The importance of how research participants think they are perceived: results from an electronic monitoring study of antiretroviral therapy in Uganda

Novel monitoring technologies in HIV research, such as electronic adherence monitors (EAMs), have changed the nature of researcher-participant interactions. Yet little is known about how EAMs and the resulting interaction between researchers and participants affect research participation and the data gathered. We interviewed participants and research assistants (RAs) in an observational cohort study involving EAMs for HIV antiretroviral therapy (ART) in Uganda. We qualitatively explored interviewees’ views about ethical issues surrounding EAMs and assessed data with conventional and directed content analysis. Participants valued their relationships with RAs and were preoccupied with RAs’ perceptions of them. Participants were pleased when the EAM revealed regular adherence, and annoyed when it revealed non-adherence that contradicted self-reported pill-taking behavior. For many, the desire to maintain a good impression incentivized adherence. But some sought to creatively conceal non-adherence, or refused to use the EAM to avoid revealing non-adherence to RAs. These findings show that participants’ perceptions of the study staff's perceptions of them affected the experience of being monitored, study participation, and ultimately the data gathered in the study. Investigators in monitoring-based research should be aware that social interactions between participants and study staff could affect both the practical and ethical conduct of that research.     

数据科学驱动下ESI潜力学科入围预测方法的实践探索

为研究“双一流”建设过程中ESI潜力学科入围全球前1%的预测方法与“暗数据”可视化分析思路的耦合关系，定期抓取与追踪ESI学科数据，合并使用WOS-SCIE、InCites、ESI、SQL数据库，联用SWOT分析法、文献调研法和回归分析法等，实现机构学科潜力全景分析，构建潜力学科入围所需论文篇数的线性预测公式，并分别从绝对指标和相对指标的不同维度搭建入围预测的绝对指标和相对指标2个数据模型，尝试对ESI潜力学科进行趋势预测，拟归纳合理或通用的预测方法，以期进一步挖掘未来的潜力学科。     

Assessment of collateral hand circulation by modified Allen’s test in normal Indian subjects

BackgroundAllen’s test (AT) and Modified Allen’s Test (MAT) are used as screening methods for assessment of the hand circulation. Few people lack the dual blood supply of hand and are at risk of hand ischemia after any intervention on radial artery. The Purpose of the study was to assess the collateral circulation of hand using MAT in normal Indian subjects and in elderly population to know the prevalence of positivity of Allen’s test.Methods900 participants (1800 hands) were divided in two groups. Group I had participants with age <50 years and group II had participants with age ≥50 years. MAT was performed in all participants and results were compared between the two groups.ResultsIn group I (n = 450, 900 hands), 313 were males and 137 were females, with mean age of 35.04 years. The relative percentages of a normal, equivocal, borderline and abnormal MAT were 77.8%, 16.6%, 3.7% and 1.6%, respectively. In group II (n = 450, 900 hands), 248 were males and 202 were females, with mean age of 60.4 years. The relative percentages of a normal, equivocal, borderline and abnormal MAT were 69.0%, 18.6%, 6.60% and 5.66%, respectively. A positive/abnormal test was significantly more common (5.66% Vs 1.66%, P < 0.00001) in older group.ConclusionMAT is simple, time tested and non invasive test to assess collateral circulation of the hand. A negative MAT safely selects patients for radial artery harvest; however, if the test is positive and in older patients then a second objective test may be needed.     

Undergraduate medical students. Simulation-based activity to conduct the informed consent process for health research studies

IntroductionTraining through medical simulation allows for continuous learning under controlled conditions. Simulation-based training activities can be used simultaneously with other educational strategies to strengthen the attitudinal skills needed to develop an informed consent process in the context of health research.ObjectiveTo facilitate learning in undergraduate medicine students, and to evaluate their competences to carry out an informed consent process in a scenario that resembles reality.Materials and methodsIn this semi-longitudinal study, a simulation-based activity was conducted with 136 medical students of the fourth (Group A) and fifth year (Group B) of the Marist University of Mérida, in southern Mexico.ResultsThe mean score for both groups was 72.48 ± 1.05 (95% CI = 70.4–74.5); 86.2 ± 0.96 (95% CI = 84.2–88.0); and 77.7 ± 0.72 (95% CI = 76.3–79.1), in the pre-test, the simulation and the post-test, respectively. The students of group A self-evaluated their performance with 3.93/5.00, and those of Group B, 4.04/5.00.DiscussionThis study showed that Group A students did not score lower on simulation-based activity when compared to students in Group B, suggesting that before the fifth year of undergraduate medical education, students could properly develop an informed consent-process for health research if they receive early education about medical ethics and research bioethics. Issues related to bioethics in human health research can be included as soon as medical students initiate research methodology courses.     

创新药吡非尼酮胶囊在中国健康人体耐受性和安全性研究

目的：评价中国健康受试者单次和多次口服1.1类创新药吡非尼酮胶囊后的人体耐受性和安全性。方法：依据动物实验结果推算起始和最大剂量，以健康受试者为研究对象，从安全起始剂量开始，进行单次和多次给药耐受性试验。采用随机单中心临床研究，统一餐后给药。单次给药耐受性试验：36例，随机分成6个剂量组：200 mg（2例），400 mg（4例），800 mg（6例），1 200 mg（8例），1 800 mg（8例），2 400 mg（8例）；多次给药耐受性试验：12例，分成2个剂量组：400 mg（6例），600 mg（6例），每天3次，连续给药7 d。观察受试者用药前后症状、生命体征、实验室检查变化（包括血尿常规、肝肾功能、心电图等）、并记录药品不良事件。结果：单次和多次给药耐受性试验的受试者用药前后生命体征和心电图无显著变化，实验室检查等表明无器质性损伤。依据试验终止标准，20例受试者完成4个剂量组的单次耐受性研究。其中单次给药耐受性试验有12例，多次给药耐受性试验有7例受试者在口服药物后出现轻中度恶心、呕吐、烧心、食欲不振、头晕和头痛等不良事件，未经处理自行缓解。本试验过程中未发生严重不良事件。结论：中国健康人体对吡非尼酮胶囊单次（200~1 200 mg）或多次（400~600 mg，tid×7 d）给药的安全性和耐受性良好，将为临床合理应用提供依据。     

Application of matched pair procedures to site-specific data in periodontal research

Application of standard statistical procedures to site-specific data in periodontal research is invalid unless site-to-site dependencies are accounted for. In this paper, we present the adjustments required for valid application of matched pair procedures, including the paired t-test and McNemar's chi 2 test for correlated proportions. Examples are given involving data arising from: (1) the comparison of pre- and post-treatment clinical measurements; (ii) split-mouth protocols.     

The effects of a triclosan/copolymer dentifrice on oral bacteria including those producing hydrogen sulfide

A clinical procedure was developed to examine the effects of short-term and extended use of a triclosan/copolymer dentifrice and a commercial fluoride dentifrice on oral bacteria, including those producing hydrogen sulfide. Healthy adults volunteered for this double-blind, crossover design clinical study and provided saliva samples for culturing on enriched and indicator media to enumerate all salivary bacteria and those producing hydrogen sulfide (odorigenic), respectively. Subjects brushed with an assigned dentifrice for 7 d and were sampled on day 8 to assess the long-term effects on bacteria. Extended use of the triclosan/copolymer dentifrice resulted in a 49% and 66% reduction of salivary and odorigenic bacteria, respectively, compared with the fluoride dentifrice. To examine short-term effects, subjects subsequently brushed with their assigned dentifrice and were sampled at 2 h and 4 h post-brushing. At 2 h and 4 h post-brushing, the triclosan/copolymer dentifrice resulted in a 62% and 52% decrease for salivary bacteria and 79% and 72% decrease for odorigenic bacteria, respectively, vs. the fluoride dentifrice. The results indicate a significant decrease of all salivary bacteria and hydrogen sulfide-producing odorigenic bacteria following use of the triclosan/copolymer dentifrice and explain previous results on the efficacy of this dentifrice on oral malodor.