Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial.

BACKGROUND: People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. METHODS: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). FINDINGS: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of -1·82 (95% CI -2·67 to -0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (-0·03, 95% CI -0·11 to 0·05) or serious adverse events (0·02, -0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. INTERPRETATION: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. FUNDING: UK National Institute for Health and Care Research.

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.

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.

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 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.

A systematic review of non-pharmacological interventions for primary Sjögren's syndrome.

OBJECTIVE: To evaluate the effects of non-pharmacological interventions for primary SS (pSS) on outcomes falling within the World Health Organization International Classification of Functioning Disability and Health domains. METHODS: We searched the following databases from inception to September 2014: Cochrane Database of Systematic Reviews; Medline; Embase; PsychINFO; CINAHL; and clinical trials registers. We included randomized controlled trials of any non-pharmacological intervention. Two authors independently reviewed titles and abstracts against the inclusion/exclusion criteria and independently assessed trial quality and extracted data. RESULTS: A total of 1463 studies were identified, from which 17 full text articles were screened and 5 studies were included in the review; a total of 130 participants were randomized. The included studies investigated the effectiveness of an oral lubricating device for dry mouth, acupuncture for dry mouth, lacrimal punctum plugs for dry eyes and psychodynamic group therapy for coping with symptoms. Overall, the studies were of low quality and at high risk of bias. Although one study showed punctum plugs to improve dry eyes, the sample size was relatively small. CONCLUSION: Further high-quality studies to evaluate non-pharmacological interventions for PSS are needed.

The role of perceived partner alliance on the efficacy of CBT-I: preliminary findings from the Partner Alliance in Insomnia Research Study (PAIRS).

Despite cognitive behavioral therapy for insomnia (CBT-I) being effective, barriers to adherence have been documented. Perceived partner alliance has been shown to influence adherence and treatment outcome across a range of other health conditions. The present study examined patients' perceptions regarding the role of their partner in CBT-I and the impact of perceived partner alliance on treatment outcome. Twenty-one patients were interviewed, following CBT-I, to examine the areas where partners were thought to influence the process of CBT-I. The majority of statements made during interviews explicitly mentioned a partner's influence (65%). Additionally, the production of more positive partner statements was associated with better treatment outcome (using the Insomnia Severity Index). The integration of perceived partner alliance into CBT-I is discussed.

Making sense of a cognitive behavioural therapy intervention for fear of falling: qualitative study of intervention development.

BACKGROUND: Fear of Falling (FoF) is commonly reported among older adults (up to 50%) and can impact negatively on physical and social activities, mood and quality of life. This paper explores the development, acceptability and feasibility of a cognitive behavioural therapy intervention (CBTi) for FoF. METHODS: The process evaluation of the CBTi development phase of an RCT (conducted in the UK) reported here, used ethnographic methods. Data included: interviews with patients and carers (n = 16), clinic staff (n = 6) and the psychologists developing the CBTi (n = 3); observational field notes and transcripts of intervention development meetings (n = 9) and stakeholder engagement meetings (n = 2); and informal discussions with staff developing the CBTi (n = 8). Data collection and thematic analysis were guided by Normalisation Process Theory (NPT). RESULTS: The process evaluation showed two domains of work necessary to develop a CBTi that made sense to stakeholders, and that could be delivered as part of an RCT. For the psychologists developing the content of the CBTi, a growing understanding of the complexity of FoF highlighted the need for an individualised rather than a manualised intervention. For the research team, the work involved adapting the structures and processes of the RCT to address preliminary concerns over the acceptability and feasibility of the proposed CBTi. CONCLUSIONS: Theory-based approaches to process evaluation can sensitise researchers to contested understandings about proposed interventions that could undermine implementation. Drawing on the coherence construct of NPT, this study emphasises the nature and extent of work required to ensure an intervention makes sufficient sense to key stakeholders in order to maximise chances of successful implementation.

Explanation for symptoms and biographical repair in a clinic for persistent physical symptoms.

Introduction: Biographical disruption describes the process by which illness impacts not just on a person's body and their participation in activities, but also on their sense of self. Biographical disruption is often followed by a process of biographical repair in which identity is reconstructed and a new normality is restored. People with persistent physical symptoms (sometimes referred to as medically unexplained symptoms) experience biographical disruption. This can be complicated by lack of explanation and the implication that if the problem is not medical, then it might be the person/psychological. We aimed to examine this tension in people attending a novel "Symptoms Clinic" for people with persistent physical symptoms. Methods: This study reports an embedded qualitative study in a UK based randomised controlled trial. Data were collected by audio recordings of consultations and semi-structured interviews with patients. We used theoretically informed thematic analysis with regular coding and discussion meetings of the analysis team. This analysis explores the role of intervention components in facilitating biographical repair. Results: The lack of acceptable explanation for persistent symptoms acted as a block to biographical repair. In the clinic, multi-layered explanations were offered and negotiated that viewed persistent symptoms as understandable entities rather than as indicators of something still hidden. These explanations allowed study participants to make sense of their symptoms and in turn opened new opportunities for self-management. The result was that participants were able to reframe their symptoms in a way that enabled them to see themselves differently. Even if symptoms had not yet improved, there was a sense of being better. This can be understood as a process of biographical repair. Conclusion: Explaining persistent physical symptoms enables biographical repair.

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.

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.

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.

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.

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.

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.

'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.

A precarious balance: using a self-regulation model to conceptualize and treat chronic fatigue syndrome.

The problem posed by chronic fatigue syndrome (CFS) to the affected individual can be conceptualized, using Leventhal's common sense model, as a health threat to be encoded and coped with accordingly. The current paper adopts an alternative use of self-regulation theory. It is hypothesized that in CFS the health threat is no longer the illness, but anything that threatens to disrupt a precarious accommodation to it. It is argued that attempts at threat regulation may become inadvertently self-defeating, promoting the threats they attempt to diminish. Evidence is presented for homeostatic mechanisms in physiological, neurocognitive and affective domains, and for their potential to become locked in vicious circles. It is further argued that illness attributions, rather than being independent cognitive processes, may be intimately linked with emotional and somatic processes. Damasio's somatic marker hypothesis is used to suggest ways in which the self-regulation of highly interconnected somatic, affective, and cognitive states may be substantially implicated in the maintenance of CFS. This perspective is used to reconsider effective treatment and to suggest new interventions. The self-regulation model is a potentially powerful explanatory framework for the consideration and treatment of CFS and medically unexplained symptoms in general.

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.

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.

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.