Are Randomized Trials Better? Comparison of Baseline Covariate Balance of a Propensity Score-Balanced Lumbar Spine IDE Trial and Comparable RCTs.

Study Design: Prospective Observational Propensity Score.

Objectives: Randomization may lead to bias when the treatment is unblinded and there is a strong patient preference for treatment arms (such as in spinal device trials). This report describes the rationale and methods utilized to develop a propensity score (PS) model for an investigational device exemption (IDE) trial (NCT03115983) to evaluate decompression and stabilization with an investigational dynamic sagittal tether (DST) vs decompression and Transforaminal Lumbar Interbody Fusion (TLIF) for patients with symptomatic grade I lumbar degenerative spondylolisthesis with spinal stenosis.

Comparative analysis of sleep physiology using qualitative and quantitative criteria for insomnia symptoms.

Despite decades of research, defining insomnia remains challenging due to its complex and variable nature. Various diagnostic systems emphasize the chronic nature of insomnia and its impact on daily functioning, relying heavily on patient self-reporting due to limitations in objective measures like polysomnography (PSG). Discrepancies between subjective experiences and objective PSG results highlight the need for more nuanced approaches, such as electroencephalogram (EEG) spectral analysis, which reveals distinct patterns of high-frequency activity in individuals with insomnia.

Nocturnal gastro-oesophageal reflux and respiratory symptoms are increased in sleep apnoea: comparison with the general population.

Aim: To assess respiratory symptoms and nocturnal gastro-oesophageal reflux (nGER) among untreated obstructive sleep apnoea (OSA) patients, compared with the general population. Also, if nGER associates differently with respiratory symptoms among OSA patients.

Methods: 2 study cohorts were included: 822 newly diagnosed subjects with moderate-severe OSA and 738 Icelandic general population study participants.

Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction.

Background: Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology.

Materials And Methods: In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery.

Long-term influence of sleep/wake history on the dynamic neurobehavioural response to sustained sleep restriction.

Chronic sleep restriction, common in today's 24/7 society, causes cumulative neurobehavioural impairment, but the dynamics of the build-up and dissipation of this impairment have not been fully elucidated. We addressed this knowledge gap in a laboratory study involving two, 5-day periods of sleep restriction to 4 hr per day, separated by a 1-day dose-response intervention sleep opportunity. We measured sleep physiological and waking neurobehavioural responses in 70 healthy adults, each randomized to one of seven dose-response intervention sleep doses ranging from 0 to 12 hr, or a non-sleep-restricted control group.

Positive airway pressure treatment affects respiratory symptoms and gastro-oesophageal reflux: the Icelandic Sleep Apnea Cohort Study.

Aim: To study the effect of positive airway pressure (PAP) treatment on nocturnal gastro-oesophageal reflux (nGOR) and respiratory symptoms among clinical obstructive sleep apnoea (OSA) patients.

Methods: 822 patients newly diagnosed with OSA referred for PAP treatment were recruited. 732 patients had a 2-year follow-up visit with continuous PAP compliance data (366 full PAP users, 366 partial/non-PAP users).

Cost-effectiveness of a 3-year tele-messaging intervention for positive airway pressure use.

Objectives: To evaluate the cost-effectiveness of a 3-year tele-messaging intervention for positive airway pressure (PAP) use in obstructive sleep apnea (OSA).

Study Design: A post hoc cost-effectiveness analysis (from US payers' perspective) of data from a 3-month tele-OSA trial, augmented with 33 months of epidemiologic follow-up.

Methods: Cost-effectiveness was compared among 3 groups of participants with an apnea-hypopnea index of at least 15 events/hour: (1) no messaging (n = 172), (2) messaging for 3 months (n = 124), and (3) messaging for 3 years (n = 46).

Facial and Intraoral Photographic Traits Related to Sleep Apnea in a Clinical Sample with Genetic Ancestry Analysis.

Craniofacial and pharyngeal morphology influences risk for obstructive sleep apnea (OSA). Quantitative photography provides phenotypic information about these anatomical factors and is feasible in large samples. However, whether associations between morphology and OSA severity differ among populations is unknown.

The sleep homeostatic response to sleep deprivation in humans is heritable.

Study Objectives: Following sleep deprivation, increases in delta power have historically been used to index increases in sleep pressure. Research in mice has demonstrated that the homeostatic delta power response to sleep deprivation is heritable. Whether this is true in humans is unknown.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

Background: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability.

EXOGEN Mitigates Risk of Fifth Metatarsal Fracture Nonunion: Results of a Novel Real-World Clinical Study.

Category:: Midfoot/Forefoot

Introduction/purpose:: Fifth metatarsal fractures are the most commonly fractured metatarsal in adults and are associated with high rates of nonunion. This study compared the 9-month incidence of nonunion in fifth metatarsal fracture patients using EXOGEN (Bioventus LLC), low-intensity pulsed ultrasound, versus a control cohort of patients receiving standard of care.

Methods:: Adults (21-80 years) prescribed EXOGEN for any acute or delayed fifth metatarsal fracture and initiated treatment within 91 days of the fracture were enrolled via prescription record abstraction and direct-to-patient outreach.

Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: are participants of randomized trials representative of sleep clinic patients?

Study Objectives: Randomized controlled trials (RCTs) have shown no reduction in adverse cardiovascular (CV) events in patients randomized to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). This study examined whether randomized study populations were representative of OSA patients attending a sleep clinic.

Methods: Sleep clinic patients were 3,965 consecutive adults diagnosed with OSA by in-laboratory polysomnography from 2006 to 2010 at a tertiary hospital sleep clinic.

Diagnostic Performance of Machine Learning-Derived OSA Prediction Tools in Large Clinical and Community-Based Samples.

Background: Prediction tools without patient-reported symptoms could facilitate widespread identification of OSA.

Research Question: What is the diagnostic performance of OSA prediction tools derived from machine learning using readily available data without patient responses to questionnaires? Also, how do they compare with STOP-BANG, an OSA prediction tool, in clinical and community-based samples?

Study Design And Methods: Logistic regression and machine learning techniques, including artificial neural network (ANN), random forests (RF), and kernel support vector machine, were used to determine the ability of age, sex, BMI, and race to predict OSA status. A retrospective cohort of 17,448 subjects from sleep clinics within the international Sleep Apnea Global Interdisciplinary Consortium (SAGIC) were randomly split into training (n = 10,469) and validation (n = 6,979) sets.

Resolution of organ dysfunction as a predictor of long-term survival in necrotizing soft tissue infections: Analysis of the AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections trial and a retrospective claims database-linked chart study.

Background: Necrotizing soft tissue infections (NSTIs) are an acute surgical condition with high morbidity and mortality. Timely identification, resuscitation, and aggressive surgical management have significantly decreased inpatient mortality. However, reduced inpatient mortality has shifted the burden of disease to long-term mortality associated with persistent organ dysfunction.

Breaking Barriers: Studying Fracture Healing in the BONES Program.

The Bioventus Observational Noninterventional EXOGEN Studies (BONES) Program includes 3 concurrent studies designed to estimate the incidence of fracture nonunions in patients treated with the EXOGEN Ultrasound Bone Healing System compared with those receiving standard fracture care. This article outlines the design and methodology within the fifth metatarsal fracture study; similar approaches are taken in the second and third BONES Program studies, which examine nonunions of the tibia and scaphoid. The BONES Program is an external comparator design and incorporates several unique, fit-for-purpose components to strengthen the approach and allow it to be submitted to the US Food and Drug Administration (FDA) to be considered for a label expansion.

Spindles are highly heritable as identified by different spindle detectors.

Study Objectives: Sleep spindles, a defining feature of stage N2 sleep, are maximal at central electrodes and are found in the frequency range of the electroencephalogram (EEG) (sigma 11-16 Hz) that is known to be heritable. However, relatively little is known about the heritability of spindles. Two recent studies investigating the heritability of spindles reported moderate heritability, but with conflicting results depending on scalp location and spindle type.

Randomized clinical trials of cardiovascular disease in obstructive sleep apnea: understanding and overcoming bias.

Three recent randomized control trials (RCTs) found that treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) did not reduce rates of future cardiovascular events. This article discusses the biases in these RCTs that may explain their negative results, and how to overcome these biases in future studies. First, sample selection bias affected each RCT.

A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103).

Background And Objective: Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI.

Defining Extreme Phenotypes of OSA Across International Sleep Centers.

Background: Extreme phenotypes of OSA have not been systematically defined.

Research Question: This study developed objective definitions of extreme phenotypes of OSA by using a multivariate approach. The utility of these definitions for identifying characteristics that confer predisposition toward or protection against OSA is shown in a new prospective sample.