Die Entwicklung des Qualitätsmanagements und die Auswirkungen auf die Betriebsorganisation im soziokulturellen Handlungsfeld

Organisationen müssen sich aufgrund von Veränderungen am Markt ständig anpassen und weiterentwickeln, um die Kundenbedürfnisse zu gewährleisten. Einflussfaktoren wie die Industrialisierung und der Wechsel von Handwerksbetrieben zu industriellen Großunternehmen beeinflussten die Betriebsorganisation wie auch das Bild der Arbeitskraft im Unternehmen. Die zunehmende Vereinheitlichung von Arbeitsprozessen wurde als tayloristisches Produktionssystem bekannt und vom Automobilproduzenten Henry Ford zum fordistischen Produktionssystem weiterentwickelt. Der Marktwandel ab den 1950er Jahren brachte die Konsumenten in eine günstige Position, und die Bedürfnisse und Wünsche der Kunden wurden über Absatzmärkte bestimmt. Nur jene Unternehmen, denen es gelang, diese Wünsche zu decken, waren erfolgreich. Es galt nun, sich vom Konkurrenten zu unterscheiden. Eine Möglichkeit dazu war die Positionierung als Qualitätsproduzent. Damit startete die betriebswissenschaftliche Diskussion über Kosten und Nutzen des Qualitätsmanagements. Es folgte eine Debatte darüber, was unter „Qualität“ zu verstehen wäre. Die Entscheidung, Qualitätsmanagement zu betreiben, sollte zusätzlich eine Veränderung der Mitarbeiter hervorrufen. Gerade in der Frage des Qualitätsbewusstseins werden Mitarbeiter stärker denn je mit der Unternehmenskultur vereint. Globalisierte Marktverhältnisse erschwerten zusätzlich das Unternehmensumfeld, Flexibilisierung und Produktivitätssteigerung rückten in das Interesse der Industrieunternehmen. Dies eröffnete unter anderem neue Marktchancen für Qualitäts- und Prozessverbesserungssysteme wie Total Quality Management, Lean und Six Sigma. Mit diesen Verbesserungssystemen wurde vor allem die Interaktion und Einbindung der Mitarbeiter in die Entscheidungsprozesse betont. Daraus ist eine Abkehr vom tayloristischen Produktionssystem abzuleiten, und einer humanen Prozesslandschaft steht im dritten Jahrtausend – so ist zu hoffen – nichts mehr im Wege. 215 In dieser Arbeit wird untersucht, wie sich die großindustrielle Fertigung entwickelt hat, und es werden die einzelnen Entwicklungsstufen der Qualitätsmanagementsysteme dargelegt. Weitere Berücksichtigung finden die Prozessverbesserungssysteme Lean und Six Sigma, die ab den 1990er Jahren mit den vorhandenen Qualitätsnormen zu interagieren begannen. Es werden die Entscheidungsgrundlagen nachvollzogen, nach denen Betriebe mehrere Qualitäts-Prozessverbesserungssysteme einsetzen. Am Fallbeispiel DuPont Performance Coatings, dem größten österreichischen Lackhersteller, wird demonstriert, wie sich diese Veränderungen auswirkten, und ob tatsächlich eine Humanisierung im Produktionsprozess stattgefunden hat. Letztendlich stehen – auf Kosten der Human-Ressourcen – weiterhin die Produktivitätssteigerung und Gewinnmaximierung im Vordergrund.Organisations need to be continually aware of changes in the market if they wish to continue to fulfil customer expectations. Influencing factors such as industrialisation and the change from craftsmanship based operations to large mass producing companies had an impact on how plants organised their processes as did the perception of employees in terms of their significance in the firm. The changes in the market during the 1950s led to the consumers suddenly finding themselves in a favourable position and their desires and wishes were transmitted to this market by means of their purchasing patterns. Only those companies that satisfied these desires and wishes were ultimately successful. The ability to be able to differentiate oneself from the competition had become vital. One example in this respect was to position oneself as the market leader from the quality perspective. Debating of the relationship between quality management and cost started and developed into the broader discussion of “Quality” as a concept. In making the decision to introduce a quality management culture the intention of an organisation was to also stimulate a change in the mentality of its workforce. In raising awareness of the significance of quality amongst their employees management was actually subconsciously uniting everyone under their company’s culture. Globalisation of markets placed additional burdens upon the strategies of companies and the resultant stress on flexibility and increased productivity resulted in a shift in the focus of industrial concerns. This led to, amongst other things, opportunities for quality and process improvement systems such as Total Quality Management, Lean and Six Sigma to flourish. With such improvement systems the involvement and engagement of employees in the decision making processes has become both fundamental and essential. 217 Due to these aspects enterprises began to turn away from the Tayloristic approaches and hopefully start with a human production concept in the third millennium. In this study the question of how large scale operation evolved will be investigated and the individual development steps of quality management systems will be demonstrated. Further consideration will be given to the process improvement systems Lean and Six Sigma from the 1990s onwards together with their integration into the existing quality systems of the time. The principles behind the decisions companies make in launching quality and process improvement systems will also be explained. In examining the case study of DuPont Performance Coatings Austria, the largest Austrian paint manufacturer, the impact of change will be shown and the question of whether or not a humanisation of production systems has actually occurred will be answered

Human and computational models of atopic dermatitis:A review and perspectives by an expert panel of the International Eczema Council

Atopic dermatitis (AD) is a prevalent disease worldwide and is associated with systemic comorbidities representing a significant burden on patients, their families, and society. Therapeutic options for AD remain limited, in part because of a lack of well-characterized animal models. There has been increasing interest in developing experimental approaches to study the pathogenesis of human AD in vivo, in vitro, and in silico to better define pathophysiologic mechanisms and identify novel therapeutic targets and biomarkers that predict therapeutic response. This review critically appraises a range of models, including genetic mutations relevant to AD, experimental challenge of human skin in vivo, tissue culture models, integration of “omics” data sets, and development of predictive computational models. Although no one individual model recapitulates the complex AD pathophysiology, our review highlights insights gained into key elements of cutaneous biology, molecular pathways, and therapeutic target identification through each approach. Recent developments in computational analysis, including application of machine learning and a systems approach to data integration and predictive modeling, highlight the applicability of these methods to AD subclassification (endotyping), therapy development, and precision medicine. Such predictive modeling will highlight knowledge gaps, further inform refinement of biological models, and support new experimental and systems approaches to AD

Treat-to-target in dermatology:A scoping review and International Eczema Council survey on the approach in atopic dermatitis

Treat-to-target (T2T) is a pragmatic therapeutic strategy being gradually introduced into dermatology after adoption in several other clinical areas. Atopic dermatitis (AD), one of the most common inflammatory skin diseases, may also benefit from this structured and practical therapeutic approach. We aimed to evaluate existing data regarding the T2T approach in dermatology, with a specific focus on AD, as well as the views of International Eczema Council (IEC) members on the potential application of a T2T approach to AD management. To do so, we systematically searched for peer-reviewed publications on the T2T approach for any skin disease in the PubMed and Scopus databases up to February 2022 and conducted a survey among IEC members regarding various components to potentially include in a T2T approach in AD. We identified 21 relevant T2T-related reports in dermatology, of which 14 were related to psoriasis, five to AD, one for juvenile dermatomyositis and one for urticaria. In the IEC member survey, respondents proposed treatable traits (with itch, disease severity and sleep problems getting the highest scores), relevant comorbidities (with asthma being selected most commonly, followed by anxiety and depression in adults), recommended specialists that should define the approach in AD (dermatologists, allergists and primary care physicians were most commonly selected in adults), and applicable assessment tools (both physician- and patient-reported), in both adult and paediatric patients, for potential future utilization of the T2T approach in AD. In conclusion, while the T2T approach may become a useful tool to simplify therapeutic goals and AD management, its foundation in AD is only starting to build. A multidisciplinary approach, including a wide range of stakeholders, including patients, is needed to further define the essential components needed to utilize T2T in AD.</p

When does atopic dermatitis warrant systemic therapy? Recommendations from an expert panel of the International Eczema Council

BackgroundAlthough most patients with atopic dermatitis (AD) are effectively managed with topical medication, a significant minority require systemic therapy. Guidelines for decision making about advancement to systemic therapy are lacking.ObjectiveTo guide those considering use of systemic therapy in AD and provide a framework for evaluation before making this therapeutic decision with the patient.MethodsA subgroup of the International Eczema Council determined aspects to consider before prescribing systemic therapy. Topics were assigned to expert reviewers who performed a topic-specific literature review, referred to guidelines when available, and provided interpretation and expert opinion.ResultsWe recommend a systematic and holistic approach to assess patients with severe signs and symptoms of AD and impact on quality of life before systemic therapy. Steps taken before commencing systemic therapy include considering alternate or concomitant diagnoses, avoiding trigger factors, optimizing topical therapy, ensuring adequate patient/caregiver education, treating coexistent infection, assessing the impact on quality of life, and considering phototherapy.LimitationsOur work is a consensus statement, not a systematic review.ConclusionThe decision to start systemic medication should include assessment of severity and quality of life while considering the individual's general health status, psychologic needs, and personal attitudes toward systemic therapies

Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis

About 1% of children and adolescents worldwide are affected by plaque psoriasis.To evaluate the long-term efficacy and safety of ixekizumab for pediatric patients with moderate to severe psoriasis.This multicenter randomized clinical trial (IXORA-PEDS) evaluated pediatric patients with plaque psoriasis. Participants were aged 6 years to younger than 18 years; had moderate to severe psoriasis, which was defined as Psoriasis Area and Severity Index (PASI) of 12 or higher, static Physician's Global Assessment (sPGA) score of 3 or higher, and psoriasis-affected body surface area of 10% or greater at screening and baseline; were candidates for phototherapy or systemic therapy; or had psoriasis that was not adequately controlled by topical therapies. Data analysis, which followed the intention-to-treat principle, was conducted from May to October 2021.Pediatric patients were randomized 2:1 to receive either a weight-based dose of ixekizumab every 4 weeks or placebo. After a 12-week placebo-controlled period, patients entered a 48-week, open-label ixekizumab maintenance period (weeks 12-60), followed by an extension period that lasted through 108 weeks. A substudy evaluated the randomized withdrawal of ixekizumab after week 60.Efficacy outcomes at week 108 included the percentage of patients achieving 75% (PASI 75), 90% (PASI 90), or 100% (PASI 100) improvement from baseline; an sPGA score of 0 or 1 or score of 0; and improvement of 4 points or higher from baseline in the Itch Numeric Rating Scale. Safety outcomes included assessments of adverse events (AEs), including treatment-emergent AEs, serious AEs, and AEs of special interest, as well as improvement from baseline in a range of challenging body areas. Missing data for categorical outcomes were imputed using modified nonresponder imputation.A total of 171 patients (mean [SD] age, 13.5 [3.04] years; 99 female children [57.9%]) were randomized to either ixekizumab (n = 115) or placebo (n = 56). Of 166 patients who entered the maintenance period, 139 (83.7%) completed week 108 of the trial. Primary and gated secondary end points were sustained through week 108, with patients achieving PASI 75 (91.7% [n = 86]), PASI 90 (79.0% [n = 74]), PASI 100 (55.1% [n = 52]), sPGA 0 or 1 (78.3% [n = 74]), and sPGA 0 (52.4% [n = 49]). Fifty-five patients (78.5%) reported an Itch Numeric Rating Scale improvement of 4 points or higher. In patients who received ixekizumab, at week 108, clearance of nail psoriasis was reported in 68.1% (n = 28), clearance of palmoplantar psoriasis was reported in 90.0% (n = 10), clearance of scalp psoriasis was reported in 76.2% (n = 83), and clearance of genital psoriasis was reported in 87.5% (n = 24). There were no new safety findings during weeks 48 to 108 of the trial, including no new cases of inflammatory bowel disease or candida infection.Results of this study showed improvements across patient-reported outcomes and objective measures of complete skin clearance of psoriasis among pediatric patients who received ixekizumab, and these response rates were sustained through week 108 of the trial. Safety of ixekizumab was consistent with previously reported findings in this population and the known safety profile of this treatment.ClinicalTrials.gov Identifier: NCT03073200

Efficacy and safety of dupilumab treatment with concomitant topical corticosteroids in children aged 6 months to 5 years with severe atopic dermatitis

   Article full text  The article associated with this page has been accepted for online publication and is in the final stages of production. The link to the full text will be made available on this page in the next few days.  The above infographic and video abstract represents the opinions of the authors. For a full list of declarations, including funding and author disclosure statements, and copyright information, please see the full text online. (see “read the peer-reviewed publication” opposite). </p

Efficacy and Safety of Tralokinumab in Adolescents With Moderate to Severe Atopic Dermatitis: The Phase 3 ECZTRA 6 Randomized Clinical Trial

IMPORTANCE: Safe and effective long-term treatments for adolescents with moderate to severe atopic dermatitis (AD) are limited. OBJECTIVE: To evaluate the efficacy and safety of interleukin-13-targeted treatment with tralokinumab monotherapy in adolescents with AD. DESIGN, SETTING, AND PARTICIPANTS: The 52-week, randomized, double-blinded, placebo-controlled, phase 3 ECZTRA 6 trial was conducted from July 17, 2018, through March 16, 2021, at 72 centers across 10 countries in North America, Europe, Asia, and Australia. Enrolled patients were 12 to 17 years old with moderate to severe AD (Investigator's Global Assessment [IGA] score ≥3; Eczema Area and Severity Index [EASI] ≥16). INTERVENTIONS: Patients were randomized (1:1:1) to tralokinumab (150 or 300 mg) or placebo every 2 weeks for 16 weeks. Patients with an IGA score of 0 (clear) or 1 (almost clear) and/or 75% or higher improvement in EASI (EASI 75) at week 16 without rescue medication received maintenance treatment; other patients switched to open-label tralokinumab, 300 mg, every 2 weeks. MAIN OUTCOMES AND MEASURES: Primary end points at week 16 were an IGA score of 0 or 1 and/or achieving EASI 75. Key secondary end points were a reduction of Adolescent Worst Pruritus Numeric Rating Scale of 4 or more, change in SCORing AD, and change in Children's Dermatology Life Quality Index from baseline to week 16. Safety end points were the number of adverse events and serious adverse events. RESULTS: Of 301 patients randomized, 289 comprised the full analysis set (median [IQR] age, 15.0 [13.0-16.0] years; 149 [51.6%] male). More patients receiving tralokinumab, 150 mg, (n = 98), and tralokinumab, 300 mg (n = 97), achieved an IGA score of 0 or 1 without rescue medication at week 16 (21 [21.4%] and 17 [17.5%], respectively) vs placebo (n = 94; 4 [4.3%]) (adjusted difference, 17.5% [95% CI, 8.4%-26.6%]; P < .001 and 13.8% [95% CI, 5.3%-22.3%]; P = .002, respectively). More patients receiving tralokinumab, 150 mg (28 [28.6%]), and tralokinumab, 300 mg, (27 [27.8%]) vs placebo (6 [6.4%]) achieved EASI 75 without rescue at week 16 (adjusted difference, 22.5% [95% CI, 12.4%-32.6%]; P < .001 and 22.0% [95% CI, 12.0%-32.0%]; P < .001, respectively). Proportions of patients with Adolescent Worst Pruritus Numeric Rating Scale reduction of 4 or more from baseline were greater with tralokinumab, 150 mg (23.2%), and tralokinumab, 300 (25.0%), vs placebo (3.3%), and adjusted mean changes were greater in SCORing AD with tralokinumab, 150 mg (-27.5), and tralokinumab, 300 mg (-29.1), vs placebo (-9.5) and in Children's Dermatology Life Quality Index with tralokinumab, 150 mg (-6.1), and tralokinumab, 300 mg (-6.7), vs placebo (-4.1) at week 16. At week 52, tralokinumab efficacy was maintained without rescue in more than 50% of patients meeting primary end point(s) at week 16. In the open-label phase, IGA score of 0 or 1 and EASI 75 were achieved in 33.3% and 57.8%, respectively, at week 52. Tralokinumab was well tolerated, without frequency of conjunctivitis increasing through week 52. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, tralokinumab was efficacious and well tolerated, supporting its value for treating adolescents with moderate to severe AD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03526861