Male smokers, with or without COPD, have a significant risk of low vBMD and vertebral fractures. COPD was associated with low vBMD after adjusting for race, sex, BMI, smoking, steroid use, exacerbations, and age. Screening for low vBMD by using QCT in men and women who are smokers will increase opportunities to identify and treat osteoporosis in this at-risk population.
Background Obstetric complications impact over a third of women globally, but are underrepresented in clinical research. Little is known about the comprehensive obstetric clinical trial landscape, how it compares to other fields, or factors associated with the successful completion of obstetric trials. Objectives To characterize obstetric clinical trials registered on ClinicalTrials.gov with the primary objective of identifying features associated with early discontinuation and results reporting. Study Design This is a cross-sectional study with descriptive, logistic regression and cox regression analyses of clinical trials registered on ClinicalTrials.gov . Our primary exposure variables were trial focus (obstetric or non-obstetric) and trial funding (industry, United States government or academic). We conducted additional exploratory analyses of other trial features including design, enrollment, and therapeutic focus. We examined the associations of exposure variables and other trial features with two primary outcomes: early discontinuation and results reporting. Results We downloaded data for all studies (n=332,417) registered on ClinicalTrials.gov from October 1, 2007 to March 9, 2020 from the Aggregate Analysis of the ClinicalTrials.gov database. We excluded studies with a non-interventional design (n=63,697) and those registered before October 1, 2007 (n=45,209). 4,276 (1.9%) obstetric trials (i.e. interventional studies), and 219,235 (98.1%) non-obstetric trials were compared. Among all trials, 2.8% of academic-funded trials, 1.9% of United States government-funded trials, and 0.4% of industry-funded trials focused on obstetrics. The quantity of obstetric trials increased over time (10.8% annual growth rate). Compared to non-obstetric trials, obstetric trials had a greater risk of early discontinuation (adjusted hazard ratio 1.40, 95% confidence interval: 1.21 to 1.62, p<0.0001) and similar odds of results reporting (adjusted odds ratio 0.89, 95% confidence interval: 0.72 to 1.10, p=0.19). Among obstetric trials funders after controlling for confounding variables, United States government-funded trials were at lowest risk of early discontinuation (US government adjusted hazard ratio 0.23, 95% confidence interval 0.07 to 0.69, p=0.009, industry reference; academic adjusted hazard ratio 1.04, 95% confidence interval 0.62 to 1.74, p=0.88). Academic-funded trials had the lowest odds of results reporting after controlling for confounding variables (academic institutions adjusted odds ratio 0.39, 95% confidence interval 0.22 to 0.68, p=0.0009; industry reference; US government adjusted odds ratio 1.06 95% confidence interval 0.53 to 2.09, p=0.87). Conclusions Obstetric trials represent only 1.9% of all clinical trials in ClinicalTrials.gov and have ...
Introduction: To assess bounds of shared decision making in orthopaedic surgery, we conducted an exploratory study to examine the extent to which patients want to be involved in decision making in the management of a musculoskeletal condition. Methods: One hundred fifteen patients at an orthopaedic surgery clinic were asked to rate preferred level of involvement in 25 common theoretical clinical decisions (passive [0], semipassive [1 to 4], equally shared involvement between patient and surgeon [5], semiactive [6 to 9], active [10]). Results: Patients preferred semipassive roles in 92% of decisions assessed. Patients wanted to be most involved in scheduling surgical treatments (4.75 ± 2.65) and least involved in determining incision sizes (1.13 ± 1.98). No difference exists in desired decision-making responsibility between patients who had undergone orthopaedic surgery previously and those who had not. Younger and educated patients preferred more decision-making responsibility. Those with Medicare desired more passive roles. Discussion: Despite the importance of shared decision making on delivering patient-centered care, our results suggest that patients do not prefer to share all decisions.
The main tenet of value-based health care is delivering high-quality care that is centered on the patient, improving health, and minimizing cost. Collaborative decision-making frameworks have been developed to help facilitate delivering care based on patient preferences (patient-centered care). The current value-based health care model, however, focuses on improving population health and overlooks the individuality of patients and their preferences for care. We highlight the importance of eliciting patient preferences in collaborative decision making and describe a conceptual framework that incorporates individual patients' preferences when defining value.
Biofilm-associated infections in orthopedic surgery lead to worse clinical outcomes and greater morbidity and mortality. The scope of the problem encompasses infected total joints, internally fixed fractures, and implanted devices. Diagnosis is difficult. Cultures are often negative, and antibiotic treatments are ineffective. The infections resist killing by the immune system and antibiotics. The organized matrix structure of extracellular polymeric substances within the biofilm shields and protects the bacteria from identification and immune cell action. Bacteria in biofilms actively modulate their redox environment and can enhance the matrix structure by creating an oxidizing environment. We postulated that a potent redox-active metalloporphyrin MnTE-2-PyP (chemical name: manganese (II) meso-tetrakis-(Nmethylpyridinium-2-yl) porphyrin) that scavenges reactive species and modulates the redox state to a reduced state, would improve the effect of antibiotic treatment for a biofilm-associated infection. An infected fracture model with a midshaft femoral osteotomy was created in C57B6 mice, internally fixed with an intramedullary 23-gauge needle and seeded with a biofilm-forming variant of Staphylococcus aureus. Animals were divided into three treatment groups: control, antibiotic alone, and combined antibioticplus MnTE-2-PyP. The combined treatment group had significantly decreased bacterial counts in harvested bone, compared with antibiotic alone. In vitro crystal violet assay of biofilm structure and corresponding nitroblue tetrazolium assay for reactive oxygen species (ROS) demonstrated that MnTE-2-PyP decreased the biofilm structure and reduced ROS in a correlated and dosedependent manner. The biofilm structure is redox-sensitive in S. aureus and an ROS scavenger improved the effect of antibiotic therapy in model of biofilm-associated infections.
Background: Distal radius buckle fractures (DRBFx) represent nearly half of the pediatric wrist injuries. DRBFx are stable injury patterns that can typically be successfully managed with brief immobilization. The purpose of this study was to evaluate opinions and preferences of pediatric orthopaedic specialists regarding the management of DRBFx. Methods: The POSNA Trauma Quality, Safety, and Value Initiative (QSVI) Committee developed a 20-question survey regarding the treatment of DRBFx in children. The survey was sent twice to all active and candidate POSNA members in June 2020 (n=1487). Questions focused on various aspects of treatment, including type and length of immobilization, follow-up, and radiographs and on potential concerns regarding patient/family satisfaction and pain control, medicolegal concerns, misdiagnosis, and mismanagement. Results: A total of 317 participants completed the survey (response rate=21.3%). In all, 69% of all respondents prefer to use a removable wrist splint, with 76% of those in practice <20 years preferring removable wrist splints compared with 51% of those in practice >20 years (χ2=21.7; P<0.01). Overall, 85% of participants utilize shared decision-making in discussing management options with patients and their families. The majority of participants felt that the risk of complications associated with DRBFx was very low, but concern for misdiagnosis and mismanagement have required some respondents to perform closed or open reductions. Conclusions: In 2020, the majority of respondents treat DRBFx with removable splints (69%) for 3 or fewer weeks (55%), minimal follow-up (85%), and no reimaging (64%). This marks a dramatic shift from the 2012 POSNA survey when only 29% of respondents used removable splinting for DRBFx. Level of Evidence: Level II.
Objectives: To collect and present the recently published methods of quantifying blood loss (BL) in orthopaedic trauma.Data Sources: A systematic review of English-language literature in PubMed, Cochrane Library, and Scopus databases was conducted according to the PRISMA guidelines on articles describing the methods of determining BL in orthopaedic trauma published since 2010.Study Selection: English, full-text, peer-reviewed articles documenting intraoperative BL in an adult patient population undergoing orthopaedic trauma surgery were eligible for inclusion.Data Extraction: Two authors independently extracted data from the included studies. Articles were assessed for quality and risk of bias using the Cochrane Collaboration's tool for assessing risk of bias and ROBINS-I. Data Synthesis:The included studies proved to be heterogeneous in nature with insufficient data to make data pooling and analysis feasible.Conclusions: Eleven methods were identified: 6 unique formulas with multiple variations, changes in hemoglobin and hematocrit levels, measured suction volume and weighed surgical gauze, transfusion quantification, cell salvage volumes, and hematoma evacuation frequency. Formulas included those of Gross, Mercuriali, Lisander, Sehat, Foss, and Stahl, with Gross being the most common (25%). All formulas used blood volume estimation, determined by equations from Nadler (94%) or Moore (6%), and measure change in preoperative and postoperative blood counts. This systematic review highlights the variability in BL estimation methods published in current orthopaedic trauma literature. Methods of quantifying BL should be taken into consideration when designing and evaluating research.
Background: Idiopathic toe walking (ITW) can result in early contact with the health care system and be distressing for patients and their families. The natural history of ITW is poorly characterized. Deciding how and when to intervene can be difficult. Patient-reported outcomes are utilized in the clinical setting to assess patient factors and indications that may better inform treatment plans. Patient-Reported Outcomes Measurement Information System (PROMIS) is an instrument designed to collect patient-reported outcomes. Minimum clinically important differences in PROMIS metrics have been established to facilitate clinical relevance and utility of these metrics. The purpose of this study was to characterize the patient perspective of ITW by utilizing the PROMIS scores. Methods: Retrospective chart review was performed to identify children aged 5 to 17 with a diagnosis of ITW treated at a single tertiary care center between 2017 and 2020. Inclusion criteria were a diagnosis of ITW and completion of a PROMIS questionnaire. Exclusion criteria were neurologic disease, autism, and previous surgical treatment. Demographic, physical exam, treatment, and available motion analysis data were collected. PROMIS scores for the following domains were available: Mobility, Peer Relationships, and Pain Interference. Results: Forty-five children were enrolled. Seventy-three percent of PROMIS scores were patient reported while the remainder were parent reported. PROMIS score means for the cohort by domain were Mobility: 45.2±8.2 (P<0.000); Peer Relationships: 46.4±11.6 (P=0.047); and Pain Interference: 47.4±9.5 (P=0.67). Motion analysis data, available for 11 children, noted age-matched gait velocity negatively correlated (r s=−0.652, P=0.03) with Peer Relationships. No correlations were found between other aspects of gait, body mass index, or limitations in dorsiflexion and PROMIS domains. Parents reported lower Mobility scores than children did. There were no other significant differences between patient-reported and parent-reported PROMIS scores. PROMIS scores did not differ significantly between those <10 years and those ≥10 years. Conclusion: In this cohort of 45 otherwise healthy children without other neurologic diagnoses, there are both clinically and statistically significant differences in PROMIS means between our cohort and the healthy age-matched population. These differences manifested in worse peer relationships and mobility scores. Level of Evidence: Level IV.
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