Validation of an indirect ELISA assay for assessment of autoantibodies against full-length TRIM21 and its individual domains.

Anti-SSA-autoantibodies are common in patients with rheumatologic disease, especially Sjögren's syndrome, systemic lupus erythematosus and rheumatoid arthritis. They consist of both autoantibodies towards Ro60 and Ro52, the latter also known as TRIM21. TRIM21 is an intracellular protein consisting of four domains; PRY/SPRY, Coiled-Coil, B-box and RING. The aim of this study was to establish an indirect ELISA detecting autoantibodies towards both the full-length TRIM21 protein and its four domains. We expressed the five constructs, created, and validated indirect ELISA protocols for each target using plasma from anti-SSA positive patients and healthy controls. Our findings were validated to the clinically used standards. We measured significantly higher levels of autoantibodies towards our full-length TRIM21, and the PRY/SPRY, Coiled-Coil and RING domains in patients compared to healthy controls. No significant difference in the level of autoantibodies were detected against the B-box domain. Our setups had a signal to noise ratio in the range of 30 to 184, and an OD between 2 and 3. Readings did not decline using NaCl of 500 mM as wash, affirming the high binding affinity of the autoantibodies measured. Our protocols allow us to further study the different autoantibodies of anti-SSA positive patients. This creates the possibility to stratify our patients into subgroups regarding autoantibody profile and specific pheno- or endotype.

Arabic-speaking male immigrants' perceptions of preventive initiatives: An interview study.

BACKGROUND: Arabic-speaking men are a sparsely investigated population in health promotion and disease prevention. This may hamper their ability to achieve the highest obtainable health due to less accessibility and acceptability of preventive measures. AIM: We explored Arabic-speaking (Palestinian, Iraqi and Somali) male immigrants' perceptions of preventive initiatives in general and such initiatives for cardiovascular diseases (CVD) in particular to understand how to address inequalities in engagement in prevention. METHODS: This qualitative study employed content analysis of semistructured interviews with 60-66-year-old Arabic-speaking men living in Denmark. Supplementary, structured data, for example, health data, were collected. From June to August 2020, 10 men were interviewed. FINDINGS: Preventive initiatives were found ethically and culturally acceptable alongside personally and socially relevant; they were perceived as humanitarian and caring for the participants' health, respecting of their self-determination and enabling their empowerment. Thus, the participants entreated that their fellow countrymen be assisted in achieving the prerequisite coping capabilities to address inequality in access, perceived acceptance and relevance. This led us to define one main category 'Preventive initiatives - Caring and humanitarian aid empower us' with the underlying subcategories: 'We are both hampered and strengthened by our basic assumptions' and 'We need help to achieve coping capabilities enabling us to engage in preventive initiatives'. CONCLUSION: Prevention was perceived as acceptable and relevant. Even so, Arabic-speaking men may be a hard-to-reach group due to their basic assumptions and impaired capabilities for engaging in prevention. Addressing inequality in accessibility, acceptability and relevance in regard to prevention may be promoted through a person-centred approach embracing invitees' preferences, needs and values; and by strengthening invitees' health literacy through efforts at the structural, health professional and individual levels. PUBLIC CONTRIBUTION: This study was based on interviews. The interviewees were recruited as public representatives to assist us in building an understanding of Arabic-speaking male immigrants' perceptions of preventive initiatives in general and preventive initiatives for CVD in particular.

Protocol for a cohort study to evaluate the effectiveness and cost-effectiveness of general population screening for cardiovascular disease: the Viborg Screening Programme (VISP).

INTRODUCTION: The prevalence of cardiovascular disease (CVD) is increasing. Furthermore, asymptomatic individuals may not receive timely preventive initiatives to minimise the risk of further CVD events. Paradoxically, 80% of CVD events are preventable by early detection, followed by prophylactic initiatives. Consequently, we introduced the population-based Viborg Screening Programme (VISP) for subclinical and manifest CVD, focusing on commonly occurring, mainly asymptomatic conditions, followed by prophylactic initiatives.The aim of the VISP was to evaluate the health benefits, harms and cost-effectiveness of the VISP from a healthcare sector perspective. Furthermore, we explored the participants' perspectives. METHODS AND ANALYSIS: From August 2014 and currently ongoing, approximately 1100 men and women from the Viborg municipality, Denmark, are annually invited to screening for abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, diabetes mellitus and cardiac arrhythmia on their 67th birthday. A population from the surrounding municipalities without access to the VISP acts as a control. The VISP invitees and the controls are followed on the individual level by nationwide registries. The primary outcome is all-cause mortality, while costs, hospitalisations and deaths from CVD are the secondary endpoints.Interim evaluations of effectiveness and cost-effectiveness are planned every 5 years using propensity score matching followed by a Cox proportional hazards regression analysis by the 'intention-to-treat' principle. Furthermore, censoring-adjusted incremental costs, life-years and quality-adjusted life-years are estimated. Finally, the participants' perspectives are explored by semistructured face-to-face interviews, with participant selection representing participants with both negative and positive screening results. ETHICS AND DISSEMINATION: The VISP is not an interventional trial. Therefore, approval from a regional scientific ethical committee is not needed. Data collection from national registries was approved by the Regional Data Protection Agency (record no. 1-16-02-232-15). We ensure patient and public involvement in evaluating the acceptability of VISP by adopting an interviewing approach in the study. TRIAL REGISTRATION NUMBER: NCT03395509.

Effects of a Co-Design-Based Invitation Strategy on Participation in a Preventive Health Check Program: Randomized Controlled Trial.

BACKGROUND: Preventive primary care programs that aim to reduce morbidity and mortality from lifestyle-related diseases are often affected by low-to-moderate participation rates. Improving participation rates is essential for clinical effectiveness and cost-effectiveness. In 2016-2017, we conducted a pilot study (TOF pilot1) for a preventive primary care intervention (TOF is the Danish abbreviation for "Early Detection and Prevention"). Among 8814 invited patients, 3545 (40.22%) consented to participate, with the highest participation rates among women and patients with higher income, education, and employment. OBJECTIVE: The aim of this study was to evaluate the effects of a revised invitation strategy on invitation comprehensibility, the overall participation rate, and participant demography. The new strategy specifically targeted men and patients of low educational attainment. METHODS: This study was embedded in the second TOF pilot study (TOF pilot2, initiated in October 2018) that tested an adjusted intervention. The revised invitation strategy comprised a prenotification postcard and a new invitation that specifically targeted men and patients of low educational attainment. The new invitation was developed in a co-design process that included communication professionals and target-group representatives. The study sample consisted of 4633 patients aged between 29 and 59 years, who resided in one of two municipalities in the Region of Southern Denmark. Eligible patients were randomly assigned to one of four invitation groups. The control group (Group 1) received the original invitation used in TOF pilot1. The intervention groups received the original invitation and the prenotification postcard (Group 2), the new revised invitation and the prenotification postcard (Group 3), or the new invitation but no prenotification postcard (Group 4). RESULTS: Overall, 2171 (46.86%) patients consented to participate. Compared to the control group, participation rates increased significantly in all three intervention groups (all P<.001). Participation across the three intervention groups increased for women and men, as well as for patients with high and low educational attainment and high and low family income. The largest relative increase in participation rates occurred among men, patients with low educational attainment, and patients with low family income. No increase in participation was detected for unemployed patients or patients of non-Danish origin. Most participants found the original (813/987, 82.37%) and new (965/1133, 85.17%) invitations easy to understand with no significant difference (P=.08) in comprehensibility between invitations. CONCLUSIONS: The results suggest that participation in preventive primary care interventions can be greatly increased by implementing a co-design-based invitation strategy that includes prenotification postcards and targeted invitations. Although firm conclusions cannot be made from this study, the observed increased participation rates for men and patients of low socioeconomic status may be relevant in programs that aim to reduce social inequality in health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03913585; https://clinicaltrials.gov/ct2/show/NCT03913585.