scores of toddlers after complex cardiac surgery were different from fine motor scores and were adequately represented by motor composite scores and, whether acute care predictors and chronic childhood health markers of gross motor scores differed from those of fine motor. METHODS: This prospective inception-cohort outcomes study included 171 toddlers after complex cardiac surgery with cardiopulmonary bypass at age <6 months, born in Northern Alberta from 2009 to 2019, and without known chromosomal abnormalities. At a mean (standard deviation) age of 21.7 (3.7) months, the Bayley Scales of Infant and Toddler Development-III determined motor composite and scaled scores (normative values, 100 (15), 10 (3), respectively). The same variables from surgery and assessment were analysed using multivariate regression to predict gross and fine motor scores; results expressed as effect size (95% confidence interval) with % variance. RESULTS: Composite, fine, and gross motor scores were 89.7 (14.2), 9.4 (2.5), and 7.2 (2.7), respectively. Predictive variables accounted for 21.2% of the variance for fine motor, and 36.9% for gross motor. Multivariate analysis for gross motor scores included toddlers need for cardiac medication, effect size (95% confidence interval) -0.801 (-1.62, -0.02), gastrostomy, -1.35 (-2.39, -0.319), and single ventricle, -0.93 (-1.71, -0.15). These same variables did not predict fine motor scores. CONCLUSION: Gross motor skills commonly were lower than fine motor skills for toddlers after complex cardiac surgery. Predictors for gross motor scores differed from fine motor scores. Separate reporting of gross motor scores could lead to improved identification of predictors of delay and to optimised early intervention.

Evaluating the Readability of Patient Education Materials for Anterior Vertebral Body Tethering, Distraction-Based Methods, and Posterior Spinal Fusion for the Treatment of Pediatric Spinal Deformity.

BACKGROUND: The Internet is an important source of information for patients, but its effectiveness relies on the readability of its content. Patient education materials (PEMs) should be written at or below a sixth-grade reading level as outlined by agencies such as the American Medical Association. This study assessed PEMs' readability for the novel anterior vertebral body tethering (AVBT), distraction-based methods, and posterior spinal fusion (PSF) in treating pediatric spinal deformity. METHODS: An online search identified PEMs using the terms "anterior vertebral body tethering," "growing rods scoliosis," and "posterior spinal fusion pediatric scoliosis." We selected the first 20 general medical websites (GMWs) and 10 academic health institution websites (AHIWs) discussing each treatment (90 websites total). Readability tests for each webpage were conducted using Readability Studio software. Reading grade levels (RGLs), which correspond to the US grade at which one is expected to comprehend the text, were calculated for sources and independent t tests compared with RGLs between treatment types. RESULTS: The mean RGL was 12.1 ± 2.0. No articles were below a sixth-grade reading level, with only 2.2% at the sixth-grade reading level. AVBT articles had a higher RGL than distraction-based methods (12.7 ± 1.6 vs 11.9 ± 1.9, P = 0.082) and PSF (12.7 ± 1.6 vs 11.6 ± 2.3, P = 0.032). Materials for distraction-based methods and PSF were comparable (11.9 ± 1.9 vs 11.6 ± 2.3, P = 0.566). Among GMWs, AVBT materials had a higher RGL than distraction-based methods (12.9 ± 1.4 vs 12.1 ± 1.8, P = 0.133) and PSF (12.9 ± 1.4 vs 11.4 ± 2.4, P = 0.016). CLINICAL RELEVANCE: Patients' health literacy is important for shared decision-making. Assessing the readability of scoliosis treatment PEMs guides physicians when sharing resources and discussing treatment with patients. CONCLUSION: Both GMWs and AHIWs exceed recommended RGLs, which may limit patient and parent understanding. Within GMWs, AVBT materials are written at a higher RGL than other treatments, which may hinder informed decision-making and patient outcomes. Efforts should be made to create online resources at the appropriate RGL. At the very least, patients and parents may be directed toward AHIWs; RGLs are more consistent.

The Alberta Infant Motor Scale as an Outcomes Measure of Gross Motor Abilities after Early Complex Cardiac Surgery.

To address the research hypothesis that the Alberta Infant Motor Scale (AIMS) completed following complex cardiac surgery (CCS) is a useful outcomes measure this study determined: (1) AIMS scores at age 8 months after CCS; (2) predictive validity of AIMS at 8 months for Bayley Scales of Infant and Toddler Development-III Gross Motor-scaled scores (GMSS) and diagnosis of cerebral palsy (CP) at 21 months; and (3) predictive demographic and surgical variables of AIMS scores. A prospective cohort study of 250/271 (92.3%) surviving children from Northern Alberta (born 2009-2020) who had CCS at age < 6 months determined AIMS scores at age mean (SD) 8.6 (2.4) and the GMSS at 21.9 (3.8) months. Gross motor delay was defined as AIMS < 5th percentile and GMSS as < 4 (-2SD). Predictions using multiple logistic regressions were expressed as Odds Ratios (OR) and 95% Confidence Interval (CI). Of children, 100/250 (40%) had AIMS < 5th predicting GMSS < 4 (n = 43); sensitivity, specificity, positive, and negative predictive values were 88%, 71%, 40%, and 97%. Hospitalization days were independently associated with AIMS < 5th, OR 1.02 (95% CI 1.007, 1.032; p = 0.005). Excluding hospital days, ventilation days independently predicted AIMS < 5th, OR 1.08 (95% CI 1.038, 1.125, p < 0.001. Gross motor delay determine by AIMS scores of < 5th percentile occurred in 40% of survivors with good prediction of continued delay. Delay determined by AIMS was predicted by longer hospitalization and ventilation; further investigations about the causes are required. AIMS results provide opportunity for early motor intervention.

Use of the Geriatric Nutritional Risk Index to Assess Risk for Postoperative Complications Following Posterior Cervical Decompression/Fusion.

BACKGROUND: Posterior cervical decompression with or without fusion (PCD/F) is used to manage degenerative spinal conditions. Malnutrition has been implicated for poor outcomes in spine surgery. The aim of this study was to assess the ability of the Geriatric Nutritional Risk Index (GNRI) as a risk calculator for postoperative complications in patients undergoing PCD/F. METHODS: The 2006 to 2018 American College of Surgeons National Surgery Quality Improvement Program Database was queried for patients undergoing PCD/F. Nutritional status was categorized as normal (GNRI greater than 98), moderately malnourished (GNRI 92-98), or severely malnourished (GNRI less than or equal to 92). Complications within 30 days of surgery were compared among the groups. Preoperative data that were statistically significant (P < 0.05) upon univariate χ2 analysis were included in the univariate then multivariate binary regression model to calculate adjusted ORs. All ORs were assessed at the 95% CI. RESULTS: Of the 7597 PCD/F patients identified, 15.6% were severely malnourished and 19.1% were moderately malnourished. Severe and moderate malnourishment were independent risk factors for mortality (OR = 3.790, 95% CI 2.492-5.763, P < 0.001; OR = 2.150, 95% CI 1.351-3.421, P = 0.011). Severe malnourishment was an independent risk factor for sepsis/septic shock (OR = 3.448, 95% CI 2.402-4.948, P < 0.001). CONCLUSIONS: In elderly patients undergoing PCD/F, severe malnutrition, as defined by the GNRI, was an independent risk factor for mortality and sepsis/septic shock. CLINICAL RELEVANCE: The GNRI may be more useful than other indices for risk stratification in elderly patients because it accounts for confounding variables such as hydration status and paradoxical malnourishment in obese patients.

Long COVID as a functional somatic symptom disorder caused by abnormally precise prior expectations during Bayesian perceptual processing: A new hypothesis and implications for pandemic response.

This review proposes a model of Long-COVID where the constellation of symptoms are in fact genuinely experienced persistent physical symptoms that are usually functional in nature and therefore potentially reversible, that is, Long-COVID is a somatic symptom disorder. First, we describe what is currently known about Long-COVID in children and adults. Second, we examine reported "Long-Pandemic" effects that create a risk for similar somatic symptoms to develop in non-COVID-19 patients. Third, we describe what was known about somatization and somatic symptom disorder before the COVID-19 pandemic, and suggest that by analogy, Long-COVID may best be conceptualized as one of these disorders, with similar symptoms and predisposing, precipitating, and perpetuating factors. Fourth, we review the phenomenon of mass sociogenic (functional) illness, and the concept of nocebo effects, and suggest that by analogy, Long-COVID is compatible with these descriptions. Fifth, we describe the current theoretical model of the mechanism underlying functional disorders, the Bayesian predictive coding model for perception. This model accounts for moderators that can make symptom inferences functionally inaccurate and therefore can explain how to understand common predisposing, precipitating, and perpetuating factors. Finally, we discuss the implications of this framework for improved public health messaging during a pandemic, with recommendations for the management of Long-COVID symptoms in healthcare systems. We argue that the current public health approach has induced fear of Long-COVID in the population, including from constant messaging about disabling symptoms of Long-COVID and theorizing irreversible tissue damage as the cause of Long-COVID. This has created a self-fulfilling prophecy by inducing the very predisposing, precipitating, and perpetuating factors for the syndrome. Finally, we introduce the term "Pandemic-Response Syndrome" to describe what previously was labeled Long-COVID. This alternative perspective aims to stimulate research and serve as a lesson learned to avoid a repeat performance in the future.

Infants less than or equal to 2.5 kg have increased mortality and worse motor neurodevelopmental outcomes at 2 years of age after Norwood-Sano palliation.

Objectives: In infants with single-ventricle congenital heart disease, prematurity and low weight at the time of the Norwood operation are risk factors for mortality. Reports assessing outcomes (including neurodevelopment) post Norwood palliation in infants ≤2.5 kg are limited. Methods: All infants who underwent a Norwood-Sano procedure between 2004 and 2019 were identified. Infants ≤2.5 kg at the time of the operation (cases) were matched 3:1 with infants >3.0 kg (comparisons) for year of surgery and cardiac diagnosis. Demographic and perioperative characteristics, survival, and functional and neurodevelopmental outcomes were compared. Results: Twenty-seven cases (mean ± standard deviation: weight 2.2 ± 0.3 kg and age 15.6 ± 14.1 days at surgery) and 81 comparisons (3.5 ± 0.4 kg and age 10.9 ± 7.9 days at surgery) were identified. Post-Norwood, cases had a longer time to lactate ≤2 mmol/L (33.1 ± 27.5 vs 17.9 ± 12.2 hours, P < .001), longer duration of ventilation (30.5 ± 24.5 vs 18.6 ± 17.5 days, P = .005), greater need for dialysis (48.1% vs 19.8%, P = .007), and greater need for extracorporeal membrane oxygenation support (29.6% vs 12.3%, P = .004). Cases had significantly greater postoperative (in-hospital) (25.9% vs 1.2%, P < .001) and 2-year (59.2% vs 11.1%, P < .001) mortality. Neurodevelopmental assessment showed the following for cases versus comparisons, respectively: cognitive delay (18.2% vs 7.9%, P = .272), language delay (18.2% vs 11.1%, P = .505), and motor delay (27.3% vs 14.3%, P = .013). Conclusions: Infants ≤2.5 kg at Norwood-Sano palliation have significantly increased postoperative morbidity and mortality up to 2-year follow-up. Neurodevelopmental motor outcomes were worse in these infants. Additional studies are warranted to assess the outcome of alternative medical and interventional treatment plans in this patient population.

Should the Criterion for Brain Death Require Irreversible or Permanent Cessation of Function? Irreversible: The UDDA Revision Series.

I argue that death is irreversible and not merely permanent. Irreversible means a state cannot be reversed and entails permanence. Permanent means a state will not be reversed and includes cases where the state could still be reversed though a decision has been made not to attempt this reversal. This distinction is important, as we shall see. Four reasons are given for why death must be irreversible and not merely permanent: no mortal can return from the state of death; unacceptable implications regarding culpability for actions and omissions; death is a physiologic state; and irreversibility is inherent in the standards to diagnose brain death. Four objections are considered including the following: permanence is the medical standard, permanence was the intent of the President's Commission on defining death, irreversible requires many hours to occur, and we should change terminology to reflect our case intuition. These objections are discussed and rejected. Finally, I clarify my views to conclude that the criterion for biological death is irreversible loss of circulation.

Enhanced Risk Stratification for Short-Term Complications Following Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures.

BACKGROUND: For patients with back pain from osteoporotic vertebral compression fractures (VCFs), vertebral augmentation remains the most utilized surgical intervention. Previous studies report 30-day readmission and mortality rates of up to 10% and 2%, respectively. These studies, however, have included patients with pathologic fractures and combined patients in different admission settings. We undertook the current study to address such shortcomings, which make risk stratification and appropriate counseling difficult. METHODS: Four consecutive years of the National Surgical Quality Improvement Program database were queried. Patients who underwent vertebral augmentation for osteoporotic VCFs were divided into 3 groups: (1) outpatient group (defined as patients with same-day discharge), (2) inpatient group (defined as those who were admitted postoperatively), and (3) preprocedure hospitalized group (defined as those who were already inpatient or were at acute/intermediate care facilities and transferred). Postoperative 30-day complications and readmission rates were compared between different groups and examined using multivariate analyses. RESULTS: A total of 1023 patients underwent outpatient surgery; 503 were admitted on the day of surgery; and 149 patients were already in-hospital or were transferred from other facility. Mortality rates were 0.68%, 0.60%, and 2.68%, and readmission rates were 6.26%, 6.76%, and 12.8%, for outpatient, inpatient, and preprocedure hospitalization cohorts, respectively. Multivariate analyses identified preprocedure hospitalization as an independent risk factor for urinary tract infection (UTI; OR = 3.98, 95% CI = 1.41-11.20, P = 0.028), pneumonia (OR = 19.69, 95% CI = 3.81-101.65, P < 0.001), readmission (OR = 1.86, 95% CI = 1.06-3.26, P = 0.032), and mortality (OR = 4.49, 95% CI = 1.22-16.53, P = 0.024). CONCLUSION: Our findings suggest that published rates of complications and mortality are substantially impacted by the cohort of patients who are already hospitalized or transferred from other facilities. Such patients are at a higher risk of UTI, pneumonia, readmission, and mortality. Conversely, we show that a relatively healthy patient being offered outpatient same-day augmentation has a readmission risk 40% lower and a mortality risk 3 times lower than previously reported.

Two-year clinical outcomes and complication rates in anatomic and reverse shoulder arthroplasty implanted with Exactech GPS intraoperative navigation.

INTRODUCTION: We compared the 2-year clinical outcomes of both anatomic and reverse total shoulder arthroplasty (ATSA and RTSA) using intraoperative navigation compared to traditional positioning techniques. We also examined the effect of glenoid implant retroversion on clinical outcomes. HYPOTHESIS: In both ATSA and RTSA, computer navigation would be associated with equal or better outcomes with fewer complications. Final glenoid version and degree of correction would not show outcome differences. MATERIAL AND METHODS: A total of 216 ATSAs and 533 RTSAs were performed using preoperative planning and intraoperative navigation with a minimum of 2-year follow-up. Matched cohorts (2:1) for age, gender, and follow-up for cases without intraoperative navigation were compared using all standard shoulder arthroplasty clinical outcome metrics. Two subanalyses were performed on navigated cases comparing glenoids positioned greater or less than 10° of retroversion and glenoids corrected more or less than 15°. RESULTS: For ASTA, no statistical differences were found between the navigated and non-navigated cohorts for postoperative complications, glenoid implant loosening, or revision rate. No significant differences were seen in any of the ATSA outcome metrics besides higher internal and external rotation in the navigated cohort. For RTSA, the navigated cohort showed an ARR of 1.7% (95% CI 0%, 3.4%) for postoperative complications and 0.7% (95% CI 0.1%, 1.2%) for dislocations. No difference was found in the revision rate, glenoid implant loosening, acromial stress fracture rates, or scapular notching. Navigated RTSA patients demonstrated significant improvements over non-navigated patients in internal rotation, external rotation, maximum lifting weight, the Simple Shoulder Test (SST), Constant, and Shoulder Arthroplasty Smart (SAS) scores. For the navigated subcohorts, ATSA cases with a higher degree of final retroversion showed significant improvement in pain, Constant, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), SST, University of California-Los Angeles shoulder score (UCLA), and Shoulder Pain and Disability Index (SPADI) scores. No significant differences were found in the RTSA subcohort. Higher degrees of version correction showed improvement in external rotation, SST, and Constant scores for ATSA and forward elevation, internal rotation, pain, SST, Constant, ASES, UCLA, SPADI, and SAS scores for RTSA. CONCLUSION: The use of intraoperative navigation shoulder arthroplasty is safe, produces at least equally good outcomes at 2 years as standard instrumentation does without any increased risk of complications. The effect of final implant position above or below 10° of glenoid retroversion and correction more or less than 15° does not negatively impact outcomes.

Fast, Broad-Band Magnetic Resonance Spectroscopy with Diamond Widefield Relaxometry.

We present an alternative to conventional Electron Paramagnetic Resonance (EPR) spectroscopy equipment. Avoiding the use of bulky magnets and magnetron equipment, we use the photoluminescence of an ensemble of Nitrogen-Vacancy centers at the surface of a diamond. Monitoring their relaxation time (or T1), we detected their cross-relaxation with a compound of interest. In addition, the EPR spectra are encoded through a localized magnetic field gradient. While recording previous data took 12 min per data point with individual NV centers, we were able to reconstruct a full spectrum at once in 3 s, over a range from 3 to 11 G. In terms of sensitivity, only 0.5 µL of a 1 µM hexaaquacopper(II) ion solution was necessary.

Non-Intentional N-Acetylcysteine Overdose Associated with Cerebral Edema and Brain Death.

N-acetylcysteine is the established treatment for acetaminophen toxicity. This medication's complex dosing schedule engenders a high incidence of medication errors. While nuisance side effects are common, only rare case reports describe serious outcomes associated with N-acetylcysteine administration, all of which take place in the setting of non-intentional N-acetylcysteine overdose. This case report contributes to a small but growing literature that suggests that large N-acetylcysteine overdose may have devastating outcomes. We describe a 15-year-old female who presented with stage III acetaminophen toxicity and who received a non-intentional 6-fold overdose of intravenous N-acetylcysteine due to a medication prescribing error. During the N-acetylcysteine infusion dosing error, the patient had clinical deterioration including seizure followed by cerebral edema and brain herniation that progressed to brain death. She developed agitation and worsening headache within 2 h of the dosing error, which progressed to seizure and intubation 14 h into the dosing error. Although possibly due to hepatic encephalopathy, at the time she developed fixed dilated pupils, her lactate, international normalized ratio, aspartate aminotransferase, and alanine aminotransferase had all improved. On review of the literature, other case reports of seizures (n = 4) and cerebral edema with brain herniation (n = 3) were found, suggesting our patient was not an isolated case. Clinicians need to be aware of the common occurrence of dosing errors for N-acetylcysteine infusions. We suggest institutions review their N-acetylcysteine ordering, dosing, and mixing protocols in order to avoid similar rare errors in the future. Iatrogenic overdose of N-acetylcysteine can cause seizure, cerebral edema, and brain death.