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OBJECTIVE: Advanced pneumatic compression devices (APCDs) have been shown to be an effective intervention for lymphedema when used as part of a self-care maintenance treatment regimen. However, adherence to self-care is poor, and APCDs require patients to be immobile during treatment. We sought to evaluate the safety and efficacy of a novel non-pneumatic compression device (NPCD) for treating lymphedema versus an APCD. METHODS: A randomized, crossover head-to-head investigation at five US sites in 2021. Patients were randomized to either the NPCD or a commercially-available APCD. Subjects used the randomly assigned initial device for 28 days with a 4-week washout period prior to a comparable 28-day utilization of the second device. RESULTS: Data from 50 adult women with unilateral breast cancer-related lymphedema (BCRL) were analyzed. When compared with the APCD, the NPCD was associated with greater mean reduction in limb edema volume (64.6% vs. 27.7%, p<0.001), significantly greater mean improvements in quality of life scores, greater adherence (95.6% vs. 49.8%, p<0.001), and greater satisfaction with the device (90% vs. 14%, p<0.001). Patients indicated that the NPCD facilitated exercise and was convenient for travel. No adverse events were reported. CONCLUSIONS: The novel NPCD is an effective maintenance treatment for reducing limb volume in BCRL patients. The device was more effective than an APCD and resulted in higher adherence to self-care interventions and greater patient satisfaction.
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Background: Our aim is to propose a framework for the development of a research case definition of lipedema, based on current available literature and those observations that can be applied to future lipedema research with the intent to standardize and strengthen the scientific evidence base. Methods and Results: We conducted a narrative review of the literature, and identified consensus characteristics and disputed characteristics that could be included in a research case definition of lipedema. After considering the strength of the evidence and how each characteristic might be measured in a research study, we recommended an approach for the development of a research case definition of lipedema that would be based on consideration of five agreed-upon characteristics, and five disputed, or less substantiated, characteristics as additional evidence to enhance specificity. Conclusions: We present a case definition framework for lipedema drawn from the scientific literature that can be applied to future studies on lipedema. Utilizing this framework should help to increase the sensitivity and specificity of case definition and provide an opportunity for meta-analysis of clinical studies and facilitate future research intercomparisons.
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