Data from four consecutive cohorts of students in Australia (2019-2022) show the impact of the COVID-19 pandemic on domestic and international university students' mental health.

INTRODUCTION: COVID-19 and related travel and social restrictions caused significant stress for university students in Australia and globally. Learning quickly moved online and many students (particularly international students) were separated from social and economic support. This study examined the impact of the pandemic from pre-pandemic (2019) to the COVID-19 Omicron wave (2022) on domestic and international students' mental health. METHODS: Participants were 1540 students (72% females, 28% international) in four first-year cohorts (2019, 2020, 2021, 2022). We screened for mental health concerns (% positive) and symptom scores for depression, anxiety and somatic distress using the PsyCheck, and general wellbeing using the Warwick-Edinburgh Mental Well-being scale. RESULTS: From pre-COVID (2019) to the first wave of COVID-19 (2020), the proportion of students screening positive for mental health problems rose in both domestic students (66-76%) and international students (46-67%). Depression symptoms and wellbeing were worse in 2020 than in 2019, 2021 and 2022. Anxiety symptoms increased from 2019 to 2020 and continued to rise in 2021 and 2022. Somatic symptoms did not show an effect of cohort. Contrary to expectations, domestic students reported higher distress and lower wellbeing than international students across cohorts. CONCLUSION: The pandemic was associated with a marked increase in psychological distress in first-year university students, not all of which settled with the easing of restrictions. Post-pandemic recovery in the Australian university sector must include university-wide access to mental health information and support for incoming students.

Three-year outcomes of an optometrist-led virtual clinic for new glaucoma referrals.

INTRODUCTION: The purpose of this study was to describe and evaluate the outcomes of an optometrist-led virtual glaucoma clinic (VGC). METHODS: New patients referred to the glaucoma service who were consultant triaged as 'low risk' were assessed virtually by specialist-trained optometrists in the VGC and either discharged or monitored for a period of 3 years. Ten percent of virtual case notes were audited by a glaucoma consultant to verify quality and generate learning objectives. Retrospective case-note review and analysis of all patients seen in the virtual clinic between 2014 and 2016 was undertaken to determine 3-year outcomes. RESULTS: A total of 1710 new patients were seen in the clinic between 1 January 2014 and 31 December 2016. Of these, 1033 (60.4%) patients required no outpatient input in 3 years of follow-up. Additionally, 320 (18.7%) were discharged at the first visit, and the proportion of glaucoma suspect and ocular hypertension patients who converted to glaucoma was 12.1% and 5.8%, respectively. At 3 years, 95 patients had died, 159 were lost to follow-up, 576 were discharged and 371 were diagnosed with glaucoma at baseline or during the 3-year follow-up. The cumulative discharge proportion from the service at the end of 3 years was 82.6%. No patients required emergency eye treatment or sight-impairment registration, and of the 12 referred back to the clinic on discharge, only five required ongoing monitoring. CONCLUSION: This optometrist-led VGC combined two aspects of novel service delivery to reduce the burden of glaucoma monitoring in outpatient departments and consolidate consultant contact to patients requiring more intervention. This model will be of value in units establishing virtual services and looking to expand the role of allied health professionals.

A world together: Global citizen identification as a basis for prosociality in the face of COVID-19.

How do global citizens respond to a global health emergency? The present research examined the association between global citizen identification and prosociality using two cross-national datasets-the World Values Survey (Study 1, N = 93,338 from 60 countries and regions) and data collected in 11 countries at the start of the COVID-19 pandemic (Study 2, N = 5,427). Results showed that individuals who identified more strongly as global citizens reported greater prosociality both generally (Study 1) and more specifically in the COVID-19 global health emergency (Study 2). Notably, global citizen identification was a stronger predictor of prosociality in response to COVID-19 than national identification (Study 2). Moreover, analyses revealed that shared ingroup identity accounted for the positive association between global citizen identification and prosociality (Study 2). Overall, these findings highlight global citizenship as a unique and promising direction in promoting prosociality and solidarity, especially in the fight against COVID-19.

Experiments make a good breakfast, but a poor supper.

Cesario's analysis has three key flaws. First, the focus on whether an effect is "real" (an "effects flaw") overlooks the importance of theory testing. Second, obsession with effects (a "fetishization flaw") sidelines theoretically informed questions about when and why an effect may arise. Third, failure to take stock of cultural and historical context (a "decontextualization flaw") strips findings of meaning.

Social Media Listening to Understand the Lived Experience of Presbyopia: Systematic Search and Content Analysis Study.

BACKGROUND: Presbyopia is defined as the age-related deterioration of near vision over time which is experienced in over 80% of people aged 40 years or older. Individuals with presbyopia have difficulty with tasks that rely on near vision. It is not currently possible to stop or reverse the aging process that causes presbyopia; generally, it is corrected with glasses, contact lenses, surgery, or the use of a magnifying glass. OBJECTIVE: This study aimed to explore how individuals used social media to describe their experience of presbyopia with regard to the symptoms experienced and the impacts of presbyopia on their quality of life. METHODS: Social media sources including Twitter, forums, blogs, and news outlets were searched using a predefined search string relating to symptoms and impacts of presbyopia. The data that were downloaded, based on the keywords, underwent manual review to identify relevant data points. Relevant posts were further manually analyzed through a process of data tagging, categorization, and clustering. Key themes relating to symptoms, impacts, treatment, and lived experiences were identified. RESULTS: A total of 4456 social media posts related to presbyopia were identified between May 2017 and August 2017. Using a random sampling methodology, we selected 2229 (50.0%) posts for manual review, with 1470 (65.9%) of these 2229 posts identified as relevant to the study objectives. Twitter was the most commonly used channel for discussions on presbyopia compared to forums and blogs. The majority of relevant posts originated in Spain (559/1470, 38.0%) and the United States (426/1470, 29.0%). Of the relevant posts, 270/1470 (18.4%) were categorized as posts written by individuals who have presbyopia, of which 37 of the 270 posts (13.7%) discussed symptoms. On social media, individuals with presbyopia most frequently reported experiencing difficulty reading small print (24/37, 64.9%), difficulty focusing on near objects (15/37, 40.5%), eye strain (12/37, 32.4%), headaches (9/37, 24.3%), and blurred vision (8/37, 21.6%). 81 of the 270 posts (30.0%) discussed impacts of presbyopia-emotional burden (57/81, 70.4%), functional or daily living impacts (46/81, 56.8%), such as difficulty reading (46/81, 56.8%) and using electronic devices (21/81, 25.9%), and impacts on work (3/81, 3.7%). CONCLUSIONS: Findings from this social media listening study provided insight into how people with presbyopia discuss their condition online and highlight the impact of presbyopia on individuals' quality of life. The social media listening methodology can be used to generate insights into the lived experience of a condition, but it is recommended that this research be combined with prospective qualitative research for added rigor and for confirmation of the relevance of the findings.

Developing Governance Structures in Health Care System Consolidation: A Framework for Nurse Leaders.

Given the acceleration and increasing complexity of integrative care models across health systems, the question how governance and management structure(s) should be operationalized and evolved to achieve peak system performance is paramount. In a recent evaluation of partnerships with the University of Kentucky HealthCare (UK HealthCare), the conceptualization of the integration management model was explored. It was recognized that nursing leadership, governance structure, and relationships are vital for successful movement and migration of appropriate care models. In this case, the evolving governance models and the forecasted impact on models of care delivery were carefully considered. This included the potential impact on nursing practice. As the model was developed, a conceptual framework was utilized to examine potential variant relationship arrangements and to provide organization to key constructs. Utilization of a blueprint to optimize decision making and provide a replicable approach was essential to management of the integration philosophy.

A latent profile analysis of the nature of social group memberships and their contribution to retirement outcomes.

Positive experiences of groups (e.g., the extent to which groups are important and supportive) tend to be associated with better retirement adjustment outcomes. However, group experiences are not always positive, and we know little about their varied contribution to adjustment outcomes. We addressed this gap by exploring the nature of social group memberships - in terms of varying positive and negative experiences of groups - to better understand how social group memberships shape retirement adjustment, life satisfaction and mental health. A latent profile analysis (using data from 489 retirees and their membership of 1887 groups) identified four profiles of social group memberships: optimal (63%), slightly straining (13%), low-supportive (18%) and ambivalent (6%). Subsequent regression analysis showed that these different profiles of group membership were differentially associated with retirement adjustment outcomes: belonging to more optimal groups was associated with better perceived adjustment, higher life satisfaction and better mental health, while belonging to slightly straining and ambivalent groups contributed to poorer adjustment, lower life satisfaction and greater depression. These findings have implications for theory and practice, not least because they advance our understanding of the diversity of people's group memberships and their contribution to retirement and health outcomes.

Improving Assessment of Adherence Behaviors and Drivers: Targeted Literature Review and Concept Elicitation Interviews in Multiple Countries and Disease Populations.

Purpose: Medication adherence is crucial for achieving clinical goals. Medication adherence drivers and behaviors were explored across multiple conditions, countries, and medication schedules/modalities to develop a conceptual model of medication adherence, which could later be used to support development of a patient-reported outcome (PRO) measure of adherence. Patients and Methods: Targeted review of qualitative literature identified important medication adherence concepts. Fifty-seven qualitative concept elicitation interviews were conducted (USA n=21, Spain n=18, Germany n=18). Participants were prescribed medication for: hypertension (n=9), asthma (n=8), multiple myeloma (n=8), psoriasis (n=8), diabetes (n=7), depression (n=7), multiple sclerosis (n=7), and/or schizophrenia (n=6). Thematic analysis of verbatim transcripts was performed. Expert clinicians (n=3) provided input throughout. Results: Nine qualitative articles were selected for review from 2168 screened abstracts. Forty-two medication adherence concepts were reported and grouped into 10 domains. Eight forms of medication adherence were reported during interviews, along with 27 drivers of non-adherence, all of which were incorporated into a conceptual model. Participants reported skipping medication doses (n=36/57; 63.2%) or taking medication later in the day than prescribed (n=29/57; 50.9%). Common drivers of non-adherence included forgetfulness (n=35/57; 61.4%), being out of the usual routine (n=31/57; 54.4%) and being busy (n=22/57; 38.6%). US participants were more likely to report non-adherence due to low perceived efficacy (n=6/21, 28.6%) and cost (n=5/21, 23.8%) than German (n=1/18, 5.6%; n=0/18, 0.0%) or Spanish (n=2/18, 11.1%; n=1/18, 5.6%) participants. Conclusion: Findings highlight the diverse forms and drivers of medication non-adherence, informing the development of a comprehensive conceptual model of medication adherence. The conceptual model builds on and advances previous models of medication adherence and can be used by healthcare professionals to understand and interpret barriers to medication adherence and how best to support patients in taking their medication as intended.

Medication adherence is the extent to which a patient takes their medication as prescribed. This paper describes a literature review and concept elicitation interviews to identify forms and drivers of medication adherence across a diverse sample of participants. Forms of non-adherence identified included: deviating from the prescription, skipping a dose, taking a different amount, and taking medication at a different time. Behaviours and drivers can vary by condition, treatment modality, and dosing schedule.This research highlights the variation in the prevalence of medication non-adherence, and the different forms and drivers of non-adherence, based on individuals' demographic and clinical characteristics. The conceptual model developed advances previous models of medication adherence and may support healthcare professionals in the management of patients and how they can be supported to take medication as intended. The research ultimately informed the development of the Adelphi Adherence Questionnaire (ADAQ^©), a novel generic patient-reported outcome measure.

Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items.

BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.

Qualitative Research to Understand the Patient Experience and Evaluate Content Validity of the Chronic Ocular Pain Questionnaire (COP-Q).

INTRODUCTION: Chronic ocular surface pain (COSP) is described as a persistent, moderate-to-severe pain at the ocular surface lasting more than 3 months. Symptoms of COSP have a significant impact on patients' vision-dependent activities of daily living (ADL) and distal health-related quality of life (HRQoL). To adequately capture patient perspectives in clinical trials, patient-reported outcome (PRO) measures must demonstrate sufficient evidence of content validity in the target population. This study aimed to explore the patient experience of living with COSP and evaluate content validity of the newly developed Chronic Ocular Pain Questionnaire (COP-Q) for use in COSP clinical trials. METHODS: Qualitative, combined concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 24 patients experiencing COSP symptoms in the USA. Interviews were supplemented with real-time data collection via a daily diary app task in a subset of patients (n = 15) to explore the day-to-day patient experience. Three healthcare professionals (HCPs) from the USA, Canada, and France were also interviewed to provide a clinical perspective. CE results were used to further inform development of a conceptual model and to refine PRO items/response options. CD interviews assessed relevance and understanding of the COP-Q. Interviews were conducted across multiple rounds to allow item modifications and subsequent testing. RESULTS: Eye pain, eye itch, burning sensation, eye dryness, eye irritation, foreign body sensation, eye fatigue, and eye grittiness were the most frequently reported symptoms impacting vision-dependent ADL (e.g., reading, using digital devices, driving) and wider HRQoL (e.g., emotional wellbeing, social functioning, work). COP-Q instructions, items, and response scales were understood, and concepts were considered relevant. Feedback supported modifications to instruction/item wording and confirmed the most appropriate recall periods. CONCLUSIONS: Findings support content validity of the COP-Q for use in COSP populations. Ongoing research to evaluate psychometric validity of the COP-Q will support future use of the instrument in clinical trial efficacy endpoints.

A virtual culinary medicine intervention for ethnically diverse individuals with type 2 diabetes: development of the Nourishing the Community through Culinary Medicine.

Virtual culinary medicine education interventions have the potential to improve dietary behaviors, nutrition knowledge, cooking skills, and health outcomes for ethnically diverse individuals with type 2 diabetes. The purpose of this study is to describe the adaptation of the Nourishing the Community through Culinary Medicine (NCCM) program for virtual delivery, and the protocol for pilot testing this intervention. The intervention includes five 90-min virtual NCCM sessions streamed live from a Teaching Kitchen. Feasibility outcomes are recruitment, retention, acceptability, and satisfaction. Short-term effectiveness outcomes are measured through self-administered questionnaires, including perceived health, average daily servings of fruits and vegetables, frequency of healthy food consumption, shopping, cooking, and eating behaviors, cooking self-efficacy, diabetes self-management, perceived barriers to healthy eating, and nutrition knowledge. Demographics and biometric outcomes are sourced from the patient's electronic medical records including glycosylated hemoglobin (HbA1c), Body Mass Index, and blood pressure. We will conduct a single-arm pilot study to test the feasibility and short-term effectiveness of NCCM program with individuals with type 2 diabetes.

More than sport: A social-identity intervention to support transitions out of elite sport.

Elite athletes often make large personal sacrifices to pursue excellence, but there is insufficient support for them when they leave elite sport. Identity loss is central to athletes' transition trajectories and hence the management of identity change is a crucial area for support. The More Than Sport (MTS) program is a novel digital intervention that aims to provide this support-helping athletes manage identity change in the process of leaving elite sport. The present research aims to study elite athletes' experiences with the MTS program and their perceptions of its usefulness in managing the transition away from elite sport. We undertook a qualitative study with athletes (N = 25) from three countries (the United Kingdom, Australia and Belgium) using reflexive thematic analysis to explore their experiences of the program and their feedback on program content. We identified three key themes and eight subthemes. The first key theme was Value of the Program, and this was underpinned by four sub-themes that centred on Program importance and novelty, how Positive and confronting experiences afford insight, the Value of developing shared understanding, and Realising the value of social groups. The second key theme was Engagement with Program Elements and here participants commented on Program content and Delivery format. The final key theme was Time and Place for Identity Management Programs which included the sub-themes of Optimal timing and Additional program beneficiaries. Overall, the results highlight the value of MTS specifically, and identity management efforts more broadly, to help elite athletes adjust successfully to life beyond sport.

"I'm more than my sport": Exploring the dynamic processes of identity change in athletic retirement.

Retirement is one of the most impactful career transitions athletes face. Researchers recognise the role that athletic identity plays in this, but analysis of identity content and change processes is limited. Addressing this gap, we conducted a qualitative study exploring the experience of identity change in 21 competitive and successful elite athletes who had retired from sport. All participated in a one-session psychoeducational program that explored the challenges of transitioning out of sport before being interviewed about their understanding of identity in sport, and their experiences negotiating identity loss and change in retirement. Using reflexive thematic analysis, we identified three themes: (i) the role of identity and self-categorizations in shaping sport performance, (ii) adjusting to identity loss (with subthemes indicating that this experience varied depending on the extent to which a person had multiple or exclusive identities), and (iii) attempts to remoor identity in the transition (with subthemes of searching for a new identity and actively repurposing identity). We interpret these themes through the lens of the Social Identity Model of Identity Change and show that this provides a framework for extending our understanding the complexities of identity change associated with retirement from elite sport.

A longitudinal examination of the role of social identity in supporting health and well-being in retirement.

Social factors are major determinants of the success of retirement transitions. However, we do not yet fully understand the nature and basis of this impact, particularly as it relates to social group belonging. To address this issue the present article investigated the role that social group memberships play in supporting people's health and well-being in the early phase of transitioning to retirement. More specifically, we drew on the social identity model of identity change (SIMIC) to examine two pathways in which social group processes are theorized to influence adjustment to life change-social identity continuity and social identity gain. To test these pathways, a sample of Australian workers who had transitioned to retirement in the last 12 months (N = 170) were surveyed about their (a) preretirement multiple group memberships and postretirement maintained and new group memberships and (b) their perceived physical health, mental health, and life satisfaction after retirement. While preretirement group memberships did not affect retirement outcomes directly, they supported them indirectly by enabling people both to maintain some existing group memberships and to gain some new group memberships postretirement; as predicted by SIMIC. These findings confirm the importance of social factors and of social group membership in particular, for retiree health and well-being. Theoretically, they support the generalizability of SIMIC and its capacity to explain adjustment to diverse life changes including retirement. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Developing engaged and 'teamful' leaders: A randomized controlled trial of the 5R identity leadership program.

The social identity approach to leadership argues that leaders' capacity to influence and inspire others is grounded in a shared sense of social identity (or 'us-ness') that those leaders create, advance, represent, and embed for the groups they lead. The approach therefore argues that a key task for leaders is to develop insights and skills of (social) identity leadership that allow them to motivate and mobilize groups and transform them into a potent social and organizational force. In contrast to other approaches and programs which focus on leaders' leader identity (their 'I-ness'), the 5R leadership development program supports the development of leaders' social identity by raising awareness of the importance of social identity ('we-ness') for leadership and taking leaders through structured activities that help them build engaged and inclusive teams. The present research assessed the benefits of facilitated and learner self-directed versions of the 5R program (Ns = 27, 22 respectively) relative to a no-treatment control (N = 27). Results (including those of an intention-to-treat analysis; N = 76) indicated that, relative to leaders in the control condition, those who participated in both forms of 5R reported large increases in identity leadership knowledge, as well as medium-sized increases in both team engagement (a compound factor comprised of team identification, team OCB, team efficacy, and work engagement) and 'teamfulness' (comprised of team reflexivity, team psychological safety, team goal clarity, and inclusive team climate). We reflect on the importance of teamfulness for leadership and team functioning and on the value of programs that help leaders develop this.

Comparison of Literature Review, Social Media Listening, and Qualitative Interview Research Methods in Generating Patient-Reported Symptom and Functional Impact Concepts of Presbyopia.

INTRODUCTION: To compare the insights obtained about the experience of individuals with presbyopia (age-related impaired near vision) across three different sources of qualitative data: a structured targeted literature review, a social media listening (SML) review, and qualitative concept elicitation (CE) interviews with individuals with presbyopia and healthcare professionals (HCPs). The number of concepts identified, depth of data, cost and time implications, and value of the patient insights generated were explored and compared for each method. METHODS: Keyword searches in bibliographic databases and review of abstracts identified 120 relevant publications; in-depth targeted literature review of the qualitative studies identified key symptoms/functioning concepts. SML was conducted using publicly accessible social media sources with focus on ophthalmologic diseases using a pre-defined search string. Relevant posts from individuals with presbyopia (n = 270) were analysed and key concepts identified. Semi-structured CE interviews were conducted with individuals with presbyopia (US n = 30, Germany n = 10, France n = 10), and HCPs (US = 3, France n = 2, Germany n = 1, Japan n = 1) who were experienced in treating presbyopia. Verbatim transcripts were coded using thematic analysis. A conceptual model summarised concepts identified across sources RESULTS: Out of the total of 158 concepts identified across the three sources, qualitative CE interviews yielded the highest number of concepts (n = 151/158, 96%), with SML yielding a third of the concepts (n = 51/158, 32%) and the literature review yielding the fewest concepts (n = 33/158, 21%). Qualitative CE interviews provided greater depth of data than SML and literature reviews. SML and literature reviews were less costly and quicker to run than qualitative CE interviews and also were less burdensome for participants. CONCLUSION: Qualitative CE interviews are considered the gold standard in providing greater depth of understanding of the patient experience, and more robust data. However, research requirements, budget, and available time should be considered when choosing the most appropriate research method. More time and cost-effective SML and literature review methods can be used to supplement qualitative CE interview data and provide early identification of measurement concepts. More research and regulatory guidance into less traditional qualitative methods, however, are needed to increase the value of SML and literature review data.

Development and content validity assessment of the Dry Eye Disease Questionnaire in patients with dry eye disease, meibomian gland dysfunction, and Sjögren's syndrome dry eye disease.

BACKGROUND: Dry eye disease (DED), Meibomian gland dysfunction (MGD), and Sjögren's syndrome dry eye disease (SS-DED) are eye dryness conditions that show significant overlap in various symptoms of ocular discomfort. The aim of this study was to qualitatively explore the patient experience and evaluate content validity of the newly developed Dry Eye Disease Questionnaire (DED-Q). METHODS: Semi-structured interviews were conducted with 61 US adults who reported experiencing ocular symptoms due to their physician-confirmed primary diagnosis of DED (n = 21), MGD (n = 20), or SS-DED (n = 20). The open-ended concept-elicitation phase was followed by cognitive debriefing (CD) of the DED-Q to evaluate participants' understanding and relevance of the instructions, items, response options, and recall periods. Interviews were also conducted with eight specialist healthcare professionals to assess clinical relevance of the concepts included. Verbatim interview transcripts were analyzed using thematic analysis in ATLAS.ti v8 software. RESULTS: A total of 29 symptoms and 14 impacts on quality of life were reported across participant interviews. Primary ocular symptoms reported included eye dryness (n = 61/61; 100%), eye irritation (n = 55/61; 90%), eye itch (n = 54/61; 89%), burning sensation (n = 52/61; 85%), and foreign body sensation (n = 51/61; 84%). The most impacted aspects of daily life were using digital screens (n = 46/61; 75%), driving (n = 45/61; 74%), working (n = 39/61; 64%), and reading (n = 37/61; 61%). CD findings showed most participants had good understanding of DED-Q items and confirmed most concepts were relevant to the lived experience of their condition. Aside from few minor changes to the items and examples to facilitate more accurate interpretation, the proposed instruction wording was modified for various symptom and impact modules to encourage participants to focus only on dry eye vision problems. CONCLUSIONS: This research identified multiple prevalent symptoms and impacts of DED, MGD, and SS-DED, most of which were similar across the conditions. The DED-Q was confirmed to be a content-valid PRO measure suitable for use in clinical studies to assess the patient experience of DED, MGD, and SS-DED. Future work will focus on evaluating the psychometric properties of the DED-Q for use as an efficacy endpoint in clinical trials.

Dry Eye Disease (DED), Meibomian Gland Dysfunction (MGD), and Sjögren's Syndrome Dry Eye Disease (SS-DED) are conditions related to dryness of the eye. There is no suitable patient-reported outcome (PRO) measure available for use across the three conditions. Interviews were conducted with 61 participants with any of the three conditions to understand the symptoms they experience and their impact on daily life. The findings were used to refine the content of a new PRO measure, the Dry Eye Disease Questionnaire (DED-Q). To evaluate the suitability of the DED-Q, participants were also asked to complete each item of the DED-Q during the interview and share their understanding of the item wording, response options and the recall period. Interviews were also conducted with eight healthcare professionals (HCPs). The main symptoms reported by the patients across three conditions were eye dryness, eye irritation, eye itch, burning sensation, and foreign body sensation. The symptoms caused difficulties in performing activities such as using digital screens, driving, working, and reading. Almost all participants demonstrated good understanding of the items on the DED-Q and found them to be relevant to their experience of their condition. The HCPs also confirmed that the concepts covered in the DED-Q were relevant to assess the participant experience across these conditions. Next steps will involve a more detailed analysis of the measurement properties of the DED-Q to confirm its usefulness in supporting primary or secondary endpoints in clinical trials.

Content validation of a caregiver diary to monitor severity and recovery of pediatric patients with respiratory syncytial virus infection.

BACKGROUND: Respiratory Syncytial Virus (RSV) is a leading cause of hospitalization and serious respiratory illness in infants/young children. The objectives of this study were to (1) identify important RSV-related signs of illness in infants that were observed by the parent/caregiver of the child and (2) assess content validity and usability of the Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) to monitor signs of RSV-related illness. METHODS: Review of medical literature identified signs of pediatric RSV-related illness in PRESORS. Semi-structured interviews with caregivers of infants (0-24 months of age) hospitalized with laboratory-confirmed RSV infection (in the two months prior to recruitment) were conducted to spontaneously elicit signs and impacts of the infant's illness from caregiver observations. Caregivers completed PRESORS using a "think-aloud" protocol to confirm comprehension, relevance, and usability of the smartphone application. Verbatim transcripts were analyzed using thematic analysis methods and Atlas.ti software. RESULTS: Interviews with 21 caregivers confirmed PRESORS captured 23/26 signs caregivers spontaneously reported. Cough, difficulty breathing, problems sleeping, and reduced feeding/drinking were the most worrying signs of severe RSV-related illness described. Cognitive debriefing indicated that caregivers: understood the wording of all PRESORS items and response options (except how to count heartbeats), recall periods were appropriate, and the PRESORS smartphone application was easy to use. Minor changes to enhance content validity were identified. CONCLUSIONS: In-depth interviews confirmed content validity and usability of the PRESORS by caregivers of infants with RSV. Next steps are to assess the revised PRESORS in clinical studies and evaluate its measurement properties.

GROUPS 2 CONNECT: An online activity to maintain social connection and well-being during COVID-19.

COVID-19 has had significant negative consequences for well-being. As well as the primary effects of the virus itself, secondary effects have resulted from the social isolation caused by the lockdowns imposed to slow the spread of the virus. Recognising the toxic effects of isolation, researchers, practitioners and policy-makers are conscious of the need to mitigate the negative effects of social distancing. Drawing on insights from a large body of research on the Social Identity Approach to Health, we devised an online activity-GROUPS 2 CONNECT (G2C)-aimed at helping people to maintain social connectedness when face-to-face interaction was not possible. Across four studies (N = 1021), we found that after completing the G2C activity, participants reported an increase in perceived quality of social connection, perceived ability to stay connected and well-being, with results showing that for two of the three longitudinal studies these uplifts were stable over time, and for all studies, the uplifts remained consistently higher for those who reported completing their social connection goals. These findings provide initial evidence of the value of G2C as a tool to support social connection, thereby reducing the risk of social isolation.

"Let's get physical" - or social: The role of physical activity versus social group memberships in predicting depression and anxiety over time.

BACKGROUND: Physical activity is often promoted as a way to prevent and combat anxiety and depression in adolescents. However, very little research has sought to establish whether the benefits of exercise arise from the excercise itself or from the social context in which it takes place. We explore the hypothesis that it is not physical activity on its own, but rather adolescents' engagement in group life (as part of a sports group or otherwise), that accounts for positive mental health effects associated with physical activity. METHODS AND RESULTS: We conducted a longitudinal study that tracked 558 high-school boys and found that anxiety and depression over time was not predicted by (a) T1 physical fitness as determined by 7 speed and agility tests, or (b) engaging in multiple sports as co-curricular activies at T1. In contrast, multiple group memberships - irrespective of the activity - predicted reduced depression and anxiety over time, particularly when these were groups that adolescents identified with and experienced as compatible with each other. LIMITATIONS: Limitations relate to (a) physical fitness only being measured at T1, (b) the absence of a measure of frequency and duration of physical activity, and (c) the homogeneity of the sample. CONCLUSIONS: We conclude that group memberships and the social identities that adolescents derive from these groups (including, but not restricted to, those involving sport) function as a psychological resource to reduce anxiety and depression over time.