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Background: A two-fold risk increase to develop basal cell carcinoma was seen in outdoor workers exposed to high solar UV radiation compared to controls. However, there is an ongoing discussion whether histopathological subtype, tumor localization and Fitzpatrick phototype may influence the risk estimates. Objectives: To evaluate the influence of histological subtype, tumor localization and Fitzpatrick phototype on the risk to develop basal cell carcinoma in highly UV-exposed cases and controls compared to those with moderate or low solar UV exposure. Methods: Six hundred forty-three participants suffering from incident basal cell carcinoma in commonly sun-exposed anatomic sites (capillitium, face, lip, neck, dorsum of the hands, forearms outside, décolleté) of a population-based, case-control, multicenter study performed from 2013 to 2015 in Germany were matched to controls without skin cancer. Multivariate logistic regression analysis was conducted stratified for histological subtype, phototype 1/2 and 3/4. Dose-response curves adjusted for age, age2, sex, phototype and non-occupational UV exposure were calculated. Results: Participants with high versus no (OR 2.08; 95% CI 1.24–3.50; p = 0.006) or versus moderate (OR 2.05; 95% CI 1.15–3.65; p = 0.015) occupational UV exposure showed a more than two-fold significantly increased risk to develop BCC in commonly UV-exposed body sites. Multivariate regression analysis did not show an influence of phototype or histological subtype on risk estimates. The restriction of the analysis to BCC cases in commonly sun-exposed body sites did not influence the risk estimates. The occupational UV dosage leading to a 2-fold increased basal cell carcinoma risk was 6126 standard erythema doses. Conclusion: The risk to develop basal cell carcinoma in highly occupationally UV-exposed skin was doubled consistently, independent of histological subtype, tumor localization and Fitzpatrick phototype. [ABSTRACT FROM AUTHOR]

With the implementation of the new EU Regulation 536/2014 (Clinical Trials Regulation - CTR) on 31 January 2022, the approval and conduct of clinical trials with medicinal products for human use are to be harmonized within the European Union (EU). Approval is granted via the electronic Clinical Trials Information System (CTIS) portal of the European Medicines Agency (EMA). In addition to commercial sponsors, sponsors at academic institutions are also affected by the implementation of the CTR in the context of investigator-initiated clinical trials (IITs). Numerous changes in the process map for regulated drug trials are necessary.New aspects concern the general user structure and the role and permission concept of CTIS. Requirements that previously applied only to investigational medicinal products/placebo now also apply to auxiliary medicinal products. Investigational and auxiliary medicinal products not yet approved in the EU must be registered in the XEVMPD drug database. Other significant changes include the reporting of "serious breaches," the publication of relevant study documents, the introduction of a "summary in layman's terms," the archiving period of 25 years, the implementation of "low intervention clinical trials," and the possibility of co-sponsorship.First experience with the application process shows that the new system needs to be further improved. This concerns, for example, the EU-wide harmonization of requirements and the elimination of technical deficiencies. In the medium and long term, however, simplifications with regard to regulatory processes should be noticeable. What is needed here are intensified agreements with national higher authorities and ethics committees, effective knowledge management, and improved communication., (© 2022. The Author(s).)

Basal cell carcinoma is the most common type of cancer in Central Europe and has a high medical relevance. Due to its high tendency of recurrence, an important parameter in the planning of therapy is the risk of recurrence. After clinical and histological diagnosis, the majority of tumors are treated surgically, although radiation and topical procedures are also possible therapeutic alternatives in certain constellations. Hedgehog inhibitors, a completely new class of substances, have recently been approved for rare metastatic and locally advanced diseases, thus significantly expanding the range of treatments. This article provides an overview of the current guideline-based diagnosis and therapy of basal cell carcinomas in Germany.

Background: Squamous cell carcinoma (SCC) is one of the most frequent types of cancer constituting a significant public health burden. Prevention strategies focus on limiting ultraviolet (UV) exposure during leisure time. However, the relative impact of occupational and nonoccupational UV exposure for SCC occurrence is unclear., Objectives: To investigate the association between occupational and nonoccupational UV exposure for SCC in a multicentre population-based case-control study hypothesizing that high occupational UV exposure increases the risk of SCC., Methods: Consecutive patients with incident SCC (n = 632) were recruited from a German national dermatology network. Population-based controls (n = 996) without history of skin cancer were recruited from corresponding residents' registration offices and propensity score matched to cases. Lifetime UV exposure, sociodemographic and clinical characteristics were assessed by trained physicians. Occupational and nonoccupational UV exposure doses were estimated by masked investigators using established reference values. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were assessed using conditional logistic regression adjusting for relevant confounders., Results: Total solar UV exposure was significantly associated with increased SCC. The OR for high (> 90th percentile) vs. low (< 40th percentile) and high vs, moderate (40-59th percentile) occupational UV exposure was 1·95 (95% CI 1·19-3·18) and 2·44 (95% CI 1·47-4·06) for SCC. Adjusting for occupational UV exposure, nonoccupational UV exposure was not significantly related to SCC incidence. Dose-response relationships were observed for occupational but not for nonoccupational solar UV exposure., Conclusions: Solar occupational UV exposure is a major determinant of incident SCC. Our findings indicate that prevention strategies should be further expanded to the occupational setting., (© 2017 British Association of Dermatologists.)

In order to address the increasing complexity and continuously changing needs and demands in the German healthcare system, there is a need to strengthen knowledge translation, evidence-based practice and the conduct of clinical trials in the field of allied health professions. An interdisciplinary working group representing the fields of nursing, midwifery, physiotherapy, occupational therapy and speech therapy developed a guide and a concept for seminars to provide potential analyses for research and innovations in the allied health professions in Germany. These potential analyses compare the current state of health care delivery for specific health problems and the corpus of evidence for the effectiveness of related interventions. Thus innovations can be identified which might improve client-centred healthcare in Germany. The introductory paper briefly reports the activities and results of the working group, describes the international context of transferring research into practice and outlines possibilities for the future development of coordinated research strategies in Germany. The following papers consist of five potential analyses: (1) Advanced Practice Nursing (APN) in long-term care; (2) giving birth in an upright position; (3) treadmill training for patients with Parkinson's disease; (4) training of everyday activities after stroke; and (5) communication training for patients with aphasia., (Copyright © 2014. Published by Elsevier GmbH.)

Objectives: A redesigned pen injector for administration of follitropin alfa (follitropin α) has been developed for use in fertility treatment cycles. Pre-summative and summative usability testing was undertaken to assess the risk of dosing errors compared with the existing follitropin α pen. The study also assessed proper use of and dose selection with the redesigned pen., Methods: Infertile women who were trying to conceive and specialist nurses were recruited from four cities in Germany. Usability goals relating to proper use of the pen device were defined from a risk assessment and further categorized as critical and functional operational goals. Individual, non-interventional, standardized, usability tests were performed with patients and nurses by four experienced research professionals using questionnaires that also included ease-of-use ratings. A non-standardized qualitative analysis of nurse-patient training sessions was performed in the presence of a research professional; reasons for confidence, safety, possible misunderstandings and risks when handling the pen were noted., Results: The overall risk of dosing errors with the redesigned pen was not higher than with the existing pen. No unexpected operational risks and no major concerns regarding the risk of misuse or dosing errors were identified., Conclusions: The study provides useful practical information on the redesigned pen from both patient and nurse perspectives.

The methods of evidence-based medicine demand high quality and up-to-date medical information. Ideally, this information is based on data from controlled clinical trials. When such external evidence is available, it provides a base for an effective patient-physician consultation, and is also essential for the consumer friendly presentation of medical information. This article sketches the international and German developments and approaches to preparing and maintaining evidence-based patient information and its influences on the models of physician-patient communication.

Now more than ever physicians need effective management of the constantly increasing flood of medical information. The authors discuss possibilities for developing clinical guidelines as a core element of this information management and the requirements of these possibilities. The development of clinical guidelines is a process also suitable for involving patient and consumer expertise in health care. Models of involving patients are described and how these processes can build an important base for shared decision making of physicians and patients.

The aim of the Cochrane Collaboration (CC) is to bridge the gap of information transfer between the clinician and the patient. For this purpose, the CC pursues since years the concept of involving the consumers in the process of collaborative review groups. In spite of a positive experience altogether, some barriers (for example the communication between the scientists involved in CC review groups and the patients) remain to be overcome. To improve the information transfer, the Cochrane Hematological Malignancies Group (CHMG) has built a consumer network within the initiatives of the German Cancer Association, for example devising specific training concepts. The German Cochrane Center, on the other hand, focuses on direct information of patients and interested consumers, and provides translated consumer synopses of all available systematic reviews (SR) adapted for use in the German health system. In the future, it will be necessary to develop more concepts to optimize the patient participation process, and to find methods to measure the impact of these projects on the patient outcome.

A study group representing the VRA (Association of Rheumatology Clinics in Germany) has worked out the structural quality paper presented here. Five guidelines for structural quality have been established by the VRA and are laid out in this paper. Required space and personnel for implementing these guidelines are considered. A highly competent, multi-disciplinary team must be available to ensure the long-term quality of in-patient treatment of rheumatic patients, the majority of whom are chronically ill and are suffering from chronic pain of varying intensity which restricts their daily activities. The necessity for such in-patient treatment is reflected in a 6-point-questionnaire (draft) adapted to the Appropriateness Evaluation Protocol. Considering the introduction of a flat-rate fee system (DRG-system) the structural quality paper describes the implementation of a specified electronic data processing documentation which is linked to a central hospital information system. According to the concept of benchmarking, the paper takes into account future developments of the German health system. It will be adjusted continuously to changing political guidelines for health services.