An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital.
ABSTRACT: BACKGROUND: International clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. The difference in clinical trial environment might influence the respective physicians' attitudes and experience towards clinical trials. Therefore, we designed a questionnaire to explore how physicians conceive the issues surrounding clinical trials in both countries. METHODS: A questionnaire survey was conducted at Kyoto University Hospital (KUHP) and Seoul National University Hospital (SNUH) in 2008. The questionnaire consisted of 15 questions and 2 open-ended questions on broad key issues relating to clinical trials. RESULTS: The number of responders was 301 at KUHP and 398 at SNUH. Doctors with trial experience were 196 at KUHP and 150 at SNUH. Among them, 12% (24/196) at KUHP and 41% (61/150) at SUNH had global trial experience. Most respondents at both institutions viewed clinical trials favorably and thought that conducting clinical trials contributed to medical advances, which would ultimately lead to new and better treatments. The main reason raised as a hindrance to conducting clinical trials was the lack of personnel support and time. Doctors at both university hospitals thought that more clinical research coordinators were required to conduct clinical trials more efficiently. KUHP doctors were driven mainly by pure academic interest or for their desire to find new treatments, while obtaining credits for board certification and co-authorship on manuscripts also served as motivation factors for doctors at SNUH. CONCLUSIONS: Our results revealed that there might be two different approaches to increase clinical trial activity. One is a social level approach to establish clinical trial infrastructure providing sufficient clinical research professionals. The other is an individual level approach that would provide incentives to encourage doctors to participate in and conduct clinical trials.
Project description:Recruitment rate of clinical trials in cancer patients is pretty low in China. Little is known about factors influencing trial recruitment in Chinese cancer patients. The aim of present study is to evaluate the barriers and facilitators to participation in clinical trials among lymphoma patients in China.From December 2014 to August 2015, the survey was carried out in the Department of Medical Oncology in Sun Yat-sen University Cancer Center. A self-made questionnaire was used among lymphoma patients (N = 331) to evaluate their attitude toward clinical trials. The questionnaire included 2 parts: patients' basic information and whether they were willing to participate in future clinical trials and their reasons.There were 53.5% patients willing to participate in clinical trials. The most common reasons were thirst for new treatments, trust on hospital and doctors, the idea that clinical trials may be more effective than conventional therapy, and to get more management and monitoring. The following patients are more likely to participate in clinical trials: patients who have children (P = .019) or spouse (P = .037), cannot afford treatment cost (P = .019), have tumor relapse (P = .045), and cared about the medical development (P = .032). Patients who have little knowledge of clinical trials are less likely to participate in clinical trials (P = .047).Popularization of knowledge about clinical trial is helpful to improve clinical trial participation in Chinese lymphoma patients.
Project description:Interprofessional collaboration between doctors and nurses is based on team mental models, in particular for each professional's roles. Our objective was to identify factors influencing concordance on the expectations of doctors' and nurses' roles and responsibilities in an Internal Medicine ward. Using a dataset of 196 doctor-nurse pairs (14x14 = 196), we analyzed choices and prioritized management actions of 14 doctors and 14 nurses in six clinical nurse role scenarios, and in five doctor role scenarios (6 options per scenario). In logistic regression models with a non-nested correlation structure, we evaluated concordance among doctors and nurses, and adjusted for potential confounders (including prior experience in Internal Medicine, acuteness of case and gender). Concordance was associated with number of female professionals (adjusted OR 1.32, 95% CI 1.02 to 1.73), for acute situations (adjusted OR 2.02, 95% CI 1.13 to 3.62), and in doctor role scenarios (adjusted OR 2.19, 95% CI 1.32 to 3.65). Prior experience and country of training were not significant predictors of concordance. In conclusion, our concordance-based approach helped us identify areas of lower concordance in expected doctor-nurse roles and responsibilities, particularly in non-acute situations, which can be targeted by future interprofessional, educational interventions.
Project description:BACKGROUND:Prospective clinical studies are the most important tool in modern medicine. The standard in good clinical practice in clinical trials has constantly improved leading to more sophisticated protocols. Moreover, translational questions are increasingly addressed in clinical trials. Such trials must follow elaborate rules and regulations. This is accompanied by a significant increase in documentation issues which require substantial manpower. Furthermore, university-based clinical centers are interested in increasing the amount of patients treated within clinical trials, and this number has evolved to be a key quality criterion. The present study was initiated to elucidate the obstacles that limit clinical scientists in screening and recruiting for clinical trials. METHODS:A specific questionnaire with 28 questions was developed focusing on all aspects of clinical trial design as well as trial management. This included questions on organizational issues, medical topics as well as potential patients' preferences and physician's goals. The questionnaire was established to collect data anonymously on a web-based platform. The survey was conducted within the Klinikum rechts der Isar, Faculty of Medicine, Technical University of Munich; physicians of all levels (Department Chairs, attending physicians, residents, as well as study nurses, and other study-related staff) were addressed. The answers were analyzed using the Survio analyzing tool (http://www.survio.com/de/). RESULTS:We collected 42 complete sets of answers; in total 28 physicians, 11 study nurses, and 3 persons with positions in administration answered our survey. The study centers reported to participate in a range of 3-160 clinical trials with a recruitment rate of 1-80%. Main obstacles were determined: 31/42 (74%) complained about limited human resources and 22/42 (52%) reported to have a lack on technical resources, too. 30/42 (71%) consented to the answer, that the documentation effort of clinical trials is too large. A possible increase of the patients' study participation rate up to over 20% was deemed to be possible if the described limitations could be overcome. DISCUSSION:The increasing documentation effort in clinical trials has led to a strong increase in the work load of scientific personnel. Recruiting of patients into clinical trials therefore is not only limited by patient issues, but also by the infrastructure of the centers. Especially the lack of study nurses is likely to be a major limitation. Furthermore, technical resources for time efficient and safe documentation within clinical routine as well as in clinical trials are required. By optimization of these factors, a significant increase in the amount of patients treated in clinical trials seems to be possible.
Project description:BACKGROUND: In many countries relatives are asked to consent on behalf of ICU patients prior to inclusion in clinical trials. However, the attitudes to drug trials among relatives of unconscious ICU patients are largely unknown. METHODS: We performed a prospective questionnaire survey at two university hospital ICUs of the next-of-kin to 50 unconscious adult patients. They were asked to complete a questionnaire within 48 hours of the patients' acute ICU admission. RESULTS: Forty-two relatives returned the questionnaire of which 41 were completed by direct family members and in one case by a friend to the patient.The majority of relatives (36/42) were positive/positive with some scepticism towards performing drug trials in unconscious ICU patients and 30/42 would most likely accept trial-participation by their relative. The majority (30/42) agreed that they should decide if their relative was to participate in a drug trial and 24 of these found that the treating clinician/ICU consultant should also consent. The majority (27/42) found that deferred consent would be acceptable if there was a limited time frame for initiation of treatment, however 8 respondents found this unacceptable when the intervention was a new drug.The majority of relatives stipulated that adherence to legislation, treatment benefit for the study patient and for future patients, no patient-risk or -discomfort and development of new drugs were important factors if their relative was to participate in an ICU drug trial. When questioned about doctors' motives for performing drug trials the wish for drug development and better patient care were highly rated among relatives. CONCLUSIONS: In general, relatives to unconscious ICU patients expressed positive attitudes to drug trials in the ICU and the inclusion of their relative in drug trials. Consent by next-of-kin and deferred consent was acceptable to the majority of relatives.
Project description:Introduction:Prospective clinical trials are essential to translate new therapy concepts or rather any scientific development into the medical routine. Besides a sophisticated trial protocol, the success of clinical trials depends on patient recruitment and participation. Patient recruitment remains a challenge and depends on several factors. To get a current picture of the patients' attitude, we conducted the present survey. Methods:We designed a survey with seven questions, which was given to all oncological patients treated within a timeframe of three months between Mai and July 2017. Participation was voluntary and anonymous. The questionnaire mainly inquires patients' participation in clinical trials in a university-based setting, their attitude towards clinical trials regarding risks and benefits, and their source of information in this context. Results:771 patients (1:1 male/female) participated with a median age of 61?years (range 18-91?years) with a response rate of 71.5%. Of all, 17.8% (137/771) were participating in a clinical trial. The most mentioned reason was to serve medical progress and cancer research. Out of the patients not currently participating in a trial, 79 (12.7%, 79/623) refusers named the following main reasons: extensive travel time to the clinic, no therapeutic advantage, and too time-consuming. Out of the patients not offered to take part in a trial, 265 (51.0%, 265/520) would participate if offered. Of all patients, 8.3% (64/771) used the clinics' homepage as a source of information, of those 79.7% (51/64) were satisfied with its content. To enhance patient recruitment strategies, we asked how patients wish to be informed about possible trials: More than half (52.0%) of the questioned patients preferred an individual medical consultation with their physician.We further analyzed the trial participation depending on age, gender, unit, and tumor entity. We could show a significant influence of age (p?<?0.001) but not for gender (p?=?0.724). The trial participation was also significantly associated with the treating unit (p?<?0.001) and tumor entity (p?=?0.001). Conclusion:Patients are willing to participate in clinical trials. Better information strategies need to be implemented. Physicians need to be aware of running trials within their department and must counseling counsel patients effectively to improve recruitment. Trial concepts should keep in mind patients' needs including an adequate number of appointments, positive risk-benefit profiles, and information material.
Project description:Two datasets were obtained to develop an understanding of factors characterizing the eLearning experience of secondary school teachers and university undergraduate students in Jordan. Both datasets were collected via electronic questionnaires. The secondary school teachers' dataset was collected toward the end of the second semester of the 2019/2020 academic year, and the university undergraduate students' dataset was collected during the summer semester of the same year. Six hundred and sixty-six participants responded to the secondary school teachers' questionnaire, and one thousand participants responded to the university undergraduate students' questionnaire. A structural equation modelling approach was utilized to analyze the data. Future research might extend the two data models by collecting data about other factors and examine their impact on the eLearning experience of secondary school teachers and university undergraduate students in Jordan and other countries. Moreover, the datasets can be compared with other data from different developing and developed countries.
Project description:BACKGROUND:Surgical site infections (SSIs) are one of the leading causes of death, and its prevention is a key element of applying the concept of patient safety and quality care. OBJECTIVE:This study aimed to assess the level of knowledge about SSIs and risks of wound infection among medical physicians in King Abdulaziz University Hospital. METHODS:All surgical and medical consultants, specialists, residents, and medical interns were invited to participate in the study. A 20-Item multiple-choice questionnaire was developed by reviewing the previous literature and with the help of a group of certified surgeons to assess the level of knowledge in all participants. RESULTS:A total of 119 doctors were included in this study. Among all respondents, 92 (77.3%) were intern doctors, 16 (13.4%) were resident doctors, and 11 (9.2%) were specialist doctors. Moreover, 66 (55.5%) doctors knew the definition of SSI. Only one-quarter, that is, 30 (25.2%) doctors knew about the incidence of SSI. In addition, 8 doctors (6.7%) had good knowledge, 75 (63.0%) had fair knowledge, and 36 (30.2%) had poor knowledge regarding SSI according to this study. CONCLUSIONS:Level of knowledge about SSIs and risks of wound infections among medical physicians should be improved to ensure better wound care and quality care for the patients.
Project description:OBJECTIVE:From 2012 to 2015, two Departments of Obstetrics and Gynecology and two Departments of Pediatrics at the University of Copenhagen implemented an English medium international project. The project allowed international students to work in pairs with local Danish speaking students in a clinical setting. The student cohort was supported by Danish doctors who were responsible for student-pair supervision in English and, ultimately, patient care. Drawing on survey responses of 113 Danish doctors, this study considers the doctors' overall evaluation of the program and their perception of the international students' knowledge, skills and attitudes compared with local students. RESULTS:The Danish doctors rated the international and local students comparable in respect to professional commitment (p?=?0.347), academic level (p?=?0.134), and English proficiency (p?=?0.080). The Danish doctors rated the international students significantly lower than the local students regarding communication with Danish doctors, other hospital staff, and patients (p?<?0.001 in all cases). Ninety percent of the doctors involved in the project supported continuing working with internationalization if it included mixed pairs of students and a Danish doctor assigned each day to be exclusively responsible for student supervision. Language barriers for international medical students could be overcome but required substantial faculty support.
Project description:Most persons with confirmed coronavirus disease (COVID-19) have no or mild symptoms. During the COVID-19 pandemic, communities need efficient methods to monitor asymptomatic patients to reduce transmission. We describe the structure and operating protocols of a community treatment center (CTC) run by Seoul National University Hospital (SNUH) in South Korea. SNUH converted an existing facility into a CTC to isolate patients who had confirmed COVID-19 but mild or no symptoms. Patients reported self-measured vital signs and symptoms twice a day by using a smartphone application. Medical staff in a remote monitoring center at SNUH reviewed patient vital signs and provided video consultation to patients twice daily. The CTC required few medical staff to perform medical tests, monitor patients, and respond to emergencies. During March 5-26, 2020, we admitted and treated 113 patients at this center. CTCs could be an alternative to hospital admission for isolating patients and preventing community transmission.
Project description:Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire.A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i) trial, (ii) site, (iii) patient, (iv) clinical team, (v) information and consent and (vi) study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment.A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes.We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using this tool with appropriate trial-specific adaptations to monitor and improve recruitment performance in an ongoing trial or conduct the survey at trial completion to gather information on facilitators and barriers to recruitment that can form the basis of interventions and strategies to improve recruitment to future clinical trials.