Safety of medical device users: A study of physiotherapists’ practices, procedures and risk perception

This thesis was submitted for the degree of Doctor of Philosophy and awarded by Brunel University.Aims: To study practices and procedures with respect to electrotherapy in physiotherapy departments and to study physiotherapists’ perception of health risk, health consequences and protection of health from different risks including electromagnetic field emissions from electrotherapy devices. Methods: This cross-sectional study was conducted in three phases from June 2002 to December 2003. The first phase was an audit of the practices and procedures regarding electrotherapy in National Health Service physiotherapy departments (N = 46 including 7 departments in pilot study) located in 12 counties in the southeast and southwest of England including Greater London. The second phase comprised one observational visit to each of the same physiotherapy departments to characterise their occupational environment. The third phase was a questionnaire survey of 584 physiotherapists working in these departments. Variables concerned perception of health risk, health consequences and protection of health associated with different risk factors. Results: In the first two phases, the recruitment rate of the departments was 80.7% (46 out of 57) and response rate of those recruited was 100% (n=46). The response rate for the last phase of the study was 66.8% (390 out of 584). Results of the practices and procedures audit show that ultrasound was the most common form of electrotherapy while microwave diathermy was neither available nor used in these departments. Pulsed shortwave diathermy was used 4-5 days per week while continuous shortwave diathermy was used rarely. Electrotherapy was provided to up to 50% of patients per week in the departments. The observational visits to the departments revealed that there were metallic objects within close proximity of diathermy equipment and wooden treatment couches for treatment with PSWD and CSWD were rare. The risk perception survey showed that physiotherapists generally perceived a moderate health risk and health consequences (harm) from exposure to EMF emissions from electrotherapy devices. Protection from EMFs in physiotherapy departments was generally perceived as ‘usually’ possible. Conclusions: Physiotherapy departments report safe electrotherapy practices. Use of diathermy devices that use RF EMFs is declining. The key predictors of physiotherapists’ perception of health risk were perception of health consequences and vice versa. Gender was a significant predictor of the perception of health risks and health consequences. The main predictor of perception of protection against risk was the knowledge of environmental and health issues. Latent dimensions of perceptions of health risk, health consequences and protection from risk were identified and confirmed and their predictors were determined.Brunel Universit

Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process

Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP).Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP.Results: The suggested framework comprises two streams of users' involvement in MDT development, that is, what might be called the end users' stream and the professional users' stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users' involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented.Conclusions: Development of medical devices from users' perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users' requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users' involvement at different stages of the MDTDP

Safety of medical device users : a study of physiotherapists' practices, procedures and risk perception

Aims: To study practices and procedures with respect to electrotherapy in physiotherapy departments and to study physiotherapists’ perception of health risk, health consequences and protection of health from different risks including electromagnetic field emissions from electrotherapy devices. Methods: This cross-sectional study was conducted in three phases from June 2002 to December 2003. The first phase was an audit of the practices and procedures regarding electrotherapy in National Health Service physiotherapy departments (N = 46 including 7 departments in pilot study) located in 12 counties in the southeast and southwest of England including Greater London. The second phase comprised one observational visit to each of the same physiotherapy departments to characterise their occupational environment. The third phase was a questionnaire survey of 584 physiotherapists working in these departments. Variables concerned perception of health risk, health consequences and protection of health associated with different risk factors. Results: In the first two phases, the recruitment rate of the departments was 80.7% (46 out of 57) and response rate of those recruited was 100% (n=46). The response rate for the last phase of the study was 66.8% (390 out of 584). Results of the practices and procedures audit show that ultrasound was the most common form of electrotherapy while microwave diathermy was neither available nor used in these departments. Pulsed shortwave diathermy was used 4-5 days per week while continuous shortwave diathermy was used rarely. Electrotherapy was provided to up to 50% of patients per week in the departments. The observational visits to the departments revealed that there were metallic objects within close proximity of diathermy equipment and wooden treatment couches for treatment with PSWD and CSWD were rare. The risk perception survey showed that physiotherapists generally perceived a moderate health risk and health consequences (harm) from exposure to EMF emissions from electrotherapy devices. Protection from EMFs in physiotherapy departments was generally perceived as ‘usually’ possible. Conclusions: Physiotherapy departments report safe electrotherapy practices. Use of diathermy devices that use RF EMFs is declining. The key predictors of physiotherapists’ perception of health risk were perception of health consequences and vice versa. Gender was a significant predictor of the perception of health risks and health consequences. The main predictor of perception of protection against risk was the knowledge of environmental and health issues. Latent dimensions of perceptions of health risk, health consequences and protection from risk were identified and confirmed and their predictors were determined.EThOS - Electronic Theses Online ServiceGBUnited Kingdo

Perceptions of gender equity and markers of achievement in a National Institute for Health Research Biomedical Research Centre : a qualitative study.

Background: The need to improve gender equity (GE) in academic medicine is well documented. Biomedical Research Centres (BRCs), partnerships between leading National Health Service (NHS) organizations and universities in England, conduct world-class translational research funded by the National Institute for Health and Care Research (NIHR). In 2011, eligibility for BRC funding was restricted to universities demonstrating sustained GE success recognized by the Athena SWAN Charter for Women in Science Silver awards. Despite this structural change, GE research in BRC settings is underdeveloped, yet critical to the acceleration of women’s advancement and leadership. To explore both women’s and men’s perceptions of GE and current markers of achievement in a BRC setting. Methods: Thematic analysis of data from two research projects: 53 GE survey respondents’ free-text comments (34 women, 16 men), and 16 semi-structured interviews with women affiliated to the NIHR Oxford BRC. Results: Four major themes emerged from the analysis: perceptions of the Athena SWAN Charter for Women in Science (GE policy); views on monitoring GE in BRCs; views on current markers of achievement in academia and GE; and recommendations for actions to improve GE in BRC settings. Monitoring of GE in BRCs was deemed to be important, but complex. Participants felt that current markers of achievement were not equitable to women, as they did not take contextual factors into account such as maternity leave and caring responsibilities. BRC-specific organizational policies and metrics are needed in order to monitor and catalyse GE. Conclusions: Markers of achievement for monitoring GE in BRCs should consider contextual factors specific to BRCs and women’s career progression and professional advancement. GE markers of achievement should be complemented with broader aspects of equality, diversity and inclusion

Adopting a Citizen Science Approach in Translational Experimental Medicine Research in Non-Alcoholic Fatty Liver Disease: A Study Protocol

Citizen science approaches are widely and successfully used in biological, environmental, and ecological sciences; however, they are rarely applied in other domains, such as translational health research, notably in the field of liver disease and metabolism. We have designed a study that aims to explore the application of the citizen science approach in a translational experimental medicine study on non-alcoholic fatty liver disease (NAFLD) and a 12-week lifestyle and weight loss program. In this methodological paper, we describe the process of involving citizen scientists in the study. We will recruit a convenience sample of 31 participants (with and without NAFLD) and a half-dozen citizen scientists (members of the public). Citizen scientists will work alongside clinical and non-clinical researchers in a translational experimental medicine study on NAFLD. Citizen scientists will be involved in the co-design and/or review of data collection tools (e.g., semi-structured open-ended questionnaire surveys and semi-structured wellbeing diaries completed by the participants), co-analysis of data on participants’ experiences and motivations, co-drafts of research findings and papers, and suggestions for policy recommendations. Citizen scientists will be trained in the research tasks they will undertake, and will be either co-authors or their names will be mentioned in the acknowledgements in research paper(s) based on the level of research contributions. Lessons learned from implementing citizen science in this study will help to reveal the advantages, limitations, and implications of involving citizen scientists in the translational medicine research. Knowing citizen scientists’ motivations, expectations, training needs, and overall experience of involvement in this study could provide insights, which could inform the planning and conduct of future translational research studies. Involving citizen scientists in translational medicine research is an important step in extending research opportunities for members of the public; however, there may be methodological challenges, which may be identified and resolved by more research studies

Trends in the availability and usage of electrophysical agents in physiotherapy practices from 1990 to 2010: A review

This is the Pre-print version of the Article. The official published version can be accessed from the link below - Copyright @ 2012 Maney PublishingBackground: The use of electrophysical agents has a historically important role in physiotherapy practice. There are anecdotal reports that the availability and usage of electrotherapy modalities are declining, which may have implications for physiotherapy practice. The aim of this literature review was to provide scientific evidence on electrotherapy usage in the last 20 years by identifying trends in availability, use, and non-use of nine electrotherapeutic modalities in physiotherapy practices during 1990s and 2000s. Methods: Review of empirical studies published in the English language from 1990 to 2010 and identified through searching online bibliographic databases, which included: Medline/OvidSP, PubMed Central, CINAHL/EBSCOhost, ScienceDirect, Scopus, ISI Web of Science, and Google Scholar. Findings: In the last 20 years, ultrasound availability and usage show increasing trends in several countries. The availability and use of pulsed shortwave diathermy and laser have shown steady trends. Transcutaneous electrical nerve stimulation, interferential, and biofeedback availability and usage have shown increasing trends in the UK and decreasing trends in Australia and the Republic of Ireland. Trends of continuous shortwave diathermy availability and use are declining irrespective of the country of the study. The availability and usage of microwave diathermy and H-wave show steeply declining trends, while there is a sharp rise in their non-availability over the last several years. Conclusions: The availability and use of electrophysical agents have greatly changed in the last 20 years. Declining trends in the availability and usage along with increasing trend of non-availability of electrotherapy modalities may have implications for electrotherapy education, training, and practice in the coming years.This study was funded by Health & Safety Executive, UK (grant no. 4371/R47.022)

Gender parity in scientific authorship in a National Institute for Health Research Biomedical Research Centre : a bibliometric analysis

Objective: Scientific authorship is a vital marker of achievement in academic careers and gender equity is a key performance metric in research. However, there is little understanding of gender equity in publications in biomedical research centres funded by the National Institute for Health Research (NIHR). This study assesses the gender parity in scientific authorship of biomedical research. Design: Descriptive, cross-sectional, retrospective bibliometric study. Setting: NIHR Oxford Biomedical Research Centre (BRC). Data: Data comprised 2409 publications that were either accepted or published between April 2012 and March 2017. The publications were classified as basic science studies, clinical studies (both trial and non-trial studies) and other studies (comments, editorials, systematic reviews, reviews, opinions, book chapters, meeting reports, guidelines and protocols). Main outcome measures: Gender of authors, defined as a binary variable comprising either male or female categories, in six authorship categories: first author, joint first authors, first corresponding author, joint corresponding authors, last author and joint last authors. Results: Publications comprised 39% clinical research (n=939), 27% basic research (n=643) and 34% other types of research (n=827). The proportion of female authors as first author (41%), first corresponding authors (34%) and last author (23%) was statistically significantly lower than male authors in these authorship categories (p<0.001). Of total joint first authors (n=458), joint corresponding authors (n=169) and joint last authors (n=229), female only authors comprised statistically significant (p<0.001) smaller proportions, that is, 15% (n=69), 29% (n=49) and 10% (n=23) respectively, compared with male only authors in these joint authorship categories. There was a statistically significant association between gender of the last author with gender of the first author (p<0.001), first corresponding author (p<0.001) and joint last author (p<0.001). The mean journal impact factor (JIF) was statistically significantly higher when the first corresponding author was male compared with female (Mean JIF: 10.00 vs 8.77, p=0.020); however, the JIF was not statistically different when there were male and female authors as first authors and last authors. Conclusions: Although the proportion of female authors is significantly lower than the proportion of male authors in all six categories of authorship analysed, the proportions of male and female last authors are comparable to their respective proportions as principal investigators in the BRC. These findings suggest positive trends and the NIHR Oxford BRC doing very well in gender parity in the senior (last) authorship category. Male corresponding authors are more likely to publish articles in prestigious journals with high impact factor while both male and female authors at first and last authorship positions publish articles in equally prestigious journals

Patients' perspectives on self-testing of oral anticoagulation therapy: Content analysis of patients' internet blogs

<p>Abstract</p> <p>Background</p> <p>Patients on oral anticoagulant therapy (OAT) require regular testing of the prothrombin time (PT) and the international normalised ratio (INR) to monitor their blood coagulation level to avoid complications of either over or under coagulation. PT/INR can be tested by a healthcare professional or by the patient. The latter mode of the testing is known as patient self-testing or home testing. The objective of this study was to elicit patients' perspectives and experiences regarding PT/INR self-testing using portable coagulometer devices.</p> <p>Methods</p> <p>Internet blog text mining was used to collect 246 blog postings by 108 patients, mainly from the USA and the UK. The content of these qualitative data were analysed using XSight and NVivo software packages.</p> <p>Results</p> <p>The key themes in relation to self-testing of OAT identified were as follows: Patient benefits reported were time saved, personal control, choice, travel reduction, cheaper testing, and peace of mind. Equipment issues included high costs, reliability, quality, and learning how to use the device. PT/INR issues focused on the frequency of testing, INR fluctuations and individual target (therapeutic) INR level. Other themes noted were INR testing at laboratories, the interactions with healthcare professionals in managing and testing OAT and insurance companies' involvement in acquiring the self-testing equipment. Social issues included the pain and stress of taking and testing for OAT.</p> <p>Conclusions</p> <p>Patients' blogs on PT/INR testing provide insightful information that can help in understanding the nature of the experiences and perspectives of patients on self-testing of OAT. The themes identified in this paper highlight the substantial complexities involved in self-testing programmes in the healthcare system. Thus, the issues elicited in this study are very valuable for all stakeholders involved in developing effective self-testing strategies in healthcare that are gaining considerable current momentum particularly for patients with chronic illness.</p

Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries

Background: Balancing opioid stewardship and the need for adequate analgesia following discharge after surgery is challenging. This study aimed to compare the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures.Methods: This international, multicentre, prospective cohort study collected data from patients undergoing common acute and elective general surgical, urological, gynaecological, and orthopaedic procedures. The primary outcomes were patient-reported time in severe pain measured on a numerical analogue scale from 0 to 100% and patient-reported satisfaction with pain relief during the first week following discharge. Data were collected by in-hospital chart review and patient telephone interview 1 week after discharge.Results: The study recruited 4273 patients from 144 centres in 25 countries; 1311 patients (30.7%) were prescribed opioid analgesia at discharge. Patients reported being in severe pain for 10 (i.q.r. 1-30)% of the first week after discharge and rated satisfaction with analgesia as 90 (i.q.r. 80-100) of 100. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity (risk ratio 1.52, 95% c.i. 1.31 to 1.76; P &lt; 0.001) and re-presentation to healthcare providers owing to side-effects of medication (OR 2.38, 95% c.i. 1.36 to 4.17; P = 0.004), but not with satisfaction with analgesia (beta coefficient 0.92, 95% c.i. -1.52 to 3.36; P = 0.468) compared with opioid-free analgesia. Although opioid prescribing varied greatly between high-income and low- and middle-income countries, patient-reported outcomes did not.Conclusion: Opioid analgesia prescription on surgical discharge is associated with a higher risk of re-presentation owing to side-effects of medication and increased patient-reported pain, but not with changes in patient-reported satisfaction. Opioid-free discharge analgesia should be adopted routinely