Medical Care as Flea Market Bargaining? An International Interdisciplinary Study of Varieties of Shared Decision Making in Physician-Patient Interactions.

Phenomenon: Shared decision making (SDM) is a core ideal in the interaction between healthcare providers and patients, but the implementation of the SDM ideal in clinical routines has been a relatively slow process. Approach: In a sociological study, 71 interactions between physicians and simulated patients enacting chronic heart failure were video-recorded in China, Germany, the Netherlands, and Turkey as part of a quasi-experimental research design. Participating physicians varied in specialty and level of experience. The secondary analysis presented in this article used content analysis to study core components of SDM in all of the 71 interactions and a grounded theory approach to observe how physicians responded actively to patients even though they did not actively employ the SDM ideal. Findings: Full realization of the SDM ideal remains an exception, but various aspects of SDM in physician-patient interaction were observed in all four locations. Analyses of longer interactions show dynamic processes of interaction that sometimes surprised both patient and physician. We observed varieties of SDM that differ from the SDM ideal but arguably achieve what the SDM ideal is intended to achieve. Our analysis suggests a need to revisit the SDM ideal-to consider whether varieties of SDM may be acceptable, even valuable, in their own right. Insights: The gap between the SDM ideal and SDM as implemented in clinical practice may in part be explained by the tendency of medicine to define and teach SDM through a narrow lens of checklist evaluations. The authors support the argument that SDM defies a checklist approach. SDM is not uniform, but nuanced, dependent on circumstances and setting. As SDM is co-produced by patients and physicians in a dynamic process of interaction, medical researchers should consider and medical learners should be exposed to varieties of SDM-related practice rather than a single idealized model. Observing and discussing worked examples contributes to the physician's development of realistic expectations and personal professional growth.

Prescription of Opioid Analgesics for Chronic Non-Cancer Pain in Germany despite Contraindications: Administrative Claims Data Analysis.

In Germany, long-term opioid treatment (L-TOT) for chronic non-tumor pain (CNTP) is discussed as not being performed according to the German guideline on L-TOT for CNTP. In the present analysis, the occurrence and predictors of inappropriate care/overuse in a cohort of German insureds with L-TOT for CNTP by the presence of a contraindication with concurrent opioid analgesic (OA) therapy were investigated. We also analyzed whether prescribing physicians themselves diagnosed a contraindication. The retrospective cohort study was based on administrative claims data from a German statutory health insurance. Eight contraindication groups were defined based on the German guideline. Logistic regressions were performed in order to identify predictors for OA prescriptions despite contraindications. The possible knowledge of the prescribing physician about the contraindication was approximated by analyzing concordant unique physician identification numbers of OA prescriptions and contraindication diagnoses. A total of 113,476 individuals (75% female) with a mean age of 72 years were included. The most common documented contraindications were primary headaches (8.7%), severe mood disorders (7.7%) and pain in somatoform disorders (4.5%). The logistic regressions identified a younger age, longer history of OA therapy, opioid related psychological problems, and outpatient psychosomatic primary care as positive predictors for all contraindication groups.

Health Economic Evaluation of an Online-Based Motivational Program to Reduce Problematic Media Use and Promote Treatment Motivation for Internet Use Disorder-Results of the OMPRIS Study.

Internet Use Disorders (IUD) have a relevant effect on national economies. In the randomized, controlled, multicenter, prospective, and single-blinded OMPRIS study (pre-registration number DRKS00019925; Innovation Fund of the Joint Federal Committee of Germany, grant number 01VSF18043), a four-week online program to reduce media addiction symptoms, was evaluated for cost-effectiveness. The intervention group (IG) was compared to a waiting control group (WCG) from German statutory health insurance (SHI) and a societal perspective. Resource use, namely indirect and direct (non) medical costs, was assessed by a standardized questionnaire at baseline and after the intervention. Additionally, intervention costs were calculated. Determining the Reliable Change Index (RCI) based on the primary outcome, assessed by the "Scale for the Assessment of Internet and Computer Game Addiction" (AICA-S), individuals with and without reliable change (RC) were distinguished. The incremental cost-effectiveness ratio was calculated using the difference-in-difference approach. There were 169 (IG n = 81, WCG n = 88) persons included in the analysis. The mean age was 31.9 (SD 12.1) years. A total of 75.1% were male, and 1.8% diverse. A total of 65% (IG) and 27% (WCG) had an RC. The cost per person with RC was about EUR 860 (SHI) and EUR 1110 (society). The intervention leads to an improvement of media addiction symptoms at moderate additional costs.

Efficacy of a short-term webcam-based telemedicine treatment of internet use disorders (OMPRIS): a multicentre, prospective, single-blind, randomised, clinical trial.

Background: Evidence-based treatments for internet use disorders (IUDs) are limited, and online therapy approaches are poorly studied. We investigated the efficacy of a manualised therapist-guided online intervention (OMPRIS) to reduce IUD symptoms and improve psychological well-being. Methods: In this multicentre, two-arm, single-blinded trial, individuals ≥16 years suffering from IUD symptoms were recruited in Germany from August 16, 2020, to March 11, 2022, through media advertisements and healthcare providers. Participants were randomly allocated by sequential balancing randomisation (1:1) to either the manualised webcam-based OMPRIS intervention or a waitlist control (WLC) group. OMPRIS provided strategies from motivational interviewing, behavioural therapy, and social counselling. The primary outcome at the end of treatment was a reduction in IUD symptoms as measured by the Assessment of Internet and Computer Scale (AICA-S). Follow-up assessments were conducted at 6 weeks and 6 months. Analyses were performed in the intention-to-treat population. This trial was registered (German Clinical Trial Register, DRKS00019925) and has been completed. Findings: A total of 180 individuals were randomly assigned to the OMPRIS intervention (n = 89) or WLC (n = 91) arm. After treatment, 81 (91.0%) participants in the OMPRIS intervention group and 88 (96.7%) in the WLC group completed the outcome assessment. The ANCOVA model showed that OMPRIS participants had a significantly greater reduction in AICA-S scores from baseline (mean score 12.1 [SD 4.6]) to post-treatment (6.8 [5.2]) than those in the WLC group (from 12.6 [5.1] to 11.0 [5.4]; estimated mean difference -3.9; [95% CI -5.2 to -2.6]; p < 0.0001; d = 0.92). No adverse events were reported to the trial team. Interpretation: Webcam-based OMPRIS therapy was effective and superior to waiting list conditions in reducing IUD symptoms. Webcam-based, specialised online therapy thus increases IUD treatment options. Funding: German Innovation Fund of Germany's Federal Joint Committee (G-BA), grant number 01VSF18043.

[Physician assistants as a future model in primary care: Experiences, needs, potentials and barriers]. / Physician Assistants als Zukunftsmodell in der hausärztlichen Versorgung ­ Erfahrungen, Bedarfe, Potenziale und Hürden.

INTRODUCTION: In the coming decades, demographic change will dramatically increase health care needs, especially for general practitioners (GPs). However, there is a shortage of young primary care physicians, with signs of (impending) underuse already becoming apparent in rural and structurally weak areas. Innovative care concepts are needed to counteract this development and ensure the future of primary care. In addition to medical assistants (MFA), academically trained physician assistants (PAs) could be considered for more demanding delegation tasks and be involved in direct patient care under the responsibility of a physician in the practice team. In England, the Netherlands and the USA, PAs have been a part of the health care systems for many years. RESEARCH QUESTIONS: 1) What are the potentials for delegation/possibilities for PAs working in primary care practices in contrast to medical assistants? 2) What structural requirements are necessary to regularly integrate PAs in primary care practices? METHODS: After preliminary interviews with PA experts and primary care researchers and practitioners (n=29), four expert interviews (n=4) with GPs and PAs were performed in a case analysis in order to elicit experiences with PAs in family practice. Based on this, three focus groups were conducted with GPs and practice staff (n=15) to discuss the extent, the need and the willingness to delegate physician services to PAs, as well as existing barriers. After transcription, analyses were performed using qualitative content analysis according to Mayring. RESULTS: The participants acknowledged the potential to reduce physician workloads and showed a high willingness to delegate tasks. Practical examples suggest that a clearly defined delegation of medical tasks to PAs, e.g. participation in infection consultations, is possible after only a few weeks working in family practices. Thus, the cooperation between GPs, PAs and medical assistants can be successful. Uncertainties exist regarding the legal possibilities and limits of delegation as well as the current and future financial reimbursement of PAs. DISCUSSION: The legal and financial framework for the utilization of PAs in ambulatory care should be reliably clarified as well as transparently communicated so that the considerable potentials of delegating tasks to academically trained staff, e.g. PAs, especially in the GP sector, can be exploited in the future. CONCLUSION: Participation of PAs in the GP team could be key to overcoming the often threatening or already existing under-provision of medical care in structurally weak regions.

Optimization of HIV testing services in Germany using HIV indicator diseases: study protocol of the HeLP study.

BACKGROUND: Despite the potentially accompanying negative clinical, epidemiologic, and health economic effects, a large proportion of persons living with the human immunodeficiency virus (HIV) are diagnosed late. Internationally, numerous diseases are known to be HIV indicator diseases. Adequate HIV testing in the presence of HIV indicator diseases could help to diagnose unknown HIV infections earlier. The objective of the HeLP study is to validate published HIV indicator diseases for the German setting and to identify guidelines in terms of these indicator diseases in order to reduce knowledge gaps and increase HIV testing when HIV indicator diseases are diagnosed. METHODS: A mixed methods approach is used. In a first step, published HIV indicator diseases will be identified in a systematic literature review and subsequently discussed with clinical experts regarding their relevance for the German setting. For the validation of selected indicator diseases different data sets (two cohort studies, namely HIV-1 seroconverter study & ClinSurv-HIV, and statutory health insurance routine data) will be analyzed. Sensitivity analyses using different time periods will be performed. Guidelines of HIV indicator diseases validated in the HeLP study will be reviewed for mentioning HIV and for HIV testing recommendations. In addition, semi-standardized interviews (followed by a free discussion) with guideline creators will identify reasons why HIV testing recommendations were (not) included. Subsequently, a random sample of physicians in medical practices will be surveyed to identify how familiar physicians are with HIV testing recommendations in guidelines and, if so, which barriers are seen to perform the recommended tests in everyday care. DISCUSSION: The HeLP-study adopts the challenge to validate published HIV indicator diseases for the German setting and has the potential to close a knowledge gap regarding this objective. This has the potential to improve targeted HIV testing for patients with HIV indicator diseases and consequently lead to earlier HIV diagnosis. TRIAL REGISTRATION: DRKS00028743.

Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study.

BACKGROUND: Allergic rhinitis (AR) and allergic asthma (AA) are chronic respiratory diseases that represent a global health problem. One aim of this study was to analyze the Health-related Quality of Life (HRQoL) of the patients in order to identify statistically significant influencing factors that determine HRQoL. Another aim was to assess and analyze data on cost-of-illness from a statutory health insurance perspective. METHODS:  The EQ-5D-5L was used to evaluate the patients' HRQoL. To identify the factors influencing the HRQoL, a multinomial logistic regression analysis was conducted using groups based on the EQ-5D-5L index value as dependent variable. Routine data were analyzed to determine total healthcare costs. RESULTS:  The average EQ-5D-5L index was 0.85 (SD 0.20). A high age, the amount of disease costs, low internal health-related control beliefs and high ozone exposure in the residential area were found to be statistically significant influencing factors for a low HRQoL, whereas low age, male sex and a good possibility to avoid the allergens were found to be statistically significant factors influencing a high HRQoL. On average, the study participants incurred annual costs of €3072 (SD: 3485), of which €699 (SD: 743) could be assigned to allergic respiratory diseases. CONCLUSIONS:  Overall, the patients in the VerSITA study showed a high level of HRQoL. The identified influencing factors can be used as starting points for improving the HRQoL of patients with allergic respiratory diseases. From the perspective of a statutory health insurance, per person expenditures for allergic respiratory diseases are rather low.

[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

Evaluation criteria for health apps supporting medication adherence in early-stage technology development - a scoping review.

Introduction: Health apps offer an approach to improve the patients' management of their medication. Although the Digital Healthcare Act (DVG) has created a claim in the statutory health insurance (SHI), the large number of health apps available and their varying quality make it difficult for service providers and especially for medical laypersons to select an adequate high-quality medication app. Manufacturers need guidance for the development of high-quality apps right from the start. Various general evaluation concepts for health apps have been available to date. However, the requirements that should be met by healthcare depend largely on the field of application and the type of apps. This article aims to provide an overview of the international evidence on specific criteria for the evaluation of medication apps. Methods: Within the framework of a scoping review, a systematic search was conducted in PubMed and EMBASE on January 29, 2020. The search was limited to publications from 2007 onwards as well as to English and German articles. Additionally, a semi-systematic research of reference lists of the previously included articles as well as a structured search of websites of relevant stakeholders were conducted. Inclusion criteria were the following: the publication deals with health apps that can be used on smartphones and focus on supporting medication intake; the publication does not refer to evaluation criteria for a single app exclusively. The included publications were examined in a qualitative content analysis searching for evaluation criteria and categorizing them according to the framework criteria of the DVG and the Digital Health Applications Ordinance (DiGAV). Results: 2,542 articles were identified in the systematic search (999 in PubMed, 1,543 in EMBASE, 560 duplicates). A total of 16 studies met the inclusion criteria. The semi-systematic research and the structured search identified one further study. A catalog of criteria was developed based on the included 17 studies. This catalog covers the general topics "patient orientation" (data protection and security, consumer protection, user friendliness) and "quality/core functions of medication apps" (reminder, self-monitoring, (drug) information, motivation to change behavior, drug/patient safety, robustness) as well as "interoperability/cooperation". Due to its specific importance for medication apps, the subcategory "motivation for behavioral change" stands out beneath the general topic "quality/core functions of medication apps". This category aims to evaluate the design of individual functions with regard to their potential to actually change the behavior of app users. Discussion: The criteria for the evaluation of health apps mentioned in the DiGAV intersected with the criteria identified in the literature research. However, the area of positive health care effects was hardly covered by the included studies. In the development of the criteria catalog, it was not possible to weight the identified criteria. Therefore, the catalog should be understood as a supporting checklist for service providers, manufacturers, and/or users. Conclusions: A large variety of possible evaluation criteria for medication apps could be shown. Future research should focus on the possibilities of weighting these diverse evaluation criteria, using not only clinical studies but also methods to identify preferences.

Effectiveness and costs of a low-threshold hearing screening programme (HörGeist) for individuals with intellectual disabilities: protocol for a screening study.

INTRODUCTION: Individuals with intellectual disabilities (ID) often suffer from hearing loss, in most cases undiagnosed or inappropriately treated. The implementation of a programme of systematic hearing screening, diagnostics, therapy initiation or allocation and long-term monitoring within the living environments of individuals with ID (nurseries, schools, workshops, homes), therefore, seems beneficial. METHODS AND ANALYSIS: The study aims to assess the effectiveness and costs of a low-threshold screening programme for individuals with ID. Within this programme 1050 individuals with ID of all ages will undergo hearing screening and an immediate reference diagnosis in their living environment (outreach cohort). The recruitment of participants in the outreach group will take place within 158 institutions, for example, schools, kindergartens and places of living or work. If an individual fails the screening assessment, subsequent full audiometric diagnostics will follow and, if hearing loss is confirmed, initiation of therapy or referral to and monitoring of such therapy. A control cohort of 141 participants will receive an invitation from their health insurance provider via their family for the same procedure but within a clinic (clinical cohort). A second screening measurement will be performed with both cohorts 1 year later and the previous therapy outcome will be checked. It is hypothesised that this programme leads to a relevant reduction in the number of untreated or inadequately treated cases of hearing loss and strengthens the communication skills of the newly or better-treated individuals. Secondary outcomes include the age-dependent prevalence of hearing loss in individuals with ID, the costs associated with this programme, cost of illness before-and-after enrolment and modelling of the programme's cost-effectiveness compared with regular care. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Ethics Review Board of the Medical Association of Westphalia-Lippe and the University of Münster (No. 2020-843 f-S). Participants or guardians will provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: DRKS00024804.

On the current psychotherapeutic situation for persons with pornography use disorder in Germany.

Background and aims: For the first time, the ICD-11 provides the diagnosis compulsive sexual behavior disorder (CSBD) that can be assigned for pornography use disorder (PUD). This study aimed to estimate the prevalence of PUD and associated consequences in Germany, to identify the psychotherapy demand among likely PUD (lPUD) cases and the treatment supply in different psychotherapeutic settings, to survey psychotherapists' level of expertise regarding PUD, and to identify predictors for psychotherapy demand. Methods: Four studies were conducted: 1. Online study in the general population (n = 2070; m = 48.9%, f = 50.8%, d = 0.2%), 2. Survey among practicing psychotherapists (n = 983), 3. Survey of psychotherapists in psychotherapeutic outpatient clinics (n = 185), 4. Interviews with psychotherapeutic inpatient clinics (n = 28). Results: The estimated prevalence of lPUD in the online study was 4.7% and men were 6.3 times more often affected than women. Compared to individuals without PUD, individuals with lPUD more often indicated negative consequences in performance-related areas. Among lPUD cases, 51.2% of men and 64.3% of women were interested in a specialized PUD treatment. Psychotherapists reported 1.2%-2.9% of lPUD cases among their patients. 43.2%-61.5% of psychotherapists stated to be poorly informed about PUD. Only 7% of psychotherapeutic inpatient clinics provided specific treatments to patients with PUD. While, among other factors, negative consequences attributed to lPUD were predictive for psychotherapy demand, weekly pornography consumption, subjective well-being, and religious attachment were not. Discussion and conclusions: Although PUD occurs quite often in Germany, availability of mental health care services for PUD is poor. Specific PUD treatments are urgently needed.

Hearts in their hands-Physicians' gestures embodying shared professional knowledge around the world.

The biomedical approach to medical knowledge is widely accepted around the world. This article considers whether the incorporated aspects of physician-patient interaction have become similarly common across the globe by comparing the gestures that physicians use in their interactions with patients. Up to this point, there has been little research on physicians' use of gestures in health-care settings. We explore how-in four university hospitals in Turkey, the People's Republic of China, The Netherlands and Germany-physicians use gesture in their discussions with simulated patients about the condition of heart failure. Our analysis confirms the importance of gestures for organising both the personal interaction and the knowledge transfer between physician and patient. From the perspective of global comparison, it is notable that physicians in all four hospitals used similar gestures. This demonstrates the globality of biomedical knowledge in an embodied mode. Physicians used gestures for a range of purposes, including to convey the idea of an 'anatomical map' and for constructing visual models of (patho-)physiological processes. Since biomedical language is rife with metaphor, it was not surprising that we also identified an accompanying metaphorical gesture which has a similar form in the various locations that were part of the study.

Socio-demographic and psycho-social determinants of HIV late presentation in Germany - results from the FindHIV study.

Delayed HIV diagnosis at advanced stages of disease remains common (33%-64%). This analysis of the multi-center FindHIV study including newly diagnosed HIV-infected adults in Germany, focused on the potential role of socio-demographic and psychological factors on late diagnosis (formerly "late presentation", AIDS diagnosis or CD4 cells <350/µL). These data were collected from patient profiles, physician-patient interviews and questionnaires. Participating centers (n = 40) represented the diverse health care settings in HIV care and geographic regions. Of 706 newly diagnosed adults (92% male, median age 39 years) between 2019 and 2020, 55% (388/706) were diagnosed late with a median CD4 cell count of 147/µL; 20% (142/706) presented with AIDS. From the physicians' perspective, earlier diagnosis would have been possible in 45% of participants (late versus non-late presentation 58% versus 29%). The most common physician-perceived reason was an underestimated risk for HIV infection by the patient (37%). In multivariable logistic regression analysis, older age, sexual contacts with both sexes as possible route of HIV transmission, being married, and a poor level of knowledge about HIV treatment were found to be associated with a significantly elevated risk for late presentation. Education, employment status, sexual relations, migration background and personality traits were not.Trial registration: German Clinical Trials Register (DRKS00016351).

Internet-Based Self-Assessment for Symptoms of Internet Use Disorder-Impact of Gender, Social Aspects, and Symptom Severity: German Cross-sectional Study.

BACKGROUND: Internet use disorder (IUD) is a new type of behavioral addiction in the digital age. At the same time, internet applications and eHealth can also provide useful support in medical treatment. OBJECTIVE: The purpose of this study is to examine if an internet-based eHealth service can reach individuals with IUD. In particular, it should be investigated whether both male and female individuals with more severe IUDs can be reached. METHODS: Data were retrieved from the OMPRIS (online-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and internet use disorder) project (DRKS00019925), an internet-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and IUD. During the recruitment process (August 2020-March 2022), a total of 3007 individuals filled out the standardized scale for the assessment of internet and computer game addiction (AICA-S). The assessment was accessible via the project homepage. There was no preselection of participants at this stage of the study; however, the offer was addressed to people with hazardous internet use and IUDs. The web-based assessment was free and could be found via search engines, but attention was also drawn to the service via newspaper articles, radio reports, and podcasts. RESULTS: Out of 3007 who participated in the web-based self-assessment, 1033 (34.4%) are female, 1740 (57.9%) are male, 67 (2.2%) are diverse individuals, and 167 (5.5%) did not disclose their gender. The IUD symptom severity score showed a wide range between the AICA-S extreme values of 0 and 27 points. On average, the total sample (mean 8.19, SD 5.47) was in the range of hazardous IUD behavior (AICA-S cutoff>7.0). Furthermore, 561 individuals (18.7% of the total sample; mean 17.42, SD 3.38) presented severe IUD (AICA-S cutoff>13.5). Focusing on female and male participants, 20.9% (363/1740) of the men and 14.9% (151/1033) of the women scored above 13.5 points, which can be considered pathological IUD behavior (χ22,2773=16.73, P<.001, effect size: Cramér V=0.078). Unemployment, being in vocational training or studying at a university, and being male were significantly associated with high IUD symptoms. CONCLUSIONS: Using a large sample, the study showed that both mildly and severely IUD-affected individuals can be reached via the internet. An internet-based eHealth offer can thus be a good way to reach patients with IUD where they are addicted-on the internet. In addition, eHealth services increase the likelihood of reaching female patients, who hardly ever come to specialized outpatient clinics and hospitals. Since social problems, especially unemployment, have a strong association with disease severity, the integration of social counseling into treatment seems advisable in terms of a multidisciplinary approach. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00019925; https://drks.de/search/de/trial/DRKS00019925.

Facilitators and barriers of vaccine uptake in patients with autoimune inflammatory rheumatic disease: a scoping review.

OBJECTIVES: Patients with autoimmune inflammatory rheumatic diseases (AIRD) often have lower vaccination coverage rates compared with the general population, despite being disproportionately affected by infectious complications. We aim to systematically review the literature regarding vaccination willingness and hesitancy in AIRD. METHODS: A scoping review was conducted in PubMed, EMBASE and the Cochrane Library in June 2021. Study selection was performed by two independent reviewers and data were extracted using a standardised form. Risk of bias was assessed using instruments from McMaster University. Identified barriers were categorised into the WHO's measuring behavioural and social drivers (BeSD) of vaccination conceptual model. RESULTS: The search yielded 1644 hits of which 30 publications were included (cross-sectional studies based on interviews (n=27) and intervention studies (n=3)). The majority of studies reported barriers to influenza and pneumococcal vaccination only (n=9) or in combination with another vaccination (n=8) from the patients' perspective. Only one study assessed the view of rheumatologists. Coverage of domains matched to the BeSD model suggests a lack of awareness of infection risk by both patients and physicians. Patients mainly mentioned behavioural and social factors that negatively influenced their willingness to be vaccinated while physicians mentioned organisational deficits as major barriers. CONCLUSIONS: The view on vaccination in patients with AIRD diverges between patients and rheumatologists. Our results show that in-depth counselling on vaccines is important for patients, whereas physicians need support in implementing specific immunisation recommendations. The themes identified provide a starting point for future interventions to improve vaccine rates in patients with AIRD.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany.

BACKGROUND: The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. METHODS: Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. RESULTS: There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as "good", while for a PCS score above 40 there is a reverse effect. CONCLUSIONS: The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.

INTRODUCTION: Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). METHODS AND ANALYSIS: The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18-65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. ETHICS AND DISSEMINATION: The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. TRIAL REGISTRATION NUMBER: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.

Care with allergen immunotherapy for allergic respiratory diseases in Germany-Predictors and deficits.

BACKGROUND: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany. METHODS: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, 'DAK-Gesundheit', were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed. RESULTS: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population. CONCLUSIONS: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits.

National medical specialty guidelines of HIV indicator conditions in Europe lack adequate HIV testing recommendations: a systematic guideline review.

BackgroundAdequate identification and testing of people at risk for HIV is fundamental for the HIV care continuum. A key strategy to improve timely testing is HIV indicator condition (IC) guided testing.AimTo evaluate the uptake of HIV testing recommendations in HIV IC-specific guidelines in European countries.MethodsBetween 2019 and 2021, European HIV experts reviewed guideline databases to identify all national guidelines of 62 HIV ICs. The proportion of HIV IC guidelines recommending HIV testing was reported, stratified by subgroup (HIV IC, country, eastern/western Europe, achievement of 90-90-90 goals and medical specialty).ResultsOf 30 invited European countries, 15 participated. A total of 791 HIV IC guidelines were identified: median 47 (IQR: 38-68) per country. Association with HIV was reported in 69% (545/791) of the guidelines, and 46% (366/791) recommended HIV testing, while 42% (101/242) of the AIDS-defining conditions recommended HIV testing. HIV testing recommendations were observed more frequently in guidelines in eastern (53%) than western (42%) European countries and in countries yet to achieve the 90-90-90 goals (52%) compared to those that had (38%). The medical specialties internal medicine, neurology/neurosurgery, ophthalmology, pulmonology and gynaecology/obstetrics had an HIV testing recommendation uptake below the 46% average. None of the 62 HIV ICs, countries or medical specialties had 100% accurate testing recommendation coverage in all their available HIV IC guidelines.ConclusionFewer than half the HIV IC guidelines recommended HIV testing. This signals an insufficient adoption of this recommendation in non-HIV specialty guidelines across Europe.

Effects of an online-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and internet use disorder (OMPRIS): study protocol for a randomised controlled trial.

INTRODUCTION: In May 2019, the WHO classified internet gaming disorder (IGD) as a mental disorder in the upcoming International Classification of Diseases 11th Revision. However, individuals affected by IGD or internet use disorders (IUDs) are often not provided with adequate therapy due to a lack of motivation or absence of adequate local treatment options. To close the gap between individuals with IUDs and the care system, we conduct an online-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and internet use disorder (OMPRIS). METHODS AND ANALYSIS: Within the randomised controlled trial, a total of n=162 participants will be allocated by sequential balancing randomisation to the OMPRIS intervention or a waitlist control group. The study includes an extensive diagnostic, followed by a 4-week psychological intervention based on motivational interviewing, (internet-related) addiction therapy, behavioural therapy techniques and additional social counselling. The primary outcome is the reduction of problematic internet use measured by the Assessment of Internet and Computer Game Addiction Scale. Secondary outcomes include time spent on the internet, motivation for change (Stages of Change Readiness and Treatment Eagerness Scale for Internet Use Disorder), comorbid mental symptoms (Patient Health Questionnaire-9, Generalized Anxiety Disorder Screener-7), quality of life (EuroQoL Standardised Measure of Health-related Quality of Life-5 Dimensions, General Life Satisfaction-1), self-efficacy (General Self-Efficacy Scale), personality traits (Big Five Inventory-10), therapeutic alliance (Helping Alliance Questionnaire) and health economic costs. The diagnosis of (comorbid) mental disorders is carried out with standardised clinical interviews. The measurement will be assessed before (T0), at midpoint (T1) and after the OMPRIS intervention (T2), representing the primary endpoint. Two follow-up assessments will be conducted after 6 weeks (T3) and 6 months (T4) after the intervention. The outcomes will be analysed primarily via analysis of covariance. Both intention-to-treat and per-protocol analyses will be conducted. ETHICS AND DISSEMINATION: Participants will provide written informed consent. The trial has been approved by the Ethics Committee of the Faculty of Medicine, Ruhr University Bochum (approval number 19-6779). Findings will be disseminated through presentations, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: DRKS00019925.