Search

Abstract Introduction Besides functional outcomes, mental health and health-related quality of life (HRQoL) are significant measures in chronic diseases, such as stroke. Post-stroke depression (PSD) is an important complication affecting up to one in three stroke survivors. So far, specific programs to screen, detect and treat these patients are lacking but might be a crucial component in stroke aftercare. Methods Between March 2024 and Febuary 2025 all consecutive adult patients with stroke, admitted to the University Hospital of Augsburg, are screened for signs of depression (PHQ-9 (Patient Health Questionnaire-9) score of ≥ 10). Eight weeks later, those patients with persisting signs of depression will be randomized to receive either a behavioural activation intervention or a mindfulness-based intervention via telephone. Depressive symptoms will be assessed at baseline (V1), after 84, 180 (V2-V3) and after 365 days (V4) using the PHQ-9 score. Secondary outcomes include the functional outcome, quality of life (EuroQol-5 Dimensions; EQ-5D), overall functioning, and incidence of major cardiovascular events including recurrent transient ischemic attack, stroke, and mortality. Perspective Our aim is to provide proof-of-concept evidence for the efficacy of telepsychological need-adapted interventions for patients with post-stroke depression. Regular screening for PSD with implementation of a feasible treatment option could reduce the long-term prevalence of PSD and improve quality of life. Trial registration This trial was registered at German Clinical Trials Register (DRKS) on 07.03.2024, ID: DRKS00033792. German Clinical Trials Register (drks.de).

Abstract Background There is evidence that inflammatory arthritis in the form of ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid arthritis are both positively and negatively associated with certain female-specific cancers. However, the study results are very heterogeneous. Methods Based on up to 375,814 European women, we performed an iterative two-sample Mendelian randomization to assess causal effects of the occurrence of the inflammatory arthritis on the risk of female-specific cancer in form of breast, endometrial, and ovarian cancer sites as well as their subtypes. Evidence was strengthened by using similar exposures for plausibility or by replication with a subsequent meta-analysis. P-values were Bonferroni adjusted. Results Genetic liability to AS was associated with ovarian cancer (OR = 1.03; 95% CI: [1.01; 1.04]; $$\:{P}_{adj}$$ =0.029) and liability to PsA with breast cancer (OR = 1.02; CI: [1.01; 1.04]; $$\:{P}_{adj}$$ =0.002). Subgroup analyses revealed that the high-grade serous ovarian cancer (OR = 1.04; CI: [1.02; 1.06]; $$\:{P}_{adj}$$ =0.015) and the ER- breast cancer (OR = 1.04; CI: [1.01; 1.07]; $$\:{P}_{adj}$$ =0.118) appeared to drive the observed associations, respectively. No further associations were found between the remaining inflammatory arthritis phenotypes and female-specific cancers. Conclusions This study suggests that AS is a risk factor for ovarian cancer, while PsA is linked to an increased breast cancer risk. These results are important for physicians caring women with inflammatory arthritis to advise their patients on cancer screening and preventive measures.

IntroductionThis study aimed to explore mental health literacy (MHL) and its related factors in a cross-sectional, registry-based sample of patients after acute myocardial infarction (AMI).MethodsAll survivors of AMI between 2017 and 2019 from the Myocardial Infarction Registry Augsburg (n=1.712) received a postal questionnaire on MHL (Mental Health Literacy Scale (MHLS-GER)) and single questions on experiences with and information on mental disorders in 2023. The response rate was 49.9%. Logistic and linear regression models were used to investigate the associations between these variables and sociodemographic factors.ResultsIn the sample of 855 patients (77.5% male, mean age 71.4 ± 10.9 years), 30.0% had experienced mental problems about 5 years after AMI. Among these, 17.4% received psychotherapy and 26.1% psychotropic drugs. Information about possible mental problems after their AMI was obtained from a physician by 30.8% of the patients and in a rehabilitation setting by 46.4%, respectively. Of the patients, 26.2% wished to receive more information on mental problems after AMI. MHLS-GER subscale scores ranged between and 54 (“Social distance”) and 76 (“Information seeking”) (best score 100). Age was the most important factor that was significantly associated with the report of mental health problems, a perceived lack of information, help seeking behavior and treatment, and MHL.DiscussionElderly and poorly educated patients were at risk of poor MHL. Further studies are required to specify the role of MHL in post-AMI life and health care.

Privacy Impact Assessments (PIAs) offer a process for assessing the privacy impacts of a project or system. As a privacy engineering strategy, they are one of the main approaches to privacy by design, supporting the early identification of threats and controls. However, there is still a shortage of empirical evidence on their use and proven effectiveness in practice. To better understand the current literature and research, this paper provides a comprehensive Scoping Review (ScR) on the topic of PIAs “in the wild,” following the well-established Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. This ScR includes 45 studies, providing an extensive synthesis of the existing body of knowledge, classifying types of research and publications, appraising the methodological quality of primary research, and summarising the positive and negative aspects of PIAs in practice, as reported by those studies. This ScR also identifies significant research gaps (e.g., evidence gaps from contradictory results and methodological gaps from research design deficiencies), future research pathways, and implications for researchers, practitioners, and policymakers developing and using PIA frameworks. As we conclude, there is still a significant need for more primary research on the topic, both qualitative and quantitative. A critical appraisal of qualitative studies revealed deficiencies in the methodological quality, and only four quantitative studies were identified, suggesting that current primary research remains incipient. Nonetheless, PIAs can be regarded as a prominent sub-area in the broader field of empirical privacy engineering, in which further scientific research to support existing practices is needed.

IntroductionSo far, health literacy (HL) and its related factors in patients with acute myocardial infarction received little attention. Thus, the objective of this study was to investigate the associations between the different dimensions of HL and disease-specific health-related quality of life (HRQOL), and factors that may affect these relations in patients after acute myocardial infarction (AMI).MethodsAll survivors of AMI between June 2020 and September 2021, from the Myocardial Infarction Registry Augsburg (n=882) received a postal questionnaire on HL [Health Literacy Questionnaire (HLQ)], HRQOL (MacNew Heart Disease HRQOL questionnaire) and depression (Patient Health Questionnaire). From the 592 respondents, 546 could be included in the analysis. Multivariable linear regression models were performed to investigate the associations between the nine subscales of the HLQ and the total score and three subscales of the MacNew questionnaire. A mediation analysis was performed to estimate direct and indirect effects of HL on HRQOL taking into account the mediating effect of depression.ResultsIn the sample of 546 patients (72.5% male, mean age 68.5 ± 12.2 years), patients with poor education showed significantly lower HLQ scores. Significant associations between the subscales of the HLQ and the MacNew were found, which remained significant after adjustment for sociodemographic variables with few exceptions. More than 50% of the association between HL and HRQOL was mediated by depression in seven HLQ subscales and a complete mediating effect was found for the HLQ subscales ‘Actively managing my health’ and ‘Appraisal of health information’.DiscussionDepression mediates the associations between HL and disease-specific HRQOL in patients with myocardial infarction.

BackgroundPulmonary embolism (PE) is a common cardiovascular disease and health literacy is necessary to deal with its consequences after the acute event. The aim of this study was to develop and validate a new questionnaire to measure PE-specific health literacy.MethodsA mixed-methods design with qualitative and quantitative elements was used in the development process. A literature review about health literacy concepts and instruments and interviews with patients with PE and clinicians were conducted. Quantitative analyses included factor analyses, item response theory with a graded partial credit model, and reliability analyses in different test and validation samples. Furthermore, convergent and known-groups validity and responsiveness were assessed.ResultsThe qualitative results supported a concept of PE-related health literacy with four main topics: dealing with PE-related health information, disease management, health-related selfcare, and social support. An initial item pool of 91 items was developed. Further interviews and an online survey with patients with PE (n = 1,013) were used to reduce the number of items and to confirm structural validity. Confirmatory factor analyses in the final evaluation study with patients with PE (n = 238) indicated a good model fit of the four-factor structure. The Health Literacy in Pulmonary Embolism (HeLP)-Questionnaire showed good reliability (Cronbach’s alpha: 0.82 to 0.90). All four subscales were responsive toward receiving a brochure with PE-related health information.ConclusionThe newly developed German HeLP Questionnaire comprises 23 items in four domains and showed good psychometric properties. Further evaluation of the questionnaire in different samples of patients with PE is needed.

New regulations worldwide are increasingly pressing organisations to review how they collect and process personal data to ensure the protection of individual privacy rights. This organisational transformation involves implementing several privacy practices (e.g., privacy policies, governance frameworks, and privacy-by-design methods) across multiple departments. The literature points to a strong influence of the organisations’ culture and climate in implementing such privacy practices, depending on how leaders and employees perceive and address privacy concerns. However, this new hybrid topic referred to as Organisational Privacy Culture and Climate (OPCC), remains poorly demarcated and weakly defined. In this paper, we report a Scoping Review (ScR) on the topic of OPCC to systematically identify and map studies, contributing with a synthesis of the existing work, distinguishing core and adjacent publications, research gaps, and pathways of future research. This ScR includes 36 studies categorised according to their demographics, research types, contribution types, research designs, proposed definitions, and conceptualisations. Also, 18 studies categorised as primary research were critically appraised, assessing the studies’ methodological quality and credibility of the evidence. Although published research has significantly advanced the topic of OPCC, more research is still needed. Our findings show that the topic is still in its embryonic stage. The theory behind OPCC has not yet been fully articulated, even though some definitions have been independently proposed. Only one measuring instrument for privacy culture was identified, but it needs to be further developed in terms of identifying and analysing its factors, and evaluating its validity and reliability. Initiatives of future research in OPCC will require interdisciplinary research efforts and close cooperation with industry to further propose and rigorously evaluate instruments. Only then OPCC would be considered an evidence-based research topic that can be reliably used to evaluate, measure, and embed privacy in organisations.

Objective: Pulmonary embolism (PE) is the third most common cardiovascular disease worldwide. However, public awareness is considerably lower than for myocardial infarction or stroke. Patients suffering from PE complain about the lack of (understandable) information and express high informational needs. To uncover if reliable information is indeed scarce, this study evaluates the quantity and quality of existing patient information for tertiary prevention using an evidence-based health information paradigm. Methods: We conducted a quantitative content analysis (n = 21 patient information brochures; n = 67 websites) evaluating content categories addressed, methodical quality, usability, and readability. Results: Results show that there is not enough patient information material focusing on PE as a main topic. Existing patient information material is mostly incomplete, difficult to understand, and low in actionability as well as readability. Conclusion: Our systematic analysis reveals the need for more high-quality patient information on PE as part of effective tertiary prevention. Innovation: This is the first review analyzing content, methodical quality, readability, and usability of patient information on PE. The findings of this analysis are guiding the development of an innovative, evidence-based patient information on PE aiming to support patients’ informational needs and their self-care behavior.

The inclusion of narratives in evidence-based patient information is a heavily discussed topic in literature. Narratives elicit intense engagement and emotional insights, but may also cause unintended persuasion effects. There is mixed evidence that adding narratives to non-narrative factual patient information is valuable for patients. In addition, providing patients with narratives about the outcome of treatments has been found to bias treatment decisions, in line with the direction implied by the narratives. This may counteract informed decision making of patients. However, narratives about the process of a treatment and personal experiences with treatments may support the well-being of patients in tertiary prevention. In order to investigate patients' views on narratives and their function in patient information, we conducted 26 semi-structured qualitative interviews with pulmonary embolism patients. Answers were coded using thematic analysis. Results show that patients are especially interested in experience and process narratives when combined with evidence-based patient information. We identified four main functions of experience and process narratives that patients ascribe to these narratives: (1) motivating self-reflection and reflection on the recovery process, (2) reducing the feeling of loneliness, (3) reducing emotional distress, and (4) inspiring mindful mastery.

Objectives The aim of the study was to develop quality standards reflecting minimal requirements for safe medication processes in nursing homes.Design In a first step, relevant key topics for safe medication processes were deducted from a systematic search for similar guidelines, prior work and discussions with experts. In a second step, the essential requirements for each key topic were specified and substantiated with a literature-based rationale. Subsequently, the requirements were evaluated with a piloted, two-round Delphi study.Setting Nursing homes in Switzerland.Participants Interprofessional panel of 25 experts from science and practice.Primary and secondary outcome measures Each requirement was rated for its relevance for a safer and resident-oriented medication on a 9-point Likert-Scale based on the RAND/UCLA method. The requirements were considered relevant if, in the second round, the median relevance rating was ≥7 and the proportion of ratings ≥7 was ≥80%.Results Five key topics with a total of 87 requirements were elaborated and rated in the Delphi study. After the second round (response rate in both rounds 100%), 85 requirements fulfilled the predefined criteria and were therefore included in the final set of quality standards. The five key topics are: (I) ‘The medication is reviewed regularly and in defined situations’, (II) ‘The medication is reviewed in a structured manner’, (III) ‘The medication is monitored in a structured manner’, (IV) ‘All healthcare professionals are committed to an optimal interprofessional collaboration’ and (V) ‘Residents are actively involved in medication process’.Conclusions We developed normative quality standards for a safer and resident-oriented medication in Swiss nursing homes. Altogether, 85 requirements define the medication processes and the behaviour of healthcare professionals. A rigorous implementation may support nursing homes in taking a step towards safer and resident-oriented medication.

The Internet of Things (IoT) paves the way for smart applications such as in E-health, E-homes, transportation, or energy production. However, IoT technologies also pose privacy challenges for their users, as they allow the tracking and monitoring of the users' behavior and context. The EU General Data Protection Regulation (GDPR) mandates data controller to follow a data protection by design and default approach by implementing for instance pseudonymity for achieving data minimisation. This paper provides a systematic literature review for answering the question of what types of privacy-preserving identifiers are proposed by the literature in IoT environments for implementing pseudonymity. It contributes with classifications and analyses of IoT environments for which privacy-preserving identifiers have been proposed and of the pseudonym types and underlying identity management architectures used. Moreover, it discusses trends and gaps in regard to addressing privacy trade-offs.

BackgroundThird-party cloud-based data analysis applications are proliferating in electronic health (eHealth) because of the expertise offered and their monetary advantage. However, privacy and security are critical concerns when handling sensitive medical data in the cloud. Technical advances based on “crypto magic” in privacy-preserving machine learning (ML) enable data analysis in encrypted form for maintaining confidentiality. Such privacy-enhancing technologies (PETs) could be counterintuitive to relevant stakeholders in eHealth, which could in turn hinder adoption; thus, more attention is needed on human factors for establishing trust and transparency. ObjectiveThe aim of this study was to analyze eHealth expert stakeholders’ perspectives and the perceived tradeoffs in regard to data analysis on encrypted medical data in the cloud, and to derive user requirements for development of a privacy-preserving data analysis tool. MethodsWe used semistructured interviews and report on 14 interviews with individuals having medical, technical, or research expertise in eHealth. We used thematic analysis for analyzing interview data. In addition, we conducted a workshop for eliciting requirements. ResultsOur results show differences in the understanding of and in trusting the technology; caution is advised by technical experts, whereas patient safety assurances are required by medical experts. Themes were identified with general perspectives on data privacy and practices (eg, acceptance of using external services), as well as themes highlighting specific perspectives (eg, data protection drawbacks and concerns of the data analysis on encrypted data). The latter themes result in requiring assurances and conformance testing for trusting tools such as the proposed ML-based tool. Communicating privacy, and utility benefits and tradeoffs with stakeholders is essential for trust. Furthermore, stakeholders and their organizations share accountability of patient data. Finally, stakeholders stressed the importance of informing patients about the privacy of their data. ConclusionsUnderstanding the benefits and risks of using eHealth PETs is crucial, and collaboration among diverse stakeholders is essential. Assurances of the tool’s privacy, accuracy, and patient safety should be in place for establishing trust of ML-based PETs, especially if used in the cloud.

Transparency of personal data processing is a basic privacy principle and a right that is well acknowledged by data protection legislation, such as the EU general data protection regulation (GDPR). The objective of ex post transparency enhancing tools (TETs) is to provide users with insight about what data have been processed about them and what possible consequences might arise after their data have been revealed, that is, ex post. This survey assesses the state of the art in scientific literature of the usability of ex post TETs enhancing privacy and discusses them in terms of their common features and unique characteristics. The article first defines the scope of usable transparency in terms of relevant privacy principles for providing transparency by taking the GDPR as a point of reference, and usability principles that are important for achieving transparency. These principles for usable transparency serve as a reference for classifying and assessing the surveyed TETs. The retrieval and screening process of the publications is then described, as is the process for deriving the subsequent classification of the characteristics of the TETs. The survey not only looks into what is made transparent by the TETs but also how transparency is actually achieved. A main contribution of this survey is a proposed classification that assesses the TETs based on their functionality, implementation and evaluation as described in the literature. It concludes by discussing the trends and limitations of the surveyed TETs in regard to the defined scope of usable TETs and shows possible directions of future research for addressing these gaps. This survey provides researchers and developers of privacy enhancing technologies an overview of the characteristics of state of the art ex post TETs, on which they can base their work.