German mammography screening program: program sensitivity between 2010 and 2016 estimated based on German health claims data.

BACKGROUND: Program sensitivity is a key quality indicator for mammography screening programs (MSP). Estimating program sensitivity usually requires a linkage of screening and cancer registry data. For the German MSP, such data linkage-based estimates have only been reported for two out of 16 federal states. We aimed to explore the potential of estimating program sensitivity for the German MSP based on information available in health claims data. METHODS: We used data from the second-largest statutory health insurance fund in Germany, BARMER (~ 9 million members all over Germany). We included women aged 50 to 69 years with a non-initial screening mammography between 2010 and 2016 and followed them up for two years. We estimated the rate of screen-detected and interval cancers as well as program sensitivity. RESULTS: Per year, we included 212,400 to 303,667 women (mean age: 60-61 years). Overall, 1,992,287 non-initial MSP screening examinations conducted in these women between 2010 and 2016 were considered for the analyses. Age-standardized program sensitivity ranged between 69.9% [95% CI: 67.3-72.0%] and 71.7% [95% CI: 69.5-73.9%] during the study period. Per 1,000 non-initial screening examinations, the rate of screen-detected breast cancer ranged between 4.6 and 5.3, and the rate of interval breast cancer rates ranged between 0.6 and 0.8 for the first and between 1.3 and 1.4 for the second year after screening. CONCLUSIONS: Our results were plausible and consistent with quality indicators estimated for the German MSP based on data linkage and thus support the value of German health claims data in this regard. The quality indicators estimated in our study are in line with levels expected according to European Guidelines.

[Home-care services in the first two waves of the COVID-19 pandemic: challenges for staff and care recipients]. / Ambulante Pflege in den ersten beiden Wellen der COVID-19-Pandemie: Herausforderungen für Personal und Pflegebedürftige.

INTRODUCTION: During the COVID-19 pandemic, people in need of long-term care were among the most vulnerable population groups. Home-care services were under exceptional strain, especially at the beginning of the pandemic. The aim of this study is to examine the situation and problems of care services and the people in need of care during the first two waves of the pandemic in Germany. METHODS: Two cross-sectional studies were conducted during the first two COVID-19 waves (first survey 28 April to 12 May 2020, second survey 12 January to 7 February 2021). In total, data from N = 1029 outpatient care services were included in the analysis. Descriptive measures were used for the analysis. RESULTS: The clients of home-care services were severely burdened in the first two waves of the pandemic. This can be seen on the one hand in an increased risk of illness and increased mortality, and on the other in the loss of various care and support services. The latter also has negative effects on the psychosocial condition of those in need of care, for example. Care services were affected by high staff absenteeism and additional work due to protective measures. DISCUSSION: The COVID-19 pandemic led to immense burdens for people in need of care and home-care services and to a reduction in care services. The deterioration of care provision met with an already tense situation. It has become clear that the provision of care for those in need of care by outpatient care services is not crisis-proof, and that additional challenges such as a pandemic can have dramatic consequences. For the future, reliable structures and readily available emergency plans should be established with concrete instructions for action.

[The situation of informal caregivers of working age in the COVID-19 pandemic-results of an online survey in Germany]. / Die Situation pflegender Angehöriger im erwerbsfähigen Alter in der COVID-19-Pandemie ­ Ergebnisse einer Onlinebefragung in Deutschland.

BACKGROUND: The consequences of the COVID-19 pandemic have posed major challenges to different groups. One of these are informal caregivers. This study investigates the changes the pandemic has caused for informal caregivers and the extent to which quality of life and burden of care have changed for specific subgroups. METHODS: Data for this cross-sectional study was gathered in the summer of 2020 in a convenient sample of informal caregivers (< 67 years of age, N = 1143). In addition to sociodemographic data, information on the care situation, compatibility of care and work, as well as stress and quality of life was collected in an online survey. The analysis of care situations and compatibility of care and work is done descriptively. Logistic regression models are used for a subgroup analysis of quality of life and care burden. RESULTS: The care situation has changed for 54.7% of participants and has become more time consuming. For 70.8% of respondents, the COVID-19 pandemic has made it even more difficult to balance care-giving and work. However, most respondents were satisfied with their employers' pandemic management (65.9%). A sharp decline in the quality of life and an increase in the burden of care for informal caregivers was ascertained. Both developments are stronger for young and female caregivers and for those caring for people with a greater need of support. DISCUSSION: The results indicate that living situations worsened for a substantial proportion of informal caregivers during the COVID-19 pandemic. Policymakers should recognize additional challenges that informal caregivers have faced since the outbreak of the COVID-19 pandemic and how they vary by subgroups. It is important to include home-based informal care as well as other care settings in future pandemic concepts.

Effectiveness of Mammography Screening on Breast Cancer Mortality - A Study Protocol for Emulation of Target Trials Using German Health Claims Data.

Background: The efficacy of mammography screening in reducing breast cancer mortality has been demonstrated in randomized trials. However, treatment options - and hence prognosis - for advanced tumor stages as well as mammography techniques have considerably improved since completion of these trials. Consequently, the effectiveness of mammography screening under current conditions is unclear and controversial. The German mammography screening program (MSP), an organized population-based screening program, was gradually introduced between 2005 and 2008 and achieved nation-wide coverage in 2009. Objective: We describe in detail a study protocol for investigating the effectiveness of the German MSP in reducing breast cancer mortality in women aged 50 to 69 years based on health claims data. Specifically, the proposed study aims at estimating per-protocol effects of several screening strategies on cumulative breast cancer mortality. The first analysis will be conducted once 10-year follow-up data are available. Methods and Analysis: We will use claims data from five statutory health insurance providers in Germany, covering approximately 37.6 million individuals. To estimate the effectiveness of the MSP, hypothetical target trials will be emulated across time, an approach that has been demonstrated to minimize design-related biases. Specifically, the primary contrast will be in terms of the cumulative breast cancer mortality comparing the screening strategies of "never screen" versus "regular screening as intended by the MSP". Ethics and Dissemination: In Germany, the utilization of data from health insurances for scientific research is regulated by the Code of Social Law. All involved health insurance providers as well as the responsible authorities approved the use of the health claims data for this study. The Ethics Committee of the University of Bremen determined that studies based on claims data are exempt from institutional review. The findings of the proposed study will be published in peer-reviewed journals.

Initial and ten-year treatment patterns among 11,000 breast cancer patients undergoing breast surgery-an analysis of German claims data.

BACKGROUND: We aimed to explore the potential of German claims data for describing initial and long-term treatment patterns of breast cancer patients undergoing surgery. METHODS: Using the German Pharmacoepidemiological Research Database (GePaRD, ~ 20% of the German population) we included patients with invasive breast cancer diagnosed in 2008 undergoing breast surgery and followed them until 2017. We described initial and long-term treatment patterns and deaths. Analyses were stratified by stage (as far as available in claims data), age at diagnosis, and mode of detection (screen-detected vs. interval vs. unscreened cases). RESULTS: The cohort comprised 10,802 patients. The proportion with neoadjuvant therapy was highest in patients < 50 years (19% vs. ≤ 8% at older ages). The proportion initiating adjuvant chemotherapy within four months after diagnosis decreased with age (< 50 years: 63%, 50-69: 46%, 70-79: 27%, 80 + : 4%). Among women < 69 years, ~ 30% had two breast surgeries in year one (70-79: 21%, 80 + : 14%). Treatment intensity was lower for screen-detected compared to interval or unscreened cases, both in year one (e.g., proportion with mastectomy ~ 50% lower) and within 2-10 years after surgery (proportions with radiotherapy or chemotherapy about one third lower each). CONCLUSIONS: This study illustrates the potential of routine data to describe breast cancer treatment and provided important insights into differences in initial and long-term treatment by mode of detection and age.

Social Health among German Nursing Home Residents with Dementia during the COVID-19 Pandemic, and the Role of Technology to Promote Social Participation.

The COVID-19 pandemic severely impacted the social health of nursing home residents with dementia due to social isolation. Consequently, the frequency of Behavioral and Psychological Symptoms in Dementia (BPSD) might increase. Technological solutions might help safeguard the social health of nursing home residents with dementia. This study investigates the impacts of the COVID-19 pandemic on clinical outcomes and the availability of social activities and technology to promote social participation in nursing home residents with dementia. The study analyzed cross-sectional data from a follow-up questionnaire nested in a larger national survey of care facilities in Germany. A mixed-methods approach integrated statistical analyses of closed-ended responses and thematic analysis of free-text responses. A total of 417 valid individual responses were received, showing an overall increase in observed BPSD-with anxiety and depression most frequently occurring. Many nursing homes canceled all social activities for residents with dementia, though a few had established procedures to facilitate social participation using technology. Requirements to promote social participation in this population using technology were identified at the micro-, meso-, and macro levels. Technology requirements permeated all three levels. During and beyond the COVID-19 pandemic, technology-driven solutions to promote social health among nursing home residents with dementia should be integrated into caregiving procedures.

COVID-19 in German Nursing Homes: The Impact of Facilities' Structures on the Morbidity and Mortality of Residents-An Analysis of Two Cross-Sectional Surveys.

The COVID-19 pandemic constitutes an exceptional risk to people living and working in nursing homes (NHs). There were numerous cases and deaths among NH residents, especially at the beginning of the pandemic when no vaccines had yet been developed. Besides regional differences, individual NHs showed vast differences in the number of cases and deaths: while in some, nobody was affected, in others, many people were infected or died. We examine the relationship between facility structures and their effect on infections and deaths of NH residents and infections of staff, while considering the influence of COVID-19 prevalence among the general population on the incidence of infection in NHs. Two nationwide German surveys were conducted during the first and second pandemic waves, comprising responses from n = 1067 NHs. Different hurdle models, with an assumed Bernoulli distribution for zero density and a negative binomial distribution for the count density, were fitted. It can be shown that the probability of an outbreak, and the number of cases/deaths among residents and staff, increased with an increasing number of staff and the general spread of the virus. Therefore, reverse isolation of NH residents was an inadequate form of protection, especially at the beginning of the pandemic.

Safety and Suitability of the SmartPill® after Abdominal Surgery: Results of the Prospective, Two-Armed, Open-Label PIDuSA Trial.

INTRODUCTION: Postoperative ileus (POI) is a common complication after abdominal surgery. Until today, an evidence-based treatment of prolonged POI is still lacking, which can be attributed to the poor quality of clinical trials. Various different surrogate markers used to define POI severity are considered to be the cause of low-quality trials making it impossible to derive treatment recommendation. The SmartPill®, which is able to record pH values, temperature and pressure after ingestion, could be an ideal tool to measure transit times and peristalsis and therefore analyze POI severity. Unfortunately, the device has no approval for postoperative use due to safety concerns. The primary objective of the study is to determine safety of the SmartPill® in patients undergoing surgery. Secondary objectives were the quality of the recorded data and the suitability of the SmartPill® for analyzing intestinal motility after different surgical procedures. METHODS: The PIDuSA Study is a prospective, 2-arm, open-label trial. At the end of surgery, the SmartPill® was applied to 49 patients undergoing abdominal surgery having a high risk for impaired intestinal motility and 15 patients undergoing extra-abdominal surgery. Patients were visited daily to access safety data of the SmartPill® on the basis of adverse and serious adverse events (AEs/SAEs). Suitability and data quality were investigated by analyzing data completeness and feasibility to determine transit times and peristalsis for all sections of the gastrointestinal tract. RESULTS: In total, 179 AEs and 8 SAEs were recorded throughout the study affecting 42 patients in the abdominal (158 AEs) and 9 patients in the extra-abdominal surgery group (21 AEs, p = 0.061); none of them were device related. Primary capsule failure was observed in 5 patients, ultimately resulting in an impossibility of data analysis in only 3 patients (4.4%). 9% of the recorded data were incomplete due to the patient's incompliance in keeping the receiver close to the body. In 3 patients (4.4%), isolated small bowel transit could not be determined due to pH alterations as a result of prolonged POI. DISCUSSION: Our study demonstrates that the use of the SmartPill® is safe after surgery but requires a reasonable patient compliance to deliver meaningful data. An objective analysis of transit times and peristalsis was possible irrespective of type and site of surgery in over 95% indicating that the SmartPill® has the potential to deliver objective parameters for POI severity in future clinical trials. However, in some patients with prolonged POI, analysis of small bowel transit could be challenging.

[Needs of long-term nursing in the COVID-19 pandemic]. / Bedarfe der Langzeitpflege in der COVID-19-Pandemie.

The SARS-CoV­2 virus and the associated disease COVID-19 pose major challenges to healthcare systems worldwide. Especially the vulnerable group of people in need of long-term care is at risk of suffering a severe course of the disease or of dying from the infection.In a nationwide cross-sectional study the situation and needs of inpatient and outpatient long-term care facilities during the SARS-CoV­2 pandemic were assessed and analyzed using an online survey.Participants from 531 institutions postulated the need for uniform recommendations for action on SARS-CoV­2, adequate and affordable protective and hygiene materials, serial tests in the institutions, well-founded advice on the implementation of interventions, a specific pandemic plan and supporting public relations work by the media. This calls for higher nursing remuneration, better staffing levels and greater appreciation of the nursing profession.In order to protect the vulnerable group of people in need of nursing care from a SARS-CoV­2 infection, long-term care must be given a stronger focus in health policy measures during the pandemic.

Pflege in Zeiten von Corona: Zentrale Ergebnisse einer deutschlandweiten Querschnittsbefragung vollstationärer Pflegeheime.

Long-term care during the Corona pandemic - Main results from a nationwide online survey in nursing homes in Germany Abstract. Background: As a highly vulnerable group, people in need of long-term care are particularly affected by the COVID-19 pandemic. Due to their care-dependency, measures of social distancing can only be carried out to a very limited extent. In addition, the social and health consequences of reduced contacts are particularly high for nursing home residents. AIM: The study aims to describe the extent to which nursing homes are affected, the human and material resources of nursing homes, the organizational handling of the situation, and their requests for public support. METHODS: More than 7,000 nursing homes were invited to participate in an online survey with quantitative and qualitative elements. Data analysis applies descriptive statistics. RESULTS: 824 nursing homes participated in the survey. One in five nursing homes has at least one confirmed case of SARS-CoV-2 among its residents and / or employees. The initial lack of protective equipment has now decreased, but the facilities still have to cope with additional corona-related care needs with reduced staff. Nursing homes have banned contacts between residents and relative to an extent that now has to be reduced again. Nursing homes demand the provision and external financing of protective equipment as well as the systematic and regular testing of nursing staff and the provision of uniform guidelines for action throughout Germany. CONCLUSIONS: As about half of all deceased people with COVID-19 have been living in nursing homes, the support of nursing homes in their attempt to restrict the pandemic requires highest attention.

Pflege in Zeiten von Corona: Ergebnisse einer deutschlandweiten Querschnittbefragung von ambulanten Pflegediensten und teilstationären Einrichtungen.

Care in times of Corona: Results of a cross-sectional study in German home care services Abstract. Background: People in need of care are particularly affected by the COVID-19 pandemic due to their age and previous illnesses. At the same time, a large number of daily contacts between nursing staff and those in need of care increase the risk of transmission of the disease. AIM: The study aims to illustrate (I) to what extent home care services and semi-residential care facilities are affected by COVID-19, (II) human and material resources, (III) the care situation of those in need of care and (IV) the organizational handling of the situation and outline support requests to politicians. METHODS: More than 12,000 home-care nursing services and semi-residential care facilities were invited to participate in an online survey with quantitative and qualitative elements, 701 nursing services (response rate 7,3 %) and 96 semi-residential facilities (response rate 3,5 %) took part. RESULTS: Almost a third (30,1 %, 189 / 627) of the nursing services surveyed are affected by confirmed or suspected cases of COVID-19 among clients. About half of the services report a reduced use of SGB V (47,6 %, 288 / 605) or SGB XI services (59,7 %, 375 / 628). Two thirds of the semi-residential facilities (65,6 %, 63 / 96) say they are currently closed due to the pandemic. Likewise, half of the nursing services (45,8 %, 253 / 552) reported that care with reduced use of services was at risk / unstable or even not ensured. CONCLUSIONS: The results show that the situation of care-dependent people served by home-care services in the present pandemic - and also with a view to a possible second wave - should receive increased attention particularly with regard to unstable / risky care arrangements.

Differences in medical specialist utilization among older people in need of long-term care - results from German health claims data.

BACKGROUND: Elderly in need of long-term care tend to have worse health and have higher need of medical care than elderly without need for long-term care. Yet, characteristics associated with long-term care need can impede health care access: Higher levels of long-term care need come with physical and cognitive decline such as frailty and memory loss. Yet, it has not been investigated whether level of long-term care need is related to medical care utilization. METHODS: We investigated the association between the level of long-term care and medical specialist utilization among nursing home residents and home care recipients. We applied zero-inflated Poisson regression with robust standard errors based on a sample of statutory health insurance members. The sample consisted of 100.000 elderly over age 60. We controlled for age, gender, morbidity and mortality, residential density, and general practitioner utilization. RESULTS: We found a strong gradient effect of the level of long-term care for 9 out of 12 medical specialties: A higher level of long-term care need was associated with a lower probability of having a medical specialist visit. Yet, we did not find clear effects of the level of long-term care need on the intensity of medical specialist care. These findings were similar for both the nursing home and home care setting. CONCLUSION: The findings indicate that inequalities in medical specialist utilization exist between elderly with differing levels of long-term care need because differences in morbidity were controlled for. Elderly with higher need of long-term care might face more access barriers to specialist medical care.

Linkage of Routine Data to Other Data Sources in Germany: A Practical Example Illustrating Challenges and Solutions.

Routine data have a high potential for epidemiological and health care research but lack information, for instance, on the cause of death. Often detailed information, such as on lifestyle factors is also missing. In Germany, obtaining the missing information by linkage to data sources is challenging, mainly due to strict data protection regulations. One key challenge arises from the fact that routine data users usually have no access to person identifiers which would be necessary for record linkage. A second key challenge is that sensitive information (i. e., the cause of death) should not be transferred to an institution that holds person identifiers. In this paper, we illustrate these key challenges and present corresponding solutions based on a practical example where claims data from statutory health insurance providers are linked to an epidemiological cancer registry to obtain cause of death information. We describe the approval procedures necessary for the record linkage, the dataflow between the involved institutions and explain the rationale of the dataflow in view of the key challenges. Finally, we generalize the questions that need to be addressed when a record linkage is planned and point to additional potential challenges. Overall, we illustrate that a linkage between routine data and other data sources in Germany is feasible, but specific restrictions and hurdles need to be taken into consideration.

Needs-based provision of medical care to nursing home residents: protocol for a mixed-methods study.

INTRODUCTION: Nursing home residents typically have greater needs for medical care than community-dwelling elderly. However, restricted cognitive abilities and limited mobility may impede their access to general practitioners and medical specialists. The provision of medical care in nursing homes may therefore be inappropriate in some areas of medical care. The purpose of this mixed-methods study is to systematically assess, evaluate and explain met and unmet medical care needs in German nursing homes and to develop solutions where medical care is found to be inappropriate. METHODS AND ANALYSIS: First, statutory health insurance claims data are analysed to identify differences in the utilisation of medical care between nursing home residents and community-dwelling elderly with and without need for long-term care. Second, the health status and medical care of 500 nursing home residents are assessed and evaluated to quantify met and unmet medical care needs. Third, qualitative expert interviews and case conferences and, fourth, quantitative analyses of linked data are used to provide structural, case-specific and generalisable explanations of inappropriate medical care among nursing home residents. Fifth, a modified Delphi study is employed to develop pilot projects aiming to improve medical care in nursing homes. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the University of Bremen on 23 November 2017. Research findings are disseminated through presentations at national and international conferences and publications in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: DRKS00012383.

A cohort study of mammography screening finds that comorbidity measures are insufficient for controlling selection bias.

OBJECTIVE: To examine the potential of claims-based comorbidity measures for controlling selection bias in observational studies of mammography screening. STUDY DESIGN AND SETTING: Based on claims data of a large German Statutory Health Insurance fund, the single comorbidities considered by the Charlson, Elixhauser, Multipurpose Australian Comorbidity Scoring System, and M3 comorbidity measures were identified for mammography screening participants and nonparticipants. Total death rates within 4 years after screening invitation were compared. Cox proportional hazards regressions were performed unadjusted and adjusted for age, federal state of residence, and comorbidity. RESULTS: Among 1,247,919 insured women aged 50-68 years (56.2% participants), 10,311 participants (death rate 375.8/100,000 person-years) and 18,113 nonparticipants (death rate 854.8/100,000 person-years) died from any cause during the follow-up. The unadjusted hazard ratio (HR) for death from any cause for participants vs. nonparticipants was 0.44 (99.9% confidence interval 0.42-0.46). Adjustments attenuated the HR to a maximum of 0.52 (0.50-0.54). CONCLUSION: The lower short-term all-cause mortality among participants cannot be explained by mammography screening effects and should be interpreted as selection bias. Adjusting for comorbidities only slightly attenuated this bias. Future studies should examine whether claims data include further information that is beneficial to adequately control selection bias in observational studies of mammography screening.

Discrepancies Between Planned and Actual Operating Room Turnaround Times at a Large Rural Hospital in Germany.

OBJECTIVES: While several factors have been shown to influence operating room (OR) turnaround times, few comparisons of planned and actual OR turnaround times have been performed. This study aimed to compare planned and actual OR turnaround times at a large rural hospital in Northern Germany. METHODS: This retrospective study examined the OR turnaround data of 875 elective surgery cases scheduled at the Marienhospital, Vechta, Germany, between July and October 2014. The frequency distributions of planned and actual OR turnaround times were compared and correlations between turnaround times and various factors were established, including the time of day of the procedure, patient age and the planned duration of the surgery. RESULTS: There was a significant difference between mean planned and actual OR turnaround times (0.32 versus 0.64 hours; P <0.001). In addition, significant correlations were noted between actual OR turnaround times and the time of day of the surgery, patient age, actual duration of the procedure and staffing changes affecting the surgeon or the medical specialty of the surgery (P <0.001 each). The quotient of actual/planned OR turnaround times ranged from 1.733-3.000. CONCLUSION: Significant discrepancies between planned and actual OR turnaround times were noted during the study period. Such findings may be potentially used in future studies to establish a tool to improve OR planning, measure OR management performance and enable benchmarking.

Introduction of a method for quantitative evaluation of spontaneous motor activity development with age in infants.

Coordination between perception and action is required to interact with the environment successfully. This is already trained by very young infants who perform spontaneous movements to learn how their body interacts with the environment. The strategies used by the infants for this purpose change with age. Therefore, very early progresses in action control made by the infants can be investigated by monitoring the development of spontaneous motor activity. In this paper, an objective method is introduced, which allows the quantitative evaluation of the development of spontaneous motor activity in newborns. The introduced methodology is based on the acquisition of spontaneous movement trajectories of the feet by 3D movement analysis and subsequent calculation of specific movement parameters from them. With these movement-based parameters, it was possible to provide an objective description of age-dependent developmental steps in healthy newborns younger than 6 months. Furthermore, it has been shown that pathologies like infantile cerebral palsy influence development of motor activity significantly. Since the introduced methodology is objective and quantitative, it is suitable to monitor how newborns train their cognitive processes, which will enable them to cope with their environment by motor interaction.

Movement analysis by accelerometry of newborns and infants for the early detection of movement disorders due to infantile cerebral palsy.

So far, developed diagnostic strategies for the early detection of movement disorders due to infantile cerebral palsy (ICP) in newborns are not easily applicable in clinical settings. They are either difficult to acquire or they are too expensive to be established in pediatric clinics and are not sufficiently usable to be integrated into daily routine. The aim of this study therefore was to develop a methodology that allows the objective diagnosis of developing movement disorders in newborns due to ICP. It should be applicable to pediatric offices and should easily integrate in daily routine. To achieve this, a simple to use and low-cost system based on accelerometers was developed to evaluate the newborn's movement. Afterward, a classificator based on a decision tree algorithm was implemented to differentiate between healthy and pathological data in order to propose the most likely diagnosis. The developed methodology was validated in a clinical study with 19 healthy and 4 affected subjects that were evaluated at the first, third and fifths month after birth (corrected age). The overall detection rate of the developed methodology reached between 88 and 92% for all evaluated measurements. The developed methodology is simple to use, therefore is applicable for the objective diagnosis of developing movement disorders in newborns due to ICP and can be established in pediatric offices for use in daily routine.