Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

Validity of various portable devices to measure sit-to-stand velocity and power in older adults

BackgroundMovement velocity and power in a single STS are related to functional performance in older adults. Identifying accessible tools that provide valid measures of STS velocity/power would allow practitioners to evaluate physical function in clinical settings where time, space and finances are limited.Research questionDoes a linear position transducer (LPT), iPhone application (App), and inertial measurement unit (IMU) obtain valid measurements of velocity and power during a single STS compared with 3D motion capture?MethodsTwenty-seven community-dwelling older adults aged ≥60 years completed a single STS test with mean velocity and power simultaneously measured with 3D motion capture, an LPT, IMU and App. Acceptable validity was established if the Pearson correlation coefficient (r) was very high (≥0.7) and bias as a standardised effect size (ES) was small (<0.6). The relationship between STS velocity/power and 30s chair STS performance was also evaluated.ResultsMeasures of STS velocity obtained by the LPT (r = 0.94, ES = −0.21) and App (r = 0.89, ES = −0.19) were very highly valid when compared to 3D motion capture, and were very strongly related to 30s STS performance (r ≥0.74). The LPT (r = 0.87, ES = 0.13) and App (r = 0.74, ES = −0.12) also showed very high correlations and negligible bias for measuring STS power. Data collected by the IMU failed to meet our pre-determined threshold of acceptable validity for STS velocity (r = 0.72, ES = 1.00) or power (r = 0.61, ES = 0.34).SignificanceThe LPT and iPhone App, but not the IMU, are valid tools for measuring STS velocity and power in community-dwelling older adults. Clinicians can use STS velocity obtained by either the LPT or App as a simple and valid proxy for functional status, which could help identify patients at high-risk of incident disability.     

生物电阻抗矢量法评估血液透析合并高血压患者的容量负荷

目的应用生物电阻抗矢量法评估血液透析合并高血压患者的容量负荷,探讨高容量负荷状态对高血压患者预后的影响。方法研究对象来自南京医科大学附属明基医院透析前收缩压(6次透析治疗前平均收缩压值)>160 mmHg的血液透析患者。用生物电阻抗矢量法评估患者容量状态,并根据患者容量状态分为容量增加组和非容量增加组(包括容量正常和容量下降的患者)。比较两组患者临床资料、实验室指标、细胞内液比例(ICW)、细胞外液比例(ECW)、体细胞质量、瘦体重、干瘦体重及其占总体重的百分比、脂肪含量占总体重的百分比、阻抗/身高、容抗/身高、相位角、疾病指数的差异。采用Kaplan⁃Meier生存曲线比较两组患者生存率的差异。结果共51例血液透析合并高血压患者入选本研究,容量增加组19例,非容量增加组32例(容量正常27例,容量下降5例)。容量增加组患者的血白蛋白、前白蛋白、血红蛋白、血细胞比容、血磷较非容量增加组显著下降,淋巴细胞比例明显升高,组间比较差异均有统计学意义(均P<0.05)。容量增加组的细胞外液比例、疾病指数显著高于非容量增加组(均P<0.01);相位角、阻抗/身高、容抗/身高显著低于非容量增加组(均P<0.01)。临床追踪20个月,容量增加组患者血压达标率(透析前收缩压<160 mmHg)低于非容量增加组(26.3%比43.8%),但差异无统计学意义。容量增加组患者全因死亡率高于非容量增加组(26.3%比15.6%),Kaplan⁃Meier生存曲线分析提示两组生存率的差异尚无统计学意义。结论容量负荷增加的血液透析合并高血压患者细胞外液增加明显,营养状态评估指标较非容量增加的高血压患者明显下降,而淋巴细胞比例升高,可能与患者微炎症状态有关。容量负荷增加的高血压患者血压更加难以控制,临床预后可能不及非容量增加的患者。     

Role of Superb Microvascular Imaging in Differentiating Between Malignant and Benign Solid Breast Masses

IntroductionThe purpose of this study was to evaluate the diagnostic performance of superb microvascular imaging (SMI) in breast lesions.Materials and MethodsEighty-five solid breast lesions were studied with color Doppler flow imaging (CDFI), power Doppler imaging (PDI), monochromatic SMI (mSMI), and contrast-enhanced ultrasonography (CEUS). The penetrating vessels (PVs) and microvascular morphologic and distribution features of the breast tumors were evaluated for each modality.ResultsThe diagnostic accuracies of CDFI, PDI, mSMI, and CEUS were calculated and compared. Surgical pathologic analysis showed 47 benign and 38 malignant lesions. Compared with CDFI and PDI, mSMI and CEUS detected more PVs in breast lesions. The microvascular architecture showed significant differences between benign and malignant lesions. Benign lesions mainly displayed avascular, line-like, and branch-like patterns, and malignant lesions tended to display root hair-like and crab claw-like patterns. mSMI and CEUS identified more root hair-like and crab claw-like patterns in malignant lesions than CDFI and PDI. The sensitivity, negative predictive value, and accuracy of mSMI findings in diagnosing malignancy based on PVs and vascular patterns were both higher than those of CDFI and PDI.ConclusionsmSMI is equal to CEUS and superior to CDFI and PDI in identifying microvascular and discriminating malignant and benign breast masses.     

Power Doppler Ultrasound Findings before and after Focused Extracorporeal Shock Wave Therapy for Achilles Tendinopathy: A Pilot Study on Pain Reduction and Neovascularization Effect

Extracorporeal shock wave therapy (ESWT) has been found to have a positive effect in the treatment of pain in Achilles tendinopathy, although the exact mechanism is not yet completely understood. Among the mechanisms suggested to underlie ESWT effects are direct stimulation of healing, neovascularization and direct suppressive effects on nociceptors and hyperstimulation, which would block the gate-control system. The neovascularization observed in flogistic tissue is associated with stimulated nerve fibers around tendons and induces a painful condition. The objectives of the present study were to evaluate the effect of ESWT on pain and function in patients with non-insertional Achilles tendinopathy (NIAT) and to assess the neovascularization phenomenon using power Doppler ultrasound (PDU). Twelve patients with NIAT underwent five sessions of focused ESWT over 5 wk. Outcome measures were the visual analogue scale, the Victorian Institute of Sport Assessment–Achilles questionnaire and active dorsiflexion and plantar flexion ankle articular range of motion. Moreover, the patients’ clinical impressions of treatment results after ESWT were investigated using the Roles and Maudsley score. Patients were assessed at baseline and 1 and 3 mo after treatment. They had a significant reduction in pain with improvement of arthrokinematic motion and functionality and a positive clinical impression of treatment outcome (50% of patients considered their clinical picture as good/excellent after 3 mo). However, the pulse Doppler ultrasound exam did not reveal neovascularization in 91.7% of the patients 1 and 2 mo after focused ESWT, and in some patients there was a reduction in blood vessels related to flogistic processes. The present observational study confirmed the efficacy of ESWT in pain reduction in NIAT, with a higher degree of patient satisfaction, although doubt persists over the neovascularization effect on the Achilles tendons treated.     

The impact of non-thermal injuries in combined burn trauma: A retrospective analysis over the past 35 years

Introduction

Combined burn trauma is rather uncommon and frequently difficult to manage. Historically combined burn trauma contributed to high mortality rates in severely injured patients. The purpose of this study was to determine the incidence, mechanisms and impact of non-thermal injuries in patients with severe burns.

Dorsal root ganglion stimulation for chronic pain modulates Aβ-fiber activity but not C-fiber activity: A computational modeling study

ObjectiveThe goal of this project was to use computational models to investigate which types of primary sensory neurons are modulated by dorsal root ganglion stimulation (DRGS) to provide pain relief.MethodsWe modeled DRGS by coupling an anatomical finite element model of a human L5 dorsal root ganglion to biophysical models of primary sensory neurons. We calculated the stimulation amplitude needed to elicit an action potential in each neuron, and examined how DRGS affected sensory neuron activity.ResultsWe showed that within clinical ranges of stimulation parameters, DRGS drives the activity of large myelinated Aβ-fibers but does not directly activate small nonmyelinated C-fibers. We also showed that the position of the active and return electrodes and the polarity of the stimulus pulse influence neural activation.ConclusionsOur results indicate that DRGS may provide pain relief by activating pain-gating mechanisms in the dorsal horn via repeated activation of large myelinated afferents.SignificanceUnderstanding the mechanisms of action of DRGS-induced pain relief may lead to innovations in stimulation technologies that improve patient outcomes.     

Brain impedance variation of directional leads implanted in subthalamic nuclei of Parkinsonian patients

ObjectiveConventional deep brain stimulation (DBS) systems with ring-shaped leads generate spherical electrical fields. In contrast, novel directional leads use segmented electrodes. Aim of this study was to quantify the impedance variations over time in subjects with the directional Cartesia-Boston® system.MethodsImpedance records, programming settings, and clinical data of 11 consecutive Parkinsonian patients implanted with DBS directional leads in two Italian centers (Udine and Vicenza) were retrospectively evaluated. Data were collected before starting stimulation (in the operating room and at days 5 and 40) and after switching stimulation on at the successive follow-up visits (1, 6 and 12 months).ResultsDirectional leads have significantly higher impedance than ring leads. Stimulated contacts had always lower impedance compared to non-stimulated contacts. Before DBS-on, all contacts had higher impedance in the operating room, with an initial decrease five days post-surgery and a subsequent increase at day 40, more evident for directional contacts. The impedance of directional leads increased post-implantation at 1 and 6 months with a plateau at 12 months.ConclusionsThere was a significant difference between the directional and ring leads at baseline (before activation of DBS) and during follow-up (chronic DBS).SignificanceOur study reveals new information about the impedance of segmented electrodes that is useful for patient management during the initial test period, as well as during long-term DBS follow-up.     

Cost of focality in TDCS: Interindividual variability in electric fields

BackgroundIn transcranial direct current stimulation (TDCS), electric current is applied via two large electrodes to modulate brain activity. Computational models have shown that large electrodes produce diffuse electric fields (EFs) in the brain, which depends on individual head and brain anatomy. Recently, smaller electrodes as well as novel electrode arrangements, including high-definition TDCS (HD-TDCS) montages, have been introduced to improve the focality of EFs. Here, we investigated whether the EFs of focal montages are more susceptible to interindividual anatomical differences.MethodsThirteen TDCS montages, including conventional M1-contralateral forehead montages with different stimulating electrode sizes as well as 4 × 1 HD and bipolar HD montages, producing varying EF focalities were modeled using the finite element method in 77 subjects, with individual anatomically realistic models based on magnetic resonance images.ResultsInterindividual variability of predicted EFs increased with EF focality for conventional M1-contralateral forehead and 4 × 1 HD montages. 4 × 1 HD-TDCS was found to have the highest EF focality and greatest variability. Bipolar HD montages targeting the region between two small electrodes did not follow this pattern, but produced EF magnitudes comparable to those of 4× 1 HD-TDCS, with a minor decrease in focality and lower interindividual variability.ConclusionsEF focality in TDCS was achieved at the cost of increased interindividual variability. Hence, individual modeling is required to plan EF doses when focal montages are used. Among the studied montages, bipolar HD montages provided a compromise between inter-individual variability, focality and magnitude of the predicted EFs.