4 research outputs found
Testing the Reliability of Optical Coherence Tomography to Measure Epidermal Thickness and Distinguish Volar and Nonvolar Skin
In persons with limb loss, prosthetic devices cause skin breakdown, largely because residual limb skin (nonvolar) is not intended to bear weight such as palmoplantar (volar) skin. Before evaluation of treatment efficacy to improve skin resiliency, efforts are needed to establish normative data and assess outcome metric reliability. The purpose of this study was to use optical coherence tomography to (i) characterize volar and nonvolar skin epidermal thickness and (ii) examine the reliability of optical coherence tomography. Four orientations of optical coherence tomography images were collected on 33 volunteers (6 with limb loss) at 2 time points, and the epidermis was traced to quantify thickness by 3 evaluators. Epidermal thickness was greater (P \u3c .01) for volar skin (palm) (265.1 ± 50.9 μm, n = 33) than for both nonvolar locations: posterior thigh (89.8 ± 18.1 μm, n = 27) or residual limb (93.4 ± 27.4 μm, n = 6). The inter-rater intraclass correlation coefficient was high for volar skin (0.887–0.956) but low for nonvolar skin (thigh: 0.292–0.391, residual limb: 0.211–0.580). Correlation improved when comparing only 2 evaluators who used the same display technique (palm: 0.827–0.940, thigh: 0.633–0.877, residual limb: 0.213–0.952). Despite poor inter-rater agreement for nonvolar skin, perhaps due to challenges in identifying the dermal–epidermal junction, this study helps to support the utility of optical coherence tomography to distinguish volar from nonvolar skin
Effect of Aspirin Versus Low-Molecular-Weight Heparin Thromboprophylaxis on Medication Satisfaction and Out-of-Pocket Costs: A Secondary Analysis of a Randomized Clinical Trial
BACKGROUND: Current guidelines recommend low-molecular-weight heparin for thromboprophylaxis after orthopaedic trauma. However, recent evidence suggests that aspirin is similar in efficacy and safety. To understand patients\u27 experiences with these medications, we compared patients\u27 satisfaction and out-of-pocket costs after thromboprophylaxis with aspirin versus low-molecular-weight heparin.
METHODS: This study was a secondary analysis of the PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT) trial, conducted at 21 trauma centers in the U.S. and Canada. We included adult patients with an operatively treated extremity fracture or a pelvic or acetabular fracture. Patients were randomly assigned to receive 30 mg of low-molecular-weight heparin (enoxaparin) twice daily or 81 mg of aspirin twice daily for thromboprophylaxis. The duration of the thromboprophylaxis, including post-discharge prescription, was based on hospital protocols. The study outcomes included patient satisfaction with and out-of-pocket costs for their thromboprophylactic medication measured on ordinal scales.
RESULTS: The trial enrolled 12,211 patients (mean age and standard deviation [SD], 45 ± 18 years; 62% male), 9725 of whom completed the question regarding their satisfaction with the medication and 6723 of whom reported their out-of-pocket costs. The odds of greater satisfaction were 2.6 times higher for patients assigned to aspirin than those assigned to low-molecular-weight heparin (odds ratio [OR]: 2.59; 95% confidence interval [CI]: 2.39 to 2.80; p \u3c 0.001). Overall, the odds of incurring any out-of-pocket costs for thromboprophylaxis medication were 51% higher for patients assigned to aspirin compared with low-molecular-weight heparin (OR: 1.51; 95% CI: 1.37 to 1.66; p \u3c 0.001). However, patients assigned to aspirin had substantially lower odds of out-of-pocket costs of at least 25, potentially improving health equity for thromboprophylaxis.
LEVEL OF EVIDENCE: Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence
Effect of Severe Distal Tibia, Ankle, and Mid- to Hindfoot Trauma on Meeting Physical Activity Guidelines 18 Months After Injury
ObjectiveTo examine the effect of severe lower extremity trauma on meeting Physical Activity Guidelines for Americans (PAGA) 18 months after injury and perform an exploratory analysis to identify demographic, clinical, and psychosocial factors associated with meeting PAGA.DesignSecondary analysis of observational cohort study.SettingA total of 34 United States trauma centers PARTICIPANTS: A total of 328 adults with severe distal tibia, ankle and mid- to hindfoot injuries treated with limb reconstruction (N=328).InterventionsNone.Main outcome measuresThe Paffenbarger Physical Activity Questionnaire was used to assess physical activity levels 18 months after injury. Meeting PAGA was defined as combined moderate- and vigorous-intensity activity ≥150 minutes per week or vigorous-intensity activity ≥75 minutes per week.ResultsFewer patients engaged in moderate- or vigorous-intensity activity after injury compared with before injury (moderate: 44% vs 66%, P<.001; vigorous: 18% vs 29%; P<.001). Patients spent 404±565 minutes per week in combined moderate- to vigorous-intensity activity before injury compared with 224±453 minutes postinjury (difference: 180min per week; 95% confidence interval [CI], 103-256). The adjusted odds of meeting PAGA were lower for patients with depression (adjusted odds ratio [AOR], 0.45; 95% CI, 0.28-0.73), women (AOR, 0.59; 95% CI, 0.35-1.00), and Black or Hispanic patients (AOR, 0.49; 95% CI, 0.28-0.85). Patients meeting PAGA prior to injury were more likely to meet PAGA after injury (odds ratio, 2.0; 95% CI, 1.20-3.31).ConclusionsPatients spend significantly less time in moderate- to vigorous-intensity physical activity after injury. Patients with depression are less likely to meet PAGA. Although the causal relationship is unclear, results highlight the importance of screening for depression
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PREVENTion of CLots in Orthopaedic Trauma (PREVENT CLOT): a randomised pragmatic trial protocol comparing aspirin versus low-molecular-weight heparin for blood clot prevention in orthopaedic trauma patients.
IntroductionPatients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. The primary aim of this trial is to compare aspirin with LMWH as a thromboprophylaxis in fracture patients.Methods and analysisPREVENT CLOT is a multicentre, randomised, pragmatic trial that aims to enrol 12 200 adult patients admitted to 1 of 21 participating centres with an operative extremity fracture, or any pelvis or acetabular fracture. The primary outcome is all-cause mortality. We will evaluate non-inferiority by testing whether the intention-to-treat difference in the probability of dying within 90 days of randomisation between aspirin and LMWH is less than our non-inferiority margin of 0.75%. Secondary efficacy outcomes include cause-specific mortality, non-fatal PE and deep vein thrombosis. Safety outcomes include bleeding complications, wound complications and deep surgical site infections.Ethics and disseminationThe PREVENT CLOT trial has been approved by the ethics board at the coordinating centre (Johns Hopkins Bloomberg School of Public Health) and all participating sites. Recruitment began in April 2017 and will continue through 2021. As both study medications are currently in clinical use for VTE prophylaxis for orthopaedic trauma patients, the findings of this trial can be easily adopted into clinical practice. The results of this large, patient-centred pragmatic trial will help guide treatment choices to prevent VTE in fracture patients.Trial registration numberNCT02984384