Patient-initiated cardiovascular monitoring with commercially available devices: How useful is it in a cardiology outpatient setting? Mixed methods, observational study.

BACKGROUND: The availability, affordability and utilisation of commercially available self-monitoring devices is increasing, but their impact on routine clinical decision-making remains little explored. We sought to examine how patient-generated cardiovascular data influenced clinical evaluation in UK cardiology outpatient clinics and to understand clinical attitudes and experiences with using data from commercially available self-monitoring devices. METHODS: Mixed methods study combining: a) quantitative and qualitative content analysis of 1373 community cardiology clinic letters, recording consultations between January-September 2020 including periods with different Covid-19 related restrictions, and b) semi-structured qualitative interviews and group discussions with 20 cardiology-affiliated clinicians at the same NHS Trust. RESULTS: Patient-generated cardiovascular data were described in 185/1373 (13.5%) clinic letters overall, with the proportion doubling following onset of the first Covid-19 lockdown in England, from 8.3% to 16.6% (p < 0.001). In 127/185 (69%) cases self-monitored data were found to: provide or facilitate cardiac diagnoses (34/127); assist management of previously diagnosed cardiac conditions (55/127); be deployed for cardiovascular prevention (16/127); or be recommended for heart rhythm evaluation (10/127). In 58/185 (31%) cases clinicians did not put the self-monitored data to any evident use and in 12/185 (6.5%) cases patient-generated data prompted an unnecessary referral. In interviews and discussions, clinicians expressed mixed views on patient-generated data but foresaw a need to embrace and plan for this information flow, and proactively address challenges with integration into traditional care pathways. CONCLUSIONS: This study suggests patient-generated data are being used for clinical decision-making in ad hoc and opportunistic ways. Given shifts towards remote monitoring in clinical care, accelerated by the pandemic, there is a need to consider how best to incorporate patient-generated data in clinical processes, introduce relevant training, pathways and governance frameworks, and manage associated risks.

Physical Examinations via Video for Patients With Heart Failure: Qualitative Study Using Conversation Analysis.

BACKGROUND: Video consultations are increasingly seen as a possible replacement for face-to-face consultations. Direct physical examination of the patient is impossible; however, a limited examination may be undertaken via video (eg, using visual signals or asking a patient to press their lower legs and assess fluid retention). Little is currently known about what such video examinations involve. OBJECTIVE: This study aimed to explore the opportunities and challenges of remote physical examination of patients with heart failure using video-mediated communication technology. METHODS: We conducted a microanalysis of video examinations using conversation analysis (CA), an established approach for studying the details of communication and interaction. In all, seven video consultations (using FaceTime) between patients with heart failure and their community-based specialist nurses were video recorded with consent. We used CA to identify the challenges of remote physical examination over video and the verbal and nonverbal communication strategies used to address them. RESULTS: Apart from a general visual overview, remote physical examination in patients with heart failure was restricted to assessing fluid retention (by the patient or relative feeling for leg edema), blood pressure with pulse rate and rhythm (using a self-inflating blood pressure monitor incorporating an irregular heartbeat indicator and put on by the patient or relative), and oxygen saturation (using a finger clip device). In all seven cases, one or more of these examinations were accomplished via video, generating accurate biometric data for assessment by the clinician. However, video examinations proved challenging for all involved. Participants (patients, clinicians, and, sometimes, relatives) needed to collaboratively negotiate three recurrent challenges: (1) adequate design of instructions to guide video examinations (with nurses required to explain tasks using lay language and to check instructions were followed), (2) accommodation of the patient's desire for autonomy (on the part of nurses and relatives) in light of opportunities for involvement in their own physical assessment, and (3) doing the physical examination while simultaneously making it visible to the nurse (with patients and relatives needing adequate technological knowledge to operate a device and make the examination visible to the nurse as well as basic biomedical knowledge to follow nurses' instructions). Nurses remained responsible for making a clinical judgment of the adequacy of the examination and the trustworthiness of the data. In sum, despite significant challenges, selected participants in heart failure consultations managed to successfully complete video examinations. CONCLUSIONS: Video examinations are possible in the context of heart failure services. However, they are limited, time consuming, and challenging for all involved. Guidance and training are needed to support rollout of this new service model, along with research to understand if the challenges identified are relevant to different patients and conditions and how they can be successfully negotiated.

Video Consultations Between Patients and Clinicians in Diabetes, Cancer, and Heart Failure Services: Linguistic Ethnographic Study of Video-Mediated Interaction.

BACKGROUND: Video-mediated clinical consultations offer potential benefits over conventional face-to-face in terms of access, convenience, and sometimes cost. The improved technical quality and dependability of video-mediated consultations has opened up the possibility for more widespread use. However, questions remain regarding clinical quality and safety. Video-mediated consultations are sometimes criticized for being not as good as face-to-face, but there has been little previous in-depth research on their interactional dynamics, and no agreement on what a good video consultation looks like. OBJECTIVE: Using conversation analysis, this study aimed to identify and analyze the communication strategies through which video-mediated consultations are accomplished and to produce recommendations for patients and clinicians to improve the communicative quality of such consultations. METHODS: We conducted an in-depth analysis of the clinician-patient interaction in a sample of video-mediated consultations and a comparison sample of face-to-face consultations drawn from 4 clinical settings across 2 trusts (1 community and 1 acute care) in the UK National Health Service. The video dataset consisted of 37 recordings of video-mediated consultations (with diabetes, antenatal diabetes, cancer, and heart failure patients), 28 matched audio recordings of face-to-face consultations, and fieldnotes from before and after each consultation. We also conducted 37 interviews with staff and 26 interviews with patients. Using linguistic ethnography (combining analysis of communication with an appreciation of the context in which it takes place), we examined in detail how video interaction was mediated by 2 software platforms (Skype and FaceTime). RESULTS: Patients had been selected by their clinician as appropriate for video-mediated consultation. Most consultations in our sample were technically and clinically unproblematic. However, we identified 3 interactional challenges: (1) opening the video consultation, (2) dealing with disruption to conversational flow (eg, technical issues with audio and/or video), and (3) conducting an examination. Operational and technological issues were the exception rather than the norm. In all but 1 case, both clinicians and patients (deliberately or intuitively) used established communication strategies to successfully negotiate these challenges. Remote physical examinations required the patient (and, in some cases, a relative) to simultaneously follow instructions and manipulate technology (eg, camera) to make it possible for the clinician to see and hear adequately. CONCLUSIONS: A remote video link alters how patients and clinicians interact and may adversely affect the flow of conversation. However, our data suggest that when such problems occur, clinicians and patients can work collaboratively to find ways to overcome them. There is potential for a limited physical examination to be undertaken remotely with some patients and in some conditions, but this appears to need complex interactional work by the patient and/or their relatives. We offer preliminary guidance for patients and clinicians on what is and is not feasible when consulting via a video link. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10913.

Analysing the role of complexity in explaining the fortunes of technology programmes: empirical application of the NASSS framework.

BACKGROUND: Failures and partial successes are common in technology-supported innovation programmes in health and social care. Complexity theory can help explain why. Phenomena may be simple (straightforward, predictable, few components), complicated (multiple interacting components or issues) or complex (dynamic, unpredictable, not easily disaggregated into constituent components). The recently published NASSS framework applies this taxonomy to explain Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability. This paper reports the first empirical application of the NASSS framework. METHODS: Six technology-supported programmes were studied using ethnography and action research for up to 3 years across 20 health and care organisations and 10 national-level bodies. They comprised video outpatient consultations, GPS tracking technology for cognitive impairment, pendant alarm services, remote biomarker monitoring for heart failure, care organising software and integrated case management via data warehousing. Data were collected at three levels: micro (individual technology users), meso (organisational processes and systems) and macro (national policy and wider context). Data analysis and synthesis were guided by socio-technical theories and organised around the seven NASSS domains: (1) the condition or illness, (2) the technology, (3) the value proposition, (4) the adopter system (professional staff, patients and lay carers), (5) the organisation(s), (6) the wider (institutional and societal) system and (7) interaction and mutual adaptation among all these domains over time. RESULTS: The study generated more than 400 h of ethnographic observation, 165 semi-structured interviews and 200 documents. The six case studies raised multiple challenges across all seven domains. Complexity was a common feature of all programmes. In particular, individuals' health and care needs were often complex and hence unpredictable and 'off algorithm'. Programmes in which multiple domains were complicated proved difficult, slow and expensive to implement. Those in which multiple domains were complex did not become mainstreamed (or, if mainstreamed, did not deliver key intended outputs). CONCLUSION: The NASSS framework helped explain the successes, failures and changing fortunes of this diverse sample of technology-supported programmes. Since failure is often linked to complexity across multiple NASSS domains, further research should systematically address ways to reduce complexity and/or manage programme implementation to take account of it.

Understanding heart failure; explaining telehealth - a hermeneutic systematic review.

BACKGROUND: Enthusiasts for telehealth extol its potential for supporting heart failure management. But randomised trials have been slow to recruit and produced conflicting findings; real-world roll-out has been slow. We sought to inform policy by making sense of a complex literature on heart failure and its remote management. METHODS: Through database searching and citation tracking, we identified 7 systematic reviews of systematic reviews, 32 systematic reviews (including 17 meta-analyses and 8 qualitative reviews); six mega-trials and over 60 additional relevant empirical studies and commentaries. We synthesised these using Boell's hermeneutic methodology for systematic review, which emphasises the quest for understanding. RESULTS: Heart failure is a complex and serious condition with frequent co-morbidity and diverse manifestations including severe tiredness. Patients are often frightened, bewildered, socially isolated and variably able to self-manage. Remote monitoring technologies are many and varied; they create new forms of knowledge and new possibilities for care but require fundamental changes to clinical roles and service models and place substantial burdens on patients, carers and staff. The policy innovation of remote biomarker monitoring enabling timely adjustment of medication, mediated by "activated" patients, is based on a modernist vision of efficient, rational, technology-mediated and guideline-driven ("cold") care. It contrasts with relationship-based ("warm") care valued by some clinicians and by patients who are older, sicker and less technically savvy. Limited uptake of telehealth can be analysed in terms of key tensions: between tidy, "textbook" heart failure and the reality of multiple comorbidities; between basic and intensive telehealth; between activated, well-supported patients and vulnerable, unsupported ones; between "cold" and "warm" telehealth; and between fixed and agile care programmes. CONCLUSION: The limited adoption of telehealth for heart failure has complex clinical, professional and institutional causes, which are unlikely to be elucidated by adding more randomised trials of technology-on versus technology-off to an already-crowded literature. An alternative approach is proposed, based on naturalistic study designs, application of social and organisational theory, and co-design of new service models based on socio-technical principles. Conventional systematic reviews (whose goal is synthesising data) can be usefully supplemented by hermeneutic reviews (whose goal is deepening understanding).

Beyond Adoption: A New Framework for Theorizing and Evaluating Nonadoption, Abandonment, and Challenges to the Scale-Up, Spread, and Sustainability of Health and Care Technologies.

BACKGROUND: Many promising technological innovations in health and social care are characterized by nonadoption or abandonment by individuals or by failed attempts to scale up locally, spread distantly, or sustain the innovation long term at the organization or system level. OBJECTIVE: Our objective was to produce an evidence-based, theory-informed, and pragmatic framework to help predict and evaluate the success of a technology-supported health or social care program. METHODS: The study had 2 parallel components: (1) secondary research (hermeneutic systematic review) to identify key domains, and (2) empirical case studies of technology implementation to explore, test, and refine these domains. We studied 6 technology-supported programs-video outpatient consultations, global positioning system tracking for cognitive impairment, pendant alarm services, remote biomarker monitoring for heart failure, care organizing software, and integrated case management via data sharing-using longitudinal ethnography and action research for up to 3 years across more than 20 organizations. Data were collected at micro level (individual technology users), meso level (organizational processes and systems), and macro level (national policy and wider context). Analysis and synthesis was aided by sociotechnically informed theories of individual, organizational, and system change. The draft framework was shared with colleagues who were introducing or evaluating other technology-supported health or care programs and refined in response to feedback. RESULTS: The literature review identified 28 previous technology implementation frameworks, of which 14 had taken a dynamic systems approach (including 2 integrative reviews of previous work). Our empirical dataset consisted of over 400 hours of ethnographic observation, 165 semistructured interviews, and 200 documents. The final nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework included questions in 7 domains: the condition or illness, the technology, the value proposition, the adopter system (comprising professional staff, patient, and lay caregivers), the organization(s), the wider (institutional and societal) context, and the interaction and mutual adaptation between all these domains over time. Our empirical case studies raised a variety of challenges across all 7 domains, each classified as simple (straightforward, predictable, few components), complicated (multiple interacting components or issues), or complex (dynamic, unpredictable, not easily disaggregated into constituent components). Programs characterized by complicatedness proved difficult but not impossible to implement. Those characterized by complexity in multiple NASSS domains rarely, if ever, became mainstreamed. The framework showed promise when applied (both prospectively and retrospectively) to other programs. CONCLUSIONS: Subject to further empirical testing, NASSS could be applied across a range of technological innovations in health and social care. It has several potential uses: (1) to inform the design of a new technology; (2) to identify technological solutions that (perhaps despite policy or industry enthusiasm) have a limited chance of achieving large-scale, sustained adoption; (3) to plan the implementation, scale-up, or rollout of a technology program; and (4) to explain and learn from program failures.

Efficacy of decentralised home-based antihypertensive treatment in older adults with multimorbidity and polypharmacy (ATEMPT): an open-label randomised controlled pilot trial.

BACKGROUND: Older patients with multimorbidity and polypharmacy have been under-represented in clinical trials. We aimed to assess the effect of different intensities of antihypertensive treatment on changes in blood pressure, major safety outcomes, and patient-reported outcomes in this population. METHODS: ATEMPT was a decentralised, two-armed, parallel-group, open-label randomised controlled pilot trial conducted in the Thames Valley area, South East England. Individuals aged 65 years or older with multimorbidity (three or more chronic conditions) or polypharmacy (five or more types of medications) and a systolic blood pressure of 115-165 mm Hg were eligible for inclusion. Participants were identified through a search of national hospital discharge databases, identification of patients registered with an online pharmacy, and via targeted advertising on social media platforms. Participants were randomly assigned to receive up to two more classes versus up to two fewer classes of antihypertensive medications. Apart from routine home visits for conducting the baseline assessment, all communication, monitoring, and management of participants by the trial team was conducted remotely. The primary outcome was change in home-measured blood pressure. FINDINGS: Between Dec 15, 2020, and Aug 31, 2022, 230 participants were randomly assigned (n=126 to more vs n=104 to fewer antihypertensive medications). The frequency of serious adverse events was similar across both groups; no cardiovascular events occurred in the more antihypertensive drugs group, compared with six in the fewer antihypertensive drugs group, of which two were fatal. Over a 13-month follow-up period, the mean systolic blood pressure in the group allocated to receive more antihypertensive medications decreased from 134·5 mm Hg (SD 10·7) at baseline to 122·1 mm Hg (10·5). By contrast, in the group allocated to receive fewer antihypertensive medications, it remained relatively unchanged, moving from 134·8 mm Hg (SD 11·2) at baseline to 132·9 mm Hg (15·3); this corresponded to a mean difference of -10·7 mm Hg (95% CI -17·5 to -4·0). INTERPRETATION: Remotely delivered antihypertensive treatment substantially reduced systolic blood pressure in older adults who are often less represented in trials, with no increase in the risk of serious adverse events. The results of this trial will inform a larger clinical trial focusing on assessing major cardiovascular events, safety, physical functioning, and cognitive function that is currently in the planning stages. These results also underscore the efficiency of decentralised trial designs, which might be of broader interest in other settings. FUNDING: National Institute for Health Research Oxford Biomedical Research Centre and the Oxford Martin School.

Blood eosinophil-guided oral prednisolone for COPD exacerbations in primary care in the UK (STARR2): a non-inferiority, multicentre, double-blind, placebo-controlled, randomised controlled trial.

BACKGROUND: Systemic glucocorticoids are recommended for use in chronic obstructive pulmonary disease (COPD) exacerbations; however, there is increased harm associated with their use. We hypothesised that the use of eosinophil biomarker-directed oral prednisolone therapy at the time of an exacerbation of COPD was effective at reducing prednisolone use without affecting adverse outcomes. METHODS: The studying acute exacerbations and response (STARR2) study was a multicentre, randomised, double-blind, placebo-controlled trial conducted in 14 primary care practices in the UK. We included adults (aged ≥40 years), who were current or former smokers (with at least a 10 pack year smoking history) with a diagnosis of COPD, defined as a post-bronchodilator FEV1/forced vital capacity ratio of less than 0·7 previously recorded by the primary care physician, and a history of at least one exacerbation in the previous 12 months requiring systemic corticosteroids with or without antibiotics. All study staff and participants were masked to study group allocation and to treatment allocation. Participants were randomly assigned (1:1) to blood eosinophil-directed treatment (BET; to receive oral prednisolone 30 mg once daily if eosinophil count was high [≥2%] or placebo if eosinophil count was low [<2%]) or to standard care treatment (ST; to receive prednisolone 30 mg once daily irrespective of the point-of-care eosinophil result). Treatment was prescribed for 14 days and all patients also received antibiotics. The primary outcome was the rate of treatment failure, defined as any need for re-treatment with antibiotics or steroids, hospitalisation for any cause, or death, assessed at 30 days after exacerbation in the modified intention-to-treat population. Participants were eligible for re-randomisation at further exacerbations (with a maximum of four exacerbations per participant). A safety analysis was conducted on all randomly assigned participants. Although designed as a superiority trial, after identification of an error in the randomisation code before data lock the study converted to show non-inferiority. An upper margin of 1·105 for the 95% CI was defined as the non-inferiority margin. This study was registered with EudraCT, 2017-001586-24, and is complete. FINDINGS: Between Nov 6, 2017, and April 30, 2020, 308 participants were recruited from 14 general practices. 144 exacerbations (73 in the BET group and 71 in the ST group) from 93 participants (mean age 70 years [range 46-84] and mean percent predicted FEV1 60·9% [SD 19·4]; 52 [56%] male and 41 [44%] female; ethnicity data was not collected]) were included in the modified intention-to-treat analysis. There were 14 (19%) treatment failures at 30 days post-exacerbation in the BET group and 23 (32%) in the ST group; we found a large non-significant estimated effect between BET and ST (RR 0·60 [95% CI 0·33-1·04]; p=0·070) in reducing treatment failures after a COPD exacerbation. The non-inferiority analysis supported that BET was non-inferior to ST. Frequency of adverse events were similar between the study groups; glycosuria (2/102 [2%] in BET group and 1/101 [1%] in the ST group) and hospital admission for COPD exacerbation (2/102 [2%] in BET group and 1/101 [1%] in the ST group) were the two most common adverse events in both groups. No deaths occurred in the study. INTERPRETATION: Blood eosinophil-directed prednisolone therapy at the time of an acute exacerbation of COPD is non-inferior to standard care and can be used to safely reduce systemic glucocorticoid use in clinical practice. FUNDING: National Institute for Health and Care Research.

"It's no good but at least I've always got it round my neck": A postphenomenological analysis of reassurance in assistive technology use by older people.

The provision of reassurance is seen as a goal and benefit of the use of assistive technology (AT) in supporting people to manage their health and care needs at a distance. Conceptually, reassurance in health and care settings remains under-theorised with the benefits of experiencing reassurance through technology use assumed rather than understood. UK health and social care service goals of managing safety and risk have largely been equated with providing reassurance to users of AT and their carers. What has not been explored is how reassurance is experienced variably by users of different types of technology-enabled care. We present data from 3 case studies of different technologies in use in health and social care provision, analysed through a postphenomenology and sociomaterial lens. Our findings point to reassurance as an important facet of AT provision but the intended functions and uses of technological devices alone did not account for people's experiences of reassurance. Participant narratives referred variously to the comfort of being monitored, having their illness/wellness verified by the device, feeling reassured by the promise of help if needed, and imbuing the device with symbolic meaning (when the user associated the device with meanings and functions other than its technical capabilities). The different ways in which reassurance was experienced provides a useful way of understanding the potential tensions with AT policy goals as well as the positive meaning attributed to devices in some cases. This study reaffirms the importance of AT implementation being anchored in what matters to the user.

Explaining the mixed findings of a randomised controlled trial of telehealth with centralised remote support for heart failure: multi-site qualitative study using the NASSS framework.

BACKGROUND: The SUPPORT-HF2 randomised controlled trial compared telehealth technology alone with the same technology combined with centralised remote support, in which a clinician responds promptly to biomarker changes. The intervention was implemented differently in different sites; no overall impact was found on the primary endpoint (proportion of patients on optimum treatment). We sought to explain the trial's findings in a qualitative evaluation. METHODS: Fifty-one people (25 patients, 3 carers, 18 clinicians, 4 additional researchers) were interviewed and observed in 7 UK trial sites in 2016-2018. We collected 110 pages of documents. The analysis was informed by the NASSS framework, a multi-level theoretical lens which considers non-adoption and abandonment of technologies by individuals and challenges to scale-up, spread and sustainability. In particular, we used NASSS to tease out why a 'standardised' socio-technical intervention played out differently in different sites. RESULTS: Patients' experiences of the technology were largely positive, though influenced by the nature and severity of their illness. In each trial site, existing services, staffing levels, technical capacity and previous telehealth experiences influenced how the complex intervention of 'telehealth technology plus centralised specialist remote support' was interpreted and the extent to which it was adopted and used to its full potential. In some sites, the intervention was quickly mobilised to fill significant gaps in service provision. In others, it was seen as usefully extending the existing care model for selected patients. Elsewhere, the new model was actively resisted and the technology little used. In one site, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service. CONCLUSIONS: Complex socio-technical interventions, even when implemented in a so-called standardised way with uniform inclusion and exclusion criteria, are inevitably implemented differently in different local settings because of how individual staff members interpret the technology and the trial protocol and because of the practical realities and path dependencies of local organisations. Site-specific iteration and embedding of a new technology-supported complex intervention may be required (in addition to co-design of the user interface) before such interventions are ready for testing in clinical trials. TRIAL REGISTRATION: BMC ISRCTN Registry 86212709 . Retrospectively registered on 5 September 2014.

Technology-Enhanced Consultations in Diabetes, Cancer, and Heart Failure: Protocol for the Qualitative Analysis of Remote Consultations (QuARC) Project.

BACKGROUND: Remote videoconsulting is promoted by policy makers as a way of delivering health care efficiently to an aging population with rising rates of chronic illness. As a radically new service model, it brings operational and interactional challenges in using digital technologies. In-depth research on this dynamic is needed before remote consultations are introduced more widely. OBJECTIVE: The objective of this study will be to identify and analyze the communication strategies through which remote consultations are accomplished and to guide patients and clinicians to improve the communicative quality of remote consultations. METHODS: In previous research, we collected and analyzed two separate datasets of remote consultations in a National Institute for Health Research-funded study of clinics in East London using Skype and a Wellcome Trust-funded study of specialist community heart failure teams in Oxford using Skype or FaceTime. The Qualitative Analysis of Remote Consultations (QuARC) study will combine datasets and undertake detailed interactional microanalysis of up to 40 remote consultations undertaken by senior and junior doctors and nurse specialists, including consultations with adults with diabetes, women who have diabetes during pregnancy, people consulting for postoperative cancer surgery and community-based patients having routine heart failure reviews along with up to 25 comparable face-to-face consultations. Drawing on established techniques (eg, conversation analysis), analysis will examine the contextual features in remote consultations (eg, restricted visual field) combined with close analysis of different modes of communication (eg, speech, gesture, and gaze). RESULTS: Our findings will address the current gap in knowledge about how technology shapes the fine detail of communication in remote consultations. Alongside academic outputs, findings will inform the coproduction of information and guidance about communication strategies to support successful remote consultations. CONCLUSIONS: Identifying the communication strategies through which remote consultations are accomplished and producing guidance for patients and clinicians about how to use this kind of technology successfully in consultations is an important and timely goal because roll out of remote consultations is planned across the National Health Service. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10913.

Long-Term Conditions Questionnaire (LTCQ): initial validation survey among primary care patients and social care recipients in England.

OBJECTIVE: The aim of this study was to validate a new generic patient-reported outcome measure, the Long-Term Conditions Questionnaire (LTCQ), among a diverse sample of health and social care users in England. DESIGN: Cross-sectional validation survey. Data were collected through postal surveys (February 2016-January 2017). The sample included a healthcare cohort of patients recruited through primary care practices, and a social care cohort recruited through local government bodies that provide social care services. PARTICIPANTS: 1211 participants (24% confirmed social care recipients) took part in the study. Healthcare participants were recruited on the basis of having one of 11 specified long-term conditions (LTCs), and social care participants were recruited on the basis of receiving social care support for at least one LTC. The sample exhibited high multimorbidity, with 93% reporting two or more LTCs and 43% reporting a mental health condition. OUTCOME MEASURES: The LTCQ's construct validity was tested with reference to the EQ-5D (5-level version), the Self-Efficacy for Managing Chronic Disease scale, an Activities of Daily Living scale and the Bayliss burden of morbidity scale. RESULTS: Low levels of missing data for each item indicate acceptability of the LTCQ across the sample. The LTCQ exhibits high internal consistency (Cronbach's α=0.95) across the scale's 20 items and excellent test-retest reliability (intraclass correlation coefficient=0.94, 95% CI 0.93 to 0.95). Associations between the LTCQ and all reference measures were moderate to strong and in the expected directions, indicating convergent construct validity. CONCLUSIONS: This study provides evidence for the reliability and validity of the LTCQ, which has potential for use in both health and social care settings. The LTCQ could meet a need for holistic outcome measurement that goes beyond symptoms and physical function, complementing existing measures to capture fully what it means to live well with LTCs.

SCALS: a fourth-generation study of assisted living technologies in their organisational, social, political and policy context.

INTRODUCTION: Research to date into assisted living technologies broadly consists of 3 generations: technical design, experimental trials and qualitative studies of the patient experience. We describe a fourth-generation paradigm: studies of assisted living technologies in their organisational, social, political and policy context. Fourth-generation studies are necessarily organic and emergent; they view technology as part of a dynamic, networked and potentially unstable system. They use co-design methods to generate and stabilise local solutions, taking account of context. METHODS AND ANALYSIS: SCALS (Studies in Co-creating Assisted Living Solutions) consists (currently) of 5 organisational case studies, each an English health or social care organisation striving to introduce technology-supported services to support independent living in people with health and/or social care needs. Treating these cases as complex systems, we seek to explore interdependencies, emergence and conflict. We employ a co-design approach informed by the principles of action research to help participating organisations establish, refine and evaluate their service. To that end, we are conducting in-depth ethnographic studies of people's experience of assisted living technologies (micro level), embedded in evolving organisational case studies that use interviews, ethnography and document analysis (meso level), and exploring the wider national and international context for assisted living technologies and policy (macro level). Data will be analysed using a sociotechnical framework developed from structuration theory. ETHICS AND DISSEMINATION: Research ethics approval for the first 4 case studies has been granted. An important outcome will be lessons learned from individual co-design case studies. We will document the studies' credibility and rigour, and assess the transferability of findings to other settings while also recognising unique aspects of the contexts in which they were generated. Academic outputs will include a cross-case analysis and progress in theory and method of fourth-generation assisted living technology research. We will produce practical guidance for organisations, policymakers, designers and service users.

The Long-Term Conditions Questionnaire: conceptual framework and item development.

PURPOSE: To identify the main issues of importance when living with long-term conditions to refine a conceptual framework for informing the item development of a patient-reported outcome measure for long-term conditions. MATERIALS AND METHODS: Semi-structured qualitative interviews (n=48) were conducted with people living with at least one long-term condition. Participants were recruited through primary care. The interviews were transcribed verbatim and analyzed by thematic analysis. The analysis served to refine the conceptual framework, based on reviews of the literature and stakeholder consultations, for developing candidate items for a new measure for long-term conditions. RESULTS: Three main organizing concepts were identified: impact of long-term conditions, experience of services and support, and self-care. The findings helped to refine a conceptual framework, leading to the development of 23 items that represent issues of importance in long-term conditions. The 23 candidate items formed the first draft of the measure, currently named the Long-Term Conditions Questionnaire. CONCLUSION: The aim of this study was to refine the conceptual framework and develop items for a patient-reported outcome measure for long-term conditions, including single and multiple morbidities and physical and mental health conditions. Qualitative interviews identified the key themes for assessing outcomes in long-term conditions, and these underpinned the development of the initial draft of the measure. These initial items will undergo cognitive testing to refine the items prior to further validation in a survey.

Type and accuracy of sphygmomanometers in primary care: a cross-sectional observational study.

BACKGROUND: Previous studies identified worrying levels of sphygmomanometer inaccuracy and have not been repeated in the era of digital measurement of blood pressure. AIM: To establish the type and accuracy of sphygmomanometers in current use. DESIGN AND SETTING: Cross-sectional, observational study in 38 Oxfordshire primary care practices. METHOD: Sphygmomanometers were evaluated between 50 and 250 mmHg, using Omron PA350 or Scandmed 950831-2 pressure meters. RESULTS: Six hundred and four sphygmomanometers were identified: 323 digital (53%), 192 aneroid (32%), 79 mercury (13%), and 10 hybrid (2%) devices. Of these, 584 (97%) could be fully tested. Overall, 503/584 (86%) were within 3 mmHg of the reference, 77/584 (13%) had one or more error of 4-9 mmHg, and 4/584 (<1%) had one or more error of more than 10 mmHg. Mercury (71/75, 95%) and digital (272/308, 88%) devices were more likely to be within 3 mmHg of the reference standard than aneroid models (150/191, 78%) (Fisher's exact test P = 0.001). Donated aneroid devices from the pharmaceutical industry performed significantly worse: 10/23 (43%) within 3 mmHg of standard compared to 140/168 (83%) aneroid models from recognised manufacturers (Fisher's exact test P<0.001). No significant difference was found in performance between manufacturers within each device type, for either aneroid (Fisher's exact test P = 0.96) or digital (Fisher's exact test P = 0.7) devices. CONCLUSION: Digital sphygmomanometers have largely replaced mercury models in primary care and have equivalent accuracy. Aneroid devices have higher failure rates than other device types; this appears to be largely accounted for by models from indiscernible manufacturers. Given the availability of inexpensive and accurate digital models, GPs could consider replacing aneroid devices with digital equivalents, especially for home visiting.