Risk-adjusted Screening for Prostate Cancer-Defining the Low-risk Group by Data from the PROBASE Trial.

BACKGROUND: Risk-adjusted screening for prostate cancer (PCa) aims to reduce harms by less frequent retesting, especially in men at a low risk of PCa. Definitions of low risk are based mainly on studies in men starting screening at age 55-60 yr. OBJECTIVE: To identify men at age 45 yr with a low risk of PCa. DESIGN, SETTING, AND PARTICIPANTS: A population-based, risk-adjusted PCa screening trial was conducted in Germany using baseline prostate-specific antigen (PSA) starting in young men (PROBASE). INTERVENTION: PSA measurements starting at the age of 45 yr. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The incidence of PCa within 5 yr was assessed in men with screen-negative baseline PSA <1.5 ng/ml compared with those with PSA 1.5-≤3.0 ng/ml. RESULTS AND LIMITATIONS: Of 23301 men who received a first PSA test at age 45 yr, 0.79% had a screen-positive PSA value of ≥3 ng/ml. Among the 89% of men who had a screen-negative baseline PSA value of <1.5 ng/ml, only 0.45% received a positive PSA test ≥3 ng/ml upon retesting after 5 yr. By contrast, for those with a screen-negative baseline PSA value of 1.5-3 ng/ml, 13% surpassed 3 ng/ml upon biennial testing within the next 4 yr. The incidence of PCa in subsequent screening rounds increased with increasing baseline PSA levels, from 0.13 per 1000 person-years for men with initial PSA level of <1.5 ng/ml to 8.0 per 1000 person-years for those with PSA levels of 1.5-3.0 ng/ml. A limitation is a follow-up time of only 5 yr, so far. CONCLUSIONS: Men with baseline PSA <1.5 ng/ml at age 45 yr are at a very low risk of PCa over the next 5 yr. PATIENT SUMMARY: The PROBASE study showed that men with baseline prostate-specific antigen (PSA) <1.5 ng/ml at age 45 yr have a very low prostate cancer detection rate over 5 yr and do not need PSA retesting during this time.

Patient-Relevant Costs for Organ Preservation versus Radical Resection in Locally Advanced Rectal Cancer.

Total neoadjuvant therapy (TNT) is an evolving treatment schedule for locally advanced rectal cancer (LARC), allowing for organ preservation in a relevant number of patients in the case of complete response. Patients who undergo this so-called "watch and wait" approach are likely to benefit regarding their quality of life (QoL), especially if definitive ostomy could be avoided. In this work, we performed the first cost-effectiveness analysis from the patient perspective to compare costs for TNT with radical resection after neoadjuvant chemoradiation (CRT) in the German health care system. Individual costs for patients insured with a statutory health insurance were calculated with a Markov microsimulation. A subgroup analysis from the prospective "FinTox" trial was used to calibrate the model's parameters. We found that TNT was less expensive (-1540 EUR) and simultaneously resulted in a better QoL (+0.64 QALYs) during treatment and 5-year follow-up. The average cost for patients under TNT was 4711 EUR per year, which was equivalent to 3.2% of the net household income. CRT followed by resection resulted in higher overall costs for ostomy care, medication and greater loss of earnings. Overall, TNT appeared to be more efficacious and cost-effective from a patient's point of view in the German health care system.

Dosimetric benefit of online treatment plan adaptation in stereotactic ultrahypofractionated MR-guided radiotherapy for localized prostate cancer.

Background: Apart from superior soft tissue contrast, MR-guided stereotactic body radiation therapy (SBRT) offers the chance for daily online plan adaptation. This study reports on the comparison of dose parameters before and after online plan adaptation in MR-guided SBRT of localized prostate cancer. Materials and methods: 32 consecutive patients treated with ultrahypofractionated SBRT for localized prostate cancer within the prospective SMILE trial underwent a planning process for MR-guided radiotherapy with 37.5 Gy applied in 5 fractions. A base plan, derived from MRI simulation at an MRIdian Linac, was registered to daily MRI scans (predicted plan). Following target and OAR recontouring, the plan was reoptimized based on the daily anatomy (adapted plan). CTV and PTV coverage and doses at OAR were compared between predicted and adapted plans using linear mixed regression models. Results: In 152 out of 160 fractions (95%), an adapted radiation plan was delivered. Mean CTV and PTV coverage increased by 1.4% and 4.5% after adaptation. 18% vs. 95% of the plans had a PTV coverage ≥95% before and after online adaptation, respectively. 78% vs. 100% of the plans had a CTV coverage ≥98% before and after online adaptation, respectively. The D0.2cc for both bladder and rectum were <38.5 Gy in 93% vs. 100% before and after online adaptation. The constraint at the urethra with a dose of <37.5 Gy was achieved in 59% vs. 93% before and after online adaptation. Conclusion: Online adaptive plan adaptation improves target volume coverage and reduces doses to OAR in MR-guided SBRT of localized prostate cancer. Online plan adaptation could potentially further reduce acute and long-term side effects and improve local failure rates in MR-guided SBRT of localized prostate cancer.

Pelvic Irradiation for Node-Positive Prostate Cancer After Prostatectomy: Long-Term Results of the Prospective PLATIN-4 and PLATIN-5 Trials.

PURPOSE: After radical prostatectomy (RP), adjuvant or salvage radiation treatment in node-positive prostate cancer is offered to prevent systemic disease. Prospective long-term survival and toxicity data on patients with radiation for nodal disease are still scarce. This study evaluates safety and feasibility of salvage radiation therapy to the pelvic lymph nodes in node-positive prostate cancer after RP. METHODS AND MATERIALS: Between 2009 and 2018, 78 patients with lymph node recurrence after RP (PLATIN-4 trial) or after RP and prostate bed radiation therapy (PLATIN-5 trial) were treated with salvage pelvic lymph node radiation therapy with boost to the involved nodes as field abutment (PLATIN-5) and boost to the prostate bed (PLATIN-4). Androgen deprivation therapy was started 2 months before radiation and recommended for 24 months. The primary endpoint was safety and feasibility of the intensity modulated radiation therapy-image guided radiation therapy technique based on the rate of treatment discontinuations and incidence of Common Terminology Criteria for Adverse Events grade 3+ toxicity. Secondary endpoints were progression-free survival and overall survival. RESULTS: No treatment discontinuations were reported in either trial. Median overall survival was not reached in PLATIN-4 and was 117 months in PLATIN-5. Median progression-free survival was 66 months in PLATIN-4 and 39 months in PLATIN-5. Late grade 3+ genitourinary and gastrointestinal toxicities were observed in 4% of patients at 24 months of follow-up. CONCLUSIONS: Salvage radiation therapy to the prostate bed and pelvic lymphatic drainage combined with long-term androgen deprivation therapy is a curative treatment option for patients with node-positive prostate cancer after RP, with excellent in-field disease control. Pelvic lymph node radiation therapy as field abutment after prostate bed radiation therapy is feasible with long-term survival and no high-grade toxicity.

Satisfaction with radiotherapy care among cancer patients treated in Germany-secondary analysis of a large multicenter study.

PURPOSE: Patient satisfaction with healthcare has been linked to clinical outcomes and regulatory agencies demand its regular assessment. Therefore, we aimed to investigate patient satisfaction with radiotherapy care and its determinants. METHODS: This is a secondary analysis of a multicenter prospective cross-sectional study. Eligible cancer patients anonymously completed questionnaires at the end of a course of radiotherapy. The outcome variable was overall patient satisfaction with radiotherapy care measured with a 10-point Likert scaled single-item. Given patient satisfaction was defined for patients scoring ≥ 8 points. Determinants of given patient satisfaction were assessed by univariable and multivariable analyses. A p-value < 0.05 was considered statistically significant. RESULTS: Out of 2341 eligible patients, 1075 participated (participation rate 46%). Data on patient satisfaction was provided by 1054 patients. There was a right-skewed distribution towards more patient satisfaction (mean = 8.8; SD = 1.68). Given patient satisfaction was reported by 85% (899/1054) of the patients. Univariable analyses revealed significant associations of lower patient satisfaction with tumor entity (rectal cancer), concomitant chemotherapy, inpatient care, treating center, lower income, higher costs, and lower quality of life. Rectal cancer as tumor entity, treating center, and higher quality of life remained significant determinants of patient satisfaction in a multivariable logistic regression. CONCLUSION: Overall patient satisfaction with radiotherapy care was high across 11 centers in Germany. Determinants of patient satisfaction were tumor entity, treating center, and quality of life. Although these data are exploratory, they may inform other centers and future efforts to maintain high levels of patient satisfaction with radiotherapy care.

Impact of 68Ga-FAPI PET/CT on Staging and Oncologic Management in a Cohort of 226 Patients with Various Cancers.

Since the development of fibroblast activation protein-targeted radiopharmaceuticals, 68Ga-fibroblast activation protein inhibitor (FAPI) PET/CT has been found to be suitable for detecting primary and metastatic lesions in many types of tumors. However, there is currently a lack of reliable data regarding the clinical impact of this family of probes. To address this gap, the present study aimed to analyze the clinical impact of 68Ga-FAPI PET/CT by examining a large cohort of patients with various tumors. Methods: In total, 226 patients (137 male and 89 female) were included in this retrospective analysis. Pancreatic cancer and head and neck cancers were the most common tumor types in this cohort. TNM stage and oncologic management were initially determined with gold standard imaging, and these results were compared with 68Ga-FAPI PET/CT. Changes were classified as major and minor. Results: For 42% of all patients, TNM stage was changed by 68Ga-FAPI PET/CT results. Most of these changes resulted in upstaging. A change in clinical management occurred in 117 of 226 patients. Although a major change in management occurred in only 12% of patients, there was a significant improvement in the ability to accurately plan radiation therapy. In general, the highest clinical impact of 68Ga-FAPI PET/CT imaging was found in patients with lung cancer, pancreatic cancer, and head and neck tumors. Conclusion: 68Ga-FAPI PET/CT is a promising imaging probe that has a significant impact on TNM stage and clinical management. 68Ga-FAPI PET/CT promises to be a crucial new technology that will improve on conventional radiologic imaging methods such as contrast-enhanced CT and contrast-enhanced MRI typically acquired for cancer staging.

Potential of ChatGPT and GPT-4 for Data Mining of Free-Text CT Reports on Lung Cancer.

Background The latest large language models (LLMs) solve unseen problems via user-defined text prompts without the need for retraining, offering potentially more efficient information extraction from free-text medical records than manual annotation. Purpose To compare the performance of the LLMs ChatGPT and GPT-4 in data mining and labeling oncologic phenotypes from free-text CT reports on lung cancer by using user-defined prompts. Materials and Methods This retrospective study included patients who underwent lung cancer follow-up CT between September 2021 and March 2023. A subset of 25 reports was reserved for prompt engineering to instruct the LLMs in extracting lesion diameters, labeling metastatic disease, and assessing oncologic progression. This output was fed into a rule-based natural language processing pipeline to match ground truth annotations from four radiologists and derive performance metrics. The oncologic reasoning of LLMs was rated on a five-point Likert scale for factual correctness and accuracy. The occurrence of confabulations was recorded. Statistical analyses included Wilcoxon signed rank and McNemar tests. Results On 424 CT reports from 424 patients (mean age, 65 years ± 11 [SD]; 265 male), GPT-4 outperformed ChatGPT in extracting lesion parameters (98.6% vs 84.0%, P < .001), resulting in 96% correctly mined reports (vs 67% for ChatGPT, P < .001). GPT-4 achieved higher accuracy in identification of metastatic disease (98.1% [95% CI: 97.7, 98.5] vs 90.3% [95% CI: 89.4, 91.0]) and higher performance in generating correct labels for oncologic progression (F1 score, 0.96 [95% CI: 0.94, 0.98] vs 0.91 [95% CI: 0.89, 0.94]) (both P < .001). In oncologic reasoning, GPT-4 had higher Likert scale scores for factual correctness (4.3 vs 3.9) and accuracy (4.4 vs 3.3), with a lower rate of confabulation (1.7% vs 13.7%) than ChatGPT (all P < .001). Conclusion When using user-defined prompts, GPT-4 outperformed ChatGPT in extracting oncologic phenotypes from free-text CT reports on lung cancer and demonstrated better oncologic reasoning with fewer confabulations. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Hafezi-Nejad and Trivedi in this issue.

Comorbidity in limited disease small-cell lung cancer: Age-adjusted Charlson comorbidity index and its association with overall survival following chemoradiotherapy.

Background: Combined, platinum-based thoracic chemoradiotherapy (TCR) is the current state-of-the-art treatment for patients with limited disease (LD) small-cell lung cancer (SCLC). There is only limited data available regarding the effect of comorbidities on survival following TRC. The purpose of this study is to assess the age-adjusted Charlson comorbidity index (ACCI) as a predictor of overall survival in LD-SCLC patients undergoing TCR. Patients and methods: We retrospectively analyzed 367 SCLC patients diagnosed with LD-SCLC who received TCR between 2003 and 2017. We evaluated the ACCI (n = 348) as a predictor of overall survival (OS). In this cohort, 322 patients (88%) received platinum-based TCR (either cisplatin or carboplatin), and 37 (10%) patients received vincristine based TCR. Median radiation dose was 60 Gy (range 24-66 Gy). Additionally, 83% of patients (n = 303) received prophylactic cranial irradiation (PCI, 30 Gy in 2 Gy fractions). Kaplan-Meier survival analysis was performed for OS. For comparison of survival curves, Log-rank (Mantel-Cox) test was used. Univariate and multivariate Cox proportional-hazards ratios (HRs) were used to assess the influence of cofactors on OS. Results: Patients with an ACCI > 6 had a significantly shorter OS compared with patients with an ACCI ≤ 6 (median 11 vs. 20 months; p = 0.005). Univariate analysis for OS revealed a statistically significant effect for ACCI > 6 (HR 1.7; 95% CI 1.2-2.4; p = 0.003), PCI (HR 0.5; 95% CI 0.3-0.7; p < 0.001), and Karnofsky performance status ≤ 70% (KPS) (HR 1.4; 95% CI 1.1-1.90; p = 0.015). In multivariate analysis, OS was significantly associated with PCI (HR 0.6; 95% CI 0.4-0.9; p = 0.022) and ACCI > 6 (HR 1.5; 95% CI 1.0-2.1; p = 0.049). Conclusion: Comorbidity is significantly associated with survival in patients with LD-SCLC undergoing TCR. The ACCI may be a valuable tool to identify patients with a shorter survival and thus might be used for risk stratification and oncological decision making.

Psychosocial distress in cancer patients undergoing radiotherapy: a prospective national cohort of 1042 patients in Germany.

PURPOSE: Psychosocial distress is common among cancer patients in general, but those undergoing radiotherapy may face specific challenges. Therefore, we investigated the prevalence and risk factors for distress in a large national cohort. METHODS: We performed a secondary analysis of a multicenter prospective cross-sectional study which surveyed cancer patients at the end of a course of radiotherapy using a patient-reported questionnaire. Distress was measured with the distress thermometer (DT), using a cut-off of ≥ 5 points for clinically significant distress. Univariate analyses and multivariate multiple regression were used to assess associations of distress with patient characteristics. A two-sided p-value < 0.05 was considered statistically significant. RESULTS: Out of 2341 potentially eligible patients, 1075 participated in the study, of which 1042 completed the DT. The median age was 65 years and 49% (511/1042) of patients were female. The mean DT score was 5.2 (SD = 2.6). Clinically significant distress was reported by 63% (766/1042) of patients. Of the patient characteristics that were significantly associated with distress in the univariate analysis, a lower level of education, a higher degree of income loss, lower global quality of life, and a longer duration of radiotherapy in days remained significantly associated with higher distress in the multivariate analysis. Yet effect sizes of these associations were small. CONCLUSION: Nearly two in three cancer patients undergoing radiotherapy reported clinically significant distress in a large multicenter cohort. While screening and interventions to reduce distress should be maintained and promoted, the identified risk factors may help to raise awareness in clinical practice. TRIAL REGISTRY IDENTIFIER: DRKS: German Clinical Trial Registry identifier: DRKS00028784.

Financial toxicity in cancer patients undergoing radiotherapy in a universal health care system - A prospective multicenter study of 1075 patients.

PURPOSE: To establish and confirm prevalence as well as risk factors of financial toxicity in a large national cohort of cancer patients undergoing radiotherapy in a universal health care system. METHODS: We conducted a prospective cross-sectional study offering a patient-reported questionnaire to all eligible cancer patients treated with radiotherapy in 11 centers in Germany during 60 consecutive days. The four-point subjective financial distress question of the EORTC QLQ-C30 was used as a surrogate for financial toxicity. Confirmatory hypothesis testing evaluated the primary study outcomes: overall prevalence of financial toxicity and its association with predefined risk factors. P-values < 0.05 were considered statistically significant. RESULTS: Of 2341 eligible patients, 1075 (46%) participated. The prevalence of subjective financial distress (=any grade higher than not present) was 41% (438/1075) exceeding the hypothesized range of 26.04-36.31%. Subjective financial distress was felt "A little" by 26% (280/1075), "Quite a bit" by 11% (113/1075) and "Very much" by 4% (45/1075) of the patients. Lower household income, lower global health status/ quality of life, higher direct costs and higher loss of income significantly predicted higher subjective financial distress per ordinal regression and confirmed these risk factors. Higher psychosocial distress and lower patient satisfaction were significantly associated with higher subjective financial distress in an exploratory ordinal regression model. CONCLUSION: The overall prevalence of financial toxicity was higher than anticipated, although reported at low or moderate degrees by most affected patients. As we confirmed risk factors associated with financial toxicity, patients at risk should be addressed early for potential support.

A Case of COVID-19-Associated Pediatric Multisystem Inflammatory Syndrome in Shock Managed by Cytokine Filtration.

Multisystem inflammatory syndrome in children (MIS-C) after COVID-19 has been recognized as a complication arising due to cytokine storm. Several management strategies including intravenous immunoglobulin and immunomodulators have been reported. This case report highlights the use of a cytokine filter (oXiris®) in the management of MIS-C. Cytokine filters eliminate cytokines and reduce the demand for vasopressors in patients with other inflammatory conditions. A 7-year-old child with prolonged fever, vomiting, hypotension, elevated inflammatory mediators, and dilatation of coronary arteries on echocardiography was found to have positive SARS-CoV-2 IgG and PCR. He was diagnosed as MIS-C and was managed in the pediatric intensive care unit. He required ventilatory support, vasopressors, and continuous renal replacement therapy (CRRT) with a cytokine filter. He showed marked improvement within 24 hours of initiating CRRT. Cytokine filters may have a potential role in the management of severely ill children due to MIS-C. To our knowledge, this is the first report of successful use of the oXiris® membrane in MIS-C. However, further case series and controlled trials are needed to establish its use in this condition.

A pan-African spatial assessment of human conflicts with lions and elephants.

African lions (Panthera leo) and African savanna (Loxodonta africana) and forest (L. cyclotis) elephants pose threats to people, crops, and livestock, and are themselves threatened with extinction. Here, we map these human-wildlife conflicts across Africa. Eighty-two percent of sites containing lions and elephants are adjacent to areas with considerable human pressure. Areas at severe risk of conflict (defined as high densities of humans, crops, and cattle) comprise 9% of the perimeter of these species' ranges and are found in 18 countries hosting, respectively, ~ 74% and 41% of African lion and elephant populations. Although a variety of alternative conflict-mitigation strategies could be deployed, we focus on assessing the potential of high-quality mitigation fences. Our spatial and economic assessments suggest that investments in the construction and maintenance of strategically located mitigation fences would be a cost-effective strategy to support local communities, protect people from dangerous wildlife, and prevent further declines in lion and elephant populations.

Digital data sources and methods for conservation culturomics.

Ongoing loss of biological diversity is primarily the result of unsustainable human behavior. Thus, the long-term success of biodiversity conservation depends on a thorough understanding of human-nature interactions. Such interactions are ubiquitous but vary greatly in time and space and are difficult to monitor efficiently at large spatial scales. However, the Information Age also provides new opportunities to better understand human-nature interactions because many aspects of daily life are recorded in a variety of digital formats. The emerging field of conservation culturomics aims to take advantage of digital data sources and methods to study human-nature interactions and thus to provide new tools for studying conservation at relevant temporal and spatial scales. Nevertheless, technical challenges associated with the identification, access, and analysis of relevant data hamper the wider adoption of culturomics methods. To help overcome these barriers, we propose a conservation culturomics research framework that addresses data acquisition, analysis, and inherent biases. The main sources of culturomic data include web pages, social media, and other digital platforms from which metrics of content and engagement can be obtained. Obtaining raw data from these platforms is usually desirable but requires careful consideration of how to access, store, and prepare the data for analysis. Methods for data analysis include network approaches to explore connections between topics, time-series analysis for temporal data, and spatial modeling to highlight spatial patterns. Outstanding challenges associated with culturomics research include issues of interdisciplinarity, ethics, data biases, and validation. The practical guidance we offer will help conservation researchers and practitioners identify and obtain the necessary data and carry out appropriate analyses for their specific questions, thus facilitating the wider adoption of culturomics approaches for conservation applications.

Fuentes de Información Digital y Métodos para la Culturomia de la Conservación Resumen La continua pérdida de biodiversidad es el resultado principal del comportamiento humano insostenible. Por esto, el éxito a largo plazo de la conservación de la biodiversidad depende de una comprensión exhaustiva de las interacciones humano-naturaleza. Dichas interacciones son ubicuas pero varían enormemente en el tiempo y el espacio, lo que dificulta su monitoreo eficiente a escalas espaciales amplias. Sin embargo, la Era de la Información también nos proporciona nuevas oportunidades para comprender de mejor manera las interacciones humano-naturaleza pues muchos aspectos de la vida diaria quedan registrados en una variedad de formatos digitales. El campo emergente de la culturomia de la conservación busca aprovechar los recursos y los métodos digitales para estudiar las interacciones humano-naturaleza y así proporcionar nuevas herramientas para el estudio de la conservación a escalas temporales y espaciales relevantes. No obstante, las dificultades técnicas asociadas con la identificación, acceso y análisis de la información relevante obstaculizan la adopción más amplia de los métodos de la culturomia. Para ayudar a superar estas barreras proponemos un marco de trabajo de investigación de culturomia de la conservación que aborde la obtención de datos, el análisis y los sesgos inherentes. Entre las principales fuentes de datos sobre culturomia se incluyen las páginas web, las redes sociales y otras plataformas digitales a partir de las cuales se pueden obtener medidas del contenido y la participación. Normalmente se busca obtener datos crudos a partir de este tipo de plataformas, pero esto requiere que se tengan en consideración las vías de acceso, el almacenaje y la preparación de la información para su posterior análisis. Los métodos para el análisis de datos incluyen analísis de redes para explorar las conexiones entre los temas, el análisis de series de tiempo para los datos temporales y el modelado espacial para resaltar los patrones espaciales. Los desafíos sobresalientes asociados a la investigación en culturomia incluyen temas de interdisciplinariedad, ética, sesgos de datos y validación. La orientación práctica que ofrecemos ayudará a los investigadores y practicantes de la conservación a identificar y obtener los datos necesarios. También les ayudará a realizar análisis apropiados para responder a sus preguntas específicas, facilitando así la adopción más amplia de las estrategias de culturomia para su aplicación en la conservación.

How to address data privacy concerns when using social media data in conservation science.

Social media data are being increasingly used in conservation science to study human-nature interactions. User-generated content, such as images, video, text, and audio, and the associated metadata can be used to assess such interactions. A number of social media platforms provide free access to user-generated social media content. However, similar to any research involving people, scientific investigations based on social media data require compliance with highest standards of data privacy and data protection, even when data are publicly available. Should social media data be misused, the risks to individual users' privacy and well-being can be substantial. We investigated the legal basis for using social media data while ensuring data subjects' rights through a case study based on the European Union's General Data Protection Regulation. The risks associated with using social media data in research include accidental and purposeful misidentification that has the potential to cause psychological or physical harm to an identified person. To collect, store, protect, share, and manage social media data in a way that prevents potential risks to users involved, one should minimize data, anonymize data, and follow strict data management procedure. Risk-based approaches, such as a data privacy impact assessment, can be used to identify and minimize privacy risks to social media users, to demonstrate accountability and to comply with data protection legislation. We recommend that conservation scientists carefully consider our recommendations in devising their research objectives so as to facilitate responsible use of social media data in conservation science research, for example, in conservation culturomics and investigations of illegal wildlife trade online.

Cómo Abordar las Preocupaciones por Privacidad al Usar las Redes Sociales en las Ciencias de las Conservación Resumen Cada vez se usan más los datos de las redes sociales en las ciencias de la conservación para estudiar las interacciones humano-naturaleza. El contenido generado por usuarios (imágenes, videos, textos y audios) y los metadatos asociados a estos pueden usarse para evaluar dichas interacciones. Un gran número de redes sociales proporcionan acceso gratuito al contenido generado por usuarios en las redes sociales. Sin embargo, como con cualquier investigación que involucre personas, las investigaciones basadas en los datos obtenidos de la redes sociales requieren cumplir con los estándares más altos de privacidad de datos y protección de la información, incluso cuando éstos están disponibles públicamente. En caso de que se le dé un uso inapropiado a la información obtenida de las redes sociales, los riesgos para la privacidad del usuario y para su bienestar pueden ser sustanciales. Investigamos las bases legales para el uso de la información de redes sociales en conjunto con la garantía de derechos para los sujetos de la información por medio de un estudio de caso basado en la Regulación de la Protección de Datos Generales (GDPR) de la Unión Europea (EU). Los riesgos asociados con el uso de información de las redes sociales en la investigación incluyen la identificación errónea accidental o intencional, la cual tiene el potencial de ocasionar daño psicológico o físico a la persona identificada. Para recolectar, almacenar, proteger, compartir y administrar la información de las redes sociales de manera que se prevengan los riesgos potenciales para los usuarios involucrados, se deben minimizar los datos, volverlos anónimos y seguir un procedimiento estricto de manejo de datos. Las estrategias basadas en riesgos, como la evaluación del impacto de la privacidad de datos, pueden usarse para identificar y minimizar los riesgos de privacidad presentes para los usuarios de las redes, para demostrar responsabilidades y para cumplir con la legislación de protección de datos. Recomendamos a los científicos de la conservación que consideren con cuidado nuestras recomendaciones para el diseño de sus objetivos de investigación para así facilitar el uso responsable de la información de redes sociales en la investigación de las ciencias de la conservación, por ejemplo para las investigaciones sobre el mercado ilegal de fauna en línea y para la culturomia de la conservación.

Fast tracking after repair of congenital heart defects.

Fast tracking after repair of congenital heart defects (CHD) is a process involving the reduction of perioperative period by timely admission, early extubation after surgery, short intensive care unit (ICU) stay, early mobilisation, and faster hospital discharge. It requires a coordinated multidisciplinary team involvement. In the last 2 decades, many centres have adopted the fast tracking strategy in paediatric cardiac population, safely and successfully extubating patients in the OR with reported benefits in terms of reduced morbidity and ICU/hospital stay. In this manuscript, we will review the literature available on early extubation after repair of CHD and share our experience with this approach.

[Design and Evaluation of a Clinical Investigator Training for Student-lead Prospective Multicentre Clinical Trials: a CHIR-Net SIGMA Research-based Learning Project]. / Design und Evaluation eines Prüf-Studierenden-Kurses für studentische prospektive Multicenterstudien ­ ein CHIR-Net-SIGMA-Projekt zum forschenden Lernen.

BACKGROUND: Scientific skills are not sufficiently taught during medical training, neither in medical school nor during postgraduate education. This results in a lack of clinician scientists. In order to counter this problem, the surgical study network (CHIR-Net) founded SIGMA (Student-initiated German Medical Audit). This paper describes the development, performance and evaluation of a Clinical Investigator Training (CIT) aiming to qualify students to autonomously conduct clinical trials. MATERIAL AND METHODS: Based on the Kern cycle, a curriculum was developed, composed of three parts: online tutorials, a workshop and a follow-up period. The educational objectives were defined according to Bloom's taxonomy of knowledge. The learning objectives were based on the requirements of the "Network of Coordinating Centers for Clinical Trials" and the German Medical Association as well as content relevant to clinical studies. A wide range of educational instruments and assessments were used. By including all relevant professional groups involved in clinical trials, an interconnected working environment for students was generated. The increase in knowledge was assessed by a multiple-choice pre/post exam. The satisfaction of participants was analysed by a 5-point Likert scale, on which 5 indicated full approval. RESULTS: The first SIGMA CIT was realised in 2018; the workshop took place in Heidelberg in February. Thirty-two medical students from thirteen different centres participated. On average, 53.8 ± 8.3% of questions were answered correctly in the pre-test, compared with 71.2 ± 7.2% in the post-test (p < 0.0001). The maximal individual improvement was 30%; the lowest difference compared to the pre-test was 5%. Subjective evaluation results were positive with an average result of 4.63 ± 0.34 on a 5-point Likert scale. CONCLUSION: It is feasible to teach medical students the fundamentals of clinical trials. A compact Clinical Investigator Training using modern principles of teaching is able to prepare students for an autonomous performance of clinical trials.

Assessing global popularity and threats to Important Bird and Biodiversity Areas using social media data.

Understanding worldwide patterns of human use of sites of international significance for biodiversity conservation is crucial for meeting global conservation targets. However, robust global datasets are scarce. In this study, we used social media data, mined from Flickr and Twitter, geolocated in Important Bird and Biodiversity Areas (IBAs) to assess i) patterns of popularity; ii) relationships of this popularity with geographical and biological variables; and iii) identify sites under high pressure from visitors. IBAs located in Europe and Asia, and in temperate biomes, had the highest density of users. Sites of importance for congregatory species, which were also more accessible, more densely populated and provided more tourism facilities, received higher visitation than did sites richer in bird species. We found 17% of all IBAs assessed to be under very high threat also received high visitation. Our results show in which IBAs enhanced monitoring should be implemented to reduce potential visitation risks to sites of conservation concern for birds, and to harness the potential benefits of tourism for conservation.

A framework for investigating illegal wildlife trade on social media with machine learning.

Article impact statement: Machine learning can be used to automatically monitor and assess illegal wildlife trade on social media platforms.

Accidental Pyrethroid Ingestion in Toddler: Near-Fatal Atypical Presentation and Successful Recovery.

We are reporting a case of pyrethroid poisoning with atypical presentation in a 21-month-old toddler who was transferred to us from a peripheral center. Signs and symptoms at presentation were predominantly of cardiopulmonary dysfunction contrary to more common presenting features of gastrointestinal and neurological impairment. The reason for this seems to be the aspiration pneumonitis as a consequence of vomiting induced by parents at home, rather than the toxin itself even though a rather rapid progression of lung injury does not rule out the possibility. He had developed decreased level of consciousness and increased work of breathing after ingestion, which had progressed to Acute Respiratory Distress Syndrome, septic shock, and multi organ failure. He even had a brief cardiac arrest with Return of Spontaneous Circulation after 5 min of cardiopulmonary resuscitation, immediately after arrival at our unit, which seemed more likely to be a consequence of inappropriate management during transfer of the child. In addition to antibiotics and vasopressors, he required high frequency oscillatory ventilation and prone positioning initially, and lung-protective conventional ventilation later. His cardiopulmonary status improved gradually and he was successfully extubated after 12 days. Other organ systems also showed complete recovery. Even though Magnetic Resonance Imaging of brain done a few days after cardiac arrest showed features suggestive of hypoxic-ischemic encephalopathy he showed complete neurological recovery. He was thriving well at three-month follow-up with no neurological deficits, good exercise tolerance, and normal renal and liver function. Atypical presentation of pyrethroid poisoning is associated with significant morbidities and there seems to no reliable parameters in children to identify the risk of the same. Considering that there is no specific antidote, prompt, and aggressive supportive therapy is necessary for a favorable outcome. This case highlights several important aspects in the care of the pediatric patient after ingestion of insecticides. First, attempt to induce emesis, especially outside of a healthcare facility is not only ineffective but also highly dangerous, and should not be done. Second, unstable patients require inter and intrahospital transfer by experienced and trained personnel; and lastly, management for these complex and atypical cases should be done as early as possible in a center which is equipped to provide high level of circulatory and ventilatory support while prioritizing neuro-protective measures, and neurologic recovery and rehabilitation.

Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) - study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study).

BACKGROUND: One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning. METHODS: PATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals. A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative. DISCUSSION: PATRONUS will provide essential insights into the patients' assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00013035 (registered on October 26, 2017). Universal Trial Number (UTN): U1111-1202-8863.