Cost-effectiveness of proactive health support-telephone-based self-management support compared with standard care for persons at risk of hospital admission.

BACKGROUND: A small share of patients account for a large proportion of costs to the healthcare system in Denmark as in many Western countries. A telephone-based self-management support, proactive health support (PaHS), was suggested for prevention of hospitalisations for persons at risk of hospital admission. These persons have chronic diseases, unplanned hospitalisations and age ≥ 65 years. However, evidence is limited on whether this type of intervention is cost-effective. AIM: The aim of this study was to assess the incremental cost-utility ratio (ICER) of PaHS, compared with standard care. METHODS: The economic evaluation was nested within a randomised controlled trial, and was based on a health system perspective, with follow-up and time horizon of 12 months. We measured incremental costs per quality-adjusted life years (QALY) gained. Total average costs per patient included PaHS programme costs, and costs in hospitals, primary care and municipalities. We analysed differences by generalised linear models with Gamma distribution for costs and mixed models for QALY. RESULTS: We analysed data on 6,139 patients, where 3,041 received PaHS and 3,098 received usual care. We found no difference in healthcare costs, and programme costs were on average €1,762 per patient, providing incremental costs of €2,075. Incremental effects on QALY were 0.007, resulting in an ICER of €296,389 per QALY gained. CONCLUSION: We found no evidence of PaHS being cost-effective in this study, but the results will be used to identify new ways to organise similar interventions and identify patients with the objective to reduce health system costs per patient.

Nurses' perspectives on challenges and facilitators when implementing a self-management support intervention as an everyday healthcare practice: A qualitative study.

AIM: To explore registered nurses' perspectives on challenges and facilitators to implementing a telephone-based self-management support (SMS) intervention (Proactive Health Support) as an everyday healthcare practice, during the early stages of implementation. DESIGN: Data were collected using a qualitative research design involving focus-group interviews and participant observations. METHODS: We conducted participant observation following nine nurses and four focus group interviews with 14 nurses. Data were analysed using thematic analyses. RESULTS: Proactive Health Support was implemented in units organized independently of the existing organizational units within healthcare services. This independent organization, along with the intervention's generic (non-disease specific) design, empowered nurses to become autonomous practitioners capable of prioritizing the operationalization of SMS as an everyday healthcare practice. However, unlearning already embedded medical practices and establishing new nursing roles necessary to accommodate the intervention in practice was experienced a challenge. Education and supervision were identified as valuable tools for successful implementation. CONCLUSION: Our study highlights the significance of organizational context and autonomy in successful SMS implementation. Balancing external factors like organizational context, priority and time is vital, but navigating the internal shift in professional practice is equally crucial. Role transition processes can constitute challenges demanding accommodation. IMPLICATIONS FOR THE PROFESSION: From a nursing perspective, this study highlights that practising SMS requires substantial training and education. Generic SMS interventions can introduce higher levels of contingency due to their versatile nature. Thus, equipping nurses with competencies that enable them to navigate this unpredictability flexibly is crucial. IMPACT: Policymakers and administrators should allocate resources and support implementation processes in ways that accommodate both internal and external conditions to facilitate nurses in delivering effective SMS. REPORTING METHOD: This study adheres to the SRQR guideline. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

A cross-sectional study of the association between family conflicts and children's health: Lolland-Falster Health Study.

BACKGROUND: Few family interaction processes are more detrimental to children's health than family conflicts. Conflictual relationships in childhood predict a host of adverse health outcomes across the life course. The current study examines associations between household conflicts and the health of children aged 6-12 years and explores to which extent this may vary by socioeconomic status (SES) and multimorbidity (MM) in the household. METHODS: Cross-sectional study using questionnaire data gathered between 2016 and 2020 as part of the Lolland-Falster Health Study (LOFUS) combined with routine register data on health care use and socio-demography from the Danish nationwide administrative databases. The study sample consisted of 1065 children 6-12 years old, who answered LOFUS4 or LOFUS11, from 777 households for which at least one adult answered LOFUS18. Main outcome was children's health complaints, defined as headache, abdominal pain, back pain, and sleep difficulties. Covariates included MM, SES, and conflicts, all three measured at household level. Multivariable logistic regression models were used. RESULTS: Conflicts were negatively associated with children's health. This was most pronounced for general conflicts in the household, with increased complaints of abdominal pain, back pain, and sleep difficulties. The associations varied when we stratified the households according to MM and SES. Significant associations were found within households without MM for abdominal pain, and within households with MM and low SES, and without MM and with high SES for sleep difficulties. While the higher level of abdominal pain for the above indicated households were found for both internal and external conflicts in the household, the higher level in sleep difficulties was mostly driven by internal conflicts. CONCLUSION: Children reporting frequent health complaints have a higher future health care use compared with children without such complaints. Our results indicate that growing up in a household with a high conflict level might be a predisposing factor.

Proactive Health Support: a randomised controlled trial of telephone-based self-management support for persons at risk of hospital admission.

BACKGROUND: Persons with frequent hospital admissions have a disease burden that may exceed their self-management skills. The evidence base of telephone-based interventions to support self-management is poor with mixed results. The aim of this study is to evaluate the effect of Proactive Health Support (PaHS): telephone-based self-management support for persons with risk of hospitalizations. METHODS: This study is a national randomised controlled trial of PaHS versus usual universal tax-funded healthcare. Participants were persons at risk of emergency hospital admissions. The intervention began with a physical start-up session followed by telephone sessions of self-management support. The two co-primary outcomes were Health-Related Quality of Life (HRQoL) (Mental Health Component Summary Score of SF36v2) analysed with mixed models and hospital admissions analysed with Poisson regression at 6 months. Secondary outcomes were at 3- and 12-month follow-up and disease subgroup analyses. RESULTS: During the study period, 6,402 persons were randomised (3,190 intervention, 3,212 control). HRQoL was significantly improved at 6 months (Est. 1.4992, P = <0.0001) and at 3 and 12 months on all 10 scales. There was no overall effect on hospital admissions at 6 months with an adjusted estimate of 0.0074 (P = 0.8691). Persons with diabetes had significant improvement of HRQoL and reduced hospital admissions. CONCLUSIONS: The PaHS intervention improved HRQoL for all participants and reduced hospital admissions for persons with diabetes only.

Reference intervals for 12 clinical laboratory tests in a Danish population: The Lolland-Falster Health Study.

Reference intervals (RIs), developed as part of the Nordic Reference Interval Project 2000 (NORIP) are widely used in most European laboratories. We aimed to examine the validity of the NORIP RIs by establishing RIs for 12 frequently used laboratory tests based on data from a local Danish population and compare these local RIs with the NORIP RIs. Using an a posteriori direct sampling approach, blood sample data were assessed from 11,138 participants aged 18+ years in the Lolland-Falster Health Study (LOFUS), of whom 2154 turned out to meet criteria for being healthy for inclusion in establishing RIs according to the NORIP methodology. The 2.5th and 97.5th percentiles were calculated for alanine aminotransferase (ALAT), albumin, alkaline phosphatase, bilirubin, creatinine, hemoglobin, high-density lipoprotein cholesterol, iron, low-density lipoprotein cholesterol, thrombocytes, total cholesterol, and triglycerides. When comparing our estimates with the NORIP, the lower reference limits (RLs) for bilirubin and iron were lower, and higher for ALAT, thrombocytes and triglycerides. Upper RLs were lower for albumin (males and females ≥70 years), bilirubin and iron, but higher for alkaline phosphatase, triglycerides and for creatinine in men. In LOFUS, approximately 20% of the participants were healthy and qualified for inclusion in the establishment of RIs. Several of the local RIs differed from the NORIP RIs.

Questionnaire development for the Lolland-Falster Health Study, Denmark: an iterative and incremental process.

In composing multi-thematic questionnaires for the Lolland-Falster Health Study (LOFUS), we faced a range of challenges, for which we found limited guidance in the literature. LOFUS is a household-based population study covering multiple medical and social research areas and targeting the mixed rural-provincial population of 103,000 persons on the Danish islands Lolland and Falster. Households were randomly selected for invitation. In this paper, we describe and discuss challenges in developing the questionnaires related to stakeholders, content of the questionnaire, and the process itself. The development process was characterised by loops of learning and can be described as an iterative and incremental process. We propose recommendations to researchers and administrators involved in similar development processes, including awareness of the non-linearity and complexity of the process, a need for negotiations and navigation among multiple stakeholders, and acknowledgement of pragmatism as an inherent part of decisions made in the process.

Lolland-Falster Health Study: Study protocol for a household-based prospective cohort study.

Introduction: Lolland-Falster consists of two islands in the southern part of Denmark where income is lower and life expectancy is shorter than in the general Danish population. It is a mixed rural-provincial area with approximately 100,000 inhabitants. The Lolland-Falster Health Study was initiated to gain knowledge on the determinants of health in this disadvantaged area. Methods: The study is a household-based prospective cohort study including people of all ages. The entire household of randomly selected inhabitants is allocated either to an invited group or to an uninvited, non-contacted control group. The data collection encompasses questionnaires, physical examination and biological samples, i.e. blood and urine for same-day analysis and biobank storage, and saliva and faeces also for biobank storage. The civil registration number links collected data for each individual, family and household, with information in Danish registers. The data collection started in February 2016 and is estimated to end by 2019 after the enrolment of 20,000 people. Analysis: A number of in-depth sub-studies are planned. Emphasis will be given to analysis of intra- and inter-family variations in health determinants, genetics, lifestyle and health status. Ethics: Region Zealand's Ethical Committee on Health Research (SJ-421) and the Danish Data Protection Agency (REG-24-2015) approved the study. Trial registration: Clinicaltrials.gov (NCT02482896). Strength and limitations of this study: The strength of this study is that Lolland-Falster Health Study is a useful scientific resource for investigating cross-sectional difference and time trends within and between individuals, families and households. LOFUS adds diversity to the previously collected Danish population studies in urbanized areas. The limitation is that data collection is expensive. Conclusions: LOFUS will contribute to the knowledge on health in disadvantaged, rural-provincial areas.

Burden of prediabetes, undiagnosed, and poorly or potentially sub-controlled diabetes: Lolland-Falster health study.

BACKGROUND: This study aimed to investigate prevalence and risk factors for prediabetes, undiagnosed diabetes mellitus, poorly and potentially sub-controlled diabetes in a rural-provincial general adult population in Denmark. METHODS: Using cross-sectional data from the Lolland-Falster Health Study, we examined a total of 10,895 individuals aged 20 years and above. RESULTS: Prevalence of prediabetes was 5.8% (men: 6.1%; women: 5.5%); of undiagnosed diabetes 0.8% (men: 1.0%; women: 0.5%); of poorly controlled diabetes 1.2% (men: 1.5%; women: 0.8%); and of potentially sub-controlled diabetes 2% (men: 3.0%; women: 1.3%). In total, 9.8% of all participants had a diabetes-related condition in need of intervention; men at a higher risk than women; RR 1.41 (95% CI 1.26-1.58); person aged + 60 years more than younger; RR 2.66 (95% CI 2.34-3.01); obese more than normal weight person, RR 4.51 (95% CI 3.79-5.38); smokers more than non-smokers, RR 1.38 (95% CI 1.19-1.62); persons with self-reported poor health perception more than those with good, RR 2.59 (95% CI 2.13-3.15); low leisure time physical activity more than those with high, RR 2.64 (95% CI 2.17-3.22); and persons with self-reported hypertension more than those without, RR 3.28 (95% CI 2.93-3.68). CONCLUSIONS: In the Lolland-Falster Health Study, nearly 10% of participants had prediabetes, undiagnosed diabetes, poorly controlled, or potentially sub-controlled diabetes. The risk of these conditions was more than doubled in persons with self-reported poor health perception, self-reported hypertension, low leisure time physical activity, or measured obesity, and a large proportion of people with diabetes-related conditions in need of intervention can therefore be identified relatively easily.

The influence of vitamin D analogs on calcification modulators, N-terminal pro-B-type natriuretic peptide and inflammatory markers in hemodialysis patients: a randomized crossover study.

BACKGROUND: The risk of cardiovascular disease is tremendously high in dialysis patients. Dialysis patients treated with vitamin D analogs show decreased cardiovascular morbidity and mortality compared with untreated patients. We examined the influence of two common vitamin D analogs, alfacalcidol and paricalcitol, on important cardiovascular biomarkers in hemodialysis patients. Anti-inflammatory effects and the influence on regulators of vascular calcification as well as markers of heart failure were examined. METHODS: In 57 chronic hemodialysis patients enrolled in a randomized crossover trial comparing paricalcitol and alfacalcidol, we examined the changes in osteoprotegerin, fetuin-A, NT-proBNP, hs-Crp, IL-6 and TNF-α, during 16 weeks of treatment. RESULTS: NT-proBNP and osteoprotegerin increased comparably in the paricalcitol and alfacalcidol-treated groups. Fetuin-A increased significantly in the alfacalcidol-treated group compared with the paricalcitol-treated group (difference 32.84 µmol/l (95% C.I.; range 0.21-67.47)) during the first treatment period. No difference was found between the groups during the second treatment period, and IL-6, TNF-α and hs-Crp were unchanged in both treatment groups. CONCLUSIONS: Paricalcitol and alfacalcidol modulate regulators of vascular calcification. Alfacalcidol may increase the level of the calcification inhibitor fetuin-A. We did not find any anti-inflammatory effect or difference in changes of NT-proBNP. TRIAL REGISTRY: ClinicalTrials.gov NCT00469599 May 3 2007.

Indexing glomerular filtration rate to body surface area: clinical consequences.

BACKGROUND: Kidney function is mostly expressed in terms of glomerular filtration rate (GFR). A common feature is the expression as ml/min per 1.73 m(2) , which represents the adjustment of the individual kidney function to a standard body surface area (BSA) to allow comparison between individuals. We investigated the impact of indexing GFR to BSA in cancer patients, as this BSA indexation might affect the reported individual kidney function. METHODS: Cross-sectional study of 895 adults who had their kidney function measured with (51) chrome ethylene diamine tetraacetic acid. Mean values of BSA-indexed GFR vs. mean absolute GFR were analyzed with a t-test for paired data. Bland-Altman plot was used to analyze agreement between the indexed and absolute GFR values. RESULTS AND CONCLUSION: BSA-GFR in patients with a BSA <1.60 m(2) overestimated GFR with a bias of 10.08 ml/min (11.46%) and underestimated GFR in those with a BSA >2 m(2) with a bias up to -20.76 ml/min (-23.59%). BSA is not a good normalization index (NI) in patients with extreme body sizes. Therefore, until a better NI is found, we recommend clinicians to use the absolute GFR to calculate individual drug chemotherapy dosage as well as express individual kidney function.

Self-Reported Health as Predictor of Allostatic Load and All-Cause Mortality: Findings From the Lolland-Falster Health Study.

Objectives: The aim was to determine the association between self-reported health (SRH), allostatic load (AL) and mortality. Methods: Data derived from the Lolland-Falster Health Study undertaken in Denmark from 2016-2020 (n = 14,104). Median follow-up time for death was 4.6 years where 456 participants died. SRH was assessed with a single question and AL by an index of ten biomarkers. Multinomial regression analysis were used to examine the association between SRH and AL, and Cox regression to explore the association between SRH, AL and mortality. Results: The risk of high AL increased by decreasing level of SRH. The ratio of relative risk (RRR) of having medium vs. low AL was 1.58 (1.11-2.23) in women reporting poor/very poor SRH as compared with very good SRH. For men it was 1.84 (1.20-2.81). For high vs. low AL, the RRR was 2.43 (1.66-3.56) in women and 2.96 (1.87-4.70) in men. The hazard ratio (HR) for all-cause mortality increased by decreasing SRH. For poor/very poor vs. very good SRH, the HR was 6.31 (2.84-13.99) in women and 3.92 (2.12-7.25) in men. Conclusion: Single-item SRH was able to predict risk of high AL and all-cause mortality.

Correlation between allostatic load index and cumulative mortality: a register-based study of Danish municipalities.

OBJECTIVES: The aim of this study was to examine population-based allostatic load (AL) indices as an indicator of community health across 14 municipalities in Denmark. DESIGN: Register-based study. SETTING: Data derived from: the Lolland-Falster Health Study, the Copenhagen General Population Study and the Danish General Suburban Population Study. Nine biomarkers (systolic blood pressure, diastolic blood pressure, pulse rate, total serum cholesterol, high-density lipoprotein cholesterol, waist-to-hip ratio, triglycerides, C-reactive protein and serum albumin) were divided into high-risk and low-risk values based on clinically accepted criteria, and the AL index was defined as the average between the nine values. All-cause mortality data were obtained from Statistics Denmark. PARTICIPANTS: We examined a total of 106 808 individuals aged 40-79 years. PRIMARY OUTCOME MEASURE: Linear regression models were performed to investigate the association between mean AL index and cumulative mortality risk. RESULTS: Mean AL index was higher in men (range 2.3-3.3) than in women (range 1.7-2.6). We found AL index to be strongly correlated with the cumulative mortality rate, correlation coefficient of 0.82. A unit increase in mean AL index corresponded to an increase in the cumulative mortality rate of 19% (95% CI 13% to 25%) for men, and 16% (95% CI 8% to 23%) for women but this difference was not statistically significant. The overall mean increase in cumulative mortality rate for both men and women was 17% (95% CI 14% to 20%). CONCLUSIONS: Our findings indicate the population-based AL index to be a strong indicator of community health, and suggest identification of targets for reducing AL.

The use of absolute values improves performance of estimation formulae: a retrospective cross sectional study.

BACKGROUND: Estimation of Glomerular Filtration Rate (GFR) by equations such as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or Modification of Diet in Renal Disease (MDRD) is usually expressed as a Body Surface Area (BSA) indexed value (ml/min per 1.73 m²). This can have severe clinical consequences in patients with extreme body sizes, resulting in an underestimation in the case of obesity or an overestimation of GFR in the case of underweight patients. The aim of this study was to compare the performance of both estimation formula expressed in ml/min, instead of ml/min per 1.73 m², with a reference method. METHODS: Retrospective single centre cross sectional study of 185 patients. GFR was measured with 51Cr-EDTA and estimated with CKD-EPI and MDRD. Bias, precision and accuracy of absolute estimated GFR was calculated. RESULTS: Bias of CKD-EPI and MDRD formulae expressed as an absolute value was 0.49 and 0.27 ml/min respectively, which is lower than previously reported. Precision was 12.95 and 16.33 and accuracy expressed as P30 was over 92.43% for CKD-EPI. There were no significant differences in GFR between the reference method and the estimation formulae. CONCLUSIONS: The performance of CKD-EPI and MDRD formulae can be significantly improved in the individual patient if the absolute values are used by removing the BSA normalization factor. Absolute estimated GFR by CKD-EPI is comparable to measured GFR, improving the performance of this formula in the assessment of individual kidney function, thus providing clinicians with an alternative to reference methods.

Who benefits from self-management support? Results from a randomized controlled trial.

Background: Self-management support models adapted to accommodate the needs of each patient are complex interventions that should be evaluated for intervention mechanisms. In a national randomized controlled trial (RCT), we evaluated the efficacy of telephone-based self-management support that demonstrated improved health-related quality of life (HRQoL), no reduction in hospital admissions, and an unexpected increase in primary healthcare services. Objective: The objective of this study is to identify RCT impact mechanisms and explore which participants could benefit the most from the PaHS intervention. Methods: This study evaluates intervention mechanisms through interaction analyses of predefined intervention moderators (sex, age, education, chronic disease, risk of hospital admissions, and coping) and post-hoc intervention mediators (contacts in primary care and anxiety medication). The one co-primary outcome HRQoL was assessed with SF26v2 and analyzed with generalized linear mixed models and the other co-primary hospital admissions was analyzed with poisson regression. Results: PaHS interacted with diabetes, multimorbidity, coping, and anxiety medication on the outcome hospital admissions. PaHS led to a significant reduction in hospital admissions in participants with diabetes or multimorbidity and an increase in hospital admissions in participants with higher baseline coping and participants using anxiety medication. The interaction analyses revealed significant intervention mediation in the outcome HRQoL by sex and diabetes. Conclusions: Participants with diabetes, multimorbidity, and women could benefit the most from telephone-based self-management support, but the intervention involves the risk of over-treatment.

Changes in fibroblast growth factor 23 during treatment of secondary hyperparathyroidism with alfacalcidol or paricalcitol.

BACKGROUND: Fibroblast growth factor 23 (FGF23) increases renal phosphate excretion and decreases the formation of 1,25 dihydroxyvitamin D. In patients with chronic kidney disease, plasma FGF23 levels are markedly elevated by unknown mechanisms. We explored the changes in FGF23 during treatment of secondary hyperparathyroidism (SHPT) with alfacalcidol or paricalcitol in haemodialysis patients. METHODS: Intravenous alfacalcidol and paricalcitol were compared in haemodialysis patients with SHPT in a randomized 2 × 16-week cross-over study, with 6 weeks washout period preceding treatment and between treatment periods. In 57 of the enrolled patients, blood samples were frozen before and after each treatment period and available for measurement of FGF23. RESULTS: Treatment with both analogues increased FGF23 (P < 0.05 in all treatment periods). The magnitude of increase was similar for alfacalcidol and paricalcitol (Period 1: 223 versus 314%; P = 0.384 and Period 2: 174 versus 227%; P = 0.510) and the levels returned to pre-treatment levels during the washout period. Independent predictors of rise in FGF23 were baseline levels of FGF23 (P < 0.01), changes in ionized calcium (P < 0.01) and phosphate (P < 0.01) and cumulative dose of vitamin D analogues (P = 0.024). CONCLUSION: Alfacalcidol and paricalcitol increase the plasma levels of FGF23 equally and substantially in haemodialysis patients.

Lung function in Lolland-Falster Health Study (LOFUS).

BACKGROUND: COPD prevalence in Denmark is estimated at 18% based on data from urban populations. However, studies suggest that using the clinical cut-off for airway obstruction in population studies may overestimate prevalence. The present study aims to compare estimated prevalence of airway obstruction using different cut-offs and to present lung function data from the Lolland-Falster Health Study, set in a rural-provincial area. METHODS: Descriptive analysis of participant characteristics and self-reported respiratory disease and of spirometry results in the total population and in subgroups defined by these characteristics. Airway obstruction was assessed using previously published Danish reference values and defined according to either FEV1 /FVC below lower limit of normal (LLN) 5% (as in clinical diagnosis) or 2.5% (suggested for population studies), or as FEV1 /FVC < 70%. RESULTS: Using either FEV1 /FVC < 70% or LLN 5% cut-off, 19.0% of LOFUS participants aged 35 years or older had spirometry, suggesting airway obstruction. By the LLN 2.5% criterion, the proportion was considerably lower, 12.2%. The prevalence of airway obstruction was higher among current smokers, in participants with short education or reporting low leisure-time physical activity and in those with known respiratory disease. Approximately 40% of participants reporting known respiratory disease had normal spirometry, and 8.7% without known respiratory disease had airway obstruction. CONCLUSION: Prevalence of airway obstruction in this rural population was comparable to previous estimates from urban Danish population studies. The choice of cut-off impacts the estimated prevalence, and using the FEV1 /FVC cut-off may overestimate prevalence. However, many participants with known respiratory disease had normal spirometry in this health study.

Allostatic load as predictor of mortality: a cohort study from Lolland-Falster, Denmark.

OBJECTIVES: The purposes of the present study were to determine the association between (1) 10 individual biomarkers and all-cause mortality; and between (2) allostatic load (AL), across three physiological systems (cardiovascular, inflammatory, metabolic) and all-cause mortality. DESIGN: Prospective cohort study. SETTING: We used data from the Lolland-Falster Health Study undertaken in Denmark in 2016-2020 and used data on systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR), waist-hip ratio (WHR) and levels of low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides, glycated haemoglobin A1c (HbA1c), C-reactive protein (CRP) and serum albumin. All biomarkers were divided into quartiles with high-risk values defined as those in the highest (PR, WHR, triglycerides, HbA1c, CRP) or lowest (HDL-c, albumin) quartile, or a combination hereof (LDL-c, SBP, DBP). The 10 biomarkers were combined into a summary measure of AL index. Participants were followed-up for death for an average of 2.6 years. PARTICIPANTS: We examined a total of 13 725 individuals aged 18+ years. PRIMARY OUTCOME MEASURE: Cox proportional hazard regression (HR) analysis were performed to examine the association between AL index and mortality in men and women. RESULTS: All-cause mortality increased with increasing AL index. With low AL index as reference, the HR was 1.33 (95% CI: 0.89 to 1.98) for mid AL, and HR 2.37 (95% CI: 1.58 to 3.54) for high AL. CONCLUSIONS: Elevated physiological burden measured by mid and high AL index was associated with a steeper increase of mortality than individual biomarkers.

No difference between alfacalcidol and paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients: a randomized crossover trial.

Alfacalcidol and paricalcitol are vitamin D analogs used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease, but have known dose-dependent side effects that cause hypercalcemia and hyperphosphatemia. In this investigator-initiated multicenter randomized clinical trial, we originally intended two crossover study periods with a washout interval in 86 chronic hemodialysis patients. These patients received increasing intravenous doses of either alfacalcidol or paricalcitol for 16 weeks, until parathyroid hormone was adequately suppressed or calcium or phosphate levels reached an upper threshold. Unfortunately, due to a period effect, only the initial 16-week intervention period for 80 patients was statistically analyzed. The proportion of patients achieving a 30% decrease in parathyroid hormone levels over the last four weeks of study was statistically indistinguishable between the two groups. Paricalcitol was more efficient at correcting low than high baseline parathyroid hormone levels, whereas alfacalcidol was equally effective at all levels. There were no differences in the incidence of hypercalcemia and hyperphosphatemia. Thus, alfacalcidol and paricalcitol were equally effective in the suppression of secondary hyperparathyroidism in hemodialysis patients while calcium and phosphorus were kept in the desired range.

Estimation of kidney function in cancer patients.

INTRODUCTION: The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula has not been validated in patients with cancer. The present investigation was undertaken in order to study how well estimated glomerular filtration rate (eGFR) using the new CKD-EPI equation correlates with measured GFR (mGFR) by (51)chrome ethylene diamine tetraacetic acid ((51)Cr-EDTA) clearance in a group of patients with cancer not known as having cancer. MATERIAL AND METHODS: We investigated 185 patients with cancer who were referred for isotope measurement of GFR with (51)Cr-EDTA before initiating chemotherapy treatment. The agreement between CKD-EPI and (51)Cr-EDTA was assessed using a Bland-Altman plot. Test performance was analysed in a contingency table and bias, precision and the percentage of estimates within 30% of the mGFR (P30) were assessed. RESULTS: Bland-Altman plot analysis showed a limit of agreement in the range from -25.59 to 27.92 ml/min./1.73 m(2). This formula was therefore not interchangeable with (51)Cr-EDTA, as the above differences are of clinical importance. Bias was low: 1.16 ml/min./1.73 m(2); P30 was high: 89.73%; and precision was 13.37 ml/min./1.73 m(2). As a screening test, the CKD-EPI had a high specificity of 98% (95% confidence interval (CI): 96 to 100%) and a high negative predictive value 97% (95% CI: 95 to 100%). The accuracy of the validation test was 96% (95% CI: 93 to 99%). CONCLUSION: The CKD-EPI may be used as a screening tool for CKD in the general population, but cannot replace isotope tests when a high GFR measurement accuracy is needed.

Predicting Individual Risk of Emergency Hospital Admissions - A Retrospective Validation Study.

PURPOSE: A high number of hospital admissions may indicate poor general health and less than optimal health care across sectors. To prevent hospital admissions, previous studies have focused on predicting readmissions relating to a defined index admission and specific condition, whereas generic models suited for community-dwelling persons are lacking. The aim of this study was to validate a generic model that predicted risk of emergency hospital admission within the following three months and to investigate regional variation. MATERIALS AND METHODS: This study is an observational register-based validation study of a prediction model. The prediction model was based on a population of frail elderly, persons with non-communicable diseases, and persons with three emergency hospital admissions using information about diagnoses and hospital contacts. The prediction model consisted of two stages. In the first stage, covariate associations to admissions are estimated from observed data in one year. In the second stage, admissions are predicted in the coming three months based on observed estimations from the first stage. The validity of the model was calculated by comparing predicted and observed admissions from August 1st to October 31st, 2016. RESULTS: The study included 112,026 persons. In nationwide data, area under the curve (AUC) was 0.7742 (95% CI 0.7698-0.7786), and the positive predictive value was 52% for the 99th percentile (the top 1%). AUC varied between regions from 0.6914 in Southern Denmark (95% CI 0.6779-0.7049) to 0.8224 (95% CI 0.8064-0.8384) in North Denmark. AUC was higher with nationwide data compared to regional. CONCLUSION: The model performed satisfactorily in predicting individual risk of emergency hospital admission.