Wearing face masks as a potential source for inhalation and oral uptake of inanimate toxins - A scoping review.

BACKGROUND: From 2020 to 2023 many people around the world were forced to wear masks for large proportions of the day based on mandates and laws. We aimed to study the potential of face masks for the content and release of inanimate toxins. METHODS: A scoping review of 1003 studies was performed (database search in PubMed/MEDLINE, qualitative and quantitative evaluation). RESULTS: 24 studies were included (experimental time 17 min to 15 days) evaluating content and/or release in 631 masks (273 surgical, 228 textile and 130 N95 masks). Most studies (63%) showed alarming results with high micro- and nanoplastics (MPs and NPs) release and exceedances could also be evidenced for volatile organic compounds (VOCs), xylene, acrolein, per-/polyfluoroalkyl substances (PFAS), phthalates (including di(2-ethylhexyl)-phthalate, DEHP) and for Pb, Cd, Co, Cu, Sb and TiO2. DISCUSSION: Of course, masks filter larger dirt and plastic particles and fibers from the air we breathe and have specific indications, but according to our data they also carry risks. Depending on the application, a risk-benefit analysis is necessary. CONCLUSION: Undoubtedly, mask mandates during the SARS-CoV-2 pandemic have been generating an additional source of potentially harmful exposition to toxins with health threatening and carcinogenic properties at population level with almost zero distance to the airways.

Work satisfaction and risk of burnout for endoscopy staff in Germany: Results of a nationwide survey.

BACKGROUND: Healthcare workers are facing ever-increasing challenges. Moreover, in many areas, there is a shortage of skilled personnel, so endoscopy staff are also increasingly exposed to the risk of developing burnout symptoms. Little is known about job satisfaction and burnout prevalence among endoscopy staff. The present study investigates the risk of burnout as well as job satisfaction among skilled personnel in German endoscopy units and practices. METHODS: An online survey was conducted among endoscopy staff, a significant proportion of whom are members of Deutsche Gesellschaft für Endoskopiefachberufe e. V. (DEGEA). In addition to general demographic variables, job satisfaction was determined by using the Short Questionnaire for the Assessment of General and Facet-Specific Job Satisfaction (KAFA), and the risk of burnout was determined by using the Maslach Burnout Inventory (MBI-D). Both were associated with structural characteristics. RESULTS: A representative sample took part in the survey (n = 674). The overall level of job satisfaction was high, with a rather elevated risk of burnout, although staff in executive positions performed better overall. Collegiality and mostly flat hierarchies are cited by the majority of those surveyed as positive aspects of their work. Nevertheless, 65 % describe their development opportunities as not performance-oriented, 20 % as virtually non-existent. Over 30 % of those surveyed consider their remuneration to be inadequate. CONCLUSION: Representative data for the situation in German endoscopy units could be collected. Despite the fact that on average job satisfaction values are high, with a low risk of burnout, especially in comparison with other occupational groups, often mentioned critical aspects regarding the lack of development opportunities and non-performance-related payment should be taken seriously, and measures should be developed to avoid endangering endoscopy care in the long term.

Work satisfaction and burnout risk of gastroenterologists in Germany: results of a nationwide survey.

BACKGROUND: More and more gastroenterologists are not satisfied with their working conditions and run the risk of developing burnout symptoms. Little is known about the job satisfaction and burnout risk among physicians working in endoscopy units in Germany. This study examines the risk of burnout and job satisfaction among gastroenterologists in Germany. METHODS: An electronic survey was distributed to gastroenterologists organized mainly in the Federal Organization of Gastroenterology in Germany (BVGD, Berufsverband Gastroenterologie Deutschland e. V.). In addition to general demographic variables, job satisfaction was determined using the Work Satisfaction Questionnaires (WSQ), and burnout risk was determined using the Maslach Burnout Inventory (MBI). RESULTS: A representative sample of gastroenterologists organized in the BVGD (Berufsverband Gastroenterologie Deutschland e. V.) took part in the study (n = 683, 22 %). Above all, we could demonstrate relevant differences with regard to burnout risk and job satisfaction depending on the place of work, clinic structure, position in the clinic, and age. Younger physicians had significantly higher depersonalization (p < 0.001) and exhaustion scores (p < 0.001) with almost medium and small effect sizes (δt = 0.45 and -0.31). The higher the position in the clinic, the higher the accomplishment scores (medium effect size 0.27). Older physicians were especially more satisfied in the areas of patient care (p < 0.001, medium effect size δt = -0.53). Employed doctors show a higher level of satisfaction in terms of "burden" compared to practice owners (p < 0.001, δt = -0.69). Compared to norms used in the EGPRN study which were adapted to physicians, almost one-third of our sample had high depersonalization scores, about 17 % had high exhaustion scores, and about half had low personal accomplishment scores showing a higher general burden among German gastroenterologists. CONCLUSION: Decreased work satisfaction and risk of burnout are important issues among German gastroenterologists. Specific actions should address this problem in order to avoid negative consequences, respectively.

[Which Proportion of Prescriptions in Germany is Evidence Based?] / Welcher Anteil der Medikamentenverordnungen in Deutschland ist evidenzbasiert?

BACKGROUND: The provision of healthcare has to take into consideration evidence-based results from valid and relevant studies; this principle is included in German social laws. The prescribing assessment scheme (PAS) of the German National Association of Statutory Health Insurance Physicians contains a systematic appraisal of the benefit of drugs on the basis of their clinical evidence, their safety, and indications for their prescription. METHODS: We analysed nationwide prescription data of physicians that have contractual relationships with statutory health insurance funds in 2014. The drugs have been classified on the basis of their clinical evidence as "standard", "reserve" or "third level" medication. We report proportions of prescriptions in the first and third priority levels of the PAS in primary care, cardiology, and neurology/psychiatry as their prescriptions have a high correspondence with the PAS. RESULTS: The proportion in the first priority in primary care was more than two-thirds of the total prescriptions. The highest proportion in this category was observed in Bremen; the lowest proportions were found in the new federal states. In cardiology, the first priority was chosen in 54%, in neurology/psychiatry in about 41% of prescriptions (DDDs). The proportion of the third priority is with one-fifth highest in cardiology, with 16%, lowest in primary care; neurology/psychiatry takes a middle position with 17.7%. CONCLUSIONS: Prescriptions predominantly conformed with the first priority of the PAS. There were variations across disciplines and regions (federal states). The PAS offers an opportunity to connect quality and indication in the prescription process.

Attention-Deficit/Hyperactivity Disorder (ADHD) and Emotion Regulation Over the Life Span.

PURPOSE OF REVIEW: Emotional symptoms are common and persistent in youth and adults with attention-deficit/hyperactivity disorder (ADHD) and cause clinically significant impairments. We review recent neuropsychological, neurophysiological, and peripheral psychophysiological evidence for emotion and emotion regulation deficits in ADHD across youth and adults. RECENT FINDINGS: Central and autonomous nervous system correlates argue in favor of more general self-regulation deficits and also specific emotional deficits in ADHD. These include general performance deficits in executive functions, and structural as well as functional impairments in neuronal networks associated with top-down self-regulation. Specific deficits with bottom-up emotional activation in the amygdala and emotion evaluation associated with the orbitofrontal cortex have also been described. Furthermore, vagally mediated, high-frequency heart rate variability is associated with emotional self-regulation deficits throughout the life span. The current evidence is based on multilevel studies that assess associations of emotion regulation. However, further studies that adequately consider the processual recursive character of emotion generation and regulation may give important new insights into emotional regulation of ADHD. Emotion regulation deficits in ADHD are associated with specific as well as general self-regulation deficits traceable on the level of neuropsychological, neurophysiological, and psychophysiological assessments. The temporal dynamics of the interplay of those different systems need further study in order to optimize and personalize treatment of emotion regulation difficulties, including emotional reactivity, in patients with ADHD.

Objective assessment of attention-deficit/hyperactivity disorder in older adults compared with controls using the QbTest.

OBJECTIVES: Attention-deficit/hyperactivity disorder (ADHD) persists into old age, with prevalence rates of 2.8% to 3.3% in adults over 60 years of age. Most diagnostic assessment tools are not validated for older adults. The Quantified behavioral Test (QbTest) is an objective assessment for the core symptoms of ADHD and is validated for children and younger adults. We investigated whether the QbTest can be used to differentiate between older adults with ADHD and healthy controls. METHODS: Older adults aged 55 to 79 years with (n = 97) or without (n = 112) ADHD were assessed with the QbTest. They also rated their ADHD symptom severity. QbTest raw scores were compared between groups. Factor scores were computed using factor loadings from a confirmatory factor analysis (CFA). Multilevel regressions were used to determine effects of background characteristics and comorbidity. Logistic regressions were performed to determine whether the QbTest differentiated between patients with ADHD and healthy controls. RESULTS: The factor structure of the CFA was comparable with that of younger age groups. Older age was associated with higher Inattention score. Parameters comprising the factors Hyperactivity and Inattention, but not Impulsivity, were shown to contribute significantly in differentiating between the groups. The QbTest had a correct classification rate of 70%, which was increased to 91% when combining QbTest scores and self-reports of ADHD symptom severity. CONCLUSIONS: The QbTest is feasible for older adults, and the factors Hyperactivity and Inattention are valid parameters for the diagnostic assessment of ADHD in older adults, when used in addition to self-reports.

Lesbian womens' access to healthcare, experiences with and expectations towards GPs in German primary care.

BACKGROUND: Lesbian women have higher rates of physical and psychiatric disorders associated with experiences of discrimination, homophobia and difficulties with coming out. Therefore, easy access to specialized healthcare in an open atmosphere is needed. We aimed to describe women's access to and experiences with healthcare in Germany, and to assess the responsibility of the general practitioner (GP) compared to other specialities providing primary health care. METHODS: A questionnaire study was conducted via internet and paper-based sampling. Using current literature, we designed a questionnaire consisting of sociodemographic data, sexual orientation, access to care and reasons for encounter, disclosure of sexual orientation, experience with the German health system (discrimination, homophobia), and psychological burden. Depression was assessed using the depression screening from the Patient Health Questionnaire (PHQ-2). RESULTS: We obtained responses from 766 lesbian women. Although 89% had a primary care physician, only 40% had revealed their sexual orientation to their doctor. The main medical contacts were GPs (66%), gynaecologists (10%) or psychiatrists (6%). Twenty-three percent claimed they were unable to find a primary care physician. Another 12.4% had experienced discrimination. Younger lesbian women with higher education levels and who were less likely to be out to other physicians were more likely to disclose their sexual orientation to their primary care physician. GPs play an important role in healthcare for lesbian women, even in a non-gatekeeping healthcare system like Germany. Study participants suggested improvements regarding gender neutral language, flyers on homosexuality in waiting areas, involvement of partners, training of physicians, directories of homosexual physicians and labelling as a lesbian-friendly practice. CONCLUSIONS: GPs should create an open atmosphere and acquire the respective knowledge to provide adequate treatment. Caring for marginal groups should be incorporated in medical training and further education. Ideally, physicians address patients' sexual orientation pro-actively in order to address individual needs accordingly.

German Validation of the Conners 3® Rating Scales for Parents, Teachers, and Children.

Objective: Attention-deficit/hyperactivity disorder (ADHD) rating scales such as the Conners' Rating Scales (CRS) are valuable adjuncts for diagnosis, since they offer parent, teacher, and self-ratings of children susceptible for ADHD. Even though the scales are widely used internationally, cross-cultural comparability has rarely been verified, and culture and language invariance have only been presumed. The Conners 3(®) rating scales are the updated version of the CRS, though hardly any studies report the psychometric properties apart from the results published in the test edition itself. To our knowledge there are no studies on the various adaptations of the Conners 3(®) in other languages. Method: The German translations of the Conners 3(®) were completed by 745 children, 953 parents, and 741 teachers (children's age range: 6­18 years, mean: 11.74 years of age). Exploratory and confirmatory factor analyses on content scale items were conducted to obtain the factor structure for the German version and to replicate the factor structure of the original American models. Cronbach's α was calculated to establish internal consistency. Results: The exploratory analyses for the German model resulted in factor structures globally different from the American model, though confirmatory analyses revealed very good model fi ts with highly satisfying Cronbach's αs. We were able to provide empirical evidence for the subscale Inattention which had only hypothetically been derived by Conners (2008). Conclusions: Even though the exploratory analyses resulted in different factor structures, the confirmatory analyses have such excellent psychometric properties that use of the German adaptation of the Conners 3(®) is justifi ed in international multicenter studies.

Ethics of Nudging in the COVID-19 Crisis and the Necessary Return to the Principles of Shared Decision Making: A Critical Review.

Nudging, a controversial technique for modifying people's behavior in a predictable way, is claimed to preserve freedom of choice while simultaneously influencing it. Nudging had been largely confined to situations such as promoting healthy eating choices but has been employed in the coronavirus disease 2019 (COVID-19) crisis in a shift towards measures that involve significantly less choice, such as shoves and behavioral prods. Shared decision making (SDM), a method for direct involvement and autonomy, is an alternative approach to communicate risk. Predominantly peer-reviewed scientific publications from standard literature databases like PubMed, PsycInfo, and Psyndex were evaluated in a narrative review. The so-called fear nudges, as well as the dissemination of strongly emotionalizing or moralizing messages can lead to intense psycho-physical stress. The use of these nudges by specialized units during the COVID-19 pandemic generated a societal atmosphere of fear that precipitated a deterioration of the mental and physical health of the population. Major recommendations of the German COVID-19 Snapshot Monitoring (COSMO) study, which are based on elements of nudging and coercive measures, do not comply with ethical principles, basic psychological principles, or evidence-based data. SDM was misused in the COVID-19 crisis, which helped to achieve one-sided goals of governments. The emphasis on utilitarian thinking is criticized and the unethical behavior of decision makers is explained by both using the concept of moral disengagement and the maturity level of coping strategies. There should be a return to an open-ended, democratic, and pluralistic scientific debate without using nudges. It is therefore necessary to return to the origins of SDM.

Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis.

BACKGROUND: The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins. METHODS: We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians' prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75,000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients' overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes). RESULTS: There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect. CONCLUSION: Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician's prescribing behaviour is affected by an established health care system, which is not easy to change. TRIAL REGISTRATION: ISRCTN71348772.

Chronic low back pain patient groups in primary care--a cross sectional cluster analysis.

BACKGROUND: Due to the heterogeneous nature of chronic low back pain (CLBP), it is necessary to identify patient groups and evaluate treatments within these groups. We aimed to identify groups of patients with CLBP in the primary care setting. METHODS: We performed a k-means cluster analysis on a large data set (n = 634) of primary care patients with CLBP. Variables of sociodemographic data, pain characteristics, psychological status (i.e., depression, anxiety, somatization), and the patient resources of resilience and coping strategies were included. RESULTS: We found three clusters that can be characterized as "pensioners with age-associated pain caused by degenerative diseases", "middle-aged patients with high mental distress and poor coping resources", and "middle-aged patients who are less pain-affected and better positioned with regard to their mental health". CONCLUSIONS: Our results supported current knowledge concerning groups of CLBP patients in primary care. In particular, we identified a group that was most disabled and distressed, and which was mainly characterized by psychological variables. As shown in our study, pain-related coping strategies and resilience were low in these patients and might be addressed in differentiating treatment strategies. Future studies should focus on the identification of this group in order to achieve effective treatment allocation. TRIAL REGISTRATION: German Clinical Trial Register DRKS00003123.

Comparison of Web-based and paper-based administration of ADHD questionnaires for adults.

BACKGROUND: Satisfactory psychometric properties in offline questionnaires do not guarantee the same outcome in Web-based versions. Any construct that is measured online should be compared to a paper-based assessment so that the appropriateness of online questionnaire data can be tested. Little research has been done in this area regarding Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. OBJECTIVE: The objective was to simultaneously collect paper-based and Web-based ADHD questionnaire data in adults not diagnosed with ADHD in order to compare the two data sources regarding their equivalence in raw scores, in measures of reliability, and in factorial structures. METHODS: Data from the German versions of the Connors Adult ADHD Rating Scales (CAARS-S), the Wender Utah Rating Scale (WURS-k), and the ADHD Self Rating Scale (ADHS-SB) were collected via online and paper questionnaires in a cross-sectional study with convenience sampling. We performed confirmatory factor analyses to examine the postulated factor structures in both groups separately and multiple group confirmatory factor analyses to test whether the postulated factor structures of the questionnaires were equivalent across groups. With Cronbach alpha, we investigated the internal consistency of the postulated factors in the different questionnaires. Mann-Whitney U tests with the effect size "Probability of Superiority (PS)" were used to compare absolute values in the questionnaires between the two groups. RESULTS: In the paper-based sample, there were 311 subjects (73.3% female); in the online sample, we reached 255 subjects (69% female). The paper-based sample had a mean age of 39.2 years (SD 18.6); the Web-based sample had a mean age of 30.4 years (SD 10.5) and had a higher educational background. The original four factor structure of the CAARS-S could be replicated in both samples, but factor loadings were different. The Web-based sample had significantly higher total scores on three scales. The five-factor structure of the German short form of the WURS-k could be replicated only in the Web-based sample. The Web-based sample had substantially higher total scores, and nearly 40% of the Web-based sample scored above the clinically relevant cut-off value. The three-factor structure of the ADHS-SB could be replicated in both samples, but factor loadings were different. Women in the Web-based sample had substantially higher total scores, and 30% of the Web-based sample scored above the clinically relevant cut-off value. Internal consistencies in all questionnaires were acceptable to high in both groups. CONCLUSIONS: Data from the Web-based administration of ADHD questionnaires for adults should not be used for the extraction of population norms. Separate norms should be established for ADHD online questionnaires. General psychometric properties of ADHD questionnaires (factor structure, internal consistency) were largely unaffected by sampling bias. Extended validity studies of existing ADHD questionnaires should be performed by including subjects with a diagnosis of ADHD and by randomizing them to Web- or paper-based administration.

Endoscopic measurement of hiatal hernias: is it reliable and does it have a clinical impact? Results from a large prospective database.

OBJECTIVES: The aim of our study was to compare the results of endoscopy and manometry with regard to the presence and longitudinal size of hiatal hernias using a cohort of patients with PPI-refractory reflux symptoms. In addition, we aimed to investigate the clinical relevance of hiatal hernias and their size in relation to the occurrence of GERD. METHODS: Five hundred patients with suspected GERD due to typical reflux symptoms (heartburn and regurgitation) and inadequate response to PPI therapy underwent standardized screening at a reflux center. After 2 weeks of PPI withdrawal, all patients underwent endoscopy, 24-h pH impedance measurement, and high-resolution manometry (HRM). Both endoscopy and HRM results were available for 487 patients. RESULTS: There was a high correlation between the endoscopic and manometric measured longitudinal size of hernias (rho = .768 (p < .001)). Absolute differences differ on a small effect basis (Cohen's d = 0.23). The presence of hernias increases significantly with the severity of GERD, regardless of whether the hernia was diagnosed by endoscopy or manometry. CONCLUSION: In summary, endoscopically and manometrically measured hiatal hernia size are highly significantly correlated. Patients with refractory reflux symptoms and a hernia size of 4 cm are very likely to have GERD. In the future, this finding could greatly simplify the diagnosis of GERD.

Possible toxicity of chronic carbon dioxide exposure associated with face mask use, particularly in pregnant women, children and adolescents - A scoping review.

Introduction: During the SARS-CoV-2-pandemic, face masks have become one of the most important ubiquitous factors affecting human breathing. It increases the resistance and dead space volume leading to a re-breathing of CO2. So far, this phenomenon and possible implications on early life has not been evaluated in depth. Method: As part of a scoping review, literature was systematically reviewed regarding CO2 exposure and facemask use. Results: Fresh air has around 0.04% CO2, while wearing masks more than 5 min bears a possible chronic exposure to carbon dioxide of 1.41% to 3.2% of the inhaled air. Although the buildup is usually within the short-term exposure limits, long-term exceedances and consequences must be considered due to experimental data. US Navy toxicity experts set the exposure limits for submarines carrying a female crew to 0.8% CO2 based on animal studies which indicated an increased risk for stillbirths. Additionally, mammals who were chronically exposed to 0.3% CO2 the experimental data demonstrate a teratogenicity with irreversible neuron damage in the offspring, reduced spatial learning caused by brainstem neuron apoptosis and reduced circulating levels of the insulin-like growth factor-1. With significant impact on three readout parameters (morphological, functional, marker) this chronic 0.3% CO2 exposure has to be defined as being toxic. Additional data exists on the exposure of chronic 0.3% CO2 in adolescent mammals causing neuron destruction, which includes less activity, increased anxiety and impaired learning and memory. There is also data indicating testicular toxicity in adolescents at CO2 inhalation concentrations above 0.5%. Discussion: There is a possible negative impact risk by imposing extended mask mandates especially for vulnerable subgroups. Circumstantial evidence exists that extended mask use may be related to current observations of stillbirths and to reduced verbal motor and overall cognitive performance in children born during the pandemic. A need exists to reconsider mask mandates.

Symptoms, the GerdQ score and patients' characteristics do not predict gastroesophageal reflux disease in patients with proton-pump-inhibitor-refractory reflux symptoms-results from a large prospective database.

Background: The number of patients with proton pump inhibitor (PPI)-refractory reflux symptoms is underestimated since many patients resign after an unsuccessful therapy attempt. Thus, it would be useful having a non-invasive tool that can help identify true gastroesophageal reflux disease (GERD) patients in order to manage them early and properly. The GerdQ is a validated tool developed for this purpose but its applicability in PPI-refractory patients has not yet been investigated. Our aim was to investigate if reflux symptoms per se, the GerdQ and patients characteristics are suitable for non-invasive diagnosis of GERD in patients with PPI refractory reflux symptoms. Methods: A total of 500 patients from a prospectively recorded data base with PPI-refractory reflux symptoms were retrospectively analyzed. All patients received comprehensive diagnostic workup including EGD, pH-impedance measurement and manometry. GERD was diagnosed according to the recent Lyon consensus. Results: Of all patients enrolled in the study, 280 (56%) finally fulfilled the criteria for objectively verified GERD according to the Lyon consensus. There were no significant differences in age and gender between the patients with and without GERD, whereas the body mass index was significantly higher in the group with verified GERD, but the discriminative value was low (Welch-Test, p < .001, Cohen's d = 0.39). Furthermore, there were no significant differences in the GerdQ values between the two groups. A GerdQ cutoff value ≥ 9 resulted in a sensitivity of 43% and specificity of 57% with a positive predictive value of 56% and a negative predictive value of 44%. Conclusion: Based on our study, neither symptoms and the GerdQ score nor patients' characteristics are appropriate tools to distinguish between GERD and other causes for reflux symptoms in patients with PPI-refractory reflux symptoms.

Physio-metabolic and clinical consequences of wearing face masks-Systematic review with meta-analysis and comprehensive evaluation.

Background: As face masks became mandatory in most countries during the COVID-19 pandemic, adverse effects require substantiated investigation. Methods: A systematic review of 2,168 studies on adverse medical mask effects yielded 54 publications for synthesis and 37 studies for meta-analysis (on n = 8,641, m = 2,482, f = 6,159, age = 34.8 ± 12.5). The median trial duration was only 18 min (IQR = 50) for our comprehensive evaluation of mask induced physio-metabolic and clinical outcomes. Results: We found significant effects in both medical surgical and N95 masks, with a greater impact of the second. These effects included decreased SpO2 (overall Standard Mean Difference, SMD = -0.24, 95% CI = -0.38 to -0.11, p < 0.001) and minute ventilation (SMD = -0.72, 95% CI = -0.99 to -0.46, p < 0.001), simultaneous increased in blood-CO2 (SMD = +0.64, 95% CI = 0.31-0.96, p < 0.001), heart rate (N95: SMD = +0.22, 95% CI = 0.03-0.41, p = 0.02), systolic blood pressure (surgical: SMD = +0.21, 95% CI = 0.03-0.39, p = 0.02), skin temperature (overall SMD = +0.80 95% CI = 0.23-1.38, p = 0.006) and humidity (SMD +2.24, 95% CI = 1.32-3.17, p < 0.001). Effects on exertion (overall SMD = +0.9, surgical = +0.63, N95 = +1.19), discomfort (SMD = +1.16), dyspnoea (SMD = +1.46), heat (SMD = +0.70), and humidity (SMD = +0.9) were significant in n = 373 with a robust relationship to mask wearing (p < 0.006 to p < 0.001). Pooled symptom prevalence (n = 8,128) was significant for: headache (62%, p < 0.001), acne (38%, p < 0.001), skin irritation (36%, p < 0.001), dyspnoea (33%, p < 0.001), heat (26%, p < 0.001), itching (26%, p < 0.001), voice disorder (23%, p < 0.03), and dizziness (5%, p = 0.01). Discussion: Masks interfered with O2-uptake and CO2-release and compromised respiratory compensation. Though evaluated wearing durations are shorter than daily/prolonged use, outcomes independently validate mask-induced exhaustion-syndrome (MIES) and down-stream physio-metabolic disfunctions. MIES can have long-term clinical consequences, especially for vulnerable groups. So far, several mask related symptoms may have been misinterpreted as long COVID-19 symptoms. In any case, the possible MIES contrasts with the WHO definition of health. Conclusion: Face mask side-effects must be assessed (risk-benefit) against the available evidence of their effectiveness against viral transmissions. In the absence of strong empirical evidence of effectiveness, mask wearing should not be mandated let alone enforced by law. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021256694, identifier: PROSPERO 2021 CRD42021256694.

Efficacy of a computer based discontinuation strategy to reduce PPI prescriptions: a multicenter cluster-randomized controlled trial.

Deprescribing of inappropriate long-term proton pump inhibitors (PPI) is challenging and there is a lack of useful methods for general practitioners to tackle this. The objective of this randomized controlled trial was to evaluate the effectiveness of the electronic decision aid tool arriba-PPI on reduction of long-term PPI intake. Participants (64.5 ± 12.9 years; 54.4% women) with a PPI intake of at least 6 months were randomized to receive either consultation with arriba-PPI from their general practitioner (n = 1256) or treatment as usual (n = 1131). PPI prescriptions were monitored 6 months before, 6 and 12 months after study initiation. In 49.2% of the consultations with arriba-PPI, the general practitioners and their patients made the decision to reduce or discontinue PPI intake. At 6 months, there was a significant reduction by 22.3% (95% CI 18.55 to 25.98; p < 0.0001) of defined daily doses (DDD) of PPI. A reduction of 3.3% (95% CI - 7.18 to + 0.62) was observed in the control group. At 12 months, the reduction of DDD-PPI remained stable in intervention patients (+ 3.5%, 95% CI - 0.99 to + 8.03), whereas control patients showed a reduction of DDD-PPI (- 10.2%, 95% CI - 6.01 to - 14.33). Consultation with arriba-PPI led to reduced prescription rates of PPI in primary care practices. Arriba-PPI can be a helpful tool for general practitioners to start a conversation with their patients about risks of long-term PPI intake, reduction or deprescribing unnecessary PPI medication.

Associations between demographic, disease related, and treatment pathway related variables and health related quality of life in primary care patients with coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is a common medical problem worldwide that demands shared care of general practitioners and cardiologists for concerned patients. In order to improve the cooperation between both medical specialists and to optimize evidence-based care, a treatment pathway for patients with CHD was developed and evaluated in a feasibility study according to the recommendation for the development and evaluation of complex interventions of the British Medical Research Council (MRC). In the context of this feasibility study the objective of the present research was to investigate the contributions of different disease related (e.g. prior myocardial infarction), pathway related (e.g. basic medication) and demographic variables on patients` perceived health related quality of life (HRQoL) as a relevant and widely used outcome measure in cardiac populations. METHODS: Data assessing demographic, disease and pathway related variables of CHD patients included in the study were collected in a quasi-experimental design with three study arms (pathway developers, users, control group) via case record forms and questionnaires at baseline and after 6 and 12 (intervention groups), and 9 months (control group), respectively after the initial implementation on GP level. Additionally, at the same measuring points the CHD patients participating in the study were interviewed by phone regarding their perceived HRQoL, measured with the EuroQol EQ-5D as an index-based health questionnaire. Due to the hierarchical structure of the data, we performed cross-sectional and longitudinal linear mixed models to investigate the impact of disease related, pathway related and demographic variables on patients` perceived HRQoL. RESULTS: Of 334 initially recruited patients with CHD, a total of 290 were included in our analysis. This was an average 13.2% dropout rate from baseline assessment to the 12-month follow-up. At all assessment points, patients` HRQoL was associated with a variety of sociodemographic variables (e.g. gender, employment, education) in each study group, but there was no association with pathway related variables. In both cross-sectional and longitudinal analyses highest HRQoL values in patients were reported in the physician group that had developed the pathway. In the longitudinal analyses there were no significant changes in the reported HRQoL values of the three groups over time. CONCLUSIONS: The found associations between sociodemographic variables and the perceived HRQoL of patients with CHD are in line with other research. As there are no associations of HRQoL with pathway related variables like the basic medication, possible weaknesses in the study design or the choice of outcome have to be considered before planning and conducting an evaluation study according to the MRC recommendations. Additionally, as patients in the developer group reported the highest HRQoL values over time, a higher commitment of the GPs in the developer group can be assumed and should be considered in further research.

Reliability and validity of the German version of the OPTION scale.

OBJECTIVE: To examine the psychometric properties of the German version of the 'observing patient involvement' scale (OPTION) by analysing video recordings of primary care consultations dealing with counselling in cardiovascular prevention. DESIGN: Cross-sectional assessment of physician-patient interaction by two rater pairs and two experts in shared decision making (SDM). SETTING: Primary care. PARTICIPANTS: Fifteen general practitioners provided 40 videographed consultations. MEASUREMENTS: Video ratings using the OPTION instrument. RESULTS: Mean differences on item level between the four raters were quite large. Most items were skewed towards minimal levels of shared decision making. Measures of inter-rater association showed low to moderate associations on item level and high associations on total score level. Cronbach-α of the whole scale based on the data of all four raters is 0.90 and therefore on a high level. An oblique factor analysis revealed two factors, but both factors were highly correlated so we can confirm a one-dimensional structure of the instrument. ROC analyses between the rater total scores and dichotomized expert ratings (SDM yes/no) revealed a good discriminability of the OPTION total score. Physicians with more expertise in shared decision making received higher OPTION ratings. CONCLUSIONS: The German version of the OPTION scale is reliable at total score level. Some items need further revision in the direction of more concrete, observable behaviour. We were only able to perform a quasi-validation of the scale. Validity issues need further research efforts.

Referral from primary to secondary care in Germany: developing a taxonomy based on cluster analysis.

AIMS: Referrals from primary to secondary care may differ regarding motivation and initiative. Previous research on the frequency and variation of referrals has mostly treated referrals as homogeneous. We intended to develop a taxonomy regarding referrals from primary to secondary care in Germany that could support decision making on a macro level. METHODS: We analyzed 3,988 referrals by 29 German general practitioners (GPs). GPs were asked to document all referrals during one week; in subsequent audits they stated the reasons and initiative for any referral. We postulated the following five referral types: clinical problem, shared care, administrative, patient initiated and shared cost. The data were analyzed with k-means cluster analysis. RESULTS: We identified three of our five postulated referral types with cluster analytic techniques: shared care, clinical problem, and patient initiated. This solution accounted for 11.7% of total variance. The majority of referrals in German primary care practices were initiated by the GP, or they were part of a shared decision with patients. CONCLUSIONS: We suggest a taxonomy of referrals that might offer insights regarding the allocation of resources within the German health system. Referrals might be reduced by improved training of primary care physicians and by giving them more competencies in routine care of chronic patients.