A Smartphone App to Support Self-Management for People Living With Sjögren's Syndrome: Qualitative Co-Design Workshops.

BACKGROUND: Sjögren's syndrome (SS) is the second most common autoimmune rheumatic disease, and the range of symptoms includes fatigue, dryness, sleep disturbances, and pain. Smartphone apps may help deliver a variety of cognitive and behavioral techniques to support self-management in SS. However, app-based interventions must be carefully designed to promote engagement and motivate behavior change. OBJECTIVE: We aimed to explore self-management approaches and challenges experienced by people living with SS and produce a corresponding set of design recommendations that inform the design of an engaging, motivating, and evidence-based self-management app for those living with SS. METHODS: We conducted a series of 8 co-design workshops and an additional 3 interviews with participants who were unable to attend a workshop. These were audio recorded, transcribed, and initially thematically analyzed using an inductive approach. Then, the themes were mapped to the Self-Determination Theory domains of competency, autonomy, and relatedness. RESULTS: Participants experienced a considerable demand in the daily work required in self-managing their SS. The condition demanded unrelenting, fluctuating, and unpredictable mental, physical, and social efforts. Participants used a wide variety of techniques to self-manage their symptoms; however, their sense of competency was undermined by the complexity and interconnected nature of their symptoms and affected by interactions with others. The daily contexts in which this labor was occurring revealed ample opportunities to use digital health aids. The lived experience of participants showed that the constructs of competency, autonomy, and relatedness existed in a complex equilibrium with each other. Sometimes, they were disrupted by tensions, whereas on other occasions, they worked together harmoniously. CONCLUSIONS: An SS self-management app needs to recognize the complexity and overlap of symptoms and the complexities of managing the condition in daily life. Identifying techniques that target several symptoms simultaneously may prevent users from becoming overwhelmed. Including techniques that support assertiveness and communication with others about the condition, its symptoms, and users' limitations may support users in their interactions with others and improve engagement in symptom management strategies. For digital health aids (such as self-management apps) to provide meaningful support, they should be designed according to human needs such as competence, autonomy, and relatedness. However, the complexities among the 3 Self-Determination Theory constructs should be carefully considered, as they present both design difficulties and opportunities.

A qualitative exploration of internet forum discussions surrounding female sexual function for individuals with Sjögren's syndrome.

Sexual dysfunction is a common experience for women with the autoimmune rheumatic disease, Sjögren's syndrome (SS); however, the lived experience of how the disease affects sexual functioning and the sexual environment remains unexplored. This qualitative study explores the conversations pertaining to female sexual function and the sexual environment that individuals with SS have on an internet forum. Qualitative data posted on one publicly accessible, worldwide, internet forum was extracted using an automated web scraping tool. A total of 247,694 posts across 23,382 threads were scraped from the forum in July 2019 and June 2022 (from the United Kingdom). A predetermined and theoretically informed keyword search strategy was used to screen the captured data for content relevant to the study aim. The dataset was cleaned to remove duplication and identifying information and screened for topic relevance. The Computer-Assisted Qualitative Data Analysis software tool, ATLAS.ti, was used to facilitate the data analysis process. Thematic analysis was conducted on 1443 female-oriented posts, and four key themes were identified: the symptoms of SS and their impact on the sexual environment; the emotional responses that are commonly evoked in response to sexual difficulties; the strategies that users have implemented to manage sexual problems; and the impact that a partner's behavior may have on the sexual environment. Together these themes provide an insight into the nature of sexual difficulties for females with SS. Our findings provide novel insights to inform clinical discussions between practitioners and patients whilst further outlining the importance of undertaking qualitative research with this population.

Recognition, explanation, action, learning: Teaching and delivery of a consultation model for persistent physical symptoms.

OBJECTIVE: To describe the teaching and delivery of an extended consultation model designed for clinicians to use with patients with persistent physical symptoms and functional disorders. The model is underpinned by current scientific knowledge about persistent physical symptoms and the communication problems that arise in dealing with them. METHODS: Process evaluation of training and delivery of the Recognition, Explanation, Action, Learning (REAL) model within the Multiple Symptoms Study 3: a randomised controlled trial of an extended-role GP "Symptoms Clinic". Evaluation used clinician and patient interviews and consultation transcripts. RESULTS: 7 GPs were trained in the intervention and 6 of them went on to deliver the REAL model in Symptoms Clinics either face-to-face or online. The Symptoms Clinic provided a set of 4 extended consultations to approximately 170 patients. Evaluation of training indicated that there was a considerable load in terms of new knowledge and skills. Evaluation of delivery found clinicians could adapt the model to individual patients while maintaining a high level of fidelity to its core components. CONCLUSION: REAL is a teachable consultation model addressing specific clinical communication issues for people with persistent physical symptoms. PRACTICE IMPLICATIONS: REAL enables clinicians to explain persistent physical symptoms in a beneficial way.

Coping strategies, illness perceptions, and relationship dynamics contribute to female sexual function and sexual distress in Sjögren's syndrome.

BACKGROUND: Sexual dysfunction and sexual distress are common complaints for women with the autoimmune rheumatic disease Sjögren's syndrome (SS); however, the role of psychosocial and interpersonal factors has not previously been explored in SS. AIM: This study investigated whether psychosocial variables, such as coping strategies, illness perceptions, and relationship dynamics, contributed to sexual function and sexual distress for women with SS. METHODS: Participants with SS completed an online cross-sectional survey that included prevalidated questionnaires assessing sexual function, sexual distress, disease-related symptom experiences, cognitive coping strategies, illness perceptions, relationship satisfaction, and partners' behavioral responses. Multiple linear regression was used to identify factors significantly associated with sexual function (total Female Sexual Function Index [FSFI] score) and sexual distress (total Female Sexual Distress Scale score) for women with SS. OUTCOMES: Study outcome measures were the FSFI, Female Sexual Distress Scale, EULAR SjÓ§gren's Syndrome Patient Reported Index, numeric rating scale for vaginal dryness (0-10), Profile of Fatigue and Discomfort, Cognitive Emotion Regulation Questionnaire (CERQ), Brief Illness Perceptions Questionnaire (B-IPQ), West Haven-Yale Multidimensional Pain Inventory (WHYMPI), and Maudsley Marital Questionnaire. RESULTS: A total of 98 cisgender women with SS participated in the study (mean age = 48.13 years, SD = 13.26). Vaginal dryness was reported by 92.9% of participants, and clinical levels of sexual dysfunction (total FSFI score <26.55) were observed in 85.2% (n = 69/81) of cases. More vaginal dryness, lower CERQ positive reappraisal, and higher CERQ catastrophizing were significantly associated with poorer self-rated sexual function (R2 = 0.420, F3,72 = 17.394, P < .001). Higher CERQ rumination, lower CERQ perspective, lower WHYMPI distracting responses, and higher B-IPQ identity were significantly associated with higher sexual distress (R2 = 0.631, F5,83 = 28.376, P < .001). CLINICAL IMPLICATIONS: This study suggests that interpersonal and psychosocial factors are important contributors to sexual function and distress in women with SS and that the development of psychosocial interventions for this population is warranted. STRENGTHS AND LIMITATIONS: This study is one of the first to explore the impacts of coping strategies, illness perceptions, and relationship dynamics on sexual function and sexual distress for women with SS. Limitations of our study include its cross-sectional nature and narrow sample demographic, which limit the generalizability of our results to other population groups. CONCLUSION: Women with SS who utilized adaptive coping strategies had better sexual function and lower levels of sexual distress than women who utilized maladaptive coping strategies.

Study protocol for the Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with persistent (medically unexplained) physical symptoms.

INTRODUCTION: Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients' quality of life and account for at least one third of referrals from General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life. METHODS AND ANALYSIS: This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders. ETHICS AND DISSEMINATION: Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups. TRIAL REGISTRATION NUMBER: ISRCTN57050216.

Altered smell and taste: Anosmia, parosmia and the impact of long Covid-19.

BACKGROUND: Qualitative olfactory (smell) dysfunctions are a common side effect of post-viral illness and known to impact quality of life and health status. Evidence is emerging that taste and smell loss are common symptoms of Covid-19 that may emerge and persist long after initial infection. The aim of the present study was to document the impact of post Covid-19 alterations to taste and smell. METHODS: We conducted exploratory thematic analysis of user-generated text from 9000 users of the AbScent Covid-19 Smell and Taste Loss moderated Facebook support group from March 24 to 30th September 2020. RESULTS: Participants reported difficulty explaining and managing an altered sense of taste and smell; a lack of interpersonal and professional explanation or support; altered eating; appetite loss, weight change; loss of pleasure in food, eating and social engagement; altered intimacy and an altered relationship to self and others. CONCLUSIONS: Our findings suggest altered taste and smell with Covid-19 may lead to severe disruption to daily living that impacts on psychological well-being, physical health, relationships and sense of self. More specifically, participants reported impacts that related to reduced desire and ability to eat and prepare food; weight gain, weight loss and nutritional insufficiency; emotional wellbeing; professional practice; intimacy and social bonding; and the disruption of people's sense of reality and themselves. Our findings should inform further research and suggest areas for the training, assessment and treatment practices of health care professionals working with long Covid.

Conceptualizing the benefits of a group exercise program developed for those with chronic fatigue: a mixed methods clinical evaluation.

PURPOSE: Fatigue is a disabling and prevalent feature of many long-term conditions. Orthostatic dizziness is a commonly experienced by those with fatigue. The purpose was; to evaluate factors contributing to successful delivery of a novel group exercise program designed for people with chronic fatigue and orthostatic symptoms and identify targets to improve future program content and delivery. RESEARCH METHODS: We used group concept mapping methodology. Participants of the exercise program with a long-term physical health condition and chronic fatigue- contributed ideas in response to a focus question. They sorted these ideas into themed piles and rated them for importance and success of the program delivery. Multidimensional scaling and cluster analysis were applied to the sort data to produce ideas clusters within a concept map. Value ratings were compared to evaluate the success of the program. RESULTS: The resulting concept map depicted seven key themed clusters of ideas: Exercises, Group atmosphere, Physical benefits, Self-management of symptoms, Acceptance and Education. Value plots of the rating data identified important and successful conceptual ideas. CONCLUSIONS: The concept maps have depicted key concepts relating to the successful delivery of a novel exercise program for people with fatigue and identified specific targets for future program enhancements.Implications for rehabilitationOrthostatic symptoms are common in those with fatigue and might be a target for group-based exercise programs.People with fatigue value a group-based exercise program that targets orthostatic symptoms.The key concepts of a group-based exercise program valued by those with fatigue are the exercises, group atmosphere, physical benefits, self-management support, acceptance, education and support with looking forwards following the program.

'Chronic cough, cause unknown': A qualitative study of patient perspectives of chronic refractory cough.

Chronic refractory cough patients have persistent, unexplained, treatment-resistant symptoms. Very little is known about non-physiological processes underlying chronic refractory cough or patients' experience of the condition. In all, 14 patients participated in semi-structured interviews. Interviews were based on the comprehensive cognitive behavioural model and analysed thematically. Eight key themes emerged illustrating that the experience of the onset and persistence of chronic refractory cough is complex, often involving multiple interlinking factors. Themes highlighted the involvement of biological and psychological factors, and the prominent role of the social dimension in how the cough is experienced, perceived and managed. Implications for intervention development are discussed.

Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study.

BACKGROUND: Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention. METHODS: Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale - International (SFES-I). Participants' adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call. RESULTS: Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up. CONCLUSIONS: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015.

Experience of sleep disruption in primary Sjögren's syndrome: A focus group study.

INTRODUCTION: Primary Sjögren's syndrome is the third most common systemic autoimmune rheumatic disease, following rheumatoid arthritis and systemic lupus erythematosus, and results in dryness, fatigue, discomfort and sleep disturbances. Sleep is relatively unexplored in primary Sjögren's syndrome. We investigated the experiences of sleep disturbances from the viewpoint of primary Sjögren's syndrome patients and their partners and explored the acceptability of cognitive behavioural therapy for insomnia. METHOD: We used focus groups to collect qualitative data from 10 patients with primary Sjögren's syndrome and three partners of patients. The data were recorded, transcribed verbatim and analysed using thematic analysis. RESULTS: Five themes emerged from the data: (a) Experience of sleep disturbances; (b) variation and inconsistency in sleep disturbances; (c) the domino effect of primary Sjögren's syndrome symptoms; (d) strategies to manage sleep; (e) acceptability of evidence-based techniques. Sleep disturbances were problematic for all patients, but specific disturbances varied between participants. These included prolonged sleep onset time and frequent night awakenings and were aggravated by pain and discomfort. Patients deployed a range of strategies to try and self-manage. Cognitive behavioural therapy for insomnia was seen as an acceptable intervention, as long as a rationale for its use is given and it is tailored for primary Sjögren's syndrome. CONCLUSION: Primary Sjögren's syndrome patients described a range of sleep disturbances. Applying tailored, evidence-based sleep therapy interventions may improve sleep, severity of other primary Sjögren's syndrome symptoms and functional ability.

A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

BACKGROUND: Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. METHODS: A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. RESULTS: As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. CONCLUSION: These interventions were acceptable to patients. Emotional and psychosocial issues presented routinely in the study patient group and CBT techniques were used, deliberately and inadvertently, in both treatment arms. This CBT "contamination" of the voice therapy only arm reflects the chief limitation of the study: one therapist delivered both treatments. TRIAL REGISTRATION: Registered with the ISRCTN under the title: Training a Speech and Language Therapist in Cognitive Behavioural Therapy to treat Functional Dysphonia - A Randomised Controlled Trial.Trial Identifier: ISRCTN20582523 Registered 19/05/2010; retrospectively registered. http://www.isrctn.com/ISRCTN20582523.

Mixed-Methods Study Identifying Key Intervention Targets to Improve Participation in Daily Living Activities in Primary Sjögren's Syndrome Patients.

OBJECTIVE: Functional ability and participation in life situations are compromised in many primary Sjögren's syndrome (SS) patients. This study aimed to identify the key barriers and priorities to participation in daily living activities, in order to develop potential future interventions. METHODS: Group concept mapping, a semiquantitative, mixed-methods approach was used to identify and structure ideas from UK primary SS patients, adult household members living with a primary SS patient, and health care professionals. Brainstorming generated ideas, which were summarized into a final set of statements. Participants individually arranged these statements into themes and rated each statement for importance. Multidimensional scaling and hierarchical cluster analysis were applied to sorted and rated data to produce visual representations of the ideas (concept maps), enabling identification of agreed priority areas for interventions. RESULTS: A total of 121 patients, 43 adult household members, and 67 health care professionals took part. In sum, 463 ideas were distilled down to 94 statements. These statements were grouped into 7 clusters: Patient Empowerment, Symptoms, Wellbeing, Access and Coordination of Health Care, Knowledge and Support, Public Awareness and Support, and Friends and Family. Patient Empowerment and Symptoms were rated as priority conceptual themes. Important statements within priority clusters indicate patients should be taken seriously and supported to self-manage symptoms of oral and ocular dryness, fatigue, pain, and poor sleep. CONCLUSION: Our data highlighted the fact that in addition to managing primary SS symptoms, interventions aiming to improve patient empowerment, general wellbeing, access to health care, patient education, and social support are important to facilitate improved participation in daily living activities.

Psychological profile of individuals presenting with chronic cough.

Chronic refractory cough (CRC) is a common problem in respiratory clinics. Adverse effects on quality of life are documented in the literature, but relatively little is known about the underlying psychological factors in this patient population. We aimed to investigate the association of psychological factors with chronic cough, comparing CRC to explained cough and non-cough groups. 67 patients attending a specialist cough clinic (CRC, n=25; explained cough, n=42) and 22 non-cough individuals participated. All participants completed the Hospital Anxiety & Depression Scale, Big Five Inventory (Personality), Chalder Fatigue Scale and Patient Health Questionnaire-15. Cough patients also completed the Illness Perception Questionnaire-Revised. Appropriate statistical analyses were used to compare participant groups. Chronic refractory coughers displayed significantly higher levels of anxiety, depression, fatigue and somatic physical symptoms than non-cough participants. Compared to explained coughers, there were higher depression and fatigue scores and significantly more negative illness representations (specifically, strong beliefs regarding negative consequences, lower illness coherence and higher emotional representations). "Explained" coughers reported significantly increased fatigue and somatic symptoms in comparison to non-coughers. The prevalence of fatigue, low mood, negative illness beliefs and increased physical symptom reporting should be considered in consultations and in developing novel interventions for CRC patients.

An investigation into the prevalence of sleep disturbances in primary Sjögren's syndrome: a systematic review of the literature.

Objectives: To identify whether sleep disturbances are more prevalent in primary SS (pSS) patients compared with the general population and to recognize which specific sleep symptoms are particularly problematic in this population. Methods: Electronic searches of the literature were conducted in PubMed, Medline (Ovid), Embase (Ovid), PsychINFO (Ovid) and Web of Science and the search strategy registered a priori . Titles and abstracts were reviewed by two authors independently against a set of prespecified inclusion/exclusion criteria, reference lists were examined and a narrative synthesis of the included articles was conducted. Results: Eight whole-text papers containing nine separate studies met the inclusion criteria and were included in the narrative analysis. Few of these studies met all of the quality assessment criteria. The studies used a range of self-reported measures and objective measures, including polysomnography. Mixed evidence was obtained for some of the individual sleep outcomes, but overall compared with controls, pSS patients reported greater subjective sleep disturbances and daytime somnolence and demonstrated more night awakenings and pre-existing obstructive sleep apnoea. Conclusions: A range of sleep disturbances are commonly reported in pSS patients. Further polysomnography studies are recommended to confirm the increased prevalence of night awakenings and obstructive sleep apnoea in this patient group. pSS patients with excessive daytime somnolence should be screened for co-morbid sleep disorders and treated appropriately. Interventions targeted at sleep difficulties in pSS, such as cognitive behavioural therapy for insomnia and nocturnal humidification devices, have the potential to improve quality of life in this patient group and warrant further investigation.

A taxonomy of explanations in a general practitioner clinic for patients with persistent "medically unexplained" physical symptoms.

OBJECTIVE: To develop a taxonomy of explanations for patients with persistent physical symptoms. METHODS: We analysed doctors' explanations from two studies of a moderately-intensive consultation intervention for patients with multiple, often "medically-unexplained," physical symptoms. We used a constant comparative method to develop a taxonomy which was then applied to all verbatim explanations. RESULTS: We analysed 138 explanations provided by five general practitioners to 38 patients. The taxonomy comprised explanation types and explanation components. Three explanation types described the overall structure of the explanations: Rational Adaptive, Automatic Adaptive, and Complex. These differed in terms of who or what was given agency within the explanation. Three explanation components described the content of the explanation: Facts - generic statements about normal or dysfunctional processes; Causes - person-specific statements about proximal or distal causes for symptoms; Mechanisms - processes by which symptoms arise or persist in the individual. Most explanations conformed to one type and contained several components. CONCLUSIONS: This novel taxonomy for classifying clinical explanations permits detailed classification of explanation types and content. Explanation types appear to carry different implications of agency. PRACTICE IMPLICATIONS: The taxonomy is suitable for examining explanations and developing prototype explanatory scripts in both training and research settings.

Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): a feasibility study protocol.

INTRODUCTION: In the UK, 1 in 5 people aged 75 and over live with sight loss. Visually impaired older people (VIOP) have an above average incidence of falls and 1.3-1.9 times more likely to experience hip fractures, than the general population. Older people with eye diseases are ∼3 times more likely than those with good vision, to limit activities due to fear of falling. This feasibility study aims to adapt the group-based Falls Management Exercise (FaME) programme to the needs of VIOP and carry out an external pilot trial to inform the design of a future definitive randomised controlled trial. METHODS AND DESIGN: A UK based 2-centre mixed methods, randomised, feasibility study will be conducted over 28 months. Stakeholder panels, including VIOP, will make recommendations for adaptations to an existing exercise programme (FaME), to meet the needs of VIOP, promoting uptake and adherence, while retaining required effective components of the exercise programme. 80 VIOP aged 60 and over, living at home, ambulant with or without a walking aid, will be recruited in Newcastle (n=40) and Glasgow (n=40) through National Health Service (NHS) Trusts and third sector partners. Participants randomised into the intervention arm will receive the adapted FaME programme. Participants randomised into the control arm will continue with usual activity. Outcomes are, recruitment rate, adherence and validated measures including fear of falling and quality of life. Postintervention in-depth qualitative interviews will be conducted with a purposive sample of VIOP (N=10). Postural stability instructors will be interviewed, before trial-specific training and following the intervention. ETHICS AND DISSEMINATION: Ethics approval was secured through the National Research Ethics Service (NRES) Committee North East, Newcastle and North Tyneside 2. Glasgow Caledonian University was approved as a non-NHS site with local ethics approval. Findings will be disseminated through peer-reviewed journals, national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN16949845.

Cognitive-behavioural therapy-based intervention to reduce fear of falling in older people: therapy development and randomised controlled trial - the Strategies for Increasing Independence, Confidence and Energy (STRIDE) study.

BACKGROUND: Falls cause fear, anxiety and loss of confidence, resulting in activity avoidance, social isolation and increasing frailty. The umbrella term for these problems is 'fear of falling', seen in up to 85% of older adults who fall. Evidence of effectiveness of physical and psychological interventions is limited, with no previous studies examining the role of an individually delivered cognitive-behavioural therapy (CBT) approach. OBJECTIVES: Primary objective To develop and then determine the effectiveness of a new CBT intervention (CBTi) delivered by health-care assistants (HCAs) plus usual care compared with usual care alone in reducing fear of falling. Secondary objectives To measure the impact of the intervention on falls, injuries, functional abilities, anxiety/depression, quality of life, social participation and loneliness; investigate the acceptability of the intervention for patients, family members and professionals and factors that promote or inhibit its implementation; and measure the costs and benefits of the intervention. DESIGN: Phase I CBTi development. Phase II Parallel-group patient randomised controlled trial (RCT) of the new CBTi plus usual care compared with usual care alone. SETTING: Multidisciplinary falls services. PARTICIPANTS: Consecutive community-dwelling older adults, both sexes, aged ≥ 60 years, with excessive or undue fear of falling per Falls Efficacy Scale-International (FES-I) score of > 23. INTERVENTIONS: Phase I Development of the CBTi. The CBTi was developed following patient interviews and taught to HCAs to maximise the potential for uptake and generalisability to a UK NHS setting. Phase II RCT. The CBTi was delivered by HCAs weekly for 8 weeks, with a 6-month booster session plus usual care. MAIN OUTCOME MEASURES: These were assessed at baseline, 8 weeks, 6 months and 12 months. Primary outcome measure Fear of falling measured by change in FES-I scores at 12 months. Secondary outcome measures These comprised falls, injuries, anxiety/depression [Hospital Anxiety and Depression Scale (HADS)], quality of life, social participation, loneliness and measures of physical function. There were process and health-economic evaluations alongside the trial. RESULTS: Four hundred and fifteen patients were recruited, with 210 patients randomised to CBTi group and 205 to the control group. There were significant reductions in mean FES-I [-4.02; 95% confidence interval (CI) -5.95 to -2.1], single-item numerical fear of falling scale (-1.42; 95% CI -1.87 to 1.07) and HADS (-1; 95% CI -1.6 to -0.3) scores at 12 months in the CBTi group compared with the usual care group. There were no differences in the other secondary outcome measures. Most patients found the CBTi acceptable. Factors affecting the delivery of the CBTi as part of routine practice were identified. There was no evidence that the intervention was cost-effective. CONCLUSIONS: Our new CBTi delivered by HCAs significantly improved fear of falling and depression scores in older adults who were attending falls services. There was no impact on other measures. FURTHER WORK: Further work should focus on a joint CBTi and physical training approach to fear of falling, more rational targeting of CBTi, the possibility of mixed group and individual CBTi, and the cost-effectiveness of provision of CBTi by non-specialists. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78396615. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 56. See the NIHR Journals Library website for further project information.

Developmental study of treatment fidelity, safety and acceptability of a Symptoms Clinic intervention delivered by General Practitioners to patients with multiple medically unexplained symptoms.

BACKGROUND: There is a need for primary care interventions for patients with multiple medically unexplained symptoms (MUS). We examined whether GPs could be taught to deliver one such intervention, the Symptoms Clinic Intervention (SCI), to patients. The intervention includes recognition and validation of patients' symptoms, explanation of symptoms and actions to manage symptoms. METHODS: We conducted an uncontrolled observational study in Northeast Scotland. GPs were recruited and received two days of structured training. Patients were identified via a two stage process (database searching followed by postal questionnaire) and received the SCI intervention from a GP in their practice. Treatment fidelity was assessed by applying a coding framework to consultation transcripts. Safety was assessed by examining changes in patient symptoms (PHQ-15) and checking for unexpected events. Acceptability was primarily assessed by patient interview. RESULTS: Four GPs delivered the SCI to 23 patients. GPs delivered all core components of the SCI, and used the components flexibly across the consultations and between patients. They spent more time on recognition than either explanation or actions components. 10 out of 17 patients interviewed described feeling validated, receiving useful explanation and learning actions. 9 out of 20 patients (45%) reported an improvement in PHQ-15 of between 3 and 8 points. Patients who reported the most improvement also described receiving all three components of the intervention. CONCLUSIONS: GPs can be taught to deliver the SCI with reasonable fidelity, safety and acceptability, although some items were inconsistently delivered: further training would be needed before use.

A concept mapping study evaluating the UK's first NHS generic fatigue clinic.

IMPORTANCE: Fatigue is a significant and debilitating symptom affecting 25% of the population. It occurs in those with a range of chronic diseases, can be idiopathic and in 0.2-0.4% of the UK population occurs in combination with other symptoms that together constitute chronic fatigue syndrome (CFS). Until recently, NHS clinical services only focussed upon CFS and excluded the majority of fatigued patients who did not meet the CFS diagnostic criteria. The CRESTA Fatigue interdisciplinary clinic was established in 2013 in response to this unmet need. OBJECTIVE: To identify the service needs of the heterogeneous group of patients accessing the CRESTA Fatigue Clinic, to prioritize these needs, to determine whether each is being met and to plan targeted service enhancements. DESIGN: Using a group concept mapping approach, we objectively identified the shared understanding of service users accessing this novel clinic. SETTING: NHS Clinics for Research & Service in Themed Assessment (CRESTA) Fatigue Clinic, Newcastle Upon Tyne, UK. PARTICIPANTS: Patients (n = 30) and referrers (n = 10) to the CRESTA Fatigue Clinic contributed towards a statement generation exercise to identify ways the clinic could support service users to improve their quality of life. Patients (n = 46) participated in the sorting and rating task where resulting statements were sorted into groups similar in meaning and rated for 'importance' and 'current success'. MAIN OUTCOME AND MEASURE: We mapped the needs of patients attending the CRESTA Fatigue Clinic and identified which high-priority needs were being successfully met and which were not. RESULTS: Multidimensional scaling and hierarchical cluster analysis depicted the following eight themed clusters from the data which related to various service-user requirements: 'clinic ethos', 'communication', 'support to self-manage', 'peer support', 'allied health services', 'telemedicine', 'written information' and 'service operation'. Service improvement targets were identified within value bivariate plots of the statements. CONCLUSION AND RELEVANCE: Service development concepts were grouped into thematic clusters and prioritized for both importance and current success. The resulting concept maps depict where the CRESTA Fatigue Clinic successfully addresses issues which matter to patients and highlights areas for service enhancement. Unmet needs of patients have been identified in a rigorous service evaluation, and these are currently being addressed in collaboration with a service-user group.

The experience of sleep in chronic fatigue syndrome: A qualitative interview study with patients.

OBJECTIVES: Sleep disturbances are common in chronic fatigue syndrome (CFS), and one of the key symptom complaints, yet it has been neglected by previous qualitative research. The aim was to explore the specific role of sleep in patients' experience of their illness. DESIGN: A qualitative semi-structured interview format facilitated a detailed and open exploration of sleep, and the extent to which its management and problems were linked to the lived experience of CFS. METHODS: Eleven semi-structured interviews were conducted with individuals with CFS. Data were transcribed verbatim and analysed thematically, to explore and describe patients' experience of their sleep, and its impact on their condition. RESULTS: Sleep emerged as a key aspect of the illness experience, and its management and effect on daytime functioning was a central pre-occupation for all 11 participants; all of them saw sleep as playing a critical role in their illness through either maintaining or exacerbating existing symptoms. Exploration of individual experiences presented three overarching themes: (1) sleep pattern variability over illness course and from day to day; (2) effect of sleep on daytime functioning; and (3) attempts at coping and sleep management. CONCLUSIONS: Each patient with CFS has a unique experience of sleep. Despite the differing narratives regarding the role of sleep in CFS, all participants held the belief that sleep is a vital process for health and well-being which has had a direct bearing on the course and progression of their CFS. Also, every participant regarded their sleep as in some way 'broken' and in need of management/repair. Patients' insights demonstrate sleep-specific influences on their CFS, and the impact of disturbed sleep should be a consideration for clinical and research work. STATEMENT OF CONTRIBUTION: What is already known on this subject? Sleep disturbances are common in CFS, and one of the key symptom complaints, yet it has been neglected by previous qualitative research. Ontology of CFS is a matter of dispute, with models ranging from the biological to the psychological competing to explain symptomatology in this illness. A qualitative study has the potential to add some clarity to the debate by making the patients' lived experience of the condition, and their own understanding of it, the focus of research. What this study adds? Coping and attempts at managing sleep problems in CFS adds to the 'illness burden' experienced by patients. Disturbed sleep is universally seen by patients with CFS as impacting on other daytime symptoms. Broken sleep may contribute to a biopsychosocial cycle that serves to maintain this illness.