Improving quality of life in cancer patients through higher participation and health literacy: study protocol for evaluating the oncological social care project (OSCAR)

BACKGROUND: Cancer patients experience psychological and social distress due to their medical treatment and social issues. However, continuous and specialized social support is still lacking. In Germany, a group of company health insurance funds has developed an approach to support cancer patients with monthly structured interviews conducted by specially trained Social Care Nurses. The nurses will identify patient needs in order to provide help with medical, personal, and social matters. One aim of the scientific evaluation is to analyze the effect of the consultations on various patient-reported outcomes, especially quality of life. The evaluation concept will be described in this study protocol. METHODS/DESIGN: The evaluation is a non-randomized, controlled, multi-center intervention study with a mixed-method design. It consists of three research modules which include primary data from questionnaires, and claims data from the health insurance funds. In Module 1, cancer patients will be recruited to form an intervention group (OSCAR, n = 150) and a control group (n = 200) in four study centers for a period of 1 year. One baseline and three follow-up questionnaires will be conducted to survey the patient-reported outcomes. Relevant secondary outcomes are health literacy, participation, and physician-patient communication. In Module 2, claims data will be used to analyze cost effects and thereby assess effectivity and hospitalization. Module 3 will involve a qualitative analysis of project diaries kept by the Social Care Nurses. The diaries will record the nurses' practical experiences and the benefits of deploying OSCAR across the German healthcare system. DISCUSSION: OSCAR is an innovative way of providing cancer patients with continuous support to improve their quality of life. The evaluation concept aims to assess the effects of the monthly consultations by the Social Care Nurses on the patients, and will use a mixed-method design. The results are important for assessing the transferability of OSCAR to the healthcare system as a whole. TRIAL REGISTRATION: German Clinical Trials Register (DRKS-ID: DRKS00013640 ). Registered 29 December 2017

Market matters: eine handlungsfundierte Erklärung von Märkten

In dieser Arbeit werden markttheoretische Ansätze vorgestellt, die den Anspruch erheben, Märkte in ihrer Wirkungsweise realistischer zu erfassen. Erreicht wird nach Meinung dieser Theoretiker eine größere Realitätsnähe dadurch, indem die handelnden Individuen als Akteure betrachtet werden, die sich aktiv mit den räumlichen und zeitlichen Gegebenheiten auseinandersetzen. In der Dissertationsschrift wird gezeigt, dass es den erwähnten Theoretiker zwar gelungen ist, eine Theorie aktiver Marktteilnehmer zu liefern; ihren Anspruch nach einer realistischeren Markttheorie lösten sie jedoch nicht ein. Die Gründe hierfür sind unterschiedlichster Natur. Während Stigler und Stiglitz daran scheiterten, dass sie die Informationen einerseits als spezielle, kostenverursachende Marktgüter und andererseits als (gratis zur Verfügung stehende) Marktgüter betrachten, beriefen sich Williamson und Hayek indirekt wieder auf den tradierten allokationstheoretischen Ansatz und gerieten damit in Widerspruch zu den von ihnen aufgestellten Effizienzkriterien. Diese fehlende markttheoretische Fundierung (und dementsprechende das fehlende markttheoretische Ergebnis) führte dazu, dass die oben genannten Theoretiker ihren Anspruch nach einer realistischeren Markttheorie nicht umsetzen konnten und es somit nicht verstanden haben, eine tragfähige Alternative zum tradierten allokationstheoretischen Ansatz zu liefern

Soil-Atmosphere Coupling: Looking from within the Soil towards the Surface

The soil-atmosphere interaction is a key control of the thermal and hydraulic regime of both compartments. The goal of this work was to analyze the potential of temperature profile measurements to extract details of the coupling processes, since they are influenced by the heat transfer itself and by an energy sink due to the evaporation of water. The surface is studied from two sides, the atmosphere and the soil. The former is accessible through remote sensing. The latter is difficult to observe, however. Hence, a method is developed to reconstruct the surface temperature from soil temperature profiles. Conduction is the dominant heat transport process in soils. Therefore, reconstructing the surface temperature means back-projecting a diffusion process which is a well-known, but ill-posed problem. It is solved through a weighted linear regression in Fourier space and its applicability is demonstrated for heat conduction and evaporation experiments in the laboratory. Deviations between data and model hint at further processes which are subsequently identified. Combining the measured and reconstructed temperatures with soil water content measurements allows the quantification of all surface energy components for the laboratory experiments. At the field scale, the temperature projection reveals a boundary layer between soil and atmosphere with distinct thermal properties. This results in an apparent decoupling of temperatures looking from above and from below the surface which highlights the challenge of quantifying the thermal dynamics of soils solely from remote sensing observations

Community care coordination for stroke survivors: results of a complex intervention study

Background: Outpatient follow-up care for stroke survivors is often inadequate and mostly self-organized by the patients themselves. In the German health care system, there are no standard care programs for patients after they are discharged from the hospital to support them with their multifaceted and heterogeneous health care needs. The objective of this complex intervention study was to evaluate the effectiveness of a post-stroke care coordination program in comparison to standard care in the first year after a stroke. Methods: Patients aged 55 and older who had survived a stroke or a transient ischemic attack (TIA) within the last 6 months before enrollment were included. Participants received care coordination either by telephone or face-to-face for up to 1 year. Patients’ health insurance claims data were used to measure outcomes. The control group consisted of stroke survivors receiving standard care and was constructed by exact matching based on six criteria. Outcome measures were health services utilization, rate of recurrent events, readmissions and accompanying costs, and mortality. Outcomes were tested using different multiple models. Results: In total, N = 361 patients were included in the analyses. Intervention participants had seen an outpatient neurologist more often (OR = 4.75; 95% CI: 2.71–8.31) and were readmitted to a hospital less frequently (IRR = 0.42; 95% CI: 0.29–0.61), resulting in lower hospital costs (IQR = €0–1910 in the intervention group, IQR = €0–4375 in the control group). There were no substantial group differences in the rate of recurrent events and mortality. Conclusion: This study showed the beneficial potential of care coordination for a vulnerable patient population: the utilization rate of important health services was increased, and the rate of hospital readmissions decreased as a result. Future research should focus on the risk of recurrent strokes and the long-term effects of improved care. Trial registration: DRKS00017526 on DRKS – German Clinical Trials Register (retrospectively registered: 21 June 2019)

Quality of life after stroke rehabilitation discharge: a 12-month longitudinal study

PURPOSE To analyse trends in quality of life (QoL) development among older stroke patients within the first year after rehabilitation discharge, and to investigate the impact of including proxy interviews in research and practice. METHODS A prospective cohort study with follow-up at 3, 6, and 12 months with 411 patients and proxy respondents was conducted. The EUROHIS-QOL 8-item index was used to assess QoL. By performing descriptive analyses, QoL development over time was compared among subgroups. Linear mixed models were calculated to estimate mean changes from baseline to 12-month follow-up. The effects of patient characteristics and time on QoL were investigated using comprehensive mixed models. RESULTS One year after rehabilitation discharge, the majority of patients had neither maintained nor regained their initial QoL. Proxy respondents reported significantly lower QoL (22.6-29.5 points, p < 0.001). Characteristics associated with lower QoL were stroke severity, depression, and pain. Having a small social network was negatively associated with QoL (-1.66 points, 95%CI: -2.84/-0.48, p = 0.006). CONCLUSIONS Quality of life scores reported at the time of rehabilitation discharge are often not lasting. Including severely impaired patients via proxies reduces the risk of overestimating QoL outcomes. Outpatient's characteristics should be taken into account when planning therapy strategies to maintain previously achieved health goals. Regular re-assessments are required.Implications for rehabilitationThere should be an awareness that improvements in quality of life (QoL) achieved during rehabilitation are not sustainable.Regularly re-assessing pain status, psychological burden, and social network size could help clinicians to determine treatment strategies for maintaining and improving rehabilitation achievements.Conducting proxy interviews is required to assess disease burden of patients with severe stroke (e.g., non-linguistic patients)

Characteristics and patient-reported outcomes associated with dropout in severely affected oncological patients: an exploratory study

Background: Patient-reported outcome measures (PROMs) are commonly-used surrogates for clinical outcomes in cancer research. When researching severe diseases such as cancer, it is difficult to avoid the problem of incomplete questionnaires from drop-outs or missing data from patients who pass away during the observation period. The aim of this exploratory study was to explore patient characteristics and the patient-reported outcomes associated with the time-to-dropout. Methods: In an Oncological Social Care Project (OSCAR) study, the condition of the participants was assessed four times within 12 months (t0: baseline, t1: 3 months, t2: 6 months, and t3: 12 months) by validated PROMs. We performed competing-risk regressions based on Fine and Gray's proportional sub-distribution hazards model for exploring factors associated with time-to-dropout. Death was considered a competing risk. Results: Three hundred sixty-two participants were analyzed in the study. 193 (53.3%) completed a follow-up after 12 months, 67 (18.5%) patients dropped out, and 102 patients (28.2%) died during the study period. Poor subjective social support was related to a higher risk of drop-out (SHR = 2.10; 95%CI: 1.01-4.35). Lower values in health-related quality of life were related to drop-out and death. The sub-scales global health status/QoL, role functioning, physical functioning, and fatigue symptom in the EORTC QLQ-C30 were key characteristics of early drop-out. Conclusion: Severely affected cancer patients with poor social support and poor quality of life seem more likely to drop out of studies than patients with higher levels of social support and a better quality of life. This should be considered when planning studies to assess advanced cancer patients. Methods of close continued monitoring should be actively used when patient experiences a substantial deterioration in their health-related quality of life and symptoms during the study. Results for such studies have to be interpreted with caution in light of specific drop-out mechanisms

Identifying and handling unbalanced baseline characteristics in a non-randomized, controlled, multicenter social care nurse intervention study for patients in advanced stages of cancer

Purpose: Given the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer. Methods: Patients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups. Results: The study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044). Conclusion: Overall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods

Serum retinol and prostate cancer risk: a nested case-control study in the prostate, lung, colorectal, and ovarian cancer screening trial.

Vitamin A (retinol) plays a key role in the regulation of cell growth and differentiation, and has been studied as a potential chemopreventive agent for prostate cancer. However, findings from epidemiologic studies on the association between circulating retinol concentrations and the risk of prostate cancer are inconsistent. We examined whether serum concentrations of retinol were associated with the risk of prostate cancer in a nested case-control study using 692 prostate cancer cases and 844 matched controls from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. We estimated the risk of prostate cancer using multivariate, conditional logistic regression to calculate odds ratios and 95% confidence intervals for overall prostate cancer and aggressive disease (stage III or IV or Gleason >7; n = 269). Serum retinol concentrations were not associated with overall prostate cancer risk; however, the highest versus lowest concentrations of serum retinol were associated with a 42% reduction in aggressive prostate cancer risk (P(trend) = 0.02), with the strongest inverse association for high-grade disease (Gleason sum >7; odds ratio, 0.52; 95% confidence interval, 0.32-0.84; P(trend) = 0.01). Our results suggest that higher circulating concentrations of retinol are associated with a decreased risk of aggressive prostate cancer. Further research is needed to better understand the significance of elevations in serum retinol concentrations and the possible biological mechanisms through which retinol affects prostate cancer. (Cancer Epidemiol Biomarkers Prev 2009;18(4):1227-31)

Measurement of real-time tissue elastography in a phantom model and comparison with transient elastography in pediatric patients with liver diseases

PURPOSEWe aimed to determine the comparability of real-time tissue elastography (RTE) and transient elastography (TE) in pediatric patients with liver diseases. MATERIALS AND METHODSRTE was performed on the Elasticity QA Phantom Model 049 (Computerized Imaging Reference Systems Company Inc., Norfolk, Virginia, USA), which has five areas with different levels of stiffness. RTE measurements of relative stiffness (MEAN [mean value of tissue elasticity], AREA [% of blue color-coded stiffer tissue]) in the phantom were compared with the phantom stiffness specified in kPa (measurement unit of TE). RTE and TE were performed on 147 pediatric patients with various liver diseases. A total of 109 measurements were valid. The participants had following diseases: metabolic liver disease (n=25), cystic fibrosis (n=20), hepatopathy of unknown origin (n=11), autoimmune hepatitis (n=12), Wilson’s disease (n=11), and various liver parenchyma alterations (n=30). Correlations between RTE and TE measurements in the patients were calculated. In addition, RTE was performed on a control group (n=30), and the RTE values between the patient and control groups were compared. RESULTSThe RTE parameters showed good correlation in the phantom model with phantom stiffness (MEAN/kPa, r=-0.97; AREA/kPa, r=0.98). However, the correlation of RTE and TE was weak in the patient group (MEAN/kPa, r=-0.23; AREA/kPa, r=0.24). A significant difference was observed between the patient and control groups (MEAN, P = 5.32 e-7; AREA, P = 1.62 e-6). CONCLUSIONIn the phantom model, RTE was correlated with kPa, confirming the presumed comparability of the methods. However, there was no direct correlation between RTE and TE in patients with defined liver diseases under real clinical conditions