Real-world Health Data and Precision for the Diagnosis of Acute Kidney Injury, Acute-on-Chronic Kidney Disease, and Chronic Kidney Disease: Observational Study.

BACKGROUND The criteria for the diagnosis of kidney disease outlined in the Kidney Disease: Improving Global Outcomes guidelines are based on a patient's current, historical, and baseline data. The diagnosis of acute kidney injury, chronic kidney disease, and acute-on-chronic kidney disease requires previous measurements of creatinine, back-calculation, and the interpretation of several laboratory values over a certain period. Diagnoses may be hindered by unclear definitions of the individual creatinine baseline and rough ranges of normal values that are set without adjusting for age, ethnicity, comorbidities, and treatment. The classification of correct diagnoses and sufficient staging improves coding, data quality, reimbursement, the choice of therapeutic approach, and a patient's outcome. OBJECTIVE In this study, we aim to apply a data-driven approach to assign diagnoses of acute, chronic, and acute-on-chronic kidney diseases with the help of a complex rule engine. METHODS Real-time and retrospective data from the hospital's clinical data warehouse of inpatient and outpatient cases treated between 2014 and 2019 were used. Delta serum creatinine, baseline values, and admission and discharge data were analyzed. A Kidney Disease: Improving Global Outcomes-based SQL algorithm applied specific diagnosis-based International Classification of Diseases (ICD) codes to inpatient stays. Text mining on discharge documentation was also conducted to measure the effects on diagnosis. RESULTS We show that this approach yielded an increased number of diagnoses (4491 cases in 2014 vs 11,124 cases of ICD-coded kidney disease and injury in 2019) and higher precision in documentation and coding. The percentage of unspecific ICD N19-coded diagnoses of N19 codes generated dropped from 19.71% (1544/7833) in 2016 to 4.38% (416/9501) in 2019. The percentage of specific ICD N18-coded diagnoses of N19 codes generated increased from 50.1% (3924/7833) in 2016 to 62.04% (5894/9501) in 2019. CONCLUSIONS Our data-driven method supports the process and reliability of diagnosis and staging and improves the quality of documentation and data. Measuring patient outcomes will be the next step in this project

Psychoanalytic and cognitive-behavior therapy of chronic depression : study protocol for a randomized controlled trial

Background: Despite limited effectiveness of short-term psychotherapy for chronic depression, there is a lack of trials of long-term psychotherapy. Our study is the first to determine the effectiveness of controlled long-term psychodynamic and cognitive-behavioral (CBT) treatments and to assess the effects of preferential vs. randomized assessment. Methods/design: Patients are assigned to treatment according to their preference or randomized (if they have no clear preference). Up to 80 sessions of psychodynamic or psychoanalytically oriented treatments (PAT) or up to 60 sessions of CBT are offered during the first year in the study. After the first year, PAT can be continued according to the ‘naturalistic’ usual method of treating such patients within the system of German health care (normally from 240 up to 300 sessions over two to three years). CBT therapists may extend their treatment up to 80 sessions, but focus mainly maintenance and relapse prevention. We plan to recruit a total of 240 patients (60 per arm). A total of 11 assessments are conducted throughout treatment and up to three years after initiation of treatment. The primary outcome measures are the Quick Inventory of Depressive Symptoms (QIDS, independent clinician rating) and the Beck Depression Inventory (BDI) after the first year. Discussion: We combine a naturalistic approach with randomized controlled trials(RCTs)to investigate how effectively chronic depression can be treated on an outpatient basis by the two forms of treatment reimbursed in the German healthcare system and we will determine the effects of treatment preference vs. randomization

Potential of Dried Blood Self-Sampling for Cyclosporine C2 Monitoring in Transplant Outpatients

Background. Close therapeutic drug monitoring of Cyclosporine (CsA) in transplant outpatients is a favourable procedure to maintain the long-term blood drug levels within their respective narrow therapeutic ranges. Compared to basal levels (C0), CsA peak levels (C2) are more predictive for transplant rejection. However, the application of C2 levels is hampered by the precise time of blood sampling and the need of qualified personnel. Therefore, we evaluated a new C2 self-obtained blood sampling in transplant outpatients using dried capillary and venous blood samples and compared the CsA levels, stability, and clinical practicability of the different procedures. Methods. 55 solid organ transplant recipients were instructed to use single-handed sampling of each 50 μL capillary blood and dried blood spots by finger prick using standard finger prick devices. We used standardized EDTA-coated capillary blood collection systems and standardized filter paper WS 903. CsA was determined by LC-MS/MS. The patients and technicians also answered a questionnaire on the procedure and sample quality. Results. The C0 and C2 levels from capillary blood collection systems (C0 [ng/mL]: 114.5 ± 44.5; C2: 578.2 ± 222.2) and capillary dried blood (C0 [ng/mL]: 175.4 ± 137.7; C2: 743.1 ± 368.1) significantly (P < .01) correlated with the drug levels of the venous blood samples (C0 [ng/mL]: 97.8 ± 37.4; C2: 511.2 ± 201.5). The correlation at C0 was ρcap.-ven. = 0.749, and ρdried blood-ven = 0.432; at C2: ρcap.-ven. = 0.861 and ρdried blood-ven = 0.711. The patients preferred the dried blood sampling because of the more simple and less painful procedure. Additionally, the sample quality of self-obtained dried blood spots for LC-MS/MS analytics was superior to the respective capillary blood samples. Conclusions. C2 self-obtained dried blood sampling can easily be performed by transplant outpatients and is therefore suitable and cost-effective for close therapeutic drug monitoring

Recovery from chronic depression and structural change : 5-year outcomes after psychoanalytic and cognitive-behavioural long-term treatments (LAC depression study)

Objective: Psychotherapy of chronic depression has remained a challenge due to limited prognosis and high rates of recurrence. We present 5-year outcome data from a multicentre trial comparing psychoanalytic (PAT) and cognitive-behavioural (CBT) long-term treatments with randomized and preferred allocations analysing symptom (N = 227) and structural change (N = 134) trajectories. Method: Self- and blinded expert ratings of depression symptoms were performed at yearly intervals using the Beck Depression Inventory-II (BDI-II) and Quick Inventory of Depressive Symptoms (QIDS-C). Blinded expert ratings of Operationalized Psychodynamic Diagnosis (OPD) and the Heidelberg Restructuring Scale (HRS) at baseline, 1, 3, and 5 years assessed structural change in a subsample. Results: Lasting and comparable symptom changes were achieved by PAT and CBT. However, compared to CBT, PAT was more successful in restructuring, a major goal of long-term psychodynamic treatments with high frequency and duration. Limitations: Due to practical reasons, the time criterion for chronic depression of an acute phase had to be defined for over 1 year in the present study, which does not correspond to the DSM-5 criterion of 2 years. Therapy duration and session frequency were not incorporated into the statistical models. Conclusion: Long-term psychotherapy helps patients with a yearlong history of depression and often multiple unsuccessful treatment attempts to achieve lasting symptom changes. Future follow-up will clarify whether restructuring promotes further sustainable improvements

Unbiased analysis of obesity related, fat depot specific changes of adipocyte volumes and numbers using light sheet fluorescence microscopy

In translational obesity research, objective assessment of adipocyte sizes and numbers is essential to characterize histomorphological alterations linked to obesity, and to evaluate the efficacies of experimental medicinal or dietetic interventions. Design-based quantitative stereological techniques based on the analysis of 2D-histological sections provide unbiased estimates of relevant 3D-parameters of adipocyte morphology, but often involve complex and time-consuming tissue processing and analysis steps. Here we report the application of direct 3D light sheet fluorescence microscopy (LSFM) for effective and accurate analysis of adipocyte volumes and numbers in optically cleared adipose tissue samples from a porcine model of diet-induced obesity (DIO). Subcutaneous and visceral adipose tissue samples from DIO-minipigs and lean controls were systematically randomly sampled, optically cleared with 3DISCO (3-dimensional imaging of solvent cleared organs), stained with eosin, and subjected to LSFM for detection of adipocyte cell membrane autofluorescence. Individual adipocytes were unbiasedly sampled in digital 3D reconstructions of the adipose tissue samples, and their individual cell volumes were directly measured by automated digital image analysis. Adipocyte numbers and mean volumes obtained by LSFM analysis did not significantly differ from the corresponding values obtained by unbiased quantitative stereological analysis techniques performed on the same samples, thus proving the applicability of LSFM for efficient analysis of relevant morphological adipocyte parameters. The results of the present study demonstrate an adipose tissue depot specific plasticity of adipocyte growth responses to nutrient oversupply. This was characterized by an exclusively hypertrophic growth of visceral adipocytes, whereas adipocytes in subcutaneous fat tissue depots also displayed a marked (hyperplastic) increase in cell number. LSFM allows for accurate and efficient determination of relevant quantitative morphological adipocyte parameters. The applied stereological methods and LSFM protocols are described in detail and can serve as a guideline for unbiased quantitative morphological analyses of adipocytes in other studies and species

Electrolyte disorders and in-hospital mortality during prolonged heat periods: a cross-sectional analysis

BACKGROUND Heat periods during recent years were associated with excess hospitalization and mortality rates, especially in the elderly. We intended to study whether prolonged warmth/heat periods are associated with an increased prevalence of disorders of serum sodium and potassium and an increased hospital mortality. METHODS In this cross-sectional analysis all patients admitted to the Department of Emergency Medicine of a large tertiary care facility between January 2009 and December 2010 with measurements of serum sodium were included. Demographic data along with detailed data on diuretic medication, length of hospital stay and hospital mortality were obtained for all patients. Data on daily temperatures (maximum, mean, minimum) and humidity were retrieved by Meteo Swiss. RESULTS A total of 22.239 patients were included in the study. 5 periods with a temperature exceeding 25 °C for 3 to 5 days were noticed and 2 periods with temperatures exceeding 25 °C for more than 5 days were noted. Additionally, 2 periods with 3 to 5 days with daily temperatures exceeding 30 °C were noted during the study period. We found a significantly increased prevalence of hyponatremia during heat periods. However, in the Cox regression analysis, prolonged heat was not associated with the prevalence of disorders of serum sodium or potassium. Admission during a heat period was an independent predictor for hospital mortality. CONCLUSIONS Although we found an increased prevalence of hyponatremia during heat periods, no convincing connection could be found for hypernatremia or disorders of serum potassium

In-vitro hemolysis and its financial impact using different blood collection systems

Background: Hemolytic specimens are among the most challenging preanalytical issues in laboratory diagnostics. The type of blood collection tube in use is claimed to influence in vitro hemolysis. We aimed to examine this hypothesis and estimate the respective financial impact, evaluating routine blood samples from the past 4 years. Methods: A total of 47,820 hemolysis index (HI) values from five different time intervals (IV1-IV5) were compared against each other, representing the following tubes: IV1-Sarstedt Monovette; IV2-8 mL/16×100 mm Greiner BioOne (GBO) Vacuette; IV3/IV4-5 mL/16×100 mm GBO Vacuette; IV5-4.5 mL/13×75 mm GBO Vacuette. For estimation of the economic impact, material, personnel and analytical costs were calculated. Results: HI mean values in time interval IV2 were significantly higher than in all other intervals, while mean values amongst all other intervals were comparable. The number of moderately and severely hemolyzed samples increased with incrementing vacuum. Overall comparable costs between intervals IV1 and IV5 were €11,370, €14,045, €12,710, €11,213 and €8138 per 10,000 samples, respectively. Conclusions: Aspiration tubes and low vacuum tubes show comparable hemolysis rates. Increasing vacuum levels are associated with higher hemolysis rates. By decreasing in vitro hemolysis, financial savings up to €5907 per 10,000 samples could be gained