Position statement: The need for EU legislation to require disclosure and labelling of the composition of medical devices.

BACKGROUND: In recent years, skin reactions secondary to the use of medical devices (MD), such as allergic contact dermatitis have increasingly been observed (e.g. to continuous blood sugar monitoring systems, insulin pumps, wound dressings, medical gloves, etc.): this is regarded as a developing epidemic. Lack of labelling of the composition of MD, as well as frequent lack of cooperation of manufacturers to disclose this relevant information, even when contacted by the clinician for the individual case of an established adverse reaction, significantly impede patient care. OBJECTIVES: To advocate for full ingredient labelling in the implementation of EU regulation for MD. METHODS: This position paper reviews the scientific literature, the current regulatory framework adopted for MD to date, and the likely impact, including some costs data in case of the absence of such labelling. RESULTS: Efforts made by several scientific teams, who are trying to identify the culprit of such adverse effects, either via asking for cooperation from companies, or using costly chemical analyses of MD, can only partly, and with considerable delay, compensate for the absence of meaningful information on the composition of MD; hence, patient management is compromised. Indeed, without knowing the chemical substances present, physicians are unable to inform patients about which substances they should avoid, and which alternative MD may be suitable/tolerated. CONCLUSION: There is an urgent need for full and accurate labelling of the chemical composition of MD in contact with the human body.

Trends and current spectrum of contact allergy in Central Europe: results of the Information Network of Departments of Dermatology (IVDK) 2007-2018.

BACKGROUND: Changing patterns of exposure lead to changes in the spectrum of contact allergy in the general population and in patients patch tested for suspected contact allergy. The main contact allergens (haptens) are assembled in the so-called 'baseline series'. OBJECTIVES: To present the current spectrum of contact allergy to baseline series allergens, and its temporal development over the last 12 years, based on data collected by the 56 active departments of the trinational Information Network of Departments of Dermatology (IVDK). METHODS: Patch-test data, along with core demographic and clinical information, subdivided into 4-year periods for all patients patch tested with the baseline series in the IVDK, were analysed descriptively. Moreover, log-binomial regression analysis addressed temporal trends of specific contact allergies, adjusted for potentially confounding factors. RESULTS: Among the 125 436 patients tested with the German baseline series, the most common allergens were nickel (14·7%), fragrance mix I (8·1%), Myroxylon pereirae resin (7·5%) and cobalt (5·2%), with no conclusive trend. The rise and fall of contact allergy to methylchloroisothiazolinone/methylisothiazolinone (MI), following (self-) regulation in the European Union, reflected the MI contact allergy epidemic. Propolis showed a marked upward trend with a prevalence of 3·94% during the period 2015-2018. CONCLUSIONS: Decreases in sensitization prevalence likely reflect reduced exposure, with some lag, as seen with hydroxyisohexyl 3-cyclohexene carboxaldehyde. If no (sufficient) decrease can be observed despite interventions, such as for nickel and chromium, affected subgroups should be identified and their causative exposures explored. Finally, increases such as that observed with propolis, certainly warrant targeted investigation of the exposures driving sensitization, and possibly intervention. What is already known about this topic? Contact allergy is prevalent in the general population. Surveillance based on clinical data offers timely information on trends concerning certain allergens or subgroups at risk. What does this study add? This analysis provides an update of the current contact allergy prevalence in Central Europe, including time trends. This study describes the demographic and clinical profile of patients tested from 2007 to 2018. This research identifies contact allergens that require (further) preventive efforts. Linked Comment: Schuttelaar. Br J Dermatol 2020; 183:800-801.

The epidemic of methylisothiazolinone contact allergy in Europe: follow-up on changing exposures.

BACKGROUND: Methylisothiazolinone (MI) has caused an unprecedented epidemic of contact allergy in Europe and elsewhere. Subsequently, regulatory action has been taken, at least in Europe, aiming at reducing risk of MI sensitization. OBJECTIVE: To follow-up on the prevalence of contact allergy to MI in consecutively patch tested patients and assess the spectrum of products containing MI or methylchloroisothiazolinone (MCI)/MI in patients positive to MI which elicited current allergic contact dermatitis. METHODS: A cross-sectional survey was performed in 2016 and 2017, including all adult patients patch tested with the baseline series (including MI 0.2% aq.) between 1 May and 31 October at 14 centres in 11 European countries. Patients with positive reactions (+ to +++) to MI were further examined regarding history, clinical characteristics and eliciting products, which were categorized into 34 types and 4 classes (leave-on, rinse-off, household, occupational). The results were compared with the reference year 2015. RESULTS: A total of 317 patients, n = 202 of 4278 tested in 2016 (4.72%) and n = 115 of 3879 tested in 2017 (2.96%), had positive reactions to MI; the previous result from 2015 was 5.97% (P < 0.0001). The share of currently relevant contact allergy among all positive reactions declined significantly as well (P = 0.0032). Concerning product classes, a relative decline of leave-on and a relative increase of rinse-off and household products was noted. CONCLUSION: The prevalence of MI contact allergy decreased by 50% from 2015 to 2017. As a consequence of regulation, the share of cosmetics products (leave-on in particular) eliciting allergic contact dermatitis is decreasing. The chosen method of analysing causative products in sensitized patients has proven useful to monitor effects of intervention.

Evaluation of urinary selenium as a biomarker of human occupational exposure to elemental and inorganic selenium.

PURPOSE: Selenium (Se) is an essential trace element, which however, exhibits a narrow safe range of intake. Selenium also occurs at several workplaces, which results in an inhalative selenium exposure of the employees. Thus, an efficient exposure assessment strategy is demanded. The most established parameter, selenium in plasma, mostly consists of protein-bound selenium. This study aimed to investigate urinary total selenium (Se-U) as an additional biomarker of recent human occupational exposure to elemental and inorganic selenium. METHODS: Pre- and post-shift urine samples from employees with exposure to selenium-containing dust were analyzed to total selenium and compared with Se levels in urine samples from controls without occupational exposure to selenium as well as correlated with the recent ambient Se exposure by personal air monitoring. RESULTS: Se-U in post-shift samples was considerably increased compared to the levels in pre-shift samples as well as to the controls. However, Se-U in pre-shift urine was elevated compared to the Se-U in controls too. Se-U in post-shift urine and even better the shift increment in Se-U correlated with the air exposure of the present shift. A rough estimation by Se-U shift increment and external exposure accounted for an inhalative resorption rate of about 1%. CONCLUSION: Our data indicate that Se-U can display the exposure. Pre-shift Se-U levels may be based on previous exposure and indicate a slow urinary elimination kinetics. The results hint for a rather low resorption rate of selenium and inorganic selenium compounds via the lung.

The role of the dermatologist in the immune-mediated/allergic diseases - position statement of the EADV task force on contact dermatitis, EADV task force on occupational skin diseases, UEMS-EBDV subcommission allergology and European Dermatology Forum.

BACKGROUND: The members of the Task Force on Contact Dermatitis and the Task Force on Occupational Dermatoses of the European Academy of Dermatology and Venereology (EADV), of the European Dermatology Forum (EDF), and the members of the UEMS Section of Dermatology-Venereology (UEMS-EBDV) we want to vindicate the fundamental role that the specialist in Dermatology has in the diagnosis and management of Immuno-mediated /allergic Diseases. OBJECTIVE: In disagreement with the blueprint paper of the UEMS section of Allergology (2013), in which dermatologists are excluded from one of their core activities it was decided to write this consensus paper. DISCUSSION: The skin occupies a crucial place in the broad spectrum of allergic diseases; there is no other organ with such a multitude of different clinical conditions mediated by so many pathogenetic immune mechanisms. Subsequently, dermatologists play a fundamental role in the management of immune-mediated diseases including among others contact dermatitis, atopic dermatitis, urticaria and angioedema or cutaneous adverse drug, food and arthropod reactions. The essential role of dermatology in the diagnostic, therapeutic and preventive management of immune mediated /allergic diseases which is crucial for patient management is justified from both the academic and professional point of view. CONCLUSION: Based on the best care of the patient with cutaneous immune allergic disease a multidisciplinary approach is desirable and the dermatologist has a pivotal role in patient management. Be so good and no one will not ignore you, dermatologist. Ideally Dermatology should be governed according the following Henry Ford statement: "Arriving together is the beginning; keeping together is progress; working together is success."

European Surveillance System on Contact Allergies (ESSCA): results with the European baseline series, 2013/14.

BACKGROUND: Contact allergy is a common condition and can severely interfere with daily life or professional activities. Due to changes in exposures, such as introduction of new substances, new products or formulations and regulatory intervention, the spectrum of contact sensitization changes. OBJECTIVE: To evaluate the current spectrum of contact allergy to allergens present in the European baseline series (EBS) across Europe. METHODS: Retrospective analysis of data collected by the European Surveillance System on Contact Allergies (ESSCA, www.essca-dc.org) in consecutively patch-tested patients, 2013/14, in 46 departments in 12 European countries. RESULTS: Altogether, 31 689 patients were included in the analysis. Compared to a similar analysis in 2004, the prevalence of contact allergy to methylisothiazolinone went up to around 20% in several departments. In comparison, contact allergy to the metals nickel, cobalt and chromium remained largely stable, at 18.1%, 5.9% and 3.2%, respectively, similar to mostly unchanged prevalence with fragrance mix I, II and Myroxylon pereirae (balsam of Peru) at 7.3%, 3.8% and 5.3%, respectively. In the subgroup of departments diagnosing (mainly) patients with occupational contact dermatitis, the prevalence of work-related contact allergies such as epoxy resin or rubber additives was found to be increased, compared to general dermatology departments. CONCLUSION: Continuous surveillance of contact allergy based on network data offers the identification of time trends or persisting problems, and thus enables focussing in-depth research (subgroup analyses, exposure analysis) on areas where it is needed.

Minimum standards on prevention, diagnosis and treatment of occupational and work-related skin diseases in Europe - position paper of the COST Action StanDerm (TD 1206).

BACKGROUND: Skin diseases constitute up to 40% of all notified occupational diseases in most European countries, predominantly comprising contact dermatitis, contact urticaria, and skin cancer. While insufficient prevention of work-related skin diseases (WRSD) is a top-priority problem in Europe, common standards for prevention of these conditions are lacking. OBJECTIVE: To develop common European standards on prevention and management of WRSD and occupational skin diseases (OSD). METHOD: Consensus amongst experts within occupational dermatology was achieved with regard to the definition of minimum evidence-based standards on prevention and management of WRSD/OSD. RESULTS: By definition, WRSDs/OSDs are (partially or fully) caused by occupational exposure. The definition of OSD sensu stricto additionally includes diverging national legal requirements, with an impact on registration, prevention, management, and compensation. With the implementation of the classification of WRSD/OSD in the International Classification of Diseases (ICD) 11th Revision in future, a valid surveillance and comparability across countries will be possible. Currently, WRDS and OSD are still under-reported. Depending on legislation and regulations, huge differences exist in notification procedures in Europe, although notification is crucial to prevent chronic and relapsing disease. Facilities for early diagnosis, essential for individual patient management, should be based on existing guidelines and include a multidisciplinary approach. Patch testing is essential if contact dermatitis persists or relapses. Workplace exposure assessment of WRSD/OSD requires full labelling of product ingredients on material safety data sheets helping to identify allergens, irritants and skin carcinogens. Comparable standards in primary, secondary and tertiary prevention must be established in Europe to reduce the burden of WRSD/OSD in Europe. CONCLUSION: The adoption of common European standards on prevention of WRSD/OSD will contribute to reduce the incidence of OSD and their socio-economic burden.

Occupational skin diseases: actual state analysis of patient management pathways in 28 European countries.

BACKGROUND: Work-related skin diseases (WSD) are caused or worsened by a professional activity. Occupational skin diseases (OSD) need to fulfil additional legal criteria which differ from country to country. OSD range amongst the five most frequently notified occupational diseases (musculoskeletal diseases, neurologic diseases, lung diseases, diseases of the sensory organs, skin diseases) in Europe. OBJECTIVE: To retrieve information and compare the current state of national frameworks and pathways to manage patients with occupational skin disease with regard to prevention, diagnosis, treatment and rehabilitation in different European countries. METHODS: A questionnaire-based survey of the current situation regarding OSD patient management pathways was carried out with experts on occupational dermatology and/or occupational medicine from 28 European countries contributing to the European Cooperation in Science and Technology (COST) Action TD 1206 (StanDerm) (www.standerm.eu). RESULTS: Besides a national health service or a statutory health insurance, most European member states implemented a second insurance scheme specifically geared at occupational diseases [insurance against occupational risks (synonyms: insurance against work accidents and occupational injuries; statutory social accident insurance)]. Legal standards for the assessment of occupationally triggered diseases with a genetic background differ between different countries, however, in most European member states recognition as OSD is possible. In one-third of the countries UV light-induced tumours can be recognized as OSD under specific conditions. CONCLUSION: OSD definitions vary between European countries and are not directly comparable, which hampers comparisons between statistics collected in different countries. Awareness of this fact and further efforts for standardization are necessary.

Sickness absence among peer-supported drivers after occupational trauma.

BACKGROUND: Psychological first aid is a common approach for providing support after potentially traumatic events (PTEs). In Germany, a peer support model is recommended by the German Statutory Accident Insurance (DGUV) to reduce sickness absence after occupational accidents, especially in public transportation. However, data on the effectiveness of peer support are very sparse. AIMS: To analyse whether peer support has an impact on sickness absence after work-related traumatic events in public transportation. METHODS: An analysis was conducted in two German public transportation corporations. Due to ethical requirements, we used a historical cohort study comparing peer support by colleagues (VAG-1), peer support at supervisor level (VGF) and a non-intervention group (VAG-0). The study period was from March 2003 to December 2012. We used a negative binominal regression model to estimate the relative risk associated with the interventions and potential confounders. RESULTS: A total of 259 incident PTEs in employees were observed. A regression analysis identified the severity of PTE (severe and fatal events), VGF and age as significant factors in predicting duration of post-event sickness absence. In a stratified analysis, the mode of peer support (VGF) and age predicted sickness absence for less severe PTEs but this was not significant for severe PTEs. CONCLUSIONS: Severe and fatal PTEs had the strongest impact on sickness absence after PTEs. For less severe PTE, peer support provided by colleagues may be superior to supervisor support.

Contact allergy to preservatives: ESSCA* results with the baseline series, 2009-2012.

BACKGROUND: Allergic contact dermatitis caused by biocides is common and causes significant patient morbidity. OBJECTIVE: To describe the current frequency and pattern of patch test reactivity to biocide allergens included in the baseline series of most European countries. METHODS: Data collected by the European Surveillance System on Contact Allergies (ESSCA) network between 2009 and 2012 from 12 European countries were analysed. RESULTS: Methylisothiazolinone 0.2% aq. produced the highest prevalence of sensitization during the study period, with an overall prevalence of 4.5%. The mixture methylchloroisothiazolinone /methylisothiazolinone tested at 0.02% aq. followed closely, with 4.1% of positive reactions. Other preservatives with lower rates of sensitization, but still over 1%, include methyldibromo glutaronitrile (MDBGN) 0.5% pet. and iodopropynyl butylcarbamate (IPBC) 0.2% pet. Formaldehyde releasers and parabens yielded less than 1% positive reactions during the study period. Some regional differences in the prevalence of contact allergy to biocides among European countries were observed. CONCLUSIONS: Contact allergy to biocides is common throughout Europe, and regional differences could be explained by differences in exposure or characteristics of the population tested. Timely regulatory action for isothiazolinones is required. Although MDBGN is banned from cosmetics products since 2005, sensitization prevalence has not appeared to plateau. IPBC is an emerging allergen with an increasing prevalence over the last few years, and its inclusion in the European baseline series may be appropriate.

Occupational contact allergy in bricklayers, tile setters etc. - Current spectrum of sensitization and recent time trends.

BACKGROUND: Occupational exposure of bricklayers, construction workers, tile setters etc. has changed during the last years. For some years now, all manually handled cement in the European Union and in Switzerland is chromate-reduced. Epoxy resin systems are being used in more and more fields of application. Improved worker's protection, especially wearing protective gloves, is promoted. These changes influence the spectrum of occupational contact sensitization. OBJECTIVE: Description of the current allergen spectrum in patients working in the building trade who suffer from occupational contact dermatitis. MATERIAL AND METHODS: Retrospective analysis of data of the Information Network of Departments of Dermatology (IVDK), 2009 - 2011. RESULTS: During the study period, 245 bricklayers, construction workers, tile setters etc. with occupational dermatitis have been patch tested. Potassium dichromate was the most frequent allergen, yielding 15.1% positive reactions, followed by epoxy resin with 13.7% positive reactions. Beyond that, there were 8 additional components of epoxy resin systems (5 reactive diluents and 3 amine hardeners), as well as 9 rubber ingredients, mainly thiurams, among the 30 most frequent allergens. In the course of time, a decline of chromate sensitization could be noted, paralleled by a decline of cobalt sensitization. In contrast, sensitization to epoxy resin has increased. CONCLUSION: Thanks to the usage of chromate-reduced cement, chromate sensitization continues to decline in the building trade. The increase of epoxy resin sensitization must prompt intensified prevention efforts. When recommending protective gloves, thiuram-free products should be preferred. The most important allergens are covered by the following test series recommended by the German Contact Dermatitis Research Group (DKG): DKG baseline series, DKG test series "building trade", DKG rubber series.

Contact allergy to fragrances: current clinical and regulatory trends.

. Several fragrances are important contact allergens. Compared to the immense multitude of more than 2,500 fragrances used in cosmetics, the spectrum of single substances and natural extracts used for patch testing appears limited, albeit comprising the supposedly most important contact allergens. The present review summarizes the most important results of the opinion of the Scientific Committee on Consumer Safety on fragrance allergens in cosmetic products from July 2012. Clinical results beyond abovementioned screening allergens, animal results in terms of the LLNA and structure activity considerations point to 100 single substances and extracts, respectively, which, in addition to those 26 already identified, must be considered contact allergens, and the presence of which should be declared in cosmetics. In case of the most commonly used fragrance terpenes limonene and linalool hydroperoxides resulting from autoxidation constitute the major allergens. These have become available as patch test material recently. Altogether 12 single substances have caused a (very) high number of published cases of sensitization. Thus their use concentration should be (further) reduced or, in case of hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC, e.g., Lyral®), use should be abandoned altogether. This is also recommended in case of oak moss and tree moss due to their content of the strong sensitizers atranol and chloroatranol. As generic maximum dose for the remaining 11 single substances 0.8 µg/cm2 are suggested, which corresponds, under conservative assumptions, a maximum concentration of 100 ppm in the finished product.

Registries in Clinical Epidemiology: the European Surveillance System on Contact Allergies (ESSCA).

BACKGROUND: Disease registries rely on consistent electronic data capturing (EDC) pertinent to their objectives; either by using existing electronic data as far as available, or by implementing specific software solutions. OBJECTIVES: To describe the current practice of an international disease registry (European Surveillance System on Contact Allergies, ESSCA, www.essca-dc.org) against different state of the art approaches for EDC. METHODS: Since 2002, ESSCA is collecting data, currently from 53 departments in 12 countries. Departmental EDC software ranges from spreadsheets to comprehensive "patch test software" based on a relational database. In the Erlangen data centre, such diverse data is imported, converted to a common format, quality checked and pooled for scientific analyses. RESULTS: Feed-back to participating departments for quality control is provided by standardised reports. Varying author teams publish scientific analyses addressing the objective of contact allergy surveillance. CONCLUSIONS: Although ESSCA represents a historically grown, heterogeneous network and not one unified approach to EDC, some of its features have contributed to its viability in the last 12 years and may be useful to consider for similar investigator-initiated networks.

[Contact allergies in the German workforce : Data of the IVDK network from 2003-2013]. / Kontaktallergien bei Erwerbstätigen in Deutschland : Ergebnisse des IVDK-Netzwerkes 2003-2013.

BACKGROUND: In Germany, occupational skin diseases rank first in the occupational skin disease statistics for many years. Especially, occupationally acquired contact allergies as well as multi-sensitization are the most important predictors for a poor prognosis and persistent eczema. OBJECTIVES: To update the spectrum and sensitization frequencies of most frequent allergens from the standard series in Germany in patients with occupationally acquired type IV sensitizations in general and within different occupational groups. METHODS: Data of all employed patients (age range: 16-68 years, n = 14234) patch tested between 2003 and 2013 in the German Departments of the Information Network of Departments of Dermatology (IVDK) and diagnosed occupationally acquired contact dermatitis after patch testing were analyzed. The control group was composed of all other patients (n = 31706) within the same time frame, in which occupationally acquired allergic contact dermatitis was negated explicitly. RESULTS: The prevalence Ratio (PR; indicating risk) was significantly increased for: Thiuram-mix (PR 5.63 95 %CI 4.97-6.4), zinkdiethyldithiocarbamate (PR 6.22 95 %CI 4.76-8.22), mercaptobenzothiazole (MBT) (PR 3.88 95 %CI 3.09-4.89), mercapto-mix without MBT (PR 3.23 95 %CI 2.59-4.03), N-isopropyl-N'-phenyl-p-phenylene diamine (IPPD) (PR 2.3195 %CI 1.87-2.86), epoxy resin (PR 2.82 95 %CI 2.45-3.25), chloromethylisothiazolinone/methylisothiazolinone (MCI/MI) (PR 2.19 95 %CI 1.97-2.42) and compositae mix II (PR 2.05 95 %CI 1.45-2.89). They were the predominant occupational allergens and were at least associated with a doubled risk (PR ≥ 2.0) for acquiring occupationally allergic contact dermatitis. The highest risk increase was identified in employees in the health services, in agriculture, metal industry, food and service industry as well as building trades CONCLUSIONS: A limited number of occupationally relevant allergens cause the majority of sensitizations in the workforce, if standard series allergens are concerned. Data analysis of national and international contact allergy data bases provide valuable information on sensitization rates and profiles in skin risk occupations to implement targeted prevention strategies. To diagnose occupational allergic contact dermatitis in individual cases additional testing of occupation related patch test series as well as patients' own products is commonly inevitable.

[Multiple contact sensitization]. / Multiple Kontaktsensibilisierungen.

Contact allergy to several non-related haptens, usually termed polysensitization (PS), is often used to characterize patients who are particularly prone to sensitization. A conventional definition for PS is positive reactions to three or more haptens of the baseline series, e.g., the baseline series of the German Contact Dermatitis Research Group. Previous genetic as well as epidemiological studies have already indicated a number of potential risk factors for PS. In this context, both endogenous as well as exogenousfactors appear to be crucial. The former comprise polymorphism of IL-16 and TNF coding genes, the latter mostly occupational exposure, which often entails intense and repeated skin contact to a set of more or less characteristic contact allergens. Moreover, age and sex are related both with contact allergy to certain substances and with PS, as is the anatomical site of contact dermatitis. The degree to which contact allergy to a specific hapten is associated with PS, i.e., with contact allergy to several other haptens, varies greatly.

[Diagnostic workup of fragrance allergy]. / Diagnostik der Duftstoffallergie.

The diagnostic workup of contact allergy to fragrances must not be limited to patch testing with the two well-established fragrance mixes. False-positive reactions to these mixes occur in up to 50 % of the patch tested patients. For the diagnostic work-up of positive reactions, and in cases of suspected fragrance allergy, patch testing with the single mix components and additional fragrances is mandatory. Frequently sensitizing fragrance materials are the 14 components of the two fragrance mixes and tree moss (Evernia furfuracea), ylang ylang oil (I + II; Cananga odorata), lemongrass oil (Cymbopogon schoenanthus), sandalwood oil (Santalum album), jasmine absolute (Jasminum spp.), and, less frequently, clove oil (Eugenia caryophyllus), cedarwood oil (Cedrus atlantica/deodara, Juniperus virginiana), Neroli oil (Citrus aurantium amara flower oil), salicylaldehyde, narcissus absolute (Narcissus spp.), and patchouli oil (Pogostemon cablin).

Compliance of nursing home residents with a nutrient- and energy-dense oral nutritional supplement determines effects on nutritional status.

OBJECTIVES: Administration of oral nutritional supplements (ONS) is an effective strategy to treat and avoid malnutrition, a persisting issue in nursing homes. However, little is known about compliance in the NH population. This study aimed to analyse the effects of compliance of NH residents with a low-volume, nutrient- and energy-dense ONS on nutritional status and to identify residents' characteristics associated with compliance. DESIGN AND SETTING: Randomized, controlled trial in nursing homes. PARTICIPANTS AND INTERVENTION: 87 nursing home residents (87 ± 6y, 91% female) with malnutrition or at risk of malnutrition were randomly allocated to an intervention group (IG) receiving 2 x 125 ml ONS (2.4 kcal/ml)/d for 12 weeks, or the control group (CG) with usual care. MEASUREMENTS: ONS intake was recorded daily and compliance calculated. Low and high compliance were defined as ≤ 30% and ≥ 80% of provided ONS actually consumed, respectively. Body weight (BW), BMI, upper-arm (UAC) and calf-circumference (CC) and MNA-SF were assessed at baseline and after 12 weeks. Associations between compliance and changes of nutritional parameters and residents' characteristics were analysed. RESULTS: Compliance was high in 35.7% and low in 28.6% of the IG (n=42). BW change was significantly higher in subjects with high compliance (median +3.0 (interquartile range +2.1;+3.8) kg, n=15) than in those with low compliance (-0.2 (-2.2;+1.6) kg, n=12) and CG (-0.1 (-1.2; +0.6) kg, n=35; p<0.001), and significantly correlated with compliance in IG (r=0.691; p<0.001). Significant differences and correlations were also identified for BMI, UAC and MNA-SF. High compliance was more often observed in residents with malnutrition (66.7 vs. 27.3%) and chewing difficulties (77.8 vs. 24.2%) than in those without these conditions. Low compliance was more prevalent in residents who were immobile (45.0 vs. 13.6%), depressed (33.3 vs. 6.7%) or had gastrointestinal complaints (50.0 vs. 17.9%) (all p<0.05). CONCLUSIONS: A high compliance of nursing home residents with a low volume, nutrient- and energy dense ONS was related to a significantly improved nutritional status in comparison to low compliance and therefore enhanced the effectiveness of ONS. A higher compliance may be achieved by consideration of different residents' characteristics.