Nurse-led care for people with early rheumatoid arthritis: Interview study with thematic analysis.

AIMS: To develop an understanding of what comprises nurse-led care in early rheumatoid arthritis from the perspective of rheumatology nurse specialists in England. DESIGN: Qualitative study. METHODS: Semi-structured telephone interviews with rheumatology nurse specialists in England were conducted in Summer 2020. Interviews were audio-recorded, transcribed verbatim and analysed using reflexive thematic analysis. Reporting follows the appropriate elements of consolidated criteria for reporting qualitative research. RESULTS: Sixteen nurses were recruited and interviews lasted 30-60 min. Four themes with 14 subthemes were identified. A SPECIALIST SERVICE DELIVERED BY EXPERIENCED RHEUMATOLOGY NURSES: Specialist care is provided by experienced nurse specialists with a high degree of autonomy in the rheumatology multidisciplinary team context. ADDRESSING PATIENTS' COMPLEX CARE NEEDS: Care is evidence-based and aims to start treatment, keep in treatment, educate and support. Access to psychology expertise is needed. CARE WITH COMPASSION USING PERSON-CENTRED, HOLISTIC AND EMPATHETIC APPROACHES: Nurses create patient relationships and a positive therapeutic environment. Nurse-led telephone advice lines are essential for treatment adjustment, patient support and empowerment. CONTINUED EVALUATION AND DEVELOPMENT OF THE SERVICE: Consultations are reviewed, and patients are asked for feedback. The COVID-19 pandemic caused disruption, but changes streamlined procedures and improved documentation and communication. CONCLUSION: Nurse-led care in early rheumatoid arthritis is a specialist service delivered with compassion, addressing complex care needs and using person-centred approaches. This study identifies key aspects of care in early disease from the nurse perspective.

Systematic co-development and testing of a digital behaviour change intervention for osteoarthritis and physical activity: Theoretical mapping and acceptability study.

Objective: Osteoarthritis (OA) affects 8.75 million people in the UK. Physical activity (PA) is recommended as a core treatment, yet nearly half of people with OA are inactive. Accessible and user-friendly interventions are needed to motivate people with OA to be active. Digital behaviour change interventions (DBCIs) might help to support people with OA to self-manage their own levels of PA. The aim of this project was to co-develop and test a DBCI to motivate people with OA to be active. Methods: A mixed methods design was adopted to build the theoretical foundations, develop, and test a complex DBCI. Two patient research partners with lived experience of OA were recruited onto the project team to assist with intervention development, which was guided by the intervention mapping (IM) approach. Interviews and think-aloud sessions were then used to explore attitudes, values, and perceived effectiveness of the website. Results: The IM approach enabled the development of a prototype website to be illustrated in a clear and transparent way, showing a link between the practical materials adopted within the website and the theoretical constructs they were attempting to change. Potential users highlighted the importance of clear, easy-to-understand information, focusing on enjoyment and social connectedness. Conclusions: DBCI development should be based on theory, adequately described, and thoroughly tested with potential users to understand how they might choose to integrate digital interventions into everyday life.

Is there a role for citizen science in death and dying research?

The COVID-19 pandemic has brought conversations about death and dying to the fore in a way not experienced for generations. This raises questions around perceptions of death and dying; the role of healthcare and the community in care; and the use of digital media for information and support. Public engagement can provoke a two-way conversation between researchers and the public and includes techniques that can engage the community not only with the topic but also in research. This perspective article considers the potential role of citizen science in death and dying research, including considerations around its potential benefits and constraints.

Sensory training system for use at home by people with complex regional pain syndrome in England: protocol for a proof-of-concept study.

INTRODUCTION: Complex regional pain syndrome (CRPS) is a disabling and distressing chronic pain condition characterised by a range of sensory, motor, autonomic and trophic symptoms. UK guidelines recommend therapy interventions to help normalise touch perception through self-administered tactile and thermal desensitisation activities. Interventions have been developed, aiming to help individuals broaden their sensory experience, thereby relieving chronic pain. However, therapy-led interventions often experience practical constraints and poor adherence. In response, a sensory training system (STS) device has been designed for unsupervised independent home-use. METHODS: This proof-of-concept study aims to explore whether people with CRPS use the device at home for 30 minutes a day for 30 days. Secondary aims are to determine whether the STS device will change tactile acuity and perceived levels of pain intensity, pain interference, sensitivity or feelings towards the affected limb. We will seek to recruit 20 eligible participants. Participants will be asked to measure tactile acuity using a two-point discrimination assessment, complete an online questionnaire before and after use of the device and complete a daily diary. On completion of the 30-day use, participants will be invited to take part in a semi-structured interview to explore their experiences of using the device. ANALYSIS: Pain intensity and pain interference will be scored using the online Assessment Center Scoring Service or using the look-up table in the PROMIS scoring manual. The remaining questionnaire data, including tactile acuity results, and device-use data, including frequency and duration of use, will be analysed using descriptive statistics. Qualitative data will be thematically analysed. ETHICS AND DISSEMINATION: London-Stanmore Research Ethics Committee provided a favourable opinion on 19 April 2021 (ref 21/LO/0200). The NHS Health Research Authority, UK, approved this study on 7 June 2021. Dissemination will include peer-reviewed publications, presentations at conferences, social media and reports to the funder and patient charities. TRIAL REGISTRATION NUMBER: ISRCTN89099843.

Hospital practitioner views on the benefits of continence education and best ways to provide training.

AIM: The aim of the study was to explore practitioners' experiences and perspectives on continence training, in order to understand its relevance to practice and how take-up of, and engagement with, such training may be improved. DESIGN: 27 qualitative interviews were conducted with nursing, medical and allied health practitioners in three hospitals. METHODS: We analysed data thematically, both manually and with the aid of NVivo software. The research adheres to the consolidated criteria for reporting qualitative research checklist. RESULTS: Practitioners asserted the likely benefits of evidence-based continence training, including more judicious use of products, reduction in associated infection, better patient skin care and more facilitative communication with patients. Practitioners also identified preferred methods of continence training, according to their role and workload. To ensure better take-up of, and engagement with, continence training, it must be authorized as essential and provided in ways that reflect professional preferences and pragmatic resource considerations.

Prognostic factors for persistent pain after a distal radius fracture: a systematic review.

Introduction: The aim of this systematic review was to synthesize the evidence regarding prognostic factors for persistent pain, including Complex Regional Pain Syndrome (CRPS), after a distal radius fracture (DRF), a common condition after which persistent pain can develop. Methods: Medline, Pubmed, Embase, Psychinfo, CINAHL, BNI, AMED and the Cochrane Register of Clinical Trials were searched from inception to May 2021 for prospective longitudinal prognostic factor studies investigating persistent pain in adults who had sustained a DRF. The Quality in Prognostic Studies (QUIPS) tool and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework were used to assess the strength of evidence. Results: A search yielded 440 studies of which 7 studies met full eligibility criteria. From five studies we found low evidence for high baseline pain or an ulnar styloid fracture as prognostic factors for persistent pain, and very low evidence for diabetes or older age. From two studies, investigating an outcome of CRPS, there was low evidence for high baseline pain, slow reaction time, dysynchiria, swelling and catastrophising as prognostic factors, and very low evidence for depression. Sex was found not to be a prognostic factor for CRPS or persistent pain. Conclusions: The associations between prognostic factors and persistent pain following a DRF are unclear. The small number of factors investigated in more than one study, along with poor reporting and methodological limitations contributed to an assessment of low to very low strength of evidence. Further prospective studies, investigating psychosocial factors as candidate predictors of multidimensional pain outcomes are recommended.

Florence Nightingale's legacy for clinical academics: A framework analysis of a clinical professorial network and a model for clinical academia.

BACKGROUND: Clinical academic nursing roles are rare, and clinical academic leadership positions even more scarce. Amongst the United Kingdom (UK) academia, only 3% of nurses who are employed within universities are clinically active. Furthermore, access to research fellowships and research grant funding for nurses in clinical or academic practice is also limited. The work of Florence Nightingale, the original role model for clinical academic nursing, is discussed in terms of how this has shaped and influenced that of clinical academic nurse leaders in modern UK healthcare settings. We analysed case studies with a view to providing exemplars and informing a new model by which to visualise a trajectory of clinical academic careers. METHODS: A Framework analysis of seven exemplar cases was conducted for a network of Clinical Academic Nursing Professors (n = 7), using a structured template. Independent analysis highlighted shared features of the roles: (a) model of clinical academic practice, (b) infrastructure for the post, (c) capacity-building initiatives, (d) strategic influence, (e) wider influence, (f) local and national implementation initiatives, (g) research area and focus and (h) impact and contribution. FINDINGS: All seven of the professors of nursing involved in this discourse were based in both universities and healthcare organisations in an equal split. All had national and international profiles in their specialist clinical areas and were implementing innovation in their clinical and teaching settings through boundary spanning. We outline a model for career trajectories in clinical academia, and how leadership is crucial. CONCLUSION: The model outlined emphasises the different stages of clinical academic roles in nursing. Nursing as a discipline needs to embrace the value of these roles, which have great potential to raise the standards of healthcare and the status of the profession.

'We tend to get pad happy': a qualitative study of health practitioners' perspectives on the quality of continence care for older people in hospital.

BACKGROUND: Bladder and bowel control difficulties affect 20% and 10% of the UK population, respectively, touch all age groups and are particularly prevalent in the older (65+ years) population. However, the quality of continence care is often poor, compromising patient health and well-being, increasing the risk of infection, and is a predisposing factor to nursing and residential home placement. OBJECTIVE: To identify factors that help or hinder good continence care for patients aged 65 years and over in hospital medical ward settings. Medical care, not surgical, was our exclusive focus. METHODS: We conducted 27 qualitative interviews with nursing, medical and allied health practitioners in three hospitals. We used a purposive sample and analysed data thematically, both manually and with the aid of NVivo software. RESULTS: Interviews revealed perspectives on practice promoting or inhibiting good quality continence care, as well as suggestions for improvements. Good continence care was said to be advanced through person-centred care, robust assessment and monitoring, and a proactive approach to encouraging patient independence. Barriers to quality care centred on lack of oversight, automatic use of incontinence products and staffing pressures. Suggested improvements centred on participatory care, open communication and care planning with a higher bladder and bowel health profile. In order to drive such improvements, hospital-based practitioners indicate a need and desire for regular continence care training. CONCLUSIONS: Findings help explain the persistence of barriers to providing good quality care for patients aged 65 years and over with incontinence. Resolute continence promotion, in hospitals and throughout the National Health Service, would reduce reliance on products and the accompanying risks of patient dependency and catheter-associated gram-negative bacteraemia. Robust assessment and care planning, open communication and regular continence care training would assist such promotion and also help mitigate resource limitations by developing safer, time-efficient continence care.

The patient perspective of nurse-led care in early rheumatoid arthritis: A systematic review of qualitative studies with thematic analysis.

INTRODUCTION: Management of rheumatoid arthritis has changed dramatically over the last decade and is characterised by early start of intensive treatment and tight monitoring of disease activity until remission. The role of nurse-led care at early stage of disease is not well understood. AIMS: To develop an understanding of rheumatology nurse-led care from the perspective of patients with early rheumatoid arthritis. METHODS: A systematic review of qualitative studies, reported in line with PRISMA checklist. In March 2019, the following databases were searched: MEDLINE, EMBASE, CINAHL, PsycINFO and OpenGrey. Studies were included if they: included adults with rheumatoid arthritis; were qualitative studies with data on patients' perspectives of nurse-led care; and published in peer-reviewed journals, in English, between 2010-2019. Due to few studies in early rheumatoid arthritis, inclusion was extended to adults with established rheumatoid arthritis. Two reviewers screened abstracts and full texts. Joanna Briggs Institute Critical Appraisal Tool was used for quality assessment. Thematic synthesis was conducted according to the framework of Thomas and Harden (2008). RESULTS: The search identified 1034 records. After screening and assessing for eligibility, eight qualitative studies were included in the review (133 patients). Three themes were identified from the synthesis. Nurse-led care was seen to provide professional expertise in planning and delivery of care. A person-centred approach was used combined with good communication skills, thus creating a positive therapeutic environment. Nurse-led care was described as providing a sense of empowerment and psychological support. CONCLUSION: Patients with rheumatoid arthritis are supportive of nurse-led care. They value its professionalism and person-centred approach which provide a sense of security and confidence. RELEVANCE TO CLINICAL PRACTICE: The findings outline ingredients of nurse-led care that are important to patients. These can inform nurses' professional development plans, service improvement and the competence framework for rheumatology nursing.

Beliefs, motives and gains associated with physical activity in people with osteoarthritis.

OBJECTIVES: Osteoarthritis (OA) affects approximately 8.75 million people in the United Kingdom. Physical activity is recommended as a core treatment, yet 44% of people with OA are inactive. Motivation and self-efficacy for exercise are considered to be key factors contributing to sustained engagement with physical activity. The aim of this study was to explore the beliefs, motives (what an individual aims to attain through participating in physical activity) and gains (what people feel they might get from participation) associated with physical activity engagement in a group of people with OA. DESIGN AND METHOD: This study adopted a cross-sectional survey research design, using two validated questionnaires: the Exercise Motives and Gains Inventory and the Exercise Self-Efficacy Scale. RESULTS: Data were gathered from 262 people with OA between August 2015 and January 2016. Those who were most active reported higher levels of both motivation and self-efficacy and were active for enjoyment, to avoid negative health, and for health and fitness reasons. A comparison of motives and gains revealed higher gain scores for social engagement and enjoyment, compared with associated motive scores. CONCLUSION: This study provides evidence of the central role that motives, gains and self-efficacy play in facilitating engagement with physical activity in this population. Future interventions should aim to foster increased self-efficacy for physical activity and promote autonomous forms of motivation by emphasising the importance of choosing activities which are enjoyable, as well as highlighting the value of social engagement.

Management of hemiplegic shoulder pain: A UK-wide online survey of physiotherapy and occupational therapy practice.

PURPOSE: The purpose of this study was to explore, via an online survey, how therapists assess, diagnose and manage hemiplegic shoulder pain (HSP) in the United Kingdom. The objectives were to explore (1) how therapists assessed HSP, (2) what the aims of therapy were, (3) what interventions therapists used, (4) what outcome measures therapists used, (5) what training of HSP therapists had, and (6) what barriers therapists experienced in the management of HSP. METHODS: An online survey was distributed to physiotherapists (PTs) and occupational therapists (OTs) working in stroke rehabilitation via professional bodies' interest groups. RESULTS: Sixty-seven responses were received: 40 (60%) were PTs and 27 (40%) were OTs. Therapists routinely screened for HSP (n = 59, 89%). When HSP was assessed, 33 (50%) spent <10 min and 34 (50%) spent >10 min on assessment. Patient-reported pain was used for assessment of HSP by 66 (99%) of respondents. Frequent interventions included positioning (n = 62, 94%), posture re-education (n = 57, 86%), and range of motion exercises (n = 55, 83%). Range of movement was used as an outcome measure by 31 (47%). Sixty (91%) respondents reported receiving training in HSP management. Time constraints (n = 41, 62%) and lack of diagnosis of HSP (n = 33, 54%) were identified as barriers to providing appropriate care to people with HSP CONCLUSION: Study findings showed varied practice in the assessment and treatment for HSP and indicate that time constraints are a considerable barrier to the management of these patients. Further research is required to establish best practice which may help improve outcomes and care for people with poststroke shoulder pain.

What are the holistic experiences of adults living long-term with the consequences of cancer and its treatment? A qualitative evidence synthesis.

PURPOSE: The number of people living with and beyond cancer is increasing; a significant number of these people will experience the long-term and late effects of cancer and its treatment. Research into this group has been identified as a priority to better understand healthcare needs. This review identified and synthesised qualitative research data relating to the lived experience of the consequences of cancer and its treatment. METHODS: A systematic search via electronic databases was conducted in July 2019. Literature was identified that explored the experience of adults living beyond cancer from their own perspective. Thematic synthesis was used to extract and analyse data. RESULTS: Six articles were reviewed. Three main themes were identified with four subthemes:1. Living with an altered sense of self; 2. Things are never going to be quite the same again (2.1. The unexpected. 2.2 The uncertain.); 3. Ways of coping with the unexpected and the uncertain. (3.1. Drawing on internal resilience. 3.2. The influence and impact of external relationships.). The findings showed that the participants' world-view changed after cancer and this affected everyday lives both positively and negatively. CONCLUSIONS: The experience of having had cancer remains significant long after diagnosis and treatment, yet effective preparation and ongoing support for living beyond cancer is lacking. The experience of living long-term after cancer is characterised by an altered sense of self and has implications for long-term wellbeing. Further research should explore healthcare needs and services required to adequately meet the needs of this growing group of people.

Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target.

INTRODUCTION: Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail. METHODS: Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we have identified recruitment and retention strategies for successful trial conduct. RESULTS: We present 13 strategies grouped across the categories of 'setting the recruitment rate', 'networking', 'patient information', 'trial management' and 'patient retention'. Moreover, six recruitment risks are also discussed. A conservative recruitment estimate, based on audits of newly referred patients to the trial centres without taking into account availability of 'old' patients or recruitment from outside centres, and assuming a 55% patient refusal rate yielded accurate numbers. CONCLUSION: Appreciation of these identified recruitment challenges and opportunities may contribute to supporting prospective investigators when they design clinical trials for chronic pain patient population groups where it has been historically difficult to conduct high-quality and robust clinical trials.

Sensory Function and Pain Experience in Arthritis, Complex Regional Pain Syndrome, Fibromyalgia Syndrome, and Pain-Free Volunteers: A Cross-Sectional Study.

OBJECTIVES: This study aimed to identify relationships between sensory function and pain in 3 common pain conditions (arthritis, Complex Regional Pain Syndrome [CRPS] and fibromyalgia syndrome [FMS]) and pain-free participants. Sensory abnormalities are known to be concomitant with some types of chronic pain but comparison across pain conditions using existing research is difficult due to methodological differences. Pragmatic Quantitative Sensory Testing (QST) methods were used. MATERIALS AND METHODS: Hot and cold sensitivity, light touch threshold (LTT), two-point discrimination and pain threshold were assessed in 143 participants (n=37 pain-free, n=34 arthritis, n=36 CRPS, n=36 FMS). Outcomes were assessed in the index ("affected" or right) and contralateral arm. Participants also completed the Brief Pain Inventory and the McGill Pain Questionnaire. RESULTS: There were statistically significant differences between groups for all QST outcomes except two-point discrimination. Relative to pain-free participants, FMS displayed heat hyperesthesia in both arms and cold hyperesthesia in the contralateral arm. CRPS demonstrated no changes in thermal sensitivity. Both CRPS and FMS exhibited bilateral pressure hyperalgesia. LTT hypoesthesia was observed bilaterally for CRPS but only in the contralateral arm for FMS. CRPS and FMS had pressure hyperalgesia in the index arm relative to arthritis patients. There were no differences between arthritis and pain-free participants for any QST outcome. In CRPS, there were significant correlations between LTT and pain outcomes bilaterally. DISCUSSION: People with FMS and CRPS demonstrate extensive sensory dysfunction. Arthritis patients had sensory profiles closer to pain-free participants. LTT may provide a clinically relevant and accessible assessment for CRPS.

Standards for the diagnosis and management of complex regional pain syndrome: Results of a European Pain Federation task force.

BACKGROUND: Complex regional pain syndrome is a painful and disabling post-traumatic primary pain disorder. Acute and chronic complex regional pain syndrome (CRPS) are major clinical challenges. In Europe, progress is hampered by significant heterogeneity in clinical practice. We sought to establish standards for the diagnosis and management of CRPS. METHODS: The European Pain Federation established a pan-European task force of experts in CRPS who followed a four-stage consensus challenge process to produce mandatory quality standards worded as grammatically imperative (must-do) statements. RESULTS: We developed 17 standards in 8 areas of care. There are 2 standards in diagnosis, 1 in multidisciplinary care, 1 in assessment, 3 for care pathways, 1 in information and education, 4 in pain management, 3 in physical rehabilitation and 2 on distress management. The standards are presented and summarized, and their generation and consequences were discussed. Also presented are domains of practice for which no agreement on a standard could be reached. Areas of research needed to improve the validity and uptake of these standards are discussed. CONCLUSION: The European Pain Federation task force present 17 standards of the diagnosis and management of CRPS for use in Europe. These are considered achievable for most countries and aspirational for a minority of countries depending on their healthcare resource and structures. SIGNIFICANCE: This position statement summarizes expert opinion on acceptable standards for CRPS care in Europe.

Cost-utility of maintained physical activity and physiotherapy in the management of distal arm pain: an economic evaluation of data from a randomized controlled trial.

BACKGROUND: Arm pain is common, costly to health services and society. Physiotherapy referral is standard management, and while awaiting treatment, advice is often given to rest, but the evidence base is weak. OBJECTIVE: To assess the cost-effectiveness of advice to remain active (AA) versus advice to rest (AR); and immediate physiotherapy (IP) versus usual care (waiting list) physiotherapy (UCP). METHODS: Twenty-six-week within-trial economic evaluation (538 participants aged ≥18 years randomized to usual care, i.e. AA (n = 178), AR (n = 182) or IP (n = 178). Regression analysis estimated differences in mean costs and Quality-Adjusted Life Years (QALYs). Incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves were generated. Primary analysis comprised the 193 patients with complete resource use (UK NHS perspective) and EQ-5D data. Sensitivity analysis investigated uncertainty. RESULTS: Baseline-adjusted cost differences were £88 [95% confidence interval (CI): -14, 201) AA versus AR; -£14 (95% CI: -87, 66) IP versus UCP. Baseline-adjusted QALY differences were 0.0095 (95% CI: -0.0140, 0.0344) AA versus AR; 0.0143 (95% CI: -0.0077, 0.0354) IP versus UCP. There was a 71 and 89% probability that AA (versus AR) and IP (versus UCP) were the most cost-effective option using a threshold of £20,000 per additional QALY.  The results were robust in the sensitivity analysis. CONCLUSION: The difference in mean costs and mean QALYs between the competing strategies was small and not statistically significant. However, decision-makers may judge that IP was not shown to be any more effective than delayed treatment, and was no more costly than delayed physiotherapy. AA is preferable to one that encourages AR, as it is more effective and more likely to be cost-effective than AR.

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

BACKGROUND: Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. METHODS: This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. DISCUSSION: If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. TRIAL REGISTRATION: ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.

Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway.

BACKGROUND: Approximately 20% of people who have total knee replacement experience chronic pain afterwards, but there is little evidence about effective interventions for managing this type of pain. This article describes the systematic development and refinement of a complex intervention for people with chronic pain after knee replacement. The intervention is a care pathway involving an assessment clinic and onward referral, with telephone follow-up as required. In the design of this multistage study, we chose to focus on ensuring that the intervention was deliverable, implementable and acceptable. METHODS: In line with the UK Medical Research Council's recommendations for comprehensive development of complex interventions, multiple phases of work were undertaken. Following on from initial development work to design the intervention, the draft intervention content was refined through consensus questionnaires with 22 health professionals and discussion at meetings with 18 healthcare professionals. Testing of intervention delivery and acceptability to patients was undertaken by two health professionals delivering the assessment clinic to ten patients. Views about future implementation within the context of a randomised trial were evaluated through a questionnaire based on the Normalisation Measure Development (NoMAD) instrument with ten health professional stakeholders. RESULTS: Consensus work with health professionals ensured the components of the intervention were appropriate and informed a number of substantive changes to improve the intervention. Testing of intervention delivery identified a number of logistical issues that were then addressed in the development of a comprehensive intervention training manual. Engagement with stakeholders indicated that the intervention could be successfully implemented in a clinical setting for evaluation in a randomised trial. CONCLUSIONS: This work has informed the development and refinement of a complex intervention for people with chronic pain after knee replacement. The next stage is to evaluate the clinical and cost-effectiveness of the STAR care pathway in a multicentre randomised trial.

Low-Dose Intravenous Immunoglobulin Treatment for Long-Standing Complex Regional Pain Syndrome: A Randomized Trial.

BACKGROUND: Two small trials suggest that low-dose intravenous immunoglobulin (IVIg) may improve the symptoms of complex regional pain syndrome (CRPS), a rare posttraumatic pain condition. OBJECTIVE: To confirm the efficacy of low-dose IVIg compared with placebo in reducing pain during a 6-week period in adult patients who had CRPS from 1 to 5 years. DESIGN: 1:1 parallel, randomized, placebo-controlled, multicenter trial for 6 weeks, with an optional 6-week open extension. Patients were randomly assigned to 1 of 2 study groups between 27 August 2013 and 28 October 2015; the last patient completed follow-up on 21 March 2016. Patients, providers, researchers, and outcome assessors were blinded to treatment assignment. (ISRCTN42179756). SETTING: 7 secondary and tertiary care pain management centers in the United Kingdom. PARTICIPANTS: 111 patients with moderate or severe CRPS of 1 to 5 years' duration. INTERVENTION: IVIg, 0.5 g/kg of body weight, or visually indistinguishable placebo of 0.1% albumin in saline on days 1 and 22 after randomization. MEASUREMENTS: The primary outcome was 24-hour average pain intensity, measured daily between days 6 and 42, on an 11-point (0- to 10-point) rating scale. Secondary outcomes were pain interference and quality of life. RESULTS: The primary analysis sample consisted of 108 eligible patients, 103 of whom had outcome data. Mean (average) pain scores were 6.9 points (SD, 1.5) for placebo and 7.2 points (SD, 1.3) for IVIg. The adjusted difference in means was 0.27 (95% CI, -0.25 to 0.80; P = 0.30), which excluded the prespecified, clinically important difference of -1.2. No statistically significant differences in secondary outcomes were found between the groups. In the open extension, 12 of the 67 patients (18%) who received 2 IVIg infusions had pain reduction of at least 2 points compared with their baseline score. Two patients in the blinded phase (1 in the placebo and 1 in the IVIg group) and 4 in the open IVIg phase had serious events. LIMITATIONS: Results do not apply to patients who have had CRPS for less than 1 year or more than 5 years and do not extend to full-dose treatment (for example, 2 g/kg). The study was inadequately powered to detect subgroup effects. CONCLUSION: Low-dose immunoglobulin treatment for 6 weeks was not effective in relieving pain in patients with moderate to severe CRPS of 1 to 5 years' duration. PRIMARY FUNDING SOURCE: Medical Research Council/National Institute for Health Research Efficacy and Mechanism Evaluation Program, Pain Relief Foundation, and Biotest United Kingdom.