Biomarkers Improve Diagnostics of Sepsis in Adult Patients With Suspected Organ Dysfunction Based on the Quick Sepsis-Related Organ Failure Assessment (qSOFA) Score in the Emergency Department.

OBJECTIVES: Consensus regarding biomarkers for detection of infection-related organ dysfunction in the emergency department is lacking. We aimed to identify and validate biomarkers that could improve risk prediction for overt or incipient organ dysfunction when added to quick Sepsis-related Organ Failure Assessment (qSOFA) as a screening tool. DESIGN: In a large prospective multicenter cohort of adult patients presenting to the emergency department with a qSOFA score greater than or equal to 1, admission plasma levels of C-reactive protein, procalcitonin, adrenomedullin (either bioavailable adrenomedullin or midregional fragment of proadrenomedullin), proenkephalin, and dipeptidyl peptidase 3 were assessed. Least absolute shrinkage and selection operator regression was applied to assess the impact of these biomarkers alone or in combination to detect the primary endpoint of prediction of sepsis within 96 hours of admission. SETTING: Three tertiary emergency departments at German University Hospitals (Jena University Hospital and two sites of the Charité University Hospital, Berlin). PATIENTS: One thousand four hundred seventy-seven adult patients presenting with suspected organ dysfunction based on qSOFA score greater than or equal to 1. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The cohort was of moderate severity with 81% presenting with qSOFA = 1; 29.2% of these patients developed sepsis. Procalcitonin outperformed all other biomarkers regarding the primary endpoint (area under the curve for receiver operating characteristic [AUC-ROC], 0.86 [0.79-0.93]). Adding other biomarkers failed to further improve the AUC-ROC for the primary endpoint; however, they improved the model regarding several secondary endpoints, such as mortality, need for vasopressors, or dialysis. Addition of procalcitonin with a cutoff level of 0.25 ng/mL improved net (re)classification by 35.2% compared with qSOFA alone, with positive and negative predictive values of 60.7% and 88.7%, respectively. CONCLUSIONS: Biomarkers of infection and organ dysfunction, most notably procalcitonin, substantially improve early prediction of sepsis with added value to qSOFA alone as a simple screening tool on emergency department admission.

[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.

[Patient group-specific data sovereignty needs and acceptance of electronic health records]. / Patientengruppenspezifische Datenhoheitsbedürfnisse und Akzeptanz der elektronischen Patientenakte.

BACKGROUND AND AIM: People in Germany are very sensitive about their health data. The electronic health record (ePA) also raises questions about the patient's need for data sovereignty and acceptance. The possibility of selectively withholding data stored in the ePA from physicians who continue to treat the patient (opt-out) and the patient's prior knowledge of the ePA could influence the need for data sovereignty and acceptance of the ePA. The aim of this explorative study is to investigate these influences for three patient groups: "acute patients," "diabetes type 2 patients," and "palliative patients," as differences are expected between these groups. MATERIALS AND METHODS: From August to October 2019, a quantitative survey was conducted among 140 patients in the abovementioned groups. RESULTS: Of the respondents, 76.0% supported the selective opt-out option and stated that this would increase their willingness to participate in the ePA. Specifically, 81.1% of acute care patients, 80.6% of palliative care patients, and 65.6% of type 2 diabetes patients made this statement. Differences between groups were not significant. A general prior knowledge of the ePA was related to a higher need for data sovereignty - 43.2% of those who had never heard of the ePA rollout would occasionally hide their health data from other physicians, compared with 54.5% who knew of the rollout. DISCUSSION: Consideration of the data sovereignty needs of patients in the further establishment of the ePA is recommended. The selective opt-out option can contribute to acceptance. Knowledge of the ePA should be expanded, especially in the doctor-patient discussion, to enable an informed decision.

Healthcare Utilization and Costs in Sepsis Survivors in Germany-Secondary Analysis of a Prospective Cohort Study.

Background: Survivors of sepsis often face long-term sequelae after intensive care treatment. Compared to the period of hospitalization, little is known about the ambulatory healthcare utilization in sepsis patients. The study evaluated healthcare utilization and associated costs of sepsis care including allied health professions after initial hospitalization. Methods: Secondary analysis was performed on data in 210 sepsis patients prospectively enrolled from nine intensive care study centers across Germany. Data was collected via structured surveys among their Primary care (Family-) physicians (PCPs) within the first month after discharge from ICU (baseline) and again at 6, 12 and 24 months after discharge, each relating to the period following the last survey. Costs were assessed by standardized cost unit rates from a health care system's perspective. Changes in healthcare utilization and costs over time were calculated using the Wilcoxon rank-sum test. Results: Of the 210 patients enrolled, 146 (69.5%) patients completed the 24 months follow-up. In total, 109 patients were hospitalized within the first 6 months post-intensive care. Mean total direct costs per patient at 0-6 months were €17,531 (median: €6047), at 7-12 months €9029 (median: €3312), and at 13-24 months €18,703 (median: €12,828). The largest contributor to the total direct costs within the first 6 months was re-hospitalizations (€13,787 (median: €2965). After this first half year, we observed a significant decline in inpatient care costs for re-hospitalizations (p ≤ 0.001). PCPs were visited by more than 95% of patients over 24 months. Conclusions: Sepsis survivors have high health care utilization. Hospital readmissions are frequent and costly. Highest costs and hospitalizations were observed in more than half of patients within the first six months post-intensive care. Among all outpatient care providers, PCPs were consulted most frequently. Clinical impact: Sepsis survivors have a high healthcare utilization and related costs which persist after discharge from hospital. Within outpatient care, possible needs of sepsis survivors as physiotherapy or psychotherapy seem not to be met appropriately. Development of sepsis aftercare programs for early detection and treatment of complications should be prioritized.

Progression of Diabetic Complications in Subgroups of People with Long Term Diabetes Type 1 According to Clinical Course.

AIMS: Prevention and prediction of microvascular complications are important aims of medical care in people with type 1 diabetes. Since the course of the disease is heterogenous, we tried to identify subgroups with specific risk profiles for microvascular complications. METHODS: Retrospective analysis of a cohort of 285 people (22637 consultations) with >10 years of type 1 diabetes. Persons were grouped into slow (<15 years), fast (>15 years) and non progressors according to the average onset of microvascular complications. Generalized estimating equations for binary outcomes were applied and pseudo coefficients of determination were calculated. RESULTS: Progression to microvascular disease was associated with age (OR: 1.034 [1.001-1.068]; p=0.04), diabetes duration (OR: 1.057 [1.021-1.094]; p=0.002), HbA1c (OR: 1.035 [1.011-1.060]; p=0.005), BMI (OR: 0.928 [0.866-0.994]; p=0.034) and the social strata index (OR: 0.910 [0.830-0.998]; p=0.046). Generalized estimating equations predicted 31.02% and exclusion of HbA1c marginally reduced the value to 28.88%. The proportion of patients with LADA was higher in fast than slow progressors [13 (26.5%) vs. 14 (11.9%); p=0.019]. A generalized estimating equation comparing slow to fast progressors revealed no significant markers. CONCLUSION: In our analysis, we were able to confirm known risk factors for microvascular disease in people with type 1 diabetes. Overall, prediction of individual risk was difficult, the effect of individual markers minor and we could not find differences regarding slow or fast progression. We therefore emphasis the need for additional markers to predict individual risk for microvascular disease.

The effect of influenza and pneumococcal vaccination in the elderly on health service utilisation and costs: a claims data-based cohort study.

BACKGROUND: To date, cost-effectiveness of influenza and pneumococcal vaccinations was assumed in several health economic modelling studies, but confirmation by real-world data is sparse. The aim of this study is to assess the effects on health care utilisation and costs in the elderly using real-world data on both, outpatient and inpatient care. METHODS: Retrospective community-based cohort study with 138,877 individuals aged ≥ 60 years, insured in a large health insurance fund in Thuringia (Germany). We assessed health care utilisation and costs due to influenza- or pneumococcal-associated diseases, respiratory infections, and sepsis in 2015 and 2016. Individuals were classified into four groups according to their vaccination status from 2008 to 2016 (none, both, or either only influenza or pneumococcal vaccination). Inverse probability weighting based on 236 pre-treatment covariates was used to adjust for potential indication and healthy vaccinee bias. RESULTS: Influenza vaccination appeared as cost-saving in 2016, with lower disease-related health care costs of - €178.87 [95% CI - €240.03;- €117.17] per individual (2015: - €50.02 [95% CI - €115.48;€15.44]). Cost-savings mainly resulted from hospital inpatient care, whereas higher costs occurred for outpatient care. Overall cost savings of pneumococcal vaccination were not statistically significant in both years, but disease-related outpatient care costs were lower in pneumococci-vaccinated individuals in 2015 [- €9.43; 95% CI - €17.56;- €1.30] and 2016 [- €12.93; 95% CI - €25.37;- €0.48]. Although we used complex adjustment, residual bias cannot be completely ruled out. CONCLUSION: Influenza and pneumococcal vaccination in the elderly can be cost-saving in selective seasons and health care divisions. As cost effects vary, interpretation of findings is partly challenging.

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.

Antidiabetic Therapy and Rate of Severe Hypoglycaemia in Patients with Type 2 Diabetes and Chronic Kidney Disease of Different Stages - A Follow-up Analysis of Health Insurance Data from Germany.

BACKGROUND: The presence of chronic kidney disease (CKD) influences the type of antiglycaemic therapy and the risk for hypoglycaemia. METHODS: In 2006, 2011 and 2016 health insurance data of people with diabetes type 2 were screened for CKD and the presence of severe hypoglycaemia (sHypo). The type of antihyperglycaemic therapy was recorded due to Anatomical Therapeutic Chemical (ATC) codes up to 3 months before suffering sHypo. RESULTS: The prevalence of CKD increased from 5.3% in 2006 to 7.3% in 2011 and 11.2% in 2016. Insulin-based therapies were used in 39.0, 39.1, and 37.9% of patients with, but only in 17.7, 17.4, and 18.8% of patients without CKD. Although the proportion of the CKD stages 1, 2 and 5 decreased, CKD stages 3 and 4 increased. The proportion of sHypo in CKD declined from 2006 (3.5%) to 2011 (3.0%) and 2016 (2.2%) but was still more than 10 times higher as compared to type 2 diabetic patients without CKD (0.3/0.2/0.2%) conferring a significantly higher probability of sHypo (OR 9.30, 95%CI 9.07-9.54) in CKD. The probability of sHypo was significantly lower in 2016 than in 2006 both in patients with (OR 0.58; CI 0.55-0.61) and without CKD (OR 0.70; CI 0.68-0.73). CONCLUSION: The prevalence of CKD increased from 2006 to 2016. Patients with CKD exhibited a 9-fold increased probability of sHypo, especially in patients treated with insulin plus oral anti-diabetic drugs. However, the rate and risk for sHypo decreased over time, probably as a consequence of new antidiabetic treatment options, better awareness of sHypo, and changed therapy goals.

Depression management within GP-centered health care - A case-control study based on claims data.

OBJECTIVE: For most patients with depression, GPs are the first and long-term medical providers. GP-centered health care (GPc-HC) programs target patients with chronic diseases. What are the effects of GPc-HC on primary care depression management? METHOD: An observational retrospective case-control study was conducted using health insurance claims data of patients with depressive disorder from July 2011 to December 2012. RESULTS: From 40,298 patients insured with the largest health plan in Central Germany participating in the GPc-HC program (intervention group, IG), we observed 4645 patients with depression over 18months: 72.2% women; 66.6years (mean); multiple conditions (morbidity-weight 2.50 (mean), 86%>1.0). We compared them with 4013 patients who did not participate (control group). In participants we found lower number of incomplete/non-specified depression diagnoses (4.46vs.4.82;MD-0.36; p<0.01); lower rate of patients consulting more than one GP-practice (49.1%vs.58.0%;PP-8.9;p<0.01); more GP-contacts (18.19vs.15.59;MD+2.60;p<0.01); more GP-initiated referrals to specialists (82.9%vs.79.3%;PP+3.6;p<0.05), more antidepressant pharmacotherapy prescribed by a GP (37.9%vs.35.4%;PP+2.5;p<0.05), more frequent guideline-concordant therapy duration (19.2%vs.13.1%;PP+6.1;p<0.01) and more patients receiving "GP-psychosomatic basic care" (38.2%vs.30.2%;PP+8.0;p<0.01). CONCLUSION: Depressive patients participating in a GPc-HC program may be more often diagnosed by a GP, receive symptom-monitoring and appropriate depression treatment.

Dental health and odontogenic infections among 6- to 16-year-old German students with special health care needs (SHCN).

OBJECTIVES: This cross-sectional study aimed to assess dental health and odontogenic infections in students with special health care needs (SHCN) in the Free State of Thuringia, Germany. METHODS: From 1283 students with SHCN aged 6-16 years, 66.0 % (n = 848 of whom are 35.7 % females and 64.3 % males) with intellectual/learning disabilities (ID/LD), physical disabilities (PD), and sensory disorders (SD) participated after informed consent in oral examinations according to WHO standards. Dental caries was assessed by dmft/DMFT, odontogenic infections by pufa/PUFA. Fissure sealants (FS) were scored in permanent molars. Data were compared to regional and national reference data and analysed by t test and age-adjusted logistic regression models. RESULTS: Students with SHCN revealed 41.2 % caries prevalence in permanent and 31.7 % in primary teeth. Highest prevalence/experience of caries and odontogenic infections in primary teeth was recorded in 6-11-year-olds with PD (65.1 %/2.3 dmft; 14.0 %/0.3 pufa). Most affected permanent teeth were observed in students with ID/LD (12-16-year-olds 59.6 %/2.4 DMFT; 6-11-year-olds 2.8 %/0.03 PUFA). All odontogenic infections in 12-16-year-olds occurred in males; n = 9 students revealed n = 9 teeth with pufa/PUFA. Students with ID/LD aged 6-11 years exhibited lowest prevalence of FS (29.0 %) and mean of 0.8 FS. Students with SHCN suffered more than twice as frequent from untreated dental caries and benefited up to 29.0 % less from FS than peers without disabilities. CONCLUSION: This first study investigating odontogenic infections of German students with SHCN revealed highest prevalence in primary teeth and in males. Oral health among students with SHCN is reduced, and FS are underutilized compared to German students without disabilities. CLINICAL RELEVANCE: Reinforcing the application of FS in students with SHCN might contribute to reducing disparities in oral health.

Assessment of PI-RADS v2 for the Detection of Prostate Cancer.

PURPOSE: To evaluate the diagnostic performance and inter-reader reliability of the multiparametric magnetic resonance imaging (mpMRI) based prostate imaging reporting and data system (PI-RADS) version 1 and version 2 for the assessment of prostate cancer. MATERIAL AND METHODS: A cohort of 82 patients underwent endorectal mpMRI at 1.5T. Patients had at least one lesion with a PI-RADS v1 assessment category of ≥3 and were selected for targeted in-bore MR-guided biopsy in a subsequent session. The results of the histopathological workup were used as reference standard. All lesions were retrospectively evaluated according to PI-RADS v2 by an experienced and unexperienced blinded reader. Diagnostic performance was compared by analyzing the area under the Receiver Operating Characteristics Curve (AUC). The weighted kappa method was used to calculate inter-reader reliability. RESULTS: Targeted MR-guided biopsy was performed in 136 lesions and revealed 39 malignant lesions in 31 patients. AUC values increased for the experienced reader (PI-RADS v1 0.79; PI-RADS v2 0.83) and unexperienced reader (PI-RADS v1 0.70; PI-RADS v2 0.83). When excluding the cases of low grade cancer (Gleason score=3+3), AUC values increased further for the experienced reader (PI-RADS v1 0.88; PI-RADS v2 0.91) and unexperienced reader (PI-RADS v1 0.78; PI-RADS v2 0.90). Specificity at the selected threshold of a PI-RADS v1/v2 assessment category ≥4 improved for both readers. Inter-reader agreement increased from κ=0.55 in PI-RADS v1 to κ=0.68 in v2. CONCLUSION: PI-RADS v2 improved diagnostic performance for the assessment of suspicious intraprostatic lesions identified in PI-RADS v1 for both readers and led to higher inter-reader reliability. These results suggest that PI-RADS v2 is a reliable and replicable reporting system for the assessment of prostate cancer.

The Impact of GP-Centered Healthcare.

BACKGROUND: In Germany, enhanced primary care ('GP-centered health care') is being promoted in order to strengthen the role of GPs and improve the quality of primary care. The aim of this study was to evaluate the impact of a GPcentered healthcare program, established in 2011 in the German federal state of Thuringia, on healthcare costs, care coordination, and pharmacotherapy. METHODS: We conducted a retrospective case-control study based on insurance claims data. Participants were followed from 18 months before the start of the program to 18 months after its introduction. The intervention and control groups were matched via propensity scores. RESULTS: 40 298 participants enrolled in the program for a minimum of 18 months (between July 2011 and December 2012) were included in the intervention arm of the study. The mean age was 64.8 years. There was no significant difference in total direct costs (primary outcome) between cases and controls. Turning to secondary outcomes, the number of GP consultations rose sharply (+47%; p<0.001), there were less patients who consulted more than one GP (-41.4%; p<0.001), and less specialist consultations without referral (-5.8%; p<0.001) among patients in the intervention group. The number of patients who participated in Disease Management Programs (DMPs) increased (+17.7%; p<0.001), as did the number of GP home visits (+5.0%; p<0.001), specialist consultations (+4.1%; p<0.01), and the number of hospitalizations (+4.3%; p=0.006). The costs for pharmaceuticals were lowered by 3.9% (p<0.001). CONCLUSION: The study indicates that the GP-centered healthcare program does not lead to lower direct health care costs. However, it may lead to more intense and better coordinated healthcare in older, chronically ill patients with multiple conditions. Further studies are needed on long-term effects and clinical endpoints.

Mortality prediction after cardiac surgery: blood lactate is indispensible.

BACKGROUND: Blood lactate is accepted as a mortality risk marker in intensive care units (ICUs), especially after cardiac surgery. Unfortunately, most of the commonly used ICU risk stratification scoring systems did not include blood lactate as a variable. We hypothesized that blood lactate alone can predict the risk of mortality after cardiac surgery with an accuracy that is comparable to those of other complex models. We therefore evaluated its accuracy at mortality prediction and compared it with that of other widely used complex scoring models statistically. METHODS: We prospectively collected data of all consecutive adult patients who underwent cardiac surgery between January 1, 2007, and December 31, 2009. By using χ2 statistics, a blood lactate-based scale (LacScale) with only four cutoff points was constructed in a developmental set of patients (January 1, 2007, and May 31, 2008). LacScale included five categories: 0 (≤ 1.7 mmol/L); 1 (1.8-5.9 mmol/L), 2 (6.0-9.3 mmol/L), 3 (9.4-13.3 mmol/L), and 4 (≥ 13.4 mmol/L). Its accuracy at predicting ICU mortality was evaluated in another independent subset of patients (validation set, June 1, 2008, and December 31, 2009) on both study-population level (calibration analysis, overall correct classification) and individual-patient-risk level (discrimination analysis, ROC statistics). The results were then compared with those obtained from other widely used postoperative models in cardiac surgical ICUs (Sequential Organ Failure Assessment [SOFA] score, Simplified Acute Physiology Score II [SAPS II], and Acute Physiology and Chronic Health Evaluation II [APACHE II] score). RESULTS: ICU mortality was 5.8% in 4,054 patients. LacScale had a reliable calibration in the validation set (2,087 patients). It was highly accurate in predicting ICU mortality with an area under the ROC curve (area under curve [AUC]; discrimination) of 0.88. This AUC was significantly larger than that of all the other models (SOFA 0.83, SAPS II: 0.79 and APACHE II: 0.76) according to DeLong's comparison. Integrating the LacScale in those scores further improved their accuracy by increasing their AUCs (0.88, 0.81, and 0.80, respectively). This improvement was also highly significant. CONCLUSION: Blood lactate accurately predicts mortality at both individual patient risk and patient cohort levels. Its precision is higher than that of other commonly used "complex" scoring models. The proposed LacScale is a simple and highly reliable model. It can be used (at bedside without electronic calculation) as such or integrated in other models to increase their accuracy.

A retrospective study on the incidence and risk factors of severe hypoglycemia in primary care.

AIMS: To investigate the incidence and risk factors of severe hypoglycemia (SH) in primary care. SH was defined as hypoglycemia with coma, or the need of glucose or glucagon injection. METHODS: We performed a cross-sectional retrospective study in patients with diabetes treated in primary care in Germany. We analyzed an unselected sample of participants with type 1 (n = 373) and type 2 diabetes (n = 4481) who participated in an insurance plan from the health care insurer Deutsche BKK. Data of participants with type 1 diabetes are as follows: women, n = 155 (42%); age, 49±16 years; diabetes duration, 20+13 years; BMI, 28±6 kg/m2; GHb, 7.1+1.5%; GHb≤7%, n = 263 (71%); GHb≥8.5%, n = 48 (13%). Data of participants with type 2 diabetes: women, n = 1979 (44%); age, 66±10 years; diabetes duration, 8±7 years; BMI, 30±5 kg/m2; GHb, 6.6±1.3%; GHb≤7%, n = 3747 (84%); GHb≥8.5%, n = 360 (8%); insulin therapy, n = 1175 (26%). RESULTS: The incidence of SH in type 1 diabetes: 1.3% (CI: 0.4%, 3.1%) per year; type 2 diabetes with insulin therapy: 0.9% (CI: 0.5%, 1.7%); without insulin therapy: 0.3% (CI: 0.1%, 0.6%). The event rate was 0.02 SH per patient/year in type 1 diabetes and 0.01 in type 2 diabetes, respectively. Low BMI, GHb, insulin therapy and female gender were associated with an increased risk of SH. CONCLUSIONS: In primary care, patients with diabetes can achieve good glycemic control with very rare events of SH. Due to low incidence, SH would have been an inappropriate parameter to evaluate the outcome quality of diabetes therapy in primary care.

Myeloproliferative neoplasm (MPN) symptom assessment form total symptom score: prospective international assessment of an abbreviated symptom burden scoring system among patients with MPNs.

PURPOSE: Myeloproliferative neoplasm (MPN) symptoms are troublesome to patients, and alleviation of this burden represents a paramount treatment objective in the development of MPN-directed therapies. We aimed to assess the utility of an abbreviated symptom score for the most pertinent and representative MPN symptoms for subsequent serial use in assessing response to therapy. PATIENTS AND METHODS: The Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (MPN-SAF TSS) was calculated as the mean score for 10 items from two previously validated scoring systems. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers. RESULTS: MPN-SAF TSS was calculable for 1,408 of 1,433 patients with MPNs who had a mean score of 21.2 (standard deviation [SD], 16.3). MPN-SAF TSS results significantly differed among MPN disease subtypes (P<.001), with a mean of 18.7 (SD, 15.3), 21.8 (SD, 16.3), and 25.3 (SD, 17.2) for patients with essential thrombocythemia, polycythemia vera, and myelofibrosis, respectively. The MPN-SAF TSS strongly correlated with overall quality of life (QOL; r=0.59; P<.001) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) functional scales (all P<.001 and absolute r≥0.50 except social functioning r=0.48). No significant trends were present when comparing therapy subgroups. The MPN-SAF TSS had excellent internal consistency (Cronbach's α=.83). Factor analysis identified a single underlying construct, indicating that the MPN-SAF TSS is an appropriate, unified scoring method. CONCLUSION: The MPN-SAF TSS is a concise, valid, and accurate assessment of MPN symptom burden with demonstrated clinical utility in the largest prospective MPN symptom study to date. This new prospective scoring method may be used to assess MPN symptom burden in both clinical practice and trial settings.

Daily-Mean-SOFA, a new derivative to increase accuracy of mortality prediction in cardiac surgical intensive care units.

BACKGROUND: Sequential organ failure assessment (SOFA) score is widely used in many cardiac surgical intensive care units (ICUs). Its derivatives (mean and maximum values) are known to be more accurate than the original daily values of SOFA itself. However, they were designed for research purposes and could be calculated only after ICU discharge. We aimed to develop a reliable derivative that can be easily calculated daily (Daily-Mean-SOFA) for aiding daily-decision-making and resource allocation. METHODS: All consecutive adult cardiac surgical patients from our ICU between January 1, 2007 and December 31, 2008 were included. We obtained Initial-SOFA (on day 1), the Original-Daily-SOFA value from the 1st to the 6th postoperative day, Max-SOFA (highest SOFA value during the whole ICU-stay), Mean-SOFA (sum of all daily SOFA values/the length of ICU-stay), and the new "Daily-Mean-SOFA" from day 2 to 6 (sum of SOFA from day 1 until day-n/n). We compared their accuracies at predicting ICU mortality using calibration and discrimination statistics. RESULTS: Total 2801 patients were included. The newly developed "Daily-Mean-SOFA" was significantly more accurate than the corresponding SOFA value of the same day in correctly predicting survival and mortality in the whole study population (OCC: 94.1 to 95.0%) and in accurately identifying the individual patient's risk of mortality (AUC: 0.859 to 0.904). It was better than all other derivatives except the Mean-SOFA which was superior to it (OCC: 96.3%; AUC: 0.913). CONCLUSIONS: The Daily-Mean-SOFA is a reliable derivative for daily risk stratification in cardiac ICUs. Due to its accuracy and daily availability, it may be used for risk-directed therapy in cardiac ICUs.

Logistic Organ Dysfunction Score (LODS): a reliable postoperative risk management score also in cardiac surgical patients?

BACKGROUND: The original Logistic Organ Dysfunction Sore (LODS) excluded cardiac surgery patients from its target population, and the suitability of this score in cardiac surgery patients has never been tested. We evaluated the accuracy of the LODS and the usefulness of its daily measurement in cardiac surgery patients. The LODS is not a true logistic scoring system, since it does not use ß-coefficients. METHODS: This prospective study included all consecutive adult patients who were admitted to the intensive care unit (ICU) after cardiac surgery between January 2007 and December 2008. The LODS was calculated daily from the first until the seventh postoperative day. Performance was assessed with Hosmer-Lemeshow (HL) goodness-of-fit test (calibration) and receiver operating characteristic (ROC) curves (discrimination) from ICU admission day until day 7. The outcome measure was ICU mortality. RESULTS: A total of 2801 patients (29.6% female) with a mean age of 66.4 ± 10.7 years were included. The ICU mortality rate was 5.2% (n = 147). The mean stay on the ICU was 4.3 ± 6.8 days. Calibration of the LODS was good with no significant difference between expected and observed mortality rates on any day (p ≥ 0.05). The initial LODS had an area under the ROC curve (AUC) of 0.81. The AUC was best on ICU day 3 with a value of 0.93, and declined to 0.85 on ICU day 7. CONCLUSIONS: Although the LODS has not previously been validated for cardiac surgery patients it showed reasonable accuracy in prediction of ICU mortality in patients after cardiac surgery.