scholarly journals An investigation into the factors affecting investigator-initiated trial start-up in Ireland

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauren Leddy ◽  
Prasanth Sukumar ◽  
Lydia O’Sullivan ◽  
Fionnuala Keane ◽  
Declan Devane ◽  
...  

Abstract Background In common with many countries, Ireland has seen an increasing trend in the number of clinical trials conducted over the past few years. Yet, as elsewhere, trialists in Ireland face several problems and barriers in the starting-up of clinical trials. These barriers impede trial activity significantly, with consequent impacts on patient care. It is critical to understand these issues, to develop approaches to facilitate trial start up. This study identifies the challenges in conducting clinical trials in Ireland and specifically the contractual, ethical, logistical, and regulatory barriers that hinder the start-up of investigator-led trials in Ireland. Methods Data for this study were collected in two stages. In the first stage, a survey was conducted among trialists in Ireland. A total of 44 trialists responded to the survey, and information was collected about their experience in conducting clinical trials, the scale and nature of their most recently completed trial, and the details of specific barriers they encountered during the starting-up of the trial. In the second stage, nine semi-structured interviews were conducted with the awardees of 2018 Irish Health Research Board’s Definitive Intervention Feasibility Award. These interviews facilitated a deeper exploration of issues and problems in conducting clinical trials in Ireland. Results This study identified several issues and bottlenecks in starting-up clinical trials in Ireland with contracts and ethical approval cited as the major issues. The data shows that site identification and activation was also problematic in some cases. Several respondents reported difficulties in accessing dedicated time for protocol development and believe that support in this area can be greatly beneficial. It was reported that availability of skilled staff members like statisticians and data managers was as an issue, especially for small trials. Conclusion This study found that several factors impact trial initiation and progression in Ireland. Delays associated with obtaining contract and ethics approval are perceived as major barriers. Specialist supports in areas such as ethics and regulatory affairs and availability of specialised staff members in areas such as statistics and data management are key actions to enable enhanced clinical trial activity in Ireland.

2020 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Dian Purworini ◽  
Desi Puji Hartuti ◽  
Dini Purnamasari

PurposeSociocultural aspects of populations residing in disaster-prone areas have not often been discussed in disaster evacuation studies. Therefore, the main purpose of this paper is to describe the sociocultural factors affecting evacuation decision-making.Design/methodology/approachThis was an exploratory research study which used in-depth semi-structured interviews to collect the data. Selection of the informants was also fulfilled via the purposive sampling method with regard to specific criteria. The informants consisted of 20 villagers that had faced a disaster and eight staff members of the Regional Board of Disaster Management of the Republic of Indonesia which is Badan Penanggulangan Bencana Daerah (BPBD), Ponorogo, who had managed it. The data analysis was ultimately performed through thematic coding.FindingsThe results of the coding analysis revealed that sociocultural aspects were among the primary reasons for evacuation decisions before disasters. In this paper, sociocultural factors shaping evacuation decision behavior could be a result of norms, roles, language, leadership, rules, habits, jobs, perceptions, family engagement, as well as other behaviors demonstrated by individuals and the community.Research limitations/implicationsThis study is not analyzing the role of the social organization or a religious one and also the economic aspect in the evacuation decision-making.Practical implicationsThis paper includes implications for the local government and the BPBD Ponorogo to establish an efficient communication strategy persuading villagers to evacuate. In general, formal policies cannot always be implemented in managing disaster; therefore, visible dedication and solidarity of the members are always needed in order to manage evacuation problems.Originality/valueThis paper meets needs for a study delineating sociocultural factors affecting evacuation decisions before disasters strike. Sociocultural theory could also describe real aspects of culture inherent in the daily lives of populations living in disaster-prone areas.


2018 ◽  
Vol 32 (1) ◽  
pp. 8-25 ◽  
Author(s):  
Watson Baldwin

PurposeHong Kong has a global reputation as an entrepreneurial hub. The Japanese restaurant community has grown and evolved over the last three decades into what many consider as a natural secondary market for Japanese food. As such, several Japanese restaurateurs have come to Hong Kong to enter Hong Kong’s premium Japanese restaurant market. The purpose of this paper is to explore this market of Japanese restaurateurship in Hong Kong.Design/methodology/approachOne of the closest methodologies within the topic and discipline from Baldwin (2017) focuses on Japaneseness as a measurement of culinary authenticity examining Hong Kong’s Michelin rated restaurants. Here, the qualitative approach using semi-structured interviews with the chefs of two sets of premium Japanese restaurants from Japan that expanded in Hong Kong, Sushi Iwa and Sushi Yoshitake. As this paper focuses on the premium and high-end market of Japanese chefs and restaurateurs in Hong Kong, the researcher combined the approaches of Kawahara & Speece and Baldwin to pursue a qualitative methodology using semi-structured interviews.FindingsFor this research, the interview process had to be divided into two stages. The first was to speak with long standing members of Hong Kong’s Japanese restaurant community. The common thread amongst the restaurateurs was that they were either the sole proprietor or a partner who was financially vested within the company not a form of sweat equity. To respect the privacy of the interviews, questions about exact monetary amounts, number of shares and equity or anything regarding holdings were not asked. The idea was to only examine their responses within the criteria of the research objectives.Research limitations/implicationsAs the Michelin and premium market of Japanese cuisine is so small, this research can only represent a certain part of the market. Future research could examine other Japanese restaurateurs outside of this market that could be examined to gain a wider perspective of the entrepreneurial strategies they used to start-up their business in Hong Kong.Originality/valueAs research in this area is very limited, this paper helps bring restaurateurship in Hong Kong into the academic front. Restaurants are one of the most common entry points for new entrepreneurs in hospitality. This paper may help shed some light on how foreign investment entrepreneurship has been achieved in Asia.


2020 ◽  
Vol 75 (3) ◽  
pp. 256-263
Author(s):  
Maria Y. Egorova ◽  
Irina A. Shuvalova ◽  
Olga I. Zvonareva ◽  
Igor D. Pimenov ◽  
Olga S. Kobyakova ◽  
...  

Background. The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study. Aims to assess the factors affecting the inclusion of Russian physicians-researchers in CT, and to determine their role in relations with patients-participants. Materials and methods. The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (20172018). The participation in the survey for doctors was anonymous and voluntary. Results. The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84 0,39), society (4,67 0,46) and slightly lower for participating patients (4,44 0,61). The expectations of medical researchers are related to improving their financial situation and attaining new experience (n = 14; 18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n = 41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n = 29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n = 38; 48,71%). Conclusions. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).


Author(s):  
Ivonne R. G. Kaya ◽  
Fildo De Lima

Tourism has become one of the major players in ‎international commerce and represents one of the main income ‎sources for many developing countries at the same time. These dynamics have turned tourism into a key driver for socio-‎economic progress.‎ This article described the potential of tourism attraction and factor affecting the development of marine tourism area in the utilization zone of Manusela National Park. Semi-structured interviews, in-depth interviews and participant observations were conducted with respondent (n=110) in Bellarizky, Air Belanda, Ora Beach and Lizar Bahari resort. The potential of tourist attractions in the utilization zone of Manusela National Park is as a snorkeling, diving and point of view. Factors affecting the development are service, transportation, supporting facilities and tourism attractions.


Author(s):  
Pernilla Sundqvist

AbstractIn recent decades the preschool has leaned more towards a learning-oriented pedagogy, where the subject of technology has been given a more prominent place. Still, studies on how individual preschool staff members perceive and teach technology is scarce. This study shows how seven preschool staff in Sweden describe their work with the subject of technology and how technology education is characterized in these descriptions. The data was produced by means of semi-structured interviews and a questionnaire and analyzed with narrative analysis. The results show very diverse practices of technology education, implying the learning possibilities for children in different preschools are not equal. Some of the staff describe a clear and conscious teaching of technology, while others describe teaching what can be viewed as a limited and/or shallow technology education, where technology is sometimes used as means for learning other subjects or contents rather than being the learning objective. Six ways to characterize technology education was found, namely: technology education (1) concerns technological objects and systems in children’s environment, (2) concerns learning to handle technological objects, (3) is doing experiments, (4) involves developing abilities, (5) is naturally included in children’s play and (6) departs from digital technology.


2021 ◽  
Vol 11 (2) ◽  
pp. 320-330
Author(s):  
Utako Sawada ◽  
Akihito Shimazu ◽  
Norito Kawakami ◽  
Yuki Miyamoto ◽  
Lisa Speigel ◽  
...  

Background: Good social climate and high work engagement are important factors affecting outcomes in healthcare settings. This study observed the effects of a program called Civility, Respect, and Engagement in the Workplace (CREW) on social climate and staff work engagement in a psychiatric ward of a Japanese hospital. Methods: The program comprised 18 sessions installed over six months, with each session lasting 30-min. Participation in the program was recommended to all staff members at the ward, including nurses, medical doctors, and others, but it was not mandatory. A serial cross-sectional study collected data at four time-points. Nurses (n = 17 to 22), medical doctors (n = 9 to 13), and others (n = 6 to 10) participated in each survey. The analysis of variance was used to evaluate the changes in the following dependent variables, the Essen climate evaluation schema (EssenCES), the CREW civility scale, and the Utrecht work engagement scale (UWES) over time. Result: We found no significant effects. The effect size (Cohen’s d) for EssenCES was 0.35 from baseline to post-installation for all staff members. Effect sizes for EssenCES for medical doctors and UWES for nurses were 0.79 and 0.56, respectively, from baseline to post-program. Conclusions: Differences in social climate and work engagement among Japanese healthcare workers between the baseline and post-installation of the CREW program were non-significant.


2021 ◽  
Vol 9 (5) ◽  
pp. 53
Author(s):  
Rayan Sharka ◽  
Jonathan P. San Diego ◽  
Melanie Nasseripour ◽  
Avijit Banerjee

Aims: This study aimed to identify the risk factors of using DSM to provide an insight into the inherent implications this has on dental professionals in practice and trainee professionals’ education. Materials and methods: Twenty-one participants (10 dental professionals and 11 undergraduate and postgraduate dental students) participated in this qualitative study using semi-structured interviews in a dental school in the UK. The interviews were analysed and categorised into themes, some of which were identified from previous literature (e.g., privacy and psychological risks) and others emerged from the data (e.g., deceptive and misleading information). Results: The thematic analysis of interview transcripts identified nine perceived risk themes. Three themes were associated with the use of DSM in the general context, and six themes were related to the use of DSM in professional and education context. Conclusions: This study provided evidence to understand the risk factors of using DSM in dental education and the profession, but the magnitude of these risks on the uptake and usefulness of DSM needs to be assessed.


2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii22-ii22
Author(s):  
Kyle Walsh

Abstract BACKGROUND Preliminary evidence indicates that glioma patients are at higher risk for COVID-19 complications due to systemic immunosuppression. Interruptions in cancer care may exacerbate patient and caregiver anxiety, but surveying patients/caregivers about their COVID-19 experiences is often limited by attainable sample sizes and over-reliance upon single-institution experiences. METHODS To explore how COVID-19 is impacting brain tumor patients/caregivers across the U.S., we performed semi-structured interviews with brain tumor patient navigators employed by two different 501(c)3 nonprofit organizations. A semi-structured interview guide was used, utilizing prompts and open-ended questions to facilitate dialogue. A core set of COVID-19 topics were covered, including: financial issues, coping strategies, geographic variability, variability by tumor grade/histology, disruptions in care continuity, accessing clinical trials, psychosocial issues, and end-of-life care. Interviews were audio-recorded, transcribed, and organized by discussion topic to identify emerging themes. Inductive sub-coding was completed using the constant comparison method, within and between transcripts. RESULTS/CONCLUSIONS Ten patient navigators were interviewed between April 15th and May 8th, with interviews lasting approximately one hour (range 38-77minutes). Navigators reported having contact with 183 unique brain tumor families during the pandemic (range 7–38 families per navigator). High concordance emerged across narratives, revealing important considerations for the neuro-oncology workforce. The most prominent theme was increased caregiver burden, attributed to maintaining social distancing by reducing visits from home-health aides and friends/family. A related theme that applied to both patients and caregivers was increased social isolation due to social distancing, suspension of in-person support groups, and church/temple closures. Accessing clinical trials was a recurrent issue, exacerbated by patients’ increasing unwillingness to travel. Glioblastoma patients, especially those with recurrent tumors, expressed greater reluctance to travel. Access to standard-of-care treatment was rarely interrupted, but reduced access to supportive services – especially physical and occupational therapy – was identified as an emerging COVID-related deficiency in clinical care.


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