Development and Update of Guideline-based Quality Indicators in Lung Cancer.

BACKGROUND: In 2022, an update of the German lung cancer guideline, first published in 2010 and revised in 2018, was released. This article aims to show the process of updating, developing, and implementing guideline-based quality indicators (QI) into the certification system for lung cancer centers (LCC). METHODS: A multidisciplinary and interprofessional working group revised the guideline QIs from 2018 using the strong recommendations of the guideline update, a systematic review for QIs, and the results of the implemented QIs from LCC. RESULTS: For 4 out of 8 indicators from the 2018 guideline, the LCC showed an improved implementation of the requirements in the last 3 years (2018-2020). For 3 indicators, the median of the results was constant at a very high level (≥96% or 100%). Only the "adjuvant cisplatin-based chemotherapy" indicator showed declining values between 2018 and 2020. The target values and plausibility limits were well achieved by LCC. After updating the guideline, one QI from 2018 was not included in the new QI set due to the small denominator population. Based on the new strong recommendations, 8 new QIs were defined. From the QI set of the guideline update, 13 of 15 indicators (7 since 2018 and 6 from 2022 on) were adopted into the certification program. CONCLUSIONS: The guideline recommendations are implemented by LCC at a high level. The process presented confirms the successful implementation of the so-called quality cycle in oncology. The QIs developed by the German Guideline Program in Oncology (GGPO) are adopted by the certification program. The implementation of the QI is measured in LCC, evaluated by the German Cancer Society (DKG), and reflected back to the GGPO. The "real world" data have led to the deletion of one QI and show a high implementation of most QIs in LCC.

[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.

[Further Development and Interoperability in Oncological Care Structures, Quality Control and Research]. / Weiterentwicklung und Vernetzung der onkologischen Versorgungsstrukturen, der Qualitätssicherung und der Forschung.

How can we improve the interoperability of medical guidelines and the implementation and measurement of outcomes in medical health care for cancer patients as well as for care providers? This is the aim of the working group "Quality and Cross-linking". The following publication gives an overview of the targets reached in the development of guidelines together with quality indicators and documentation in cancer registries.

Variation across operating sites in urinary and sexual outcomes after radical prostatectomy in localized and locally advanced prostate cancer.

PURPOSE: The extent of variation in urinary and sexual functional outcomes after radical prostatectomy (RPE) between prostate cancer (PC) operating sites remains unknown. Therefore, this analysis aims to compare casemix-adjusted functional outcomes (EPIC-26 scores incontinence, irritative/obstructive function and sexual function) between operating sites 12 months after RPE. MATERIALS AND METHODS: Analysis of a cohort of 7065 men treated with RPE at 88 operating sites (prostate cancer centers, "PCCs") between 2016 and 2019. Patients completed EPIC-26 and sociodemographic information surveys at baseline and 12 months after RPE. Survey data were linked to clinical data. EPIC-26 domain scores at 12 months after RPE were adjusted for relevant confounders (including baseline domain score, clinical and sociodemographic information) using regression analysis. Differences between sites were described using minimal important differences (MIDs) and interquartile ranges (IQR). The effects of casemix adjustment on the score results were described using Cohen's d and MIDs. RESULTS: Adjusted domain scores at 12 months varied between sites, with IQRs of 66-78 (incontinence), 89-92 (irritative/obstructive function), and 20-29 (sexual function). Changes in domain scores after casemix adjustment for sites ≥ 1 MID were noted for the incontinence domain (six sites). Cohen's d ranged between - 0.07 (incontinence) and - 0.2 (sexual function), indicating a small to medium effect of casemix adjustment. CONCLUSIONS: Variation between sites was greatest in the incontinence and sexual function domains for RPE patients. Future research will need to identify the factors contributing to this variation. TRIAL REGISTRY: The study is registered at the German Clinical Trial Registry ( https://www.drks.de/drks_web/ ) with the following ID: DRKS00010774.

Incorporating psychosocial care into routine oncological care: Insights into challenges and strategies from certified cancer centers' audit data.

PURPOSE: Provision of psychosocial care is obligatory in cancer centers certified in accordance with the criteria of the German Cancer Society, but the extent to which it is utilized differs greatly between centers. Anomalous utilization percentages are discussed during certification audits. This analysis aims to describe (1) how certified centers explain psychosocial care utilization percentages during audits and (2) the measures they then plan for improving psychosocial care utilization. The aim of the analysis is to help understand patterns of psychosocial care utilization in oncology and reduce potential disparities by describing the challenges that cancer centers face and their strategies for integrating psychosocial care into routine oncological care. METHODS: The content of free-text comments regarding psychosocial utilization percentages by certified centers during certification audits in 2019 was analyzed. In total, 178 comments were analyzed from 116 prostate, colorectal, and breast cancer centers in Germany, Switzerland, Austria, Italy, and Luxembourg. RESULTS: The explanations for utilization percentages most often mentioned involved patients' levels of interest and need, outpatient care, staff shortages, inclusion of psychosocial care in other processes in the center, documentation issues, and factors regarding different legal regulations in countries outside Germany. The measures most often planned for improving psychosocial care utilization involved adjusting work processes, increasing staff resources, optimizing documentation, and establishing quality-assurance groups/task forces. CONCLUSION: This exploratory analysis shows that the challenges and strategies involved in incorporating psychosocial care into routine oncological care are diverse. Further research should identify process-level strategies that can promote the integration of psychosocial care.

Predictors for the utilization of social service counseling by prostate cancer patients.

PURPOSE: Social service counseling (SSC) is an important instrument to support cancer patients, for example, regarding legal support, or rehabilitation. Several countries have established on-site SSC in routine care. Previous analyses have shown that SSC utilization varies across cancer centers. This analysis investigates patient and center-level predictors that explain variations in SSC utilization between centers. METHODS: Logistic multilevel analysis was performed with data from 19,865 prostate cancer patients from 102 prostate cancer centers in Germany and Switzerland. Data was collected within an observational study between July 2016 and June 2020 using survey (online and paper) and tumor documentation. RESULTS: The intraclass correlation coefficient for the null model implies that 51% of variance in SSC utilization is attributable to the center a patient is treated in. Patients aged 80 years and older, with higher education, private insurance, without comorbidities, localized intermediate risk, and undergoing androgen deprivation therapy before study inclusion were less likely to utilize SSC. Undergoing primary radiotherapy, active surveillance, or watchful waiting as compared to prostatectomy was associated with a lower likelihood of SSC utilization. Significant negative predictors at the center level were university hospital, center's location in Switzerland, and a short period of certification. CONCLUSION: The results show that patient and center characteristics contribute to explaining the variance in SSC utilization in prostate cancer centers to a large extent. The findings may indicate different organizational processes in the countries included and barriers in the sectoral structure of the healthcare system. In-depth analyses of processes within cancer centers may provide further insights into the reasons for variance in SSC utilization.

Guideline-Based Quality Indicators for Kidney and Bladder Cancer in Germany: Development and Implementation.

INTRODUCTION: As part of the development of the evidence-based (S3) clinical practice guidelines for kidney and bladder cancer by the German Guideline Program in Oncology, quality indicators (QIs) were defined to measure the quality of care. Based on these guidelines and QIs, the German Cancer Society (DKG) developed two new certification systems. The aim of this article is to show the process of development and implementation of QIs in certified cancer centres. METHODS: Based on strong recommendations of each guideline and an additional systematic literature review for national and international QIs, two sets of QIs were derived in a multistep standardized approach. These QIs were implemented in the centres in certification data sheets to measure their outcomes. First results of treatment years 2018 and 2019 are available. RESULTS: The final sets include 9 QIs for kidney cancer and 12 QIs for bladder cancer. Two-thirds of the QIs were transferred to the data sheets. In 2018 and 2019, the results of all but one QI are within the plausibility limits. From 2020 on, they are replaced by stricter target values that will challenge centres to improve their outcomes. CONCLUSIONS: Guideline-derived QIs make relevant aspects of patient care measurable and consequently improvable. The first QI results are encouraging. However, the DKG certification system and the methods of measuring quality are under ongoing development. Systematic QI implementation and evaluation may help to generate broader databases and thus expand knowledge.

[Heidelberg Milestones Communication (HeiMeKOM) - Experiences, Best Practice Examples and Recommendations from the Final Symposium on January 30 and 31 in 2020]. / Heidelberger Meilenstein Kommunikation (HeiMeKOM) ­ Erfahrungen, Best Practice Beispiele und Empfehlungen aus dem Abschluss-Symposium am 30./31. Januar 2020.

The National Cancer Plan emphasises the importance of medical communication and calls for its integration into medical education and training. In this context, the Milestone Communication Approach meets the communicative challenges in dealing with lung cancer patients. Interprofessional tandems, consisting of doctors and nurses, conduct structured conversations at defined moments with patients and their relatives. The concept aims at shared decision making, continuity in the care of lung cancer patients and the early integration of palliative care. During the symposium on the Heidelberg Milestone Communication in January 2020, recommendations on the care situation of lung cancer patients in advanced stages were developed. In addition, the further adaptability of HeiMeKOM to other settings and hospitals and to other diseases was discussed as well as the possibility of implementing such a concept in standard care. This article presents the experiences, best practice examples and recommendations discussed during the symposium in order to enable their extrapolation to other similarly oriented projects. The long-term goal is to transfer the milestone concept to other hospital, primarily certified lung cancer centers, and to ensure permanent funding. For further dissemination of the concept and, above all, to have it established in standard care, health policy awareness and support are required in addition to the integration of the concept in competence catalogues of continuing medical and nursing education.

The Prostate Cancer Outcomes (PCO) study in prostate cancer centres certified by the German Cancer Society.

Since 2016, certified prostate cancer centres have been able to participate in the Prostate Cancer Outcomes (PCO) study. The aim of this study is to compare outcomes across centres after local treatment for prostate cancer. The study originated from a support group initiative and is jointly carried out by the German Cancer Society (Deutsche Krebsgesellschaft), the certification institute OnkoZert, patient support groups and the participating centres. So far, centres have been more successful at recruiting patients undergoing surgery than those receiving radiotherapy as the definitive treatment. This means that conclusions for the latter group of patients are almost impossible. It is important to us that all types of treatment are equally well represented in the study; thus, we encourage radiation therapists to participate in the PCO study.

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.

Implementing quality metrics in European Cancer Centers (ECCs).

PURPOSE: Since 2014, prostate cancer centers outside Germany (PCCoG) are eligible for certification according to the criteria set out by the German Cancer Society (DKG). These centers must fulfill the same requirements as their German counterparts. The article reports on the experiences of the first nine certified PCCoG, with a focus on their indicator results. METHOD: Following a descriptive analysis about primary case distribution, indicator definitions, and patient numbers, we compared indicator results for all 114 German PCC with all 9 PCCoG that have been certified for at least 3 years. Median centers' proportion was calculated and overall proportion for every indicator. Two-sided Cochran-Armitage tests were applied to detect trends over time. RESULTS: The number of primary cases increased for both groups steadily from 2015 to 2017 as did fulfillment of most other indicators including PCa guideline-derived indicators. Requirements that proved to be hard to fulfill for PCCoG initially included psycho-oncological services (POS) and social service counselling (SCC). Fulfillment of POS requirements improved in the following years after initial certification in PCCoG. SCC rates remain low in PCCoG due to the different health system structures. CONCLUSION: Acquiring a certificate by the DKG is achievable for PCCoG. Candidate centers need to be aware that substantial effort is required to fulfill the criteria, but once this is done, typically an improvement of indicators and an increase in patient numbers can be observed. Different health-care systems need to be taken into consideration and the certification requirements adapted in different areas to allow country-specific implementation.

Determinants of self-reported functional status (EPIC-26) in prostate cancer patients prior to treatment.

PURPOSE: The self-reported functional status (sr-FS) of prostate cancer (PCa) patients varies substantially between patients and health-care providers before treatment. Information about this issue is important for evaluating comparisons between health-care providers and to assist in treatment decision-making. There have been few reports on correlates of pretherapeutic sr-FS. The objective of the article, therefore, is to describe clinical and sociodemographic correlates of pretherapeutic sr-FS, based on a subset of the TrueNTH Global Registry, a prospective cohort study. METHODS: A total of 3094 PCa patients receiving local treatment in 44 PCa centers in Germany were recruited between July 2016 and April 2018. Multilevel regression models were applied to predict five pretherapeutic sr-FS (EPIC-26) scores based on clinical characteristics (standard set suggested by the International Consortium for Health Outcomes Measurement), sociodemographic characteristics, and center characteristics. RESULTS: Impaired pretherapeutic sr-FS tended to be associated with lower educational level and poorer disease characteristics-except for "urinary incontinence" which was only associated with age. Notably, age was a risk factor ("urinary incontinence," "urinary irritative/obstructive," "sexual") as well as a protective factor ("hormonal") for pretherapeutic sr-FS. Pretherapeutic sr-FS varies little across centers. CONCLUSIONS: Pretherapeutic sr-FS varies by clinical patient characteristics and age as well as by socioeconomic status. The findings point out the benefit of collecting and considering socioeconomic information in addition to clinical and demographic patient characteristics for treatment decision-making and fair comparisons between health-care providers.

Psychometric validation of the German version of the EPIC-26 questionnaire for patients with localized and locally advanced prostate cancer.

PURPOSE: For patients with prostate cancer, validated and reliable instruments are essential for measuring patient-reported outcomes. The aim of this study was to validate the German version of the widely established Expanded Prostate Cancer Index Composite with 26 items (EPIC-26). METHODS: A German translation of the original questionnaire was tested in 3094 patients with localized or locally advanced (any T, any N and M0) prostate cancer with treatment intent (including radical prostatectomy, brachytherapy, active surveillance, watchful waiting). They completed the EPIC-26 questionnaire before treatment. A total of 521 of them also completed a questionnaire 12 months afterward. Internal consistency, sensitivity to change, and construct validity were assessed. RESULTS: The internal consistency of all domains was sufficient (Cronbach's alpha between 0.64 and 0.93). Item-to-scale correlation coefficients showed acceptable associations between items and their domain score (all > 0.30), with the lowest scores for "bloody stools" (r = 0.37) and "breast problems" (r = 0.32). Confirmatory and exploratory factor analysis confirmed the five-dimension structure of the EPIC-26 (comparative fit index 0.95). CONCLUSIONS: Psychometric evaluation suggests that the German version of the EPIC-26 is a well-constructed instrument for measuring patient-reported health-related symptoms in patients with prostate cancer.

Clinicians' knowledge and attitudes towards patient reported outcomes in colorectal cancer care - insights from qualitative interviews.

INTRODUCTION: Patient-reported outcomes (PROs) can be used in cancer care to monitor patients' disease-related symptoms and functional status. However, successful implementation of such instruments is only possible if clinical staff are convinced of the clinical benefits. It is therefore crucial to investigate the attitudes of clinical staff to PROs in routine cancer care. METHODS: Semi-structured, guideline-based interviews were held with 12 clinicians working in certified colorectal cancer centers in Germany who are taking part in an observational study on PROs (five surgeons, two oncologists, one psycho-oncologist, two oncological care nurses, one stoma therapist, and one physician assistant) in order to investigate firstly, how clinicians describe PRO instruments ("wording"); and secondly, the clinicians' general attitude toward PROs. A qualitative content analysis according to Kuckartz was performed. RESULTS: The wording used to describe PROs was not consistent. Statements on attitudes toward PROs were very heterogeneous and were therefore categorized into "(rather) positive" and "(rather) negative." The principal advantages of PROs mentioned by participants included broader, structured knowledge about patients and treatment, as well as relevance for patients. Subcategories for (rather) negative attitudes included statements expressing doubts about the questionnaires and "no need for PROs." DISCUSSION: The clinicians participating mainly expressed fairly positive attitudes toward PROs. However, they had little knowledge about PROs in general and the interviews therefore mainly reflect their expectations and assumptions about them. These initial impressions may be regarded as providing a basis for future implementation strategies and for training of clinicians on how to use PROs in routine cancer care.

Could existing infrastructure for using patient-reported outcomes as quality measures also be used for individual care in patients with colorectal cancer?

BACKGROUND: There has been increasing interest in integrating patient-reported outcomes (PROs) into routine oncological practice. To date, however, PROs have rarely been implemented in Germany. Currently, PROs are being used as performance measures in colorectal cancer centers in Germany. This content analysis identified factors that may inhibit or facilitate the additional use of PROMs for individual patient management. METHODS: The analysis follows an exploratory approach. Out of 103 centers that participated in a multicentric PRO quality management and benchmarking program in Germany, twelve oncological health-care providers from eight certified colorectal cancer centers were interviewed using a semi-structured interview guide. The interviewees were clinicians (physicians, nurses, psycho-oncologist and physician assistant) who care for colorectal cancer patients. This analysis evaluated whether and how PROs that are primarily collected for quality management/benchmarking reasons could also be used for the management of individual patients. The data was analyzed using a content-analysis approach. RESULTS: The interviewees were not using PRO in their routine clinical work, but they recognized its added value and pointed out potential example uses. Identified inhibiting factors for the use of PROs in clinical routine work were effortful access to PRO reports, lacking coordinating structures, time delays and time points of measurements as well as redundancy with other instruments. Facilitating factors for the use of PROs in clinical routine work that were identified included access via electronic patient records, implementation of coordinating structures for PRO processes in the center, clear PRO reports that are easy to interpret, and measurements at relevant time points. DISCUSSION: Clinicians had quite a positive attitude toward PROs and recognized their added value. Inhibiting and facilitating factors of an organizational and technical nature were identified. CONCLUSIONS: These findings indicate how PROs used for quality management purposes may also be used for the management of individual patients. Therefore, existing structures and processes in the certified colorectal cancer centers, as well as lessons learned from the literature on the implementation of PROs monitoring individual patients need to be taken into account.

[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.

[Evaluation of Quality Indicators of Evidence-Based Guidelines Using ADT/GEKID Base Dataset and its Organ-Specific Modules]. / Berechenbarkeit der Qualitätsindikatoren der onkologischen S3-Leitlinien mit dem ADT-/GEKID-Basisdatensatz und seiner Zusatzmodule.

AIM: According to the Cancer Screening and Registers Act (KFRG, §65c SGB V), clinical cancer registration in Germany has to be based on the consistent set of variables developed by the "Association of German Tumor Centers" (ADT) and "Association of Population-based Cancer Registries in Germany" (GEKID) to improve oncological care. Quality indicators in evidence-based guidelines are measures to assess the quality of treatment and outcome in clinical care. The aim of this study was to find out the extent to which it is possible to determine these quality indicators using the ADT/GEKID's set of variables and the organ-specific modules. METHODS: After screening all available evidence-based guidelines for inclusion and exclusion criteria to calculate quality indicators, we evaluated for each indicator whether it can be computed using a single variable or a combination of variables of the ADT/GEKID's base variables set and the organ-specific modules. RESULTS: A total of 151 quality indicators were defined in 17 available evidence-based guidelines. Of these, 82 (54%) quality indicators could be determined with the variables of the base dataset. The highest proportion of calculable quality indicators was 100% for pancreatic cancer, which, however, was the only entity where all indicators were calculable. The least proportion of quality indicators was calculable for cancer of the oral cavity (10%). CONCLUSIONS: This analysis shows considerable differences in the possibility to evaluate the quality indicators defined in S3-guidelines for different tumor entities based on the variables documented in the clinical cancer registries throughout Germany. The ADT/GEKID core variables set should be extended with additional modules, for instance, for colorectal cancer, to allow a complete documentation of all criteria needed for the determination of clinical quality indicators as suggested in the pertinent evidence-based guidelines.

[Manual for Methods and Use of Routine Practice Data for Knowledge Generation]. / Manual für Methoden und Nutzung versorgungsnaher Daten zur Wissensgenerierung.

" There are more and more good reasons for using existing care data, with the focus in particular on the use of register data. The associated, clearly structured methodological procedure has so far been insufficiently combined, prepared and presented transparently. The German Network for Health Services Research (DNVF) has therefore set up an ad hoc commission for the use of routine practice data (RWE/RWD). The rapid report prepared by IQWiG on the scientific development of concepts for "generation of care-related data and their evaluation for the purpose of benefit assessment of medicinal products according to § 35a SGB V" is an essential step for the use of register data for the generation of evidence. The "Memorandum Register - Update 2019" published by DNVF 2020 also describes the requirements and methodological foundations of registers. Best practice examples from oncology, which are based on the uniform oncological basic data set for clinical cancer registration (§ 65c SGB V), show, for example, that guidelines can be checked and recommendations for guidelines and necessary interventions can be derived in the sense of knowledge-generating health services research using register data. At the same time, however, there are no clear quality requirements and structured formal and content-related procedures in the areas of data consolidation, data verification and the use of specific methods depending on the question at hand. The previously inconsistent requirements are to be revised and a method guide for the use of suited data is to be developed and published. The first chapter of the manual on methods of care-related data explains the objective and structure of the manual. It explains why the use of the term "routine practice data" is more effective than the use of the terms Real Word Data (RWD) and Real World Evidence (RWE). By avoiding the term "real world" it should be emphasized in particular that high-quality research can also be based on routine practice data (e. g. register-based comparative studies).

Quality assurance in melanoma care: guideline-based quality indicators for melanoma - implementation, evaluation and update process.

BACKGROUND: In 2018, an update of the German evidence-based (S3) guidelines "Diagnosis, Therapy and Follow-up of Melanoma" first issued in 2013 was published under the auspices of the German Guideline Program in Oncology. The update also included a revision of existing guideline-based quality indicators (QIs). PATIENTS AND METHODS: Using a standardized multi-step process, the guideline-derived QIs were revised by a multidisciplinary, interprofessional working group based on the strong (level A) recommendations contained in the guideline update as well as on a systematic literature search for international indicators and on the outcomes of existing QIs as reported by certified German skin cancer centers. RESULTS: Based on the original set of twelve guideline-based QIs agreed upon in 2013, the working group developed an updated set containing nine indicators. Four QIs were kept unchanged; two were modified; two were removed; and three new QIs were added. Unlike 2013, the working group was now able to incorporate the outcomes of QIs previously implemented at the various skin cancer centers. CONCLUSIONS: Close cooperation between guideline group and certification commission allows for the implementation of guideline-based QIs in cancer care. Measured outcomes form the basis for updating both the guidelines and the QI development process. They provide information about the care of cancer patients in a real-world setting as well as on guideline adherence and the feasibility of QIs themselves. This is a dynamic process that can be described in a transparent manner and that requires regular updating.

Benchmarking of a checklist for the identification of familial risk for breast and ovarian cancers in a prospective cohort.

The detection of deleterious germline mutations in BRCA1 and BRCA2 considerably influences the clinical management of healthy and diseased carriers. Therefore, the identification of persons at risk who could uptake genetic counseling and testing is pivotal. We developed a checklist with validated criteria to improve the identification, and prospectively evaluate the incidence, of familial cancer history in 5091 breast cancer patients. The rate of 30.4% of patients at high genetic risk underpins the demand for care in risk identification and counseling. The easy-to-use instrument promotes the implementation and dissemination of risk counseling by physicians.