Assessing progress in managing and improving quality in nascent integrated care systems in England.

OBJECTIVES: In 2022, England embarked on an ambitious reorganisation to produce an integrated health and care system, intended also to maximise population health. The newly created integrated care systems (ICSs) aim to improve quality of care, by achieving the best outcomes for individuals and populations through the provision of evidence-based services. An emerging approach for managing quality in organisations is the Quality Management System (QMS) framework. Using the framework, this study assessed how ICSs are managing and improving quality. METHODS: Four ICSs were purposively sampled, with the data collected between November 2021 and May 2022. Semi-structured interviews with system leaders (n=60) from health and social care, public health and local representatives were held. We also observed key ICS meetings and reviewed relevant documents. A thematic framework approach based on the QMS framework was used to analyse the data. RESULTS: The ICSs placed an emphasis on population health, reducing inequity and improving access. This represents a shift in focus from the traditional clinical approach to quality. There were tensions between quality assurance and improvement, with concerns that a narrow focus on assurance would impede ICSs from addressing broader quality issues, such as tackling inequalities and unwarranted variation in care and outcomes. Partnerships, a key enabler for integration, was seen as integral to achieving improvements in quality. Overall, the ICSs expressed concerns that any progress made in quality development and in improving population health would be tempered by unprecedented system pressures. CONCLUSION: It is unclear whether ICSs can achieve their ambition. As they move away from an assurance-dominated model of quality to one that emphasises openness, learning and improvement, they must simultaneously build the digital infrastructure, staff expertise and culture to support such a shift.

Commissioning [Integrated] Care in England: An Analysis of the Current Decision Context.

Background: The emergence of Integrated Care Systems (ICSs) across England poses an additional challenge and responsibility for local commissioners to accelerate the implementation of integrated care programmes and improve the overall efficiency across the system. To do this, ICS healthcare commissioners could learn from the experience of the former local commissioning structures and identify areas of improvement in the commissioning process. This study describes the investment decision process in integrated care amid the transition toward ICSs, highlights challenges, and provides recommendations to inform ICSs in their healthcare commissioning role. Methods: Twenty-six semi-structured interviews were conducted with local commissioners and other relevant stakeholders in South East England in 2021. Interviews were supplemented with literature. Results: England's local healthcare commissioning has made the transition towards a new organisational architecture, with some integrated care programmes running, and a dual top-down and bottom-up prioritisation process in place. The commissioning and consequent development of integrated care programmes have been hindered by various barriers, including difficulties in accessing and using information, operational challenges, and resource constraints. Investment decisions have mainly been driven by national directives and budget considerations, with a mixture of subjective and objective approaches. A systematic and data-driven framework could replace this ad-hoc prioritisation of integrated care and contribute to a more rational and transparent commissioning process. Conclusion: The emerging ICSs seem to open an opportunity for local commissioners to strengthen the commissioning process of integrated care with evidence-based priority-setting approaches similar to the well-established health technology assessment framework at the national level.

Use of the Long-Term Conditions Questionnaire (LTCQ) for monitoring health-related quality of life in people affected by cognitive impairment including dementia: pilot study in UK memory clinic services.

PURPOSE: The aim of this study was to validate the Long-Term Conditions Questionnaire (LTCQ) among patients using memory clinic services in England. LTCQ is a short self-administered measure of 'living well with long-term conditions' that has not been previously tested in patients with cognitive impairment. METHODS: The mixed-methods study included cognitive interviews to test the comprehensibility and content validity of LTCQ from the patient's perspective, followed by a pilot survey to test the measure's internal consistency, construct validity, structural validity, and responsiveness. Participants were recruited through memory clinics following a diagnosis of mild cognitive impairment or dementia. RESULTS: Interview respondents (n = 12) all found LTCQ's content relevant, with only minor formatting modifications required. Among survey respondents (n = 105), most patients (86%) were able to self-report answers to LTCQ. High multimorbidity among the sample was associated with reduced LTCQ and EQ-5D scores. Internal consistency of LTCQ was high (Cronbach's α = 0.93), no floor or ceiling effects were observed, and missing data levels were low. Factor analysis results further supported LTCQ's structural validity, and predicted positive correlation with EQ-5D indicated construct validity. Score changes observed in a four-month follow-up survey (n = 61) are suggestive of LTCQ's responsiveness. CONCLUSION: LTCQ is a valid means of assessing health-related quality of life for people living with cognitive impairment (including dementia) in the early period of support following diagnosis. Owing to high levels of multimorbidity in this patient population, LTCQ offers an advantage over dementia-specific measures in capturing the cumulative impact of all LTCs experienced by the patient.

Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT.

BACKGROUND: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers. DESIGN: This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target sample size was 500 patients. A web-based randomisation system was used to allocate treatments. SETTING: Twenty-seven NHS hospitals (68 surgeons). PARTICIPANTS: Patients with medial compartment knee osteoarthritis. INTERVENTIONS: The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated. MAIN OUTCOME MEASURES: The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed. RESULTS: A total of 528 patients were randomised (partial knee replacement, n = 264; total knee replacement, n = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval -0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) (n = 233), mean 35.1 (standard deviation 9.1) (n = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 'failures' of partial knee replacement and 38 'failures' of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use. LIMITATIONS: It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure. CONCLUSIONS: Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years. FUTURE WORK: Further (10-year) follow-up is in progress to assess the longer-term stability of these findings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 20. See the NIHR Journals Library website for further project information.

WHAT WAS THE QUESTION?: Two types of knee replacement are available for patients with arthritis of the inner part of their knee: a partial knee replacement or a total knee replacement. It is not known which replacement offers most benefit for the patient or for the health-care system. WHAT DID WE DO?: We performed a large study involving 528 patients at 27 hospitals with 68 experienced surgeons, in which half of the patients underwent partial knee replacement and the other half underwent total knee replacement. We took yearly scores and measures, including pain, function, whether or not the operation was successful, and the costs of each patient for 5 years. Comparison between treatments was assessed at 5 years post operation. WHAT DID WE FIND?: Good outcomes and relatively few complications were observed after both operations. The measurements taken to assess the clinical benefit were largely very similar between the two groups. Where differences did occur at 5 years, there were only small differences between the two knee replacements and partial knee replacement was generally favoured. Some measurements, however, did show a larger difference between the two groups, including whether or not the operation addressed the patients' problems and whether or not the patient would have the operation again. These measurements were also in favour of partial knee replacement, but caution is required not to overstate importance, as patients in the study knew which device they had had implanted. The number of patients requiring further operations or revision surgery was similar in the two groups. This last finding contrasts with information from previously obtained, mainly non-randomised, studies and is of high relevance. The cost of each operation in relation to the benefit obtained was clearly in favour of partial knee replacement. WHAT DOES THIS MEAN?: Both operations are effective for use in the NHS. There appear to be some modest clinical advantages for patients to undergo partial knee replacement over total knee replacement but, importantly, the study casts doubt over previous concerns on high reoperation rates for partial knee replacement. The study has shown that reoperation rates recorded from different sources (cohort or trials) can be conflicting.

Assessment on patient outcomes of primary hip replacement: an interrupted time series analysis from 'The National Joint Registry of England and Wales'.

OBJECTIVES: Effects of the UK Department of Health's national Enhanced Recovery After Surgery (ERAS) Programme on outcomes after primary hip replacement. DESIGN: Natural experimental study using interrupted time series to assess the changes in trends before, during and after ERAS implementation (April 2009 to March 2011). SETTING: Surgeries in the UK National Joint Registry were linked with Hospital Episode Statistics containing inpatient episodes from National Health Service trusts in England and patient reported outcome measures. PARTICIPANTS: Patients aged ≥18 years from 2008 to 2016. MAIN OUTCOME MEASURES: Regression coefficients of monthly means of length of hospital stay, bed day cost, change in Oxford Hip Scores (OHS) 6 months post-surgery, complications 6 months post-surgery and revision rates 5 years post-surgery. RESULTS: 438 921 primary hip replacements were identified. Hospital stays shortened from 5.6 days in April 2008 to 3.6 in December 2016. There were also improvements in bed day costs (£7573 in April 2008 to £5239 in December 2016), positive change in self-reported OHS from baseline to 6 months post-surgery (17.7 points in April 2008 to 22.9 points in December 2016), complication rates (4.1% in April 2008 to 1.7% March 2016) and 5 year revision rates (5.9 per 1000 implant-years (95% CI 4.8 to 7.2) in April 2008 to 2.9 (95% CI 2.2 to 3.9) in December 2011). The positive trends in all outcomes started before ERAS was implemented and continued during and after the programme. CONCLUSIONS: Patient outcomes after hip replacement have improved over the last decade. A national ERAS programme maintained this improvement but did not alter the existing rate of change.

The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial.

BACKGROUND: Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years. METHODS: Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247). FINDINGS: Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI -0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (-£910, 95% CI -1503 to -317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR. INTERPRETATION: Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis. FUNDING: National Institute for Health Research Health Technology Assessment Programme.

Self-efficacy and health-related quality of life: a cross-sectional study of primary care patients with multi-morbidity.

BACKGROUND: Multi-morbidity in chronic long-term conditions is a major concern for health services. Self-management in concert with clinical care forms part of the effective management of multi-morbidity. Self-efficacy is a mechanism through which self-management can be achieved. Quality of life is adversely impacted by multi-morbidity but could be improved by effective self-management. This study examines the relationship between self-efficacy and quality of life in primary care patients with multi-morbidity. METHODS: A cross-sectional survey was conducted with primary care patients in England. Potential participants were mailed a questionnaire containing quality of life measures (the EQ-5D-5L and the Long-Term Conditions Questionnaire (LTCQ)), the Disease Burden Impact Scale (DBIS) and the Self-efficacy for Managing Chronic Disease Scale. Descriptive statistics, analysis of variance and linear regression analyses were conducted to examine the relationship between quality of life (dependent variable), self-efficacy, and demographic and disease-related variables. RESULTS: The 848 participants living with multi-morbidity reported a mean of 6.46 (SD 3.49) chronic long-term conditions, with the mean number of physical conditions 5.99 (SD 3.34) and mental health conditions 0.47 (SD 0.66). The mean scores were 15.45 (SD 12.00) for disease burden, 0.69 (SD 0.28) for the EQ-5D-5L, 65.44 (SD 23.66) for the EQ-VAS, and 69.31 (SD 21.77) for the LTCQ. The mean self-efficacy score was 6.69 (SD 2.53). The regression models were all significant at p < 0.001 (adjusted R2 > 0.70). Significant factors in all models were self-efficacy, disease burden and being permanently sick or disabled. Other factors varied between models, with the most notable being the presence of a mental health condition in the LTCQ model. CONCLUSIONS: Multi-morbid primary care patients with lower self-efficacy and higher disease burden have lower quality of life. Awareness of self-efficacy levels among patients with multi-morbidity may help health professionals identify patients who are in need of enhanced self-management support. Providing self-management support for chronic disease has been hailed as a hallmark of good care. Higher self-efficacy may lead to enhanced quality of life in multi-morbidity.

Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT.

BACKGROUND: Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). OBJECTIVES: To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture. DESIGN: We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation. SETTING: Five NHS hospitals in England. PARTICIPANTS: Men with unilateral, intermediate-risk, clinically localised PCa. INTERVENTIONS: Radical prostatectomy compared with HIFU. PRIMARY OUTCOME MEASURE: The randomisation of 80 men. SECONDARY OUTCOME MEASURES: Findings of the QRI and assessment of data capture methods. RESULTS: Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and 'tips' documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) - with University College Hospital failing to enrol any participants - than centres offering HIFU in the trial context only. CONCLUSIONS: Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted. FUTURE WORK: Men recruited to the feasibility study will be followed up for 36 months in accordance with the protocol. We will design a full RCT, taking into account the lessons learnt from this study. CRFs will be streamlined, and the length and frequency of PROMs and resource use diaries will be reviewed to reduce the burden on patients and research nurses and to optimise data completeness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN99760303. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 52. See the NIHR Journals Library website for further project information.

The context of coping: a qualitative exploration of underlying inequalities that influence health services support for people living with long-term conditions.

Coping with chronic illness encapsulates both practical and emotional aspects of living life in relation to one's long-term health condition(s). Dominant health psychology approaches for understanding coping, which underpin a more recent policy discourse on 'self-management', focus sharply on the person affected by illness and potentially mask the influence of overarching social structure. In this paper we draw on qualitative interviews with 48 people living with long-term conditions (LTCs), in order to highlight the role that structural configurations such as healthcare systems may play in either helping or hindering people's efforts to cope with chronic illness. We argue that coping is a social process in which health and related services, situated within their wider political-economic contexts, play an active role in shaping people's attempts to live well with LTCs. More specifically, health systems are sites of social and cultural capital exchange that can differentially mobilise coping resources through access, continuity of care, and coordination across services. Whilst it is essential to recognise the personal agency of people living with chronic illness, it is also vital to acknowledge the underlying inequalities that affect the ways in which services can support such resourcefulness.

Creating connections - the development of a mobile-health monitoring system for heart failure: Qualitative findings from a usability cohort study.

OBJECTIVE: There is significant interest in the role of digital health technology in enabling optimal monitoring of heart failure patients. To harness this potential, it is vital to account for users' capacity and preferences in the development of technological solutions. We adopted an iterative approach focussed on learning from users' interactions with a mobile-health monitoring system. METHODS: We used a participatory mixed methods research approach to develop and evaluate a mobile-health monitoring system. Fifty-eight heart failure patients were recruited from three health care settings in the UK and provided with Internet-enabled tablet computers that were wirelessly linked to sensor devices for blood pressure, heart rate and weight monitoring. One to two home visits were conducted with a subgroup of 29 participants to evaluate the usability of the system over a median follow-up period of six months. The thematic analysis of observational data and 45 interviews was informed by the domestication of technology theory. RESULTS: Our findings indicate that digital health technologies need to create and extend connections with health professionals, be incorporated into users' daily routines, and be personalised according to users' technological competencies and interest in assuming a proactive or more passive role in monitoring their condition. CONCLUSIONS: Users' patterns of engagement with health technology changes over time and varies according to their need and capacity to use the technology. Incorporating diverse user experiences in the development and maintenance of mobile-health systems is likely to increase the extent of successful uptake and impacts on outcomes for patients and providers.

Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial].

BACKGROUND: Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears. DESIGN: Two parallel-group randomised controlled trial. SETTING: Nineteen teaching and district general hospitals in the UK. PARTICIPANTS: Patients (n = 273) aged ≥ 50 years with degenerative rotator cuff tendon tears. INTERVENTIONS: Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. MAIN OUTCOME MEASURES: The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. RESULTS: The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was -0.76 [95% confidence interval (CI) -2.75 to 1.22; p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score -0.46, 95% CI -5.30 to 4.39; p = 0.854). The questionnaire response rate was > 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was £2567 (SD £176) for arthroscopic surgery and £2699 (SD £149) for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by £371 (95% CI £135 to £607). Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI -0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol. CONCLUSION: In patients aged > 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97804283. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 80. See the NIHR Journals Library website for further project information.

Perspectives from health, social care and policy stakeholders on the value of a single self-report outcome measure across long-term conditions: a qualitative study.

OBJECTIVES: To explore the views of a range of stakeholders regarding whether patient-reported outcome measures (PROMs) can be developed to measure key attributes of long-term conditions (LTCs) care in England, and the potential value of a single generic measure. DESIGN: Qualitative semistructured interview study, analysed using a framework approach. PARTICIPANTS AND SETTING: Interviews with 31 stakeholders from primary care, secondary care, social care, policy and patient-focused voluntary organisations in England. RESULTS: There was broad support for a single PROM that could be used to measure outcomes for patients with any LTCs in any health or social care setting. Interviewees identified three desired uses for a PROM: to improve the quality of individual care; to increase people's engagement in their own care; and to monitor the performance of services. Interviewees felt that a PROM for LTCs should incorporate a mixture of traditional and non-traditional domains, such as functioning, empowerment and social participation, and be codesigned with patients and professional end-users. Stakeholders emphasised the need for a PROM to be feasible for practical implementation at the individual clinical level as a first priority. A number of concerns and potential problems were identified in relation to the application and interpretation of an LTC PROM. CONCLUSIONS: This study has demonstrated support for a single self-report outcome measure that reflects the priorities of people with LTCs, if such a measure can be shown to be meaningful and useful at the individual level. People with LTCs and professional end-users in health and social care should be involved in the development and evaluation of such a measure.

Experiences of front-line health professionals in the delivery of telehealth: a qualitative study.

BACKGROUND: Telehealth is an emerging field of clinical practice but current UK health policy has not taken account of the perceptions of front-line healthcare professionals expected to implement it. AIM: To investigate telehealth care for people with long-term conditions from the perspective of the front-line health professional. DESIGN AND SETTING: A qualitative study in three sites within the UK (Kent, Cornwall, and the London Borough of Newham) and embedded in the Whole Systems Demonstrator evaluation, a large cluster randomised controlled trial of telehealth and telecare for patients with long-term and complex conditions. METHOD: Semi-structured qualitative interviews with 32 front-line health professionals (13 community matrons, 10 telehealth monitoring nurses and 9 GPs) involved in the delivery of telehealth. Data were analysed using a modified grounded theory approach. RESULTS: Mixed views were expressed by front-line professionals, which seem to reflect their levels of engagement. It was broadly welcomed by nursing staff as long as it supplemented rather than substituted their role in traditional patient care. GPs held mixed views; some gave a cautious welcome but most saw telehealth as increasing their work burden and potentially undermining their professional autonomy. CONCLUSION: Health care professionals will need to develop a shared understanding of patient self-management through telehealth. This may require a renegotiation of their roles and responsibilities.

Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial.

PURPOSE OF THE STUDY: to examine the costs and cost-effectiveness of 'second-generation' telecare, in addition to standard support and care that could include 'first-generation' forms of telecare, compared with standard support and care that could include 'first-generation' forms of telecare. DESIGN AND METHODS: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care. PRIMARY OUTCOME MEASURE: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective. RESULTS: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY. IMPLICATIONS: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs. TRIAL REGISTRATION NUMBER: ISRCTN 43002091.

A randomised controlled trial of the clinical effectiveness and cost-effectiveness of different knee prostheses: the Knee Arthroplasty Trial (KAT).

BACKGROUND: In the late 1990s, new developments in knee replacement were identified as a priority for research within the NHS. The newer forms of arthroplasty were more expensive and information was needed on their safety and cost-effectiveness. OBJECTIVES: The Knee Arthroplasty Trial examined the clinical effectiveness and cost-effectiveness of four aspects of knee replacement surgery: patellar resurfacing, mobile bearings, all-polyethylene tibial components and unicompartmental replacement. DESIGN: This study comprised a partial factorial, pragmatic, multicentre randomised controlled trial with a trial-based cost-utility analysis which was conducted from the perspective of the NHS and the patients treated. Allocation was computer generated in a 1 : 1 ratio using a central system, stratified by eligible comparisons and surgeon, minimised by participant age, gender and site of disease. Surgeons were not blinded to allocated procedures. Participants were unblinded if they requested to know the prosthesis they received. SETTING: The setting for the trial was UK secondary care. PARTICIPANTS: Patients were eligible for inclusion if a decision had been made for them to have primary knee replacement surgery. Patients were recruited to comparisons for which the surgeon was in equipoise about which type of operation was most suitable. INTERVENTIONS: Patients were randomised to receive a knee replacement with the following: patellar resurfacing or no patellar resurfacing irrespective of the design of the prosthesis used; a mobile bearing between the tibial and femoral components or a bearing fixed to the tibial component; a tibial component made of either only high-density polyethylene ('all polyethylene') or a polyethylene bearing fixed to a metal backing plate with attached stem; or unicompartmental or total knee replacement. MAIN OUTCOME MEASURES: The primary outcome was the Oxford Knee Score (OKS). Other outcomes were Short Form 12; EuroQol 5D; intraoperative and postoperative complications; additional surgery; cost; and cost-effectiveness. Patients were followed up for a median of 10 years; the economic evaluation took a 10-year time horizon, discounting costs and quality-adjusted life-years (QALYs) at 3.5% per annum. RESULTS: A total of 116 surgeons in 34 centres participated and 2352 participants were randomised: 1715 in patellar resurfacing; 539 in mobile bearing; 409 in all-polyethylene tibial component; and 34 in the unicompartmental comparisons. Of those randomised, 345 were randomised to two comparisons. We can be more than 95% confident that patellar resurfacing is cost-effective, despite there being no significant difference in clinical outcomes, because of increased QALYs [0.187; 95% confidence interval (CI) -0.025 to 0.399] and reduced costs (-£104; 95% CI -£630 to £423). We found no definite advantage or disadvantage of mobile bearings in OKS, quality of life, reoperation and revision rates or cost-effectiveness. We found improved functional results for metal-backed tibias: complication, reoperation and revision rates were similar. The metal-backed tibia was cost-effective (particularly in the elderly), costing £35 per QALY gained. CONCLUSIONS: The results provide evidence to support the routine resurfacing of the patella and the use of metal-backed tibial components even in the elderly. Further follow-up is required to assess the stability of these findings over time and to inform the decision between mobile and fixed bearings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45837371. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and the orthopaedic industry. It will be published in full in Health Technology Assessment; Vol. 18, No. 19. See the NIHR Journals Library website for further project information.

The effect of telecare on the quality of life and psychological well-being of elderly recipients of social care over a 12-month period: the Whole Systems Demonstrator cluster randomised trial.

BACKGROUND: home-based telecare (TC) is utilised to manage risks of independent living and provide prompt emergency responses. This study examined the effect of TC on health-related quality of life (HRQoL), anxiety and depressive symptoms over 12 months in patients receiving social care. DESIGN: a study of participant-reported outcomes [the Whole Systems Demonstrator (WSD) Telecare Questionnaire Study; baseline n = 1,189] was nested in a pragmatic cluster-randomised trial of TC (the WSD Telecare trial), held across three English Local Authorities. General practice (GP) was the unit of randomisation and TC was compared with usual care (UC). METHODS: participant-reported outcome measures were collected at baseline, short-term (4 months) and long-term (12 months) follow-up, assessing generic HRQoL, anxiety and depressive symptoms. Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed questionnaire measures at baseline assessment plus at least one other assessment (n = 873). RESULTS: analyses found significant differences between TC and UC on Short Form-12 mental component scores (P < 0.05), with parameter estimates indicating being a member of the TC trial-arm increases mental component scores (UC-adjusted mean = 40.52; TC-adjusted mean = 43.69). Additional significant analyses revealed, time effects on EQ5D (decreasing over time) and depressive symptoms (increasing over time). CONCLUSIONS: TC potentially contributes to the amelioration in the decline in users' mental HRQoL over a 12-month period. TC may not transform the lives of its users, but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC. International Standard Randomised Controlled Trial Number Register: ISRCTN 43002091.

Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial.

BACKGROUND: In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two fundamentally different approaches to knee replacement for patients with unicompartmental disease: some surgeons feel that it is always best to replace both the knee compartments with a total knee replacement (TKR); whereas others feel it is best to replace just the damaged component of the knee using a partial or unicompartment replacement (UKR). Both interventions are established and well-documented procedures. Little evidence exists to prove the clinical and cost-effectiveness of either management option. This provides an explanation for the high variation in treatment of choice by individual surgeons for the same knee pathology.The aim of the TOPKAT study will be to assess the clinical and cost effectiveness of TKRs compared to UKRs in patients with medial compartment osteoarthritis. METHODS/DESIGN: The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. Blinding will not be possible as the surgical scars for each procedure differ.We aim to recruit 500 patients from approximately 28 secondary care orthopaedic units from across the UK including district general and teaching hospitals. Participants will be randomised to either UKR or TKR. Randomisation will occur using a web-based randomisation system. The study is pragmatic in terms of implant selection for the knee replacement operation. Participants will be followed up for 5 years. The primary outcome is the Oxford Knee Score, which will be collected via questionnaires at 2 months, 1 year and then annually to 5 years. Secondary outcomes will include cost-effectiveness, patient satisfaction and complications data. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03013488; ClinicalTrials.gov Identifier: NCT01352247.

Cost-minimisation analysis of subcutaneous methotrexate versus biologic therapy for the treatment of patients with rheumatoid arthritis who have had an insufficient response or intolerance to oral methotrexate.

This study aims to model the economic impact of subcutaneous methotrexate (SC MTX) or a biologic over a 12-month period using a hypothetical population of rheumatoid arthritis patients who failed to tolerate or respond to oral MTX and were suitable candidates for biologic therapy. A decision-based model was developed using current National Institute for Health and Clinical Excellence (NICE) guidance to determine the management of this hypothetical UK population. Published data on the continuation rates of SC MTX and biologics were used to compare the costs of the two treatment options. The economic model used a cost-minimisation methodology from a UK National Health Service (NHS) perspective, with the cost of all drugs and resources being estimated on this basis. Sensitivity analyses were also performed to determine the effects of changing key assumptions on the mean cost differences. The routine use of SC MTX following oral MTX failure has the potential to save an estimated £7,197 per patient in the first year of therapy and £9.3m per year nationally in new patients. Sensitivity analyses support the robustness of the results. The results of this study suggest that routine use of SC MTX following oral MTX failure has the potential to provide considerable savings to the NHS through optimised use of MTX first-line therapy. It is proposed, therefore, that patients should start on oral MTX with a subsequent switch to SC MTX in the case of an insufficient response or tolerability issues, before introducing a biologic agent.

Carer quality of life and experiences of health services: a cross-sectional survey across three neurological conditions.

BACKGROUND: Neurological conditions have a substantial impact on carers, with carer well-being having been shown to be influenced by a number of demographic, patient and caregiving factors. Support given to carers can lead to better coping. This study investigated the relationship between carer well-being and experiences with health and social services. METHODS: A cross-sectional survey was conducted of 1910 (37.4%) of carers of 5109 people with motor neuron disease (MND) (n=434, 54.9%), multiple sclerosis (MS) (n=721, 30.7%) and Parkinson's disease (PD) (n=755, 38.2%). Carers completed a generic health status measure (SF-12), a carer strain measure (Carer Strain Index- CSI) and a newly developed questionnaire on health and social care experiences. Data were analysed by analysis of variance with p set at <0.05. RESULTS: Carer well-being was found to be compromised and differed significantly between the three conditions. Furthermore, a considerable number of carers experienced problems with aspects of health and social care, although there was no clear pattern according to the condition that was cared for. The total number of problems reported did not differ significantly between conditions but was significantly (all p<0.001) associated with carer quality of life (both physical and mental health) and strain, even when other influencing factors (demographic and caregiving variables) were corrected for. The association was particularly strong for carer strain, and less strong (but still significant) for quality of life. CONCLUSIONS: The results show that carer well-being is compromised, in line with previous studies. Furthermore, the link of carer well-being to the number of problems reported suggests that minimizing problems experienced could improve carer well-being. This stresses the importance of health and social services appropriately supporting carers.