Aetiology of occupational hand eczema in hairdressers: Tackling the complexity of exposure combinations to identify patterns associated with increased risk of hand eczema.

INTRODUCTION: Hairdressers are exposed to wet work and manifold allergens at work, rendering exposure complex and the aetiology of occupational hand eczema (OHE) often multifactorial in this occupational group. OBJECTIVES: To identify exposure patterns associated with increased risk of hand eczema in hairdressers. METHODS: All hairdressers graduating from 2004 to 2007 and 2015 to 2018 received a questionnaire in 2009 and 2020, respectively. Current exposures (with or without regular glove use) and OHE were self-reported, and their association examined. Patterns of exposure were identified by latent class analysis (LCA). RESULTS: A total response of 39.9% (668/1675) was obtained. Six exposure profiles (#1-6) were identified by LCA across 11 tasks performed with or without gloves as well as deep conditioning, that is, 23 task items. Compared to profile #1 with the lowest OHE risk (reference) an increased risk of current OHE were seen in profile #4 [adjusted odds ratio [aOR] 6.5, 95% confidence interval [CI] 1.5-44.8 and #6 (aOR 39.4, 95%CI 6.1-362.8)] in logistic regression analysis. Profile #1 and #6 had performed the same tasks, but in profile #6 regular glove use was performed in 9.1% (1/ 11) of tasks compared to 72.7% (8/11) of tasks in profile #1 (p = 0.002). CONCLUSION: Although occupational exposures in hairdressing are complex, meaningful patterns associated with a wide range of OHE risk can be identified by LCA. The increase of OHE risk seems predominantly to be due to poor compliance with protective gloves. LCA could be applied to further fields of complex (skin) exposures.

Contact allergy to ingredients of hair cosmetics in female hairdressers and female consumers-An update based on IVDK data 2013-2020.

BACKGROUND: Hair cosmetic products contain several, partly potent contact allergens, including excipients like preservatives. Hand dermatitis in hairdressers is common, scalp and face dermatitis in clients or self-users (summarised here as 'consumers') may be severe. OBJECTIVE: To compare frequencies of sensitization to hair cosmetic ingredients and other selected allergens between female patch tested patients working as hairdressers and consumers without professional background, respectively, who were tested for suspected allergic contact dermatitis to such products. METHODS: Patch test and clinical data collected by the IVDK (https://www.ivdk.org) between 01/2013 and 12/2020 were descriptively analysed, focusing on age-adjusted sensitization prevalences in the two subgroups. RESULTS: Amongst the 920 hairdressers (median age: 28 years, 84% hand dermatitis) and 2321 consumers (median age: 49 years, 71.8% head/face dermatitis), sensitization to p-phenylenediamine (age-standardised prevalence: 19.7% and 31.6%, respectively) and toluene-2,5-diamine (20 and 30.8%) were most common. Contact allergy to other oxidative hair dye ingredients was also more commonly diagnosed in consumers, whereas ammonium persulphate (14.4% vs. 2.3%) and glyceryl thioglycolate (3.9 vs. 1.2%) as well as most notably methylisothiazolinone (10.5% vs. 3.1%) were more frequent allergens in hairdressers. CONCLUSIONS: Hair dyes were the most frequent sensitizers both in hairdressers and in consumers; however, as indication for patch testing may differ, prevalences cannot directly be compared. The importance of hair dye allergy is evident, often with marked coupled reactivity. Workplace and product safety need to be further improved.

Non-pharmacological, psychosocial MAKS-s intervention for people with severe dementia in nursing homes: results of a cluster-randomised trial.

BACKGROUND: Severe dementia is one of the most challenging conditions when caring for people in nursing homes. A manualised non-pharmacological, psychosocial group intervention especially adapted to the needs of people with severe dementia (PWSDs) is currently still lacking. To close this gap, we adapted the evidence-based multicomponent non-pharmacological MAKS intervention (Motor stimulation, ADL stimulation, Cognitive [german: Kognitive] stimulation, and Social functioning in a group setting) to the special needs of PWSDs called the MAKS-s intervention, where the s stands for severe dementia. METHODS: In a prospective, multicentre, cluster-randomised trial with a waitlist control group design, 26 nursing homes comprising 152 PWSDs were randomly assigned to either the MAKS-s intervention group (IG) or control group (CG) - 121 PWSDs were still alive after the 6-month intervention period (t6) and included in the intention-to-treat (ITT) sample. The two primary outcomes, behavioural and psychological symptoms (BPSDs, measured with NPI-NH) and quality of life (QoL, measured with QUALIDEM), and the secondary outcome, activities of daily living (ADLs, measured with ADCS-ADL-sev), were assessed at baseline (t0) and at t6. Mixed ANOVAs were computed to investigate possible effects of the MAKS-s intervention on the outcomes. RESULTS: In the ITT sample, BPSDs and QoL did not change significantly over time, and group assignment did not affect them, although the IG participants had significantly better overall QoL than the CG participants. ADLs decreased significantly over time, but group assignment did not affect them. Analyses in the per protocol (PP) sample showed comparable results, with the exception that the IG participants showed a significantly greater increase in BPSDs than the CG participants did. DISCUSSION: Under the situational conditions of the Covid-19 pandemic, no beneficial effects of the MAKS-s intervention on BPSDs, QoL, or ADLs were observed. This finding also means that under 'normal circumstances' (i.e., if there had been no pandemic), we could not make any statements about the effect or non-effect of MAKS-s. In order to be able to address the hypotheses formulated here, the study will have to be repeated incorporating helpful experiences of the present study. TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN15722923 (Registered prospectively, 07. August 2019).

A nationwide skin protection program introduced in hairdressing vocational schools was followed by a decreased risk of occupational hand eczema.

BACKGROUND: Compliance with glove use and safe work practices are important factors in primary prevention of occupational hand eczema (OHE) in hairdressers. OBJECTIVE: To assess the risk OHE and compliance with skin protective measures in hairdressers trained before and after implementation of a nationwide skin protection program in Danish hairdressing vocational schools in 2011. METHODS: A repeated cross-sectional study was performed. A questionnaire was sent in 2009 and 2020. The Danish Labour Market Supplementary Pension Scheme provided information on yearly payments from the hairdressing profession. RESULTS: A response rate of 66.6% (305/460) was obtained in the 2009 survey and of 29.9% (363/1215) in the 2020 survey. The career time prevalence of OHE decreased from 42.8% to 29.0% (adjusted odds ratio 0.55 95% confidence interval [CI] 0.40-0.77) and the incidence rate of OHE decreased from 57.5 (95%CI 48.4-68.4) to 42.0 (95%CI 34.6-50.9) per 1000 person years (incidence rate ratio 0.73 [95%CI 0.56-0.95] between the two surveys). A statistically significant (P < .05) increase in glove use when doing wet-work and when handling hair dyes, permanent wave solutions and bleaching products was observed in the 2020 compared to the 2009 survey. CONCLUSION: Our data suggest that skin protection training during apprenticeship reduces the risk of OHE in hairdressers. The lack of primary prevention of OHE in hairdressing vocational schools may be a missed opportunity in the prevention of the disease.

[Effects of the Covid-19 Restrictions on Supermarket Visits in Germany]. / Auswirkungen der Ausgangsbeschränkungen im Zusammenhang mit Covid-19 auf Supermarktbesuche in Deutschland.

BACKGROUND: The lockdown measures imposed in Germany starting in mid-March had a significant impact on public life. While the avoidance of social contacts was possible in many areas, the responsibility to provide themselves with food was placed in the hands of private households. OBJECTIVES: To investigate whether and to what extent the restrictions led to changes regarding visits to supermarkets using cars. MATERIALS AND METHODS: Data were available on the parking movements on 136 parking spaces of supermarkets in Germany between the beginning of February and the end of May. The analyses focused on changes in the total number of parking events per day and slot as well as their duration. RESULTS: Regarding the parking events, there was a clear reduction until the end of April, interrupted by an increase around Easter. After the introduction of mandatory masking, the values recovered to just below the level before lockdown. The duration changed relatively slightly. Initially it decreased, but later rose slightly above the level observed before the restrictions. Over the medium term, there was a slight reduction of parking events and an extension of their duration by a little more than 5%. Discussion Despite the explicit exclusion of food purchases from the lockdown measures, a dynamic adaptation behaviour of the population to the changing circumstances is also evident in this context. In terms of parking movements, a lasting effect on shopping behaviour seems unlikely.

In-hospital mortality and failure to rescue following hepatobiliary surgery in Germany - a nationwide analysis.

BACKGROUND: Recent observational studies on volume-outcome associations in hepatobiliary surgery were not designed to account for the varying extent of hepatobiliary resections and the consequential risk of perioperative morbidity and mortality. Therefore, this study aimed to determine the risk-adjusted in-hospital mortality for minor and major hepatobiliary resections at the national level in Germany and to examine the effect of hospital volume on in-hospital mortality, and failure to rescue. METHODS: All inpatient cases of hepatobiliary surgery (n = 31,114) in Germany from 2009 to 2015 were studied using national hospital discharge data. After ranking hospitals according to increasing hospital volumes, five volume categories were established based on all hepatobiliary resections. The association between hospital volume and in-hospital mortality following minor and major hepatobiliary resections was evaluated by multivariable regression methods. RESULTS: Minor hepatobiliary resections were associated with an overall mortality rate of 3.9% and showed no significant volume-outcome associations. In contrast, overall mortality rate of major hepatobiliary resections was 10.3%. In this cohort, risk-adjusted in-hospital mortality following major resections varied widely across hospital volume categories, from 11.4% (95% CI 10.4-12.5) in very low volume hospitals to 7.4% (95% CI 6.6-8.2) in very high volume hospitals (risk-adjusted OR 0.59, 95% CI 0.41-0.54). Moreover, rates of failure to rescue decreased from 29.38% (95% CI 26.7-32.2) in very low volume hospitals to 21.38% (95% CI 19.2-23.8) in very high volume hospitals. CONCLUSIONS: In Germany, patients who are undergoing major hepatobiliary resections have improved outcomes, if they are admitted to higher volume hospitals. However, such associations are not evident following minor hepatobiliary resections. Following major hepatobiliary resections, 70-80% of the excess mortality in very low volume hospitals was estimated to be attributable to failure to rescue.

Soluble intercellular adhesion molecule-1 is a prognostic marker in colorectal carcinoma.

PURPOSE: Serological tumor markers are routinely used to monitor tumor onset and progression. In colorectal carcinoma (CRC), the carcinoembryonic antigen (CEA) is roughly elevated in 50% of patients at initial diagnosis. Soluble ICAM-1 (sICAM-1) is elevated in different cancers. The aim of this study was to evaluate the prognostic relevance of sICAM-1 combined with CEA in patients with CRC. METHODS: In blood samples of 297 CRC patients, sICAM-1 was determined by ELISA and CEA by microparticle enzyme immunoassay the day before oncologic resection. Separation in patients with sICAM-1high and sICAM-1low was performed by minimum p value approach; separation in CEA normal and elevated was performed according to the established diagnostic cutoff. Clinical data were obtained from the prospective collected data from the Erlangen Registry for Colorectal Carcinomas. RESULTS: Cancer-related 5-year survival rate of patients with sICAM-1low (< 290 ng/ml, n = 208) was significantly increased (83.4%) as compared to that of patients with sICAM-1high (≥ 290 ng/ml, n = 89) (66.2%; p < 0.001). Patients with normal CEA concentrations (n = 199; 90.8%) showed a significantly (p < 0.001) improved cancer-related 5-year survival rate compared to patients with elevated CEA concentrations (n = 98; 52.1%). Moreover, high sICAM-1 was an independent risk factor (hazard ratio 1.6) in multivariate analysis. Of note, increased sICAM-1 levels, either within normal or within elevated CEA, allowed to identify high-risk subgroups, both for overall (p < 0.001) and cancer-related survival (p < 0.001). CONCLUSION: Application of a novel risk score combining CEA/sICAM-1 serum concentrations allows the identification of high-risk groups for poor survival in CRC patients.

Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery.

OBJECTIVES: The "angiosome" concept as a model for decision making in revascularisation of patients with critical limb ischaemia (CLI) has been subject to lively discussion in recent years. The aim of this prospective pilot study was to use intra-operative fluorescence angiography to provide further data on the angiosome concept on the level of microcirculation after tibial bypass surgery. DESIGN, MATERIALS, AND METHODS: This was a prospective analysis of 40 patients presenting with CLI Rutherford stage IV to VI before and after tibial bypass surgery. The macrocirculation was measured by the ankle brachial index. Skin microcirculation was assessed by intra-operative fluorescence angiography. The alteration of microcirculation was compared in direct and indirect revascularised angiosomes. Clinical follow-up investigations were performed and the wound healing rate was compared between the different revascularisation methods. RESULTS: Cumulated microcirculation parameters showed a significant improvement after surgery (ingress, ingress rate p<.001). Likewise, general microcirculatory improvement was observed in each foot angiosome after revascularisation, regardless of the tibial artery revascularised. Furthermore, a comparison of the direct (DR) and the indirect revascularised (IR) angiosomes did not show a significant difference concerning the improvement of microcirculation (difference DR-IR, ingress: 1.69, 95% CI 71.73-75.11; ingress rate: 0.08, 95% CI -12.91 to 13.07). The wound healing rate was similar in both groups, although the time to wound healing was faster by on average 2.5 months in the DR group (p=.083). CONCLUSION: Microcirculatory improvement was seen over the whole foot after tibial bypass. Therefore, fluorescence angiography is a promising tool to evaluate the angiosome concept in future larger studies. Clinicaltrials.gov: NCT03012750.

[Knowledge and information sources of parents of 3­ to 6­year-old children concerning skin cancer risk factors]. / Kenntnisse und Wissensquellen zu Hautkrebs-Risikofaktoren bei Eltern von 3­ bis 6­jährigen Kindern.

BACKGROUND: The dissemination of knowledge on risk factors and preventive strategies is a core element of skin cancer prevention. However, little is known about the information channels utilised by the population for this purpose. OBJECTIVES: Descriptive analysis of information sources used by parents of 3­ to 6­year-old children as a particularly relevant target group and analysis of association patterns between socio-demographic factors, types of information sources and acquired knowledge. MATERIALS AND METHODS: A cross-sectional study was performed using a self-administered questionnaire with an online option between October 2011 and February 2012 with 3129 families who had at least one child visiting a kindergarten in the county of Erlangen-Höchstadt, the city of Erlangen or the city of Ansbach (Bavaria, Germany), with an 87.5% response rate on the level of kindergartens and 56.5% on the level of observational units (families). RESULTS: There were few structural differences between study regions. The internet was used by only 13.3% of participants. A positive association was found between the use of multiple information sources and relevant knowledge and, partly, protective behaviour. A negative association was identified between the use of the internet and knowledge. In contrast, the use of print media or audio-visual or personal channels of information was positively associated with knowledge. CONCLUSIONS: Preventive efforts should be increased that target parts of the population with lower formal education. The internet does not seem to play an important role and may even adversely affect knowledge, possibly due to unvalidated and misleading information.

Long-term development of parental knowledge about skin cancer risks in Germany: Has it changed for the better?

Substantial public health efforts have been undertaken throughout the last 25years to increase awareness about skin cancer risks in the German population. An evaluation of long-term effects of these awareness campaigns and preventive activities on the population level and in specific subgroups is yet lacking. We address the temporal development of knowledge about skin cancer risk factors and agreement to the necessity of sun protection in different outdoor situations among parents of young children. We compiled data from four population-based surveys comprising data from 8184 parents of 3- to 6-year-old children in two regions of Germany performed over a nineteen-year period between 1993 and 2012. These individual cross-sectional studies used an identical methodology to recruit study subjects and to assess the principal outcome measures. Overall, parental knowledge about skin cancer risk factors and agreement to the necessity of sun protection improved significantly over the nineteen-year period. For instance, the recognition of fair skin/hair, sunburns during childhood and a high number of naevi, respectively, being risk factors for skin cancer increased by 20.0%, 19.9% and 19.2% from the first to the most recent survey. Two remaining knowledge gaps became evident: (i) the underrating of intermittent intensive sun exposure as a skin cancer risk factor and (ii) the erroneous belief that clouds provide sufficient sun protection at midday during summertime. The messages of future public health campaigns in Germany addressing skin cancer risks and informing about preventive measures for sun protection should thus be refined regarding these aspects.

The Angiosome Concept Evaluated on the Basis of Microperfusion in Critical Limb Ischemia Patients-an Oxygen to See Guided Study.

OBJECTIVES: Aim of this clinical study was to evaluate the angiosome concept with regard to the microcirculation of the foot in patients with CLI and to evaluate its relevance by means of combined laser Doppler flowmetrie and white-light tissue spectrophotometry. METHODS: Twenty-eight patients who underwent leg revascularization in the stage of CLI were prospectively examined. The microperfusion was assessed by light guided spectrophotometry. The measuring points were set according to the angiosome concept into direct and indirect revascularized areas of the foot. Investigations were performed pre and postinterventionally and after 4 and 12 weeks in baseline-position as well as in an elevated position of the leg. RESULTS: Microcirculation parameters (oxygen saturation, blood flow, velocity) of the revascularized leg showed a significant increase in elevation and baseline position compared to the preoperative values in most analyses. No significant differences between the direct and indirect revascularized angiosome were apparent. CONCLUSION: The light-guided spectrophotometry measurement proved to be feasible in terms of measuring changes in the microcirculation after leg revascularization. However, our data do not support the value of the "angiosome concept" concerning the individual changes in microperfusion of the foot in patients with CLI.

Low postoperative dietary intake is associated with worse functional course in geriatric patients up to 6 months after hip fracture.

We examined the relationship between postoperative dietary intake (DI) of geriatric hip fracture (HF) patients and their functional and clinical course until 6 months after hospital discharge. In eighty-eight HF patients ≥ 75 years, postoperative DI was estimated with plate diagrams of main meals over four postoperative days. DI was stratified as >50, >25-50, ≤ 25 % of meals served. Functional status according to Barthel index (activities of daily living) and patients' mobility level before fracture, postoperatively, at discharge and 6 months later were assessed and related to DI levels. In-hospital complications were recorded according to clinical diagnosis. Associations were evaluated using χ2 and Kruskal-Wallis tests, and repeated-measures ANOVA and ANCOVA. Postoperatively, 28 % of participants ate >50 %, 43 % ate >25-50 % and 28 % ≤ 25 % of meals served. Irrespective of pre-fracture functional status, patients with DI ≤ 25 % had significantly lower Barthel index scores at all times after surgery (all P50 % more often had regained their pre-fracture mobility level than those with DI ≤ 25 % at discharge (>50 %: 36 %; >25-50 %: 10 %; ≤ 25 %: 0 %; P= 0·001) and 6 months after discharge (88; 87; 68 %; P= 0·087) and had significantly less complications (median 2 (25th-75th percentile 1-3); 3 (25th-75th percentile 2-4); 3 (25th-75th percentile 3-4); P= 0·012). To conclude, geriatric HF patients had very low postoperative voluntary DI and thus need specific nutritional interventions to achieve adequate DI to support functional and clinical recovery.

Characteristics of patients patch tested in the European Surveillance System on Contact Allergies (ESSCA) network, 2009-2012.

BACKGROUND: Patch test results often vary between departments, and also between countries. Such variation may be partly attributable to systematic effects introduced by patient characteristics, differing exposures, patient selection, or methodological differences. OBJECTIVE: To examine the amount of variation of patient characteristics in terms of the MOAHLFA index and of the proportion of patients with at least one positive reaction to the (European) baseline series ('P' measure), and to examine potential reasons for the variation. METHODS: A retrospective analysis was performed of patch test data from 63 530 consultations collected by 53 departments from 12 countries participating in the European Surveillance System on Contact Allergies (ESSCA) ( www.essca-dc.org) between 2009 and 2012. RESULTS: Considerable variation in the prevalence of the MOAHLFA factors between departments was found, caused, for example, by differing specializations (e.g. occupational dermatology) or patient characteristics. Notable variation concerning the 'P' measure was observed; however, larger national networks (contributing to the ESSCA) tend to have quite similar ranges of this measure. CONCLUSIONS: Data from one department per country give valuable insights into the spectrum of contact allergy prevalence rates in that country, but are not as representative as national data pooled from several departments.

Good, but Not Perfect: Parental Knowledge About Risk Factors for Skin Cancer and the Necessity of Sun Protection in Southern Germany.

The level of knowledge and awareness of skin cancer risks in parents of young children is largely unknown. The Erlangen Kindergarten study, which enrolled 3,129 parents of 3- to 6-year-old children in southern Germany, addressed this. The population-based survey found an overall high level of knowledge about skin cancer risks and strong support for the necessity of sun protection but identified two areas (role of intermittent sun exposure, sun protection on cloudy summer days) offering a target for improvement in future public health campaigns.

Computer-based auditory phoneme discrimination training improves speech recognition in noise in experienced adult cochlear implant listeners.

OBJECTIVE: Specific computer-based auditory training may be a useful completion in the rehabilitation process for cochlear implant (CI) listeners to achieve sufficient speech intelligibility. This study evaluated the effectiveness of a computerized, phoneme-discrimination training programme. DESIGN: The study employed a pretest-post-test design; participants were randomly assigned to the training or control group. Over a period of three weeks, the training group was instructed to train in phoneme discrimination via computer, twice a week. Sentence recognition in different noise conditions (moderate to difficult) was tested pre- and post-training, and six months after the training was completed. The control group was tested and retested within one month. STUDY SAMPLE: Twenty-seven adult CI listeners who had been using cochlear implants for more than two years participated in the programme; 15 adults in the training group, 12 adults in the control group. RESULTS: Besides significant improvements for the trained phoneme-identification task, a generalized training effect was noted via significantly improved sentence recognition in moderate noise. No significant changes were noted in the difficult noise conditions. Improved performance was maintained over an extended period. CONCLUSIONS: Phoneme-discrimination training improves experienced CI listeners' speech perception in noise. Additional research is needed to optimize auditory training for individual benefit.

Contact sensitization to cobalt--multifactorial analysis of risk factors based on long-term data of the Information Network of Departments of Dermatology.

BACKGROUND: Cobalt contact sensitization in consecutively tested patients is common. The sources of exposure, and thus clinical relevance, are mostly unclear. OBJECTIVE: To examine (i) long-term time trends of sensitization, (ii) risk factors that may point to relevant exposures, and (iii) coupling with nickel sensitization. METHODS: Data of all patients patch tested with cobalt(II) chloride hexahydrate (1% pet.) between 1992 and 2012 (n = 185 050) in the Information Network of Departments of Dermatology (IVDK, www.ivkd.org) were subjected to descriptive stratified and Poisson regression analysis. RESULTS: The overall prevalence of positive patch test reactions was 5.23% (95% confidence interal 5.13-5.33%). Regarding time trends, there were significant increases for males aged 18-44 years and for females aged ≥45 years, and a significant variation of co-reactivity with nickel over time. Female sex almost doubled the risk of sensitization; age ≥45 years was associated with a 30% decrease in the risk of positive patch test reactions to cobalt, and atopic eczema with an approximately 20% increase. CONCLUSIONS: Notwithstanding some diagnostic difficulties with the test preparation, a persistent, notable proportion of cobalt sensitization, isolated or coupled with nickel allergy, can be observed. This warrants further in-depth research into causative exposures, both at the workplace and in consumers.

Contact allergy to ingredients of hair cosmetics - a comparison of female hairdressers and clients based on IVDK 2007-2012 data.

BACKGROUND: Cosmetics for bleaching, waving/relaxing and dyeing hair contain well-known allergens, leading to a substantial number of cases of allergic contact dermatitis. OBJECTIVE: To compare the frequency of important contact allergens (i) between two distinct groups of exposed patients, and (ii) with previous surveillance data. METHODS: On the basis of data collected by the Information Network of Departments of Dermatology (IVDK; www.ivkd.org) between 2007 and 2012 in 824 female hairdressers and 2067 female clients, the current spectrum of contact sensitization to ingredients of hair cosmetics, as contained in different pertinent series, is described. RESULTS: A similar burden of sensitization as in previous analyses was observed, but with some increase in sensitization to oxidative hair dye components in clients. Some allergens mainly affected hairdressers, such as ammonium persulfate (18.7% positive) and glyceryl monothioglycolate (GMTG; still 4.7% positive, with a few cases also in young hairdressers, despite removal from the German market). CONCLUSIONS: Hair dyes remain important contact allergens, despite various attempts by the cosmetic industry to introduce hair dyes with lower allergenic potential. The re-emergence of GMTG as an occupational allergen should be considered as a warning signal ('sentinel event') prompting close monitoring.

The Level of Agreement between Self-Assessments and Examiner Assessments of Melanocytic Nevus Counts: Findings from an Evaluation of 4548 Double Assessments.

Cutaneous melanoma (CM) is a candidate for screening programs because its prognosis is excellent when diagnosed at an early disease stage. Targeted screening of those at high risk for developing CM, a cost-effective alternative to population-wide screening, requires valid procedures to identify the high-risk group. Self-assessment of the number of nevi has been suggested as a component of such procedures, but its validity has not yet been established. We analyzed the level of agreement between self-assessments and examiner assessments of the number of melanocytic nevi in the area between the wrist and the shoulder of both arms based on 4548 study subjects in whom mutually blinded double counting of nevi was performed. Nevus counting followed the IARC protocol. Study subjects received written instructions, photographs, a mirror, and a "nevometer" to support self-assessment of nevi larger than 2 mm. Nevus counts were categorized based on the quintiles of the distribution into five levels, defining a nevus score. Cohen's weighted kappa coefficient (κ) was estimated to measure the level of agreement. In the total sample, the agreement between self-assessments and examiner assessments was moderate (weighted κ = 0.596). Self-assessed nevus counts were higher than those determined by trained examiners (mean difference: 3.33 nevi). The level of agreement was independent of sociodemographic and cutaneous factors; however, participants' eye color had a significant impact on the level of agreement. Our findings show that even with comprehensive guidance, only a moderate level of agreement between self-assessed and examiner-assessed nevus counts can be achieved. Self-assessed nevus information does not appear to be reliable enough to be used in individual risk assessment to target screening activities.

A multimodal aftercare intervention improves the outcome after kidney transplantation - results of the KTx360° aftercare program using claims data.

Background: The after-care treatment project KTx360° aimed to reduce graft failure and mortality after kidney transplantation (KTx). Methods: The study was conducted in the study centers Hannover, Erlangen and Hannoversch Muenden from May 2017 to October 2020 under the trial registration ISRCTN29416382. The program provided a multimodal aftercare program including specialized case management, telemedicine support, psychological and exercise assessments, and interventions. For the analysis of graft failure, which was defined as death, re-transplantation or start of long-term dialysis, we used longitudinal claims data from participating statutory health insurances (SHI) which enabled us to compare participants with controls. To balance covariate distributions between these nonrandomized groups we used propensity score methodology, in particular the inverse probability of treatment weighting (IPTW) approach. Findings: In total, 930 adult participants were recruited at three different transplant centres in Germany, of whom 320 were incident (enrolled within the first year after KTx) and 610 prevalent (enrolled >1 year after KTx) patients. Due to differences in the availability of the claims data, the claims data of 411 participants and 418 controls could be used for the analyses. In the prevalent group we detected a significantly lower risk for graft failure in the study participants compared to the matched controls (HR = 0.13, 95% CI = 0.04-0.39, p = 0.005, n = 389 observations), whereas this difference could not be detected in the incident group (HR = 0.92, 95% CI = 0.54-1.56, p = 0.837, n = 440 observations). Interpretation: Our findings suggest that a multimodal and multidisciplinary aftercare intervention can significantly improve outcome after KTx, specifically in patients later after KTx. For evaluation of effects on these outcome parameters in patients enrolled within the first year after transplantation longer observation times are necessary. Funding: The study was funded by the Global Innovation fund of the Joint Federal Committee of the Federal Republic of Germany, grant number 01NVF16009.

Clinical and immunological benefits of full primary COVID-19 vaccination in individuals with SARS-CoV-2 breakthrough infections: A prospective cohort study in non-hospitalized adults.

BACKGROUND: SARS-CoV-2 variants of concern (VOC) may result in breakthrough infections (BTIs) in vaccinated individuals. The aim of this study was to investigate the effects of full primary (two-dose) COVID-19 vaccination with wild-type-based SARS-CoV-2 vaccines on symptoms and immunogenicity of SARS-CoV-2 VOC BTIs. METHODS: In a longitudinal multicenter controlled cohort study in Bavaria, Germany, COVID-19 vaccinated and unvaccinated non-hospitalized individuals were prospectively enrolled within 14 days of a PCR-confirmed SARS-CoV-2 infection. Individuals were visited weekly up to 4 times, performing a structured record of medical data and viral load assessment. SARS-CoV-2-specific antibody response was characterized by anti-spike-(S)- and anti-nucleocapsid-(N)-antibody concentrations, anti-S-IgG avidity and neutralization capacity. RESULTS: A total of 300 individuals (212 BTIs, 88 non-BTIs) were included with VOC Alpha or Delta SARS-CoV-2 infections. Full primary COVID-19 vaccination provided a significant effectiveness against five symptoms (relative risk reduction): fever (33 %), cough (21 %), dysgeusia (22 %), dizziness (52 %) and nausea/vomiting (48 %). Full primary vaccinated individuals showed significantly higher 50 % inhibitory concentration (IC50) values against the infecting VOC compared to unvaccinated individuals at week 1 (269 vs. 56, respectively), and weeks 5-7 (1,917 vs. 932, respectively) with significantly higher relative anti-S-IgG avidity (78% vs. 27 % at week 4, respectively). CONCLUSIONS: Full primary COVID-19 vaccination reduced symptom frequencies in non-hospitalized individuals with BTIs and elicited a more rapid and longer lasting neutralization capacity against the infecting VOC compared to unvaccinated individuals. These results support the recommendation to offer at least full primary vaccination to all adults to reduce disease severity caused by immune escape-variants.