Prioritization and Resource Allocation in the Context of the COVID-19 Pandemic: Recommendations for Colorectal and Pancreatic Cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by (1) the urgency relevant to avoid or reduce harm, (2) the likelihood of success of the diagnostic or therapeutic measure advised, and (3) the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin, and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for (1) diagnostic procedures, (2) surgical procedures for cancer, and (3) systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

[Routine Practice Data for Health Care Analyses: Part 3 of the Manual]. / Versorgungsnahe Daten für Versorgungsanalysen ­ Teil 3 des Manuals.

Analyses of health and health care (hereafter referred to as "health care analyses") usually aim to make transparent the structures, processes, results and interrelationships of health care and to record the degree to which health care systems and their actors have achieved their goals. Health care-related data are an indispensable source of data for many health care analyses. A prerequisite for the examination of a degree of goal achievement is first of all an agreement on those goals that are to be achieved by the system and its substructures, as well as the identification of the determinants of the achievement of the objectives. Primarily it must be examined how safely, effectively and patient-centred systems, facilities and service providers are operating. It also addresses issues of need, accessibility, utilisation, timeliness, appropriateness, patient safety, coordination, continuity, and health economic efficiency and equity of health care. The results of health care include system services (outputs), on the one hand, and results (outcomes), on the other, whereby the results (patient-reported outcomes) and experiences (patient-reported experiences) reported are of particular importance. Health care analyses answer basic questions of health care research: who does what, when, how, why and with which resources and effects in routine health care. Health care analyses thus provide the necessary findings and key figures to further develop health care in order to improve the quality of health care. The applications range from capacity analyses to following innovations up to the concept of regional and supra-regional monitoring of the quality of care given to the population. Given the progress of digitalisation in Health Care, direct data from the care processes will be increasingly available for health care research. This can support care givers significantly if the findings of the studies are applied precisely and correctly within an adequate methodological frame. This can lead to measurable improved health care quality for patients. Data from the process of health care provision have a high potential. Their use needs the same scientific scrutiny as in all other scientific studies.

Use of social service counseling by cancer patients: an analysis of quality assurance data of 6339 breast cancer patients from 13 certified centers in Germany treated between 2015 and 2017.

BACKGROUND: Integrated social care may help to mitigate social risk factors in order to achieve more equitable health outcomes. In cancer centers certified according to the criteria set out by the German Cancer Society, every patient must be given low-threshold access to qualified social workers at the center for in-house social service counseling (SSC). Previous analyses have demonstrated large variation in the utilization of these services across individual centers. Therefore, this research aims at investigating whether SSC utilization varies regarding breast cancer patient characteristics and center characteristics presenting a unique approach of using routine data. METHODS: Multilevel modeling was performed using quality assurance data based on 6339 patients treated in 13 certified breast cancer centers in Germany in order to investigate whether SSC utilization varies with patient sex, age, and disease characteristics as well as over time and across centers. RESULTS: In the sample, 80.3% of the patients used SSC. SSC use varies substantially between centers for the unadjusted model (ICC = 0.24). Use was statistically significantly (P < .001) more likely in women, patients with invasive (in comparison to tumor in situ/ductal carcinoma in situ) diseases (P < .001), patients with both breasts affected (P = .03), patients who received a surgery (P < .001), patients who were diagnosed in 2015 or 2017 compared to 2016 (P < .001) and patients older than 84 years as compared to patients between 55 and 64 years old (P = .002). CONCLUSION: The analysis approach allows a unique insight into the reality of cancer care. Sociodemographic and disease-related patient characteristics were identified to explain SSC use to some extent.

[Consulting Ethics Committees about a Multicenter Observational Study in Germany - A Report on Effort and Costs]. / Die Beratung durch Ethikkommissionen bei einer multizentrischen Beobachtungsstudie in Deutschland ­ Aufwand und Kosten.

AIM OF THE STUDY: Ethics committees (ECs) have an indispensable monitoring and regulatory function in research on human beings. In multicenter observational studies, approvals of several local ECs are often required. The aim of this analysis was to provide an overview of the resources used and the process for consulting ECs about a multicenter observational study in Germany. METHODS: For this purpose, a cross-sectional analysis was carried out. Resources and activities within the consultation process were documented by the central study management for the period April 2018-April 2019. The study for which the consultation was obtained involved 106 certified colorectal cancer centers in 15 federal states in Germany. RESULTS: We submitted applications to ECs in 14 medical associations and 7 university hospitals. In total, 6,305 euros consultation fees were charged by the ECs, with the fees varying between 50 and 1,400 euros. For the application documents, at least 2,986 sheets of DIN A4 paper were printed and sent by post to the EC. Partly, several copies of the application documents were required. The central study management spent about 210 working hours. The median of the processing time was 32 days (range: 5-177 days). CONCLUSION: In order to significantly reduce the financial, material and personnel costs for scientists and ECs, a standardized and nationwide procedure for consulting ECs about multicenter studies should be pursued in the future. In the interests of economic and ecological sustainability, online procedures should be considered.

The European Prostate Cancer Centres of Excellence: A Novel Proposal from the European Association of Urology Prostate Cancer Centre Consensus Meeting.

BACKGROUND: High-quality management of prostate cancer is needed in the fields of clinics, research, and education. OBJECTIVE: The objective of this project was to develop the concept of "European Prostate Cancer Centres of Excellence" (EPCCE), with the specific aim of identifying European centres characterised by high-quality cancer care, research, and education. DESIGN, SETTING, AND PARTICIPANTS: A task force of experts aimed at identifying the general criteria to define the EPCCE. Discussion took place in conference calls and by e-mail from March 2017 to November 2017, and the final consensus meeting named "European Association of Urology (EAU) Prostate Cancer Centre Consensus Meeting" was held in Barcelona on November 16, 2017. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The required criteria were grouped into three main steps: (1) clinics, (2) research, and (3) education. A quality control approach for the three steps was defined. RESULTS AND LIMITATIONS: The definition of EPCCE consisted of the following steps: (1) clinical step-five items were identified and classified as core team, associated services, multidisciplinary approach, diagnostic pathway, and therapeutic pathway; (2) research step-internal monitoring of outcomes was required; clinical data had to be collected through a prespecified database, clinical outcomes had to be periodically assessed, and prospective trials had to be conducted; (3) educational step-it consists of structured fellowship programmes of 1yr, including 6mo of research and 6mo of clinics; and (4) quality assurance and quality control procedures, related to the quality assessment of the previous three steps. A limitation of this project was that the definition of standards and items was mainly based on a consensus among experts rather than being an evidence-based process. CONCLUSIONS: The EAU Prostate Cancer Centre Consensus Meeting defined the criteria for the identification of the EPCCE in the fields of clinics, research, and education. The inclusion of a quality control approach represents the novelty that supports the excellence of these centres. PATIENT SUMMARY: A task force of experts defined the criteria for the identification of European Prostate Cancer Centres of Excellence, in order to certify the high-quality centres for prostate cancer management.

Unmet information needs and limited health literacy in newly diagnosed breast cancer patients over the course of cancer treatment.

OBJECTIVE: To investigate unmet information needs in newly diagnosed breast cancer patients over the course of cancer treatment and its association with health literacy. METHODS: We present results from a prospective, multicenter cohort study (PIAT). Newly diagnosed breast cancer patients (N=1060) were surveyed directly after breast cancer surgery, 10 and 40 weeks later. Pooled linear regression modeling was employed analyzing changes in unmet information needs over time and its association with health literacy. RESULTS: Unmet information needs on side effects and medication and medical examination results and treatment options were high and increased during the first 10 weeks after breast cancer surgery. Considering health promotion and social issues, unmet information needs started high and decreased during post-treatment. Patients with limited health literacy had higher unmet information needs. CONCLUSION: Our results indicate a mismatch in information provision and breast cancer patients' information needs. Patients with limited health literacy may be at a distinct disadvantage in having their information needs met over the course of breast cancer treatment. PRACTICE IMPLICATIONS: Strategies are needed to reduce unmet information needs in breast cancer patients considering treatment-phase and health literacy and thereby enable them to better cope with their diseases.

Quality assessment in prostate cancer centers certified by the German Cancer Society.

PURPOSE: In 2008, the German Cancer Society certification program for prostate cancer centers (PCCs) was introduced, fostering multidisciplinary and interprofessional cooperation. Since then, 97 PCCs have been certified. This paper describes the PCC certification program, quality indicators (QI) that are reported during certification, as well as changes over time and correlates of QI fulfillment. METHODS: Observational data from 70,683 primary prostate cancer (PCa) cases treated between 2010 and 2013 in certified PCC sites are analyzed using descriptive and correlation analyses. RESULTS: Fulfillment of the requirements is high with over 80 % of the sites fulfilling the requirements for most of the presented QIs with defined target values. Fulfillment increased slightly over time, with significant improvements in conducting multidisciplinary tumor conferences (increasing proportion of cases presented pre- and post-treatment, increasing participation of specialists), psycho-oncologic care, social service counseling and research participation. Bivariate associations between hospital characteristics and QIs observed were most distinct for time since first certification. CONCLUSIONS: Results suggest that the PCC certification program presented contributes to establishing multidisciplinary teams over time and assures the provision of high-quality PCa care. However, differences in fulfillment of the requirements exist with regard to hospital characteristics beyond the scope of the certification system.

After initial treatment for primary breast cancer: information needs, health literacy, and the role of health care workers.

PURPOSE: After a short hospital stay of just some days follows long-term outpatient care for breast cancer patients. The aim of the study is to describe the information needs of breast cancer outpatients and to get in touch with aspects of health literacy, as well as contact various health care workers. METHODS: In a multicenter study, patients were asked about their information needs 10 weeks after surgery. The analysis on hand includes data about 1248 female patients. In addition to descriptive analyses identifying the most prevalent information needs, logistic regression analyses were calculated to identify factors associated with these. RESULTS: The results show that information needs of breast cancer outpatients are mainly in "follow-up after acute treatment", "coping with long-term side effects", and "heredity of breast cancer". In addition to sociodemographic patient characteristics, perceived helpful contacts with various health care workers as well as a satisfactory patient's level of health literacy reduced the probability of unmet information needs. CONCLUSIONS: Breast cancer outpatients have numerous information needs. In addition to provide information at the right time regarding a specific disease phase, it is important that health professionals' support affected breast cancer patients in coping with the new situation.

The Influence of Health Literacy on Information Needs Among Women Newly Diagnosed With Breast Cancer, With Special Reference to Employment Status.

Breast cancer is the most frequent type of malignancy among women throughout Germany. The present analysis aimed to identify information needs and aspects of health literacy in women of working age newly diagnosed with breast cancer. PIAT is a prospective multicenter cohort study in which patients were asked about their information needs at 3 assessment points: postoperatively, after 10 weeks, and after 40 weeks. The present analysis includes data from 1,344 female patients after the first assessment point. In addition to descriptive analyses, logistic regression analyses were calculated. Results of the study show that, in addition to sociodemographic characteristics, the level of health literacy and the employment status of the women who responded to the inquiry influence specific unmet information needs. Most frequently mentioned unmet information needs relate to supplementary naturopathy, nutrition, health-promoting measures, and working during breast cancer. Patients with breast cancer are often provided with large amounts of information during their hospital stay indicating this information is not targeted to patient needs and may be overwhelming. The results show that information on everyday life needs such as supplementary naturopathy were important for the sample newly diagnosed with breast cancer. Employed women in particular have questions regarding working during cancer or tax relief.

Meeting patients' health information needs in breast cancer center hospitals - a multilevel analysis.

BACKGROUND: Breast cancer patients are confronted with a serious diagnosis that requires them to make important decisions throughout the journey of the disease. For these decisions to be made it is critical that the patients be well informed. Previous studies have been consistent in their findings that breast cancer patients have a high need for information on a wide range of topics. This paper investigates (1) how many patients feel they have unmet information needs after initial surgery, (2) whether the proportion of patients with unmet information needs varies between hospitals where they were treated and (3) whether differences between the hospitals account for some of these variation. METHODS: Data from 5,024 newly-diagnosed breast cancer patients treated in 111 breast center hospitals in Germany were analyzed and combined with data on hospital characteristics. Multilevel linear regression models were calculated taking into account hospital characteristics and adjusting for patient case mix. RESULTS: Younger patients, those receiving mastectomy, having statutory health insurance, not living with a partner and having a foreign native language report higher unmet information needs. The data demonstrate small between-hospital variation in unmet information needs. In hospitals that provide patient-specific information material and that offer health fairs as well as those that are non-teaching or have lower patient-volume, patients are less likely to report unmet information needs. CONCLUSION: We found differences in proportions of patients with unmet information needs between hospitals and that hospitals' structure and process-related attributes of the hospitals were associated with these differences to some extent. Hospitals may contribute to reducing the patients' information needs by means that are not necessarily resource-intensive.