scholarly journals Status of Institutional Review Board Meetings Conducted Through Web Conference Systems in Japanese National University Hospitals During the COVID-19 Pandemic: Questionnaire Study (Preprint)

2020 ◽  
Author(s):  
Kenta Yagi ◽  
Kazuki Maeda ◽  
Satoshi Sakaguchi ◽  
Masayuki Chuma ◽  
Yasutaka Sato ◽  
...  
Keyword(s):  
Financial Burden ◽  
Controlled Trial ◽  
Institutional Review Board ◽  
Current Status ◽  
University Hospitals ◽  
State Of Emergency ◽  
Face To Face ◽  
Institutional Review ◽  
National University ◽  
The Cost

BACKGROUND With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. OBJECTIVE This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. METHODS A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. RESULTS The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. CONCLUSIONS Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members’ screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.

scholarly journals Status of Institutional Review Board Meetings Conducted Through Web Conference Systems in Japanese National University Hospitals During the COVID-19 Pandemic: Questionnaire Study

10.2196/22302 ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. e22302
Author(s):  
Kenta Yagi ◽  
Kazuki Maeda ◽  
Satoshi Sakaguchi ◽  
Masayuki Chuma ◽  
Yasutaka Sato ◽  
...  
Keyword(s):  
Financial Burden ◽  
Controlled Trial ◽  
Institutional Review Board ◽  
Current Status ◽  
University Hospitals ◽  
State Of Emergency ◽  
Face To Face ◽  
Institutional Review ◽  
National University ◽  
The Cost

Background With the global proliferation of the novel COVID-19 disease, conventionally conducting institutional review board (IRB) meetings has become a difficult task. Amid concerns about the suspension of drug development due to delays within IRBs, it has been suggested that IRB meetings should be temporarily conducted via the internet. Objective This study aimed to elucidate the current status of IRB meetings conducted through web conference systems. Methods A survey on conducting IRB meetings through web conference systems was administered to Japanese national university hospitals. Respondents were in charge of operating IRB offices at different universities. This study was not a randomized controlled trial. Results The survey was performed at 42 facilities between the end of May and early June, 2020, immediately after the state of emergency was lifted in Japan. The survey yielded a response rate of 74% (31/42). Additionally, while 68% (21/31) of facilities introduced web conference systems for IRB meetings, 13% (4/31) of the surveyed facilities postponed IRB meetings. Therefore, we conducted a further survey of 21 facilities that implemented web conference systems for IRB meetings. According to 71% (15/21) of the respondents, there was no financial burden for implementing these systems, as they were free of charge. In 90% (19/21) of the facilities, IRB meetings through web conference systems were already being conducted with personal electronic devices. Furthermore, in 48% (10/21) of facilities, a web conference system was used in conjunction with face-to-face meetings. Conclusions Due to the COVID-19 pandemic, the number of reviews in clinical trial core hospitals has decreased. This suggests that the development of pharmaceuticals has stagnated because of COVID-19. According to 71% (15/21) of the respondents who conducted IRB meetings through web conference systems, the cost of introducing such meetings was US $0, showing a negligible financial burden. Moreover, it was shown that online deliberations could be carried out in the same manner as face-to-face meetings, as 86% (18/21) of facilities stated that the number of comments made by board members did not change. To improve the quality of IRB meetings conducted through web conference systems, it is necessary to further examine camera use and the content displayed on members’ screens during meetings. Further examination of all members who use web conference systems is required. Our measures for addressing the requests and problems identified in our study could potentially be considered protocols for future IRB meetings, when the COVID-19 pandemic has passed and face-to-face meetings are possible again. This study also highlights the importance of developing web conference systems for IRB meetings to respond to future unforeseen pandemics.

scholarly journals ‘Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing’ (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039299
Author(s):  
Douglas J Opel ◽  
Jeffrey D Robinson ◽  
Heather Spielvogle ◽  
Christine Spina ◽  
Kathleen Garrett ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Motivational Interviewing ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Communication Strategy ◽  
Institutional Review Board ◽  
Cluster Randomised ◽  
Institutional Review ◽  
Randomised Controlled ◽  
Immunisation Status

IntroductionA key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents’ minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.Methods and analysisWe describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.Ethics and disseminationThis study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration numberNCT03885232.

The DISCO App: A pilot test of an electronic patient intervention to reduce the financial burden of cancer through improved cost communication.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 1-1
Author(s):  
Lauren M. Hamel ◽  
David W. Dougherty ◽  
Theresa A. Hastert ◽  
Erlene Kuizon Seymour ◽  
Seongho Kim ◽  
...  
Keyword(s):  
Self Efficacy ◽  
Treatment Cost ◽  
Financial Burden ◽  
Controlled Trial ◽  
Treatment Costs ◽  
Patient Acceptance ◽  
Financial Toxicity ◽  
Post Intervention ◽  
Intervention Measures ◽  
The Cost

1 Background: Financial toxicity, the burden of treatment cost, affects 30-50% of people with cancer in the US. Although experts recommend patients and oncologists discuss treatment cost to identify patients who need assistance, cost discussions occur in fewer than half of cancer treatment discussions. We pilot-tested the feasibility and efficacy of the Discussions of Cost (DISCO) App, a patient communication intervention designed to improve cost discussions and other financial toxicity-related outcomes during and following oncology treatment consultations. The DISCO App provides an individualized list of cost-related questions patients can ask their oncologist, specific to a patient’s economic situation. Methods: While waiting to see their oncologist, newly diagnosed patients with breast or lung cancer (n=32) used the DISCO App on an iPad. Clinic visits were videorecorded and patients completed pre- and post-intervention measures of self-efficacy for managing treatment costs, self-efficacy for interacting with oncologists, cost-related distress, and perceptions of the DISCO App. A trained coder observed the recordings to determine the presence of a cost discussion, the cost-related topic, and any emergent factors. Results: Findings showed increases in patients’ self-efficacy for managing treatment costs (p=.02) and interacting with oncologists (p=.001). Cost-related distress decreased but not significantly (p=.20). Patients reported the DISCO App was understandable (M=4.5 out of 5), useful as they talked with their oncologist (M=4.0), and 84% of patients reported needing less than 15 minutes to use the DISCO App. Most (94%) interactions were videorecorded (in two cases technical difficulties prevented videos from being collected); all (100%) of the videorecorded interactions included a cost discussion. The most frequently discussed topics were: insurance, time off from work, and financial navigation. Frequently, the oncologist asked the patient for his/her question list and discussed/answered the questions. Conclusions: Findings suggest the DISCO App is feasible to implement in the clinic and effective in improving patient-oncologist cost discussions and financial toxicity-related outcomes. Patient acceptance of the DISCO App and oncologist engagement suggested the intervention prompted cost discussions. Next steps include conducting a longitudinal randomized controlled trial to determine the effectiveness of the DISCO App on financial toxicity, and other outcomes. Clinical trial information: NCT03676920 .

scholarly journals New model of integrated care for uncontrolled type 2 diabetes in a retrospective, underserved adult population in the USA: a study protocol for an effectiveness and cost-effectiveness analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e038084
Author(s):  
Rita Bosetti ◽  
Laila Tabatabai ◽  
George Naufal ◽  
Rosbel Brito ◽  
Bita Kash
Keyword(s):  
Type 2 Diabetes ◽  
Cost Effectiveness ◽  
Patient Outcomes ◽  
Diabetes Care ◽  
Institutional Review Board ◽  
New Model ◽  
Institutional Review ◽  
The Usa ◽  
The Cost

IntroductionType 2 diabetes prevalence is increasing in the USA, especially in underserved populations. Patient outcomes can be improved by providing access to specialty care within Federally Qualified Health Centers, possibly improving the cost-effectiveness of diabetes care.Methods and analysisA new model of diabetes care based on multidisciplinary teams of clinical fellows, supported by an endocrinologist for underserved adult populations, is presented. The study uses a retrospective, non-randomised cohort of patients with diabetes who visited the community clinic between 1 January 2012 and 31 December 2018. A quasi-experimental method to analyse the causal evidence of the effect of the new model is presented. Discontinuity regression is used to compare two interventions, the intervention by a Clinical Fellow Endocrinology Programme and usual care by a primary care physician. Patients are referred to the Clinical Fellow Endocrinology Programme in case of uncontrolled diabetes (glycated haemoglobin (HbA1c)≥9%). The regression discontinuity design allows the construction of a treatment group for patients with an HbA1c equal or above the threshold in comparison with a control group for patients with an HbA1c below the threshold. The patient outcomes and cost-effectiveness of the new model are analysed. Regression models will be used to assess the differences between treatment and control groups.Ethics and disseminationQuantitative patient data are received by the study team in a de-identified format for analysis via an institutional review board-approved protocol. The quantitative study has been approved by the Houston Methodist Research Institute Institutional Review Board, Houston, Texas, USA. Anticipated results will not only provide evidence about the impact of patient outcomes in underserved diabetic populations, but also give an idea of the cost-effectiveness of the new model and whether or not cost savings can be attained for patients, third-party payers and society. The results will help set up evidence-based policy guidelines in diabetes care. Results will be disseminated through papers, conferences and public health/policy fora.

scholarly journals Paths to Knowledge Management in Small and Medium-Sized Hotels

2008 ◽  
Vol 3 (4) ◽  
Author(s):  
Mik Kim ◽  
Wusheng Zhang
Keyword(s):  
Knowledge Management ◽  
Empirical Investigation ◽  
Secondary Data ◽  
Current Status ◽  
Face To Face ◽  
Interview Method ◽  
Doing Business ◽  
Research Questions ◽  
The Cost ◽  
Depth Interviews

The purpose of this paper is to investigate what path options can facilitate small and medium-sized hotels’ knowledge management? And how the options are realised by them? In order to answer these questions, this study undertook an empirical investigation into the current status and practice of knowledge management in small and medium-sized hotels. The empirical investigation was performed through thirteen face-to-face in-depth interviews with owners and managers in small and medium-sized hotels. While the interview method is selected so as to answer the questions, secondary data are utilised to support this study such as in defining the research questions and informing the study findings. This study observed that there were four broad approaches to the way in which hotels put their paths to knowledge management. Each type of the paths is named as: Match, Combination, Divergence, and Specialisation. As arguably, knowledge management is both part of the cost of doing business and the most likely source of competitive advantage, it is as important to the sole operator as to the large corporation. By understanding the different options, hotels will be able to make better decisions in the choice of their suitable paths to knowledge management.

scholarly journals Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e040955
Author(s):  
Aaron J Blashill ◽  
Janna R Gordon ◽  
Sarah A Rojas ◽  
Christian B Ramers ◽  
Chii-Dean Lin ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Patient Navigation ◽  
Controlled Trial ◽  
Institutional Review Board ◽  
State University ◽  
Pilot Randomised Controlled Trial ◽  
Latino Msm ◽  
Institutional Review ◽  
San Diego State University ◽  
Randomised Controlled

IntroductionMen who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.Methods and analysisThrough extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention’s potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.Ethics and disseminationThis study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.Registration detailsRegistered under the National Institutes of Health’s ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017–0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.

scholarly journals Validation of Wearable Devices to Measure Energy Consumption

2020 ◽  
Vol 22 (1) ◽  
pp. 33-37
Author(s):  
Ji-Soo Ryu ◽  
Jung-Jun Park
Keyword(s):  
Energy Expenditure ◽  
Motion Detection ◽  
Wearable Devices ◽  
Institutional Review Board ◽  
Gas Analyzer ◽  
Outdoor Activities ◽  
Institutional Review ◽  
National University ◽  
The Subject ◽  
Healthy Males

OBJECTIVES The purpose of this study is to verify how accurately wearable devices measure energy expenditure while walking outdoors.METHODS A total of 20 people, 10 healthy males and 10 females, participated in the study. After approval by the Institutional Review Board of Pusan National University, the experiment was conducted with the consent of the subject. All subjects wore four wearable devices (Fitbit Surge, Android Phone, iPhone, pedometer) and a portable gas analyzer simultaneously and walked on flat, downhill and uphill road respectively. All subjects repeated these experiments on each slope three times. The validity was verified through correlation analyses and paired <i>t</i>-test between the energy expenditure measured by the wearable devices and by a portable gas analyzer.RESULTS Under all three road slopes (flat, downhill, uphill road), the energy expenditure as measured by iPhone, Android phones, and pedometer significantly correlated with the portable gas analyzer. However, all three devices were significantly overestimated or underestimated the energy expenditure as compared to the gas analyzer under all three road slopes. Fitbit Surge did not correlate with the gas analyzer for measuring energy expenditure under any conditions, and significantly overestimated energy expenditure.CONCLUSION The validity of energy expenditure measurement during outdoor activities using wearable devices is still low, and more valid motion detection sensors and algorithms need to be developed.

scholarly journals Awareness, perception and acceptability of digital physiotherapy intervention among Malaysian physiotherapist

2021 ◽  
Vol 10 (4) ◽  
pp. 778
Author(s):  
Rajkumar Krishnan Vasanthi ◽  
Lee Cai Ling ◽  
Yughdtheswari Muniandy
Keyword(s):  
Professional Development ◽  
Digital Health ◽  
Financial Burden ◽  
Treatment Plan ◽  
Digital Tools ◽  
Clinical Protocols ◽  
Face To Face ◽  
Physiotherapy Intervention ◽  
The Cost ◽  
Provision Of Care

Digital health intervention (DHI) can solve the patient's problem, such as geographical inaccessibility, delayed provision of care, low-level adherence to clinical protocols, and financial burden. DHI does not necessary to work as a substitution for a functioning health system but helps strengthen its function. Therefore, this study aimed to determine the awareness, perception, and acceptability of digital physiotherapy intervention (DPI) among Malaysian physiotherapists. A total of 209 practicing physiotherapists representing all the regions in Malaysia participated in this online self-reported questionnaire, including demographics profile, continuous professional development, awareness, perception and acceptability of DPI. Analyzed the collected data to determine the knowledge of DPI by using descriptive statistical methods. A 75.1% of the Malaysian physiotherapist aware of digital physiotherapy intervention, 69.38% perceived it reduces the cost for face to face, reduce the time for traveling 47.85%, improve adherence to exercises 42.58%, 78% of them agree with the DPI and 75.1% of them accepted to recommend the digital tools to their patient. Malaysian physiotherapists are aware, agree and recommend the digital physiotherapy intervention to their treatment plan. However, it should still raise awareness about digital physiotherapy intervention to lead them to the future. Developing new digital tools, utilization, and overcoming the various healthcare institutions' low acceptability considering the cost, conventional interventions, and time-consuming should be strategized in Malaysia.

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