Comparative Safety of In Utero Exposure to Buprenorphine Combined With Naloxone vs Buprenorphine Alone.

Importance: Buprenorphine combined with naloxone is commonly used to treat opioid use disorders outside of pregnancy. In pregnancy, buprenorphine alone is generally recommended because of limited perinatal safety data on the combination product.

Objective: To compare perinatal outcomes following prenatal exposure to buprenorphine with naloxone vs buprenorphine alone.

Angiotensin-Converting Enzyme Inhibitors or Angiotensin-Receptor Blockers for Advanced Chronic Kidney Disease : A Systematic Review and Retrospective Individual Participant-Level Meta-analysis of Clinical Trials.

Background: In patients with advanced chronic kidney disease (CKD), the effects of initiating treatment with an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin-receptor blocker (ARB) on the risk for kidney failure with replacement therapy (KFRT) and death remain unclear.

Purpose: To examine the association of ACEi or ARB treatment initiation, relative to a non-ACEi or ARB comparator, with rates of KFRT and death.

Data Sources: Ovid Medline and the Chronic Kidney Disease Epidemiology Collaboration Clinical Trials Consortium from 1946 through 31 December 2023.

Association of Longitudinal B-Type Natriuretic Peptide Monitoring With Kidney Failure in Patients With CKD: A Cohort Study.

Rationale & Objective: Both hypervolemia and hypovolemia are associated with chronic kidney disease (CKD) progression. Although longitudinal monitoring of B-type natriuretic peptide (BNP) may aid physicians' decision making about the optimization of volume status, its clinical benefit remains uncertain in CKD. This study assessed the association between BNP monitoring and the risk of incident kidney replacement therapy (KRT).

Pulmonary Artery Catheter Use and Risk of In-hospital Death in Heart Failure Cardiogenic Shock.

Background: Pulmonary artery catheters (PACs) are increasingly used to guide management decisions in cardiogenic shock (CS). The goal of this study was to determine if PAC use was associated with a lower risk of in-hospital mortality in CS owing to acute heart failure (HF-CS).

Methods And Results: This multicenter, retrospective, observational study included patients with CS hospitalized between 2019 and 2021 at 15 US hospitals participating in the Cardiogenic Shock Working Group registry.

Effectiveness of an Intervention to Improve Decision Making for Older Patients With Advanced Chronic Kidney Disease : A Randomized Controlled Trial.

Background: Older patients with advanced chronic kidney disease (CKD) face difficult decisions about managing kidney failure, frequently experiencing decisional conflict, regret, and treatment misaligned with preferences.

Objective: To assess whether a decision aid about kidney replacement therapy improved decisional quality compared with usual care.

Design: Multicenter, randomized, controlled trial.

Hypoalbuminemia Is Associated with Increased 30-Day Complications following Rectourethral Fistula Repair: A National Surgical Quality Improvement Program Study.

Introduction: We sought to assess patient risk factors for 30-day postoperative complications among men undergoing surgical management of rectourethral fistula (RUF).

Methods: The American College of Surgeons National Surgical Quality Improvement Program database was queried for all male patients who underwent RUF repair (2006-2018). Hypoalbuminemia was defined as preoperative serum albumin <3.

The confounder matrix: A tool to assess confounding bias in systematic reviews of observational studies of etiology.

Systematic reviews and meta-analyses are essential for drawing conclusions regarding etiologic associations between exposures or interventions and health outcomes. Observational studies comprise a substantive source of the evidence base. One major threat to their validity is residual confounding, which may occur when component studies adjust for different sets of confounders, fail to control for important confounders, or have classification errors resulting in only partial control of measured confounders.

The Inverse OARSI-OMERACT Criteria Is a Valid Indicator of the Clinical Worsening of Knee Osteoarthritis: Data From the Osteoarthritis Initiative.

Objective: We assessed if the inverse Osteoarthritis Research Society International (OARSI) and Outcome Measures in Rheumatology (OMERACT) criteria relate to concurrent radiographic knee osteoarthritis (KOA) progression and decline in walking speed, as well as future knee replacement.

Methods: We conducted knee-based analyses of data from the Osteoarthritis Initiative. All knees had symptomatic OA: at least doubtful radiographic KOA (Kellgren-Lawrence grade ≥ 1) and knee pain ≥ 10/100 (Western Ontario and McMaster Universities Osteoarthritis Index pain) at the 12-month visit.

Association between Pre-Intervention Physical Activity Level and Treatment Response to Exercise Therapy in Persons with Knee Osteoarthritis - An Exploratory Study.

Objective: Examine whether pre-intervention physical activity (PA) level is associated with achieving a positive treatment response of pain and/or function improvement after a 12-week exercise intervention in participants with knee osteoarthritis (OA).

Methods: We performed a secondary analysis of a randomized, single-blind comparative effectiveness trial showing similar treatment effects between Tai Chi mind-body exercise and standard physical therapy intervention for knee OA. Baseline PA was assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire and, in a subsample, by tri-axial accelerometers.

The Predictive Approaches to Treatment effect Heterogeneity (PATH) Statement.

Heterogeneity of treatment effect (HTE) refers to the nonrandom variation in the magnitude or direction of a treatment effect across levels of a covariate, as measured on a selected scale, against a clinical outcome. In randomized controlled trials (RCTs), HTE is typically examined through a subgroup analysis that contrasts effects in groups of patients defined "1 variable at a time" (for example, male vs. female or old vs.

Assessment of long-term neurodevelopmental outcome following trials of medicinal products in newborn infants.

There is significant uncertainty over the role of assessment of long-term neurodevelopmental outcome (LTO) in neonatal clinical trials. A multidisciplinary working group was established to identify key issues in this area and to make recommendations about optimal approaches to evaluate LTO in therapeutic trials in newborns, which can be developed by sponsors and investigators with other key stakeholders. A key consideration for neonatal trials is the potential for the investigational product to cause widespread effects and drives the need to assess outcome in multiple organs.

Validation of a new symptom outcome for knee osteoarthritis: the Ambulation Adjusted Score for Knee pain.

Objective: Validation of a symptom measure for early knee OA may help identify new treatments and modifiable risk factors. Symptom measures that consider pain in the context of activity level may provide better discrimination than pain alone. Therefore, we aimed to compare sensitivity to change for radiographic progression between Ambulation Adjusted Score for Knee pain (AASK), which accounts for self-reported ambulation, and Western Ontario McMaster Osteoarthritis (WOMAC) knee pain score.

Evaluating the Effectiveness of the Translated "A Matter of Balance" Fall Prevention Program Materials for Non-English-Speaking Participants.

A Matter of Balance (MOB) is an evidence-based fall prevention program shown to reduce fear of falling (FOF) in English-speaking participants. The effectiveness of translated (Chinese and Spanish) MOB materials in reducing FOF is unknown. The objective of this study was to evaluate whether MOB was associated with reduced FOF in Chinese- and Spanish-speaking participants and included an English-speaking comparison group.

Early Blood Transfusions in Sepsis: Unchanged Survival and Increased Costs.

Background: Early red blood cell transfusions are a common treatment for adults hospitalized for sepsis without shock. However, their utility and association with mortality and costs have not been well studied.

Objectives: To examine early transfusion rates for patients with sepsis treated outside intensive care units, and to find a correlation between transfusion rates and survival rates and costs.

Could Activity Modifications Indicate Physical Decline Among Adults With Symptomatic Knee Osteoarthritis?

Objectives: Mobility activity modifications indicate early functional losses that act as precursors to future declines among community-dwelling older adults. However, there is scarce evidence on whether activity modifications indicate poorer physical health among adults with symptomatic osteoarthritis, a major cause of disability. Our purpose was to investigate whether patient-reported mobility activity modifications indicated poorer physical health among adults with symptomatic knee osteoarthritis.

Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates.

The study of medications among pediatric patients has increased worldwide since 1997 in response to new legislation and regulations, but these studies have not yet adequately addressed the therapeutic needs of neonates. Additionally, extant guidance developed by regulatory agencies worldwide does not fully address the specificities of neonatal drug development, especially among extremely premature newborns who currently survive. Consequently, an international consortium from Canada, Europe, Japan, and the United States was organized by the Critical Path Institute to address the content of guidance.

PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.

Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single-sponsor, single-drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real-world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints-aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights.

Retrospective evaluation of the incidence and prognostic significance of spontaneous echocardiographic contrast in relation to cardiac disease and congestive heart failure in cats: 725 cases (2006-2011).

Objective: To determine whether the presence of spontaneous echocardiographic contrast (SEC) in cats with cardiomyopathy is associated with increased mortality. To establish whether specific types of cardiomyopathy are more often associated with SEC in an attempt to provide a risk-stratification scheme for cats with increased risk of thromboembolic events.

Design: Retrospective study 2006-2011.

Outcome Expectations and Osteoarthritis: Association of Perceived Benefits of Exercise With Self-Efficacy and Depression.

Objective: Outcome expectancy is recognized as a determinant of exercise engagement and adherence. However, little is known about which factors influence outcome expectations for exercise among people with knee osteoarthritis (OA). This is the first study to examine the association of outcome expectations for exercise with demographic, physical, and psychosocial outcomes in individuals with knee OA.

Magnitude of rib fracture displacement predicts opioid requirements.

Introduction: It is unknown whether the magnitude of rib fracture (RF) displacement predicts pain medication requirements in blunt chest trauma patients.

Methods: Adult blunt RF patients undergoing computed tomography (CT) of the chest admitted to an urban Level 1 trauma center (2007-2012) were retrospectively reviewed. Pain management in those with displaced RF (DRF), nondisplaced RF (NDRF), or combined DRF and NDRF (CRF) was compared by univariate analysis.

Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis.

Background: The comparative effectiveness of performing instrumented (rigid pedicle screws affixed to titanium alloy rods) lumbar spinal fusion in addition to decompressive laminectomy in patients with symptomatic lumbar grade I degenerative spondylolisthesis with spinal stenosis is unknown.

Methods: In this randomized, controlled trial, we assigned patients, 50 to 80 years of age, who had stable degenerative spondylolisthesis (degree of spondylolisthesis, 3 to 14 mm) and symptomatic lumbar spinal stenosis to undergo either decompressive laminectomy alone (decompression-alone group) or laminectomy with posterolateral instrumented fusion (fusion group). The primary outcome measure was the change in the physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36; range, 0 to 100, with higher scores indicating better quality of life) 2 years after surgery.

Altered Appetite-Mediating Hormone Concentrations Precede Compensatory Overeating After Severe, Short-Term Energy Deprivation in Healthy Adults.

Background: Adaptive responses of appetite-mediating hormones to negative energy balance are thought to contribute to a counterregulatory response that drives weight regain, but they have not been studied while controlling for reduced diet volume.

Objective: In this secondary analysis, we aimed to determine the effects of short-term, severe energy deprivation (ED) on appetite and appetite-mediating hormone concentrations.

Methods: Twenty-one adults with a mean ± SD age of 21 ± 3 y and body mass index of 25 ± 3 kg/m(2) consumed isovolumetric diets provided over separate 48-h periods while increasing habitual energy expenditure by 1683 ± 329 kcal/d through light- and moderate-intensity exercise.

Development of a Rapid Cartilage Damage Quantification Method for the Lateral Tibiofemoral Compartment Using Magnetic Resonance Images: Data from the Osteoarthritis Initiative.

The purpose of this study was to expand and validate the cartilage damage index (CDI) to detect cartilage damage in the lateral tibiofemoral compartment. We used an iterative 3-step process to develop and validate the lateral CDI: development (100 knees), testing (80 knees), and validation (100 knees). The validation set included 100 knees from the Osteoarthritis Initiative that was enriched to include all grades of lateral joint space narrowing (JSN, 0-3).

Magnetic Resonance Image Sequence Influences the Relationship between Bone Marrow Lesions Volume and Pain: Data from the Osteoarthritis Initiative.

Subchondral bone marrow lesions (BMLs) are related to structural and symptomatic osteoarthritis progression. However, it is unclear how sequence selection influences a quantitative BML measurement and its construct validity. We compared quantitative assessment of BMLs on intermediate-weighted fat suppressed (IW FS) turbo spin echo and 3-dimensional dual echo steady state (3D DESS) sequences.