Developing a patient care pathway for emotional support around the point of multiple sclerosis diagnosis: A stakeholder engagement study.

BACKGROUND: Diagnosing multiple sclerosis (MS) can be a lengthy process, which can negatively affect psychological well-being, condition management, and future engagement with health services. Therefore, providing timely and appropriate emotional support may improve adjustment and health outcomes. PURPOSE: To develop a patient care pathway for providing emotional support around the point of diagnosing MS, and to explore potential barriers and facilitators to delivery and implementation. METHODS: Focus groups were conducted with 26 stakeholders, including 16 people living with MS, 5 carers/family members and 5 professionals working with people living with MS (3 MS nurses, 1 psychiatrist, and 1 charity staff member). Discussions were audio-recorded, transcribed verbatim and analyzed using framework analysis. RESULTS: Participants suggested that a patient care pathway should include comprehensive information provision as a part of emotional support at diagnosis, and follow-up sessions with a healthcare professional. Barriers including increasing staff workloads and financial costs to health services were acknowledged, thus participants suggested including peer support workers to deliver additional emotional support. All participants agreed that elements of a care pathway and embedded interventions should be individually tailored, yet provided within a standardized system to ensure accessibility. CONCLUSIONS: A patient care pathway was developed with stakeholders, which included an embedded MS Nurse support intervention supplemented with peer support sessions. Participants suggested that the pathway should be delivered within a standardized system to ensure equity of service provision across the country. PATIENT OR PUBLIC CONTRIBUTION: This research was conceptualized and designed collaboratively with Nottingham Multiple Sclerosis Patient and Public Involvement and Engagement (PPIE) group members. One member is a co-author and was actively involved in every key stage of the research process, including co-design of the pathway and research protocol, data collection (including presenting to participants and moderating group discussions), analysis and write-up. Authors consulted with PPIE members at two meetings (9 and 11 PPIE attendees per meeting) where they gave feedback on the research design, findings and the resulting pathway. People living with MS and carers of people with MS were included in the focus groups as participants.

Experiences of receiving a diagnosis of multiple sclerosis: a meta-synthesis of qualitative studies.

PURPOSE: This meta-synthesis aimed to synthesise qualitative evidence on experiences of people with Multiple Sclerosis (MS) in receiving a diagnosis, to derive a conceptual understanding of adjustment to MS diagnosis. METHODS: Five electronic databases were systematically searched to identify qualitative studies that explored views and experiences around MS diagnosis. Papers were quality-appraised using a standardised checklist. Data synthesis was guided by principles of meta-ethnography, a well-established interpretive method for synthesising qualitative evidence. RESULTS: Thirty-seven papers were selected (with 874 people with MS). Synthesis demonstrated that around the point of MS diagnosis people experienced considerable emotional upheaval (e.g., shock, denial, anger, fear) and difficulties (e.g., lengthy diagnosis process) that limited their ability to make sense of their diagnosis, leading to adjustment difficulties. However, support resources (e.g., support from clinicians) and adaptive coping strategies (e.g., acceptance) facilitated the adjustment process. Additionally, several unmet emotional and informational support needs (e.g., need for personalised information and tailored emotional support) were identified that, if addressed, could improve adjustment to diagnosis. CONCLUSIONS: Our synthesis highlights the need for providing person-centred support and advice at the time of diagnosis and presents a conceptual map of adjustment for designing interventions to improve adjustment following MS diagnosis.Implications for RehabilitationThe period surrounding Multiple Sclerosis diagnosis can be stressful and psychologically demanding.Challenges and disruptions at diagnosis can threaten sense of self, resulting in negative emotions.Adaptive coping skills and support resources could contribute to better adjustment following diagnosis.Support interventions should be tailored to the needs of newly diagnosed people.

Neuropsychological evaluation and rehabilitation in multiple sclerosis (NEuRoMS): protocol for a mixed-methods, multicentre feasibility randomised controlled trial.

BACKGROUND: Cognitive problems affect up to 70% of people with multiple sclerosis (MS), which can negatively impact mood, ability to work, and quality of life. Addressing cognitive problems is a top 10 research priority for people with MS. Our ongoing research has systematically developed a cognitive screening and management pathway (NEuRoMS) tailored for people with MS, involving a brief cognitive evaluation and rehabilitation intervention. The present study aims to assess the feasibility of delivering the pathway and will inform the design of a definitive randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of the intervention and eventually guide its clinical implementation. METHODS: The feasibility study is in three parts. Part 1 involves an observational study of those who receive screening and support for cognitive problems, using routinely collected clinical data. Part 2 is a two-arm, parallel group, multicentre, feasibility RCT with a nested fidelity evaluation. This part will evaluate the feasibility of undertaking a definitive trial comparing the NEuRoMS intervention plus usual care to usual care only, amongst people with MS with mild cognitive problems (n = 60). In part 3, semi-structured interviews will be undertaken with participants from part 2 (n = 25), clinicians (n = 9), and intervention providers (n = 3) involved in delivering the NEuRoMS cognitive screening and management pathway. MS participants will be recruited from outpatient clinics at three UK National Health Service hospitals. DISCUSSION: Timely screening and effective management of cognitive problems in MS are urgently needed due to the detrimental consequences of cognitive problems on people with MS, the healthcare system, and wider society. The NEuRoMS intervention is based on previous and extant literature and has been co-constructed with relevant stakeholders. If effective, the NEuRoMS pathway will facilitate timely identification and management of cognitive problems in people with MS. TRIAL REGISTRATION: ISRCTN11203922 . Prospectively registered on 09.02.2021.

Cognitive assessment in multiple sclerosis clinical care: A qualitative evaluation of stakeholder perceptions and preferences.

There is a growing consensus that cognitive assessments should form part of routine clinical care in Multiple Sclerosis (MS). However, what remains unclear is which assessments are preferred by "stakeholders" (including people with MS, family members, charity volunteers, clinicians, and healthcare commissioners), in which contexts, and in which formats. Therefore, the aim of this study was to collect and synthesize stakeholders' perceptions of the assessments that are acceptable and feasible for routine administration in the UK healthcare system.We interviewed 44 stakeholders and held one focus group (n = 5). We asked stakeholders about their experience with cognitive impairment and assessment and their views on how cognitive assessment could be implemented within routine clinical care.Using framework analysis, we summarized three themes: the current cognitive screening situation; the suitability of commonly used assessments; and feasibility aspects, including modality and location of testing. All participants acknowledged that cognitive impairment could have a significant impact on the quality of life, but that assessment and monitoring are not routinely performed in clinics. Barriers and enablers were described, and most participants reported that brief, routine screening with tests such as symbol substitution was acceptable. Electronic, self-administration of cognitive screening would be beneficial in minimizing clinic attendance and staff time.

Cognitive measures used in adults with multiple sclerosis: A systematic review.

Cognitive problems are common in people with Multiple Sclerosis (MS), and researchers and clinicians have used a vast array of measures to assess cognition. Our aim was to systematically identify cognitive measures routinely used in MS research, and outline their different uses. Previous recommendations of cognitive measures to use in MS have relied on expert consensus approaches. We believe this systematic review is a starting point for an evidence-based approach to recommend cognitive tests for use with people with MS. We systematically searched electronic databases using relevant search terms for studies that assessed cognitive functioning in MS (last search in February 2020). From 11,854 abstracts retrieved, based on title and abstract review, 2563 remained. Data were extracted from 1526 studies. Studies used 5665 measures of cognition, with 316,053 people with MS. Substitutional style tests, serial addition tests, and word list learning tests were the most commonly used individual tests, and the Brief Repeatable Battery of Neuropsychological Tests was the most commonly used battery. Some of the most frequently used measures were potentially inappropriate due to measuring irrelevant domains of cognition, and issues with sensitivity. Further research is needed to ascertain the psychometric properties, and acceptability of measures for people with MS.

Are dental-related psychological variables important for dental attendance in China? A cross-sectional study.

OBJECTIVE: Dental services are expanding in China, yet there is little evidence available on the dental-related psychological factors contributing to the uptake of dental services. Our study explored whether beliefs, anxiety, and cognitions significantly differ across different levels of attendance, and whether dental-related psychological variables can independently predict dental attendance in Chinese adults. We also explored the extent to which cognitions and beliefs relate to attendance as a function of dental anxiety. METHOD: In our cross-sectional study 480 adult participants in China completed a questionnaire including dental attendance and measures of dental-related psychological variables (dental cognitions, beliefs, anxiety, and fear of dental pain). RESULTS: Only 25.8% of participants visited the dentist regularly. There was a significant difference for all dental-related psychological variables (p < 0.001), across all three levels of dental attendance (never; irregularly or regularly attend). Thus, fear of dental pain and dental anxiety are higher, and cognitions and beliefs are more negative, for those who have less favorable dental service utilization. All these variables, except fear of dental pain, were also independent predictors of dental attendance (p < 0.05). Moreover, how individuals think, and what they believe, about the dentist (and the dental context) were only partially explained through dental anxiety. Thus, beliefs (ß = 0.579, SE = 0.035, p < 0.001) and cognitions (ß = 0.594, SE = 0.045, p < 0.001) are impacting on dental attendance, mostly independent of whether the individual is anxious. CONCLUSION: Our preliminary findings show dental-related psychological factors are related to dental attendance and these should be explored further in a larger sample.

Magnetoencephalography abnormalities in adult mild traumatic brain injury: A systematic review.

BACKGROUND: The global incidence of traumatic brain injuries is rising, with at least 80% being classified as mild. These mild injuries are not visible on routine clinical imaging. The potential clinical role of a specific imaging biomarker be it diagnostic, prognostic or directing and monitoring progress of personalised treatment and rehabilitation has driven the exploration of several new neuroimaging modalities. This systematic review examined the evidence for magnetoencephalography (MEG) to provide an imaging biomarker in mild traumatic brain injury (mTBI). METHODS: Our review was prospectively registered on PROSPERO: CRD42019151387. We searched EMBASE, MEDLINE, trial registers, PsycINFO, Cochrane Library and conference abstracts and identified 37 papers describing MEG changes in mTBI eligible for inclusion. Since meta-analysis was not possible, based on the heterogeneity of reported outcomes, we provide a narrative synthesis of results. RESULTS: The two most promising MEG biomarkers are excess resting state low frequency power, and widespread connectivity changes in all frequency bands. These may represent biomarkers with potential for diagnostic application, which reflect time sensitive changes, or may be capable of offering clinically relevant prognostic information. In addition, the rich data that MEG produces are well-suited to new methods of machine learning analysis, which is now being actively explored. INTERPRETATION: MEG reveals several promising biomarkers, in the absence of structural abnormalities demonstrable with either computerised tomography or magnetic resonance imaging. This review has not identified sufficient evidence to support routine clinical use of MEG in mTBI currently. However, verifying MEG's potential would help meet an urgent clinical need within civilian, sports and military medicine.

Developing a clinical pathway to identify and manage cognitive problems in Multiple Sclerosis: Qualitative findings from patients, family members, charity volunteers, clinicians and healthcare commissioners.

BACKGROUND: Cognitive problems are a common and debilitating symptom of multiple sclerosis (MS). Screening and treatment for cognitive problems are recommended, however these are not routinely delivered in UK clinics. We collected and synthesised stakeholder perspectives to develop a care pathway for cognitive problems in MS and produce a logic model, illustrating how this pathway might operate. METHODS: Forty-nine stakeholders, including people with MS and care providers, participated in semi-structured interviews and focus groups. Participants viewed information that illustrated how the pathway might work and provided feedback. Data, transcribed verbatim and analysed using Framework Analysis, were mapped onto a preliminary logic model and accompanying thematic framework. RESULTS: The proposed pathway was perceived as helpful in providing standardised support for a neglected MS symptom. Training packages, online cognitive screening, and triaging decisions were viewed as crucial activities. Shared responsibility, a person-centred approach, and addressing the complexity of cognitive problems were important engagement mechanisms. Allocating time during clinic appointments and within staff workloads were essential resources for implementation. CONCLUSION: Our co-constructed MS cognitive screening and management pathway will be evaluated for clinical and cost-effectiveness in a trial. However, in the interim, clinicians can adapt and implement this pathway in their own services and evaluate it locally.

The notion of "invisibility" in people's experiences of the symptoms of multiple sclerosis: a systematic meta-synthesis.

PURPOSE: Invisible symptoms have a negative impact on people living with Multiple Sclerosis (MS), related to the very notion that they are "unseen." It is important to understand the notion of "invisibility" in MS, as invisible symptoms are particularly distressing, and there is a paucity of research focussing on their invisible nature and its specific impact. We aimed to systematically identify, appraise and synthesise qualitative research regarding the notion of "invisibility" in relation to people's lived experience of symptoms of MS. METHODS AND MATERIALS: Articles meeting inclusion criteria were critically appraised and synthesised using a meta-ethnographic approach. RESULTS: 17 articles were identified from six electronic databases. Three third-order themes were presented as a line of argument. "Invisibility" was conceptualised by people with MS as a discrepancy between the internal experience of symptoms and what is observed externally. "Invisibility" of MS symptoms was found to have numerous impacts, including not feeling understood or validated by others, issues around the perceived legitimacy of the illness, and living with needs which are hidden. We found that "invisibility" by its nature offers people a choice of strategies they use to navigate it. This choice introduces a dilemma: disclose the diagnosis to be "seen," or remain "invisible." CONCLUSIONS: This review revealed the manner in which people with MS are affected by the invisibility of their symptoms and the various adaptations used to navigate these lived experiences. We highlight the need to improve clinician and public understanding, and to better respond to these experiences. Future research focusing on the exploration of people's experiences of "invisibility" in MS, including the ways in which "invisibility" is managed on a day-to-day basis could raise clinical and public awareness of the impact of "invisibility" and how to provide support for this, thus easing the dilemmas faced by those with MS.IMPLICATIONS FOR REHABILITATIONPeople with Multiple Sclerosis (MS) experience symptoms that are not overtly visible to others, impacting their emotional and social wellbeing negatively.It is important for healthcare professionals to validate MS patients' experiences around "invisibility" and provide appropriate support.Healthcare professionals should address with MS patients any issues around disclosure of their diagnosis to those around them and support them to navigate these decisions.Raising awareness about the impact of "invisibility" for people with MS may help to lessen patient burden and promote understanding amongst healthcare professionals and the general public.

Experiences of adjustment to secondary progressive multiple sclerosis: a meta-ethnographic systematic review.

PURPOSE: To provide an overview of the experiences and needs of patients adjusting to life after receiving a diagnosis of secondary progressive multiple sclerosis (SPMS). METHOD: We conducted a meta-ethnographic synthesis of qualitative studies on the experiences of transition to SPMS, based on a systematic literature search of CINAHL, PsycINFO, Embase, MEDLINE, and Web of Science. Identified studies were quality-appraised using a critical appraisal checklist, and individual findings synthesised inductively. RESULTS: The synthesis included 12 articles with 144 people with SPMS. Adjusting to SPMS transition encompassed a variety of reactions and coping strategies. Successful adjustment was associated with accepting and adapting coping strategies, and availability of social support and relationships. Clinical services increased uncertainty around adjustment where patients felt clinicians were not transparent with them about their changing diagnosis. CONCLUSIONS: People adjust to SPMS in different ways, with the success of adjustment influenced by a patient's primary coping mechanism. Coping mechanisms are determined by pre-existing individual differences, alongside engagement with, and quality of, social support networks and activities. Services should ensure that people are provided with informational support about their illness progression, and emotional support concerning coping strategies, social networks, and physical activity, as these are key determinants of successful adjustment.IMPLICATIONS FOR REHABILITATIONAdjusting to secondary progressive multiple sclerosis is a difficult and stressful time for patients.Coping strategies patients use, their support network and their activity levels are key determinants of successful adjustment.Clinicians should be open with patients about their assessment of their changing diagnosis, rather than trying to avoid upsetting the patient by withholding information.Clinical services should be proactive in supporting patients during adjustment with learning positive coping strategies, and maintaining or increasing social relationships and activity levels.

Informal carers' experiences of caring for someone with Multiple Sclerosis: A photovoice investigation.

OBJECTIVES: This study explores the lived experiences of carers of people with Multiple Sclerosis (MS), specifically in relation to their quality of life (QoL), through the use of images and narratives, with the aim of gaining a nuanced insight into the complex nature of QoL in the MS caregiving context. DESIGN: Real-time qualitative design using the photovoice method. METHODS: Twelve MS carers (aged 30-73 years) took photographs of objects/places/events that represented enhancement or compromise to their QoL and composed written narratives for each photograph based on their experiences of caregiving. In total, 126 photographs and their corresponding narratives were analysed using content analysis. RESULTS: Seven inter-related themes were identified. MS caregiving-related challenges, sense of loss (e.g., loss of activities), emotional impact (e.g., feeling lonely), urge to escape, and sense of anxiety over the unpredictability of MS carer role were discussed in relation to the negative experiences that compromised their QoL. The themes precious moments (e.g., time spent with loved ones or hobbies) and helpful support (e.g., family and pets) encompassed participants' positive experiences that enhanced their QoL. CONCLUSIONS: Findings demonstrated the multi-faceted and complex nature of MS caregiver's QoL and highlighted that although the experiences of MS carers were mostly negative, there were also some positive aspects to caregiving, that helped enhance carers' QoL by ameliorating these negative experiences. These findings can be used to inform support programmes and enhance service provision for MS carers.

Psychosocial adjustment to multiple sclerosis diagnosis: A meta-review of systematic reviews.

This meta-review aimed to synthesise evidence on psychosocial adjustment to multiple sclerosis, to identify available treatment models and services for recently diagnosed individuals, and to explore their effectiveness. MEDLINE, CINAHL, EMBASE, PsycINFO, Web of Science, Cochrane Database of Systematic Reviews and grey literature were searched to include systematic reviews on psychosocial adjustment in multiple sclerosis. Two reviewers independently screened and assessed the quality of the selected reviews. Data were synthesised using narrative approach. Overall, thirty systematic reviews were included (with ~131,813 people with multiple sclerosis). A variety of psychosocial factors were identified in relation to adjustment to multiple sclerosis. Seven theoretical models that underpinned the available services and ten different intervention categories (e.g. cognitive behavioural approaches, mindfulness) for adjustment to multiple sclerosis were identified. There was some evidence that these interventions improved quality of life and coping, however, the difference they could make to people's adjustment was inconclusive. It was also difficult to conclude whether these interventions were particularly effective with the newly diagnosed. There is some support for the effectiveness of adjustment interventions. However, there is a need to design and rigorously evaluate support programmes for newly diagnosed people with multiple sclerosis, specifically focusing on information and adjustment support.

Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT.

BACKGROUND: There is currently insufficient evidence for the clinical effectiveness and cost-effectiveness of psychological therapies for post-stroke depression. OBJECTIVE: To evaluate the feasibility of undertaking a definitive trial to evaluate the clinical effectiveness and cost-effectiveness of behavioural activation (BA) compared with usual stroke care for treating post-stroke depression. DESIGN: Parallel-group, feasibility, multicentre, randomised controlled trial with nested qualitative research and a health economic evaluation. SETTING: Acute and community stroke services in three sites in England. PARTICIPANTS: Community-dwelling adults 3 months to 5 years post stroke who are depressed, as determined by the Patient Health Questionnaire-9 (PHQ-9) or the Visual Analogue Mood Scales 'Sad' item. Exclusions: patients who are blind and/or deaf, have dementia, are unable to communicate in English, do not have mental capacity to consent, are receiving treatment for depression at the time of stroke onset or are currently receiving psychological intervention. RANDOMISATION AND BLINDING: Participants were randomised (1 : 1 ratio) to BA or usual stroke care. Randomisation was conducted using a computer-generated list with random permuted blocks of varying sizes, stratified by site. Participants and therapists were aware of the allocation, but outcome assessors were blind. INTERVENTIONS: The intervention arm received up to 15 sessions of BA over 4 months. BA aims to improve mood by increasing people's level of enjoyable or valued activities. The control arm received usual care only. MAIN OUTCOME MEASURES: Primary feasibility outcomes concerned feasibility of recruitment to the main trial, acceptability of research procedures and measures, appropriateness of baseline and outcome measures, retention of participants and potential value of conducting the definitive trial. Secondary feasibility outcomes concerned the delivery of the intervention. The primary clinical outcome 6 months post randomisation was the PHQ-9. Secondary clinical outcomes were Stroke Aphasic Depression Questionnaire - Hospital version, Nottingham Leisure Questionnaire, Nottingham Extended Activities of Daily Living, Carer Strain Index, EuroQol-5 Dimensions, five-level version and health-care resource use questionnaire. RESULTS: Forty-eight participants were recruited in 27 centre-months of recruitment, at a recruitment rate of 1.8 participants per centre per month. The 25 participants randomised to receive BA attended a mean of 8.5 therapy sessions [standard deviation (SD) 4.4 therapy sessions]; 23 participants were allocated to usual care. Outcome assessments were completed by 39 (81%) participants (BA, n = 18; usual care, n = 21). Mean PHQ-9 scores at 6-month follow-up were 10.1 points (SD 6.9 points) and 14.4 points (SD 5.1 points) in the BA and control groups, respectively, a difference of -3.8 (95% confidence interval -6.9 to -0.6) after adjusting for baseline PHQ-9 score and centre, representing a reduction in depression in the BA arm. Therapy was delivered as intended. BA was acceptable to participants, carers and therapists. Value-of-information analysis indicates that the benefits of conducting a definitive trial would be likely to outweigh the costs. It is estimated that a sample size of between 580 and 623 participants would be needed for a definitive trial. LIMITATIONS: Target recruitment was not achieved, although we identified methods to improve recruitment. CONCLUSIONS: The Behavioural Activation Therapy for Depression after Stroke trial was feasible with regard to the majority of outcomes. The outstanding issue is whether or not a sufficient number of participants could be recruited within a reasonable time frame for a definitive trial. Future work is required to identify whether or not there are sufficient sites that are able to deliver the services required for a definitive trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12715175. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 47. See the NIHR Journals Library website for further project information.

Approximately one-third of stroke patients experience depression, which can have negative effects on recovery and quality of life (QoL). Currently, we do not have sufficient evidence to indicate which psychological interventions are effective and affordable to the NHS for treating post-stroke depression. We aimed to determine whether or not it is feasible to conduct a future large-scale study to evaluate a psychological intervention, called behavioural activation (BA) therapy, for treating post-stroke depression. BA aims to improve mood by identifying what stroke patients enjoy doing and helping them to undertake these activities. BA can be used with all stroke patients with depression, including people with cognitive or communication difficulties. We recruited 48 post-stroke patients who had suffered a stroke between 3 months and 5 years previously. People with dementia or significant aphasia were excluded. Participants were divided into two groups at random. About half of the participants received BA over a 4-month period and the other half did not. Participants received all other available care. After 6 months, participants completed questionnaires about their mood, activity level and QoL. We also interviewed 16 participants and 10 carers about their views on the actual research process and therapy. Although we were able to recruit participants to the study, we recruited fewer than the original target of 72 participants owing to delays in starting recruitment. However, we have identified ways to improve participant recruitment in a future study. We found that it was feasible to deliver BA, and the therapy was found to be acceptable to participants, carers and therapists. The results indicate that the benefits of conducting a large-scale future study would outweigh the costs. However, the main consideration will be whether or not we could identify enough stroke services able to run the study for a long enough period to recruit the large number of participants required.

Everyday memory measures in multiple sclerosis: a systematic review.

Everyday memory is one of the most affected cognitive functions in multiple sclerosis (MS). Assessing everyday memory problems is crucial for monitoring the impact of memory deficits on individuals' day-to-day lives and evaluating the effectiveness of interventions that aim to improve cognitive functions. The aim of this systematic review was to identify the research literature on everyday memory measures used with people with MS, describe the types of measures used, and summarise their psychometric properties. Empirical studies of cognitive function in MS using standardised everyday memory measures were included. Online databases (MEDLINE, PsycINFO, PsycARTICLES, Embase) and Google Scholar were searched. Forty-four studies met the inclusion criteria. A total of 12 measures were identified, with varied uses and administration methods. The majority of papers did not report any psychometric properties for MS populations. The few papers that did, reported that the measures have good reliability and appear to have good face, concurrent, and ecological validity, but these need to be evaluated further. This review presents researchers and clinicians with an overview of the various everyday memory measures used in studies with people with MS, to help them choose the appropriate measure for their evaluations.

Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of conducting a trial of a pre-surgical psychological intervention on pain, function, and mood in people with knee osteoarthritis listed for total knee arthroplasty. DESIGN: Multi-centre, mixed-methods feasibility randomized controlled trial of intervention plus usual care versus usual care. SETTING: Participants' homes or hospital. PARTICIPANTS: Patients with knee osteoarthritis listed for total knee arthroplasty and score >7 on either subscales of Hospital Anxiety and Depression Scale. INTERVENTION: Up-to 10 sessions of psychological intervention (based on cognitive behavioural therapy). MAIN MEASURES: Feasibility outcomes (recruitment and retention rates, acceptability of trial procedures and intervention, completion of outcome measures), and standardized questionnaires assessing pain, function, and mood at baseline, and four and six months post-randomisation. RESULTS: Of 222 people screened, 81 did not meet inclusion criteria, 64 did not wish to participate, 26 were excluded for other reasons, and 51 were randomized. A total of 30 completed 4-month outcomes and 25 completed 6-month outcomes. Modal number of intervention sessions completed was three (range 2-8). At 6-month follow-up, mood, pain, and physical function scores were consistent with clinically important benefits from intervention, with effect sizes ranging from small ( d = 0.005) to moderate ( d = 0.74), and significant differences in physical function between intervention and usual care groups ( d = 1.16). Feedback interviews suggested that participants understood the rationale for the study, found the information provided adequate, the measures comprehensive, and the intervention acceptable. CONCLUSION: A definitive trial is feasible, with a total sample size of 444 people. Pain is a suitable primary outcome, but best assessed 6 and 12 months post-surgery.

Caregiving in multiple sclerosis and quality of life: A meta-synthesis of qualitative research.

OBJECTIVE: The lack of adequate conceptualisation and operationalisation of quality of life (QoL) limits the ability to have a consistent body of evidence to improve QoL research and practice in informal caregiving for people with multiple sclerosis (MS). Thus, we conducted a meta-synthesis of qualitative research to improve the conceptual understanding of the experiences of MS carers and to identify factors that affect carers' QoL. DESIGN: Systematic searches of five electronic databases yielded 17 qualitative studies which were synthesised using the principles of meta-ethnography. RESULTS: The synthesis resulted in nine inter-linking themes: Changes and losses; challenges revolving around MS; caregiving demands; burden of care; future concerns; external stressors; experiences of support; strategies used in managing the caregiving role; and motivating factors. Our findings suggest that MS carers can have both positive and negative experiences which may bring challenges and rewards to the carers. CONCLUSION: We present a proposed QoL model for MS caregiving which can be used to inform the development of interventions for MS carers to improve their QoL. However, further empirical research is needed to examine the utility of this model and to explore the concept of QoL in MS carers in more detail.