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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.

Agricultural pests present a significant challenge to humanity, often managed through synthetic chemicals that, when misused, can cause irreversible harm to both the environment and human health. This study focuses on endemic plants from the Yucatán Peninsula in Mexico, particularly from the state of Campeche, to identify their historical uses and propose an updated list of species with pesticide potential in the region. We systematically reviewed specimens from the Center for Sustainable Development and Wildlife Management (CEDESU) herbarium and local databases. Of the 3084 specimens collected, 2524 (81.84%) were from Campeche. The collection encompasses 106 botanical families, 459 genera, and 747 species. The study identified 201 plant species from 48 taxonomic families that are endemic to the Yucatán Peninsula Biotic Province (YPBP), of which 123 species are exclusive to the Mexican Yucatán Peninsula (MYP), representing 61.19% of the endemic species. Campeche contains 134 species (66.66%), distributed across 96 genera and 43 families. Notably, 46.26% of the species (62 species) belong to the Mexican region, with 8 species (12.90%) exclusive to Campeche. The research revealed that 27.90% of the families and 19.79% of the genera present in the state have been the subject of previous scientific studies regarding their use as pesticides. The most extensively studied families were Euphorbiaceae and Fabaceae. However, there is a notable lack of research on endemic plants from the Yucatán Peninsula, underscoring the need for increased attention to these species. The identified genera and families contain chemical compounds with activity against significant pests, demonstrating substantial potential for the development of natural pesticides.

OBJECTIVES/GOALS: Weaimed to compare subjective and objective sleep in individuals with chronic post-concussive symptoms. We hypothesized an association between self-reported sleep quality and objective sleep parameters, which is different for concussed and control cohorts. METHODS/STUDY POPULATION: 28 individuals with chronic post-concussive symptoms and 13 age-matched controls (no concussion history) completed the ISI, PSQI, PROMIS Depression, Anxiety, Stress and Cognitive questionnaires at enrollment. Objective sleep parameters were obtained for a minimum of 7 days and up to 30 days with a validated sleep monitoring device placed under the subject’s bed (Emfit). For each night, raw activity data per minute were analyzed to determinein-bed, sleep, wake, andout-of-bedtimes. These measures were used to calculate total sleep time (TST), sleep onset latency (SOL), and wake after sleep onset (WASO) for each night. RESULTS/ANTICIPATED RESULTS: Concussed individuals reported worse sleep with PSQI and ISI scores significantly higher than controls. They also showedsignificant associations between PSQI and Dep ression, ISI and Depression, and ISI and Anxiety scores. There was no difference between objective sleep parameters in the concussed and control cohorts (in-bed/sleep/wake/out-of-bed times, TST, SOL, and WASO). Instead, higher PSQI, ISI, Depression, Anxiety, and Stress scores (greater symptom burden) were all associated with later sleep times, where as higher Cognitive scores (greater cognitive function) were associated with earlier sleep times, regardless of group status. DISCUSSION/SIGNIFICANCE: Concussed individuals report worse subjective sleep but no differences to controls when objectively assessing sleep. Depression/anxiety, and not concussion status, determine objective sleep parameters. Psychiatric comorbidities should inform the treatment of post-concussive sleep disturbances.

Abstract Ocean Acidification (OA), due to rising atmospheric CO2, can affect the seagrass holobiont by changing the plant's ecophysiology and the composition and functioning of its epiphytic community. However, our knowledge of the role of epiphytes in the productivity of the seagrass holobiont in response to environmental changes is still very limited. CO2 vents off Ischia Island (Italy) naturally reduce seawater pH, allowing to investigate the adaptation of the seagrass Posidonia oceanica L. (Delile) to OA. Here, we analyzed the percent cover of different epiphytic groups and the epiphytic biomass of P. oceanica leaves, collected inside (pH 6.9–7.9) and outside (pH 8.1–8.2) the CO2 vents. We estimated the contribution of epiphytes to net primary production (NPP) and respiration (R) of leaf sections collected from the vent and ambient pH sites in laboratory incubations. Additionally, we quantified net community production (NCP) and community respiration (CR) of seagrass communities in situ at vent and ambient pH sites using benthic chambers. Leaves at ambient pH sites had a 25% higher total epiphytic cover with encrusting red algae (32%) dominating the community, while leaves at vent pH sites were dominated by hydrozoans (21%). Leaf sections with and without epiphytes from the vent pH site produced and respired significantly more oxygen than leaf sections from the ambient pH site, showing an average increase of 47 ± 21% (mean ± SE) in NPP and 50 ± 4% in R, respectively. Epiphytes contributed little to the increase in R; however, their contribution to NPP was important (56 ± 6% of the total flux). The increase in productivity of seagrass leaves adapted to OA was only marginally reflected by the results from the in situ benthic chambers, underlining the complexity of the seagrass community response to naturally occurring OA conditions.

ObjectiveWe 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.MethodsIn 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.ResultsWe 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.ConclusionPeople 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.

Crying is an essential behaviour in infants, occurring on a continuum, and only rarely indicates serious underlying diagnosis. Searching online for information about excessive crying has become common, using the internet to seek health information and support through forums. The aim of this study was to examine data systematically derived from discussion threads on two online parent forums to explore discussions around excessive infant crying. This study utilised two qualitative approaches; the first, a thematic analysis to explore concerns around excessive crying, and the second, discursive psychology, to explore how diagnostic labels (underlying medical cause of crying) are negotiated within an online thread. The thematic analysis identified a tension between interpreting what is ‘normal’ crying and when crying is a sign of an ‘underlying problem’ leading to a search for a diagnostic label. This tension seemed to be heightened when expectations that infancy should be a ‘happy time’ were threatened by excessive crying. Responses to original posts offered support for parents/caregivers to ‘trust their instincts' and to explore different diagnostic labels. The discursive psychology analysis explored responders' accounts of their experiences to increase credibility and showcase expertise. Forums play an important social role, meeting needs for reassurance, validation, and empowerment. This study suggests that labels are used interchangeably, and further work is needed to understand how perceptions are developed and acted on in the community, as well as online. Furthermore, this study suggests there is a need for supporting parents/caregivers in understanding and managing common behaviours such as excessive crying.

Abstract 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.

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.

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.

IntroductionFalls 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.MethodsA 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.ResultsFour 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.ConclusionDyads 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.

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.

The use of Lagenaria siceraria rootstocks in watermelon production has favored fruit yield and quality under conditions of environmental stress. However, it is necessary to know if the differential characteristics of fruit and seed L. siceraria are related to watermelon yield and fruit in grafted plant. The objective was to evaluate two dissimilar groups of Mexican L. siceraria as rootstock in Tri-X 33 watermelon variety to relationship the morphological characteristics of rootstock with productive variables and fruit quality. The treatments were Tri-X 313 variety ungrafted and grafted with accessions of group 1 (L46 and L56) and group 2 (L48, L50 and L54). Variables evaluated were fruit and yield and quality parameters. No differences were found between groups of L. siceraria in fruit yield and external quality parameters. With the exception of pulp firmness and luminosity, LG1 surpassed group LG2 by 30.7 and 5.0%, respectively. While, when comparing grafted and ungrafted plants, it was found that grafted plants were superior, with increases of 277.8% in number of fruits per m2, 330.2% in commercial production, 54.6% in rind thickness, 85.2% in external firmness and 36.3% in chroma value of fruit pulp. Meanwhile, pulp percentage and hue were reduced by 13.8% and 15.5%, respectively, in grafted watermelons. Thus, the seed and fruit characteristics are not sufficient criteria to select L. siceraria rootstocks for watermelon production.

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.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.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.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.

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.15 MS patients participated in in-depth semi-structured interviews which were analysed using inductive thematic analysis.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.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.