Outdoor air pollution, green space, and cancer incidence in Saxony: a semi-individual cohort study.

BACKGROUND: There are a few epidemiological studies that (1) link increased ambient air pollution (AP) with an increase in lung cancer incidence rates and (2) investigate whether residing in green spaces could be protective against cancer. However, it is completely unclear whether other forms of cancer are also affected by AP and if residential green spaces could lower cancer incidence rates in general. Therefore, the objective was to estimate whether AP and green space are associated with several cancer types. METHODS: The analysis was based on routine health care data from around 1.9 million people from Saxony who were free of cancer in 2008 and 2009. Incident cancer cases (2010-2014) of mouth and throat, skin (non-melanoma skin cancer - NMSC), prostate, breast, and colorectum were defined as: (1) one inpatient diagnosis, or (2) two outpatient diagnoses in two different quarters within one year and a specific treatment or death within two quarters after the diagnosis. Exposures, derived from freely available 3rd party data, included particulate matter with aerodynamic diameter of less than 10 µm (PM10) and nitrogen dioxide (N02) as well as green space (Normalized Difference Vegetation Index - NDVI). Associations between air pollutants, green space, and cancer incidence were assessed by multilevel Poisson models. Age, sex, physician contacts, short- and long-term unemployment, population density, and having an alcohol-related disorder were considered as potential confounders. RESULTS: Three thousand one hundred seven people developed mouth and throat cancer, 33,178 NMSC, 9611 prostate cancer, 9577 breast cancer, and 11,975 colorectal cancer during the follow-up period (2010-2014). An increase in PM10 of 10 µg/m3 was associated with a 53% increase in relative risk (RR) of mouth and throat cancer and a 52% increase in RR of NMSC. Prostate and breast cancer were modestly associated with PM10 with an increase in RR of 23 and 19%, respectively. The associations with N02 were in the same direction as PM10 but the effect estimates were much lower (7-24%). A 10% increase in NDVI was most protective of mouth and throat cancer (- 11% RR) and of NMSC (- 16% RR). Colorectal cancer was not affected by any of the exposures. CONCLUSIONS: In addition to the studies carried out so far, this study was able to provide evidence that higher ambient AP levels increase the risk of mouth and throat cancer as well as of NMSC and that a higher residential green space level might have a protective effect for NMSC in areas with low to moderate UV intensity. Nevertheless, we cannot rule out residual confounding by socioeconomic or smoking status.

Cancer patients' control preferences in decision making and associations with patient-reported outcomes: a prospective study in an outpatient cancer center.

PURPOSE: "Shared decision making" has been proposed as a prerequisite of patient-centered care. However, little is known on factors, which may influence cancer patients' decision control preferences (DCP) in routine care. This study investigated possible determinants of the patients' DCP with respect to patient characteristics and patient-reported outcomes (PROs). METHODS: Consecutive patients presenting at a comprehensive cancer center between May 2014 and October 2014 were offered a self-administered electronic questionnaire including standardized PRO measures and patients' DCP. Results were linked with patient characteristics from the hospital information system and analyzed using cross-sectional methods. RESULTS: Out of 126 patients participating, 102 (81%; 65% male; mean age 62 years) completed the DCP-item. Overall, 49% (n = 50) preferred shared treatment decision responsibility, 29% (n = 30) preferred to leave the control to his/her physician, whereas 22% (n = 22) preferred to be in control of his/her treatment decision. Higher age (p = 0.035) and elevated distress levels (p = 0.038) were significantly associated with an increased willingness to leave the decision control to the physician. Further sociodemographic and PRO measures were not associated with patients' DCP. CONCLUSION: Our findings demonstrate that DCP assessment in routine cancer care is possible and provides important information to the treating oncologist. Information on DCP combined with PRO may contribute to more individualized decision making in cancer care.

Einsatz und Wirksamkeit von Systemtherapien bei Erwachsenen mit schwerer Neurodermitis: Erste Ergebnisse des deutschen Neurodermitis-Registers TREATgermany.

HINTERGRUND: Versorgungsregister dienen der Erfassung des Einsatzes und der Wirksamkeit von Therapien unter realen Versorgungsbedingungen und sind als Basis einer evidenzbasierten Gesundheitsversorgung unverzichtbar. METHODIK: Das deutsche Neurodermitis-Register TREATgermany wurde als weltweit erstes Register für Patienten mit schwerer Neurodermitis 2011 initiiert. Erwachsene mit schwerer Neurodermitis (aktuelle/frühere antientzündliche Systemtherapie und/oder objektiver SCORAD ≥ 40) werden über einen Zeitraum von 24 Monaten prospektiv beobachtet. Anhand validierter Erhebungsinstrumente werden die klinische Erkrankungsschwere (EASI, SCORAD), Lebensqualität (DLQI), Symptome, globale Erkrankungsschwere sowie die Patientenzufriedenheit erfasst und die durchgeführten Therapien dokumentiert. Die vorliegende Analyse beschreibt die Charakteristika, Therapiewahl und Wirksamkeit der eingesetzten antiinflammatorischen Systemtherapien der bis Oktober 2014 eingeschlossenen Patienten. ERGEBNISSE: An fünf Zentren wurden insgesamt 78 Patienten (Durchschnittsalter 39 Jahre, 61 % männlich) eingeschlossen. Bei den Patienten besteht eine hohe Inanspruchnahme ambulanter und stationärer Leistungen. Ciclosporin war das am häufigsten eingesetzte Systemtherapeutikum und zeigte die höchste klinische Effektivität (EASI-50-Ansprechrate 51 %; EASI-75-Ansprechrate 34 % nach zwölfwöchiger Therapie). Azathioprin, Methotrexat (MTX), Prednisolon oral, Mycophenolat, Alitretinoin und Leflunomid wurden ebenfalls bei einzelnen Patienten eingesetzt. SCHLUSSFOLGERUNGEN: Die vorliegende Registerauswertung gibt wichtige Hinweise zur derzeitigen Versorgung von Erwachsenen mit schwerer Neurodermitis in Deutschland, dokumentiert die hohe Erkrankungslast, den Nutzen vorhandener Therapien und den Bedarf an weiteren, effektiven und in der Langzeitanwendung sicheren Therapieoptionen.

Usage and effectiveness of systemic treatments in adults with severe atopic eczema: First results of the German Atopic Eczema Registry TREATgermany.

BACKGROUND: The goal of clinical registries is to document the use and effectiveness of therapeutic interventions under real-life conditions. They are an indispensable prerequisite of evidence-based health care. METHODS: Initiated in 2011, the German Atopic Dermatitis Registry TREATgermany is the first registry of patients with severe atopic dermatitis worldwide. Adults with severe atopic dermatitis (current/prior systemic antiinflammatory treatment and/or objective SCORAD ≥ 40) are prospectively followed over the course of 24 months. Employed treatment modalities are documented, and validated measuring tools are used to assess clinical disease severity (EASI, objective SCORAD), quality of life (DLQI), symptoms (POEM), global disease severity, as well as patient satisfaction. Herein, we describe the characteristics, therapeutic selection, and effectiveness of systemic antiinflammatory treatments of patients enrolled in the registry until October 2014. RESULTS: Overall, 78 individuals (mean age 39 years, 61 % men) were enrolled at five recruitment centers. Patients frequently made use of inpatient and outpatient services. Not only was cyclosporine the most frequently administered systemic treatment, but also the most effective (EASI 50 response rate 51 %; EASI 75 response rate 34 % at 12 weeks). Azathioprine, methotrexate, oral prednisolone, mycophenolate, alitretinoin, and leflunomide were also used in some patients. CONCLUSIONS: The present analysis of the German Atopic Dermatitis Registry provides important data with respect to current medical care of adults with severe atopic dermatitis in Germany. It shows the high disease burden, the benefits of current treatment options, and the need for additional effective and safe long-term treatment options.

Electronic real-time assessment of patient-reported outcomes in routine care-first findings and experiences from the implementation in a comprehensive cancer center.

PURPOSE: Cancer patients suffer from a variety of physical and mental complaints. Since physician assessment of symptoms seems insufficient to reveal the complete range of patients' ailments, patient-reported outcomes (PRO) have become of key importance in modern cancer treatment. The implementation and first results of a systematic electronic real-time assessment of PRO in routine care is described. METHODS: Consecutive patients presenting for the first time to a German comprehensive cancer center were asked to fill in an adaptive self-administered electronic questionnaire consisting of standardized PRO measures. After completion, patient-reported data was linked to the patients' medical files for discussion in the first consultation with the treating physician. Interviews with staff were conducted to identify barriers in implementation. RESULTS: Out of 160 cancer patients, 126 (79 %; mean age 63 years, 67 % males) agreed to participate. The number of recruited patients increased over time. Of participating patients, 67 % provided complete information on all PRO-related scales. On average, 31 min (range 3-140) were required to fill in the questionnaire. Of participating patients, 53.0 % comprised need for psychooncological support and 62 % revealed moderate to severe psychosocial distress. The mean score for global quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was 55.2 (SD ±25.6). CONCLUSIONS: Comprehensive oncological treatment needs to consider disease symptoms, quality of life, preferences, and comorbidities of individual patients in a structured, standardized, and transparent way. Our findings indicate that an adaptive, self-administered electronic assessment tool for cancer patients to report a broad set of PRO can be feasibly implemented and is well accepted by patients in a realistic setting.

Implementation of a mobile inpatient quality of life (QoL) assessment for oncology nursing.

PURPOSE: Cancer patients suffer from a variety of symptoms, but little is known about changes during hospitalization and symptom burden at discharge. We implemented an electronic quality of life (QoL) assessment used by the nursing team in routine inpatient care. Feasibility, acceptance, and the course of QoL were investigated. METHODS: A self-administered electronic questionnaire based on the EQ-5D and the EORTC QLQ-C30 was applied in clinical routine. Cancer patients were approached by the nursing staff to complete the QoL assessment twice, at admission and at the day of discharge. Both the feedback of the nursing staff as well as characteristics of participants were used to evaluate the electronic assessment. RESULTS: Out of 210 patients from an oncologic ward, 85 patients (40 %) were invited to participate, 95 % of whom (n = 81) agreed to participate. Participation rate depended on the day of admission, the presence of the coordinating nurse, the overall morbidity assessed by patient clinical complexity level, and the patient age. Forty-six patients (56 %) asked for assistance in completing the questionnaire. Patients older than 53 years and male patients were more likely to need assistance. Twenty-two percent of the nursing staff (n = 5) use the information assessed for individual patient care. Fifty-two percent (n = 12) rated the additional workload as very little or little and 68 % (n = 15) agreed that handling for the patient was easy. Global QoL improved during the stay. Most severe symptoms at admission included fatigue, pain, appetite loss, and insomnia. CONCLUSIONS: The results of this study indicate that it is feasible to implement and use an electronic QoL assessment by the nursing staff in routine inpatient cancer care. Obstacles and worries of staff members have to be considered when further developing this program.

Evidence-based quality standards improve prognosis in colon cancer care.

BACKGROUND: Colon cancer requires interdisciplinary care with quality of initial surgical treatment being a major prognostic factor. Implementation of quality standards based on structural and procedural indicators in routine care via certification (Germany) or accreditation (USA) is an established quality assurance method. However, evidence on effects is scarce. We undertook a population-based cohort study to investigate the effectiveness of colon cancer care in certified vs non-certified hospitals. MATERIALS AND METHODS: We utilized data of a large statutory health insurance including in- and outpatient data from 2005 to 2015 of >2 million individuals from Saxony, Germany. Case definitions were based on diagnosis, medical procedures and prescriptions. Patients treated in certified hospitals (CH) were compared to patients treated in non-certified hospitals (NCH) using logistic and Cox regression models adjusting for relevant confounders concerning overall survival (OS), disease-specific survival (DSS), 30-day mortality, recurrence, complications and second resections within 6 months after first resection (SR). RESULTS: Overall, 6186 patients with incident colon cancer undergoing surgery were identified (mean age 74.1 ± 11.0 years, 51.1% male) with 2120 (34.3%) patients treated in a CH. Confounder-adjusted regression models indicated positive effects in CH on OS (HR = 0.90, 95%CI: 0.83-0.97), DSS (HR = 0.71, 95%CI: 0.57-0.88), 30-day mortality (OR = 0.69, 95%CI: 0.55-0.87) and SR (OR = 0.51, 95%CI: 0.30-0.87). These results remained stable after adjustment for hospital volume. 30-day mortality in 2014 was 41% lower in CH (7.4%) compared to NCH (12.6%). CONCLUSIONS: This study indicates that the implementation and assurance of evidence-based quality standards has substantial positive effects on various patient-relevant outcomes in colon cancer care.

Associations of myeloid hematological diseases of the elderly with osteoporosis: A longitudinal analysis of routine health care data.

BACKGROUND: Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) are hematological stem cell diseases mainly of the elderly. Studies indicate a close relationship between bone metabolism and hematopoietic stem cells within the osteo-hematopoietic niche. However, it remains unclear how the disturbed interaction within the osteo-hematopoietic niche affects bone homeostasis in MDS and AML patients. METHODS: We utilized data of a large German statutory health insurance of approximately 2 million persons living in the German federal state of Saxony. Applying case definitions based on diagnosis, procedures and prescriptions we identified prevalent and incident cases with MDS, AML and osteoporosis (OSP) in persons aged ≥60 years. We applied time-to-event analyses to determine the relationship of MDS and AML with OSP with a specific focus on temporality. RESULTS: Among all individuals aged ≥60 years (n = 891,095), 2.62% (n = 23,326), 0.14% (n = 1219) and 0.10% (n = 893) were identified with incident OSP, MDS and AML, respectively. The risk of incident OSP was significantly increased in patients with prevalent MDS (sex and age-adjusted model: HR = 1.87, 95%CI: 1.51-2.23). Conversely, patients with prevalent OSP had an increased risk to be diagnosed with incident MDS in the adjusted model (HR = 1.42, 1.19-1.65). For AML no significant associations were observed (adjusted models: inc. OSP with pre. AML; HR = 1.06, 0.65-1.47; inc. AML with pre. OSP; HR = 0.82, 0.41-1.23). DISCUSSION: Our results could indicate a clinically relevant relationship between MDS and OSP in elderly patients, most likely resulting from a disturbed microenvironment within the osteo-hematopoietic niche. An alternative, non-causal explanation that MDS is caused by the medication prescribed for OSP can be partially ruled out, as the association between the two diseases remains if incident OSP cases are considered in patients with pre-existing MDS. These results need to be confirmed within other prospective studies and may allow then for comprehensive strategies for the prevention, early detection and clinical care of patients with MDS and OSP.

Occupational UV-Exposure is a Major Risk Factor for Basal Cell Carcinoma: Results of the Population-Based Case-Control Study FB-181.

OBJECTIVE: The aim of this study was to investigate the role of occupational and nonoccupational ultraviolet (UV)-exposure concerning the development of basal cell carcinoma (BCC). METHODS: We undertook a population-based multicenter case-control study. Patients with first incident BCC (n = 836) were propensity score matched by age and sex to controls without skin cancer (n = 836). Sociodemographic characteristics, clinical characteristics, and lifetime UV-exposure were assessed by trained investigators. The differential estimation of occupational and nonoccupational UV-exposure dosages was based on validated instruments and established reference values. Associations were assessed using multivariable-adjusted conditional logistic regression models. RESULTS: Individuals with high levels of occupational UV-exposure were at significantly increased BCC-risk compared with individuals with low [odds ratio (OR) 1.84; 95% confidence interval (95% CI) 1.19 to 2.83 and moderate (OR 1.97; 95% CI 1.20 to 3.22) occupational UV-exposure. Nonoccupational UV-exposure was not independently associated with BCC. CONCLUSION: Skin cancer prevention strategies should be expanded to the occupational setting.

Implementation and first results of a tablet-based assessment referring to patient-reported outcomes in an inpatient cancer care unit.

BACKGROUND: Inclusion of patient-reported outcomes (PROs) in routine cancer care is of key importance for individualized treatment, shared decision making and patient satisfaction. OBJECTIVE: To describe the implementation under routine conditions of an electronic self-administered PRO assessment and comparison of PROs before and after inpatient treatment in oncologic care. METHODS: In a tablet-based survey PROs on symptom burden, global health status/ quality of life (QoL) and health utility were collected twice (at hospital admission and discharge) in an inpatient oncological setting over a 17-month period using the EORTC QLQ-C30 and EQ-5D questionnaires. Data were linked to the hospital information system (HIS). Patient acceptability, recruitment rates, symptom burden, and clinically meaningful changes in PROs over time were analyzed. RESULTS: From a total of 384 hospitalized patients invited to participate at admission 371 (96.6 %) participated. At discharge, 195 patients were approached for a follow-up assessment, and 192 patients (98.5 %) participated. Despite strong acceptance among patients, recruitment rates were decreasing over time. During the hospital stay clinically meaningful improvements were observed for health utility (33.3 %, n = 64) and global health status/QoL (43.2 %, n = 83). Patients reported a variety of symptoms at admission and discharge. CONCLUSIONS: Implementation of PRO assessment in routine care and data integration into the HIS provides valuable information for the entire medical staff as symptom burden is present during the entire hospital stay. IMPLICATIONS FOR PRACTICE: Long-term maintenance of PRO assessment in a clinical setting as a prerequisite of value-based healthcare requires continuous involvement of the nursing team, which can only be achieved by allocating resources to this task.

Burden of soft-tissue and bone sarcoma in routine care: Estimation of incidence, prevalence and survival for health services research.

BACKGROUND: Sarcomas constitute a rare group of malignant tumors which can originate from any organ, tissue, bone or cartilage. Due to their heterogeneity, estimates of sarcoma incidence, prevalence and survival are rare. We estimated the burden of sarcoma in Germany from a large unselected cohort of patients from routine healthcare. METHODS: We utilized the AOK PLUS health services research database covering complete medical information on 2,615,865 individuals from the German federal state of Saxony from 2005 to 2012. Persons were defined as sarcoma cases if they had ≥4 medical accounts with respective ICD-10 code C49 (soft-tissue sarcoma) or C40/C41 (bone sarcoma). We assessed sarcoma burden by calculating five-year prevalences, cumulative incidences, and one- and five-year relative survival rates. RESULTS: Overall 1,468 persons with soft-tissue sarcoma and 671 persons with bone sarcoma were identified. Age-standardized cumulative incidence was 4.5/100,000 persons for soft-tissue and 2.1/100,000 persons for bone sarcoma (European Standard). One- and five-year relative survival was 87.8% and 66.4% for soft-tissue and 91.8% and 52.9% for bone sarcoma, respectively. CONCLUSION: This is the first estimation of the burden of sarcoma based on an unselected sample of routine care data and the first estimation of the burden of sarcoma in Germany. We believe that the proposed methods offer a valuable approach for further outcomes research on cancer.