Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Psychological health of medical and dental students in Saudi Arabia : a longitudinal study

Introduction: Many studies have indicated the poor psychological health of medical and dental students. However, few studies have assessed the longitudinal trajectory of that psychological health at different times in an academic year. Aim: To evaluate the positive and negative aspects of psychological health among preclinical medical and dental students in Saudi Arabia prospectively. Methods: A total of 317 preclinical medical and dental students were recruited for a longitudinal study design from second and third-year students at Umm Al-Qura University in the 2012-2013 academic year. The students were assessed at the middle of the first term and followed up after 3-monthes at the beginning of the second term. Questionnaires included assessment of depression, anxiety, stress, self-efficacy, and satisfaction with life. Results: Depression, anxiety, stress, and satisfaction with life were improved significantly at the beginning of the second term, whereas self-efficacy did not change significantly. The medical, female, and third-year student subgroups had the most significant changes. Depression and stress were significantly changed at the beginning of the second term in most demographic subgroups. Conclusion: Preclinical medical and dental students have different psychological health levels at different times of the same academic year. It is recommended to consider time of data collection when analyzing the results of such studies.

Factors associated with mental health of medical students in Vietnam: A national study

This project was the first national study of the health and wellbeing of medical students in Vietnam. Data from over 2,000 students from eight universities indicate that, while the majority are healthy, significant proportions have poor mental and/or physical health and other life adversities. For many students, heavy academic demands were not a major stressor; rather, difficulties within their family, interpersonal relations, dissatisfaction with career choice and housing and financial problems appear to cause the most strain. This study provides evidence that will be useful for the development of professional counseling services in Vietnamese universities.

Determinants of the citation rate of medical research publications from a developing country

Background The number of citations received by an article is considered as an objective marker judging the importance and the quality of the research work. The present study aims to study the determinants of citations for research articles published by Sri Lankan authors. Methods Papers were selectively retrieved from the SciVerse Scopus® (Elsevier Properties S.A, USA) database for 10 years from 1st January 1997 to 31st December 2006, of which 50% were selected for inclusion by simple random sampling. The primary outcome measure was citation rate (defined as the number of citations during the 2 subsequent years after publication). Citation data was collected using the SciVerse Scopus® Citation Analyzer and self citations were excluded. A linear regression analysis was performed with ‘number of citations’ as the continuous dependent variable and other independent variables. Result The number of publications has steadily increased during the period of study. Over three quarter of papers were published in international journals. More than half of publications were research studies (55.3%), and most of the research studies were descriptive cross-sectional studies (27.1%). The mean number of citations within 2 years of publication was 1.7 and 52.1% of papers were not cited within the first two years of publication. The mean number of citations for collaborative studies (2.74) was significantly higher than that of non-collaborative studies (0.66). The mean number of citations did not significantly change depending on whether the publication had a positive result (2.08) or not (2.92) and was also not influenced by the presence (2.30) or absence (1.99) of the main study conclusion in the title of the article. In the linear regression model, the journal rank, number of authors, conducting the study abroad, being a research study or systematic review/meta-analysis and having regional and/or international collaboration all significantly increased the number of citations. Conclusion The journal rank, number of authors, conducting the study abroad, being a research study or systematic review/meta-analysis and having regional and/or international collaboration all significantly increased the number of citations. However, the presence of a positive result in the study did not influence the citation rate.

Policing of road safety in Oman: Perceptions and beliefs of traffic police officers

With increasing motorisation, road safety has become a major concern within Oman. Internationally, traffic policing plays a major role in improving road safety. Within Oman, the Royal Oman Police's (ROP) Directorate General of Traffic is responsible for policing traffic laws. Many common enforcement approaches originate from culturally different jurisdictions. The ROP is a relatively young policing force and may have different operational practices. Prior to applying practices from other jurisdictions it is important to understand the beliefs and expectations within the Directorate General of Traffic. Further, there is a need for individuals to understand their role and what is expected of them. Therefore, it is important to explore the agreement between levels of the ROP to determine how strategies and expectations transfer within the organisation. Interviews were conducted with 19 police officers from various levels of the ROP. A number of themes and findings emerged. Individuals at the upper level of the traffic police had a clear knowledge of the role of the ROP, believed that traffic police know what is expected of them, are well trained in their role and can have a very positive influence on road safety. These beliefs were less certain lower within the organisations with traffic officers having little knowledge of the role of the ROP or what was expected of them, felt undertrained, and believed their peers have little positive impact on road safety. There is a need to address barriers within the ROP in order to positively impact road safety.

Organisational age cultures: The interplay of chief executive officers age and attitudes toward younger and older employees

This article investigates the interactive effects of chief executive officer (CEO) age and CEO attitudes toward younger and older employees on organisational age cultures. Data was collected from 66 CEOs of small and medium-sized businesses and 274 employees. Results were consistent with expectations based on organisational culture and upper echelons theories. The relationship between CEO age and organisational age culture for younger employees was negative for CEOs with a less positive attitude toward younger employees and positive for those with a more positive attitude toward younger employees. The relationship between CEO age and organisational age culture for older employees was positive for CEOs with a more positive attitude toward older employees and non-significant for those with a less positive attitude toward older employees. The findings provide initial support for the existence of organisational age cultures, suggesting that these cultures can be predicted by the interplay of CEO age and age-related attitudes.

Where and how to conserve: Extending the scope of spatial reserve network design

Ongoing habitat loss and fragmentation threaten much of the biodiversity that we know today. As such, conservation efforts are required if we want to protect biodiversity. Conservation budgets are typically tight, making the cost-effective selection of protected areas difficult. Therefore, reserve design methods have been developed to identify sets of sites, that together represent the species of conservation interest in a cost-effective manner. To be able to select reserve networks, data on species distributions is needed. Such data is often incomplete, but species habitat distribution models (SHDMs) can be used to link the occurrence of the species at the surveyed sites to the environmental conditions at these locations (e.g. climatic, vegetation and soil conditions). The probability of the species occurring at unvisited location is next predicted by the model, based on the environmental conditions of those sites. The spatial configuration of reserve networks is important, because habitat loss around reserves can influence the persistence of species inside the network. Since species differ in their requirements for network configuration, the spatial cohesion of networks needs to be species-specific. A way to account for species-specific requirements is to use spatial variables in SHDMs. Spatial SHDMs allow the evaluation of the effect of reserve network configuration on the probability of occurrence of the species inside the network. Even though reserves are important for conservation, they are not the only option available to conservation planners. To enhance or maintain habitat quality, restoration or maintenance measures are sometimes required. As a result, the number of conservation options per site increases. Currently available reserve selection tools do however not offer the ability to handle multiple, alternative options per site. This thesis extends the existing methodology for reserve design, by offering methods to identify cost-effective conservation planning solutions when multiple, alternative conservation options are available per site. Although restoration and maintenance measures are beneficial to certain species, they can be harmful to other species with different requirements. This introduces trade-offs between species when identifying which conservation action is best applied to which site. The thesis describes how the strength of such trade-offs can be identified, which is useful for assessing consequences of conservation decisions regarding species priorities and budget. Furthermore, the results of the thesis indicate that spatial SHDMs can be successfully used to account for species-specific requirements for spatial cohesion - in the reserve selection (single-option) context as well as in the multi-option context. Accounting for the spatial requirements of multiple species and allowing for several conservation options is however complicated, due to trade-offs in species requirements. It is also shown that spatial SHDMs can be successfully used for gaining information on factors that drive a species spatial distribution. Such information is valuable to conservation planning, as better knowledge on species requirements facilitates the design of networks for species persistence. This methods and results described in this thesis aim to improve species probabilities of persistence, by taking better account of species habitat and spatial requirements. Many real-world conservation planning problems are characterised by a variety of conservation options related to protection, restoration and maintenance of habitat. Planning tools therefore need to be able to incorporate multiple conservation options per site, in order to continue the search for cost-effective conservation planning solutions. Simultaneously, the spatial requirements of species need to be considered. The methods described in this thesis offer a starting point for combining these two relevant aspects of conservation planning.

Is The Burden of Medical Education Affecting Ethics of Medical Treatment?

A substantial number of medical students in India have to bear an enormous financial burden for earning a bachelor's degree in medicine referred to as MBBS (bachelor of medicine and bachelor of surgery). This degree program lasts for four and one-half years followed by one year of internship. A postgraduate degree, such as MD, has to be pursued separately on completion of a MBBS. Every medical college in India is part of a hospital where the medical students get clinical exposure during the course of their study. All or at least a number of medical colleges in a given state are affiliated to a university that mainly plays a role of an overseeing authority. The medical colleges usually have no official interaction with other disciplines of education such as science and engineering, perhaps because of their independent location and absence of emphasis on medical research. However, many of the medical colleges are adept in imparting high-quality and sound training in medical practices including diagnostics and treatment. The medical colleges in India are generally of two types, i.e., government owned and private. Since only a limited number of seats are available across India in the former category of colleges, only a small fraction of aspiring candidates can find admission in these colleges after performing competitively in the relevant entrance tests. A major advantage of studying in these colleges is the nominal tuition fees that have to be paid. On the other hand, a large majority of would-be medical graduates have to seek admission in the privately run medical institutes in which the tuition and other related fees can be mind boggling when compared to their public counterparts. Except for candidates of exceptionally affluent background, the only alternative for fulfilling the dream of becoming a doctor is by financing one's study through hefty bank loans that may take years to pay back. It is often heard from patients that they are asked by doctors to undergo a plethora of diagnostic tests for apparently minor illnesses, which may financially benefit those prescribing the tests. The present paper attempts to throw light on the extent of disparity in cost of a medical education between state-funded and privately managed medical colleges in India; the average salary of a new medical graduate, which is often ridiculously low when compared to what is offered in entry-level engineering and business jobs; and the possible repercussions of this apparently unjust economic situation regarding the exploitation of patients.

Transfer of Medical Sensor Technologies to Environmental Monitoring, Solomons, Maryland, April 6-8, 2005: workshop proceedings

(pdf contains 23 pages)

Designing for validation of medical devices and equipment

Validation is important in the design, development and production of medical devices since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations.