Target Product Profile for a Machine Learning-Automated Retinal Imaging Analysis Software for Use in English Diabetic Eye Screening: Protocol for a Mixed Methods Study.

BACKGROUND: Diabetic eye screening (DES) represents a significant opportunity for the application of machine learning (ML) technologies, which may improve clinical and service outcomes. However, successful integration of ML into DES requires careful product development, evaluation, and implementation. Target product profiles (TPPs) summarize the requirements necessary for successful implementation so these can guide product development and evaluation. OBJECTIVE: This study aims to produce a TPP for an ML-automated retinal imaging analysis software (ML-ARIAS) system for use in DES in England. METHODS: This work will consist of 3 phases. Phase 1 will establish the characteristics to be addressed in the TPP. A list of candidate characteristics will be generated from the following sources: an overview of systematic reviews of diagnostic test TPPs; a systematic review of digital health TPPs; and the National Institute for Health and Care Excellence's Evidence Standards Framework for Digital Health Technologies. The list of characteristics will be refined and validated by a study advisory group (SAG) made up of representatives from key stakeholders in DES. This includes people with diabetes; health care professionals; health care managers and leaders; and regulators and policy makers. In phase 2, specifications for these characteristics will be drafted following a series of semistructured interviews with participants from these stakeholder groups. Data collected from these interviews will be analyzed using the shortlist of characteristics as a framework, after which specifications will be drafted to create a draft TPP. Following approval by the SAG, in phase 3, the draft will enter an internet-based Delphi consensus study with participants sought from the groups previously identified, as well as ML-ARIAS developers, to ensure feasibility. Participants will be invited to score characteristic and specification pairs on a scale from "definitely exclude" to "definitely include," and suggest edits. The document will be iterated between rounds based on participants' feedback. Feedback on the draft document will be sought from a group of ML-ARIAS developers before its final contents are agreed upon in an in-person consensus meeting. At this meeting, representatives from the stakeholder groups previously identified (minus ML-ARIAS developers, to avoid bias) will be presented with the Delphi results and feedback of the user group and asked to agree on the final contents by vote. RESULTS: Phase 1 was completed in November 2023. Phase 2 is underway and expected to finish in March 2024. Phase 3 is expected to be complete in July 2024. CONCLUSIONS: The multistakeholder development of a TPP for an ML-ARIAS for use in DES in England will help developers produce tools that serve the needs of patients, health care providers, and their staff. The TPP development process will also provide methods and a template to produce similar documents in other disease areas. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/50568.

Knowledge, attitude and practice of infection prevention and control precautions among laboratory staff: a mixed-methods systematic review.

BACKGROUND: Clinical laboratories provide diagnostic testing services to support the effective delivery of care in today's complex healthcare systems. Processing clinical material and the use of chemicals or radiation presents potential hazard to laboratory workers, from both biological and chemical sources. Nevertheless, the laboratory should be a safe workplace if the identification of possible hazards, clear guidelines, safety rules and infection prevention and control (IPC) precautions are applied and followed. The main aim of this systematic review was to identify, critically appraise and synthesise the research evidence to gain a clear explanation of the implementation and knowledge, attitude and practice (KAP) of IPC guidelines among hospital laboratory staff. METHODS: For this systematic review we searched MEDLINE, EMBASE, Scopus and CINAHL (EBSCO), PubMed, grey literature, reference lists and citations for studies published between database inception and November, 2021. All qualitative, quantitative and mixed-methods studies whose aim was to explore risk perception and KAP of IPC guidelines among laboratory staff in any healthcare setting were included, without language or date restrictions. Evidence was narratively synthesised into group of themes. The quality of the evidence was assessed with Joanna Briggs Institutes Critical Appraisal Tools. RESULTS: After the full-text screening, a total of 34 articles remained and were included in the final review. Thirty papers were considered to be of high quality and the remaining four were considered to be of low quality. The available evidence shows that there was good knowledge, good attitudes and moderate immunisation status, but there was still poor practice of IPC precautions and an inadequate level of training among laboratory workers. CONCLUSION: There is a gap among KAP related to the implementation of IPC guidelines, which indicates that laboratory staff may be at high risk of acquiring infections in the workplace. These findings suggest that training (including IPC precautions, safety policies, safety equipment and materials, safety activities, initial biohazard handling, ongoing monitoring and potential exposure) of laboratory staff to increase their knowledge about IPC precautions could improve their use of these precautions.

Safety and efficacy of an artificial intelligence-enabled decision tool for treatment decisions in neovascular age-related macular degeneration and an exploration of clinical pathway integration and implementation: protocol for a multi-methods validation study.

INTRODUCTION: Neovascular age-related macular degeneration (nAMD) management is one of the largest single-disease contributors to hospital outpatient appointments. Partial automation of nAMD treatment decisions could reduce demands on clinician time. Established artificial intelligence (AI)-enabled retinal imaging analysis tools, could be applied to this use-case, but are not yet validated for it. A primary qualitative investigation of stakeholder perceptions of such an AI-enabled decision tool is also absent. This multi-methods study aims to establish the safety and efficacy of an AI-enabled decision tool for nAMD treatment decisions and understand where on the clinical pathway it could sit and what factors are likely to influence its implementation. METHODS AND ANALYSIS: Single-centre retrospective imaging and clinical data will be collected from nAMD clinic visits at a National Health Service (NHS) teaching hospital ophthalmology service, including judgements of nAMD disease stability or activity made in real-world consultant-led-care. Dataset size will be set by a power calculation using the first 127 randomly sampled eligible clinic visits. An AI-enabled retinal segmentation tool and a rule-based decision tree will independently analyse imaging data to report nAMD stability or activity for each of these clinic visits. Independently, an external reading centre will receive both clinical and imaging data to generate an enhanced reference standard for each clinic visit. The non-inferiority of the relative negative predictive value of AI-enabled reports on disease activity relative to consultant-led-care judgements will then be tested. In parallel, approximately 40 semi-structured interviews will be conducted with key nAMD service stakeholders, including patients. Transcripts will be coded using a theoretical framework and thematic analysis will follow. ETHICS AND DISSEMINATION: NHS Research Ethics Committee and UK Health Research Authority approvals are in place (21/NW/0138). Informed consent is planned for interview participants only. Written and oral dissemination is planned to public, clinical, academic and commercial stakeholders.

Stakeholder Perspectives of Clinical Artificial Intelligence Implementation: Systematic Review of Qualitative Evidence.

BACKGROUND: The rhetoric surrounding clinical artificial intelligence (AI) often exaggerates its effect on real-world care. Limited understanding of the factors that influence its implementation can perpetuate this. OBJECTIVE: In this qualitative systematic review, we aimed to identify key stakeholders, consolidate their perspectives on clinical AI implementation, and characterize the evidence gaps that future qualitative research should target. METHODS: Ovid-MEDLINE, EBSCO-CINAHL, ACM Digital Library, Science Citation Index-Web of Science, and Scopus were searched for primary qualitative studies on individuals' perspectives on any application of clinical AI worldwide (January 2014-April 2021). The definition of clinical AI includes both rule-based and machine learning-enabled or non-rule-based decision support tools. The language of the reports was not an exclusion criterion. Two independent reviewers performed title, abstract, and full-text screening with a third arbiter of disagreement. Two reviewers assigned the Joanna Briggs Institute 10-point checklist for qualitative research scores for each study. A single reviewer extracted free-text data relevant to clinical AI implementation, noting the stakeholders contributing to each excerpt. The best-fit framework synthesis used the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework. To validate the data and improve accessibility, coauthors representing each emergent stakeholder group codeveloped summaries of the factors most relevant to their respective groups. RESULTS: The initial search yielded 4437 deduplicated articles, with 111 (2.5%) eligible for inclusion (median Joanna Briggs Institute 10-point checklist for qualitative research score, 8/10). Five distinct stakeholder groups emerged from the data: health care professionals (HCPs), patients, carers and other members of the public, developers, health care managers and leaders, and regulators or policy makers, contributing 1204 (70%), 196 (11.4%), 133 (7.7%), 129 (7.5%), and 59 (3.4%) of 1721 eligible excerpts, respectively. All stakeholder groups independently identified a breadth of implementation factors, with each producing data that were mapped between 17 and 24 of the 27 adapted Nonadoption, Abandonment, Scale-up, Spread, and Sustainability subdomains. Most of the factors that stakeholders found influential in the implementation of rule-based clinical AI also applied to non-rule-based clinical AI, with the exception of intellectual property, regulation, and sociocultural attitudes. CONCLUSIONS: Clinical AI implementation is influenced by many interdependent factors, which are in turn influenced by at least 5 distinct stakeholder groups. This implies that effective research and practice of clinical AI implementation should consider multiple stakeholder perspectives. The current underrepresentation of perspectives from stakeholders other than HCPs in the literature may limit the anticipation and management of the factors that influence successful clinical AI implementation. Future research should not only widen the representation of tools and contexts in qualitative research but also specifically investigate the perspectives of all stakeholder HCPs and emerging aspects of non-rule-based clinical AI implementation. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) CRD42021256005; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=256005. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/33145.

Theorising the shift to video consulting in the UK during the COVID-19 pandemic: Analysis of a mixed methods study using practice theory.

We studied video consulting in the National Health Service during 2020-2021 through video interviews, an online survey and online discussions with people who had provided and participated in such consultations. Video consulting had previously been used for selected groups in limited settings in the UK. The pandemic created a seismic shift in the context for remote consulting, in which video transformed from a niche technology typically introduced by individual clinicians committed to innovation and quality improvement to offering what many felt was the only safe way to deliver certain types of healthcare. A new practice emerged: a co-constitution of technology and healthcare made possible by new configurations of equipment, connectivity and physical spaces. Despite heterogeneous service settings and previous experiences of video consulting, we found certain kinds of common changes had made video consulting possible. We used practice theory to analyse these changes, interpreting the commonalities found in our data as changes in purpose, material arrangements and a relaxing of rules about security, confidentiality and location of consultations. The practice of video consulting was equivocal. Accounts of, and preferences for, video consulting varied as did the extent to which it was sustained after initial take-up. People made sense of video consulting in different ways, ranging from interpreting video as offering a new modality of healthcare for the future to a sub-optimal, temporary alternative to in-person care. Despite these variations, video consulting became a recognisable social phenomenon, albeit neither universally adopted nor consistently sustained. The nature of this social change offers new perspectives on processes of implementation and spread and scale-up. Our findings have important implications for the future of video consulting. We emphasise the necessity for viable material arrangements and a continued shared interpretation of the meaning of video consulting for the practice to continue.

Stakeholder Perspectives on Clinical Decision Support Tools to Inform Clinical Artificial Intelligence Implementation: Protocol for a Framework Synthesis for Qualitative Evidence.

BACKGROUND: Quantitative systematic reviews have identified clinical artificial intelligence (AI)-enabled tools with adequate performance for real-world implementation. To our knowledge, no published report or protocol synthesizes the full breadth of stakeholder perspectives. The absence of such a rigorous foundation perpetuates the "AI chasm," which continues to delay patient benefit. OBJECTIVE: The aim of this research is to synthesize stakeholder perspectives of computerized clinical decision support tools in any health care setting. Synthesized findings will inform future research and the implementation of AI into health care services. METHODS: The search strategy will use MEDLINE (Ovid), Scopus, CINAHL (EBSCO), ACM Digital Library, and Science Citation Index (Web of Science). Following deduplication, title, abstract, and full text screening will be performed by 2 independent reviewers with a third topic expert arbitrating. The quality of included studies will be appraised to support interpretation. Best-fit framework synthesis will be performed, with line-by-line coding completed by 2 independent reviewers. Where appropriate, these findings will be assigned to 1 of 22 a priori themes defined by the Nonadoption, Abandonment, Scale-up, Spread, and Sustainability framework. New domains will be inductively generated for outlying findings. The placement of findings within themes will be reviewed iteratively by a study advisory group including patient and lay representatives. RESULTS: Study registration was obtained from PROSPERO (CRD42021256005) in May 2021. Final searches were executed in April, and screening is ongoing at the time of writing. Full text data analysis is due to be completed in October 2021. We anticipate that the study will be submitted for open-access publication in late 2021. CONCLUSIONS: This paper describes the protocol for a qualitative evidence synthesis aiming to define barriers and facilitators to the implementation of computerized clinical decision support tools from all relevant stakeholders. The results of this study are intended to expedite the delivery of patient benefit from AI-enabled clinical tools. TRIAL REGISTRATION: PROSPERO CRD42021256005; https://tinyurl.com/r4x3thvp. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/33145.

Changing healthcare professionals' non-reflective processes to improve the quality of care.

RATIONALE: Translating research evidence into clinical practice to improve care involves healthcare professionals adopting new behaviours and changing or stopping their existing behaviours. However, changing healthcare professional behaviour can be difficult, particularly when it involves changing repetitive, ingrained ways of providing care. There is an increasing focus on understanding healthcare professional behaviour in terms of non-reflective processes, such as habits and routines, in addition to the more often studied deliberative processes. Theories of habit and routine provide two complementary lenses for understanding healthcare professional behaviour, although to date, each perspective has only been applied in isolation. OBJECTIVES: To combine theories of habit and routine to generate a broader understanding of healthcare professional behaviour and how it might be changed. METHODS: Sixteen experts met for a two-day multidisciplinary workshop on how to advance implementation science by developing greater understanding of non-reflective processes. RESULTS: From a psychological perspective 'habit' is understood as a process that maintains ingrained behaviour through a learned link between contextual cues and behaviours that have become associated with those cues. Theories of habit are useful for understanding the individual's role in developing and maintaining specific ways of working. Theories of routine add to this perspective by describing how clinical practices are formed, adapted, reinforced and discontinued in and through interactions with colleagues, systems and organisational procedures. We suggest a selection of theory-based strategies to advance understanding of healthcare professionals' habits and routines and how to change them. CONCLUSION: Combining theories of habit and routines has the potential to advance implementation science by providing a fuller understanding of the range of factors, operating at multiple levels of analysis, which can impact on the behaviours of healthcare professionals, and so quality of care provision.

Factors shaping the implementation and use of Clinical Cancer Decision Tools by GPs in primary care: a qualitative framework synthesis.

OBJECTIVE: Clinical Cancer Decision Tools (CCDTs) aim to alert general practitioners (GPs) to signs and symptoms of cancer, supporting prompt investigation and onward referral. CCDTs are available in primary care in the UK but are not widely utilised. Qualitative research has highlighted the complexities and mechanisms surrounding their implementation and use; this has focused on specific cancer types, formats, systems or settings. This study aims to synthesise qualitative data of GPs' attitudes to and experience with a range of CCDTs to gain better understanding of the factors shaping their implementation and use. DESIGN: A systematic search of the published (MEDLINE, CINAHL, Web of Science and EMBASE) and grey literature (July 2020). Following screening, selection and assessment of suitability, the data were analysed and synthesised using normalisation process theory. RESULTS: Six studies (2011 to 2019), exploring the views of GPs were included for analysis. Studies focused on the use of several different types of CCDTs (Risk Assessment Tools (RAT) or electronic version of RAT (eRAT), QCancer and the 7-point checklist). GPs agreed CCDTs were useful to increase awareness of signs and symptoms of undiagnosed cancer. They had concerns about the impact on trust in their own clinical acumen, whether secondary care clinicians would consider referrals generated by CCDT as valid and whether integration of the CCDTs within existing systems was achievable. CONCLUSIONS: CCDTs might be a helpful adjunct to clinical work in primary care, but without careful development to legitimise their use GPs are likely to give precedence to clinical acumen and gut instinct. Stakeholder consultation with secondary care clinicians and consideration of how the CCDTs fit into a GP consultation are crucial to successful uptake. The role and responsibilities of a GP as a clinician, gatekeeper, health promoter and resource manager affect the interaction with and implementation of innovations such as CCDTs.

Cost Consequences for the NHS of Using a Two-Step Testing Method for the Detection of Clostridium difficile with a Point of Care, Polymerase Chain Reaction Test as the First Step.

Clostridium difficile infection (CDI) is a common healthcare-associated infection. Current practice for diagnosing CDI in the Newcastle upon Tyne Hospitals NHS Foundation Trust involves a three-step, laboratory testing strategy using glutamate dehydrogenase (GDH) enzyme immunoassay (EIA), followed by a polymerase chain reaction (PCR) test then a toxin EIA. However, a PCR point of care test (POCT) for the C. difficile tcdB gene for screening suspected CDI cases, may provide a more efficient way of facilitating an equally effective, two-step, testing strategy with a toxin EIA. This study evaluated the cost consequences of changing from the three-step to a two-step testing strategy. A cost-consequences model was developed to compare the costs and consequences of the two strategies. Uncertainties in the model inputs were investigated with one- and two-way sensitivity analysis. The two-step, POCT strategy was estimated to save £283,282 per 1000 hospitalized NHS patients with suspected infectious diarrhea. Sensitivity analysis indicated that the turnaround time for the POCT was the largest driver for cost savings. Providing the POCT has sufficiently high diagnostic accuracy for detecting C. difficile, the two-step, POCT strategy for CDI identification is likely to be cost saving for NHS hospitals with an offsite laboratory.

Large-scale health system transformation in the United Kingdom.

PURPOSE: Following publication of a new vision for the English National Health Service (NHS) in 2014, known as the NHS Five-Year Forward View, a Vanguard programme was introduced by NHS England charged with the task of designing and delivering a range of new care models (NCMs) aimed at tackling deep-seated problems of a type facing all health systems to a greater or lesser degree. Drawing upon recent theoretical developments on the multilevel nature of context, we explore factors shaping the implementation of five NCM initiatives in the North East of England. DESIGN/METHODOLOGY/APPROACH: Data collection was based on semi-structured interviews (66 in total) between December 2016 and May 2017 with key informants at each site and a detailed review of Trusts' internal documents and policies related to the implementation of each NCM. Our analysis explores factors shaping the implementation of five NCM pilot sites as they touched on the multiple levels of context ranging from the macro policy level to the micro-level setting of workforce redesign. FINDINGS: It is far too early to conclude with any confidence that a successful outcome for the NCM programme will be forthcoming although the NHS Long-Term Plan seeks to build on the earlier vision set out in the Five-Year Forward View. Early indications show some signs of promise, especially where there is evidence of the ground having been prepared and changes already being put in place prior to the official launch of NCM initiatives. At the same time our findings demonstrate that all five pilot sites experienced, and were subject to, unrealistic pressure placed upon them to deliver outcomes. ORIGINALITY/VALUE: Our findings demonstrate the need for a deeper understanding of the multilevel nature of context by exploring factors shaping the implementation of five NCMs in the North East of England. Exploring the wider national policy context is desirable as well as understanding the perceptions of front-line staff and service users in order to establish the degree of alignment or, conversely, to identify where policy and practice are at risk of pushing and pulling against each other.

Facilitating transition of young people with long-term health conditions from children's to adults' healthcare services - implications of a 5-year research programme.

BACKGROUND: During transition from children's to adults' healthcare, young adults with long-term conditions may show delays in psychosocial development compared to their peers without long-term conditions, and deterioration of their conditions' medical control. METHODS: This paper integrates the findings, already published in 10 separate papers, of a 5-year transition research programme. IMPLICATIONS: There is an important role for funders (commissioners) of adults' services to fund transitional healthcare, in addition to funders of children's services who currently take responsibility.It is important that healthcare provider organisations adopt an organisation-wide approach to implementation to ensure that good practice is adopted in children's and adults' services, not just adopted by enthusiasts in some specialties. This includes provision of 'developmentally appropriate healthcare' which recognises the changing biopsychosocial developmental needs of young people.Three features of transitional healthcare were associated with improved outcomes: appropriate parent involvement, promotion of young people's confidence in managing their health and meeting the adult team before transfer. These should be maintained or introduced as a priority.Child and adult healthcare providers should routinely explore with a young person how they approach transition and personalise their clinical approach thereafter.These implications are relevant for a range of stakeholders, including funders of transitional healthcare, organisations providing transitional healthcare and clinical practitioners.

Acute kidney injury electronic alerts: mixed methods Normalisation Process Theory evaluation of their implementation into secondary care in England.

OBJECTIVE: Around one in five emergency hospital admissions are affected by acute kidney injury (AKI). To address poor quality of care in relation to AKI, electronic alerts (e-alerts) are mandated across primary and secondary care in England and Wales. Evidence of the benefit of AKI e-alerts remains conflicting, with at least some uncertainty explained by poor or unclear implementation. The objective of this study was to identify factors relating to implementation, using Normalisation Process Theory (NPT), which promote or inhibit use of AKI e-alerts in secondary care. DESIGN: Mixed methods combining qualitative (observations, semi-structured interviews) and quantitative (survey) methods. SETTING AND PARTICIPANTS: Three secondary care hospitals in North East England, representing two distinct AKI e-alerting systems. Observations (>44 hours) were conducted in Emergency Assessment Units (EAUs). Semi-structured interviews were conducted with clinicians (n=29) from EAUs, vascular or general surgery or care of the elderly. Qualitative data were supplemented by Normalization MeAsure Development (NoMAD) surveys (n=101). ANALYSIS: Qualitative data were analysed using the NPT framework, with quantitative data analysed descriptively and using χ2 and Wilcoxon signed-rank test for differences in current and future normalisation. RESULTS: Participants reported familiarity with the AKI e-alerts but that the e-alerts would become more normalised in the future (p<0.001). No single NPT mechanism led to current (un)successful implementation of the e-alerts, but analysis of the underlying subconstructs identified several mechanisms indicative of successful normalisation (internalisation, legitimation) or unsuccessful normalisation (initiation, differentiation, skill set workability, systematisation). CONCLUSIONS: Clinicians recognised the value and importance of AKI e-alerts in their practice, although this was not sufficient for the e-alerts to be routinely engaged with by clinicians. To further normalise the use of AKI e-alerts, there is a need for tailored training on use of the e-alerts and routine feedback to clinicians on the impact that e-alerts have on patient outcomes.

Lessons learnt from the implementation of new care models in the NHS: a qualitative study of the North East Vanguards programme.

OBJECTIVE: To examine lessons learnt from the implementation of five Vanguard initiatives in the North East of England. DESIGN: Data collection comprised semistructured interviews with key informants at each site. SETTING: The study took place across six local authority areas in the North East of England and within six clinical commissioning groups responsible for the delivery of each Vanguard's aims and objectives. PARTICIPANTS: Sixty-six interviewees with participants from five Vanguard initiatives in the North East of England, including senior clinicians, project leads and directors, commissioners, and healthcare managers. RESULTS: While the context for each Vanguard is separate and distinct, there also exists a set of common issues which have a regional dimension. Participants felt that the national programme helped to raise the profile of local change initiatives and also contributed to the wider understanding of regional service integration issues. At the same time our findings demonstrate that all five sites experienced, and were subject to, unrealistic pressure placed on them to deliver outcomes. Of particular concern among all sites was the sheer scale and pace of change occurring at the same time as the National Health Service was being tasked with making significant, if unrealistic, efficiency savings. CONCLUSIONS: It is too early to conclude with any confidence that a successful outcome for the new care models programme will be forthcoming. While early indications show some encouraging signs of promise, the overall context in which the complex and ambitious changes are being implemented remains both fragile and fluid.

Negotiating commissioning pathways for the successful implementation of innovative health technology in primary care.

BACKGROUND: Commissioning innovative health technologies is typically complex and multi-faceted. Drawing on the negotiated order perspective, we explore the process by which commissioning organisations make their decisions to commission innovative health technologies. The empirical backdrop to this discussion is provided by a case study exploring the commissioning considerations for a new photoplethysmography-based diagnostic technology for peripheral arterial disease in primary care in the UK. METHODS: The research involved an empirical case study of four Clinical Commissioning Groups (CCGs) involved in the commissioning of services in primary and secondary care. Semi-structured in-depth interviews (16 in total) and two focus groups (a total of eight people participated, four in each group) were conducted with key individuals involved in commissioning services in the NHS including (i) senior NHS clinical leaders and directors (ii) commissioners and health care managers across CCGs and (iii) local general practitioners. RESULTS: Commissioning of a new diagnostic technology for peripheral arterial disease in primary care involves high levels of protracted negotiations over funding between providers and commissioners, alliance building, conflict resolution and compromise of objectives where the outcomes of change are highly contingent upon interventions made across different care settings. Our evidence illustrates how reconfigurations of inter-organisational relations, and of clinical and related work practices required for the successful implementation of a new technology could become the major challenge in commissioning negotiations. CONCLUSIONS: Innovative health technologies such as the diagnostic technology for peripheral arterial disease are commissioned in care pathways where the value of such technology is realised by those delivering care to patients. The detail of how care pathways are commissioned is complex and involves high degrees of uncertainty concerning such issues as prioritisation decisions, patient benefits, clinical buy-in, value for money and unintended consequences. Recent developments in the new care models and integrated care systems (ICSs) in the UK offer a unique opportunity for the successful commissioning arrangements of innovative health technologies in primary care such as the new diagnostic technology for peripheral arterial disease.

Opportunities and challenges of a novel cardiac output response to stress (CORS) test to enhance diagnosis of heart failure in primary care: qualitative study.

OBJECTIVE: To explore the role of the novel cardiac output response to stress (CORS), test in the current diagnostic pathway for heart failure and the opportunities and challenges to potential implementation in primary care. DESIGN: Qualitative study using semistructured in-depth interviews which were audio recorded and transcribed verbatim. Data from the interviews were analysed thematically using an inductive approach. SETTING: Newcastle upon Tyne, UK. PARTICIPANTS: Fourteen healthcare professionals (six males, eight females) from primary (general practitioners (GPs), nurses, healthcare assistant, practice managers) and secondary care (consultant cardiologists). RESULTS: Four themes relating to opportunities and challenges surrounding the implementation of the new diagnostic technology were identified. These reflected that the adoption of CORS test would be an advantage to primary care but the test had barriers to implementation which include: establishment of clinical utility, suitability for immobile patients and cost implication to GP practices. CONCLUSION: The development of a simple non-invasive clinical test to accelerate the diagnosis of heart failure in primary care maybe helpful to reduce unnecessary referrals to secondary care. The CORS test has the potential to serve this purpose; however, factors such as cost effectiveness, diagnostic accuracy and seamless implementation in primary care have to be fully explored.

Framing the failure of medical implants: Media representations of the ASR hip replacements in the UK.

BACKGROUND: During the twentieth century, hip replacement became one of the most popular and successful operations. In the 1990s, a new type of hip replacement namely the metal-on-metal hip resurfacing was developed. This paper draws on one of the available implants, namely the DePuy Orthopaedics' Articular Surface Replacement (ASR) hip system which was withdrawn from the market because of higher than expected rates of failure. It examines media representations on the failure of the ASR metal-on-metal hip replacement device and its subsequent withdrawal from the market. METHODS: Drawing on content analysis this paper explores how systemic failure of the medical implant was framed and performed by press media in the UK. RESULTS: Two narratives were particularly important in framing press media coverage of the ASR case: the role of patients as passive recipients of care and a distinction between health and disability identities as related to how individuals' narratives about the past shaped their sense of present and future. In all cases, the voice of the orthopaedic surgeons responsible for the selection and implantation of the ASR devices remains silent. CONCLUSIONS: Press media coverage of medically induced harm in the UK is significantly less common than coverage of any other patient safety issues and public health debates. This study aims to contribute to the evidence base on how public discourse on medically induced harm becomes framed through the reported experiences of individuals in press media and also how this process influences the legitimacy of various solutions to medical errors or unanticipated outcomes.

Correction to: Facilitating the implementation of clinical technology in healthcare: what role does a national agency play?

Upon publication of the original article [1], Gregory Maniatopoulos' name was incorrectly given as 'Greg Maniatopoulous'. This has now been corrected in the original article.