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.

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.

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.

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.

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.

The effectiveness of non-pharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis.

OBJECTIVE: About two thirds of people with chronic pain report problems sleeping. We aimed to evaluate the effectiveness of non-pharmacological sleep interventions for improving sleep in people with chronic pain. DESIGN: We conducted a systematic review of non-pharmacological and non-invasive interventions to improve sleep quality or duration for adults with chronic non-cancer pain evaluated in a randomised controlled trial. Our primary outcome of interest was sleep; secondary outcomes included pain, health-related quality of life, and psychological wellbeing. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO and CINAHL from inception to April 2020. After screening, two reviewers evaluated articles and extracted data. Meta-analysis was conducted using a random effects model. Risk of bias was assessed with the Cochrane tool. RESULTS: We included 42 trials involving 3346 people randomised to 94 groups, of which 56 received an intervention targeting sleep. 10 studies were of fair and 32 of good methodological quality. Overall risk of bias was judged to be low in 11, high in 10 and unclear in 21 studies. In 9 studies with 385 people randomised, cognitive behavioural therapy for insomnia showed benefit post-treatment compared with controls for improved sleep quality, standardised mean difference - 1.23 (95%CI -1.76, - 0.70; p < 0.00001). The effect size was only slightly reduced in meta-analysis of 3 studies at low risk of bias. The difference between groups was lower at 3 and 6 months after treatment but still favoured cognitive behavioural therapy for insomnia. Pain, anxiety and depression were reduced post-treatment, but evidence of longer term benefit was lacking. There was no evidence that sleep hygiene interventions were effective in improving sleep and there was some evidence in comparative studies to suggest that cognitive behavioural therapy for insomnia was more effective than sleep hygiene. Numerous other interventions were evaluated in small numbers of studies, but evidence was insufficient to draw conclusions about effectiveness. CONCLUSIONS: Cognitive behavioural therapy for insomnia is an effective treatment to improve sleep for people with chronic pain, but further high-quality primary research is required to explore combined CBT content that will ensure additional improvements to pain, quality of life and psychological health and longer-term maintenance of benefits. Primary research is also needed to evaluate the effectiveness of interventions for which insufficient evidence exists. TRIAL REGISTRATION: PROSPERO registration number: CRD42019093799 .

Progression of chronic pain and associated health-related quality of life and healthcare resource use over 5 years after total knee replacement: evidence from a cohort study.

OBJECTIVE: As part of the STAR Programme, a comprehensive study exploring long-term pain after surgery, we investigated how pain and function, health-related quality of life (HRQL), and healthcare resource use evolved over 5 years after total knee replacement (TKR) for those with and without chronic pain 1 year after their primary surgery. METHODS: We used data from the Clinical Outcomes in Arthroplasty Study prospective cohort study, which followed patients undergoing TKR from two English hospitals for 5 years. Chronic pain was defined using the Oxford Knee Score Pain Subscale (OKS-PS) where participants reporting a score of 14 or lower were classified as having chronic pain 1-year postsurgery. Pain and function were measured with the OKS, HRQL using the EuroQoL-5 Dimension, resource use from yearly questionnaires, and costs estimated from a healthcare system perspective. We analysed the changes in OKS-PS, HRQL and resource use over a 5-year follow-up period. Multiple imputation accounted for missing data. RESULTS: Chronic pain was reported in 70/552 operated knees (12.7%) 1 year after surgery. The chronic pain group had worse pain, function and HRQL presurgery and postsurgery than the non-chronic pain group. Those without chronic pain markedly improved right after surgery, then plateaued. Those with chronic pain improved slowly but steadily. Participants with chronic pain reported greater healthcare resource use and costs than those without, especially 1 year after surgery, and mostly from hospital readmissions. 64.7% of those in chronic pain recovered during the following 4 years, while 30.9% fluctuated in and out of chronic pain. CONCLUSION: Although TKR is often highly beneficial, some patients experienced chronic pain postsurgery. Although many fluctuated in their pain levels and most recovered over time, identifying people most likely to have chronic pain and supporting their recovery would benefit patients and healthcare systems.

The priorities of people with mesothelioma and their carers: A qualitative interview study of trial participation and treatment decisions.

PURPOSE: Treatment options for mesothelioma are increasing, as are the number of clinical trials available to patients. However, little is known about patients' and relatives' priorities when making decisions about treatment and trial participation. The aim of this study was to provide insight into people's experiences of participating in clinical research and explore the factors influencing decision-making. METHODS: Face to face, semi-structured interviews were undertaken with mesothelioma patients who were participating in the TILT trial (a randomised trial of intra-pleural immunotherapy) and their relatives. Interviews were audio-recorded, transcribed and analysed thematically. RESULTS: Twelve people were interviewed, comprising five mesothelioma patients and seven relatives. Four themes were identified relating to the experience of mesothelioma: physicality, quality of life, uncertainty and risk, and planning for an unpredictable future. A further theme related to attitudes to research participation. PARTICIPANTS: valued physical strength and were careful not to jeopardise this with potential side effects of medication. Quality of life was important and was often prioritised over survival. Participants found ambiguity challenging and sought certainty, potentially in response to the uncertainty surrounding their future. The desire for certainty impacted on risk perception; an important factor in decision-making. Relatives often advocated on behalf of patients and were more reluctant about research participation due to concern about potential risks. CONCLUSION: The study confirmed previous qualitative findings around physicality, stoicism and uncertainty, building on these themes to highlight their influence on decision-making. Important findings for practice include the challenges associated with risk communication and the differing care needs and attitudes to research of relatives.

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial.

BACKGROUND: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. METHODS: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. FINDINGS: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was -0·65 (95% CI -1·17 to -0·13; p=0·014) and the mean between-group difference in the BPI interference score was -0·68 (-1·29 to -0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. INTERPRETATION: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. FUNDING: National Institute for Health Research.

Screening to Identify Postoperative Pain and Cross-Sectional Associations Between Factors Identified in This Process With Pain and Function, Three Months After Total Knee Replacement.

OBJECTIVE: To describe the screening and recruitment process of a randomized trial and evaluate associations with knee pain and function 3 months after total knee replacement (TKR). METHODS: In order to screen for a multicenter trial, a total of 5,036 patients were sent the Oxford Knee Score (OKS) questionnaire 10 weeks post-TKR. Patients who reported pain in their replaced knee (score of ≤14 on the OKS pain component) completed a second OKS questionnaire 12 weeks post-TKR. Those patients who were still experiencing pain 12 weeks post-TKR completed a detailed questionnaire 13 weeks post-TKR. These data were used to characterize pain in a cross-sectional analysis. Multivariable regression was performed in order to identify factors associated with pain and function at 13 weeks post-TKR. RESULTS: We received OKS questionnaires from 3,058 of 5,063 TKR patients (60%), and 907 of the 3,058 (30%) reported pain in their replaced knee 10 weeks post-TKR. By 12 weeks, 179 of 553 patients (32%) reported improved pain (score of >14 on the OKS pain component). At 13 weeks, 192 of 363 patients (53%) who completed a detailed questionnaire reported neuropathic pain, 94 of 362 (26%) reported depression symptoms, and 95 of 363 (26%) anxiety symptoms. More severe pain at 13 weeks postoperatively was associated with poorer general health, poorer physical health, more pain worry, and lower satisfaction with surgery outcome. More severe functional limitation was associated with higher levels of depression, more pain worry, lower satisfaction with surgery outcome, and higher pain acceptance. CONCLUSION: Screening after TKR identified individuals with pain. We identified several potential targets (physical and mental health outcomes, acceptance of pain, and quality of life) for tailored intervention to improve outcomes for patients. Future trials of multidisciplinary interventions warranted.

"It's Not My Knee": Understanding Ongoing Pain and Discomfort After Total Knee Replacement Through Re-Embodiment.

OBJECTIVE: Up to 20% of people who undergo total knee replacement surgery have ongoing pain and discomfort. The aim of this study was to understand what role the concepts of embodiment (of both having a body and experiencing the world through one's body) and incorporation (integrating something into one's body) might have in understanding experiences of pain and discomfort after total knee replacement. METHODS: We conducted semistructured interviews with 34 people who had received total knee replacement at either of 2 National Health Service hospitals in the UK, and who had chronic postsurgical pain (n = 34, ages 55-93 years). Data were audiorecorded, transcribed, and analyzed thematically. RESULTS: Two main themes were identified: 1) when describing chronic postsurgical pain, some participants also described sensations of discomfort, including heaviness, numbness, pressure, and tightness associated with the prosthesis; 2) participants reported a lack of felt connection with and agency over their replaced knee, often describing it as alien or other, and lacked confidence in the knee. CONCLUSION: Participants' experiences indicate that some people do not achieve full incorporation of the prosthesis. Our study emphasizes the importance of physicians treating patients as whole people and moving beyond clinical and procedural ideas of success. Our findings suggest that to optimize postoperative outcomes, rehabilitation must focus not only on strengthening the joint and promoting full recovery to tasks but on modifying a person's relationship to the new joint and managing sensations of otherness to achieve full incorporation of the joint or re-embodiment.

Risk factors associated with poor pain outcomes following primary knee replacement surgery: Analysis of data from the clinical practice research datalink, hospital episode statistics and patient reported outcomes as part of the STAR research programme.

OBJECTIVE: Identify risk factors for poor pain outcomes six months after primary knee replacement surgery. METHODS: Observational cohort study on patients receiving primary knee replacement from the UK Clinical Practice Research Datalink, Hospital Episode Statistics and Patient Reported Outcomes. A wide range of variables routinely collected in primary and secondary care were identified as potential predictors of worsening or only minor improvement in pain, based on the Oxford Knee Score pain subscale. Results are presented as relative risk ratios and adjusted risk differences (ARD) by fitting a generalized linear model with a binomial error structure and log link function. RESULTS: Information was available for 4,750 patients from 2009 to 2016, with a mean age of 69, of whom 56.1% were female. 10.4% of patients had poor pain outcomes. The strongest effects were seen for pre-operative factors: mild knee pain symptoms at the time of surgery (ARD 18.2% (95% Confidence Interval 13.6, 22.8), smoking 12.0% (95% CI:7.3, 16.6), living in the most deprived areas 5.6% (95% CI:2.3, 9.0) and obesity class II 6.3% (95% CI:3.0, 9.7). Important risk factors with more moderate effects included a history of previous knee arthroscopy surgery 4.6% (95% CI:2.5, 6.6), and use of opioids 3.4% (95% CI:1.4, 5.3) within three months after surgery. Those patients with worsening pain state change had more complications by 3 months (11.8% among those in a worse pain state vs. 2.7% with the same pain state). CONCLUSIONS: We quantified the relative importance of individual risk factors including mild pre-operative pain, smoking, deprivation, obesity and opioid use in terms of the absolute proportions of patients achieving poor pain outcomes. These findings will support development of interventions to reduce the numbers of patients who have poor pain outcomes.

Post-operative determinants of chronic pain after primary knee replacement surgery: Analysis of data on 258,386 patients from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR).

Objective: To identify post-operative risk factors for the development of chronic pain after knee replacement. Design: Primary knee replacements in persons aged ≥18 years between April 2008 and December 2016 from the National Joint Registry, linked with English Hospital Episode Statistics data, and Patient Reported Outcome Measures. The outcome was chronic pain 6-months after surgery (Oxford Knee pain score). Logistic regression modelling identified risk factors for chronic pain outcome. Results: 258,386 patients; 56.7% women; average age 70.1 years (SD â€‹± â€‹8.8 years). 43,702 (16.9%) were identified as having chronic pain 6-months post-surgery. Within 3 months of surgery complications were uncommon: intra-operative complications 1224 (0.5%); ≥1 medical complication 6073 (2.4%)); 32,930 (12.7%) hospital readmissions; 3848 (1.5%) re-operation; 835 (0.3%) revision. Post-surgical risk factors of chronic pain were: mechanical complication of prosthesis odds ratio (OR) 1.56 (95% Confidence Interval 1.35, 1.80); surgical site infection OR 1.13 (0.99, 1.29); readmission OR 1.47 (1.42, 1.52); re-operation OR 1.39 (1.27, 1.51); revision OR 1.92 (1.64, 2.25); length of stay e.g. 6+ vs. <2 days OR 1.48 (1.35, 1.63), blood transfusion OR 0.47 (0.26, 0.86) and myocardial infarction OR 0.69 (0.49, 0.97). Discriminatory ability of the model was only fair (c-statistic 0.71) indicating that post-surgical predictors explain a limited amount of variability in chronic pain. Conclusions: We identified a number of post-operative factors relating to the operation and early recovery that are associated with chronic pain following primary knee replacement. The model had weak discriminatory ability indicating that there remains considerable unexplained variability in chronic pain outcome.

Post-surgery and recovery experiences following one- and two-stage revision for prosthetic joint infection-A qualitative study of patients' experiences.

Deep prosthetic hip infection is a devastating complication of hip replacement surgery, and treatment often involves multiple revision surgeries with antibiotic chemotherapy to control the infection. The aim of this study was to explore patients' experiences of early and longer-term recovery after one-stage or two-stage revision with an excised hip, a temporary cement spacer or a custom-made articulating spacer. We interviewed 32 participants taking part in a surgical trial at two time points (2-4 months and 18 months) following one- or two-stage revision surgery. The analytic approach was inductive using the constant comparative method to generate themes from the data. Participants' early recovery after revision was characterised by a long hospital stay with burdensome antibiotics and limited physiotherapy provision. Participants undergoing two-stage revision with an excised hip or a cement spacer described severe mobility restrictions which affected all aspects of their lives, while those undergoing one-stage revision, or two-stage revision with an articulating spacer were more mobile and independent, with some limitations. Participants with a cement spacer also reported more pain than other treatment groups, while those with an articulating spacer appeared to perceive that their recovery was slow. At 18 months, participants in all groups described both improvements and losses in mobility and functional ability. Participants in all treatment groups expressed considerable emotional resilience during recovery from revision, which may be linked to opportunities to talk with the trial personnel. Participants identified the need for better information and psychological and physical support. Experience of recovery differs after one- and two-stage revision, and further in relation to the use of spacers. Mobility, function, independence and pain are important aspects of recovery which affect all aspects of day-to-day life. Increased information and more opportunities to talk and share experiences may provide psychological support during recovery.

Why don't patients seek help for chronic post-surgical pain after knee replacement? A qualitative investigation.

BACKGROUND: Although many people are satisfied with their outcome after total knee replacement surgery for osteoarthritis, around 20% report chronic post-surgical pain. People are often disappointed and unsure about whether their pain is normal and what can be done about it. Given the high prevalence of long-term post-operative pain after knee replacement, there is potentially a large hidden population with an unaddressed need for care. OBJECTIVE: In this study, we focus on understanding why some people choose not to consult health care for chronic post-surgical pain after knee replacement. METHODS: Semi-structured interviews were conducted with people who had received total knee replacement, at either of two National Health Service hospitals in the United Kingdom, and who had chronic post-surgical pain (n = 34, age 55-93 years). Data were audio-recorded, transcribed and analysed thematically. RESULTS: We found an overall sense of futility amongst participants who believed that nothing further could be done for their on-going pain. People's perception of their pain was often discordant with that of surgeons and physicians. Other factors that contributed to decisions not to seek help included low expectations about effectiveness and the risks involved in further treatment, treatment burden, participants' prioritization of other health conditions and views about candidacy. Many accepted their on-going pain. CONCLUSION: Our study indicates why some people with chronic pain after knee replacement do not seek further health care. Understanding patients' beliefs and expectations about chronic post-surgical pain can inform approaches that might enable people to seek help in the future.

What are patients' preferences for revision surgery after periprosthetic joint infection? A discrete choice experiment.

OBJECTIVES: Understanding patients' preferences for treatment is crucial to provision of good care and shared decisions, especially when more than one treatment option exists for a given condition. One such condition is infection of the area around the prosthesis after hip replacement, which affects between 0.4% and 3% of patients. There is more than one treatment option for this major complication, and our study aimed to assess the value that patients place on aspects of revision surgery for periprosthetic hip infection. DESIGN: We identified four attributes of revision surgery for periprosthetic hip infection. Using a discrete choice experiment (DCE), we measured the value placed on each attribute by 57 people who had undergone either one-stage or two-stage revision surgery for infection. SETTING: The DCE was conducted with participants from nine National Health Service hospitals in the UK. PARTICIPANTS: Adults who had undergone revision surgery for periprosthetic hip infection (N=57). RESULTS: Overall, the strongest preference was for a surgical option that resulted in no restrictions on engaging in valued activities after a new hip is fitted (ß=0.7). Less valued but still important attributes included a shorter time taken from the start of treatment to return to normal activities (6 months; ß=0.3), few or no side effects from antibiotics (ß=0.2), and having only one operation (ß=0.2). CONCLUSIONS: The results highlight that people who have had revision surgery for periprosthetic hip infection most value aspects of care that affect their ability to engage in normal everyday activities. These were the most important characteristics in decisions about revision surgery.

Home health monitoring around the time of surgery: qualitative study of patients' experiences before and after joint replacement.

OBJECTIVES: Hip and knee replacements are common major elective surgical interventions with over 200 000 performed annually in the UK. Not all patients achieve optimal outcomes or experience problems or delays in recovery. The number of patients needing these operations is set to increase, and routine clinical monitoring is time-consuming and resource-consuming for patients and healthcare providers; therefore, innovative evaluation of surgical outcomes is needed. The aim of this qualitative study was to capture the patient experience of living with a novel home monitoring sensing system during the period around joint replacement. SETTING: One secondary care hospital in the South West, UK. PARTICIPANTS: 13 patients (8 female, 63-89 years) undergoing total hip or knee replacement enrolled into the study. DESIGN: Qualitative study with thematic analysis. The system remained in situ for up to 12 weeks after their surgery and comprised a group of low-powered sensors monitoring the environment (temperature, light and humidity) and activity of people within the home. Patients were interviewed at two timepoints: before and after surgery. Interviews explored views about living with the technology, its acceptability, as well as attitudes towards health technology. RESULTS: Three main themes emerged: installation of home-sensing technology on the journey to surgery, the home space and defining unobtrusiveness and pivotal role of social support networks. CONCLUSIONS: Patients who agreed to the technology found living with it acceptable. A home-sensing system that monitors the environment and activity of the people in the home could provide an innovative way of assessing patients' surgical outcomes. At a time characterised by reduced mobility, functional limitations and increased pain, patients in this study relied on informal and formal supportive networks to help maintain the system through the busy trajectory of the perioperative period.