Subject Participation Research Articles

Research on adaptive impedance control technology of upper limb rehabilitation robot based on impedance parameter prediction.

Introduction: With the aggravation of aging and the growing number of stroke patients suffering from hemiplegia in China, rehabilitation robots have become an integral part of rehabilitation training. However, traditional rehabilitation robots cannot modify the training parameters adaptively to match the upper limbs' rehabilitation status automatically and apply them in rehabilitation training effectively, which will improve the efficacy of rehabilitation training. Methods: In this study, a two-degree-of-freedom flexible drive joint rehabilitation robot platform was built. The forgetting factor recursive least squares method (FFRLS) was utilized to estimate the impedance parameters of human upper limb end. A reward function was established to select the optimal stiffness parameters of the rehabilitation robot. Results: The results confirmed the effectiveness of the adaptive impedance control strategy. The findings of the adaptive impedance control studies showed that the adaptive impedance control had a significantly greater reward than the constant impedance control, which was in line with the simulation results of the variable impedance control. Moreover, it was observed that the levels of robot assistance could be suitably modified based on the subject's different participation. Discussion: The results facilitated stroke patients' upper limb rehabilitation by enabling the rehabilitation robot to adaptively change the impedance parameters according to the functional status of the affected limb. In clinic therapy, the proposed control strategy may help to adjust the reward function for different patients to improve the rehabilitation efficacy eventually.

Research on information collaboration strategy of fresh agricultural products supply chain under carbon cap-and-trade

The information coordination of fresh agricultural products supply chain is conducive to improving the overall efficiency and competitiveness of the supply chain, and reducing carbon emissions. Under the carbon cap-and-trade policy, this paper constructed an evolutionary game model of supply chain information collaboration involving a fresh agricultural products supplier, a cold chain logistics service provider and a fresh agricultural products retailer, explored the selection of information collaboration strategies of each subject, and simulated it with system dynamics. The results show that: The stability strategy of the game system is related to the initial willingness of each subject. When any two parties participate in information collaboration, the other party will also choose to participate in collaboration. In addition, the choice of information collaboration strategy of the subject is also related to the collaborative planning ability, collaborative strategy formulation ability, consumers’ preference, the initial cost of each subject, revenue sharing and cost sharing mechanism, government subsidies, government regulation and carbon cap-and-trade policy. It is worth noting that the collaborative planning capability is more conducive to promoting the subject to choose information collaborative strategy than the collaborative strategy formulation capability; the carbon trading price has a greater impact on the subject’s participation in collaboration, while the total amount of carbon quota has no impact on the choice of the subject’s information collaboration strategy. Furthermore, based on the research results, the corresponding management suggestions are put forward from the two aspects of the government and the participants.

A Phase 3b, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-Njft (P1101) in Adult Patients with Polycythemia Vera

Background and Significance: Polycythemia vera (PV), the most common chronic myeloproliferative neoplasm in the United States, is a long-term, debilitating, life-threatening cancer with limited treatment options. Most patients with PV receive phlebotomy and low-dose aspirin to prevent thrombosis. Cytoreductive therapy is recommended for high-risk and in some low-risk patients. Ropeginterferon alfa-2b-njft (P1101) is the first and only FDA-approved interferon for treating PV regardless of patients' risk category or past treatment history. The FDA-approved dosing for ropeginterferon alfa-2b-njft in patients with PV is a starting dose of 50 or 100 mcg every 2 weeks, with dose increases of 50 mcg every 2 weeks up to a maximum of 500 mcg. Clinical trial results confirmed high complete hematologic response (CHR) rates and molecular responses to ropeginterferon alfa-2b-njft, however, time to achieve CHR can take 6 months or longer because dose escalation to the highest maintenance dose ranged from 16 to 28 weeks. It is expected that the faster and simpler dosing scheme of 250-350-500 mcg, escalated every 2 weeks may allow patients to achieve complete hematologic responses significantly earlier with acceptable tolerability and safety. This notion was supported in a recently reported clinical study (Jin et al. Exp Hematol Onc 2023). To further assess the 250-350-500 mcg dosing regimen, this Phase 3b, randomized, open-label, parallel group, multicenter study (NCT05481151) of U.S. and Canadian patients will evaluate the efficacy and safety of ropeginterferon alfa-2b-njft when using the above described dose-escalation scheme directly compared with the approved dosing scheme. Study Design and Methods: The planned enrollment for this study is approximately 100 patients with PV aged ≥18 years from the U.S. and Canada. Patients will be randomized (1:1) into either the approved dosing regimen arm or the amended dose-escalation scheme arm (Figure 1). Inclusion criteria include diagnosis of PV according to the WHO 2008 or 2016 criteria, hemoglobin ≥10 g/dL for females, and hemoglobin ≥11 g/dL for males at screening, neutrophil count ≥1.5 × 10 9/L at screening. Exclusion criteria include: any contraindications to interferon alfa or hypersensitivity to interferon alfa, having stopped prior interferon alfa therapy due to low efficacy or poor tolerability, severe or serious diseases or any other diseases that the investigator determines may affect the subject's participation in this study, or the use of any investigational drug <4 weeks prior to the first dose of ropeginterferon alfa-2b-njft. Treatment-naïve patients and those pretreated with hydroxyurea (HU) will be included. Patients in the approved dosing arm will undergo HU tapering by 25% for the first 2 weeks, followed by 50% for weeks 3-4, 75% for weeks 5-6, and discontinuing completely during week 7 and onwards. Patients in the amended dose-escalation scheme arm are required to discontinue HU immediately upon initiation of ropeginterferon alfa-2b-njft. The primary efficacy endpoint is CHR (defined as hematocrit <45% in the absence of phlebotomy in the previous 12 weeks, white blood cell count ≤10 × 10 9/L, and platelets ≤400 × 10 9/L) at Week 24. Secondary endpoints include time to CHR, proportion of patients in CHR at Weeks 8, 12, 16, 20, 24, 36, and 48; time to maintenance dose (stable dose for 3 consecutive doses); and time to freedom from phlebotomies. The core treatment period will be 24 weeks followed by a 24-week extension period and a 4-week safety follow-up. Ropeginterferon alfa-2b-njft (P1101) will be provided in single-use 500-mcg prefilled syringes for subcutaneous administration every 2 weeks. The approved dosing arm will initiate with a starting dose of 100 mcg (Day 0) and increase by 50-mcg every 2 weeks up to a maximum dose of 500 mcg. The amended dosing arm will initiate with a starting dose of 250 mcg (Day 0), increase to 350 mcg at Week 2, and increase to a maximum of 500 mcg at Week 4. Dose adjustments will be allowed if safety or tolerability concerns arise. Cochran-Mantal-Haenszel test stratified by investigator sites will be used for analyzing the primary efficacy endpoint at Week 24. General statistical summaries will be applied to primary and secondary endpoints. For categorical variables, frequency and percentage will be presented with a 95% confidence interval.

Application of the Validated Social Assessment Instrument for Liver Transplantation Candidates

The use of appropriate instruments for social assessment in health aims at both the participation of the subject and effectiveness in resolving demands. The objective of this study was to characterize the population assessed by the Validated Social Assessment Instrument and its implications; a descriptive, documental study with participant and dialectical observation. The data survey were taken from the social assessments applied from July 2020 to June 2021 in a transplant center in northwestern São Paulo state in Brazil. Descriptive statistics were performed. The 65 social evaluations of candidates for liver transplantation (LTx) have presented the following sociodemographic characteristics: male sex (n=47; 72.3%); mean age of 55.05 years (range: 24-75 years old); with a partner (n=50; 76.9%); low education level (n=30; 46.2%); and coming from the state of São Paulo (n=54; 83.1). Of those evaluated, 48 candidates (74%) were professionally inactive and 37 (56.9%) received assistance or social security benefits; 62 (95.4%) had a family caregiver; 61 (93.9%) had a resolutive compliance family response; 57 (87.7%) had facilitated accessibility; 59 (90.8%) met satisfactory housing standards; and 60 (92.3%) had full acceptance for LTx. The 65 candidates' (100%) social opinions were favorable, and 21 (32.3%) had some limitations and required further assistance. All of them received basic and specific social orientations, and 25 (38.5%) required social referrals. The variables have allowed a view at the totality of the social being in addition to widening the subject's participation in order to identify the real demands and facilitate the monitoring of actions, thus contributing for favorable conditions for treatment.

Development and Electromyographic Validation of a Compliant Human-Robot Interaction Controller for Cooperative and Personalized Neurorehabilitation.

BackgroundAppropriate training modalities for post-stroke upper-limb rehabilitation are key features for effective recovery after the acute event. This study presents a cooperative control framework that promotes compliant motion and implements a variety of high-level rehabilitation modalities with a unified low-level explicit impedance control law. The core idea is that we can change the haptic behavior perceived by a human when interacting with the rehabilitation robot by tuning three impedance control parameters.MethodsThe presented control law is based on an impedance controller with direct torque measurement, provided with positive-feedback compensation terms for disturbances rejection and gravity compensation. We developed an elbow flexion-extension experimental setup as a platform to validate the performance of the proposed controller to promote the desired high-level behavior. The controller was first characterized through experimental trials regarding joint transparency, torque, and impedance tracking accuracy. Then, to validate if the controller could effectively render different physical human-robot interaction according to the selected rehabilitation modalities, we conducted tests on 14 healthy volunteers and measured their muscular voluntary effort through surface electromyography (sEMG). The experiments consisted of one degree-of-freedom elbow flexion/extension movements, executed under six high-level modalities, characterized by different levels of (i) corrective assistance, (ii) weight counterbalance assistance, and (iii) resistance.ResultsThe unified controller demonstrated suitability to promote good transparency and render both compliant and stiff behavior at the joint. We demonstrated through electromyographic monitoring that a proper combination of stiffness, damping, and weight assistance could induce different user participation levels, render different physical human-robot interaction, and potentially promote different rehabilitation training modalities.ConclusionWe proved that the proposed control framework could render a wide variety of physical human-robot interaction, helping the user to accomplish the task while exploiting physiological muscular activation patterns. The reported results confirmed that the control scheme could induce different levels of the subject's participation, potentially applicable to the clinical practice to adapt the rehabilitation treatment to the subject's progress. Further investigation is needed to validate the presented approach to neurological patients.

592-P: Patient Perception of RT-CGM for Lifestyle Change Six Months after Two Sessions of RT-CGM

Background: Real-time continuous glucose monitoring (RT-CGM) provides glucose readings to patients with diabetes, potentially supporting self-care. Preliminary data suggests efficacy of these devices influencing behavior change but data are limited on the sustainability of this change following short term use. Methods: Following completion of a 14 week intervention involving use of RT-CGM as a behavior modification tool, a 6 month follow up survey was conducted. The survey included ten questions evaluating the impact of the subject's participation in the study on their continued lifestyle and health. The final question of the survey inquired if the subject had a significant other available to answer questions regarding their awareness of the subject's participation and impact on their own lifestyle choices. Results: Twenty-two participants with diabetes participated in the initial intervention, of which sixteen responded to the survey. In the six months since their participation, 100% of respondents reported that CGM continues to contribute to a healthier lifestyle. 75% reported that they have excluded or limited certain foods as a result of participating and participation has motivated them to increase activity level. If available, 88% reported that they would you like to wear a CGM device on a regular basis. 68.8 % reported subjective weight loss since participating in the study with 7 (63.7%) of those participants reporting a weight loss of 10lbs or greater. Of the 16 participants, 3 subjects had a significant other that lived with the subject throughout the study and was able to be contacted. Of these three, 1 reported feeling healthier and changing their food choices as a result of their partner wearing a CGM. Conclusion: In patients with diabetes, RT-CGM creates a sustainable lifestyle impact 6 months following use and is a desired tool for self care. However, longer prospective studies need to be completed. Further evaluation of RT-CGM contribution to the “health” of the household is also needed. Disclosure M. W. Porter: None. L. Needleman: None. S. Ramhmdani: None. N. M. Ehrhardt: Advisory Panel; Self; Novo Nordisk, Research Support; Self; Dexcom, Inc., Merck & Co., Inc., Novo Nordisk.

A New Ankle Robotic System Enabling Whole-Stage Compliance Rehabilitation Training

Robot-assisted physical therapy can encourage a subject's voluntary participation to achieve rapid motor function recovery. To enhance the subject's cooperation, and training safety during training sessions, we develop a new ankle robotic system with three rehabilitation training strategies based on an admittance controller, namely, patient-passive compliance exercise, isotonic exercise, and patient-active exercise, which fully consider the patient's muscle strength level, and different stages of recovery. The developed parallel two-UPS/RRR ankle rehabilitation robot is actuated by two servo linear actuators, and one servo motor, and has three rotational degrees of freedom. The mechanism is simple, and ensures that the rotation center of the ankle joint complex from different patients coincides with the robot's rotation center. All three strategies are based on the admittance controller, and its derivatives, and the controller's output is obtained based on proportional, and time-shifting methods according to the continuous measured torque. In particular, the developed two-UPS/RRR ankle robotic system covers the whole-stage compliance rehabilitation training, ensuring the safety of full-cycle training sessions. Experiments of the three rehabilitation training strategies were carried out on five healthy subjects, with the results showing good compliance, and trajectory tracking performance.

A Novel Robot-Aided Upper Limb Rehabilitation Training System Based on Multimodal Feedback

During robot-aided rehabilitation exercises, monotonous, and repetitive actions can, to the subject, feel tedious and tiring, so improving the subject's motivation and active participation in the training is very important. A novel robot-aided upper limb rehabilitation training system, based on multimodal feedback, is proposed in this investigation. To increase the subject's interest and participation, a friendly graphical user interface and diversiform game-based rehabilitation training tasks incorporating multimodal feedback are designed, to provide the subject with colorful and engaging motor training. During this training, appropriate visual, auditory, and tactile feedback is employed to improve the subject's motivation via multi-sensory incentives relevant to the training performance. This approach is similar to methods applied by physiotherapists to keep the subject focused on motor training tasks. The experimental results verify the effectiveness of the designed multimodal feedback strategy in promoting the subject's participation and motivation.

Toward Multimodal Human-Robot Interaction to Enhance Active Participation of Users in Gait Rehabilitation.

Robotic exoskeletons for physical rehabilitation have been utilized for retraining patients suffering from paraplegia and enhancing motor recovery in recent years. However, users are not voluntarily involved in most systems. This paper aims to develop a locomotion trainer with multiple gait patterns, which can be controlled by the active motion intention of users. A multimodal human-robot interaction (HRI) system is established to enhance subject's active participation during gait rehabilitation, which includes cognitive HRI (cHRI) and physical HRI (pHRI). The cHRI adopts brain-computer interface based on steady-state visual evoked potential. The pHRI is realized via admittance control based on electromyography. A central pattern generator is utilized to produce rhythmic and continuous lower joint trajectories, and its state variables are regulated by cHRI and pHRI. A custom-made leg exoskeleton prototype with the proposed multimodal HRI is tested on healthy subjects and stroke patients. The results show that voluntary and active participation can be effectively involved to achieve various assistive gait patterns.

Effect of probiotics on digestibility and immunity in infants: A study protocol for a randomized controlled trial.

The gastrointestinal (GI) tract of a fetus in utero is sterile but it becomes colonized with environmental microorganisms shortly after birth. Since the gut microbiota undergoes substantial changes in early life, healthy gut microflora is essential to an infant's gut health and immune system and probably also has an effect on overall health status in later life. Probiotics, defined as viable microbial preparations that have a beneficial effect on the health of the host, represent a rapidly expanding field. Although randomized controlled trials using probiotics in infants have shown promising results in the prevention and treatment of common diseases such as diarrhea and allergy, little is known about whether probiotics could offer benefits to healthy infants. We have designed a randomized controlled trial to test the hypothesis that an oral preparation of probiotics is superior to placebo in improving digestive and immune function in healthy infants.The trial will be a randomized, double-blind, placebo-controlled, 2-parallel-group study in Shanghai, China. After a 2-week run-in period, 200 exclusively formula-fed healthy infants aged 4 to 6 months will be randomly allocated to receive either a probiotic product containing Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052 or an identical placebo once daily for 4 weeks and will be followed up for 8 weeks. The duration of the subject's participation will be 14 weeks, with a total of 5 visits: inclusion (Visit 1, Day 1), start of intervention (V2, D15), end of intervention (V3, D44), and follow-up (V4 and V5, D72 and D100). Stool and saliva samples will be collected at the first 3 visits to measure microbial populations and secretory immunoglobulin A (SIgA), respectively. Physical examination will be performed at each visit, and tolerance records will be completed 1 day prior to each visit. The primary endpoints will be the changes in the composition of fecal microbiota, particularly the Bifidobacterium bifidum population. The secondary endpoints will include the change in salivary SIgA level, growth parameters, digestive tolerance, and adverse events.An effective, practical, and acceptable probiotic intervention in manipulating the gut microbiota and boosting the immune system in formula-fed infants would represent a major clinical advance. The administration of probiotic supplementation or follow-on formula to infant may be associated with some clinic benefits.

Beyond perezhivanie, sense, and language: An empirical study of early childhood teachers' subjective senses

Based on the Theory of Subjectivity in a cultural-historical perspective, this paper presents an empirical study of two infant teachers and their subjective dynamics of being enchanted with singular aspects of their professional lives. Through the constructive-interpretative principle driven from the Qualitative Epistemology, the study aims to understand the relationship between the subjects and the specific manner in which they express ways of being and feeling as early childhood teachers. The way teachers express themselves indicates the way they experience their working lives in a symbolic and emotional amalgam which cannot otherwise be captured from a formal linguistic perspective and in isolation from the subject's integral expression. A review of Vygotsky's concepts of perezhivanie and sense highlights the value of two common characteristics widely considered in the current development of our theoretical approach. Both concepts (1) compose an integrated theoretical model of psychic functioning, and (2) are oriented towards the quality of the subject's participation in his/her everyday life's processes. The study challenges cognitive-linguistic reductionist bias and demonstrates the value of the concept of subjective senses as a theoretical alternative. Consequently, it enhances our understanding of the symbolic-emotional nature in which individuals shape their life stories through their current experiences.International Research in Early Childhood Education, vol. 7, no. 1, p. 219-237

EEG Analysis During Active and Assisted Repetitive Movements: Evidence for Differences in Neural Engagement.

Two key ingredients of a successful neuro-rehabilitative intervention have been identified as intensive and repetitive training and subject's active participation, which can be coupled in an active robot-assisted training. To exploit these two elements, we recorded electroencephalography, electromyography and kinematics signals from nine healthy subjects performing a 2×2 factorial design protocol, with subject's volitional intention and robotic glove assistance as factors. We quantitatively evaluated primary sensorimotor, premotor and supplementary motor areas activation during movement execution by computing event-related desynchronization (ERD) patterns associated to mu and beta rhythms. ERD patterns showed a similar behavior for all investigated regions: statistically significant ERDs began earlier in conditions requiring subject's volitional contribution; ERDs were prolonged towards the end of movement in conditions in which the robotic assistance was present. Our study suggests that the combination between subject volitional contribution and movement assistance provided by the robotic device (i.e., active robot-assisted modality) is able to provide early brain activation (i.e., earlier ERD) associated with stronger proprioceptive feedback (i.e., longer ERD). This finding might be particularly important for neurological patients, where movement cannot be completed autonomously and passive/active robot-assisted modalities are the only possibilities of execution.

Investigating Effects of Cyclosporine on Eltrombopag Pharmacokinetics in Healthy Volunteers: A Phase 1 Crossover, Drug-Drug Interaction Study

Background: Eltrombopag, an orally bioavailable thrombopoietin receptor agonist, is approved for the treatment of chronic idiopathic thrombocytopenic purpura (adults and children), hepatitis C virus-related thrombocytopenia, in multiple countries. In the US, eltrombopag is also approved for severe aplastic anemia (SAA) in patients with insufficient response to immunosuppressive therapy. In SAA, patients frequently take cyclosporine (CsA), concurrently with eltrombopag. Eltrombopag is a substrate of breast cancer resistance protein (BCRP), and CsA is reported to be an inhibitor of this transporter. To assess this BCRP interaction further, the effect of CsA on plasma pharmacokinetics (PK) of eltrombopag was assessed in a clinical drug-drug interaction study in healthy human subjects.Methods: In a phase 1, open-label, randomized, three-period crossover study, healthy subjects were randomized to one of the three treatment sequences: (D0, D1, D2), (D1, D0, D2), or (D1, D2, D0), where D0 = 50 mg eltrombopag, D1 = 50 mg eltrombopag + 200 mg CsA, and D2 = 50 mg eltrombopag + 600 mg CsA. Eltrombopag was administered on the first day of each treatment period. On Day -1 of each treatment period, subjects checked into the clinical research unit, where they remained until the 72-hour PK blood draw on Day 4. After a 3- to 10-day washout period, they returned for Day 1 of the next treatment period. The total duration of a subject's participation in the study from screening to final discharge was approximately 6 weeks (assuming 3-day washouts between treatment periods). Safety and PK were analyzed during each period.Results: Thirty-nine healthy subjects were randomized to receive treatment (13 subjects per treatment sequence); 28 (72%) were men and 11 (28%) were women. All 39 subjects completed the study; all subjects were included in the PK and safety analyses. In general, the plasma eltrombopag PK profiles were consistent across the three treatment arms and consistent with that previously reported for eltrombopag in healthy adult subjects (see Figure). Plasma eltrombopag PK parameters and their statistical comparisons are shown in the Table below. On average, eltrombopag AUC(0-inf) and Cmax decreased by 18% and 25%, respectively, when coadministered with 200 mg CsA and decreased by 24% and 39% when coadministered with 600 mg CsA. Median time to Cmax (tmax) of eltrombopag increased from 3 hours to 4 hours in the presence of 200 mg and 600 mg CsA. The most common adverse events (AE) were hot feeling (62%), headache (36%), and nausea (18%). Except for one subject who had a Grade 2 headache, all AEs reported during the study were Grade 1 events. No clinically significant abnormal electrocardiograms were reported. There were no severe adverse events in this study.Conclusions: Given that the eltrombopag dose adjustment is permitted during the course of treatment for achieving the target platelet count, the decrease in exposure following co-administration of 200 mg or 600 mg CsA was not considered clinically meaningful, and therefore no starting dose adjustment is recommended when eltrombopag is co-administered with CsA.Funding: This study was sponsored by GlaxoSmithKline; eltrombopag is an asset of Novartis AG as of March 2, 2015. [Display omitted] [Display omitted] DisclosuresZhang:Parexel: Employment. Erickson-Miller:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership, Patents & Royalties: Patents but no royalties. Chan:Novartis Pharmaceuticals Corporation: Employment. Zhou:Novartis Pharmaceuticals Corporation: Employment.

Correlates of male involvement in maternal and newborn health: a cross-sectional study of men in a peri-urban region of Myanmar.

BackgroundEvidence suggests that increasing male involvement in maternal and newborn health (MNH) may improve MNH outcomes. However, male involvement is difficult to measure, and further research is necessary to understand the barriers and enablers for men to engage in MNH, and to define target groups for interventions. Using data from a peri-urban township in Myanmar, this study aimed to construct appropriate indicators of male involvement in MNH, and assess sociodemographic, knowledge and attitude correlates of involvement.MethodsA cross-sectional study of married men with one or more children aged up to one year was conducted in 2012. Structured questionnaires measured participants’ involvement in MNH, and their sociodemographic characteristics, knowledge and attitudes. An ordinal measure of male involvement was constructed describing the subject’s participation across five areas of MNH, giving a score of 1–4. Proportional-odds regression models were developed to determine correlates of male involvement.ResultsA total of 210 men participated in the survey, of which 203 provided complete data. Most men reported involvement level scores of either 2 or 3 (64 %), with 13 % reporting the highest level (score of 4). Involvement in MNH was positively associated with wives’ level of education (AOR = 3.4; 95 % CI: 1.9-6.2; p < 0.001) and men’s level of knowledge of MNH (AOR = 1.2; 95 % CI: 1.1-1.3; p < 0.001), and negatively correlated with number of children (AOR = 0.78; 95 % CI: 0.63-0.95; p = 0.016).ConclusionsThese findings can inform the design of programs aiming to increase male involvement, for example by targeting less educated couples and addressing their knowledge of MNH. The composite index proved a useful summary measure of involvement; however, it may have masked differential determinants of the summed indicators. There is a need for greater understanding of the influence of gender attitudes on male involvement in Myanmar and more robust indicators that capture these gender dynamics for use both in Myanmar and globally.Electronic supplementary materialThe online version of this article (doi:10.1186/s12884-015-0561-9) contains supplementary material, which is available to authorized users.

Research on the E-Commerce Model of Small and Medium Enterprises

In this paper, the SME e-business financing for the study, analysis of business operation mode based e-commerce platform, focusing on big data platform based in the cloud as a means of e-business financing model, to a certain extent to solve the financing market asymmetric information problems in order to achieve the factory operation SME financing; while its limitations, namely the closed nature of the platform, the limited nature of the subject's participation as a breakthrough, build e-commerce platform as the core to the line a variety of financial non-financial large financial institutions to participate in party mode, to solve financing problems of SMEs. The end of the analysis of the profitability of the parties involved, as well as problems and deficiencies that may be encountered, verify its economic viability and future development of the platform to do a certain degree of outlook.

Bayesian Semi- and Non-parametric Models for Longitudinal Data with Multiple Membership Effects in R.

We introduce growcurves for R that performs analysis of repeated measures multiple membership (MM) data. This data structure arises in studies under which an intervention is delivered to each subject through the subject's participation in a set of multiple elements that characterize the intervention. In our motivating study design under which subjects receive a group cognitive behavioral therapy (CBT) treatment, an element is a group CBT session and each subject attends multiple sessions that, together, comprise the treatment. The sets of elements, or group CBT sessions, attended by subjects will partly overlap with some of those from other subjects to induce a dependence in their responses. The growcurves package offers two alternative sets of hierarchical models: 1. Separate terms are specified for multivariate subject and MM element random effects, where the subject effects are modeled under a Dirichlet process prior to produce a semi-parametric construction; 2. A single term is employed to model joint subject-by-MM effects. A fully non-parametric dependent Dirichlet process formulation allows exploration of differences in subject responses across different MM elements. This model allows for borrowing information among subjects who express similar longitudinal trajectories for flexible estimation. growcurves deploys "estimation" functions to perform posterior sampling under a suite of prior options. An accompanying set of "plot" functions allow the user to readily extract by-subject growth curves. The design approach intends to anticipate inferential goals with tools that fully extract information from repeated measures data. Computational efficiency is achieved by performing the sampling for estimation functions using compiled C++.

Should Patients with Severe Reflux Esophagitis Undergo Repeat Endoscopy After 8 to 12 Weeks of Proton Pump Inhibitor (PPI) Therapy to Exclude Underlying Barrettʼs Esophagus (BE)? Preliminary Results from Two Prospective Trials

Purpose: Retrospective reports have suggested that 5-25% of patients with reflux esophagitis (RE) at baseline, who undergo repeat esophagogastroduodenoscopy (EGD) following PPI therapy, have concomitant BE—most short in segment length. Given the retrospective nature of these reports, it is not clear how many patients had intestinal metaplasia of the cardia misdiagnosed as BE. We are recruiting subjects with RE into 2 prospective studies, each with different primary aims. A uniting secondary aim is to assess the prevalence of suspected and unsuspected BE in patients with RE treated with PPI therapy for 8-12 weeks. Methods: Subjects from two studies were pooled for this analysis. Study A's primary aim is to assess the role of compliance in GERD symptom resolution in subjects with Los Angeles (LA) grades B, C and D RE. Follow-up EGD was left to the discretion of the primary physician. Study B's primary aim is to compare the percent of subjects with LA grades C and D RE who achieve resolution after 8 weeks PPI treatment (morning vs. bedtime dosing). Follow-up EGD was mandatory. Endoscopists were not informed of the subject's participation in a research study. Subjects previously diagnosed with BE were excluded from this analysis. Results: Study A recruited 50 subjects [25 (50%) male, mean age 56 (SD 15), B=40, C=5, D=5], of whom 10 [4 (40%) male, mean age 58 (SD 15), B=7, C=1, D=2] had a follow-up EGD. To date, Study B has recruited 57 subjects of which 45 [31 (69%) male, mean age 56.8 (SD 13), C=27, D=18] have undergone a follow-up EGD. Thus, 55 subjects (B=7, C=28, D=20, BMI 31.5) have undergone baseline and follow-up EGD after 8-12 weeks PPI therapy and are the subjects of this analysis. Five (C=3, D=2) of 55 (9%) subjects were newly diagnosed with biopsy-proven BE at follow-up EGD [overall 2 (40%) male; mean age 55 (SD 11); BMI 35.3, short (< 3 cm) N=4 (2 male, lengths ranging from islands to 2 cm); long (>3 cm) N=1 (0 male, 5 cm). In 5 (100%) cases, BE was unexpected. The BMI of the 50 RE subjects who did not have BE at follow up EGD was 31.3 (p=0.16). Conclusion: In this prospective study, 10% of subjects with LA grade C or D RE had concomitant BE that could not be recognized during the initial endoscopy in the setting of diffuse inflammation. Unsuspected BE was not found in subjects with LA grade B RE. Subjects with RE and BE tended to be more obese than subjects with RE alone, although this finding did not achieve statistical significance. These prospective results suggest that patients with severe LA grade C or D disease undergo repeat EGD after 8 to 12 weeks of PPI therapy to exclude underlying BE. Disclosure: Dr Alexander - Consulting Meritigae Pharmacia and Wyeth; Research Funding - Merck, Novartis, and Glaxo Smith Kline. Dr Howden - Consultant - Santarus and Takeda, Speakers Bureau - Santarus and Takeda. Dr Romero - Grant/Research Support and Consultant, Santarus, makers of omeprazole/sodium bicarbonate (Zegerid), and Grant/Research Support and Consultant, AstraZeneca, makers of esomeprazole (Nexium). No disclosures for: Drs Jung, Francis, Arora, Grothe, Enders, Dabade, Murray, Farrugia, Kane, Buttar, Crowell, Locke, Wong Kee Song, Wang, Prasad, Sharma, Namasivayam, and Achem, and Mrs Geno, Fredericksen, and Diehl. This research was supported by an industry grant from AstraZeneca funded Study A in this abstract. They supplied esomeprazole. Santarus funded Study B in this abstract. They supplied omeprazole/sodium bicarbonate. Note, they are both referred to as PPI therapy. The names of their products are not described in the abstract.

Work Analysis And Autonomy – Socialisme ou Barbarie's Concept of Revolutionary Work Research

"Socialisme ou Barbarie", Castoriadis' political group from 1949 to 1967, was not only an independent and original project of left-wing activism in post-war France, but also the source of a novel concept of work analysis that still stimulates today’s researchers. Crucial was their attempt to analyse daily work and work experiences and to search for the hidden traces of self-organisation. The core finding at work is that the contradictory bureaucratic organisation requires the subject's participation (inclusion) and his/her exclusion at the same time. Bureaucratisation for Castoriadis was the characteristic and – differing from Weber – pseudo-rational tendency of modern capitalism, expressing itself most clearly in the realm of work. In this sense Castoriadis draws a good deal of his theoretical inspiration from "Socialisme ou Barbarie's" work analysis. The group tried to establish a work research in revolutionary perspective with qualitative, most authentic methods to gain informations: through the collection of testimonials of proletarian experiences and their self-interpretation by their authors themselves ("témoignages"). These témoignages are thick descriptions of daily work life and of work experiences. Its insights from the inside inform us about the double life of the enterprise as a formal and informal organisation. And since inclusion and exclusion tendencies here exist as parallels, autonomy and heteronomy seem to be simultaneous tendencies in bureaucratic organisations. From here derives the group's and Castoriadis' temporary optimism and their hope to find germs of autonomy and of emancipation and to advance work's and society's humanisation.

Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.

Estimation of the intervention effect in a non-randomized study with pre- and post-mismeasured binary responses

In non-randomized clinical studies, the regression phenomenon can confound interpretation of the effectiveness of an intervention. The regression effect arises due to daily variation and/or misclassification of the biologic marker used in selection as well as in the assessment of the intervention effect. We consider a scenario in which the selection criterion for a subject's participation in the study is such that he/she must have a positive diagnostic test at screening. The disease status is then reassessed at the end of intervention. Thus, two repeated measurements of a binary disease outcome are available, with only selected subjects having a second measurement upon follow-up. We propose methods for estimating the change in event probability resulting from implementing the intervention while adjusting for the misclassification that produces the regression effect. We extend this approach to estimation of both the placebo and intervention effects in placebo-controlled studies designed with a misclassified binary outcome. Analyses of two biomedical studies are used for illustration.