BACKGROUND:The COVID-19 public health emergency had significant impacts on people living with long-term health conditions. The specific impacts of COVID-19 on people with asthma across key stages of the pandemic are less certain. This study therefore aimed to explore the experiences of people with asthma across the pandemic as risk levels changed in a retrospective cross-sectional study. METHODS:Semi-structured interviews (N = 20), conducted at one timepoint, asked about experiences covering pre-COVID, initial outbreak/lockdown, restrictions lifting, key-stages salient to them (e.g., vaccination) and longer-term. Data were analysed using thematic-analysis. FINDINGS:There were three themes. 'Doing my own risk assessment' was an active process using pre-existing/acquired knowledge to determine risk and subsequent asthma-management/COVID-19 behaviours at all stages. 'Asthma from background to foreground' highlighted how asthma that was mostly previously unobtrusive was suddenly a 'pre-existing condition' leading to prolonged stress and anxiety. 'Place in society' describes how the participants were included/excluded by society due to safety concerns from the initial outbreak onwards, which was influenced by government, friends, family and neighbours, the media, health care systems and even themselves. DISCUSSION:Findings highlight how some people with asthma experienced the pandemic as a threat to mortality, with evidence of both poor and good adjustment to their asthma management, as per the Transdiagnostic model. When there are future rapid changes in contexts affecting long term conditions, government agencies should use the present study's findings to (a) guide decision-making, (b) inform public health messaging aimed at targeting at-risk populations and (c) provide support for at-risk populations.
Objectives:There is no research evidence about how healthcare professionals (HCPs) prioritise assessment and management of pain in different paediatric chronic musculoskeletal conditions (e.g. inflammatory or non-inflammatory). This study investigated and compared paediatric rheumatology HCPs' pain assessment/management priorities in inflammatory and non-inflammatory chronic musculoskeletal conditions and explored perceived barriers to implementation of prioritised pain assessment/management approaches. Methods:Participants were presented with online vignettes describing a young person with an inflammatory (JIA) or non-inflammatory (diffuse idiopathic pain) chronic musculoskeletal condition. Participants completed closed questions on pain assessment/management priorities and open questions on perceived barriers to implementation of these priorities in clinical practice. Data were analysed using within-subjects bivariate statistical analysis and content analysis. Results:Results from 56 HCPs (11 countries) found that broadly similar pain assessments were selected for both conditions. Biomedical management approaches were more frequently selected for the inflammatory condition, whereas psychosocial approaches were primarily selected for the non-inflammatory condition. Barriers to implementation of assessment/management approaches included limited time, resources, knowledge and skillset and HCPs' habits and beliefs about pain care (e.g. limiting access to components of biopsychosocial pain management due to preconceived beliefs about the musculoskeletal condition). Conclusion:Paediatric rheumatology HCPs generally prioritise similar pain assessments for inflammatory and non-inflammatory chronic musculoskeletal conditions. However, some HCPs perceive psychosocial pain management approaches as less important for managing pain in inflammatory conditions. Importantly, pain is always biopsychosocial in nature and clinical guidelines (that emphasise the biopsychosocial perspective) should ideally be followed regardless of condition type.
Objective People with knee osteoarthritis exhibit overactivity of the knee muscles during functional tasks. This will increase mechanical loads and may exacerbate pain. Cognitive Muscular TherapyTM (CMT) is a new conservative intervention that aims to reduce muscle overactivity and change habitual responses to pain. This study was designed to assess the feasibility of a future randomised controlled trial, designed to compare CMT with usual care. Methods Patients with knee osteoarthritis, who had failed to benefit from previous therapeutic exercise, were randomised to receive CMT or usual care. Participants in the CMT arm were offered seven individual sessions, delivered by an NHS physiotherapist trained to deliver the intervention. Trial feasibility was assessed by monitoring recruitment, adherence, retention, treatment fidelity and acceptability through an embedded process evaluation. Secondary outcome measures included WOMAC and the Pain Catastrophizing Scale. Results 82 patients were recruited from 164 screened. Of the 42 allocated to the CMT arm, 32 completed the treatment. Retention was acceptable in the CMT arm but higher than anticipated in the usual care arm. Both patients and physiotherapists found the treatment to be acceptable, and the mean intervention fidelity score was 91%. Composite WOMAC score reduced by 17.1 points in the CMT arm from baseline to 20-weeks, and 2.8 points in the control arm over the same period. Conclusions CMT is an acceptable intervention for people with knee osteoarthritis. Future large-scale trials are now required to quantify the clinical effectiveness of this promising new treatment. Trial registration ISRCTN25291958
Objective: People with knee osteoarthritis exhibit overactivity of the knee muscles during functional tasks. This will increase mechanical loads and may exacerbate pain. Cognitive Muscular Therapy™ (CMT) is a new conservative intervention that aims to reduce muscle overactivity and change habitual responses to pain. This study was designed to assess the feasibility of a future randomised controlled trial, designed to compare CMT with usual care. Methods: Patients with knee osteoarthritis, who had failed to benefit from previous therapeutic exercise, were randomised to receive CMT or usual care. Participants in the CMT arm were offered seven individual sessions, delivered by an NHS physiotherapist trained to deliver the intervention. Trial feasibility was assessed by monitoring recruitment, adherence, retention, treatment fidelity and acceptability through an embedded process evaluation. Secondary outcome measures included WOMAC and the Pain Catastrophizing Scale. Results: 82 patients were recruited from 164 screened. Of the 42 allocated to the CMT arm, 32 completed the treatment. Retention was acceptable in the CMT arm but higher than anticipated in the usual care arm. Both patients and physiotherapists found the treatment to be acceptable, and the mean intervention fidelity score was 91%. Composite WOMAC score reduced by 17.1 points in the CMT arm from baseline to 20-weeks, and 2.8 points in the control arm over the same period. Conclusions: CMT is an acceptable intervention for people with knee osteoarthritis. Future large-scale trials are now required to quantify the clinical effectiveness of this promising new treatment. Trial registration: ISRCTN25291958.
The biopsychosocial (BPS) approach is increasingly recommended as best practice for physiotherapists managing chronic pain. It integrates physical, psychological, and social factors into treatment. Unlike the traditional biomedical model, which focuses solely on addressing physical symptoms, the BPS approach emphasises empowering patients to manage their pain holistically. With chronic lower back pain (CLBP) affecting a significant portion of the UK population and being a leading cause of disability, it is crucial that physiotherapists possess the necessary skills to support patients in their pain management journey. While qualified physiotherapists are expected to adopt these psychologically informed strategies, it is equally important to equip student physiotherapists with the foundational competencies in BPS-based pain management during their education. Ensuring that students develop confidence in these skills is essential for effectively managing CLBP once they are qualified practitioners. The aim of the current study was to explore undergraduate physiotherapy students’ perceptions and understanding of utilising the BPS approach in helping patients manage CLBP, and to assess their readiness and confidence in applying this approach in clinical practice. Semi-structured interviews were conducted with seven undergraduate physiotherapy students from five UK universities. A clinical vignette depicting a patient with CLBP was used to facilitate discussion during the interviews. Reflexive thematic analysis was applied to interpret the data. Three linked themes were developed into a thematic framework: (1) developing a professional identity, which included perceptions around professional titles, and transitioning from student to physiotherapist whilst finding pressure to be a source of accuracy for the patients. (2) Comprehending and communicating the complexity of chronic lower back pain, which involved pain perceptions and educational need around communication and forming assumptions about the patients’ perceptions. Lastly, (3) superficial application of the BPS model to pain management which centralized around the theory-practice gap in the application of the BPS approach, and a biomedical approach creep in learning and practice. The findings suggest that undergraduate physiotherapy students face challenges in developing a professional identity that integrates psychologically informed approaches, such as the BPS model, for managing CLBP. Students reported limited confidence in addressing the psychosocial aspects of pain and communicating effectively with patients. Recommendations for clinical practice include providing more practical opportunities for students to apply biopsychosocial principles in real-world settings. Additionally, physiotherapy curricula should enhance training in communication skills and clarify the professional scope related to managing the psychological aspects of chronic pain. E. Lambing: None. E. Johnstone: None. N. Brookes: None. D. Ghio: None.
Cognitive Muscular Therapy™ for Chronic Low Back Pain. BACKGROUND:Chronic low back pain (cLBP) is a major cause of disability. Research shows that people with cLBP over activate the abdominal and superficial paraspinal muscles and this may indicate an underlying pattern of antagonistic flexor-extensor tone. This study was designed test a new intervention for cLBP, Cognitive Muscular Therapy™ (CMT). CMT integrates biomechanical training to improve postural tone with psychological techniques for pain management. METHODS:The CMT intervention included five components: Understanding back pain, General relaxation, Postural deconstruction, Contextual triggers, and Functional integration and incorporated Electromyography (EMG) biofeedback to visualise erector spinae activity. An observational case series was carried out on fifteen participants with cLBP, who each received seven weekly sessions of CMT. Alongside disability and psychological factors, the activation profile of the erector spinae was measured during walking, using EMG. Five participants provided qualitative feedback through interviews. RESULTS:Significant clinical improvements were observed. The Roland-Morris Disability Questionnaire score reduced by 7 points, the Pain catastrophizing scale reduced by 13.2 points and the Tampa scale of kinesiophobia reduced by 7.8 points. EMG data suggested improved phasic activation of the erector spinae during walking, while interviews showed increased self-efficacy and improved pain management. CONCLUSION:This is the first study of CMT for cLBP, showing promising results in reducing pain and disability. By integrating psychological strategies within a biomechanical framework, CMT offers a novel approach to retraining muscle activity. Future work is now required to explore the proposed mechanism of action and fully quantify the clinical effectiveness of this new intervention. TRIAL REGISTRATION:NCT05611476.
OBJECTIVES:Juvenile idiopathic arthritis (JIA) is a group of childhood-onset inflammatory rheumatic conditions characterized by pain as one of the most common and distressing symptoms. This cross-sectional study aimed to investigate whether relationships between reported pain and disease activity in JIA affected beliefs about pain, known as "personal models." METHODS:187 out of a possible 363 participants with JIA who completed questionnaires about function and pain perception were recruited through the Childhood Arthritis Prospective Study (CAPS). A pre-selected pain score threshold and validated disease activity score cut-offs were used to assign the participants into four groups: low pain/low disease, low pain/high disease, high pain/low disease, and high pain/high disease. Multivariable linear regressions examined associations between the groups and their "personal models." RESULTS:Compared to participants with low pain/low disease, those with high pain/high disease and those with high pain/low disease were more likely to sense greater threat, have more negative emotional representations, and perceive less control over their pain. Participants with low pain/high disease had similar pain beliefs compared to those with low pain/low disease. CONCLUSION:This is the first study to compare "personal models" of pain in JIA. Children and young people who experience high pain severity regardless of disease activity perceived high pain threat, low controllability, and negative emotional representations. This highlights the importance of considering and addressing personal models of pain at diagnosis, especially those who present high levels of pain.
Young people with juvenile idiopathic arthritis (JIA) experience physical and psychological symptoms that negatively impact functional activities. Our team previously developed the JIA Option Map, a web-based patient decision aid to support decision-making for JIA pain management. Qualitative work identified a need to expand the JIA Option Map to include ways to manage symptoms beyond pain, such as fatigue, stiffness and mental health symptoms (eg, stress and anxiety), and provide tips to participate in meaningful activities. To inform the expansion of the JIA Option Map, we summarized the evidence for approaches to manage JIA symptoms. We conducted a scoping review following the Arksey and O’Malley framework. We assembled a research team comprised of people with lived experience, health care providers and researchers, and searched major databases for clinical practice guidelines (CPGs) which included systematic reviews (SRs), SRs and randomized controlled trials (RCTs) of approaches for arthritis-symptom treatment other than approaches aimed primarily at reducing disease activity such as disease-modifying antirheumatic drugs. We included approaches that can be used in addition to arthritis treatment to manage pain, stiffness, fatigue and mental health in JIA compared to any control group from database inception to September 2024. We extracted study information including effectiveness and safety of approaches. We assessed the methodological quality of the studies using the Appraisal of guidelines for research and evaluation II (AGREE II), Assessing the methodological quality of systematic reviews 2 (AMSTAR 2) and the Cochrane Risk of Bias 2.0, as well as the strength of evidence using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). We included a total of 5 CPGs, 9 SRs and 43 RCTs. We found evidence for splints and orthoses, massage, low-energy laser therapy, various physical activity interventions such as therapeutic exercises and pilates, educational programs and self-management interventions using cognitive behavioral therapy, as well as non-steroidal anti-inflammatory drugs (NSAIDs). Both pharmacological and non-pharmacological approaches were effective although most studies were of low or moderate quality. This scoping review shows that a wide variety of approaches are effective in improving JIA symptoms although there is a need for more high-quality studies. Efforts are underway to present this evidence to young people with JIA and parents/caregivers, HCPs and researchers to agree on the information to add to the expanded JIA Option Map. Supported by a CIORA grant
Background Eczema is a common condition with significant impact on quality of life. The main cause of treatment failure is non-use of prescribed treatments because treatments are time-consuming to apply; they may sting when first applied to inflamed skin; there are concerns about the safety of some treatments; and because people often receive conflicting advice about how and when to use them. Objectives Objectives of the present study are to: (1) explore the self-care support needs of children with eczema and their parents/carers, and young people with eczema, (2) review current best evidence about the safest and best ways to use topical corticosteroids for eczema, (3) develop theory-, evidence- and person-based online interventions to support eczema self-management in young people with eczema and parents/carers of children with eczema, (4) evaluate the clinical and cost-effectiveness of the interventions in two randomised controlled trials and (5) conduct a process evaluation and implementation planning. Design Five qualitative studies, four systematic reviews (one qualitative) and two parallel randomised controlled trials with nested process evaluation and economic evaluation. Setting Primary care. Participants Children and young people aged 13–25 years with eczema, and parents/carers of children aged 0–12 years with eczema. Participants with very mild or inactive eczema were excluded. Interventions We developed and evaluated two online behavioural interventions to support eczema management in: (1) young people and (2) parents/carers of children. Participants were not blinded to group allocation. Main outcome measures Primary outcome measure in the randomised controlled trials was participant-reported eczema severity measured by the patient-oriented eczema measure over 24 weeks. Secondary outcomes included patient-oriented eczema measures over 52 weeks, quality of life and patient enablement. Results Qualitative reviews and interviews provided in-depth understanding of the views, experiences and contexts within which young people and families manage eczema and identified barriers and facilitators to key behaviours. Systematic literature reviews on topical corticosteroid safety and effectiveness found no evidence of harm when topical corticosteroids were used intermittently to treat or prevent eczema flares. Our Cochrane review, which included 104 trials (8443 participants), found that potent and moderate topical corticosteroids are probably more effective than mild topical corticosteroids for treating moderate or severe eczema and that effectiveness is similar between once and twice daily use. Findings informed development of two online interventions, which were evaluated in two randomised controlled trials comparing intervention plus usual care to usual care only. Three hundred and forty parents/carers (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised [mean baseline patient-oriented eczema measure 12.8 (standard deviation 5.3) and 15.2 (standard deviation 5.4), respectively]. An intention-to-treat analysis approach to the analysis was taken. Follow-up rates were: 92.4% (314/340) parents/carers and 90.2% (304/337) young people at 24 weeks. Compared with usual care over 24 weeks, eczema severity (patient-oriented eczema measure) improved in the intervention groups: adjusted mean difference −1.5 (95% confidence interval −2.5 to −0.6) for parents/carers, and −1.9 (95% confidence interval −3.0 to −0.8) for young people. Effects were sustained for 52 weeks in both groups. Enablement showed an important difference favouring the intervention group in both trials [adjusted mean difference at 24 weeks −0.7 (95% confidence interval −1.0 to −0.4) for parents/carers and −0.9 (95% confidence interval −1.3 to −0.6) for young people]. No harms were identified in either group. Economic analysis found both interventions were low cost and cost-effective with almost all analyses (with the exception of the complete-case cost–utility analysis for the parent/carer trial) estimating the interventions to be dominant (cost saving and effective). Process evaluation demonstrated that both groups found the interventions usable, relatable and trustworthy, and perceived that they helped to manage their eczema. The interventions have been redeveloped into an English and Welsh product ready for dissemination and an implementation strategy has been developed. Limitations This research was conducted during the COVID-19 pandemic. While this did not have a major impact on our research plans or delivery, it may have had impacts (positive and negative) on people’s eczema, their eczema management and access to health care. Conclusions Eczema Care Online is effective and acceptable to its target groups. Findings from this programme support the wide-scale implementation of the interventions, available at www.eczemacareonline.org.uk. Future work Future work may explore how Eczema Care Online can be implemented in different settings and contexts and adapted for severe eczema. More research is also needed on the long-term safety of topical corticosteroids. Trial registration This trial is registered as Current Controlled Trials ISRCTN79282252. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0216-20007) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information. Plain language summary Eczema is a very common skin condition and can reduce quality of life for various reasons including itching and poor sleep. Eczema treatments include regular moisturisers (emollients) and flare-control cream (usually steroid cream). People often do not use these for a range of reasons, including uncertainty about how to use them and concerns about their safety. We spoke to over 130 young people, children and families to get an in-depth understanding of their views and experiences around eczema management. We also looked at all the evidence about the best and safest ways to use flare control creams. These findings were brought together in websites to support (1) young people with eczema and (2) parents/carers of children to help them manage their eczema. The two websites were tested in two large trials where young people and parents/carers of children with eczema were recruited by general practices in England. If they chose to take part, half were randomised to be given access to the website. Everyone still accessed their usual eczema care and got treatments in the same way. Participants were asked to fill in questionnaires for a year to ask about their eczema. We found that the websites helped improve eczema over 24 weeks when compared to usual care on its own. This improvement could still be seen after 1 year. The websites represent good value for money, and interviews with people who used them found that the websites were highly valued. Our eczema websites lead to small but long-lasting improvements in eczema. We have redeveloped these into a single website, available in English and Welsh, and developed plans to promote the website in the National Health Service and in the community. The website can be found at www.eczemacareonline.org.uk and is free to use with no registration. Scientific summary Background Eczema is a common itchy skin condition with a significant impact on quality of life. For most people with eczema, treatments include flare-control creams [topical corticosteroids (TCSs) and topical calcineurin inhibitors] to manage disease exacerbations and daily emollient moisturisers. The main cause of treatment failure is non-use of prescribed treatments for reasons such as treatments being time-consuming to apply; that they may sting when first applied to inflamed skin; concerns about the safety of some treatments; and because people often receive conflicting or insufficient advice about how and when to use them. Objectives To understand facilitators and barriers to effective eczema management for patients and parents/carers. To update and combine existing evidence around the safety of TCSs and develop knowledge tools for patients and healthcare professionals. To develop online behavioural interventions to support eczema self-care for patients and parents/carers. To determine the clinical and cost-effectiveness of online behavioural self-care interventions compared to standard clinical care. To formulate and initiate an implementation plan for integrating interventions into clinical practice and facilitating their uptake, informed by process evaluation. Methods This programme consists of five related workstreams. 1.Understanding barriers and facilitators to effective eczema management We carried out extensive qualitative work to inform intervention development. We conducted a systematic review and thematic synthesis of qualitative studies to explore the views and experiences of people with eczema and parents/carers of children with eczema. We conducted a secondary analysis of 23 transcripts of interviews with young people aged 16–25 years with eczema collected as part of the HealthTalk.org SKINS project. Primary qualitative research was conducted with (1) children aged 6–12 with eczema, (2) young people aged 13–25 with eczema and (3) parents/carers of children aged 0–12 with eczema. Participants were recruited through primary care and secondary care. Interviews were analysed using thematic analysis. Analyses in all three of these studies explored views and experiences of topics such as living with eczema, eczema treatments, perceived causes and triggers and experiences of transitioning to co-management or self-management. 2.Evidence for the best and safest way of using topical corticosteroids We reviewed the scientific evidence of the best and safest ways of using TCSs for eczema through three systematic reviews of the literature. We conducted an umbrella review of systematic reviews of studies using topical steroids for eczema to summarise what is already known about the safety of using TCSs from published systematic reviews. We conducted a Cochrane review of randomised controlled trials (RCTs) evaluating different strategies for using TCSs to examine the safety and effectiveness of different strategies. We conducted a systematic review of the longer-term safety of TCSs for eczema when used for more than a year. Key findings informed knowledge support tools for patients and health professionals to support the appropriate use of eczema treatments and ensure consistent messaging and signpost to Eczema Care Online (ECO). 3.Developing interventions to support eczema self-care Two complex behavioural interventions were developed to support eczema management: one for young people aged 13–25 years and other for parents/carers of children aged 0–12 years with eczema. The interventions were online and developed using theory-based, evidence-based and person-based approaches. The interventions were co-produced with an intervention development group which comprised patient and public contributors, dermatologists, nurses, general practitioners (GPs), psychologists and skin researchers. Intervention planning was carried out alongside workstreams 1 and 2 to guide our programme theory and provide us with an in-depth understanding of the key issues, needs and behavioural challenges of our two target groups. Programme theory was developed for each intervention, including guiding principles, behavioural analysis and an intervention logic model. Intervention materials and prototype interventions were optimised using qualitative think-aloud interviews with participants recruited through database search and mail-outs from eight GP practices. Interviews were analysed using the person-based approach table of changes. 4.Clinical and cost-effectiveness of our online behavioural interventions Two independent, pragmatic, parallel-group, online RCTs were conducted to determine the clinical and cost-effectiveness of the two online behavioural interventions developed in workstream 3. Participants were recruited through database search and mail-outs from 98 general practices in England. Participants were eligible to take part if they were a young person aged 13–25 years with eczema (trial 1) or a parent/carer of a child aged 0–12 years with eczema (trial 2). People were excluded if they reported very mild or inactive eczema [scoring 5 or less on the patient-oriented eczema measure (POEM)]. Eligible participants were randomised (1 : 1) to receive usual eczema care, or to an online behavioural intervention for eczema plus usual care. Participants in the usual care group were given access to the intervention at the end of the trial period. The primary outcome in both trials was eczema symptoms reported using POEM every 4 weeks for 24 weeks. POEM includes seven questions about the frequency of eczema symptoms over the previous week that are summed to give a score from 0 (no eczema) to 28 (worst possible eczema). Secondary outcomes included POEM scores every 4 weeks over 52 weeks, quality of life, eczema control, itch intensity (young people only), patient enablement, treatment use, adherence problems and intervention use (intervention group only). Service and treatment use data were collected through medical notes review. Separate analyses were carried out for each of the two trials, and according to intention-to-treat principles. Health economic evaluations were conducted from an NHS perspective and included cost–utility and cost-effectiveness analyses. 5.Integrating interventions into clinical practice and facilitating uptake A qualitative and quantitative process evaluation was nested within the two trials to understand likely causal mechanisms for the interventions, how effects may vary between user groups and settings, and to inform implementation of the interventions. Semistructured qualitative interviews were conducted with a sample of trial participants selected using purposive sampling to ensure a range of ages, gender, ethnicity, eczema severity, socioeconomic status, recruitment site, trial group and intervention usage. Interviews explored views of the website content, delivery features, changes that resulted from the intervention, the impact of the COVID-19 pandemic and reasons for any low intervention usage. Interviews from both groups were analysed together using thematic analysis. Intervention modifications for dissemination were identified using the person-based approach table of changes method. Intervention usage data were collected to describe patterns of intervention usage for all participants in the intervention arm. Mediation analysis was used to determine whether patient enablement, treatment use or barriers to adherence mediate the intervention effect on eczema severity. Subgroup analysis was carried out to explore whether the intervention effect was different among pre-specified categories of baseline variables. Logistic regression explored associations between higher intervention use and various demographic and baseline factors. We developed an implementation strategy in consultation with a wide range of stakeholders. Results 1.Understanding barriers and facilitators to effective eczema management Database searches and screening identified 39 papers reporting 32 qualitative studies for review. Thematic synthesis of the data identified four overarching analytical themes: (1) eczema not viewed as a long-term condition; (2) significant psychosocial impact of eczema not acknowledged by others; (3) hesitancy (patient/carer uncertainty) about eczema treatments; and (4) insufficient information and advice about eczema. Review findings informed workstream 3 intervention planning and guided our primary qualitative research. Qualitative data from 72 participants were analysed in this workstream. The sample included 30 parents of children aged 0–12 years, 14 children aged 6–12 years, 5 young people aged 13–16 years, plus secondary analysis of data collected from 23 young people aged 16–24 years (SKINS project). Findings enabled us to develop an in-depth understanding of the views and experiences of young people and families managing eczema. Key barriers and facilitators were identified, which support the development of our programme theory and behavioural interventions in workstream 3. 2.Evidence for the best and safest way of using topical corticosteroids Database searches for the umbrella review identified 38 systematic reviews of the safety of TCS in eczema which included 106 studies (77 RCTs and 29 observational studies). No evidence was found that TCSs cause harm when used intermittently ‘as required’ to treatment eczema flares or as ‘weekend therapy’ to prevent flares. Adverse events were uncommon with short-term use of TCSs, but high-quality evidence was limited. The Cochrane systematic review of safety and effectiveness of different strategies of using TCSs for eczema included 104 RCTs with a total of 8443 participants. Key findings included evidence that moderate and potent TCS are better than mild TCSs, that once-daily use of TCSs is as effective as twice daily and that ‘weekend therapy’ is effective and safe for preventing flares. Reported adverse events were infrequent. Our systematic review of the long-term safety of TCS for eczema included two RCTs (n = 2570, including 1288 receiving TCS), two cohort studies (all participants received some form of TCS n = 148) and three case-control studies (cases n = 10,322, controls n = 12,201). Overall, the limited body of evidence provides some indication that TCSs used intermittently for eczema are safe over periods of up to 5 years, but gaps remain in our understanding of the lifelong effects of TCS use. Key findings from this programme were developed into a knowledge tool following extensive stakeholder engagement. The tool signpost to EczemaCareOnline.org.uk and focuses on the primary message of the main interventions, ‘two treatments used well’, to support consistent messaging around treatment use among health professionals and people and families with eczema. 3.Developing interventions to support eczema self-care Findings from workstreams 1 and 2 informed the programme theory and evidence base for intervention development. The interventions were developed to target the following key behaviours: Improve emollient use. Improve the use of TCSs for flare-ups. Improve management of irritants and triggers. Improve emotional management. Reduce scratching. The online interventions were developed and optimised through qualitative think-aloud interviews with 25 parents/carers of children with eczema and 30 young people aged 13–25 years with eczema. Interviews lasted 45–90 minutes and were recorded and transcribed verbatim. Participants found the information and advice clear, easy to follow, helpful and relatable, particularly the quotes and tips from others like them. Participants found the information on TCSs reassuring. Young people found most content interesting and helpful, whereas parents/carers found the initial prototype intervention lengthy and repetitive, which led to the content being streamlined and made more interactive, which participants valued and found acceptable and engaging. 4.Clinical and cost-effectiveness of our two online behavioural interventions to support eczema management Three hundred and forty parents/carers of children (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised into the trials. All randomised participants were included in the analyses. Retention was excellent: 92.4% (314/340) parents/carers and 90.2% (304/337) young people at 24 weeks. Our two brief online behavioural interventions to support eczema management for parents/carers of children and for young people provided a useful benefit in eczema severity at 24 weeks. After controlling for baseline severity and confounders, compared with usual care over 24 weeks, eczema severity (POEM) improved in the intervention groups: −1.5 [95% confidence interval (CI) −2.5 to −0.6] for parents/carers, and −1.9 (95% CI −3.0 to −0.8) for young people. Effects were sustained for 52 weeks in both trials. No harm or unintended effects were identified in either group. We did not detect a difference in the use of eczema treatments between groups, yet did find statistically significant differences between groups in patient enablement instrument scores. Enablement showed an important difference favouring the intervention group in both trials [adjusted mean difference at 24 weeks −0.7 (95% CI −1.0 to −0.4) for parents/carers and −0.9 (95% CI −1.3 to −0.6) for young people]. Economic analysis found that both interventions were low cost and cost-effective with almost all analyses estimating the interventions to be dominant (that is cost saving and more effective than usual care). The exception was the cost–utility analysis for the parent/carer trial where the incremental cost per quality-adjusted life-years was < £20,000. 5.Process evaluation and implementation to integrate interventions into clinical practice and facilitate uptake Qualitative process evaluation included interviews with 17 parents/carers and 17 young people who took part in the RCTs. Feedback was mostly positive. Participants found the intervention trustworthy and valuable, and participants felt the intervention websites helped them manage their or their child’s eczema. Participants reported that ECO helped them to understand and feel confident in managing eczema; improve their use of treatments; avoid irritants and triggers; engage in productive treatment conversations with health professionals; and involve their child in eczema management (parents). Quantitative process evaluation found that, for parents/carers, about 30% of the intervention effect on the POEM score at 24 weeks was mediated by increasing patient enablement. For young people, about 50% of the intervention effect was mediated by increasing enablement. Process evaluation showed that the interventions were commonly accessed on smartphones, suggesting the need for an adaptable product and that we needed a stable platform over a few years where software would be updated. As part of our implementation strategy, we therefore decided to redevelop the interventions into a product for dissemination. We worked with a commercial software provider to develop the two interventions into one mobile adaptive website www.eczemacareonline.org.uk. Theory-informed analysis of the qualitative work in this programme and stakeholder consultations also enabled us to identify value propositions (unique identified benefits of the product within the marketplace), target audiences, key stakeholders and avenues for implementation. Conclusions We have developed, tested and implemented online interventions to support the self-management of eczema. The benefits on clinical outcomes of using the ECO intervention have been demonstrated in two RCTs, targeting two key user groups: parents of children with eczema and young people learning to manage their own eczema. A within-trial cost-effectiveness analysis suggests that use of the intervention represents value for money for the NHS, resulting in potential cost savings and improved outcomes. In eczema, self-management support is particularly important due to the complexity and high burden of treatment adherence. By promoting the use of ECO, as well as providing evidence that the interventions improve eczema outcomes, we hope that signposting to self-management support will become increasingly embedded in routine care. Our two interventions have been redeveloped into one website www.eczemacareonline.org.uk. This resource is freely available in English and Welsh. Trial registrations The trial is registered as Current Controlled Trials ISRCTN79282252. Workstream 1: systematic review of qualitative studies PROSPERO registration number CRD42018110496. Workstream 2: umbrella review PROSPERO registration number CRD42018079409. Workstream 2: Cochrane review CD013356. Workstream 2: long-term safety review PROSPERO registration number CRD42021286413. Workstream 4: trials are registered ISRCTN79282252. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0216-20007) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information.
AIM:To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals. DESIGN:Semi-structured qualitative interviews. METHODS:Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis. RESULTS:Based on interviews with 25 mothers, four main themes were developed. 'The need for answers' highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. 'The importance of health professionals' and 'Experiencing health professional support' identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. 'Foundations to help-seeking' highlighted important roles of social support and online help for valued shared experiences, emotional and practical support. CONCLUSION:Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE:Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary. IMPACT:Findings can inform the development of resources to support professionals/families managing unsettled babies. REPORTING METHOD:Standards for Reporting Qualitative Research. PUBLIC INVOLVEMENT:A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group. WHAT DOES THIS PAPER CONTRIBUTE TO THE WIDER GLOBAL CLINICAL COMMUNITY?: Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.
IntroductionChildren and young people experiencing chronic pain are at greater risk of inequitable and poor-quality pain management, which has implications for future management of pain in adulthood. Most chronic pain research is conducted with adults who are more likely to be middle-class, white and monocultured. Inclusive and diverse recruitment practices in paediatric pain research can be an area in which we can address this imbalance of representation. The aim of this current work was to explore these practices and to co-produce recommendations regarding recruitment strategies for paediatric pain research.MethodsThe research team worked with Your Rheum, a United Kingdom young person's advisory group (ages 11–24 years) and diagnosed with rheumatic condition(s), the opportunity to input into rheumatology research. At a virtual Your Rheum meeting, eight young people (female = 7, male = 1, age range 12–24) took part in group discussions, sharing their experiences of taking part in research and their decision process. Online tools, including Mentimeter and Miro, were used to aid conversations and share ideas.ResultsMost young people had experience of taking part in research as a study participant (n = 5). Recommendations synthesised included increased awareness of research in general. The young people discussed being open to hearing about research opportunities; they reflected that they are rarely exposed to these invitations or hear about current research. The clinic environment was highlighted as a “good and trustworthy” recruitment area – being approached by a member of the research team was considered ideal, even if it was someone they had not met previously. Many young people recalled little discussions of research at their clinical appointments. Deciding to participate in research included the following considerations: benefit/impact; connecting with others; research topic; which is then balanced against convenience, and reimbursement. The young people felt that taking part in research was empowering and helped them take ownership of their pain management.ConclusionIt is essential to understand the perspectives of potential study participants, to plan successful recruitment strategies. Ensuring we consider these factors when designing our studies and recruitment strategies is beneficial to all involved. Co-produced recruitment strategies would aid inclusive (and increased) research participation.
AIMS:To explore parents' experiences of unsettled babies and medical labels. DESIGN:Qualitative systematic review, thematic synthesis and development of a conceptual model. REVIEW METHODS:Systematic review and thematic synthesis of primary, qualitative research into parents' experiences of unsettled babies <12 months of age. 'Unsettled' was defined as perception of excessive crying with additional feature(s) such as vomiting, skin or stool problems. The Critical Appraisal Skills Programme (CASP) checklist was used to assess trustworthiness. DATA SOURCES:Structured searches completed in CINAHL, Medline, Embase, PsychINFO and CochraneCT on 23 March 2022 and rerun on 14 April 2023. RESULTS:Ten eligible studies were included across eight countries contributing data from 103 mothers and 24 fathers. Two analytical themes and eight descriptive themes were developed. Firstly, parents expressed fearing judgement, feeling guilty and out of control as a result of babies' unsettled symptoms and seeking strategies to construct an 'Identity as a "Good Parent"'. This desire for positive parenting identity underpinned the second analytical theme 'Searching for an explanation' which included seeking external (medical) causes for babies' unsettled behaviours. CONCLUSION:Parents can become trapped in a cycle of 'searching for an explanation' for their baby's unsettled behaviours, experiencing considerable distress which is exacerbated by feelings of guilt and failure. IMPACT AND IMPLICATIONS FOR PATIENT CARE:Insight gained from this review could inform interventions to support parents, reducing inaccurate medicalization. Health visiting teams supporting parents with unsettled baby behaviour could focus on supporting a positive parenting identity by managing expectations, normalizing the continuum of infant behaviours, reducing feelings of guilt or uncertainty and helping parents regain a feeling of control. REPORTING METHOD:ENTREQ guidelines were adhered to in the reporting of this review. PATIENT OR PUBLIC CONTRIBUTION:Parent input was crucial in the design phase; shaping the language used (e.g., 'unsettled babies') and in the analysis sense-checking findings.
Purpose: Cognitive Muscular Therapy (CMT) is a novel physiotherapist-led intervention which combines psychologically informed practice with muscle biofeedback training. Rather than focus on muscle strengthening, the aim of CMT is to reduce overactivity of the knee muscles as this may lead to a reduction in mechanical loading and therefore nociceptive input. In the first part of the intervention, the aim is to challenge patient’s beliefs around the cause of their knee pain and longer-term prognosis of their condition. This is delivered alongside pain neuroscience education which targets central sensitivity to pain.
Background: Cognitive Muscular TherapyTM( )(CMT) is an integrated behavioural intervention developed for knee osteoarthritis. CMT teaches patients to reconceptualise the condition, integrates muscle biofeedback and aims to reduce muscle overactivity, both in response to pain and during daily activities. This nested qualitative study explored patient and physiotherapist perspectives and experiences of CMT. Methods: Five physiotherapists were trained to follow a well-defined protocol and then delivered CMT to at least two patients with knee osteoarthritis. Each patient received seven individual clinical sessions and was provided with access to online learning materials incorporating animated videos. Semi-structured interviews took place after delivery/completion of the intervention and data were analysed at the patient and physiotherapist level. Results: Five physiotherapists and five patients were interviewed. All described a process of changing beliefs throughout their engagement with CMT. A framework with three phases was developed to organise the data according to how osteoarthritis was conceptualised and how this changed throughout their interactions with CMT. Firstly, was an identification of pain beliefs to be challenged and recognition of how current beliefs can misalign with daily experiences. Secondly was a process of challenging and changing beliefs, validated through new experiences. Finally, there was an embedding of changed beliefs into self-management to continue with activities. Conclusion: This study identified a range of psychological changes which occur during exposure to CMT. These changes enabled patients to reconceptualise their condition, develop a new understanding of their body, understand psychological processes, and make sense of their knee pain.
Purpose: People with knee osteoarthritis (OA) are known to exhibit overactivity of the knee muscles in standing and during functional tasks, such as walking. Such overactivity will increase mechanical loading on the knee joint and surrounding structures and is likely to stimulate nociceptive input to the central nervous system. Emerging research has demonstrated a link between increased knee muscle activity and postural control, indicating the need to integrate postural training into future physiotherapist-led interventions for knee OA.