Digital Therapeutic (Mika) Targeting Distress in Patients With Cancer: Results From a Nationwide Waitlist Randomized Controlled Trial.

BACKGROUND: Distress is highly prevalent among patients with cancer, but supportive care needs often go unmet. Digital therapeutics hold the potential to overcome barriers in cancer care and improve health outcomes. OBJECTIVE: This study conducted a randomized controlled trial to investigate the efficacy of Mika, an app-based digital therapeutic designed to reduce distress across the cancer trajectory. METHODS: This nationwide waitlist randomized controlled trial in Germany enrolled patients with cancer across all tumor entities diagnosed within the last 5 years. Participants were randomized into the intervention (Mika plus usual care) and control (usual care alone) groups. The participants completed web-based assessments at baseline and at 2, 6, and 12 weeks. The primary outcome was the change in distress from baseline to week 12, as measured by the National Comprehensive Cancer Network Distress Thermometer. Secondary outcomes included depression, anxiety (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), and quality of life (Clinical Global Impression-Improvement Scale). Intention-to-treat and per-protocol analyses were performed. Analyses of covariance were used to test for outcome changes over time between the groups, controlling for baseline. RESULTS: A total of 218 patients (intervention: n=99 and control: n=119) were included in the intention-to-treat analysis. Compared with the control group, the intervention group reported greater reductions in distress (P=.03; ηp²=0.02), depression (P<.001; ηp²=0.07), anxiety (P=.03; ηp²=0.02), and fatigue (P=.04; ηp²=0.02). Per-protocol analyses revealed more pronounced treatment effects, with the exception of fatigue. No group difference was found for quality of life. CONCLUSIONS: Mika effectively diminished distress in patients with cancer. As a digital therapeutic solution, Mika offers accessible, tailored psychosocial and self-management support to address the unmet needs in cancer care. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00026038; https://drks.de/search/en/trial/DRKS00026038.

End-of-life care in Germany between 2016 and 2020 - A repeated cross-sectional analysis of statutory health insurance data.

BACKGROUND: The Hospice and Palliative Care Act of 2015 aimed at developing and regulating the provision of palliative care (PC) services in Germany. As a result of the legal changes, people with incurable diseases should be enabled to experience their final stage of life including death according to their own wishes. However, it remains unknown whether the act has impacted end-of-life care (EoLC) in Germany. OBJECTIVE: The present study examined trends in EoLC indicators for patients who died between 2016 and 2020, in the context of Lower Saxony, Germany. METHODS: Repeated cross-sectional analysis was conducted on data from the statutory health insurance fund AOK Lower Saxony (AOK-LS), referring to the years 2016-2020. EoLC indicators were: (1) the number of patients receiving any form of outpatient PC, (2) the number of patients receiving generalist outpatient PC and (3) specialist outpatient PC in the last year of life, (4) the onset of generalist outpatient PC and (5) the onset of specialist outpatient PC before death, (6) the number of hospitalisations in the 6 months prior to death and (7) the number of days spent in hospital in the 6 months prior to death. Data for each year were analysed descriptively and a comparison between 2016 and 2020 was carried out using t-tests and chi-square tests. RESULTS: Data from 160,927 deceased AOK-LS members were analysed. The number of patients receiving outpatient PC remained almost consistent over time (2016 vs. 2020 p = .077). The number of patients receiving generalist outpatient PC decreased from 28.4% (2016) to 24.5% (2020; p < .001), whereas the number of patients receiving specialist outpatient PC increased from 8.5% (2016) to 11.2% (2020; p < .001). The onset of generalist outpatient PC moved from 106 (2016) to 93 days (2020; p < .001) before death, on average. The onset of specialist outpatient PC showed the reverse pattern (2016: 55 days before death; 2020: 59 days before death; p = .041). CONCLUSION: Despite growing needs for PC at the end of life, the number of patients receiving outpatient PC did not increase between 2016 and 2020. Furthermore, specialist outpatient PC is being increasingly prescribed over generalist outpatient PC. Although the early initiation of outpatient PC has been proven valuable for the majority of people at the end of life, generalist outpatient PC was not initiated earlier in the disease trajectory over the study period, as was found to be true for specialist outpatient PC. Future studies should seek to determine how existing PC needs can be optimally met within the outpatient sector and identify factors that can support the earlier initiation of especially generalist outpatient PC. TRIAL REGISTRATION: The study "Optimal Care at the End of Life" was registered in the German Clinical Trials Register (DRKS00015108; 22 January 2019).

[Controversies in promoting young talent in orthopedics and trauma surgery]. / Kontroversen in der Nachwuchsförderung in der Orthopädie und Unfallchirurgie.

BACKGROUND: The field of orthopedics and trauma surgery is facing a serious shortage of new talent due to the increasing average age of active surgeons and a growing need for staff. The appeal of these specialties is declining among medical students. SOLUTIONS: This trend could be reversed by introducing practice-oriented curricula, mentoring programs, and early integration into professional societies. The quality of surgical education, especially bedside teaching, needs to be improved, as it is often compromised by a lack of time and insufficient pedagogical training of the educators. The practical year (PY) is crucial to attract students to these specialties, but data indicate that the quality of training in orthopedics and trauma surgery is inferior compared to other fields. Professional societies could enhance junior development through targeted programs. Moreover, the problem of recruitment is compounded by imbalanced gender ratios and working conditions that do not align with modern family models or efficient surgical training. There needs to be a rethinking of work scheduling and task distribution in surgery to make the profession more attractive and to ensure the quality of training.

Pregnancy and acromegaly: clinical outcomes of retrospectively analysed data from the German acromegaly registry.

CONTEXT: Acromegaly is a rare disease caused by excessive growth hormone (GH) secretion, mostly induced by pituitary adenomas. The care of pregnant women with acromegaly is challenging, in part due to existing clinical data being limited and not entirely consistent with regard to potential risks for mother and child. OBJECTIVE: To retrospectively examine data on pregnancy and maternal as well as neonatal outcomes in patients with acromegaly. DESIGN & METHODS: Retrospective data analysis from 47 pregnancies of 31 women treated in centers of the German Acromegaly Registry. RESULTS: 87.1% of the studied women underwent transsphenoidal surgery before pregnancy. In 51.1% a combination of dopamine agonists and somatostatin analogs were used before pregnancy. Three women did not receive any therapy for acromegaly. During pregnancy only 6.4% received either somatostatin analogs or dopamine agonists. In total, 70.2% of all documented pregnancies emerged spontaneously. Gestational diabetes was diagnosed in 10.6% and gravid hypertension in 6.4%. Overall, no preterm birth was detected. Indeed, 87% of acromegalic women experienced a delivery without complications. CONCLUSION: Pregnancies in women with acromegaly are possible and the course of pregnancy is in general safe for mother and child both with and without specific treatment for acromegaly. The prevalence of concomitant metabolic diseases such as gestational diabetes is comparable to the prevalence in healthy pregnant women. Nevertheless, larger studies with more data in pregnant patients with acromegaly are needed to provide safe and effective care for pregnant women with this condition.

Prevalence and implications of bilateral and solely contralateral lymph node metastases in oral squamous cell carcinoma.

OBJECTIVES: Effective management of neck in oral squamous cell carcinoma (OSCC) is pivotal for oncological outcomes. Although consensus exists for ipsilateral neck dissection (ND), the necessity for contralateral ND remains controversial. This study aimed to assess the prevalence and implications of bilateral/solely contralateral (B/SC) lymph node metastases (LNMs) to determine the need for contralateral elective ND. Additionally, it examined the prevalence and implications of occult B/SC metastases. MATERIALS AND METHODS: In a retrospective cohort study, 420 OSCC patients underwent primary surgical treatment following German guidelines at a tertiary center. Preoperative contrast-enhanced computed tomography was conducted, and ND adhered to a standardized approach. RESULTS: Solely contralateral metastases occurred in 0.95% of patients, with bilateral metastases observed in 7.13%. Occult B/SC metastases occurred in 3.81% of the cases. Correlation analysis revealed a statistically significant association between B/SC metastases and higher tumor stages, tumor localization at the upper jaw or floor of the mouth, proximity to the midline, ipsilateral LNMs, and lymphatic invasion (all p < 0.05). Patients with B/SC metastases showed poorer disease-free survival, with statistical significance reached in the bilateral LNMs group (p = 0.010). Similarly, a significant difference was noted in overall survival between patients with bilateral and solely ipsilateral metastases (p = 0.044). CONCLUSIONS: B/SC LNMs are rare in patients with OSCC, especially in those who present with clinico-radiologically negative ipsilateral necks. Higher rates of B/SC metastases occur in case of advanced tumors and those localized at the upper jaw or floor of the mouth. Ipsilateral LNMs significantly elevate the risk of contralateral LNMs, tripling the associated risk. CLINICAL RELEVANCE: These findings provide valuable insights for surgeons considering contralateral ND or extended adjuvant treatment for OSCC patients. However, the absence of high-level evidence from randomized controlled trials impedes the establishment of a definitive standard of care.

Problems and Barriers Related to the Use of mHealth Apps From the Perspective of Patients: Focus Group and Interview Study.

BACKGROUND: Since fall 2020, mobile health (mHealth) apps have become an integral part of the German health care system. The belief that mHealth apps have the potential to make the health care system more efficient, close gaps in care, and improve the economic outcomes related to health is unwavering and already partially confirmed. Nevertheless, problems and barriers in the context of mHealth apps usually remain unconsidered. OBJECTIVE: The focus groups and interviews conducted in this study aim to shed light on problems and barriers in the context of mHealth apps from the perspective of patients. METHODS: Guided focus groups and individual interviews were conducted with patients with a disease for which an approved mHealth app was available at the time of the interviews. Participants were recruited via self-help groups. The interviews were recorded, transcribed, and subjected to a qualitative content analysis. The content analysis was based on 10 problem categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs") identified in a previously conducted scoping review. Participants were asked to fill out an additional questionnaire about their sociodemographic data and about their use of technology. RESULTS: A total of 38 patients were interviewed in 5 focus groups (3 onsite and 2 web-based) and 5 individual web-based interviews. The additional questionnaire was completed by 32 of the participants. Patients presented with a variety of different diseases, such as arthrosis, tinnitus, depression, or lung cancer. Overall, 16% (5/32) of the participants had already been prescribed an app. During the interviews, all 10 problem categories were discussed and considered important by patients. A myriad of problem manifestations could be identified for each category. This study shows that there are relevant problems and barriers in the context of mHealth apps from the perspective of patients, which warrant further attention. CONCLUSIONS: There are essentially 3 different areas of problems in the context of mHealth apps that could be addressed to improve care: quality of the respective mHealth app, its integration into health care, and the expandable digital literacy of patients.

[Oncological Rehabilitation for Breast Cancer]. / Onkologische Rehabilitation bei Mammakarzinom.

As a result of increasingly individualized and multimodal therapy, prognosis of breast cancer has improved significantly over the last years. However, multimodal treatment and the use of new medications can lead to a variety of somatic, sometimes new, side effects such as fatigue, polyneuropathy or autoimmune toxicities. This and the oncological diagnosis lead to a high level of psychological distress in the women affected and often to subsequent psychological disorders (sleep/anxiety disorders, depression, ...). Both the diverse complaints after oncological therapy and the increasingly improved overall prognosis underline the importance of multimodal rehabilitation concepts to improve quality of life and successful professional reintegration.In the following, these secondary disorders after breast cancer, their multimodal therapy and their significance for social-medical performance assessment are presented in more detail.

Real-world evidence of treatment patterns and survival of metastatic gastric cancer patients in Germany.

BACKGROUND: Patients with metastatic gastric cancer (mGC) have poor prognosis. This real-world study aimed to describe treatment regimens and survival of mGC patients. METHODS: A retrospective analysis was conducted using anonymized German claims data (AOK PLUS) covering a period from 2010 to 2021. The study population included newly diagnosed mGC cases identified from 2011 to 2020. The index date was defined as the first diagnosis of metastasis on or after gastric cancer diagnosis. Therapy regimens were identified based on inpatient and outpatient data, and subsequently stratified by line of treatment. Survival analyses were conducted using the Kaplan-Meier method. RESULTS: The cohort consisted of 5,278 mGC incident cases (mean age: 72.7 years; male: 61.9%). Nearly half of the incident cases received mGC-related treatment (49.8%). Treated patients were more often male, younger, and had fewer comorbidities compared to untreated patients. Of the 2,629 mGC patients who started the first line of treatment (1LOT), 32.8% switched to 2LOT, and 10.2% reached 3LOT. Longer survival time was observed among disease-specific treated cases compared with untreated cases (median real-world overall survival (rwOS): 12.7 months [95%CI 12.1 - 13.3 months] vs. 3.7 months [95%CI 3.4 - 4.0 months]). CONCLUSION: Systemic therapy was not received in almost half of the mGC patients. In those patients, a very short median rwOS was observed. Treatment patterns were generally in line with the guideline recommendations, however, therapy switching rates and poor prognosis indicate high unmet needs also in the treated population.

Patient-Reported Outcome Measures (PROMs) with Refractive and Diffractive Extended Depth of Focus (EDOF) Intraocular Lenses.

BACKGROUND: Extended depth of focus intraocular lenses (EDOF-IOLs) provide unaided far- and mid-range vision. Refractive IOLs, in contrast to diffractive designs, are associated with a lower depth of focus and absence of dysphotopsia. The aim of this study was to assess spectacle independence for far-range, mid-range, and near-vision activities in patients after implantation of refractive or diffractive EDOF-IOLs using patient-reported outcome measures (PROMs) in a real-world setting. PATIENTS AND METHODS: In 2021 and 2022, all patients in a single center referred for bilateral cataract surgery were assigned to 7 experienced cataract surgeons who either bilaterally implanted only a diffractive EDOF-IOL (Carl Zeiss Meditec AG, AT LARA Jena, Germany, three surgeons) or refractive EDOF-IOL (Johnson & Johnson Vision Inc., Tecnis Eyhance Irvine, California, USA, four surgeons) at the surgeon's discretion, with the aim of bilateral emmetropia. Six months after both cataract surgeries, all patients were contacted by telephone and asked to report their outcomes using a structured questionnaire investigating their spectacle usage for various daily activities and their experience with night glare or halos. Inclusion criteria were a normal postoperative visual potential based on the preoperative examination and completion of the questionnaire regarding postoperative visual experience. RESULTS: Of the patients, 514 underwent bilateral cataract surgery aiming for bilateral emmetropia with the implantation of EDOF-IOLs (422 with Tecnis Eyhance and 92 with AT LARA). A complete questionnaire was obtained from 472 (92%) patients, who were included in the study (393 vs. 79). Comparing Tecnis Eyhance with AT LARA IOL, 54 vs. 57% patients were able to perform most of their daily activities without spectacles, 9 vs. 19% reported not being dependent on spectacles at all, 25 vs. 29% reported using their smartphones without spectacles, 15 vs. 49% patients reported experiencing glares or halos at night, and 1 vs.15% with driving disturbance. Overall, 95 vs. 93% patients described themselves as "satisfied" or "highly satisfied" with their IOL. CONCLUSIONS: With both types of EDOF-IOLs, the majority of patients could perform most of their daily activities without spectacles, except reading, and were highly satisfied with their IOLs. Patients with diffractive Zeiss AT LARA EDOF-IOLs were more likely to accomplish unaided near-range visual tasks; however, they were also at a higher risk of experiencing glares or halos at night.

The Nuremberg Racial Laws: The End of Jewish Medical Teaching in Germany. Who Were the Last Jewish Medical Professors in Berlin?

BACKGROUND: On 7 April 1933, the Nazi Law for the Restoration of the Professional Civil Service was enacted. The law triggered the dismissal of most Jewish medical staff from German universities. A few Jewish professors in Berlin were permitted to continue their academic activity with restrictions. Those professors were gradually dismissed as laws and restrictions were enforced. OBJECTIVES: To identify the last Jewish medical professors who, despite severe restrictions, continued their academic duties and prepared students for their examinations in Berlin after the summer of 1933. METHODS: We reviewed dissertations written by the medical faculty of Berlin from 1933 to 1937 and identified Jewish professors who mentored students during those years. RESULTS: Thirteen Jewish tutors instructed dissertations for the medical examinations after the Nazi regime seized power. They were employees of different university hospitals, including the Jewish hospitals. We did not identify Aryan students instructed by Jewish professors. The professors were active in different medical disciplines. Half of the reviewed dissertations were in the disciplines of surgery and gynecology. The last Jewish tutors were dismissed in October 1935. However, some of their studies were submitted for examination after that date. CONCLUSIONS: After the Nazi regime seized power, academic activities and medical research by Jewish professors declined but did not stop. However, these professors worked with only Jewish students on their theses. Most dissertations were approved and examined after the Jewish academics were dismissed by the university, in some cases even after they left Germany.

[Quality of live of palliative outpatient care in Westphalia-Lippe focusing on contentedness of patients and their relatives - a multicenter cohort study]. / Qualität der ambulanten Palliativversorgung im Modell Westfalen-Lippe hinsichtlich der Zufriedenheit von Patienten und ihren Zugehörigen : Eine multizentrische Kohortenstudie.

BACKGROUND: In Westphalia-Lippe - unlike the rest of Germany - outpatient palliative care, as general and specialized palliative care (AAPV and SAPV), exists as part of an innovative care model. Ten years after its introduction, an evaluation is to be carried out, focusing on the treatment satisfaction of patients and their relatives as well as the extent to which the model has proved successful in urban versus rural care contexts. METHODS: In a multicenter cohort study, in 2019/20, from a total of 36 palliative care regions, 12 - 4 metropolitan, mixed and rural each - were randomly selected, with 20 palliative patients each. Using established instruments (MIDOS, HOPE), the patients were questioned about stressful symptoms and quality of life. Additionally, their relatives were asked about their satisfaction with the care provided. RESULTS: 227 patients were included. The care period was 82.3 days on average (median 47.5). Distressing symptoms were consistently well controlled with a slight tendency for symptoms to increase at the end of life (NRS < 4). There were no significant differences between urban and rural regions. The outpatient palliative care provided by doctors and nurses in Westphalia-Lippe was largely viewed positively by the relatives. CONCLUSIONS: In Westphalia-Lippe, patients in need of palliative care can be offered early and low- threshold structured outpatient palliative care, which is mainly provided by GPs and outpatient specialists. The role of the GP in primary medical care is being strengthened. In this interprofessional and interdisciplinary model, patient care is demand-oriented, that is, the intensity of care can switch between general (AAPV) and specialized care (SAPV) according to the disease progress. This model has proven itself in practice and provides good services benefits for palliative patients and their relatives.

Gender equality and smoking among 15 to 25 year olds-a time-based ecological analysis of developments in Germany from 1960 to 2005.

Introduction: Smoking is a major risk factor for premature death and health problems in which there are significant gender differences in the prevalence of smoking. This ecological study examines the correlation between changes in gender equality and prevalence of smoking among young adults (15-25 years old) in Germany over a period of 45 years (1960-2005). Methods: Gender inequality was measured using the United Nations Gender Inequality Index (GII), which is composed of three dimensions; health, empowerment and labour market. It was calculated for the entire registered German population in five-year intervals with values between 0 and 1 (1 = highest inequality). The smoking prevalence of young women and men in Germany was established using a reconstruction method. A gender smoking ratio (GSR) with values between 0 and 1 was determined (1 = identical smoking prevalence among men and women). The smoking behaviour was illustrated and stratified by education. The correlation between the GII and the GSR was analysed. Results: The GII decreased from 0.98 to 0.56 between 1960 and 2005. The GSR increased from 0.34 to 0.93. There was a strong negative correlation between the GII and the GSR (r = -0.71). The strength of the correlation fell slightly as the level of education decreased. An increase in gender equality as measured by the GII came along with similarities of smoking prevalence between young women and young men. Conclusion: Successful tobacco prevention among young women and men may benefit from involving experts in gender-specific public health research to develop counter-advertising and gender-specific information as needed.

Use, applicability, and dissemination of patient versions of clinical practice guidelines in oncology in Germany: a qualitative interview study with healthcare providers.

BACKGROUND: People with cancer have high information needs; however, they are often inadequately met. Patient versions of clinical practice guidelines (PVGs), a special form of evidence-based information, translate patient-relevant recommendations from clinical practice guidelines into lay language. To date, little is known about the experience of PVGs from healthcare providers' perspective in healthcare. This study aims to investigate the use, applicability, and dissemination of PVGs in oncology from the healthcare providers' perspective in Germany. METHODS: Twenty semi-structured telephone interviews were conducted with oncological healthcare providers in Germany between October and December 2021. Interviews were recorded and transcribed verbatim. Mayring's qualitative content analysis with MAXQDA software was utilised to analyse the data. RESULTS: A total of 20 healthcare providers (14 female, 6 male), mainly working as psychotherapists/psycho-oncologists and physicians, participated. Most participants (75%) were aware of the existence of PVGs. The content was predominantly perceived as comprehensible and relevant, whereas opinions on the design and format were mixed. The perceived lack of up-to-date information limited participants' trust in the content. Most felt that PVGs positively impact healthcare owing to the fact that they improve patients' knowledge about their disease. Additionally, PVGs served as a guide and helped healthcare providers structure physician-patient talks. Healthcare provider's unawareness of the existence of PVGs was cited as an obstructive factor to its dissemination to patients. CONCLUSION: Limited knowledge of the existence of PVGs among healthcare providers, coupled with alternative patient information, hinders the use and dissemination of PVGs in healthcare. However, the applicability of PVGs seemed to be acceptable owing to their content and good comprehensibility, especially with respect to physician-patient communication.

Point Pattern Analysis (PPA) as a tool for reproducible archaeological site distribution analyses and location processes in early iron age south-west Germany.

Point Pattern Analysis (PPA) has gained momentum in archaeological research, particularly in site distribution pattern recognition compared to supra-regional environmental variables. While PPA is now a statistically well-established method, most of the data necessary for the analyses are not freely accessible, complicating reproducibility and transparency. In this article, we present a fully reproducible methodical framework to PPA using an open access database of archaeological sites located in south-west Germany and open source explanatory covariates to understand site location processes and patterning. The workflow and research question are tailored to a regional case study, but the code underlying the analysis is provided as an R Markdown file and can be adjusted and manipulated to fit any archaeological database across the globe. The Early Iron Age north of the Alps and particularly in south-west Germany is marked by numerous social and cultural changes that reflect the use and inhabitation of the landscape. In this work we show that the use of quantitative methods in the study of site distribution processes is essential for a more complete understanding of archaeological and environmental dynamics. Furthermore, the use of a completely transparent and easily adaptable approach can fuel the understanding of large-scale site location preferences and catchment compositions in archaeological, geographical and ecological research.