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 .

Digital pen technology for conducting cognitive assessments: a cross-over study with older adults.

Many digitalized cognitive assessments exist to increase reliability, standardization, and objectivity. Particularly in older adults, the performance of digitized cognitive assessments can lead to poorer test results if they are unfamiliar with the computer, mouse, keyboard, or touch screen. In a cross-over design study, 40 older adults (age M = 74.4 ± 4.1 years) conducted the Trail Making Test A and B with a digital pen (digital pen tests, DPT) and a regular pencil (pencil tests, PT) to identify differences in performance. Furthermore, the tests conducted with a digital pen were analyzed manually (manual results, MR) and electronically (electronic results, ER) by an automized system algorithm to determine the possibilities of digital pen evaluation. ICC(2,k) showed a good level of agreement for TMT A (ICC(2,k) = 0.668) and TMT B (ICC(2,k) = 0.734) between PT and DPT. When comparing MR and ER, ICC(2,k) showed an excellent level of agreement in TMT A (ICC(2,k) = 0.999) and TMT B (ICC(2,k) = 0.994). The frequency of pen lifting correlates significantly with the execution time in TMT A (r = 0.372, p = 0.030) and TMT B (r = 0.567, p < 0.001). A digital pen can be used to perform the Trail Making Test, as it has been shown that there is no difference in the results due to the type of pen used. With a digital pen, the advantages of digitized testing can be used without having to accept the disadvantages.

Economic evaluations of system-based obesity interventions - the case for a new approach.

System-based interventions are of increasing interest as they seek to modify environments (e.g. socio-cultural system, transport system or policy system) that promote development of conditions such as obesity and its related risk factors. In our commentary, we draw attention to features of the system-based approach that may explain the relative absence of economic evaluations of the cost-effectiveness of these interventions, needed to guide decision-making on which to deploy. We present and discuss potentially applicable methods and alternative approaches based on our experiences in two major system-based interventions currently underway (in Melbourne, Australia and Gaggenau, Germany) that begin to fill this gap. We feel the issues and potential solutions outlined in this commentary are important for a broad range of stakeholders (e.g. clinicians, interventionalists, policy makers) to consider as they seek to address the issue of obesity.

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.

Representative survey on the reprocessing of endodontic instruments in Germany.

Aim The aim of the study was to review the implementation of hygiene guidelines for the reprocessing of endodontic files in a representative survey and to determine the time needed for the procedure.Methods A questionnaire with nine items was sent to 4,000 German dentists. In addition to obtaining personal information, it asked for the total time required for the reprocessing of instruments and contained specific questions about the cleaning procedure in order to assess whether the requirements of the German Federal Ministry of Health, as defined by the Robert Koch Institute, were complied with. Approval by the Ethics Committee was obtained. The data were analysed statistically using the Chi-square test and Cramer's V as a measurement of effect size.Results The response rate was 29.4% (n = 1,177/4,000). On 59 questionnaires, answers to several questions were missing; 1,118 questionnaires (28.0%) could be included in the evaluation. With effect sizes between 0.12 and 0.21, the survey could be classified as statistically representative of German dentists in terms of age and gender. The guidelines were adhered to by 31.7% (n = 354/1118) of respondents, while 68.3% (n = 764/1118) adhered to them either not fully, or not at all (P < 0.001). There were no significant differences in adherence to guidelines between younger (up to 44 years) and older (45 years and above) dentists (P = 0.31) or between women and men (P = 0.194). The reported time for cleaning a patient-related instrument set was more than nine minutes for 68.1% of respondents, not including the time needed for sterilisation; 5% of respondents treated files as single-use instruments.Conclusions The guidelines of the German Federal Ministry of Health for cleaning, disinfecting and sterilising endodontic files are widely disregarded in Germany. The designation and use of endodontic files as single-use instruments should be considered.

[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.

Association Strength of Three Adiposity Measures with Autonomic Nervous System Function in Apparently Healthy Employees.

OBJECTIVES: To investigate the association of different measures of central (abdominal) and overall adiposity with autonomic nervous system (ANS) function, indexed by heart rate variability (HRV), in apparently healthy human adults. DESIGN AND MEASUREMENTS: Cross-sectional data of 8,538 participants (20% female, age: 41 ± 11 years, body mass index (BMI): 24 ± 4 kg/m2, waist circumference (WC): 91 ± 12 cm, waist-to-height ratio (WHtR): 0.45 ± 0.08) were available for analysis. RESULTS: All measures of adiposity were inversely correlated with vagally-mediated HRV indexed by RMSSD (all p<0.001). Strongest associations were found with WC and RMSSD (r = -0.29). Associations were stronger in males (WC r = -0.32) than in females (WC r = -0.23). Partial correlations revealed the same pattern for RMSSD (WC all pcc = -0.12 p<0.001; WC male pcc = -0.14 p<0.001; WC female pcc = -0.06 p<0.05). Correlation strength of BMI and WHtR with RMSSD were similar and significantly weaker compared to WC (p < .001) in unadjusted analysis. Overall, nonparametric Kendall's τb led to the same conclusions. CONCLUSION: The present data supports previous findings, that HRV is related to measures of adiposity in healthy individuals. In line with previous research, we found that WC is more strongly related to measures of HRV, indicating that WC best captures adiposity related risk.

Metabolic profiles during an oral glucose tolerance test in pregnant women with and without gestational diabetes.

BACKGROUND/AIM: Gestational diabetes (GDM) is a complex metabolic condition associated with hyperpglycemia that is diagnosed in an oral glucose tolerance test (OGTT) during pregnancy. For a deeper understanding of the pathology of the disease, further investigations during pregnancy are required, ideally under metabolic challenging conditions. METHODS: We performed targeted metabolomics in a group of 24 well-matched women during an oral glucose tolerance test (OGTT). 231 plasma metabolites were profiled and compared to conventional clinical diagnostics. RESULTS: A pattern of 8 metabolites differed between GDM and healthy controls as early as 30 min in an OGTT (AUC 0.977±0.008), and an increase in acylcarnitine C18:0, decreased concentrations of diacyl phosphatidylcholines (PC aa) C34:4, PC aa C36:4, PC aa C38:5, Lyso PC C20:4 and arachidonic acid were associated with insulin resistance. CONCLUSION: Our data suggest an additional value of metabolite pattern in the diagnosis of GDM and describe altered pathways that might be subjected to a more precise diagnosis and individualized therapy.

[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.

Estimating the lifetime cost of childhood obesity in Germany: Results of a Markov Model.

BACKGROUND: Child obesity is a growing public health concern. Excess weight in childhood is known to be associated with a high risk of obesity and obesity-related comorbidities in adulthood. OBJECTIVES: This study quantifies lifetime excess costs of overweight and obese adults in Germany taking the history of obesity in childhood into account. METHODS: A two-stage Markov cohort state transition model was developed. At stage 1, the distribution of body mass index (BMI) categories was tracked from childhood (ages 3-17) to adulthood (age 17 and up). Based on these results, it was distinguished whether adults had been normal in weight or overweight/obese as child. At stage 2, age-specific and lifetime costs from age 18 onwards were simulated in two further Markov cohort models, one for each of the two BMI groups. Model parameter values were obtained from the German Interview and Examination Survey for Children and Adolescents (KiGGS), the German Microcensus 2009 and published literature. RESULTS: When compared with normal weight adults, lifetime excess costs are higher among adults who had been overweight or obese at any point during childhood. For 18-year-old women (men), who have been overweight/obese during their childhood (ages 3-17), undiscounted lifetime excess costs are estimated at €19,479 (€14,524), with 60% (67%) occurring beyond age 60. Discounted (3%) lifetime excess costs are considerably lower, amounting to €4262 for men and €7028 for women. CONCLUSIONS: Because childhood obesity determines healthcare costs occurring in adulthood, interventions preventing the persistence of child obesity and obesity-related comorbidities during adulthood could have a substantial impact on reducing the burden of the obesity epidemic.

Experimental amine-epoxide sealer: a physicochemical study in comparison with AH Plus and EasySeal.

AIM: To compare selected physicochemical and biological properties of an experimental sealer with those of two commercially available sealers. METHODOLOGY: AH Plus and EasySeal were used as model materials for commercially available amine-epoxide sealers. They were mixed as stated by the manufacturer. The two components of experimental sealer EvoSeal A were mixed 1 : 1 vol%. The setting time was determined in two different ways: first, by setting of sealers in a temperature- and moisture-controlled environment followed by testing with a Gilmore needle and secondly, by oscillating measurements of setting behaviour using a rheometer. Differential scanning calorimetry (DSC) of the sealer was performed for comparison of thermal properties. Flow and film thickness were determined by applying pressures of 100 g and 15.3 kg, respectively, on the materials between two glass plates and measuring the diameters of the compressed sealer and the thickness with a micrometer gauge. Solubility of set materials was conducted by layering the samples with water, storing in a temperature- and humidity-controlled environment and evaporating the solvent. The solved sealer parts were then weighed. The radiopacity was measured in an X-ray experiment comparing radiopacity of a cured sealer to an aluminium step wedge. Volume shrinkage was defined by measuring the densities of samples before and after setting. The film thickness, fluidity, curing time, radiopacity and solubility of the test materials were performed as specified in DIN EN ISO 6876:2010 draft. The volume shrinkage was determined in a method adapted from standard DIN 13907:2007-01. Antibacterial activity was tested against Gram-positive Streptococcus oralis cultures in a contact test based on standard ISO 22196:2011 (E). Statistical analysis was performed using Mann-Whitney U-test where applicable. Significant differences were determined with P < 0.05. RESULTS: The experimental sealer, EvoSeal A, reached standard specifications. In terms of film thickness, the highest value was measured for EvoSeal A with a film thickness of 27 µm, comparing to 6 µm for EasySeal (P ≤ 0.001) and 8 µm for AH Plus (P ≤ 0.001). Comparing the flow, all values corresponded to EasySeal with a diameter of 17.3 mm. The only significant difference was determined for AH Plus compared to EvoSeal A (P = 0.0353). Volume shrinkage of EvoSeal A was 48% smaller compared to EasySeal and approximately 20% lower compared to AH Plus. The shortest curing time was determined for EvoSeal A (3.0 h) followed by EasySeal (4.1 h) and AH Plus (24 h). For all groups, significant differences were observed (P ≤ 0.001). EvoSeal A had a significantly higher radiopacity than EasySeal (P ≤ 0.001) but significantly lower values than AH Plus (P ≤ 0.001). The solubility of AH Plus and EvoSeal A was <0.5% (P = 0.2435). Compared to EasySeal with a solubility of 2.7%, significant differences were observed (P ≤ 0.02). Three weeks after setting, EasySeal and EvoSeal A still had an antibacterial effect against S. oralis in contrast to AH Plus. In this respect, comparing AH Plus with EvoSeal A and EasySeal, respectively, significant differences were observed (P ≤ 0.001). No significant differences between EasySeal with EvoSeal A (P = 0.540) were determined. CONCLUSIONS: The physical and chemical properties of the experimental sealer EvoSeal A were comparable to the two commercially established sealers EasySeal and AH Plus.

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.