Utilization and quality of palliative care in patients with hematological and solid cancers: a population-based study.

BACKGROUND: Palliative care (PC) contributes to improved end-of-life care for patients with hematologic malignancies (HM) and solid tumors (ST) by addressing physical and psychological symptoms and spiritual needs. Research on PC in HM vs. ST patients is fragmented and suggests less use. METHODS: We analyzed claims data of all deceased members of a large German health insurance provider for the year before death. First, we analyzed the frequency and the beginning of different types of PC and compared patients with HM vs. ST. Second, we analyzed the adjusted impact of PC use on several end-of-life quality outcomes in patients with HM vs. ST. We performed simple and multiple (logistic) regression analysis, adjusted for relevant covariates, and standardized for age and sex. RESULTS: Of the 222,493 deceased cancer patients from 2016 to 2020, we included 209,321 in the first analysis and 165,020 in the second analysis. Patients with HM vs. ST received PC less often (40.4 vs. 55.6%) and later (34 vs. 50 days before death). PC use significantly improved all six quality indicators for good end-of-life care. HM patients had worse rates in five of the six indicators compared with ST patients. Interaction terms revealed that patients with ST derived greater benefit from PC in five of six quality indicators than those with HM. CONCLUSION: The data highlight the need to integrate PC more often, earlier, and more effectively into the care of patients with HM.

Understanding health care pathways of patients with sepsis: protocol of a mixed-methods analysis of health care utilization, experiences, and needs of patients with and after sepsis.

BACKGROUND: Sepsis is associated with about 20% of deaths worldwide. It often presents with non-specific initial symptoms, making its emergency treatment an interdisciplinary and cross-sectoral challenge. Three in four sepsis survivors suffers from new cognitive, psychological, or physical sequelae for which specific treatment concepts are scarce. The AVENIR project aims to improve the understanding of patient pathways, and subjective care experiences and needs along the entire healthcare pathway before, with and after sepsis. Based on this, concrete recommendations for the organization of care and patient information materials will be developed with close patient participation. METHODS: Mixed-methods study including (1) analysis of anonymized nationwide health claims data from Germany, (2) linkage of health claims data with patient care reports (PCR) of emergency medical services from study regions in two federal states within Germany, and (3) qualitative exploration of the patient, relative, and care provider perspective on sepsis care. In (1), we analyze inpatient and outpatient health care utilization until 30 days pre-sepsis; clinical sepsis care including intra- and inter-hospital transfers; and rehabilitation, inpatient and outpatient aftercare of sepsis survivors as well as costs for health care utilization until 24 months post-sepsis. We attempt to identify survivor classes with similar health care utilization by Latent Class Analyses. In (2), PCR are linked with health claims data to establish a comprehensive database outlining care pathways for sepsis patients from pre-hospital to follow-up. We investigate e.g., whether correct initial assessment is associated with acute (e.g., same-day lethality) and long-term (e.g., new need for care, long-term mortality) outcomes of patients. We compare the performance of sepsis-specific screening tools such as qSOFA, NEWS-2 or PRESEP in the pre-clinical setting. In (3), semi-structured interviews as well as synchronous and asynchronous online focus groups are conducted and analyzed using qualitative content analyses techniques. DISCUSSION: The results of the AVENIR study will contribute to a deeper understanding of sepsis care pathways in Germany. They may serve as a base for improvements and innovations in sepsis care, that in the long-term can contribute to reduce the personal, medical, and societal burden of sepsis and its sepsis sequelae. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00031302, date of registration: 5th May 2023).

[A regional comparison of outcomes quality and costs of general and specialized palliative care in Germany: a claims data analysis]. / Ergebnisqualität und Kosten der allgemeinen und spezialisierten Palliativversorgung in Deutschland im regionalen Vergleich: eine GKV-Routinedatenstudie.

BACKGROUND: The main framework conditions for palliative care are set at the regional level. The scope of the forms of care used (outpatient, inpatient, general, specialized) varies widely. What is the quality of outcomes achieved by the palliative care provided on a federal states level? What are the associated costs of care? METHOD: Retrospective observational study using BARMER claims data from 145,372 individuals who died between 2016 and 2019 and had palliative care in the last year of life. Regional comparison with regard to the following outcomes: proportion of palliative care patients who died in the hospital, potentially burdensome care in the last 30 days of life (ambulance calls, [intensive care] hospitalizations, chemotherapy, feeding tubes, parenteral nutrition), total cost of care (last three months), cost of palliative care (last year), and cost-effectiveness ratios. Calculation of patient/resident characteristic adjusted rates, costs, and ratios. RESULTS: Federal states vary significantly with respect to the outcomes (also adjusted) of palliative care. Palliative care costs vary widely, most strongly for specialized outpatient palliative care (SAPV). Across all indicators and the cost-effectiveness ratio of total cost of care to at-home deaths, Westphalia-Lippe shows favorable results. CONCLUSION: Regions with better quality and more favorable cost (ratios) can provide guidance for other regions. The extent to which the new federal SAPV agreement can incorporate the empirical findings should be reviewed. Patient-relevant outcome parameters should be given greater weight than parameters aiming at structures of care.

Return to work after sepsis-a German population-based health claims study.

Background: Long-term impairments after sepsis can impede the return to work in survivors. We aimed to describe rates of return to work 6 and 12 months postsepsis. Methods: This retrospective, population-based cohort study was based on health claims data of the German AOK health insurance of 23.0 million beneficiaries. We included 12-months survivors after hospital-treated sepsis in 2013/2014, who were ≤60 years at the time of the admission and were working in the year presepsis. We assessed the prevalence of return to work (RTW), persistent inability to work and early retirement. Results: Among 7,370 working age sepsis survivors, 69.2% returned to work at 6 months postsepsis, while 22.8% were on sick leave and 8.0% retired early. At 12 months postsepsis, the RTW rate increased to 76.9%, whereas 9.8% were still on sick leave and 13.3% retired early. Survivors who returned to work had a mean of 70 (SD 93) sick leave days in the 12 months presepsis (median 28 days, IQR 108 days). Conclusion: One out of four working age sepsis survivors does not resume work in the year postsepsis. Specific rehabilitation and targeted aftercare may be opportunities to reduce barriers to RTW after sepsis.

[General practitioners' palliative care activities in Westphalia-Lippe compared to other federal states - Secondary analysis of a survey]. / Hausärztliche Palliativversorgung in Westfalen-Lippe im Vergleich mit anderen Bundesländern ­ sekundäre Auswertung einer Befragungsstudie.

INTRODUCTION: In palliative home care frictional loss at the interface between primary palliative care (PPC) and specialised palliative home care (SPHC) is repeatedly pointed out. PPC and SPHC appear to be insufficiently interlinked. The model implemented in Westphalia-Lippe differs from others in Germany: it relies on close cooperation between general practitioners (GPs) and palliative consultancy services (PCS), an early start of the palliative care process and comprehensive/widespread collaboration. We hypothesize that the framework conditions applying in Westphalia-Lippe have positive effects on the uptake of palliative care activities by GPs. The objective of this study therefore is to compare GPs' attitudes and their willingness to provide palliative care between GPs in Westphalia-Lippe and GPs in other federal states/Associations of Statutory Health Insurance Physicians (ASHIPs) in order to empirically test our hypothesis. METHODS: Secondary evaluation of a nationwide paper-based survey from 2018 for national data acquisition of GPs' palliative care activities at the interface of SPHC. Answers of the participating GPs from Westphalia-Lippe (n=119) are contrasted with the answers of the GPs from seven other federal states (n=1,025). RESULTS: GPs from Westphalia-Lippe have a consistently higher self-perception of being responsible for palliative care of their patients, more often take responsibility for palliative care activities and feel more confident in carrying them out. GPs from Westphalia-Lippe are more likely to know other palliative care facilities/actors and they find them to be more likely available for GPs. They rate the quality of the overall palliative infrastructure higher. For GPs from Westphalia-Lippe the involvement of PCS/SPHC providers is less important than for GPs from other regional ASHIPs. If they are involved in the palliative treatment of a patient, GPs from Westphalia-Lippe feel more frequently involved in the course of treatment. DISCUSSION: Our study indicates that the special framework conditions for palliative care provided by GPs in Westphalia-Lippe have positive effects on their uptake of palliative care activities. An essential factor could be the PPC- and SPHC-integrated approach to palliative care in Westphalia-Lippe. CONCLUSION: Westphalia-Lippe may provide orientation for other regions regarding the involvement of GPs at the interface to specialized palliative care. Whether the type of palliative home care in Westphalia-Lippe also produces advantages in terms of quality and costs of care compared to the rest of Germany is something that needs to be investigated in the future.

[Utilization of palliative care at the end of life in Germany: temporal trend (2016-2019) and regional variability]. / Inanspruchnahme von Palliativversorgung am Lebensende in Deutschland: zeitlicher Verlauf (2016­2019) und regionale Variabilität.

BACKGROUND: In Germany, palliative care (PC) is provided on a homecare, inpatient, general, and specialized basis. Since little is currently known about the temporal course and regional differences in the forms of care, the present study was aimed to investigate this. METHOD: In a retrospective routine data study with 417,405 BARMER-insured persons who died between 2016 and 2019, we determined the utilization rates of primary PC (PPC), specially qualified and coordinated palliative homecare (PPC+), specialized palliative homecare (SPHC), inpatient PC, and hospice care on the basis of services billed at least once in the last year of life. We calculated time trends and regional variability and controlled for needs-related patient characteristics and access-related county of community characteristics. RESULTS: From 2016 to 2019, total PC increased from 33.8 to 36.2%, SPHC from 13.3 to 16.0% (max: Rhineland-Palatinate), and inpatient PC from 8.9 to 9.9% (max: Thuringia). PPC decreased from 25.8 to 23.9% (min: Brandenburg) and PPC+ came in at 4.4% (max: Saarland) in 2019. Hospice care remained constant at 3.4%. Regional variability in utilization rates remained high, increased for PPC and inpatient PC from 2016 to 2019, and decreased for SPHC and hospice care. The regional differences were also evident after adjustment. CONCLUSION: Increasingly more SPHC, less PPC, and high regional variability, which cannot be explained by demand- or access-related characteristics, indicate that the use of PC forms is oriented less to demand than to regionally available care capacities. In view of the growing need for palliative care due to demographic factors and decreasing personnel resources, this development must be viewed critically.

The Effects of Postacute Rehabilitation on Mortality, Chronic Care Dependency, Health Care Use, and Costs in Sepsis Survivors.

Rationale: Sepsis often leads to long-term functional deficits and increased mortality in survivors. Postacute rehabilitation can decrease long-term sepsis mortality, but its impact on nursing care dependency, health care use, and costs is insufficiently understood. Objectives: To assess the short-term (7-12 months postdischarge) and long-term (13-36 months postdischarge) effect of inpatient rehabilitation within 6 months after hospitalization on mortality, nursing care dependency, health care use, and costs. Methods: An observational cohort study used health claims data from the health insurer AOK (Allgemeine Ortskrankenkasse). Among 23.0 million AOK beneficiaries, adult beneficiaries hospitalized with sepsis in 2013-2014 were identified by explicit codes from the International Classification of Diseases, Tenth Revision. The study included patients who were nonemployed presepsis, for whom rehabilitation is reimbursed by the AOK and thus included in the dataset, and who survived at least 6 months postdischarge. The effect of rehabilitation was estimated by statistical comparisons of patients with rehabilitation (treatment group) and those without (reference group). Possible differential effects were investigated for the subgroup of ICU-treated sepsis survivors. The study used inverse probability of treatment weighting based on propensity scores to adjust for differences in relevant covariates. Costs for rehabilitation in the 6 months postsepsis were not included in the cost analysis. Results: Among 41,918 6-month sepsis survivors, 17.2% (n = 7,224) received rehabilitation. There was no significant difference in short-term survival between survivors with and without rehabilitation. Long-term survival rates were significantly higher in the rehabilitation group (90.4% vs. 88.7%; odds ratio [OR] = 1.2; 95% confidence interval [95% CI] = 1.1-1.3; P = 0.003). Survivors with rehabilitation had a higher mean number of hospital readmissions (7-12 months after sepsis: 0.82 vs. 0.76; P = 0.014) and were more frequently dependent on nursing care (7-12 months after sepsis: 47.8% vs. 42.3%; OR = 1.2; 95% CI = 1.2-1.3; P < 0.001; 13-36 months after sepsis: 52.5% vs. 47.5%; OR = 1.2; 95% CI = 1.1-1.3; P < 0.001) compared with those without rehabilitation, whereas total health care costs at 7-36 months after sepsis did not differ between groups. ICU-treated sepsis patients with rehabilitation had higher short- and long-term survival rates (short-term: 93.5% vs. 90.9%; OR = 1.5; 95% CI = 1.2-1.7; P < 0.001; long-term: 89.1% vs. 86.3%; OR = 1.3; 95% CI = 1.1-1.5; P < 0.001) than ICU-treated sepsis patients without rehabilitation. Conclusions: Rehabilitation within the first 6 months after ICU- and non-ICU-treated sepsis is associated with increased long-term survival within 3 years after sepsis without added total health care costs. Future work should aim to confirm and explain these exploratory findings.

[White Paper - Improving the care of patients with impairments following sepsis and infections]. / White Paper ­ Verbesserung der Versorgungs- und Behandlungsangebote für Menschen mit Sepsis- und Infektionsfolgen.

Hundreds of thousands of individuals who experience lasting sequelae after sepsis and infections in Germany do not receive optimal care. In this White Paper we present measures for improvement, which were developed by a multidisciplinary expect panel as part of the SEPFROK project. Improved care rests on four pillars: 1. cross-sectoral assessment of sequelae and a structured discharge and transition management, 2. interdisciplinary rehabilitation and aftercare with structural support, 3. strengthening the specific health literacy of patients and families, and 4. increased research into causes, prevention and treatment of sequelae. To achieve this, appropriate cross-sectoral care structures and legal frameworks must be created.

Epidemiology and Costs of Postsepsis Morbidity, Nursing Care Dependency, and Mortality in Germany, 2013 to 2017.

Importance: Sepsis survivorship is associated with postsepsis morbidity, but epidemiological data from population-based cohorts are lacking. Objective: To quantify the frequency and co-occurrence of new diagnoses consistent with postsepsis morbidity and mortality as well as new nursing care dependency and total health care costs after sepsis. Design, Setting, and Participants: This retrospective cohort study based on nationwide health claims data included a population-based cohort of 23.0 million beneficiaries of a large German health insurance provider. Patients aged 15 years and older with incident hospital-treated sepsis in 2013 to 2014 were included. Data were analyzed from January 2009 to December 2017. Exposures: Sepsis, identified by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) hospital discharge codes. Main Outcomes and Measures: New medical, psychological, and cognitive diagnoses; long-term mortality; dependency on nursing care; and overall health care costs in survivors at 1 to 12, 13 to 24, and 25 to 36 months after hospital discharge. Results: Among 23.0 million eligible individuals, we identified 159 684 patients hospitalized with sepsis in 2013 to 2014. The mean (SD) age was 73.8 (12.8) years, and 75 809 (47.5%; 95% CI, 47.2%-47.7%) were female patients. In-hospital mortality was 27.0% (43 177 patients; 95% CI, 26.8%-27.3%). Among 116 507 hospital survivors, 86 578 (74.3%; 95% CI, 74.1%-74.6%) had a new diagnosis in the first year post sepsis; 28 405 (24.4%; 95% CI, 24.1%-24.6%) had diagnoses co-occurring in medical, psychological, or cognitive domains; and 23 572 of 74 878 survivors (31.5%; 95% CI, 31.1%-31.8%) without prior nursing care dependency were newly dependent on nursing care. In total, 35 765 survivors (30.7%; 95% CI, 30.4%-31.0%) died within the first year. In the second and third year, 53 089 (65.8%; 95% CI, 65.4%-66.1%) and 40 959 (59.4%; 95% CI, 59.0%-59.8%) had new diagnoses, respectively. Health care costs for sepsis hospital survivors for 3 years post sepsis totaled a mean of €29 088/patient ($32 868/patient) (SD, €44 195 [$49 938]). New postsepsis morbidity (>1 new diagnosis) was more common in survivors of severe sepsis (75.6% [95% CI, 75.1%-76.0%]) than nonsevere sepsis (73.7% [95% CI, 73.4%-74.0%]; P < .001) and more common in survivors treated in the intensive care unit (78.3% [95% CI, 77.8%-78.7%]) than in those not treated in the intensive care unit (72.8% [95% CI, 72.5%-73.1%]; P < .001). Postsepsis morbidity was 68.5% (95% CI, 67.5%-69.5%) among survivors without prior morbidity and 56.1% (95% CI, 54.2%-57.9%) in survivors younger than 40 years. Conclusions and Relevance: In this study, new medical, psychological, and cognitive diagnoses consistent with postsepsis morbidity were common after sepsis, including among patients with less severe sepsis, no prior diagnoses, and younger age. This calls for more efforts to elucidate the underlying mechanisms, define optimal screening for common new diagnoses, and test interventions to prevent and treat postsepsis morbidity.

Effectiveness of two types of palliative home care in cancer and non-cancer patients: A retrospective population-based study using claims data.

BACKGROUND: Comparative effectiveness of different types of palliative homecare is sparsely researched internationally-despite its potential to inform necessary decisions in palliative care infrastructure development. In Germany, specialized palliative homecare delivered by multi-professional teams has increased in recent years and factors beyond medical need seem to drive its involvement and affect the application of primary palliative care, delivered by general practitioners who are supported by nursing services. AIM: To compare effectiveness of primary palliative care and specialized palliative homecare in reducing potentially aggressive interventions at the end-of-life in cancer and non-cancer. DESIGN: Retrospective population-based study with claims data from 95,962 deceased adults in Germany in 2016 using multivariable regression analyses. SETTINGS/PARTICIPANTS: Patients having received primary palliative care or specialized palliative homecare (alone or in addition to primary palliative care), for at least 14 days before death, differentiating between cancer and non-cancer patients. RESULTS: Rates of potentially aggressive interventions in most indicators were higher in primary palliative care than in specialized palliative homecare (p < 0.01), in both cancer and non-cancer patients: death in hospital (odds ratio (OR) 4.541), hospital care (OR 2.720), intensive care treatment (OR 6.749), chemotherapy (OR 2.173), and application of a percutaneous endoscopic gastrostomy (OR 4.476), but not for parenteral nutrition (OR 0.477). CONCLUSION: Specialized palliative homecare is more strongly associated with reduction of potentially aggressive interventions than primary palliative care in the last days of life. Future research should identify elements of specialized palliative homecare applicable for more effective primary palliative care, too. German Clinical Trials Register (DRKS00014730).

Clinical and economic outcomes of a collaborative cardiology care program.

OBJECTIVES: We evaluated a collaborative care program aimed at improving cooperation among general practitioners (GPs) and cardiologists in Baden-Wuerttemberg, Germany. The program focused on improving care for patients with chronic cardiac conditions. STUDY DESIGN: We conducted a retrospective cohort study. The observation period was 2 years. METHODS: The study was based on claims data and compared groups of patients who participated in the collaborative care program (GP-centered care and the cardiology contract) with patients receiving usual care. The evaluation focused on care coordination, quality, health service utilization, and costs in patients with heart failure, coronary heart disease, heart rhythm disorders, and/or valvular heart disease (disease cohorts). Multivariable regression models were used to adjust for differences in patient characteristics between the groups. RESULTS: Across all disease cohorts, participation in the collaborative care program was associated with better care coordination and improved quality in a broad range of indicators (pharmacotherapy and vaccination). Results showed lower emergency service utilization and hospitalizations, lower consultation frequencies with GPs and specialists, and a shift from inpatient to outpatient procedures. Program participation resulted in higher costs for outpatient cardiologist treatment, but disease-specific costs were lower overall. CONCLUSIONS: The results underline evidence that health care service programs that strengthen collaboration between GPs and cardiologists can substantially improve the care of patients with chronic cardiac conditions while simultaneously reducing costs.

[Palliative care at the end of life in Germany : Utilization and regional distribution]. / Palliativversorgung am Lebensende in Deutschland : Inanspruchnahme und regionale Verteilung.

BACKGROUND: Palliative care supply increased in Germany in recent years. But how many people use which forms of palliative care and how does this differ between regions? METHOD: Retrospective cohort study with claims data from insured persons who died in 2016: Based on services billed at least once in the last six months of life, we determined the use of primary palliative care (PPC), specialized palliative homecare (SPHC), as well as inpatient palliative and hospice care, using regional billing codes for PPC and SPHC services for the first time. RESULTS: Of the 95,962 deceased in the study population, 32.7% received palliative care nationwide, with variations from 26.4% in Bremen to 40.8% in Bavaria. PPC services were billed at 24.4% (16.9% in Brandenburg to 34.1% in Bavaria). SPHC services received 13.1% (6.3% in Rhineland-Palatinate to 18.9% in Brandenburg and 22.9% in Westphalia-Lippe with different SPHC practices). Inpatient palliative care was received by 8.1% (6.7% in Schleswig-Holstein/Hesse to 13.0% in Thuringia); 3.3% (1.6% in Bremen to 5.6% in Berlin) with hospice services. CONCLUSION: SPHC is used more frequently than previously reported, while PPC is declining. Utilization seems to be based less on objective needs than on region-specific framework conditions. Besides needs criteria, further development of palliative care should be oriented more towards outcomes and relevant framework conditions.

[Date of Service Provision and Date of Payment in Claims Data: Dealing with Time Differences]. / Leistungs- und Abrechnungsdatum in GKV-Routinedaten: Umgang mit zeitlichen Abweichungen.

AIM: The paper quantifies discrepancies between date of payment and date of service provision when doing analyses in relation to date of death and also in relation to the end of a calendar year. In analyses of this type, time differences between service provision and payment can lead to both under- and overestimation of service use. We aim to capture these phenomena in claims data from different sectors (primary care, medication prescription, prescription of remedies and medical aids, hospital care). METHOD: We have used pre-structured claims data from a scientific data warehouse of a large German statutory health insurance covering people that died in 2016. We investigated the discrepancies in time between date of service provision and date of payment for different outpatient and inpatient services based on data from 2015 to 2017. An exact date (dd/mm/yyyy) was only available for data covering prescriptions of remedies and medical aids. Data covering medication prescriptions were only exact to the month of payment (mm/yyyy), whereas data covering outpatient physician care were only exact to the quarter of payment (q/yyyy). RESULTS: For both outpatient physician care and hospital care, less than 1% had a payment date after the date of death. The share is considerably higher (28-31%) for prescriptions of remedies and medical aids. The majority of payments occurred within 3 months after death (93% for prescriptions of remedies and medical aids, 67% for primary care services). Less than 1% of outpatient physician care and about 18% of remedies had been paid after the end of the calender year 2015. Here too, the majority of payments were made within the first 3 months of 2016 (100% of prescriptions of remedies and medical aids, 65% of primary care services). CONCLUSIONS: Discrepancies in time between date of service provision and date of payment pose a challenge and are a potential source of under-/overestimation of health service utilization when doing analyses in relation to date of death or the end of a calendar year. This needs to be taken into account when requesting the data, but also in preparing and analysing them. The primary recommendation is to ensure that services with a payment date after death are included explicitly.

Study protocol for a multi-methods study: SAVOIR - evaluation of specialized outpatient palliative care (SAPV) in Germany: outcomes, interactions, regional differences.

BACKGROUND: Since 2007, the German statutory health insurance covers Specialized Outpatient Palliative Care (SAPV). SAPV offers team-based home care for patients with advanced and progressive disease, complex symptoms and life expectancy limited to days, weeks or months. The introduction of SAPV is ruled by a directive (SAPV directive). Within this regulation, SAPV delivery models can and do differ regarding team structures, financing models, cooperation with other care professionals and processes of care. The research project SAVOIR is funded by G-BA's German Innovations Fund to evaluate the implementation of the SAPV directive. METHODS: The processes, content and quality of SAPV will be evaluated from the perspectives of patients, SAPV teams, general practitioners and other care givers and payers. The influence of different contracts, team and network structures and regional and geographic settings on processes and results including patient-reported outcomes will be analyzed in five subprojects: [1] structural characteristics of SAPV and their impact on patient care, [2] quality of care from the perspective of patients, [3] quality of care from the perspective of SAPV teams, hospices, ambulatory nursing services, nursing homes and other care givers, content and extent of care from [4] the perspective of General Practitioners and [5] from the perspective of payers. The evaluation will be based on different types of data: team and organizational structures, treatment data based on routine documentation with electronic medical record systems, prospective assessment of patient-reported outcomes in a sample of SAPV teams, qualitative interviews with other stakeholders like nursing and hospice services, a survey in general practitioners and a retrospective analysis of claims data of all SAPV patients, covered by the health insurance fund BARMER in 2016. DISCUSSION: Data analysis will allow identification of variables, associated with quality of SAPV. Based on these findings, the SAVOIR study group will develop recommendations for the Federal Joint Committee for a revision of the SAPV directive. TRIAL REGISTRATION: German Clinical Trials Register (DRKS): DRKS00013949 (retrospectively registered, 14.03.2018), DRKS00014726 (14.05.2018), DRKS00014730 (30.05.2018). Subproject 3 is an interview study with professional caregivers and therefore not registered in DRKS as a clinical study.

Calcium and Phosphate Metabolism, Blood Lipids and Intestinal Sterols in Human Intervention Studies Using Different Sources of Phosphate as Supplements-Pooled Results and Literature Search.

Phosphates are associated with negative physiological effects. The objectives of this publication were to compare differential effects of supplementation with calcium phosphate or phosphate alone in healthy humans. Four adult human studies were conducted with pentacalcium hydroxy-trisphosphate supplementation (CaP; 90 subjects) and their data were pooled for assessment. For literature search; PubMed and ISI Web of Knowledge were used and 21 items were assigned to three main topics. The pooled study results show that following CaP supplementation, faecal calcium and phosphorus and urinary calcium were increased, blood lipids were positively modulated, and faecal bile acids were increased, as compared with placebo. The literature search reveals that following calcium phosphate supplementation, urinary calcium was increased. Following solely phosphate supplementation, urinary phosphorus was increased and urinary calcium was decreased. Postprandial calcium concentrations were increased following calcium phosphate supplementation. Postprandial phosphate concentrations were increased following solely phosphate supplementation. Calcium phosphate supplementation resulted in rather positively modulated blood lipids and gut-related parameters. The presented results show the relevance to distinguish between calcium phosphate and solely phosphate supplementations, and the importance of a balanced calcium and phosphorus intake.

Habitual Intakes, Food Sources and Excretions of Phosphorus and Calcium in Three German Study Collectives.

Phosphorus intake in Europe is far above recommendations. We present baseline data from three human intervention studies between 2006 and 2014 regarding intake and excretion of phosphorus and calcium. All subjects documented their nutritional habits in weighed dietary records. Fasting blood samples were drawn, and feces and urine were quantitatively collected. Dietary phosphorus intake was estimated based on weighed dietary records and urine phosphorus excretions. Food sources were identified by allocation to defined food product groups. Average phosphorus consumption was 1338 mg/day and did not change from 2006 to 2014, while calcium intake decreased during this period (1150 to 895 mg/day). The main sources for phosphorus intake were bread/cereal products, milk/milk products and meat/meat products/sausage products and the main sources of calcium intake included milk/milk products/cheese, bread/cereal products and beverages. There was no difference between estimated phosphorus intake from the weighed dietary records and urine phosphorus excretion. In conclusion, we demonstrated constant phosphorus intakes far above the recommendations and decreasing calcium intakes below the recommendations in three German collectives from 2006 to 2014. Furthermore, we could show in case of usual intakes that an estimated phosphorus intake from urine phosphorus excretion is similar to the calculated intake from weighed dietary records.

A combination of calcium phosphate and probiotics beneficially influences intestinal lactobacilli and cholesterol metabolism in humans.

BACKGROUND & AIMS: The study focuses on the influence of a probiotic supplement alone and in combination with a calcium supplement on faecal lactobacilli colonisation and beneficial health effects such as a lowering of blood cholesterol. METHODS: Thirty-two men and women participated in the double-blind, placebo-controlled, cross-over study. All participants consumed a probiotic drink containing 10(10)CFU/d Lactobacillus paracasei (LPC37) for four weeks. In addition, one group consumed bread enriched with pentacalcium hydroxy-triphosphate (CaP; 1g Ca/d) and the other group had bread without CaP. After a two-week washout and a two-week placebo period, the intervention was switched for further four weeks. RESULTS: After intervention with LPC37+CaP, total cholesterol and LDL-cholesterol concentration in plasma decreased significantly compared to LPC37 and placebo. The faecal concentration of L. paracasei and that of all lactobacilli increased significantly after LPC37+CaP and LPC37 compared to placebo. Moreover, secondary bile acids in faeces increased significantly after LPC37+CaP intervention compared to placebo. CONCLUSIONS: CaP modulates the colonisation of LPC37 in the human gut under combinatory supplementation of CaP and LPC37. The combined supplementation also decreases plasma LDL-cholesterol and the LDL/HDL ratio in healthy, moderately hypercholesterolemic men and women, which could be also due to the CaP supplementation. CLINICAL TRIAL REGISTRATION NUMBER: NCT01033461.

Faecal steroid excretion in humans is affected by calcium supplementation and shows gender-specific differences.

BACKGROUND: Previous human studies on the effect of dietary calcium supplementation on faecal excretion of bile acids (BA) and faecal water concentrations of animal neutral sterols (NSt, cholesterol and its metabolites) lack detailed information about single BA and NSt. AIM OF THE STUDY: We investigated whether single BA and NSt in faeces and especially in faecal water are affected by calcium supplementation and whether this affects genotoxicity of faecal water. In addition, we differentiated between men and women with regard to the concentrations of BA and NSt in faecal water. METHODS: Thirty-one healthy volunteers consumed a calcium supplemented bread (1.0 g/day) and a placebo bread, respectively, for 4 weeks in a double-blind, randomised cross-over trial. Faeces were collected quantitatively for 5 days in the last week of each period. NSt and BA were analysed by GC-MS. RESULTS: Due to calcium supplementation faecal concentrations of lithocholic acid (LCA, 14%, P = 0.008), deoxycholic acid (DCA, 19%, P < 0.001) and 12 keto-deoxycholic acid (12 keto DCA, 29%, P = 0.049) significantly increased whereas BA concentrations in faecal water were only marginally affected. In contrast, concentrations of cholesterol (30%, P = 0.020) and its metabolites coprostanol (43%, P = 0.004), coprostanone (36%, P = 0.003), cholestanol (44%, P = 0.001) and cholestenone (32%, P = 0.038) in faecal water significantly decreased. Total NSt concentration in faecal water was found to be significantly higher in women compared to men (P = 0.018). The genotoxicity of faecal water was neither affected by calcium supplementation nor were there gender-specific differences. CONCLUSIONS: Dietary calcium supplementation diversely affects BA and NSt in faeces and in faecal water but does not influence the genotoxicity of faecal water in healthy adults.

Absorption of black currant anthocyanins by monolayers of human intestinal epithelial Caco-2 cells mounted in ussing type chambers.

Anthocyanins (ACNs) have been reported to have multiple biological properties imparting benefits to human health. Their role in human nutrition, however, needs to be related to biokinetic data, such as bioavailability. The purpose of the present study was to focus on the potential absorption of black currant ( Ribes nigrum L.) ACNs. Caco-2 monolayers were used as an in vitro model of the absorptive intestinal epithelium. For absorption studies, Caco-2 cells grown on permeable filters were mounted into Ussing type chambers. The monolayer integrity was monitored by measuring the transepithelial electrical resistance (TEER). Luminal to serosal transport of ACNs was examined by comparing ACN disappearance from the luminal solution of Ussing chambers not containing any inserts (control chambers) with that of Ussing chambers containing inserts. ACNs (C total ACN approximately 180 microM) were not detected in any serosal solution. However, it was shown that ACNs disappeared from the luminal side, not due to ACN degradation processes but rather--at least in part--due to physiological actions of the cells. The luminal net disappearance of ACNs was calculated (max(t20 min) approximately 11% for total ACNs) and labeled as "absorption efficiency". This apical transport might occur to a much larger extent than the further translocation across the basolateral membrane. Thus, cell metabolism and translocation across the basolateral membrane may be the key determinants of ACN absorption and bioavailability.