Evaluation of a COVID-19 fundamental nursing care guideline versus usual care: The COVID-NURSE cluster randomized controlled trial.

AIM: To evaluate the impact of usual care plus a fundamental nursing care guideline compared to usual care only for patients in hospital with COVID-19 on patient experience, care quality, functional ability, treatment outcomes, nurses' moral distress, patient health-related quality of life and cost-effectiveness. DESIGN: Parallel two-arm, cluster-level randomized controlled trial. METHODS: Between 18th January and 20th December 2021, we recruited (i) adults aged 18 years and over with COVID-19, excluding those invasively ventilated, admitted for at least three days or nights in UK Hospital Trusts; (ii) nurses caring for them. We randomly assigned hospitals to use a fundamental nursing care guideline and usual care or usual care only. Our patient-reported co-primary outcomes were the Relational Aspects of Care Questionnaire and four scales from the Quality from the Patient Perspective Questionnaire. We undertook intention-to-treat analyses. RESULTS: We randomized 15 clusters and recruited 581 patient and 418 nurse participants. Primary outcome data were available for 570-572 (98.1%-98.5%) patient participants in 14 clusters. We found no evidence of between-group differences on any patient, nurse or economic outcomes. We found between-group differences over time, in favour of the intervention, for three of our five co-primary outcomes, and a significant interaction on one primary patient outcome for ethnicity (white British vs. other) and allocated group in favour of the intervention for the 'other' ethnicity subgroup. CONCLUSION: We did not detect an overall difference in patient experience for a fundamental nursing care guideline compared to usual care. We have indications the guideline may have aided sustaining good practice over time and had a more positive impact on non-white British patients' experience of care. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: We cannot recommend the wholescale implementation of our guideline into routine nursing practice. Further intervention development, feasibility, pilot and evaluation studies are required. IMPACT: Fundamental nursing care drives patient experience but is severely impacted in pandemics. Our guideline was not superior to usual care, albeit it may sustain good practice and have a positive impact on non-white British patients' experience of care. REPORTING METHOD: CONSORT and CONSERVE. PATIENT OR PUBLIC CONTRIBUTION: Patients with experience of hospitalization with COVID-19 were involved in guideline development and writing, trial management and interpretation of findings.

Diabetes Distress and Associations With Demographic and Clinical Variables: A Nationwide Population-Based Registry Study of 10,186 Adults With Type 1 Diabetes in Norway.

OBJECTIVE: To estimate diabetes distress prevalence and associations with demographic and clinical variables among adults with type 1 diabetes in Norway. RESEARCH DESIGN AND METHODS: In this nationwide population-based registry study, the 20-item Problem Areas in Diabetes (PAID-20) questionnaire was sent to 16,255 adults with type 1 diabetes. Linear regression models examined associations of demographic and clinical variables with distress. RESULTS: In total, 10,186 individuals (62.7%) completed the PAID-20, with a mean score of 25.4 (SD 18.4) and 21.7% reporting high distress. Respondents endorsed worrying about the future and complications as the most problematic item (23.0%). Female sex, younger age, non-European origin, primary education only, unemployment, smoking, continuous glucose monitoring use, more symptomatic hypoglycemia, reduced foot sensitivity, treated retinopathy, and higher HbA1c were associated with higher distress. CONCLUSIONS: Diabetes distress is common among adults with type 1 diabetes and associated with clinically relevant factors, underlining that regular care should include efforts to identify and address distress.

Evaluation of an interprofessional follow-up intervention among people with type 2 diabetes in primary care-A randomized controlled trial with embedded qualitative interviews.

With an ageing population and improved treatments people live longer with their chronic diseases, and primary care clinics face more costly and difficult-to-treat multimorbid patients. To meet these challenges, current guidelines for the management of type 2 diabetes suggest that an interprofessional team should collaborate to enhance the delivery of worthwhile self-management support interventions. In this study, we aimed to evaluate the effects of an empowerment-based interprofessional follow-up intervention in people with type 2 diabetes in primary care on patient-reported outcomes, biomarkers and weight, and to explore the experiences of patients attending the intervention. We invited patients during regular visits to their general practitioners. The 12-month intervention included 1) empowerment-based counselling; 2) a standardized medical report. The control group received consultations with physicians only. The primary outcome was the Patient Activation Measure, a patient-reported measure assessing individual knowledge, skills, and confidence integral to managing one's health and healthcare. After the trial we conducted qualitative interviews. We observed no difference in the primary outcome scores. On secondary outcomes we found a significant between-group intervention effect in favor of the intervention group, with mean differences in glycemic control after 12 months (B [95% CI] = -8.6 [-17.1, -0.1] mmol/l; p = 0.045), and significant within-group changes of weight (B [95% CI] = -1.8 kg [-3.3, -0.3]; p = 0.02) and waist circumference (B [95% CI] = -3.9 cm [-7.3, -0.6]; p = 0.02). The qualitative data showed that the intervention opened patients' eyes for reflections and greater awareness, but they needed time to take on actions. The patients emphasized that the intervention gave rise to other insights and a greater understanding of their health challenges. We suggest testing the intervention among patients with larger disease burden and a more expressed motivation for change.

An mHealth Intervention to Improve Guardians' Adherence to Children's Follow-Up Care for Acute Lymphoblastic Leukemia in Tanzania (GuardiansCan Project): Protocol for a Development and Feasibility Study.

BACKGROUND: Cancer is a leading cause of death during childhood and in low- and middle-income countries survival rates can be as low as 20%. A leading reason for low childhood cancer survival rates in low- and middle-income countries such as Tanzania is treatment abandonment. Contributing factors include poor communication between health care providers and children's guardians, insufficient cancer knowledge, and psychological distress. OBJECTIVE: Our aim is to respond to Tanzanian guardians' poor adherence to children's follow-up care after treatment for acute lymphoblastic leukemia with the help of mobile health (mHealth) technology. Our goal is to increase guardians' adherence to children's medications and follow-up visits and to decrease their psychological distress. METHODS: Following the Medical Research Council framework for developing and evaluating complex interventions, we will undertake the GuardiansCan project in an iterative phased approach to develop an mHealth intervention for subsequent testing. Public contribution activities will be implemented throughout via the establishment of a Guardians Advisory Board consisting of guardians of children with acute lymphoblastic leukemia. We will examine the acceptability, feasibility, and perceived impact of Guardians Advisory Board activities via an impact log and semistructured interviews (study I). In phase 1 (intervention development) we will explore guardians' needs and preferences for the provision of follow-up care reminders, information, and emotional support using focus group discussions and photovoice (study II). We will then co-design the mHealth intervention with guardians, health care professionals, and technology experts using participatory action research (study III). In phase 2 (feasibility), we will examine clinical, methodological, and procedural uncertainties associated with the intervention and study procedures to prepare for the design and conduct of a future definitive randomized controlled trial using a single-arm pre-post mixed methods feasibility study (study IV). RESULTS: Data collection for the GuardiansCan project is anticipated to take 3 years. We plan to commence study I by recruiting Guardians Advisory Board members in the autumn of 2023. CONCLUSIONS: By systematically following the intervention development and feasibility phases of the Medical Research Council Framework, and working alongside an advisory board of guardians, we intend to develop an acceptable, culturally appropriate, feasible, and relevant mHealth intervention with the potential to increase guardians' adherence to children's follow-up care after treatment of acute lymphoblastic leukemia, leading to a positive impact on children's health and chances to survive, and reducing distress for guardians. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48799.

Patient activation in adults attending appointments in general practice: a cross-sectional study.

BACKGROUND: Patient activation refers to patients' knowledge, confidence, skills, ability, beliefs, and willingness to manage their health and healthcare. Patient activation is an essential component of self-management and identifying patient activation levels will identify people at risk for health decline at an earlier stage. We aimed to explore patient activation in among adults attending general practice by (1) investigating differences in patient activation according to characteristics and markers of health-related behaviour; (2) examining the associations of quality of life and satisfaction with health with patient activation; and (3) comparing patient activation between persons with or without type 2 diabetes (T2D) and with or without elevated T2D risk. METHODS: We performed a cross-sectional study and recruited 1,173 adult patients from four Norwegian general practices between May to December 2019. The participants completed a questionnaire containing sociodemographic and clinical variables, the Patient Activation Measure (PAM-13), the quality of life and satisfaction with health items from the WHO Quality of Life-BREF, three questions about exercise (regularity, intensity and exercise time), the Finnish Diabetes Risk Score (FINDRISC) and Body Mass Index. We tested differences between groups and associations using Chi-squared tests, Fisher's exact tests, t-tests, one-way ANOVAs and Spearman's rho tests. RESULTS: The sample's mean PAM-13 score was 69.8 (0-100) (SD 14.8). In the total population, we found that participants reporting higher patient activation scores also reported more favourable health-related behaviours (exercise and healthy eating). We found positive correlations between the PAM-13 scores and, respectively, the quality of life score and the satisfaction with health score. We found no differences in patient activation between people with or without T2D and those with or without elevated T2D risk. CONCLUSIONS: We found that higher patient activation was associated with favourable health-related behaviours, a better quality of life and better satisfaction with health among adults attending four general practices in Norway. Assessing patient activation has the potential to help general practitioners identify patients who might benefit from closer follow-up in advance of negative health outcomes.

A multicomponent complex intervention for supportive follow-up of persons with chronic heart failure: a randomized controlled pilot study (the UTILE project).

BACKGROUND: Heart failure (HF) is a progressive disease associated with a high burden of symptoms, high morbidity and mortality, and low quality of life (QoL). This study aimed to evaluate the feasibility and potential outcomes of a novel multicomponent complex intervention, to inform a future full-scale randomized controlled trial (RCT) in Switzerland. METHODS: We conducted a pilot RCT at a secondary care hospital for people with HF hospitalized due to decompensated HF or with a history of HF decompensation over the past 6 months. We randomized 1:1; usual care for the control (CG) and intervention group (IG) who received the intervention as well as usual care. Feasibility measures included patient recruitment rate, study nurse time, study attrition, the number and duration of consultations, intervention acceptability and intervention fidelity. Patient-reported outcomes included HF-specific self-care and HF-related health status (KCCQ-12) at 3 months follow-up. Clinical outcomes were all-cause mortality, hospitalization and days spent in hospital. RESULTS: We recruited 60 persons with HF (age mean = 75.7 years, ± 8.9) over a 62-week period, requiring 1011 h of study nurse time. Recruitment rate was 46.15%; study attrition rate was 31.7%. Follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55), and 3.1 (mean, ± 1.7) additional telephone contacts. Intervention acceptability was high. Mean intervention fidelity was 0.71. We found a 20-point difference in mean self-care management change from baseline to 3 months in favour of the IG (Cohens' d = 0.59). Small effect sizes for KCCQ-12 variables; less IG participants worsened in health status compared to CG participants. Five deaths occurred (IG = 3, CG = 2). There were 13 (IG) and 18 (CG) all-cause hospital admissions; participants spent 8.90 (median, IQR = 9.70, IG) and 15.38 (median, IQR = 18.41, CG) days in hospital. A subsequent full-scale effectiveness trial would require 304 (for a mono-centric trial) and 751 participants (for a ten-centre trial) for HF-related QoL (effect size = 0.3; power = 0.80, alpha = 0.05). CONCLUSION: We found the intervention, research methods and outcomes were feasible and acceptable. We propose increasing intervention fidelity strategies for a full-scale trial. TRIAL REGISTRATION: ISRCTN10151805 , retrospectively registered 04/10/2019.

Nurses' strategies for overcoming barriers to fundamental nursing care in patients with COVID-19 caused by infection with the SARS-COV-2 virus: Results from the 'COVID-NURSE' survey.

AIMS: To identify strategies used by registered nurses and non-registered nursing care staff in overcoming barriers when providing fundamental nursing care for non-invasively ventilated inpatients with COVID-19. DESIGN: Online survey with open-ended questions to collect qualitative data. METHODS: In August 2020, we asked UK-based nursing staff to describe any strategies they employed to overcome barriers to delivering care in 15 fundamental nursing care categories when providing care to non-invasively ventilated patients with COVID-19. We analysed data using Framework Analysis. RESULTS: A total of 1062 nurses consented to participate in our survey. We derived four themes. 1) Communication behaviours included adapting verbal and non-verbal communication with patients, using information technology to enable patients' significant others to communicate with staff and patients, and establishing clear information-sharing methods with other staff. 2) Organizing care required clustering interventions, carefully managing supplies, encouraging patient self-care and using 'runners' and interdisciplinary input. 3) Addressing patients' well-being and values required spending time with patients, acting in loco familiae, providing access to psychological and spiritual support, obtaining information about patients' wishes early on and providing privacy and comforting/meaningful items. 4) Management and leadership behaviours included training, timely provision of pandemic information, psychological support, team huddles and facilitating regular breaks. CONCLUSIONS: Our respondents identified multiple strategies in four main areas of clinical practice. Management and leadership are crucial to both fundamental care delivery and the well-being of nurses during pandemics. Grouping strategies into these areas of action may assist nurses and leaders to prepare for pandemic nursing. IMPACT: As these strategies are unlikely to be exclusive to the COVID-19 pandemic, their global dissemination may improve patient experience and help nurses deliver fundamental care when planning pandemic nursing. However, their effectiveness is unknown. Therefore, we are currently evaluating these strategies in a cluster randomized controlled trial.

Efficacy and moderators of cognitive therapy versus behavioural activation for adults with depression: study protocol of a systematic review and meta-analysis of individual participant data.

BACKGROUND: Cognitive therapy and behavioural activation are both widely applied and effective psychotherapies for depression, but it is unclear which works best for whom. Individual participant data (IPD) meta-analysis allows for examining moderators at the participant level and can provide more precise effect estimates than conventional meta-analysis, which is based on study-level data. AIMS: This article describes the protocol for a systematic review and IPD meta-analysis that aims to compare the efficacy of cognitive therapy and behavioural activation for adults with depression, and to explore moderators of treatment effect. (PROSPERO: CRD42022341602). METHOD: Systematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library, to identify randomised clinical trials comparing cognitive therapy and behavioural activation for adult acute-phase depression. Investigators of these trials will be invited to share their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to assess treatment effects and to examine various available demographic, clinical and psychological participant characteristics as potential moderators. The primary outcome measure will be depressive symptom level at treatment completion. Secondary outcomes will include post-treatment anxiety, interpersonal functioning and quality of life, as well as follow-up outcomes. CONCLUSIONS: To the best of our knowledge, this will be the first IPD meta-analysis concerning cognitive therapy versus behavioural activation for adult depression. This study has the potential to enhance our knowledge of depression treatment by using state-of-the-art statistical techniques to compare the efficacy of two widely used psychotherapies, and by shedding more light on which of these treatments might work best for whom.

Impact of COVID-19 and other infectious conditions requiring isolation on the provision of and adaptations to fundamental nursing care in hospital in terms of overall patient experience, care quality, functional ability, and treatment outcomes: systematic review.

AIM: This systematic review identifies, appraises and synthesizes the evidence on the provision of fundamental nursing care to hospitalized patients with a highly infectious virus and the effectiveness of adaptations to overcome barriers to care. DESIGN: Systematic review. DATA SOURCES: In July 2020, we searched Medline, PsycINFO (OvidSP), CINAHL (EBSCOhost), BNI (ProQuest), WHO COVID-19 Database (https://search.bvsalud.org/) MedRxiv (https://www.medrxiv.org/), bioRxiv (https://www.biorxiv.org/) and also Google Scholar, TRIP database and NICE Evidence, forwards citation searching and reference checking of included papers, from 2016 onwards. REVIEW METHODS: We included quantitative and qualitative research reporting (i) the views, perceptions and experiences of patients who have received fundamental nursing care whilst in hospital with COVID-19, MERS, SARS, H1N1 or EVD or (ii) the views, perceptions and experiences of professional nurses and non-professionally registered care workers who have provided that care. We included review articles, commentaries, protocols and guidance documents. One reviewer performed data extraction and quality appraisal and was checked by another person. RESULTS: Of 3086 references, we included 64 articles; 19 empirical research and 45 review articles, commentaries, protocols and guidance documents spanning five pandemics. Four main themes (and 11 sub-themes) were identified. Barriers to delivering fundamental care were wearing personal protective equipment, adequate staffing, infection control procedures and emotional challenges of care. These barriers were addressed by multiple adaptations to communication, organization of care, staff support and leadership. CONCLUSION: To prepare for continuation of the COVID-19 pandemic and future pandemics, evaluative studies of adaptations to fundamental healthcare delivery must be prioritized to enable evidence-based care to be provided in future. IMPACT: Our review identifies the barriers nurses experience in providing fundamental care during a pandemic, highlights potential adaptations that address barriers and ensure positive healthcare experiences and draws attention to the need for evaluative research on fundamental care practices during pandemics.

Fundamental nursing care in patients with the SARS-CoV-2 virus: results from the 'COVID-NURSE' mixed methods survey into nurses' experiences of missed care and barriers to care.

BACKGROUND: Patient experience of nursing care is associated with safety, care quality, treatment outcomes, costs and service use. Effective nursing care includes meeting patients' fundamental physical, relational and psychosocial needs, which may be compromised by the challenges of SARS-CoV-2. No evidence-based nursing guidelines exist for patients with SARS-CoV-2. We report work to develop such a guideline. Our aim was to identify views and experiences of nursing staff on necessary nursing care for inpatients with SARS-CoV-2 (not invasively ventilated) that is omitted or delayed (missed care) and any barriers to this care. METHODS: We conducted an online mixed methods survey structured according to the Fundamentals of Care Framework. We recruited a convenience sample of UK-based nursing staff who had nursed inpatients with SARS-CoV-2 not invasively ventilated. We asked respondents to rate how well they were able to meet the needs of SARS-CoV-2 patients, compared to non-SARS-CoV-2 patients, in 15 care categories; select from a list of barriers to care; and describe examples of missed care and barriers to care. We analysed quantitative data descriptively and qualitative data using Framework Analysis, integrating data in side-by-side comparison tables. RESULTS: Of 1062 respondents, the majority rated mobility, talking and listening, non-verbal communication, communicating with significant others, and emotional wellbeing as worse for patients with SARS-CoV-2. Eight barriers were ranked within the top five in at least one of the three care areas. These were (in rank order): wearing Personal Protective Equipment, the severity of patients' conditions, inability to take items in and out of isolation rooms without donning and doffing Personal Protective Equipment, lack of time to spend with patients, lack of presence from specialised services e.g. physiotherapists, lack of knowledge about SARS-CoV-2, insufficient stock, and reluctance to spend time with patients for fear of catching SARS-CoV-2. CONCLUSIONS: Our respondents identified nursing care areas likely to be missed for patients with SARS-CoV-2, and barriers to delivering care. We are currently evaluating a guideline of nursing strategies to address these barriers, which are unlikely to be exclusive to this pandemic or the environments represented by our respondents. Our results should, therefore, be incorporated into global pandemic planning.

The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study.

BACKGROUND: Most patients who present with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common (at least 50% of patients treated for depression will relapse after a single episode) and leads to considerable morbidity and decreased quality of life for patients. The majority of patients will relapse within 6 months, and those with a history of relapse are more likely to relapse in the future than those with no such history. GPs see a largely undifferentiated case-mix of patients, and once patients with depression reach remission, there is limited guidance to help GPs stratify patients according to risk of relapse. We aim to develop a prognostic model to predict an individual's risk of relapse within 6-8 months of entering remission. The long-term objective is to inform the clinical management of depression after the acute phase. METHODS: We will develop a prognostic model using secondary analysis of individual participant data drawn from seven RCTs and one longitudinal cohort study in primary or community care settings. We will use logistic regression to predict the outcome of relapse of depression within 6-8 months. We plan to include the following established relapse predictors in the model: residual depressive symptoms, number of previous depressive episodes, co-morbid anxiety and severity of index episode. We will use a "full model" development approach, including all available predictors. Performance statistics (optimism-adjusted C-statistic, calibration-in-the-large, calibration slope) and calibration plots (with smoothed calibration curves) will be calculated. Generalisability of predictive performance will be assessed through internal-external cross-validation. Clinical utility will be explored through net benefit analysis. DISCUSSION: We will derive a statistical model to predict relapse of depression in remitted depressed patients in primary care. Assuming the model has sufficient predictive performance, we outline the next steps including independent external validation and further assessment of clinical utility and impact. STUDY REGISTRATION: ClinicalTrials.gov ID: NCT04666662.

COVID-NURSE: evaluation of a fundamental nursing care protocol compared with care as usual on experience of care for noninvasively ventilated patients in hospital with the SARS-CoV-2 virus-protocol for a cluster randomised controlled trial.

INTRODUCTION: Patient experience of nursing care is correlated with safety, clinical effectiveness, care quality, treatment outcomes and service use. Effective nursing care includes actions to develop nurse-patient relationships and deliver physical and psychosocial care to patients. The high risk of transmission of the SARS-CoV-2 virus compromises nursing care. No evidence-based nursing guidelines exist for patients infected with SARS-CoV-2, leading to potential variations in patient experience, outcomes, quality and costs. METHODS AND ANALYSIS: we aim to recruit 840 in-patient participants treated for infection with the SARS-CoV-2 virus from 14 UK hospitals, to a cluster randomised controlled trial, with embedded process and economic evaluations, of care as usual and a fundamental nursing care protocol addressing specific areas of physical, relational and psychosocial nursing care where potential variation may occur, compared with care as usual. Our coprimary outcomes are patient-reported experience (Quality from the Patients' Perspective; Relational Aspects of Care Questionnaire); secondary outcomes include care quality (pressure injuries, falls, medication errors); functional ability (Barthell Index); treatment outcomes (WHO Clinical Progression Scale); depression Patient Health Questionnaire-2 (PHQ-2), anxiety General Anxiety Disorder-2 (GAD-2), health utility (EQ5D) and nurse-reported outcomes (Measure of Moral Distress for Health Care Professionals). For our primary analysis, we will use a standard generalised linear mixed-effect model adjusting for ethnicity of the patient sample and research intensity at cluster level. We will also undertake a planned subgroup analysis to compare the impact of patient-level ethnicity on our primary and secondary outcomes and will undertake process and economic evaluations. ETHICS AND DISSEMINATION: Research governance and ethical approvals are from the UK National Health Service Health Research Authority Research Ethics Service. Dissemination will be open access through peer-reviewed scientific journals, study website, press and online media, including free online training materials on the Open University's FutureLearn web platform. TRIAL REGISTRATION NUMBER: ISRCTN13177364; Pre-results.

Effectiveness of collaborative care in reducing suicidal ideation: An individual participant data meta-analysis.

To assess whether CC is more effective at reducing suicidal ideation in people with depression compared with usual care, and whether study and patient factors moderate treatment effects. METHOD: We searched Medline, Embase, PubMed, PsycINFO, CINAHL, CENTRAL from inception to March 2020 for Randomised Controlled Trials (RCTs) that compared the effectiveness of CC with usual care in depressed adults, and reported changes in suicidal ideation at 4 to 6 months post-randomisation. Mixed-effects models accounted for clustering of participants within trials and heterogeneity across trials. This study is registered with PROSPERO, CRD42020201747. RESULTS: We extracted data from 28 RCTs (11,165 patients) of 83 eligible studies. We observed a small significant clinical improvement of CC on suicidal ideation, compared with usual care (SMD, -0.11 [95%CI, -0.15 to -0.08]; I2, 0·47% [95%CI 0.04% to 4.90%]). CC interventions with a recognised psychological treatment were associated with small reductions in suicidal ideation (SMD, -0.15 [95%CI -0.19 to -0.11]). CC was more effective for reducing suicidal ideation among patients aged over 65 years (SMD, - 0.18 [95%CI -0.25 to -0.11]). CONCLUSION: Primary care based CC with an embedded psychological intervention is the most effective CC framework for reducing suicidal ideation and older patients may benefit the most.

Use of patient-reported outcome measures (PROMs) in clinical diabetes consultations: the DiaPROM randomised controlled pilot trial.

OBJECTIVE: To pilot test the proposed DiaPROM trial components and address uncertainties associated with conducting a full-scale randomised controlled trial (RCT) to evaluate whether such a trial is feasible. DESIGN: Two-arm pilot RCT. PARTICIPANTS: Adults aged ≥18-39 years, with minimum 1 year type 1 diabetes duration, attending outpatient follow-up. Exclusion criteria were pregnancy, severe cognitive, somatic or psychiatric conditions and impaired vision. RANDOMISATION AND INTERVENTION: All participants completed electronic Patient-Reported Outcome Measures (PROMs) prior to the annual diabetes consultation. Using computer-generated block-randomisation without blinding, we assigned participants in a 1:1 ratio stratified by sex to receive standard care or an intervention. Physicians reviewed diabetes distress scores (Problem Areas In Diabetes scale) and referred individuals with scores ≥30 or single item(s) ≥3 to minimum two diabetes nurse consultations where reported problems were reviewed and discussed. OUTCOMES: Recruitment and retention rates; participants perceptions about intervention components. Variance and estimated between-group differences in follow-up scores (Diabetes Distress Scale (DDS), WHO 5-Well-being Index, Perceived Competence for Diabetes Scale and glycaemic control) and DDS correlation with baseline scores, to assist sample size calculations. RESULTS: We randomised 80 participants to the control or intervention arm (one participant was later excluded). 23/39 intervention arm participants qualified for additional consultations and 17 attended. 67/79 attended the 12-month follow-up (15.2% attrition); 5/17 referred to additional consultations were lost to follow-up (29.4% attrition). Participants reported PROMs as relevant (84.6%) and acceptable (97.4%) but rated the usefulness of consultations as moderate to low. Baseline mean±SD DDS score was 2.1±0.69; DDS SD was 0.71 (95% CI: 0.60 to 0.86) at follow-up; correlation between baseline and follow-up DDS scores was 0.8 (95% CI: 0.7 to 0.9). CONCLUSIONS: The pilot trial revealed need for intervention modifications ahead of a full-scale trial to evaluate use of PROMs in diabetes consultations. Specifically, participant acceptability and intervention implementation need further investigation.

Self-care, symptom experience, needs, and past health-care utilization in individuals with heart failure: results of a cross-sectional study.

AIMS: Self-care in heart failure (HF) is generally sub-optimal and impacts morbidity and mortality. To describe self-care prevalence and explore its relationships with symptom experience, patient needs, and health-care utilization in a Swiss hospital providing regional secondary care. METHODS AND RESULTS: Cross-sectional study, convenience sample of individuals with HF from four campuses of one regional Swiss hospital. Self-care was assessed via the Self-Care of Heart Failure Index (SCHFI) and the European Heart Failure Self-care Behaviour Scale (EHFScBS), symptom experience via the M.D. Anderson Symptom Inventory-HF (MDASI-HF) and needs via the Heart Failure Needs Assessment Questionnaire (HFNAQ). Healthcare utilization reflected the preceding year's hospitalization incidence. A cut-off level of ≥70% indicated adequate self-care. We analysed SCHFI, EHFScBS, MDASI-HF and HFNAQ scores' relationships with hospitalizations using Spearman's rho correlation; no prior hypotheses were stated. Sample of 310 individuals with HF (37.4% female; mean age 76.8; 55% NYHA III). Adequate self-care maintenance, management, and confidence were reported by 24%, 10%, and 61%. respectively. The sample's mean number of experienced symptoms was 12.8 (SD 4.0) and 14.0 (SD 5.8) for needs. Over the previous year, 269 hospitalizations had occurred (median: 0, IQR 1). Hospitalizations positively correlated with self-care; symptom experience with needs. Neither symptom experience nor needs correlated with hospitalizations. CONCLUSION: The findings indicated low self-care levels and suggest a need for increased support to maintain physiological stability, manage symptoms and prevent hospitalizations. This study is the first of its kind in Switzerland and among few studies worldwide to report on self-care, symptom experience, needs, and health-care utilization. Interventional studies are warranted considering baseline self-care capabilities, symptoms, and needs of individuals with HF.

Young adults with type 1 diabetes and their experiences with diabetes follow-up and participation in the DiaPROM pilot trial: A qualitative study.

AIM: To explore young adults' experiences of outpatient follow-up appointments, completing electronic Patient-Reported Outcome Measures (PROMs), and using the Problem Areas In Diabetes (PAID) scale during the Diabetes Patient-Reported Outcome Measures (DiaPROM) pilot trial. METHODS: We performed a qualitative study among 19 young adults (aged 22-39 years) with type 1 diabetes who participated in the pilot trial. Between February and June 2019, we conducted individual, semi-structured telephone interviews with participants from the intervention and control arms. We analysed the data using thematic analysis. RESULTS: Our analyses generated three themes, each with two subthemes: (1) Follow-up with limitations; (i) Marginal dialogue about everyday challenges, (ii) Value of supportive relationships and continuity, indicate that previous follow-up had been experienced as challenging and insufficient. (2) New insights and raised awareness; (i) More life-oriented insights, (ii) Moving out of the comfort zone, suggest mostly positive experiences with completing questionnaires and discussing the PAID scores. (3) Addressing problem areas with an open mind; (i) Need for elaboration, (ii) Preparedness for dialogue, indicate that both openness and explanations were vital in the follow-up. CONCLUSIONS: Participants characterised the previous follow-up as challenging and insufficient. They described completing and using the PAID as somewhat uncomfortable yet worthwhile. Our findings also suggest that by utilising diabetes distress data alongside health and biomedical outcomes, consultations became more attuned to the young adults' wishes and needs, mainly because the dialogue was more focused and direct. Hence, the PAID has the potential to facilitate person-centredness and improve patient-provider relationships.

Basal Segmental Longitudinal Strain: A Marker of Subclinical Myocardial Involvement in Anderson-Fabry Disease.

BACKGROUND: Cardiac involvement in Anderson-Fabry disease (AFD) is associated with increased left ventricular (LV) wall thickness. The aim of this study was to evaluate if two-dimensional global and regional strain in patients with AFD can identify early myocardial involvement (when LV wall thickness and function are normal). Additionally, the association of altered strain with adverse cardiovascular events was evaluated. METHODS: In a retrospective cross-sectional study, 43 patients with AFD, before enzyme replacement therapy (mean age, 44 ± 12 years; 58.1% men), were compared with age- and gender-matched healthy control subjects. The mean follow-up duration among patients with AFD for major adverse cardiovascular events (MACE) was 82 months. RESULTS: LV ejection fraction was similar between groups (patients with AFD vs control subjects, 61 ± 8% vs 61 ± 6%; P = .89). However, global longitudinal strain (LS) was impaired in patients with AFD compared with control subjects (-16.5 ± 3.8% vs -20.2 ± 1.7%, P < .001), with greater impairment in patients with AFD with increased LV wall thickness (-15.4 ± 3.9% vs -18.7 ± 2.3%, P < .006). Additionally, LS was most impaired in the basal segments in patients with AFD (-14.8 ± 3.7% vs -20.3 ± 1.1%, P < .001). MACE occurred in 19 of 43 patients (four women, 15 men), and Kaplan-Meier analysis demonstrated that MACE were associated with impaired basal LS. CONCLUSIONS: In patients with AFD, altered basal LS is present even in those with normal LV wall thickness and is associated with MACE. Therefore, basal LS should be considered when screening for cardiac involvement in AFD, particularly in female patients with AFD with normal LV wall thickness.

Compositional and structural analysis of Fukushima-derived particulates using high-resolution x-ray imaging and synchrotron characterisation techniques.

Both the three-dimensional internal structure and elemental distribution of near-field radioactive fallout particulate material released during the March 2011 accident at the Fukushima Daiichi Nuclear Power Plant is analysed using combined high-resolution laboratory and synchrotron radiation x-ray techniques. Results from this study allow for the proposition of the likely formation mechanism of the particles, as well as the potential risks associated with their existence in the environment, and the likely implications for future planned reactor decommissioning. A suite of particles is analyzed from a locality 2 km from the north-western perimeter of the site - north of the primary contaminant plume in an area formerly attributed to being contaminated by fallout from reactor Unit 1. The particles are shown to exhibit significant structural similarities; being amorphous with a textured exterior, and containing inclusions of contrasting compositions, as well as an extensive internal void volume - bimodal in its size distribution. A heterogeneous distribution of the various elemental constituents is observed inside a representative particle, which also exhibited a Fukushima-derived radiocesium (134Cs, 135Cs and 137Cs) signature with negligible natural Cs. We consider the structure and composition of the particle to suggest it formed from materials associated with the reactor Unit 1 building explosion, with debris fragments embedded into the particles surface. Such a high void ratio, comparable to geological pumice, suggests such material formed during a rapid depressurisation and is potentially susceptible to fragmentation through attrition.