Motivation for participating in phase 1 vaccine trials: Comparison of an influenza and an Ebola randomized controlled trial

Introduction/Hypothesis

Recruitment of participants into phase 1 vaccine clinical trials can be challenging since these vaccines have not been used in humans and there is no perceived benefit to the participant. Occasionally, as was the case with a phase 1 clinical trial of an Ebola vaccine in Halifax, Canada, during the 2014–2016 West African Ebola virus outbreak, recruitment is less difficult. In this study, we explored the motivations of participants in two phase 1 vaccine trials that were concurrently enrolling at the same centre and compared the motivations of participants in a high-profile phase 1 Ebola vaccine trial to those in a less high-profile phase 1 adjuvanted seasonal influenza vaccine study.

基于xMOOC模式的校园公开课程参与者角色剖析

以目前国内外MOOC建设中存在的问题为切入点,结合校园公开课程在线学习的特殊性,采用文献综述及理论分析的方法对高校校园公开课程开展的xMOOC模式进行了探讨,重点剖析了学习者、教师、执行体系以及观察者这四种参与角色,发现存在角色定位不准确甚至缺失的情况,并对高校校园公开课xMOOC开展提出了建议。     

单个病例数据系统评价/Meta分析优先报告条目简介

2015年,单个病例数据系统评价/Meta分析优先报告条目(Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data, PRISMA-IPD)声明的推出对单个病例数据系统评价/Meta 分析(Systematic reviews and Meta-Analyses of Individual Patient Data)的规范报告将会发挥重要的作用。本文旨在对PRISMA-IPD声明形成的背景、过程及其内容和要求进行介绍。     

Unidentified communication challenges in the intensive care unit: A qualitative study using multiple triangulations

BackgroundCommunication in the intensive care unit is challenged by patients’ inability to speak owing to intubation, treatment, and illness. Research has focused on the use of communication tools or techniques, characteristics of the communication between patients and clinicians, and their experiences of communication challenges. However, few studies have combined the perspectives of patients, family members, and clinicians. We explored communication from different angles and investigated challenges that cannot be explained by ineffective use of aids and communication techniques.ObjectivesThe aim of this study was to explore communication between patients, family members, and nurses and to investigate previously unidentified communication challenges.MethodsThis study used a case-oriented design with multiple triangulations. It was conducted in two general intensive care units at a Norwegian university hospital. Participant observations were conducted on nine mechanically ventilated patients while communicating with family members and healthcare personnel. Following the observations, individual interviews were conducted with six patients, six family members, and nine healthcare personnel.FindingsCommunication often seemed uncomplicated at the time of observations, but information from the interviews revealed another picture. We demonstrate what participants emphasised differently when they discussed their experiences, revealing a discrepancy in perceived importance in the situation. Family members had an important role in interpreting signs from the patient, uncovering challenges that would have been unknown to the nurses otherwise.ConclusionsThis study illustrates how communication challenges in the intensive care unit may not be perceptible to an observer or to all of the participants involved at the time of the communication. Nurses need to be aware of these communication challenges and realise that the patient might face issues that cannot be easily solved without extensive involvement of the patient, family, and nurses, and perhaps not even until a later stage in the patient's recovery process.     

What's said and what's done: the reality of sexually transmitted disease consultations

OBJECTIVE: Indirect data collection methods, or approaches which disturb usual practice, are generally used in health care evaluation. We have compared what doctors report at interview what is observed by an identified researcher with an unobtrusive measure of their usual practice. DESIGN: Private practitioners who provide a service to sexually transmitted disease (STD) patients were interviewed regarding their usual case management. An identified researcher carried out structured observations of consultations between physicians and patients. Simulated clients then sought consultations, presenting a standardised history and symptom profile. Structured reporting of the history taking, examination, treatment and counselling aspects of these consultations was undertaken. SUBJECTS: Eighteen private practitioners in Madras (now Chennai), India. MAIN OUTCOME MEASURES: Comparisons between interviews, observations by identified researchers and the experiences of simulated clients were carried out. RESULTS: Interviews with physicians and observations by identified researchers indicated more favourable practice than was seen during simulated client visits. These differences were substantial and would lead to a severe misrepresentation of the actual situation-and thus of intervention needs, if data from interviews or observations were relied upon. CONCLUSIONS: The usual methods used in the evaluation of medical services and in carrying out medical audit may produce highly unreliable findings. STD services in the study area are failing to realise their potential of improving the sexual health of populations. The methodological and substantive findings of this study could be combined through the introduction of simulated client visits in the monitoring, improvement and licensing of STD (and perhaps other medical) services.     

Increased Utilization of Virtual Visits and Electronic Approaches in Clinical Research During the COVID-19 Pandemic and Thereafter

ObjectivesTo assess the impact of the COVID-19 pandemic on clinical research and the use of electronic approaches to mitigate this impact.MethodsWe compared the utilization of electronic consenting, remote visits, and remote monitoring by study monitors in all research studies conducted at Mayo Clinic sites (Arizona, Florida, and Minnesota) before and during the COVID-19 pandemic (ie, between May 1, 2019 and December 31, 2020). Participants are consented through a participant-tracking system linked to the electronic health record.ResultsBetween May 2019, and December 2020, there were 130,800 new consents across every modality (electronic and paper) to participate in a non-trial (107,176 [82%]) or a clinical trial (23,624 [18%]). New consents declined from 5741 in February 2020 to 913 in April 2020 but increased to 11,864 in November 2020. The mean (standard deviation [SD]) proportion of electronic consent increased from 22 (2%) before to 45 (20%) during the pandemic (P=.001). Mean (SD) remote electronic consenting increased from 0.3 (0.5%) to 29 (21%) (P<.001). The mean (SD) number of patients with virtual visits increased from 3.5 (2.4%) to 172 (135%) (P=.003) per month between pre-COVID (July 2019 to February 2020) and post-COVID (March to December 2020) periods. Virtual visits used telemedicine (68%) or video (32%). Requests for remote monitor access to complete visits increased from 44 (17%) per month between May 2019 and February 2020 to 111 (74%) per month between March and December 2020 (P=.10).ConclusionAfter a sharp early decline, the enrollment of new participants and ongoing study visits recovered during the COVID-19 pandemic. This recovery was accompanied by the increased use of electronic tools.     

Participant Selection Biases in a Randomized Clinical Trial of Alcoholism Treatment Settings and Intensities

Eligible participants and decliners in a randomized study of inpatient, intense outpatient, and standard outpatient treatments for alcoholics were compared and contrasted on a series of demographic, social stability, psychological, legal, drug use, problem severity, and treatment history variables. Among 302 individuals meeting eligibility requirements, those agreeing to participate, compared with decliners, were more likely to be unemployed, be residentially less stable, have legal problems, use other drugs, have a more severe alcohol problem, have a recent treatment history, and were less likely to have problems with violence. Participants also were more likely to be male and non-white, although gender and racial effects were not significant when other variables were controlled for. The implications of these findings for generalizing the results of inpatient-outpatient studies are discussed, and the need for routine reporting of decliner characteristics in research reports is stressed.     

Avoidable hospitalisation for diabetes mellitus among immigrants and natives: Results from the Italian Network for Longitudinal Metropolitan Studies

Background and aimsItaly has experienced a relevant increase in migration inflow over the last 20 years. Although the Italian Health Service is widely accessible, immigrants can face many barriers that limit their use of health services. Diabetes mellitus (DM) has a different prevalence across ethnic groups, but studies focusing on DM care among immigrants in Europe are scarce. This study aimed to compare the rates of avoidable hospitalisation (AH) between native and immigrant adults in Italy.Methods and resultsA multi-centre open cohort study including all 18- to 64-year-old residents in Turin, Venice, Reggio-Emilia, Modena, Bologna and Rome between 01/01/2001 and 31/12/2013–14 was conducted. Italian citizens were compared with immigrants from high migratory pressure countries who were further divided by their area of origin. We calculated age-, sex- and calendar year-adjusted rate ratios (RRs) and 95% confidence intervals (95% CIs) of AH for DM by citizenship using negative binomial regression models. The RRs were summarized using a random effects meta-analysis. The results showed higher AH rates among immigrant males (RR: 1.63, 95% CI: 1.16–2.23), whereas no significant difference was found for females (RR: 1.14, 95% CI: 0.65–1.99). Immigrants from Asia and Africa showed a higher risk than Italians, whereas those from Central-Eastern Europe and Central-Southern America did not show any increased risk.ConclusionAdult male immigrants were at higher risk of experiencing AH for DM than Italians, with differences by area of origin, suggesting that they may experience lower access to and lower quality of primary care for DM. These services should be improved to reduce disparities.