Nasal sprays and behavioural interventions compared with usual care for acute respiratory illness in primary care: a randomised, controlled, open-label, parallel-group trial.

BACKGROUND: A small amount of evidence suggests that nasal sprays, or physical activity and stress management, could shorten the duration of respiratory infections. This study aimed to assess the effect of nasal sprays or a behavioural intervention promoting physical activity and stress management on respiratory illnesses, compared with usual care. METHODS: This randomised, controlled, open-label, parallel-group trial was done at 332 general practitioner practices in the UK. Eligible adults (aged ≥18 years) had at least one comorbidity or risk factor increasing their risk of adverse outcomes due to respiratory illness (eg, immune compromise due to serious illness or medication; heart disease; asthma or lung disease; diabetes; mild hepatic impairment; stroke or severe neurological problem; obesity [BMI ≥30 kg/m2]; or age ≥65 years) or at least three self-reported respiratory tract infections in a normal year (ie, any year before the COVID-19 pandemic). Participants were randomly assigned (1:1:1:1) using a computerised system to: usual care (brief advice about managing illness); gel-based spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); saline spray (two sprays per nostril at the first sign of an infection or after potential exposure to infection, up to 6 times per day); or a brief behavioural intervention in which participants were given access to a website promoting physical activity and stress management. The study was partially masked: neither investigators nor medical staff were aware of treatment allocation, and investigators who did the statistical analysis were unaware of treatment allocation. The sprays were relabelled to maintain participant masking. Outcomes were assessed using data from participants' completed monthly surveys and a survey at 6 months. The primary outcome was total number of days of illness due to self-reported respiratory tract illnesses (coughs, colds, sore throat, sinus or ear infections, influenza, or COVID-19) in the previous 6 months, assessed in the modified intention-to-treat population, which included all randomly assigned participants who had primary outcome data available. Key secondary outcomes were possible harms, including headache or facial pain, and antibiotic use, assessed in all randomly assigned participants. This trial was registered with ISRCTN, 17936080, and is closed to recruitment. FINDINGS: Between Dec 12, 2020, and April 7, 2023, of 19 475 individuals screened for eligibility, 13 799 participants were randomly assigned to usual care (n=3451), gel-based nasal spray (n=3448), saline nasal spray (n=3450), or the digital intervention promoting physical activity and stress management (n=3450). 11 612 participants had complete data for the primary outcome and were included in the primary outcome analysis (usual care group, n=2983; gel-based spray group, n=2935; saline spray group, n=2967; behavioural website group, n=2727). Compared with participants in the usual care group, who had a mean of 8·2 (SD 16·1) days of illness, the number of days of illness was significantly lower in the gel-based spray group (mean 6·5 days [SD 12·8]; adjusted incidence rate ratio [IRR] 0·82 [99% CI 0·76-0·90]; p<0·0001) and the saline spray group (6·4 days [12·4]; 0·81 [0·74-0·88]; p<0·0001), but not in the group allocated to the behavioural website (7·4 days [14·7]; 0·97 [0·89-1·06]; p=0·46). The most common adverse event was headache or sinus pain in the gel-based group: 123 (4·8%) of 2556 participants in the usual care group; 199 (7·8%) of 2498 participants in the gel-based group (risk ratio 1·61 [95% CI 1·30-1·99]; p<0·0001); 101 (4·5%) of 2377 participants in the saline group (0·81 [0·63-1·05]; p=0·11); and 101 (4·5%) of 2091 participants in the behavioural intervention group (0·95 [0·74-1·22]; p=0·69). Compared with usual care, antibiotic use was lower for all interventions: IRR 0·65 (95% CI 0·50-0·84; p=0·001) for the gel-based spray group; 0·69 (0·45-0·88; p=0·003) for the saline spray group; and 0·74 (0·57-0·94; p=0·02) for the behavioural website group. INTERPRETATION: Advice to use either nasal spray reduced illness duration and both sprays and the behavioural website reduced antibiotic use. Future research should aim to address the impact of the widespread implementation of these simple interventions. FUNDING: National Institute for Health and Care Research.

Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context.

BACKGROUND: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence. AIMS: The aim of this study was to generate an experts' consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs. METHOD: An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health. RESULTS: Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general. CONCLUSION: The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.

Determining the clinical and cost-effectiveness of nasal sprays and a physical activity and stress management intervention to reduce respiratory tract infections in primary care: A protocol for the 'Immune Defence' randomised controlled trial.

BACKGROUND: Most adults in the UK experience at least one viral respiratory tract infection (RTI) per year. Individuals with comorbidities and those with recurrent RTIs are at higher risk of infections. This can lead to more severe illness, worse quality of life and more days off work. There is promising evidence that using common nasal sprays or improving immune function through increasing physical activity and managing stress, may reduce the incidence and severity of RTIs. METHODS AND DESIGN: Immune Defence is an open, parallel group, randomised controlled trial. Up to 15000 adults from UK general practices, with a comorbidity or risk factor for infection and/or recurrent infections (3 or more infections per year) will be randomly allocated to i) a gel-based nasal spray designed to inhibit viral respiratory infections; ii) a saline nasal spray, iii) a digital intervention promoting physical activity and stress management, or iv) usual care with brief advice for managing infections, for 12 months. Participants will complete monthly questionnaires online. The primary outcome is the total number of days of illness due to RTIs over 6 months. Key secondary outcomes include: days with symptoms moderately bad or worse; days where work/normal activities were impaired; incidence of RTI; incidence of COVID-19; health service contacts; antibiotic usage; beliefs about antibiotics; intention to consult; number of days of illness in total due to respiratory tract infections over 12 months. Economic evaluation from an NHS perspective will compare the interventions, expressed as incremental cost effectiveness ratios. A nested mixed methods process evaluation will examine uptake and engagement with the interventions and trial procedures. TRIAL STATUS: Recruitment commenced in December 2020 and the last participant is expected to complete the trial in April 2024. DISCUSSION: Common nasal sprays and digital interventions to promote physical activity and stress management are low cost, accessible interventions applicable to primary care. If effective, they have the potential to reduce the individual and societal impact of RTIs. TRIAL REGISTRATION: Prospectively registered with ISRCTN registry (17936080) on 30/10/2020. SPONSOR: This RCT is sponsored by University of Southampton. The sponsors had no role in the study design, decision to publish, or preparation of the manuscript.

How do people with MND and caregivers experience a digital mental health intervention? A qualitative study.

Objective: We urgently need to develop and evaluate more psychological interventions to support people with Motor Neurone Disease (MND) and caregivers. We used the person-based approach to develop a digital mental health intervention and conducted two studies to explore people's experiences of using it. Methods: In Study 1, we conducted think-aloud interviews with 9 people with MND and 8 caregivers, and used findings to refine the intervention. In Study 2, 18 people with MND and 9 caregivers used the intervention for 6 weeks after which in-depth interviews were conducted. Data from both studies were combined and analysed using thematic analysis. Results: We developed 3 main themes around intervention acceptability, engagement, and usefulness. Participants highlighted the importance of accessibility and realistic presentation of information and support. Tailoring and timing intervention use to suit own needs, preferences, and disease stage was also important. Participants used the strategies presented to develop a positive outlook and regain some control. They also faced some challenges using these strategies in the context of dealing with progressive loss. Conclusion: People with MND and caregivers can find digital mental health interventions useful. Intervention accessibility and flexibility are important for developing acceptable and engaging interventions for MND.

Experiences of psychological interventions in neurodegenerative diseases: a systematic review and thematic synthesis.

Background: Psychological interventions for managing emotional distress in neurodegenerative diseases are needed, but progressive worsening of symptoms and increasing disability might pose difficulties with engagement. We aimed to synthesise the experiences of engaging with and using psychological interventions in neurodegenerative diseases and identify relevant barriers and facilitators. Methods: Systematic searches were conducted in six electronic databases and results were screened. We included qualitative and mixed methods studies reporting patient or caregivers' views or experiences of psychological interventions. Qualitative data were extracted and thematically synthesised. Results: 34 papers were included, covering a range of diseases and interventions. Engagement was facilitated by flexible intervention formats and tailoring to the specific needs of people with neurodegenerative diseases. Interventions were sometimes inaccessible or burdensome because of physical and cognitive symptoms, and the time and effort required for the intervention. Participants' levels of acceptance and readiness often differed and influenced engagement with the intervention. Across different interventions, participants experienced wide-ranging benefits including changes in insight, perspective, self-efficacy, emotions and relationships. Conclusion: Although people with neurodegenerative diseases and caregivers experience benefits from psychological interventions, burden-reducing adaptations and sensitive tailoring to the specific disease context is required to improve acceptability and engagement.

Perceptions of people with Parkinson's and their caregivers of falling and falls-related healthcare services- a qualitative study.

INTRODUCTION: Falls are common in Parkinson's disease, and a recognised research priority. Falls lead to physical and psychological morbidity in people with Parkinson's disease and their caregivers, however, those with cognitive impairment/ dementia and caregivers have often been excluded from previous studies. This qualitative study explored how people with Parkinson's disease and their family caregivers understood and experienced falling and healthcare services relating to falls prevention and management. METHODS: A varied and purposive sample of 20 people with Parkinson's disease (40% confirmed or suspected cognitive impairment/ dementia) and 18 caregivers took part in semi-structured interviews. Eight people with Parkinson's disease and their caregivers were interviewed as a dyad, 22 participants were interviewed alone. Interviews were analysed through inductive thematic analysis. RESULTS: Four themes were developed: (i) struggling with thoughts and feelings about falling, (ii) recognising and managing risks surrounding falling, (iii) navigating health and care provision for falling, and (iv) changing as a couple due to falling. Different aspects of falls provoked a range of negative emotions and a variety of coping strategies were adopted. Falls and trying to avoid falls burdened a couple in a number of ways; beyond physical health they also affected functioning, physiological wellbeing, and relationships. Dyads analysed falls to understand their aetiology and described working together to manage them. This often happened in the absence of adequate support and advice with little involvement of healthcare professionals. When cognitive impairment/ dementia was present this brought additional challenges to falls management, with caregivers taking on a greater and more frustrating role. CONCLUSION: Dyads required relevant falls-related information and the difficulties associated with cognitive decline should be recognised by researchers and healthcare professionals. Dyads required support in attributing reasons for falls, and increased awareness of healthcare professionals' different roles to improve patient- professional communication and facilitate patient-centred care.

Using nasal sprays to prevent respiratory tract infections: a qualitative study of online consumer reviews and primary care patient interviews.

OBJECTIVES: Nasal sprays could be a promising approach to preventing respiratory tract infections (RTIs). This study explored lay people's perceptions and experiences of using nasal sprays to prevent RTIs to identify barriers and facilitators to their adoption and continued use. DESIGN: Qualitative research. Study 1 thematically analysed online consumer reviews of an RTI prevention nasal spray. Study 2 interviewed patients about their reactions to and experiences of a digital intervention that promotes and supports nasal spray use for RTI prevention (reactively: at 'first signs' of infection and preventatively: following possible/probable exposure to infection). Interview transcripts were analysed using thematic analysis. SETTING: Primary care, UK. PARTICIPANTS: 407 online customer reviews. 13 purposively recruited primary care patients who had experienced recurrent infections and/or had risk factors for severe infections. RESULTS: Both studies identified various factors that might influence nasal spray use including: high motivation to avoid RTIs, particularly during the COVID-19 pandemic; fatalistic views about RTIs; beliefs about alternative prevention methods; the importance of personal recommendation; perceived complexity and familiarity of nasal sprays; personal experiences of spray success or failure; tolerable and off-putting side effects; concerns about medicines; and the nose as unpleasant and unhygienic. CONCLUSIONS: People who suffer disruptive, frequent or severe RTIs or who are vulnerable to RTIs are interested in using a nasal spray for prevention. They also have doubts and concerns and may encounter problems. Some of these may be reduced or eliminated by providing nasal spray users with information and advice that addresses these concerns or helps people overcome difficulties.

Patient perceptions of vulnerability to recurrent respiratory tract infections and prevention strategies: a qualitative study.

OBJECTIVES: Respiratory tract infections (RTIs) are extremely common, usually self-limiting, but responsible for considerable work sickness absence, reduced quality of life, inappropriate antibiotic prescribing and healthcare costs. Patients who experience recurrent RTIs and those with certain comorbid conditions have higher personal impact and healthcare costs and may be more likely to suffer disease exacerbations, hospitalisation and death. We explored how these patients experience and perceive their RTIs to understand how best to engage them in prevention behaviours. DESIGN: A qualitative interview study. SETTING: Primary care, UK. METHODS: 23 participants who reported recurrent RTIs and/or had relevant comorbid health conditions were interviewed about their experiences of RTIs. Interviews took place as the COVID-19 pandemic began. Data were analysed using inductive thematic analysis. RESULTS: Three themes were developed: Understanding causes and vulnerability, Attempting to prevent RTIs, Uncertainty and ambivalence about prevention, along with an overarching theme; Changing experiences because of COVID-19. Participants' understandings of their susceptibility to RTIs were multifactorial and included both transmission via others and personal vulnerabilities. They engaged in various approaches to try to prevent infections or alter their progression yet perceived they had limited personal control. The COVID-19 pandemic had improved their understanding of transmission, heightened their concern and motivation to avoid RTIs and extended their repertoire of protective behaviours. CONCLUSIONS: Patients who experience frequent or severe RTIs are likely to welcome and benefit from advice and support regarding RTI prevention. To engage people effectively, those developing interventions or delivering health services must consider their beliefs and concerns about susceptibility and prevention.

Emotional distress and well-being among people with motor neurone disease (MND) and their family caregivers: a qualitative interview study.

OBJECTIVE: We aimed to get an in-depth understanding of the emotions experienced by people with motor neurone disease (MND) and their caregivers, and to explore what impacts emotional distress and well-being. DESIGN: Qualitative study using semi-structured interviews with people with MND and caregivers. SETTING: Participants were recruited from across the UK and took part in interviews conducted either face to face, by telephone or email to accommodate for varying levels of disability. PARTICIPANTS: 25 people with MND and 10 caregivers took part. Participants were purposively sampled based on their MND diagnosis, symptoms and time since diagnosis. DATA ANALYSIS: Data were analysed using inductive reflexive thematic analysis. RESULTS: Eight broad themes were generated (20 subthemes). Participants described the emotional distress of losing physical function and having a threatened future because of poor prognosis. Keeping up with constant changes in symptoms and feeling unsupported by the healthcare system added to emotional distress. Finding hope and positivity, exerting some control, being kinder to oneself and experiencing support from others were helpful strategies for emotional well-being. CONCLUSION: The study provides a broad understanding of what impacts emotional distress and well-being and discusses implications for psychological interventions for people with MND and caregivers. Any communication and support provided for people with MND and their caregivers, needs to pay attention to concepts of hope, control and compassion.

Implementing a digital intervention for managing uncontrolled hypertension in Primary Care: a mixed methods process evaluation.

BACKGROUND: A high proportion of hypertensive patients remain above the target threshold for blood pressure, increasing the risk of adverse health outcomes. A digital intervention to facilitate healthcare practitioners (hereafter practitioners) to initiate planned medication escalations when patients' home readings were raised was found to be effective in lowering blood pressure over 12 months. This mixed-methods process evaluation aimed to develop a detailed understanding of how the intervention was implemented in Primary Care, possible mechanisms of action and contextual factors influencing implementation. METHODS: One hundred twenty-five practitioners took part in a randomised controlled trial, including GPs, practice nurses, nurse-prescribers, and healthcare assistants. Usage data were collected automatically by the digital intervention and antihypertensive medication changes were recorded from the patients' medical notes. A sub-sample of 27 practitioners took part in semi-structured qualitative process interviews. The qualitative data were analysed using thematic analysis and the quantitative data using descriptive statistics and correlations to explore factors related to adherence. The two sets of findings were integrated using a triangulation protocol. RESULTS: Mean practitioner adherence to escalating medication was moderate (53%), and the qualitative analysis suggested that low trust in home readings and the decision to wait for more evidence influenced implementation for some practitioners. The logic model was partially supported in that self-efficacy was related to adherence to medication escalation, but qualitative findings provided further insight into additional potential mechanisms, including perceived necessity and concerns. Contextual factors influencing implementation included proximity of average readings to the target threshold. Meanwhile, adherence to delivering remote support was mixed, and practitioners described some uncertainty when they received no response from patients. CONCLUSIONS: This mixed-methods process evaluation provided novel insights into practitioners' decision-making around escalating medication using a digital algorithm. Implementation strategies were proposed which could benefit digital interventions in addressing clinical inertia, including facilitating tracking of patients' readings over time to provide stronger evidence for medication escalation, and allowing more flexibility in decision-making whilst discouraging clinical inertia due to borderline readings. Implementation of one-way notification systems could be facilitated by enabling patients to send a brief acknowledgement response. TRIAL REGISTRATION: ( ISRCTN13790648 ). Registered 14 May 2015.

How and for whom does supportive adjustment to multiple sclerosis cognitive-behavioural therapy work? A mediated moderation analysis.

The supportive adjustment for multiple sclerosis (saMS) randomised controlled trial showed cognitive behavioural therapy (CBT) reduced distress at 12-months compared to supportive listening (SL). Larger changes in distress and functional impairment following CBT occurred in participants with clinical distress at baseline. This secondary analysis investigates whether CBT treatment effects occur through pre-defined CBT mechanisms of change in the total cohort and clinically distressed subgroup. 94 participants were randomised to saMS CBT or SL. Primary outcomes were distress and functional impairment (12 months). Mediators included cognitive-behavioural variables at post-treatment (15 weeks). Structural equation mediation and mediated-moderation models adjusting for baseline confounders assessed mediation overall and by distress level. Significant mediation was found but only for those with clinical distress at baseline. Illness acceptance (-0.20, 95% confidence interval -0.01 to -0.46) and reduced embarrassment avoidance behaviours (-0.22, -0.02 to -0.58) mediated CBT's effect on distress. Changes in beliefs about processing emotions (-0.19, -0.001 to -0.46) mediated CBT's effect on functional impairment. saMS CBT had effects on distress and functional impairment via some of the hypothesised mechanisms drawn from a theoretical model of adjustment for MS but only among participants with clinical distress at baseline. Increasing acceptance and emotional expression and decreasing embarrassment avoidance improves MS adjustment.

Falls Self-Management Interventions for People with Parkinson's Disease: A Systematic Review.

BACKGROUND: Falls are common in Parkinson's disease (PD). Increased involvement of people with Parkinson's (PwP) in their care has been associated with enhanced satisfaction. Self-management programmes in other long-term conditions (LTCs) have led to improvements in physical and psychological outcomes. These have been more effective when targeted toward a specific behavior. OBJECTIVE: This paper aimed to identify and review falls self-management interventions for PwP. METHODS: A systematic review was conducted. Electronic databases were searched in June 2018. Primary research studies (any design) reporting the delivery of falls self-management interventions to PwP were included. Data was extracted from each article and synthesised narratively. RESULTS: Six articles were identified, relating to five different self-management interventions. All described a self-management intervention delivered alongside physiotherapy. Intervention delivery was through either group discussion (n = 3) or falls booklets (n = 3). Interventions were often incompletely described; the most common components were information about the condition, training/ rehearsal for psychological strategies and lifestyle advice and support. Arising from the design of articles included the effects of self-management and physiotherapy could not be separated. Three articles measured falls, only one led to a reduction. Four articles measured quality of life, only one led to improvement. No articles assessed skill acquisition or adherence to the self-management intervention. CONCLUSIONS: Few falls self-management interventions for PwP have been evaluated and reported. The components of an effective intervention remain unclear. Given the benefits of self-management interventions in other LTCs, it is important that falls self-management interventions are developed and evaluated to support PwP.

Young People's Experiences of Viewing the Fitspiration Social Media Trend: Qualitative Study.

BACKGROUND: Social media use has become ubiquitous in the lives of many people, especially young adults. A popular recent trend emerging on social media is that of posting and following 'Fitspirational' content - material that purports to motivate and showcase healthy lifestyle habits, particularly relating to exercise and diet. There is very limited existing literature on how engaging with this type of content influences people's psychological and physical heath. Initial studies have focused on concerns over potential negative effects on psychological wellbeing including body image, self-esteem and eating disorders. OBJECTIVE: We aimed to address a gap in the literature for exploratory research on this topic from the perspective of users. We used a qualitative approach to explore how people experience viewing Fitspiration on social media including why and how they engage with this material and how they perceive that it affects their thoughts, emotions, behaviour and health. METHODS: We recruited 20 young adults (14 females, 6 males, aged 18-25) who self-declared themselves to be Fitspiration followers to participate in either focus groups or individual interviews. We asked detailed, open-ended questions about their motivations for following Fitspiration, experiences of viewing this content and its perceived impact. We used inductive thematic analysis to derive themes that represented common and salient features of the data set. RESULTS: Four main themes were developed: 1) A tool with the potential to support healthy living, 2) Unrealistic, untrustworthy content, 3) Negative effects on emotional wellbeing, and 4) Vulnerability and protective factors. Following Fitspirational posts on social media can provide young people with knowledge and motivation that may support healthy lifestyle behaviours. However, a range of harms also appeared to arise from Fitspiration viewing ranging from minor annoyances and frustrations to more meaningful negative effects on psychological & physical health. These negative effects seemed to persist despite individuals acknowledging that the material can be unrealistic, and believing that they are personally equipped to minimise harms to themselves. CONCLUSIONS: This study suggests that Fitspiration on social media can be attractive and compelling for young people but appears to bring about negative as well as positive effects. Future research should aim to confirm the scale and intensity of positive and negative effects and investigate ways of harnessing desirable outcomes and minimising undesirable outcomes.

Qualitative process study to explore the perceived burdens and benefits of a digital intervention for self-managing high blood pressure in Primary Care in the UK.

OBJECTIVES: Digital interventions can change patients' experiences of managing their health, either creating additional burden or improving their experience of healthcare. This qualitative study aimed to explore perceived burdens and benefits for patients using a digital self-management intervention for reducing high blood pressure. A secondary aim was to further our understanding of how best to capture burdens and benefits when evaluating health interventions. DESIGN: Inductive qualitative process study nested in a randomised controlled trial. SETTING: Primary Care in the UK. PARTICIPANTS: 35 participants taking antihypertensive medication and with uncontrolled blood pressure at baseline participated in semistructured telephone interviews. INTERVENTION: Digital self-management intervention to support blood pressure self-monitoring and medication change when recommended by the healthcare professional. ANALYSIS: Data were analysed using inductive thematic analysis with techniques from grounded theory. RESULTS: Seven themes were developed which reflected perceived burdens and benefits of using the intervention, including worry about health, uncertainty about self-monitoring and reassurance. The analysis showed how beliefs about their condition and treatment appeared to influence participants' appraisal of the value of the intervention. This suggested that considering illness and treatment perceptions in Burden of Treatment theory could further our understanding of how individuals appraise the personal costs and benefits of self-managing their health. CONCLUSIONS: Patients' appraisal of the burden or benefit of using a complex self-management intervention seemed to be influenced by experiences within the intervention (such as perceived availability of support) and beliefs about their condition and treatment (such as perceived control and risk of side effects). Developing our ability to adequately capture these salient burdens and benefits for patients could help enhance evaluation of self-management interventions in the future. Many participants perceived important benefits from using the intervention, highlighting the need for theory to recognise that engaging in self-management can include positive as well as negative aspects. TRIAL REGISTRATION NUMBER: ISRCTN13790648; Pre-results.

Do people with multiple sclerosis want to know their prognosis? A UK nationwide study.

BACKGROUND: Multiple sclerosis (MS) has a varied and uncertain trajectory. The recent development of analytical processing tools that draw on large longitudinal patient databases facilitates personalised long-term prognosis estimates. This has the potential to improve both shared treatment decision-making and psychological adjustment. However, there is limited research on how people with MS feel about prognosis communication and forecasting. This study investigated the prognosis communication experiences and preferences of people with MS and explored whether clinical, demographic and psychological factors are associated with prognosis information preferences. METHODS: 3175 UK MS Register members (59% of those with active accounts) completed an online survey containing 17 questions about prognosis communication experiences, attitudes and preferences. Participants also completed validated questionnaires measuring coping strategies, tendencies to seek out ('monitor') or avoid ('blunt') information in threatening situations, and MS risk perceptions and reported their clinical and sociodemographic characteristics. Data already held on the MS Register about participants' quality of life, anxiety and depression symptoms and MS impact were obtained and linked to the survey data. RESULTS: 53.1% of participants had never discussed long-term prognosis with healthcare professionals. 54.2% lacked clarity about their long-term prognosis. 76% had strong preferences for receiving long-term prognosis information. 92.8% were interested in using tools that generate personalised predictions. Most participants considered prognostication useful for decision-making. Participants were more receptive to receiving prognosis information at later time-points, versus at diagnosis. A comprehensive set of sociodemographic, clinical and psychological variables predicted only 7.9% variance in prognosis information preferences. CONCLUSIONS: People with MS have an appetite for individualised long-term prognosis forecasting and their need for information is frequently unmet. Clinical studies deploying and evaluating interventions to support prognostication in MS are now needed. This study indicates suitable contexts and patient preferences for initial trials of long-term prognosis tools in clinical settings.

Using digital interventions for self-management of chronic physical health conditions: A meta-ethnography review of published studies.

OBJECTIVES: To understand the experiences of patients and healthcare professionals (HCPs) using self-management digital interventions (DIs) for chronic physical health conditions. METHODS: A systematic search was conducted in 6 electronic databases. Qualitative studies describing users' experiences of self-management DIs were included, and authors' interpretations were synthesised using meta-ethnography. RESULTS: 30 papers met the inclusion criteria, covering a range of DIs and chronic conditions, including hypertension, asthma and heart disease. The review found that patients monitoring their health felt reassured by the insight this provided, and perceived they had more meaningful consultations with the HCP. These benefits were elicited by simple tele-monitoring systems as well as multifaceted DIs. Patients appeared to feel more reliant on HCPs if they received regular feedback from the HCP. HCPs focused mainly on their improved clinical control, and some also appreciated patients' increased understanding of their condition. CONCLUSIONS: Patients using self-management DIs tend to feel well cared for and perceive that they adopt a more active role in consultations, whilst HCPs focus on the clinical benefits provided by DIs. PRACTICE IMPLICATIONS: DIs can simultaneously support patient condition management, and HCPs' control of patient health. Tele-monitoring physiological data can promote complex behaviour change amongst patients.

How Do People with Multiple Sclerosis Experience Prognostic Uncertainty and Prognosis Communication? A Qualitative Study.

BACKGROUND: Disease progression in multiple sclerosis (MS) is highly variable and predicting prognosis is notoriously challenging. Patients' prognosis beliefs, responses to prognostic uncertainty and experiences of prognosis-related communication with healthcare professionals (HCPs) have received little study. These issues have implications for patients' psychological adjustment and are important in the context of the recent development of personalised prognosis forecasting tools. This study explored patient perspectives on the experience of prognostic uncertainty, the formation of expectations about personal prognosis and the nature of received and desired prognosis communication. METHODS: 15 MS patients participated in in-depth semi-structured interviews which were analysed using inductive thematic analysis. RESULTS: Six themes captured key aspects of the data: Experiencing unsatisfactory communication with HCPs, Appreciating and accepting prognostic uncertainty, Trying to stay present-focused, Forming and editing personal prognosis beliefs, Ambivalence towards forecasting the future, and Prognosis information delivery. MS patients report having minimal communication with HCPs about prognosis. Over time MS patients appear to develop expectations about their disease trajectories, but do so with minimal HCP input. Provision of prognosis information by HCPs seems to run counter to patients' attempts to remain present-focused. Patients are often ambivalent about prognosis forecasting and consider it emotionally dangerous and of circumscribed usefulness. CONCLUSIONS: HCPs must carefully consider whether, when and how to share prognosis information with patients; specific training may be beneficial. Future research should confirm findings about limited HCP-patient communication, distinguish predictors of patients' attitudes towards prognostication and identify circumstances under which prognostic forecasting benefits patients.

A Visualization Tool to Analyse Usage of Web-Based Interventions: The Example of Positive Online Weight Reduction (POWeR).

BACKGROUND: Attrition is a significant problem in Web-based interventions. Consequently, this research aims to identify the relation between Web usage and benefit from such interventions. A visualization tool has been developed that enables researchers to more easily examine large datasets on intervention usage that can be difficult to make sense of using traditional descriptive or statistical techniques alone. OBJECTIVE: This paper demonstrates how the visualization tool was used to explore patterns in participants' use of a Web-based weight management intervention, termed "positive online weight reduction (POWeR)." We also demonstrate how the visualization tool can be used to perform subsequent statistical analyses of the association between usage patterns, participant characteristics, and intervention outcome. METHODS: The visualization tool was used to analyze data from 132 participants who had accessed at least one session of the POWeR intervention. RESULTS: There was a drop in usage of optional sessions after participants had accessed the initial, core POWeR sessions, but many users nevertheless continued to complete goal and weight reviews. The POWeR tools relating to the food diary and steps diary were reused most often. Differences in participant characteristics and usage of other intervention components were identified between participants who did and did not choose to access optional POWeR sessions (in addition to the initial core sessions) or reuse the food and steps diaries. Reuse of the steps diary and the getting support tools was associated with greater weight loss. CONCLUSIONS: The visualization tool provided a quick and efficient method for exploring patterns of Web usage, which enabled further analyses of whether different usage patterns were associated with participant characteristics or differences in intervention outcome. Further usage of visualization techniques is recommended to (1) make sense of large datasets more quickly and efficiently; (2) determine the likely active ingredients in Web-based interventions, and thereby enhance the benefit they may provide; and (3) guide in designing (or redesigning) of future interventions to promote greater use and engagement by enabling users to easily access valued intervention content/tools. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 31685626; http://www.isrctn.com/ISRCTN31685626 (Archived by WebCite at http://www.webcitation.org/6YXYIw9vc).

Using mixed methods to develop and evaluate an online weight management intervention.

PURPOSE: This article illustrates the use of mixed methods in the development and evaluation of the Positive Online Weight Reduction (POWeR) programme, an e-health intervention designed to support sustainable weight loss. The studies outlined also explore how human support might enhance intervention usage and weight loss. METHODS: Mixed methods were used to develop and evaluate POWeR. In the development phase, we drew on both quantitative and qualitative findings to plan and gain feedback on the intervention. Next, a feasibility trial, with nested qualitative study, explored what level of human support might lead to the most sustainable weight loss. Finally, a large community-based trial of POWeR, with nested qualitative study, explored whether the addition of brief telephone coaching enhances usage. RESULTS: Findings suggest that POWeR is acceptable and potentially effective. Providing human support enhanced usage in our trials, but was not unproblematic. Interestingly, there were some indications that more basic (brief) human support may produce more sustainable weight loss outcomes than more regular support. Qualitative interviews suggested that more regular support might foster reliance, meaning patients cannot sustain their weight losses when support ends. Qualitative findings in the community trial also suggested explanations for why many people may not take up the opportunity for human support. CONCLUSIONS: Integrating findings from both our qualitative and quantitative studies provided far richer insights than would have been gained using only a single method of inquiry. Further research should investigate the optimum delivery of human support needed to maximize sustainable weight loss in online interventions. Statement of contribution What is already known on this subject? There is evidence that human support may increase the effectiveness of e-health interventions. It is unclear what level of human support might be optimal or how human support improves effectiveness. Triangulation of quantitative and qualitative methods can be used to inform the design and implementation of interventions What does this study add? This paper demonstrates the value of a mixed methods approach when developing and evaluating an intervention. Qualitative methods provided complementary insights into the optimal level of human support. Brief human support is valued by some and may enhance usage and outcomes of an e-health intervention for weight loss.

Understanding usage of a hybrid website and smartphone app for weight management: a mixed-methods study.

BACKGROUND: Advancements in mobile phone technology offer huge potential for enhancing the timely delivery of health behavior change interventions. The development of smartphone-based health interventions (apps) is a rapidly growing field of research, yet there have been few longitudinal examinations of how people experience and use these apps within their day-to-day routines, particularly within the context of a hybrid Web- and app-based intervention. OBJECTIVE: This study used an in-depth mixed-methods design to examine individual variation in (1) impact on self-reported goal engagement (ie, motivation, self-efficacy, awareness, effort, achievement) of access to a weight management app (POWeR Tracker) when provided alongside a Web-based weight management intervention (POWeR) and (2) usage and views of POWeR Tracker. METHODS: Thirteen adults were provided access to POWeR and were monitored over a 4-week period. Access to POWeR Tracker was provided in 2 alternate weeks (ie, weeks 1 and 3 or weeks 2 and 4). Participants' goal engagement was measured daily via self-report. Mixed effects models were used to examine change in goal engagement between the weeks when POWeR Tracker was and was not available and whether the extent of change in goal engagement varied between individual participants. Usage of POWeR and POWeR Tracker was automatically recorded for each participant. Telephone interviews were conducted and analyzed using inductive thematic analysis to further explore participants' experiences using POWeR and POWeR Tracker. RESULTS: Access to POWeR Tracker was associated with a significant increase in participants' awareness of their eating (ß1=0.31, P=.04) and physical activity goals (ß1=0.28, P=.03). The level of increase varied between individual participants. Usage data showed that participants used the POWeR website for similar amounts of time during the weeks when POWeR Tracker was (mean 29 minutes, SD 31 minutes) and was not available (mean 27 minutes, SD 33 minutes). POWeR Tracker was mostly accessed in short bursts (mean 3 minutes, SD 2 minutes) during convenient moments or moments when participants deemed the intervention content most relevant. The qualitative data indicated that nearly all participants agreed that it was more convenient to access information on-the-go via their mobiles compared to a computer. However, participants varied in their views and usage of the Web- versus app-based components and the informational versus tracking tools provided by POWeR Tracker. CONCLUSIONS: This study provides evidence that smartphones have the potential to improve individuals' engagement with their health-related goals when used as a supplement to an existing online intervention. The perceived convenience of mobile access to information does not appear to deter use of Web-based interventions or strengthen the impact of app access on goal engagement. A mixed-methods design enabled exploration of individual variation in daily usage of the app-based tools.