In risk we trust? Making decisions about knee replacement.

Risk communication is a key legal and ethical component of shared decision-making. Decisions about total knee replacement, a common surgery, must contend with the fact that a minority of cases result in unintended outcomes, some of which have devastating effects. To understand how risks are communicated during decision-making, we audio-recorded and analysed 62 consultations between surgeons and patients. Various communication methods were evident, including listing risks without elaboration, discussing them in a conversational manner, abrogating discussion of risk, or using decision-tools. Discussion of risks was often brief in nature, and risk communication was sometimes curtailed or deferred by both patients and surgeons. Risks could also be observed to play a part in reinforcing policy norms of the doctor-patient relationship that highlighted patient responsibility. Nevertheless, patients and surgeons in the observed consultations appeared more interested in developing trusting relationships than in discussing risks. Because patients had sometimes experienced considerable deterioration in their knee function before their consultation, were in pain and struggled with mobility, the realities of clinical practice clashed with the policy norms of choice and patient responsibility. Rather, decisions could appear coerced by the disease process rather than being clear-cut examples of self-determination. While policy norms putatively use risk disclosure to frame communication between patients and clinicians as a transaction between customer and technician, the lack of conformity to these norms in the consultations may indicate resistance to this framing. A greater emphasis on determining positive roles for trust and care would help policy to present a nuanced understanding of decision-making. Risk communication could be seen as a factor in the formation of trusting relationships, improving its role in decision-making processes while recognising its inherent tensions with practice.

Prevalence and patterns of neuropathic pain in people with chronic post-surgical pain after total knee arthroplasty.

Aims: The aim of this study was to describe the prevalence and patterns of neuropathic pain over one year in a cohort of patients with chronic post-surgical pain at three months following total knee arthroplasty (TKA). Methods: Between 2016 and 2019, 363 patients with troublesome pain, defined as a score of ≤ 14 on the Oxford Knee Score pain subscale, three months after TKA from eight UK NHS hospitals, were recruited into the Support and Treatment After Replacement (STAR) clinical trial. Self-reported neuropathic pain and postoperative pain was assessed at three, nine, and 15 months after surgery using the painDETECT and Douleur Neuropathique 4 (DN4) questionnaires collected by postal survey. Results: Symptoms of neuropathic pain were common among patients reporting chronic pain at three months post-TKA, with half reporting neuropathic pain on painDETECT (191/363; 53%) and 74% (267/359) on DN4. Of those with neuropathic pain at three months, half continued to have symptoms over the next 12 months (148/262; 56%), one-quarter had improved (67/262; 26%), and for one-tenth their neuropathic symptoms fluctuated over time (24/262; 9%). However, a subgroup of participants reported new, late onset neuropathic symptoms (23/262; 9%). Prevalence of neuropathic symptoms was similar between the screening tools when the lower cut-off painDETECT score (≥ 13) was applied. Overall, mean neuropathic pain scores improved between three and 15 months after TKA. Conclusion: Neuropathic pain is common in patients with chronic pain at three months after TKA. Although neuropathic symptoms improved over time, up to half continued to report painful neuropathic symptoms at 15 months after TKA. Postoperative care should include screening, assessment, and treatment of neuropathic pain in patients with early chronic postoperative pain after TKA.

Modelled cost-effectiveness analysis of the Support and Treatment After Replacement (STAR) care pathway for chronic pain after total knee replacement compared with usual care.

BACKGROUND: The aim of the study was to estimate the long-term cost-effectiveness of the Support and Treatment After Replacement (STAR) care pathway for chronic pain after total knee replacement compared with usual postoperative care. METHODS: Study design: A decision-analytic (cohort Markov) model was used for the simulation with time dependent annual transition probabilities and a time horizon of five years. SETTING: Patients treated by National Health Service (NHS) hospitals in England and Wales. STUDY POPULATION: Adults classified as having chronic pain three months after undergoing a total knee replacement. INTERVENTION: The STAR care pathway following a total knee replacement. COMPARATOR: Usual postoperative care following a total knee replacement. PERSPECTIVE: The study was undertaken from the perspective of the NHS. OUTCOME MEASURES: Quality-adjusted life years and healthcare costs. Discounting: A rate of 3.5% for both costs and health utility. RESULTS: Model results indicate that the STAR intervention would dominate current practice by providing a gain in quality-adjusted life years (QALYs) of 0.086 and a reduction of £375 (per person) in costs over the first five years. The incremental net monetary benefit of the STAR intervention was estimated at £2,086 (at a threshold of £20,000 per QALY). Probabilistic sensitivity analysis suggests the STAR intervention is likely to be cost-effective with a probability of 0.62. The results remain robust to changes in model assumptions on comparator utility and the timing of the start of the intervention. If hospital admission costs are assumed not to be reduced by the STAR intervention, it would no longer be cost saving, but it would likely be cost-effective based on probabilistic sensitivity analysis (0.59). CONCLUSION: Evidence from the economic model suggests that the STAR care pathway is likely to be cost-effective and potentially dominant from an NHS perspective. TRIAL REGISTRATION: The STAR trial is registered with ISRCTN, ISRCTN92545361.

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial.

OBJECTIVES: To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement. DESIGN: Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study. SETTING: Two National Health Service (NHS) secondary care hospitals in England and Wales. PARTICIPANTS: Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0-28 on the Sleep Condition Indicator questionnaire. INTERVENTION: The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals. OUTCOME MEASURES: The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients. RESULTS: Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable. CONCLUSIONS: This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible. TRIAL REGISTRATION NUMBER: ISRCTN14233189.

Model of multidisciplinary teamwork in hip fracture care: a qualitative interview study.

OBJECTIVES: Hip fractures are common injuries in older age with high mortality requiring multidisciplinary clinical care. Despite guidance, there is considerable variation in hip fracture services and patient outcomes; furthermore, little is known about how successful multidisciplinary working can be enabled. This study aimed to characterise professionals' views about the core components of multidisciplinary teamwork in hip fracture care. DESIGN: The study comprised qualitative interviews with healthcare professionals delivering hip fracture care. Interviews were audio recorded, transcribed and analysed abductively: material was coded inductively and grouped into higher level concepts informed by theories and frameworks relating to teamwork. SETTING: Four hospitals in England. PARTICIPANTS: Participants were 40 healthcare professionals including orthopaedic surgeons, orthogeriatricians, physiotherapists and service managers. RESULTS: Results identified four components of successful multidisciplinary teamwork: (1) defined roles and responsibilities, (2) information transfer processes, (3) shared goals and (4) collaborative leadership. These were underpinned by a single concept: shared responsibility. Defined roles and responsibilities were promoted through formal care pathways, reinforced through induction and training with clear job plans outlining tasks. Information transfer processes facilitated timely information exchange to appropriate individuals. Well-defined common purpose was hindered by complex interdisciplinary professional relationships, particularly between orthogeriatric and orthopaedic staff, and encouraged through multidisciplinary team meetings and training. Clinical service leads were integral to bridging interdisciplinary boundaries. Mutual trust and respect were based on recognition of the value of different professional groups. Teamwork depended on formal clinical leads with facilitative and motivational roles, and on hospital leadership that created an environment supporting collaboration. Shared responsibility for patients was encouraged by joint orthopaedic and orthogeriatric care models. Staff shared responsibility by assisting colleagues when needed. CONCLUSIONS: Shared responsibility across the multidisciplinary team is fundamental to delivery of hip fracture care. Findings will inform development of clinical practice recommendations and training to build teamworking competencies.

Improving patients' experiences of diagnosis and treatment of vertebral fracture: co-production of knowledge sharing resources.

BACKGROUND: Osteoporosis involves changes to bones that makes them prone to fracture. The most common osteoporotic fracture is vertebral, in which one or more spinal vertebrae collapse. People with vertebral fracture are at high risk of further fractures, however around two-thirds remain undiagnosed. The National Institute for Health and Care Excellence (NICE) recommends bone protection therapies to reduce this risk. This study aimed to co-produce a range of knowledge sharing resources, for healthcare professionals in primary care and patients, to improve access to timely diagnosis and treatment. METHODS: This study comprised three stages: 1. In-depth interviews with primary care healthcare professionals (n = 21) and patients with vertebral fractures (n = 24) to identify barriers and facilitators to diagnosis and treatment. 2. A taxonomy of barriers and facilitators to diagnosis were presented to three stakeholder groups (n = 18), who suggested ways of identifying, diagnosing and treating vertebral fractures. Fourteen recommendations were identified using the nominal group technique. 3. Two workshops were held with stakeholders to co-produce and refine the prototype knowledge sharing resources (n = 12). RESULTS: Stage 1: Factors included lack of patient information about symptoms and risk factors, prioritisation of other conditions and use of self-management. Healthcare professionals felt vertebral fractures were harder to identify in lower risk groups and mistook them for other conditions. Difficulties in communication between primary and secondary care meant that patients were not always informed of their diagnosis, or did not start treatment promptly. Stage 2: 14 recommendations to improve management of vertebral fractures were identified, including for primary care healthcare professionals (n = 9) and patients (n = 5). Stage 3: The need for allied health professionals in primary care to be informed about vertebral fractures was highlighted, along with ensuring that resources appealed to under-represented groups. Prototype resources were developed. Changes included help-seeking guidance and clear explanations of medical language. CONCLUSIONS: The study used robust qualitative methods to co-produce knowledge sharing resources to improve diagnosis. A co-production approach enabled a focus on areas stakeholders thought to be beneficial to timely and accurate diagnosis and treatment. Dissemination of these resources to a range of stakeholders provides potential for substantial reach and spread.

The STAR care pathway for patients with chronic pain after total knee replacement: four-year follow-up of a randomised controlled trial.

BACKGROUND: The Support and Treatment After Replacement (STAR) care pathway is a clinically important and cost-effective intervention found to improve pain outcomes over one year for people with chronic pain three months after total knee replacement (TKR). We followed up STAR trial participants to evaluate the longer-term clinical- and cost-effectiveness of this care pathway. METHODS: Participants who remained enrolled on the trial at one year were contacted by post at a median of four years after randomisation and invited to complete a questionnaire comprising the same outcomes collected during the trial. We captured pain (co-primary outcome using the Brief Pain Inventory (BPI) pain severity and interference scales; scored 0-10, best to worst), function, neuropathic characteristics, emotional aspects of pain, health-related quality of life, and satisfaction. Electronic hospital informatics data on hospital resource use for the period of one to four years post-randomisation were collected from participating hospital sites. The economic evaluation took an National Health Service (NHS) secondary care perspective, with a four-year time horizon. RESULTS: Overall, 226/337 (67%) of participants returned completed follow-up questionnaires, yielding adjusted between-group differences in BPI means of -0.42 (95% confidence interval, CI (-1.07, 0.23); p = 0.20) for pain severity and - 0.64 (95% CI -1.41, 0.12); p = 0.10) for pain interference. Analysis using a multiple imputed data set (n = 337) showed an incremental net monetary benefit in favour of the STAR care pathway of £3,525 (95% CI -£990 to £8,039) at a £20,000/QALY willingness-to-pay threshold, leading to a probability that the intervention was cost-effective of 0.94. CONCLUSIONS: The magnitude of the longer-term benefits of the STAR care pathway are uncertain due to attrition of trial participants; however, there is a suggestion of some degree of sustained clinical benefit at four years. The care pathway remained cost-effective at four years. TRIAL REGISTRATION: ISRCTN: 92,545,361.

"Pouring their heart out in Sainsbury's": qualitative study of young people's, parents' and mental health practitioners' experiences of adapting to remote online mental health appointments during COVID-19.

BACKGROUND: During the COVID-19 pandemic, technologies such as videoconferencing were used to deliver mental health appointments remotely online. For many people, this was a change from previous methods of mental healthcare receipt and delivery. We aimed to explore in-depth how practitioners, young people and parents in the UK experienced this transition. METHODS: We used qualitative methods to collect data, triangulating between free-text online survey data (n = 38), focus groups (n = 5) (3 young adult groups (total n = 11); 2 practitioner groups (total n = 7)), and semi-structured interviews (practitioners n = 8; parents n = 4). Data were analysed using reflexive thematic analysis. RESULTS: Participants held mixed views about remote appointments, which were encompassed within the five themes of: home as clinic; disrupted therapeutic relationships; difficulties with engagement; uncontained risk; and scope of care provision. While appointments at home could be regarded as more comfortable, naturalistic and accessible, it was also recognised that remoteness compromised practitioner control with consequences for their ability to monitor patient engagement, manage risk and ensure confidentiality when others were present in the home. This could create an additional burden for parents as they tried to facilitate appointments but felt unsupported in this role. Relatedly, remoteness was seen to hinder interpersonal communication, formation of trust, communication of empathy and opportunities to observe body language, all of which were deemed important to building and maintaining effective therapeutic relationships. Despite this, others thought the anonymity of a remote exchange may allow earlier disclosure. There was disagreement as to whether remote provision narrowed or expanded the scope of practice. CONCLUSIONS: While some had positive views of remote mental health appointments, others found them challenging. Findings highlight key areas requiring attention and mitigation in future offerings of remote provision, namely: risk management, parental burden, and problematic engagement.

Development of a Smart Home Interface With Older Adults: Multi-Method Co-Design Study.

BACKGROUND: Smart home technologies have the potential to support aging in place; however, older people's perceptions of the value of smart homes may be influenced by their access to the information gathered by the technology. This information is needed to support their informed decision-making. Limited research has been conducted on how best to design visualizations of smart home data in keeping with the needs and wishes of older people. OBJECTIVE: We aimed to investigate the design options that impact the usefulness of smart home systems, older people's information needs, their perceptions of data visualization, and the ways they would like information displayed to them. METHODS: We used a qualitative approach to empower the participants as co-designers. Data collection comprised a sequence of methods such as interviews, observation, focus groups, scenario design, probes, and design workshops. Each phase informed the next. Overall, 13 older adults (n=8, 62% female and n=5, 38% male; aged 65-89 years) consented to participate. A thematic approach was used to analyze the data set, and participants were actively involved in designing the in-home interface, which enabled them to better conceptualize their needs. RESULTS: The information collected was clustered into 5 themes: enabling home, health, and self-monitoring; enabling opportunities for social inclusion and engagement; enhancing cognitive abilities; customizability of the display; and promoting inclusion in recreation and leisure activities. These themes informed 5 design sessions in which participants co-designed visual metaphors for the themes based on their own experiences in an age-inclusive manner. Together, the participants produced a user-friendly prototype, which they chose to call My Buddy. They found it useful to receive social and cognitive triggers, as well as recommendations for special diets or activities based on their mood, health, and social status. CONCLUSIONS: Smart home data visualization is much more than a nice-to-have option. Visualization is a must-have feature because it deepens the understanding of the information collected and means that technology provides information of value and relevance to older people. This may improve the acceptability and perceived utility of in-home technology. By understanding what older people want to know from smart home technology and considering how to visualize data in ways that work for them, we can provide an appropriate in-home interface. Such an interface would suggest ways or opportunities to connect and socialize; stimulate contact with close friends or family members; maintain awareness of health and well-being; provide support in decision-making, cognitive tasks, and daily life activities; and monitor health status. Older adults are the best co-designers for the development of visual metaphors that resonate with their own experiences. Our findings promote the development of technologies that foreground and reflect the information needs of older people and engage them as designers of the display.

Healthcare professionals' views on implementing the STAR care pathway for people with chronic pain after total knee replacement: A qualitative study.

For many people with advanced osteoarthritis, total knee replacement is an effective treatment to relieve pain and improve function. However, 10-34% of people experience chronic postsurgical pain in the months and years after total knee replacement. The Support and Treatment After Replacement (STAR) randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. Our objective was to identify factors promoting or inhibiting its implementation, and to inform future training and wider implementation of the pathway. We conducted a prospective process evaluation using qualitative interviews with eight Extended Scope Practitioners and six Principal Investigators from seven trial sites who were involved in delivering the STAR care pathway during the trial. We used Normalization Process Theory as a theoretical framework for qualitative data collection and content analysis. We identified that factors promoting the implementation of the pathway were quick familiarisation with the pathway, valuing patient-centredness, formalising referral processes, and increasing confidence to address neuropathic pain. Challenges to implementation were availability of time and resources, sensitivity in referral process, and ensuring collective understanding of the pathway. These findings have enabled us to make recommendations about the future implementation of the STAR care pathway and will inform the development of a training package, and updated manual for successful delivery in usual care. Furthermore, this model of care has potential value in diverse elective surgeries and pain conditions.

Mental Health Practitioners' and Young People's Experiences of Talking About Social Media During Mental Health Consultations: Qualitative Focus Group and Interview Study.

BACKGROUND: Increasing concerns among mental health care professionals have focused on the impact of young people's use of digital technology and social media on their mental well-being. It has been recommended that the use of digital technology and social media be routinely explored during mental health clinical consultations with young people. Whether these conversations occur and how they are experienced by both clinicians and young people are currently unknown. OBJECTIVE: This study aimed to explore mental health practitioners' and young people's experiences of talking about young people's web-based activities related to their mental health during clinical consultations. Web-based activities include use of social media, websites, and messaging. Our aim was to identify barriers to effective communication and examples of good practice. In particular, we wanted to obtain the views of young people, who are underrepresented in studies, on their social media and digital technology use related to mental health. METHODS: A qualitative study was conducted using focus groups (11 participants across 3 groups) with young people aged 16 to 24 years and interviews (n=8) and focus groups (7 participants across 2 groups) with mental health practitioners in the United Kingdom. Young people had experience of mental health problems and support provided by statutory mental health services or third-sector organizations. Practitioners worked in children and young people's mental health services, statutory services, or third-sector organizations such as a university counseling service. Thematic analysis was used to analyze the data. RESULTS: Practitioners and young people agreed that talking about young people's web-based activities and their impact on mental health is important. Mental health practitioners varied in their confidence in doing this and were keen to have more guidance. Young people said that practitioners seldom asked about their web-based activities, but when asked, they often felt judged or misunderstood. This stopped them from disclosing difficult web-based experiences and precluded useful conversations about web-based safety and how to access appropriate web-based support. Young people supported the idea of guidance or training for practitioners and were enthusiastic about sharing their experiences and being involved in the training or guidance provided to practitioners. CONCLUSIONS: Practitioners would benefit from structured guidance and professional development to enable them to support young people in feeling more willing to disclose and talk about their web-based experiences and their impact on their mental health. This is reflected in practitioners' desire for guidance to improve their confidence and skills to safely support young people in navigating the challenges of the web-based world. Young people want to feel comfortable discussing their web-based activities during their consultations with mental health practitioners, both in tackling the challenges and using the opportunity to discuss their experiences, gain support, and develop coping strategies related to web-based safety.

Digital Technology Use and Mental Health Consultations: Survey of the Views and Experiences of Clinicians and Young People.

BACKGROUND: Digital technologies play an increasingly important role in the lives of young people and have important effects on their mental health. OBJECTIVE: We aimed to explore 3 key areas of the intersection between digital technology and mental health: the views and experiences of young people and clinicians about digital technology and mental health; implementation and barriers to the UK national guidance recommendation-that the discussion of digital technology use should form a core part of mental health assessment; and how digital technology might be used to support existing consultations. METHODS: Two cross-sectional web-based surveys were conducted in 2020 between June and December, with mental health clinicians (n=99) and young people (n=320). Descriptive statistics were used to summarize the proportions. Multilinear regression was used to explore how the answers varied by gender, sexuality, and age. Thematic analysis was used to explore the contents of the extended free-text answers. Anxiety was measured using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7). RESULTS: Digital technology use was ubiquitous among young people, with positive and negative aspects acknowledged by both clinicians and young people. Negative experiences were common (131/284, 46.1%) and were associated with increased anxiety levels among young people (GAD-7 3.29; 95% CI 1.97-4.61; P<.001). Although the discussion of digital technology use was regarded as important by clinicians and acceptable by young people, less than half of clinicians (42/85, 49.4%) routinely asked about the use of digital technology and over a third of young people (48/121, 39.6%) who had received mental health care had never been asked about their digital technology use. The conversations were often experienced as unhelpful. Helpful conversations were characterized by greater depth and exploration of how an individual's digital technology use related to mental health. Despite most clinicians (59/83, 71.1%) wanting training, very few (21/86, 24.4%) reported receiving training. Clinicians were open to viewing mental health data from apps or social media to help with consultations. Although young people were generally, in theory, comfortable sharing such data with health professionals, when presented with a binary choice, most reported not wanting to share social media (84/117, 71.8%) or app data (67/118, 56.8%) during consultations. CONCLUSIONS: Digital technology use was common, and negative experiences were frequent and associated with anxiety. Over a third of young people were not asked about their digital technology use during mental health consultations, and potentially valuable information about relevant negative experiences on the web was not being captured during consultations. Clinicians would benefit from having access to training to support these discussions with young people. Although young people recognized that app data could be helpful to clinicians, they appeared hesitant to share their own data. This finding suggests that data sharing has barriers that need to be further explored.

Toward Enhanced Clinical Decision Support for Patients Undergoing a Hip or Knee Replacement: Focus Group and Interview Study With Surgeons.

BACKGROUND: The current assessment of recovery after total hip or knee replacement is largely based on the measurement of health outcomes through self-report and clinical observations at follow-up appointments in clinical settings. Home activity-based monitoring may improve assessment of recovery by enabling the collection of more holistic information on a continuous basis. OBJECTIVE: This study aimed to introduce orthopedic surgeons to time-series analyses of patient activity data generated from a platform of sensors deployed in the homes of patients who have undergone primary total hip or knee replacement and understand the potential role of these data in postoperative clinical decision-making. METHODS: Orthopedic surgeons and registrars were recruited through a combination of convenience and snowball sampling. Inclusion criteria were a minimum required experience in total joint replacement surgery specific to the hip or knee or familiarity with postoperative recovery assessment. Exclusion criteria included a lack of specific experience in the field. Of the 9 approached participants, 6 (67%) orthopedic surgeons and 3 (33%) registrars took part in either 1 of 3 focus groups or 1 of 2 interviews. Data were collected using an action-based approach in which stimulus materials (mock data visualizations) provided imaginative and creative interactions with the data. The data were analyzed using a thematic analysis approach. RESULTS: Each data visualization was presented sequentially followed by a discussion of key illustrative commentary from participants, ending with a summary of key themes emerging across the focus group and interview data set. CONCLUSIONS: The limitations of the evidence are as follows. The data presented are from 1 English hospital. However, all data reflect the views of surgeons following standard national approaches and training. Although convenience sampling was used, participants' background, skills, and experience were considered heterogeneous. Passively collected home monitoring data offered a real opportunity to more objectively characterize patients' recovery from surgery. However, orthopedic surgeons highlighted the considerable difficulty in navigating large amounts of complex data within short medical consultations with patients. Orthopedic surgeons thought that a proposed dashboard presenting information and decision support alerts would fit best with existing clinical workflows. From this, the following guidelines for system design were developed: minimize the risk of misinterpreting data, express a level of confidence in the data, support clinicians in developing relevant skills as time-series data are often unfamiliar, and consider the impact of patient engagement with data in the future. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2018-021862.

Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial.

OBJECTIVES: To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures. DESIGN: Pragmatic, parallel group, open label, randomised controlled trial. SETTING: High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018. PARTICIPANTS: 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision). INTERVENTIONS: A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure. MAIN OUTCOME MEASURES: The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups. RESULTS: The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval -8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; €1.4). CONCLUSIONS: At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery. TRIAL REGISTRATION: ISRCTN registry ISRCTN10956306.

A trial of intra-pleural bacterial immunotherapy in malignant pleural mesothelioma (TILT) - a randomised feasibility study using the trial within a cohort (TwiC) methodology.

BACKGROUND: Malignant pleural mesothelioma (MPM) is an aggressive thoracic malignancy with a poor prognosis. Systemic immunotherapy is an effective frontline treatment for MPM, and there is a scientific rationale supporting the possible efficacy of local, i.e. intra-pleural immune modulators. Trial of intra-pleural bacterial immunotherapy (TILT) investigated the feasibility of performing a randomised trial of intra-pleural bacterial immunotherapy in people with MPM, using the trials within cohorts (TwiC) methodology. METHODS: TILT was a multicentre, three-armed, randomised, feasibility TwiC of intra-pleural OK432, BCG, or usual care in people with MPM. Eligible participants were identified from within the ASSESS-meso study, a prospective, longitudinal, observational cohort study, and were randomly selected to be offered a single dose of OK432 or BCG, via an indwelling pleural catheter. The primary outcome was feasibility, evaluated against prespecified recruitment, attrition and data completeness targets. The acceptability of trial processes and interventions was assessed during qualitative interviews with participants and family members at the end of the trial. TILT was registered prospectively on the European Clinical Trials Registry (EudraCT number 2016-004,727-23) and the ISRCTN Register on 04 December 2017. RESULTS: Seven participants were randomised from a planned sample size of 12; thus, the 66% recruitment rate target was not met. Two participants withdrew after randomisation, breaching the pre-stated attrition threshold of 10%. It was not possible to maintain blinding of control participants, which negated a fundamental tenet of the TwiC design. The trial processes and methodology were generally acceptable to participants and relatives, despite several recipients of intra-pleural bacterial agents experiencing significant local and systemic inflammatory responses. CONCLUSION: It was possible to design a clinical trial of an investigational medicinal product based on the TwiC design and to obtain the necessary regulatory approvals. However, whilst acceptable to participants and relatives, the TwiC design was not a feasible method of investigating intra-pleural bacterial immunotherapy in people with MPM. Future trials investigating this topic should consider the eligibility constraints and recruitment difficulties encountered. TRIAL REGISTRATION: TILT was registered prospectively on the European Clinical Trials Registry (EudraCT number 2016-004727-23 ) and the ISRCTN Register ( 10432197 ) on 04 December 2017.

The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence.

We are currently in the midst of a sleep crisis. Our current work and lifestyle environments are normalizing poor sleep with substantial negative impact on our health. Research on sleep has linked sleep deprivation to poorer mental health, obesity, cancer, diabetes, heart disease, and a myriad of other health conditions. Sleep deprivation is an even greater issues for people with musculoskeletal conditions and chronic pain. Between 67% and 88% of individuals with chronic pain experience sleep disruption and insomnia, and at least 50% of people with insomnia report chronic pain. The link between sleep and pain is well documented. Experimental, cohort, and longitudinal studies have all demonstrated that restricted sleep is linked to greater pain. Poor sleep therefore not only affects general health but has a direct impact on inflammation, pain response, and experience. Improving sleep in people living with musculoskeletal conditions and with chronic pain has the potential to deliver great benefit to many. This article describes the evidence base that can underpin such work, including research about the link between pain and sleep as well as theories and approaches to intervention that may help. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Developing good practice indicators to assist mental health practitioners to converse with young people about their online activities and impact on mental health: a two-panel mixed-methods Delphi study.

BACKGROUND: Online activity has been linked to poor mental health in children and young people, particularly those with existing vulnerability who may inadvertently or otherwise access harmful content. It is suggested health and social care practitioners should address online activity during mental health consultations, but guidance about acceptable or effective ways to do this is lacking. This study sought to derive good practice guidance to support mental health practitioners to engage young people in conversations about their online activities and impact on mental health. METHODS: A mixed-methods Delphi (consensus) study was conducted with a panel of mental health practitioners (n = 21) and a panel of young people (n = 22). Practitioners worked with children or young adults in the UK, mostly in statutory services (80.9%), in varied clinical roles, with 2 - 30 years of experience and most were female (87.5%). Young people were mostly female (77.3%), 13-22 years old, reported varied mental health diagnoses and had sought help from services. Across 3 rounds, panellists completed questionnaires which involved rating agreement with statements and answering open-ended questions. Iterative analysis informed subsequent questionnaire content. The percentage of participants rating their level of agreement with each statement was calculated. The threshold for inclusion as a good practice indicator (GPI) was 75% across both panels. Thematic analysis was used for free-text data. RESULTS: Twenty-seven GPIs emerged covering 'who' (which young people) should be asked about online activities, 'when', 'what' should be discussed, and with what 'outcome'. Panels agreed conversations should be initiated with all young people from first meeting and regularly thereafter, with 'red flags' indicating a conversation may be pertinent. Core topics were identified with additional areas for patients presenting with disordered eating or self-harm. Panels emphasised conversations should be fluid, normalised, and encourage reflection and self-awareness. CONCLUSIONS: Mental health practitioners could empower young people to exercise agency in relation to online safety and capitalise on positive features. Findings also identify training needs for practitioners. Further research should explore real-world application of the GPIs and transferability to underrepresented groups within our panels, such as males and younger children. Ethnicity and deprivation were not recorded.

Primary care consultations and pain medicine prescriptions: a comparison between patients with and without chronic pain after total knee replacement.

BACKGROUND: Approximately 20% of patients experience chronic pain after total knee replacement (TKR). The impact of chronic pain after TKR on primary care services in the UK is currently unknown. The aim of this study was to compare primary care consultations and pain medicine prescriptions between patients with and without chronic pain after TKR. METHODS: Data from 5,055 patients who received TKR between 2009 and 2016 with anonymised linked data from the Clinical Practice Research Datalink Gold (CPRD) and English Hospital Episode Statistics (HES) Patient Reported Outcome Measures (PROMs) programme were analysed. The exposure time was from 10 years pre-operative to eight years post-operative. Patients with a score ≤ 14 on the Oxford Knee Score pain component scale at 6 months post-operative were classified as having chronic pain after TKR. Primary care consultations and prescribed pain medicines were quantified, and costs calculated based on national cost data. RESULTS: 721 patients (14%) had chronic pain after TKR. The prevalence and costs of primary care consultations and pain medicine prescriptions per year were consistently higher for patients with chronic pain after TKR compared with those without chronic pain after TKR; these differences were observed both before and after surgery. There was a substantial and sustained increase in the cost of opioid prescriptions after surgery for patients with chronic pain after TKR, peaking at seven years post-operative. CONCLUSIONS: Increased primary care consultations and pain medicine prescriptions associated with chronic pain after TKR represent a considerable financial cost to primary care services. Evaluation of interventions to reduce the risk of developing this pain condition and improve the early management of pain after TKR are needed to improve outcomes for patients and reduce costs to healthcare services.

Experiences of recovery and a new care pathway for people with pain after total knee replacement: qualitative research embedded in the STAR trial.

BACKGROUND: Approximately 20% of people experience chronic postsurgical pain after total knee replacement. The STAR randomised controlled trial (ISCRTN92545361) evaluated the clinical- and cost-effectiveness of a new multifaceted and personalised care pathway, compared with usual care, for people with pain at three months after total knee replacement. We report trial participants' experiences of postoperative pain and the acceptability of the STAR care pathway, which consisted of an assessment clinic at three months, and up to six follow-up telephone calls over 12 months. METHODS: Semi-structured interviews were conducted with 27 people (10 men, 17 women) between February 2018 and January 2020. Participants were sampled purposively from the care pathway intervention group and interviewed after completion of the final postoperative trial questionnaire at approximately 15 months after knee replacement. Interviews were audio-recorded, transcribed, anonymised and analysed using inductive thematic analysis. FINDINGS: Many participants were unprepared for the severity and impact of postoperative pain, which they described as extreme and constant and that tested their physical and mental endurance. Participants identified 'low points' during their recovery, triggered by stiffening, pain or swelling that caused feelings of anxiety, depression, and pain catastrophising. Participants described the STAR assessment clinic as something that seemed "perfectly normal" suggesting it was seamlessly integrated into NHS care. Even in the context of some ongoing pain, the STAR care pathway had provided a source of support and an opportunity to discuss concerns about their ongoing recovery. CONCLUSIONS: People who have knee replacement may be unprepared for the severity and impact of postoperative pain, and the hard work of recovery afterwards. This highlights the challenges of preparing patients for total knee replacement and suggests that clinical attention is needed if exercise and mobilising is painful beyond the three month postoperative period. The STAR care pathway is acceptable to people with pain after total knee replacement.