A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial.

BACKGROUND: Glioblastoma (GBM) is the most common adult malignant brain tumour, with an incidence of 5 per 100,000 per year in England. Patients with tumours showing O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation represent around 40% of newly diagnosed GBM. Relapse/tumour recurrence is inevitable. There is no agreed standard treatment for patients with GBM, therefore, it is aimed at delaying further tumour progression and maintaining health-related quality of life (HRQoL). Limited clinical trial data exist using cannabinoids in combination with temozolomide (TMZ) in this setting, but early phase data demonstrate prolonged overall survival compared to TMZ alone, with few additional side effects. Jazz Pharmaceuticals (previously GW Pharma Ltd.) have developed nabiximols (trade name Sativex®), an oromucosal spray containing a blend of cannabis plant extracts, that we aim to assess for preliminary efficacy in patients with recurrent GBM. METHODS: ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to assess cannabinoids in patients with recurrent MGMT methylated GBM who are suitable for treatment with TMZ. Patients who have relapsed ≥ 3 months after completion of initial first-line treatment will be randomised 2:1 to receive either nabiximols or placebo in combination with TMZ. The primary outcome is overall survival time defined as the time in whole days from the date of randomisation to the date of death from any cause. Secondary outcomes include overall survival at 12 months, progression-free survival time, HRQoL (using patient reported outcomes from QLQ-C30, QLQ-BN20 and EQ-5D-5L questionnaires), and adverse events. DISCUSSION: Patients with recurrent MGMT promoter methylated GBM represent a relatively good prognosis sub-group of patients with GBM. However, their median survival remains poor and, therefore, more effective treatments are needed. The phase II design of this trial was chosen, rather than phase III, due to the lack of data currently available on cannabinoid efficacy in this setting. A randomised, double-blind, placebo-controlled trial will ensure an unbiased robust evaluation of the treatment and will allow potential expansion of recruitment into a phase III trial should the emerging phase II results warrant this development. TRIAL REGISTRATION: ISRCTN: 11460478. CLINICALTRIALS: Gov: NCT05629702.

Understanding how shared decision-making approaches and patient aids influence patients with advanced cancer when deciding on palliative treatments and care: A realist review.

BACKGROUND: Patients with advanced incurable cancer face difficult decisions about palliative treatment options towards their end of life. However, they are often not provided with the appropriate information and support that is needed to make informed decisions. This review aimed to identify contexts and mechanisms associated with communication tools, patient decision-aids and shared decision-making (SDM) approaches that influence patient outcomes. METHODS: We used a realist review method to search for published studies of patients (adults > 18) with advanced cancer who were expected to make a decision about palliative treatment and/or supportive care in consultation with healthcare practitioners. We appraised and synthesised literature describing the contexts of (when and how) decision aids and SDM approaches are used, and how these contexts interact with mechanisms (resources and reasoning) which impact patient outcomes. Stakeholders including academics, palliative healthcare professionals (HCPs) and people with lived experience of supporting people with advanced incurable cancer contributed to identifying explanatory accounts. These accounts were documented, analysed and consolidated to contribute to the development of a programme theory. RESULTS: From the 33 included papers, we consolidated findings into 20 explanatory accounts to develop a programme theory that explains key contexts and mechanisms that influence patient and SDM. Contexts include underlying patients' and HCPs' attitudes and approaches. These need to be understood in relation to key mechanisms, including presenting information in multiple formats and providing adequate time and opportunities to prepare for and revisit decisions. Contexts influenced mechanisms which then influence the levels of patient decisional satisfaction, conflict and regret. CONCLUSIONS: Our programme theory highlights mechanisms that are important in supporting shared treatment decisions for advanced noncurative cancer. The findings are informative for developing and evaluating interventions to improve understanding and involvement in SDM for patients with advanced incurable cancer. PATIENT AND PUBLIC CONTRIBUTION: We included patient and public involvement (PPI) representatives in four stakeholder meetings. PPI helped to define the scope of the review, identify their unique experiences and perspectives, synthesise their perspectives with our review findings, make decisions about which theories we included in our programme theory and develop recommendations for policy and practice and future research.

Communication of palliative care needs in discharge letters from hospice providers to primary care: a multisite sequential explanatory mixed methods study.

BACKGROUND: The provision of palliative care is increasing, with many people dying in community-based settings. It is essential that communication is effective if and when patients transition from hospice to community palliative care. Past research has indicated that communication issues are prevalent during hospital discharges, but little is known about hospice discharges. METHODS: An explanatory sequential mixed methods study consisting of a retrospective review of hospice discharge letters, followed by hospice focus groups, to explore patterns in communication of palliative care needs of discharged patients and describe why these patients were being discharged. Discharge letters were extracted for key content information using a standardised form. Letters were then examined for language patterns using a linguistic methodology termed corpus linguistics. Thematic analysis was used to analyse the focus group transcripts. Findings were triangulated to develop an explanatory understanding of discharge communication from hospice care. RESULTS: We sampled 250 discharge letters from five UK hospices whereby patients had been discharged to primary care. Twenty-five staff took part in focus groups. The main reasons for discharge extracted from the letters were symptoms "managed/resolved" (75.2%), and/or the "patient wishes to die/for care at home" (37.2%). Most patients had some form of physical needs documented on the letters (98.4%) but spiritual needs were rarely documented (2.4%). Psychological/emotional needs and social needs were documented in 46.4 and 35.6% of letters respectively. There was sometimes ambiguity in "who" will be following up "what" in the discharge letters, and whether described patients' needs were resolved or ongoing for managing in the community setting. The extent to which patients received a copy of their discharge letter varied. Focus groups conveyed a lack of consensus on what constitutes "complexity" and "complex pain". CONCLUSIONS: The content and structure of discharge letters varied between hospices, although generally focused on physical needs. Our study provides insights into patterns associated with those discharged from hospice, and how policy and guidance in this area may be improved, such as greater consistency of sharing letters with patients. A patient-centred set of hospice-specific discharge letter principles could help improve future practice.

Randomised controlled trial and economic evaluation of a targeted cancer awareness intervention for adults living in deprived areas of the UK.

BACKGROUND: Cancer outcomes are poor in socioeconomically deprived communities, with low symptom awareness contributing to prolonged help-seeking and advanced disease. Targeted cancer awareness interventions require evaluation. METHODS: This is a randomised controlled trial involving adults aged 40+ years recruited in community and healthcare settings in deprived areas of South Yorkshire and South-East Wales. INTERVENTION: personalised behavioural advice facilitated by a trained lay advisor. CONTROL: usual care. Follow-up at two weeks and six months post-randomisation. PRIMARY OUTCOME: total cancer symptom recognition score two weeks post-randomisation. RESULTS: Two hundred and thirty-four participants were randomised. The difference in total symptom recognition at two weeks [adjusted mean difference (AMD) 0.6, 95% CI: -0.03, 1.17, p = 0.06] was not statistically significant. Intervention participants reported increased symptom recognition (AMD 0.8, 95% CI: 0.18, 1.37, p = 0.01) and earlier intended presentation (AMD -2.0, 95% CI: -3.02, -0.91, p < 0.001) at six months. "Lesser known" symptom recognition was higher in the intervention arm (2 weeks AMD 0.5, 95% CI: 0.03, 0.97 and six months AMD 0.7, 95% CI: 0.16, 1.17). Implementation cost per participant was £91.34, with no significant between-group differences in healthcare resource use post-intervention. CONCLUSIONS: Improved symptom recognition and earlier anticipated presentation occurred at longer-term follow-up. The ABACus Health Check is a viable low-cost intervention to increase cancer awareness in socioeconomically deprived communities. CLINICAL TRIAL REGISTRATION: ISRCTN16872545.

COVID-19 testing in English care homes and implications for staff and residents.

INTRODUCTION: Care home residents are at high risk of dying from coronavirus disease 2019 (COVID-19). Regular testing, producing rapid and reliable results is important in this population because infections spread quickly, and presentations are often atypical or asymptomatic. This study evaluated current testing pathways in care homes to explore the role of point-of-care tests (POCTs). METHODS: A total of 10 staff from eight care homes, purposively sampled to reflect care organisational attributes that influence outbreak severity, underwent a semi-structured remote videoconference interview. Transcripts were analysed using process mapping tools and framework analysis focussing on perceptions about, gaps within and needs arising from current pathways. RESULTS: Four main steps were identified in testing: infection prevention, preparatory steps, swabbing procedure and management of residents. Infection prevention was particularly challenging for mobile residents with cognitive impairment. Swabbing and preparatory steps were resource-intensive, requiring additional staff resource. Swabbing required flexibility and staff who were familiar to the resident. Frequent approaches to residents were needed to ensure they would participate at a suitable time. After-test management varied between sites. Several homes reported deviating from government guidance to take more cautious approaches, which they perceived to be more robust. CONCLUSION: Swab-based testing is organisationally complex and resource-intensive in care homes. It needs to be flexible to meet the needs of residents and provide care homes with rapid information to support care decisions. POCT could help address gaps but the complexity of the setting means that each technology must be evaluated in context before widespread adoption in care homes.

Enhanced lateral flow testing strategies in care homes are associated with poor adherence and were insufficient to prevent COVID-19 outbreaks: results from a mixed methods implementation study.

INTRODUCTION: Care homes have been severely affected by the SARS-CoV-2 pandemic. Rapid antigen testing could identify most SARS-CoV-2 infected staff and visitors before they enter homes. We explored implementation of staff and visitor testing protocols using lateral flow devices (LFDs). METHODS: An evaluation of a SARS-CoV-2 LFD-based testing protocol in 11 care homes in Liverpool, UK, including staff and visitor testing, plus a qualitative exploratory study in nine of these homes. The proportion of pilot homes with outbreaks, and outbreak size, were compared to non-pilot homes in Liverpool. Adherence to testing protocols was evaluated. Fifteen staff were interviewed, and transcript data were thematically coded using an iterative analysis to identify and categorize factors influencing testing implementation. RESULTS: In total, 1,638 LFD rapid tests were performed on 407 staff. Protocol adherence was poor with 8.6% of staff achieving >75% protocol adherence, and 25.3% achieving $\ge$50%. Six care homes had outbreaks during the study. Compared to non-pilot care homes, there was no evidence of significant difference in the proportion of homes with outbreaks, or the size of outbreaks. Qualitative data showed difficulty implementing testing strategies due to excessive work burden. Factors influencing adherence related to test integration and procedural factors, socio-economic factors, cognitive overload and the emotional value of testing. CONCLUSION: Implementation of staff and visitor care home LFD testing protocols was poorly adhered to and consequently did not reduce the number or scale of COVID-19 outbreaks. More focus is needed on the contextual and behavioural factors that influence protocol adherence.

COVID-19 point-of-care testing in care homes: what are the lessons for policy and practice?

COVID-19 has devastated care homes. Point-of-care tests (POCTs), mainly using lateral flow devices (LFDs), have been deployed hurriedly without much consideration of their usability or impact on care workflow. Even after the pandemic, POCTs, particularly multiplex tests, may be an important control against spread of SARS-CoV-2 and other respiratory infections in care homes by enabling identification of cases. They should not, however, replace other infection control measures such as barrier methods and quarantine. Adherence to LFDs as implemented among care home staff is suboptimal. Other tests-such as point-of-care polymerase chain reaction and automated antigen tests-would also need to be accommodated into care home workflows to improve adherence. The up-front costs of POCTs are straightforward but additional costs, including staffing preparation and reporting processes and the impacts of false positive and negative tests on absence rates and infection days, are more complex and as yet unquantified. A detailed appraisal is needed as the future of testing in care homes is considered.

Is point-of-care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a point-of-care polymerase chain reaction test for SARS-CoV-2.

INTRODUCTION: Reliable rapid testing for COVID-19 is needed in care homes to reduce the risk of outbreaks and enable timely care. This study aimed to examine the usability and test performance of a point of care polymerase chain reaction (PCR) test for detection of SARS-CoV-2 (POCKITTM Central) in care homes. METHODS: POCKITTM Central was evaluated in a purposeful sample of four UK care homes. Test agreement with laboratory real-time PCR and usability and used errors were assessed. RESULTS: No significant usability-related hazards emerged, and the sources of error identified were found to be amendable with minor changes in training or test workflow. POCKITTM Central has acceptable sensitivity and specificity based on RT-PCR as the reference standard, especially for symptomatic cases.Asymptomatic specimens showed 83.3% (95% confidence interval (CI): 35.9-99.6%) positive agreement and 98.7% negative agreement (95% CI: 96.2-99.7%), with overall prevalence and bias-adjusted kappa (PABAK) of 0.965 (95% CI: 0.932- 0.999). Symptomatic specimens showed 100% (95% CI: 2.5-100%) positive agreement and 100% negative agreement (95% CI: 85.8-100%), with overall PABAK of 1.Recommendations are provided to mitigate the frequency of occurrence of the residual use errors observed. Integration pathways were discussed to identify opportunities and limitations of adopting POCKIT™ Central for screening and diagnostic testing purposes. CONCLUSIONS: Point-of-care PCR testing in care homes can be considered with appropriate preparatory steps and safeguards. Further diagnostic accuracy evaluations and in-service evaluation studies should be conducted, if the test is to be implemented more widely, to build greater certainty on this initial exploratory analysis.

Implementing lateral flow devices in long-term care facilities: experiences from the Liverpool COVID-19 community testing pilot in care homes- a qualitative study.

INTRODUCTION: Antigen-based lateral flow devices (LFDs) offer the potential of widespread rapid testing. The scientific literature has primarily focused on mathematical modelling of their use and test performance characteristics. For these tests to be implemented successfully, an understanding of the real-world contextual factors that allow them to be integrated into the workplace is vital. To address this gap in knowledge, we aimed to explore staff's experiences of integrating LFDs into routine practice for visitors and staff testing with a view to understand implementation facilitators and barriers. METHODS: Semi-structured interviews and thematic analysis. RESULTS: We identified two main themes and five subthemes. The main themes included: visitor-related testing factors and staff-related testing factors. Subthemes included: restoring a sense of normality, visitor-related testing challenges, staff-related testing challenges, and pre-pilot antecedent factors. CONCLUSION: Our study demonstrates that the real-world implementation of LFDs to test visitors and staff faces significant challenges as a result of several contextual factors negatively affecting the work practice and environment. More comprehensive studies are needed to identify and inform effective implementation strategies to ensure that LFDs can be adopted in an agile way that better supports an already exhausted and morally depleted workforce.

Recruitment and retention of participants from socioeconomically deprived communities: lessons from the Awareness and Beliefs About Cancer (ABACus3) Randomised Controlled Trial.

BACKGROUND: Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. METHODS: Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. RESULTS: The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n = 42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n = 212) retention at 2-weeks and 85% (n = 199) at 6-months. Community settings yielded 75% (n = 176) of participants. Participants had a mean age of 61.3 years and 63.3% (n = 148) were female, with 66% (n = 154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. CONCLUSIONS: The ABACus3 trial achieved recruitment and high retention with a population that is often "hard to reach" or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement. This study adheres to CONSORT guidelines. TRIAL REGISTRATION: Retrospectively registered with ISRCTN ( http://www.isrctn.com/ISRCTN16872545 ) on 12.01.2018.

Improving cancer symptom awareness and help-seeking among adults living in socioeconomically deprived communities in the UK using a facilitated health check: A protocol for the Awareness and Beliefs About Cancer (ABACus) Randomised Control Trial.

BACKGROUND: Cancer survival is lower in socioeconomically deprived communities, partly due to low awareness of symptoms, negative beliefs and delayed help-seeking. We developed an interactive health check questionnaire facilitated by trained lay advisors. It entails 29 questions about background, lifestyle and health with tailored behaviour change advice. Personalised results are printed using a traffic light (red/amber/green) system, highlighting areas where action should be taken. This is an individually randomised control trial to test effectiveness of the health check on symptom recognition. METHODS: A total 246 participants aged 40+ years will be recruited from community and healthcare settings in socioeconomically deprived areas of Yorkshire and South Wales. Participants will be randomised to receive the health check or standard care (1:1 ratio). Outcome measures include: adapted Awareness and Beliefs about Cancer (primary outcome), brief State Trait Anxiety Inventory, intentions and motivation to adopt recommended health behaviours (early symptom presentation, cancer screening and lifestyle behaviours), adapted Client Service Receipt Inventory, brief medical history/screening and demographic questionnaire at: baseline; 2-weeks; and 6-months post-randomisation. A purposive sample of intervention sessions will be audio-recorded (n = 24) and half will additionally be observed (n = 12). Semi-structured interviews will take place at 2-weeks (n = 30) and 6-months (n = 15-20) post-randomisation. The primary analysis will compare cancer symptom recognition scores between arms at 2-weeks. Secondary analysis will assess cancer beliefs, barriers/time to presentation, screening and lifestyle behaviours, anxiety and costs. A process evaluation will assess intervention fidelity, dose and contamination. The London-Surrey NHS Research Ethics Committee (Ref: 17/LO/1507) approved this trial. DISCUSSION: This is a trial of a theoretically underpinned complex intervention which has undergone phase 1 and 2 development work. The findings will evaluate evidence about the effect of the health check on symptom awareness. Although there are few exclusion criteria there are limitations regarding the population we are able to reach, who may have even higher risks of late diagnosis and poor cancer prognosis. However, the health check has the potential to improve cancer symptom awareness and encourage early help-seeking behaviour in deprived populations, thereby reducing inequalities in longer term cancer outcomes. TRIAL REGISTRATION: Retrospectively registered with ISRCTN (Ref: ISRCTN16872545 ) on 12.01.2018.

Work Domain Analysis for understanding medication safety in care homes in England: an exploratory study.

Medication safety and errors are a major concern in care homes. In addition to the identification of incidents, there is a need for a comprehensive system description to avoid the danger of introducing interventions that have unintended consequences and are therefore unsustainable. The aim of this study was to explore the impact and uniqueness of Work Domain Analysis (WDA) to facilitate an in-depth understanding of medication safety problems within the care home system and identify the potential benefits of WDA to design safety interventions to improve medication safety. A comprehensive, systematic and contextual overview of the care home medication system was developed for the first time. The novel use of the abstraction hierarchy (AH) to analyse medication errors revealed the value of the AH to guide a comprehensive analysis of errors and generate system improvement recommendations that took into account the contextual information of the wider system. PRACTITIONER SUMMARY: It is widely acknowledged that a systems approach is necessary to improve medication safety. This study used a cognitive engineering method, Work Domain Analysis, to map the care home medication system and analyse medication errors. A macro-level view of the system was developed and this has provided a knowledge base for future interventions.

Modelling and simulation of complex sociotechnical systems: envisioning and analysing work environments.

Accurate comprehension and analysis of complex sociotechnical systems is a daunting task. Empirically examining, or simply envisioning the structure and behaviour of such systems challenges traditional analytic and experimental approaches as well as our everyday cognitive capabilities. Computer-based models and simulations afford potentially useful means of accomplishing sociotechnical system design and analysis objectives. From a design perspective, they can provide a basis for a common mental model among stakeholders, thereby facilitating accurate comprehension of factors impacting system performance and potential effects of system modifications. From a research perspective, models and simulations afford the means to study aspects of sociotechnical system design and operation, including the potential impact of modifications to structural and dynamic system properties, in ways not feasible with traditional experimental approaches. This paper describes issues involved in the design and use of such models and simulations and describes a proposed path forward to their development and implementation. PRACTITIONER SUMMARY: The size and complexity of real-world sociotechnical systems can present significant barriers to their design, comprehension and empirical analysis. This article describes the potential advantages of computer-based models and simulations for understanding factors that impact sociotechnical system design and operation, particularly with respect to process and occupational safety.

Methylphenidate Versus Placebo for Treating Fatigue in Patients With Advanced Cancer: Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial.

PURPOSE: To compare effects and side effects of 6 weeks of individually dose-titrated methylphenidate or placebo on fatigue in palliative care patients with advanced cancer. METHODS: This is a randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients had advanced incurable cancer and fatigue >3/10. Principal exclusions were hypertension; psychiatric, cardiovascular, cerebrovascular, renal, liver, or blood disorders; substance dependency; and epilepsy. Patients were randomly assigned 1:1 methylphenidate or placebo starting at 5 mg twice daily. Dose of methylphenidate/placebo was titrated once per week, over 6 weeks, up to a maximum of 20 mg three times daily. Trial ended at 10 weeks. Primary outcome was the difference in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scores between groups at 6 ± 2 weeks. Secondary outcomes included adverse effects, quality of life, and mood. RESULTS: One hundred sixty-two patients (73 men; mean, 65.8; standard deviation [SD], 10.3 years) were randomly assigned, and three were excluded from analysis. Seventy-seven were allocated placebo (baseline FACIT-F = 22 [SD, 10]); 82 were allocated methylphenidate (FACIT-F = 20 [SD, 9]). After 6 ± 2 weeks, FACIT-F scores were 1.97 points (95% CI, -0.95 to 4.90; P = .186) higher (better) on methylphenidate than placebo. Across 10 weeks of the study, FACIT-F was nominally higher in the methylphenidate group versus placebo (Diff, 2.20 [95% CI, 0.39 to 4.01]), but this did not reach the minimally clinically important difference (5-points). At 6 weeks, there were no differences between groups in quality-of-life or symptom domains except for depression scores (nominally reduced in the methylphenidate group: Diff, -1.35 [95% CI, -2.41 to -0.30]). There were no differences in mortality or serious adverse events. CONCLUSION: After 6 ± 2 weeks of treatment, methylphenidate was not superior to placebo for treating fatigue in advanced cancer. Methylphenidate was safe and well-tolerated.

State of science: human factors and ergonomics in healthcare.

The past decade has seen an increase in the application of human factors and ergonomics (HFE) techniques to healthcare delivery in a broad range of contexts (domains, locations and environments). This paper provides a state of science commentary using four examples of HFE in healthcare to review and discuss analytical and implementation challenges and to identify future issues for HFE. The examples include two domain areas (occupational ergonomics and surgical safety) to illustrate a traditional application of HFE and the area that has probably received the most research attention. The other two examples show how systems and design have been addressed in healthcare with theoretical approaches for organisational and socio-technical systems and design for patient safety. Future opportunities are identified to develop and embed HFE systems thinking in healthcare including new theoretical models and long-term collaborative partnerships. HFE can contribute to systems and design initiatives for both patients and clinicians to improve everyday performance and safety, and help to reduce and control spiralling healthcare costs. PRACTITIONER SUMMARY: There has been an increase in the application of HFE techniques to healthcare delivery in the past 10 years. This paper provides a state of science commentary using four illustrative examples (occupational ergonomics, design for patient safety, surgical safety and organisational and socio-technical systems) to review and discuss analytical and implementation challenges and identify future issues for HFE.

Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system.

Objectives: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement. Design: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency. Setting: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA. Participants: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement. Main outcome measures: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied. Results: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems. Conclusions: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied.

A strategy for human factors/ergonomics: developing the discipline and profession.

Human factors/ergonomics (HFE) has great potential to contribute to the design of all kinds of systems with people (work systems, product/service systems), but faces challenges in the readiness of its market and in the supply of high-quality applications. HFE has a unique combination of three fundamental characteristics: (1) it takes a systems approach (2) it is design driven and (3) it focuses on two closely related outcomes: performance and well-being. In order to contribute to future system design, HFE must demonstrate its value more successfully to the main stakeholders of system design. HFE already has a strong value proposition (mainly well-being) and interactivity with the stakeholder group of 'system actors' (employees and product/service users). However, the value proposition (mainly performance) and relationships with the stakeholder groups of 'system experts' (experts fromtechnical and social sciences involved in system design), and 'system decision makers' (managers and other decision makers involved in system design, purchase, implementation and use), who have a strong power to influence system design, need to be developed. Therefore, the first main strategic direction is to strengthen the demand for high-quality HFE by increasing awareness among powerful stakeholders of the value of high-quality HFE by communicating with stakeholders, by building partnerships and by educating stakeholders. The second main strategic direction is to strengthen the application of high-quality HFE by promoting the education of HFE specialists, by ensuring high-quality standards of HFE applications and HFE specialists, and by promoting HFE research excellence at universities and other organisations. This strategy requires cooperation between the HFE community at large, consisting of the International Ergonomics Association (IEA), local (national and regional) HFE societies, and HFE specialists. We propose a joint world-wide HFE development plan, in which the IEA takes a leadership role. PRACTITIONER SUMMARY: Human factors/ergonomics (HFE) has much to offer by addressing major business and societal challenges regarding work and product/service systems. HFE potential, however, is underexploited. This paper presents a strategy for the HFE community to strengthen demand and application of high-quality HFE, emphasising its key elements: systems approach, design driven, and performance and well-being goals.

Usability challenges in the use of medical devices in the home environment: A systematic review of literature.

BACKGROUND: Home care medical devices are the fastest-growing segment of the medical device industry with associated safety and usability challenges. Human factor studies in the home environment present many difficulties resulting in limited knowledge of device use in this setting. This systematic review aims to identify usability challenges reported directly by end-users in the home environment. METHODS: A systematic review of the literature was conducted concentrating on studies involving end user reporting. Reported challenges were grouped into a) device-user, b) device use environment and c) device-user interface challenges. RESULTS: 3471 studies were screened and 202 underwent full-text review. Only twelve studies had direct involvement of end users. Multiple challenges were identified, with device-user interface problems being the most common. No effective, standardised method was found to collect patient/user feedback on usability challenges in the post-market stage, leading to a knowledge gap. CONCLUSIONS: This study brought together multiple usability challenges reported by individual studies. Involvement of medical device end-users in usability studies is essential and their experiences must be effectively utilised in device design.

Current status of medical device malfunction reporting: using end user experience to identify current problems.

INTRODUCTION: The current under-reporting of medical device malfunctions, difficulties with the current system and absence of continuous good-quality data has removed the possibility for constant data interrogation and trend recognition to identify evolving issues. This research used end user experiences aiming to understand causes for the lack of data and knowledge on device performance and associated patient risks. This approach was used to identify existing barriers and methods for improvement. METHODS: This is a qualitative study involving semistructured interviews and surveys with clinicians (15 interviews, 39 surveys) and manufacturers (13 interview participants, 5 surveys). Multiple sources of recruiting were used. Data collected were thematically analysed. Interview results were used to design the surveys. Standards for Reporting Qualitative Research was used. RESULTS: Medical device use is based on personal experience rather than evidence which is scarce. Multiple barriers to reporting were identified alongside patient safety and system related aspects. Furthermore, the acceptable level of error was variable as were effects on working practice. Many workarounds have been developed to overcome problems and have become normalised in daily work. These factors were found to have a limiting impact on improvements and learning. Greater system transparency, feedback on submitted reports, a more efficient system of reporting and better communication with manufacturers were reported as some of the required improvements. CONCLUSIONS: This study has identified numerous complex issues affecting reporting of medical device performance and their subsequent effect on patient safety and clinical staff. The focus on incidents has created many limitations to learning and development. The rich experience of end users should be appropriately used to identify system weaknesses and seek improvement methods. Better communication methods should be developed between healthcare and MedTech (Medical Technologies) industry.

'The perfect is the enemy of the good' - ergonomics research and practice. Institute of Ergonomics and Human Factors Annual Lecture 2010.

The relationship between research and practice in ergonomics and human factors has rarely been addressed in the literature. This presents specific problems for researchers when seeking to relate their work to the research community. Equally, practitioners are often frustrated by the lack of appropriate research to meet their needs. This paper seeks to identify current drivers for ergonomics research along with an analysis of how these are changing. Specifically, the use of bibliometric data to assess research output and its impact on a multi-disciplinary subject such as ergonomics is examined. Areas where action may be required to stimulate better research and improved practice are proposed. These include a greater role for the practitioner in completing the circle of knowledge and improving the evidence base for practice with, in particular, practitioners becoming more active in determining research priorities. It is concluded that combined effort is needed by researcher and practitioner communities to enable and promote a more effective understanding of the true impact of ergonomics across industry and society. STATEMENT OF RELEVANCE: The relationship between ergonomics research and practice is examined. Research 'drivers' are identified, including the influence of bibliometric data. Implications for researchers and practitioners are discussed. The role of practitioners in completing the circle of knowledge and improving the ergonomics evidence base is stressed, as is the need to promote the impact of ergonomics across society.