VersKiK: Study protocol of an observational registry-based study on the current state of follow-up care and adherence to follow-up guidelines after cancer in childhood or adolescence.

BACKGROUND: This article describes the study design of the quantitative part of the VersKiK study, The primary objectives of this study are to examine the occurrence of late effects in survivors of childhood or adolescent cancer (module 1), investigate health-related vulnerabilities and medical service utilization within this survivor group (modules 1 and 3), and assess the alignment between documented follow-up care for cardiological and audiological late effects with guideline recommendations, along with evaluating the extent of adherence among paediatric cancer survivors (module 3). METHODS: This is a non-interventional retrospective observational cohort study. It is based on stochastically linked insurance claims data from approximately 150,000 statutory insured persons with information concerning around 25,000-30,000 cancer survivors recorded in the German Childhood Cancer Register (GCCR). To explore adherence to selected follow-up guidelines, intention to treat treatment data from clinical study groups for particular diagnostic entities will be additionally included. DISCUSSION: The growing group of survivors after cancer in childhood and adolescence is representing a special population with an increasing demand for life-long healthcare services through relative high probability of late effects. Currently, there is a limited evidence in Germany on utilization of corresponding medical services and adherence to follow-up guidelines. With this study design, we are aiming to address these gaps and, consequently, suggest improvements to existing follow-up guidelines and follow-up care provision in Germany.

Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence (VersKiK): study protocol of a large scale multi-methods non-interventional study.

BACKGROUND: It has been shown previously that a relevant proportion of childhood cancer survivors suffers from late effects, which are often directly related to the cancer itself or its therapy, resulting in particular follow-up needs, additionally burdening healthcare systems. Being diagnosed with cancer at a vulnerable stage of development, this group of cancer survivors is at comparatively higher risk of relapse or subsequent cancer. Although national and international follow-up guidelines based on treatment modalities have been developed, their implementation seems to leave room for improvement. Additionally, they lack a sufficient consideration of the survivors' psychosocial needs, affecting their adherence to them. The aim of the VersKiK study is to provide representative information on late effects in childhood and adolescence cancer survivors in Germany. The main research objectives are: (1) to describe the state of follow-up care among survivors after a cancer diagnosis in childhood or adolescence; (2) to quantify the occurrence of late effects among this group of survivors; (3) to examine the adherence to selected audiological and cardiological follow-up guidelines and to identify factors affecting it; (4) to explore actual follow-up needs of paediatric cancer survivors; (5) to review selected follow-up guidelines with the aim to improve and expand them. METHODS: VersKiK is designed as a mixed-methods non-interventional study. We will use claims data from statutory health insurance companies in combination with individually linked population-based registry data from the German Childhood Cancer Registry (GCCR). This data base will permit us to quantify diagnoses and procedures in comparison to the general population as well as the adherence to existing follow-up guidelines. Additional information will be obtained through interviews with childhood and adolescence cancer survivors and their informal caregivers, as well as in focus groups with healthcare professionals. DISCUSSION: The present study aims to research the actual needs of individuals after cancer diagnosis and treatment in childhood or adolescence - physical, psychological and organisational - in order to improve existing follow-up guidelines. These improvements might further positively affect not only actual care provided to paediatric cancer survivors, but also benefit healthcare systems in general while decreasing consequent medical visits in this group of patients. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00025960 and DRKS00026092).

Initiation of lactation and the provision of human milk to preterm infants in German neonatal intensive care units from the mothers' perspective.

BACKGROUND: If infants with a very low birth weight (VLBW) are to be fed exclusively with human milk, it is essential to focus on lactation initiation. The aim of the study is to learn more about the current state of lactation initiation and human milk provision in neonatal intensive care units in Germany from the mothers' perspective. METHODS: Written surveys were conducted with mothers of VLBW infants to learn more about the timing of initiation of lactation, pumping frequency during the first three days postpartum and feeding of the preterm infant during hospitalisation. RESULTS: The data of 437 mothers (response rate: 44.7%) were included in the analyses. Of these, only 7.8% stated that they had initiated lactation immediately after delivery and 38.2% within 6 h. In terms of pumping frequency, 50.1% pumped 7-9 times a day within the first 3 days postpartum; 60.9% reported that their infant received formula feedings during the hospital stay. CONCLUSION: Overall, deficits were still evident with regard to the initiation of lactation in mothers of VLBW infants in Germany, resulting in a large proportion of VLBW infants receiving formula in the hospital. TRIAL REGISTRATION: German Clinical Trial Register: DRKS00017755 .

A Consensus German Reporting Standard for Secondary Data Analyses, Version 2 (STROSA-STandardisierte BerichtsROutine für SekundärdatenAnalysen).

Although secondary data analyses have been established in recent years in health research, explicit recommendations for standardized, transparent and complete reporting of secondary data analyses do not exist as yet. Therefore, between 2009 and 2014, a first proposal for a specific reporting standard for secondary data analysis was developed (STROSA 1). Parallel to this national process in Germany, an international reporting standard for routine data analysis was initiated in 2013 (RECORD). Nevertheless, because of the specific characteristics of the German health care system as well as specific data protection requirements, the need for a specific German reporting standard for secondary data analyses became evident. Therefore, STROSA was revised and tested by a task force of 15 experts from the working group Collection and Use of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) as well as from the working group Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF). The consensus STROSA-2 checklist includes 27 criteria, which should be met in the reporting of secondary data analysis from Germany. The criteria have been illustrated and clarified with specific explanations and examples of good practice. The STROSA reporting standard aims at stimulating a wider scientific discussion on the practicability and completeness of the checklist. After further discussions and possibly resulting modifications, STROSA shall be implemented as a reporting standard for secondary data analyses from Germany. This will guarantee standardized and complete information on secondary data analyses enabling assessment of their internal and external validity.

[Quality Assurance using routine data: Overdiagnosis by radiological imaging for back pain]. / Überdiagnostik mit Bildgebung bei Rückenschmerzen.

UNLABELLED: Background and Problem: Acute nonspecific back pain disorders are typically self-limiting. According to the national guideline low back pain, only in case of clinical suspicion of a serious course radiological imaging should take place immediately. Otherwise, the guideline recommends waiting at least six weeks. PATIENTS AND METHODOLOGY: Using Statutory Health Insurance (SHI) routine data of the Techniker Krankenkasse we analyzed how many of the insured persons suffering from acute back pain for the first time with no indication of a serious outcome received a non-indicated diagnostic imaging. RESULTS: In about 10 % diagnostic imaging is conducted after initial diagnosis. If an imaging is carried out, roughly one third of these cases takes place ahead of time or is completely unnecessary. Methodically this is a very conservative estimation, thus it seems likely that the extent of overdiagnosis in actual medical care situation is even larger. CONCLUSIONS: Every third patient who received radiological diagnostics due to first acute nonspecific back pain underwent the procedure more quickly than recommended (less than six weeks). Overdiagnosis is not only economically problematic but also with respect to patient orientation and patient safety. It may cause substantial damage to patients - either by the use of diagnostics itself or by means of therapies initiated after diagnostics.

[Brachytherapy for Prostate Cancer: Potentials and Limitations of Social Health Insurance Data for Benefit Assessment]. / Brachytherapie beim Prostata-Ca: Möglichkeiten und Limitationen von GKV-Routinedaten für eine Nutzenbewertung.

BACKGROUND: Due to the insufficient data base the Federal Joint Committee (G-BA) had in 2009 after 7 years of deliberation decided to initiate consultation regarding ambulatory brachytherapy for localised prostate cancer for 10 years from social health insurance (SHI) benefits. The aim is to gain more findings by means of comparative studies. PROBLEM: Based on the non-availability of clinical primary data of a methodologically acceptable level, it was analysed to what extent secondary data of the SHI may be used in order to arrive at valid conclusions for benefit aspects. METHODS: As base approx. 8 million insured of TK with their data of cost reimbursement between 2006 and 2011 were considered. In SHI secondary data no clinical information regarding tumour stage and other prognostic factors are available. Therefore, a novel method with therapy-specific multisectoral inclusion and exclusion criteria, respectively, was developed in order to differentiate between localised and advanced tumours of the prostate. Overall survival, relapse-free survival, event-free survival and side-effects associated to prostate cancer were analysed. RESULTS: Out of 87 822 insured persons with the diagnosis prostate cancer, 795 with PBT, 10 936 with RP and 1 925 with EBRT were investigated in detail. The 4-year event-free survival rate was 73% for RP, 77% for PBT and 71% for EBRT. Many prostate cancer-specific side effects appeared already before intervention. Side effects of the intestinal tract (23.8%) and sexual impairments (26.5%) were more frequent for EBRT than for RP (17.1%/14.8%) and PBT (16.4%/13.2%). CONCLUSION: By means of SHI secondary data and adequate operationalisation important findings regarding relevant aspects of prostate cancer in healthcare research can be generated. However, these hold methodological limitations and are not suited to draw valid conclusions for benefit assessment. Based solely on SHI routine data valid statements regarding comparative benefit assessment are limited. Limitations could be reduced by applying a record linkage with clinical data. Such primary data should include information on tumour stages as well as therapy assignment and observation of survival time.

[Disease management programs: Difficulties in the analysis of benefit]. / Disease-Management-Programme : Schwierigkeiten bei der Nutzenbewertung.

After an introduction to the theme with an overview of the implementation of the Disease Management Programs (DMP), accompanying documentation, present utilization and costs of the programs, the present article is primarily devoted to the issue of the analysis of the benefits of DMP. Following an assessment of the legally specified evaluation requirements, in the absence of a prospective, randomized, controlled trial (RCT), the results of three studies are first summarized, which, with the application of propensity score matching, utilize the routine data of the statutory health insurance schemes to form a control group. The overview concludes with a look at the planned changes in evaluation and the intended expansion of the DMP to programs for other chronic illnesses.

Evaluating methods for intersectoral comparison of quality of care. A routine data analysis of elective percutaneous coronary interventions.

OBJECTIVES: To compare the quality of care regarding the use of elective percutaneous coronary interventions (PCIs) in the inpatient and outpatient setting and to evaluate different methods of confounder control in this context. METHODS: Based on data of three statutory health insurances including more than nine million insurance members, a retrospective cohort study between 2005 and 2009 was conducted. The occurrence of myocardial infarction, stroke, further coronary intervention and death was ascertained following the first PCI in the study period, which was preceded by a one-year period without a PCI. A Cox proportional hazard model was used to assess the influence of the setting of the elective PCI on the risk for complications after the PCI for each outcome separately. Age, sex, the number of diseases of the Elixhauser comorbidity measure, past acute coronary syndrome, coronary artery disease, dyslipidemia, past stroke, past coronary artery bypass surgery and the year of the PCI were included as covariables. The analyses were repeated in a propensity score matched cohort as well as in inverse probability of treatment weighted analyses. RESULTS: The cohort comprised 4,269 patients with an outpatient PCI and 26,044 patients with an inpatient PCI. The majority of the analyses revealed no statistically significant effect of the setting of the PCI on the risk of myocardial infarction, stroke and further coronary interventions, whereas a reduced mortality risk was observed for outpatient PCIs. Similar results were obtained in the propensity score analyses. CONCLUSIONS: The analysis revealed that the adjusted risk for complications following an elective PCI is similar between the inpatient and the outpatient setting. For mortality the risk differed but this might be explained by residual or unmeasured confounding. The different methods applied in this study revealed mostly similar results. Since our study only covered one aspect of quality of care in the field of PCI and did not consider drug treatment in hospital or in the outpatient setting, further studies are needed which include these aspects.

[Disease management programs in Germany: Validity of the medical documentation]. / Validität der ärztlichen Dokumentation von Disease Management Programmen.

BACKGROUND AND AIM: The specific documentation for disease management programs (DMP) in Germany with respect to §â€Š137 Social Code Book V is the basis for evaluating the DMP. DMP run up costs of the order of a billion euro without assessing evidence-based benefit so far. Aim of this study was to question if and to which extent this documentation may be suitable for reliable quality assurance in its present form. METHODS: Data of nearly 300000 insured persons of a German Statutory Health Insurance (Techniker Krankenkasse, TK) which were continuously registered from July 1st 2009 until December 31st 2010 in a DMP were analyzed. We analyzed how items which were components of claims data and of DMP documentation were matched. RESULTS: With regard to prescriptions there were some considerable differences. Prescription of glibenclamid was documented twice as frequently in the DMP documentation compared to prescriptions filled in pharmacies. Only a fraction of emergency hospitalizations documented in the claims data were found in the DMP documentation. Investigations of the fundus oculi for diabetics are mentioned three times more frequently in the DMP documentation than they are accounted by ophthalmologists. CONCLUSION: There are considerable differences between claims data and DMP specific documentation. The latter shows a plainly reduced validity for investigated fields in the documentation forms. Reasons for this are manifold. Former evaluations of DM Ps carried out just on the basis of DMP documentation are thus highly questionable. Therefore, the DMPs themselves and their documentation have to be reformed.