Effect of electronic patient record use on mortality in End Stage Renal Disease, a model chronic disease: retrospective analysis of 9 years of prospectively collected data

<p>Abstract</p> <p>Background</p> <p>In chronic disease, health information technology promises but has yet to demonstrate improved outcomes and decreased costs. The main aim of the study was to determine the effects on mortality and cost of an electronic patient record used in daily patient care in a model chronic disease, End Stage Renal Disease, treated by chronic maintenance hemodialysis. Dialysis treatment is highly regulated, and near uniform in treatment modalities and drugs used.</p> <p>Methods</p> <p>The particular electronic patient record, patient-centered and extensively coded, was used first in patient care in 3 dialysis units in New York, NY in 1998, 1999, and 2000. All data were stored "live"; none were archived. By December 31, 2006, the patients had been treated by maintenance hemodialysis for a total of 3924 years. A retrospective analysis was made using query tools embedded in the software. The United States Renal Data System dialysis population served as controls. In all there were 1790 patients, with many underlying primary diseases and multiple comorbid conditions affecting many organ systems. Year by year mortality, hospital admissions, and staffing were analyzed, and the data were compared with national data compiled by the United States Renal Data System.</p> <p>Results</p> <p>Analyzed by calendar year after electronic patient record implementation, mortality decreased strikingly. In years 3–9 mortality was lower than in years 1–2 by 23%, 48%, and 34% in the 3 units, and was 37%, 37%, and 35% less than that reported by the United States Renal Data System. Clinical staffing was 25% fewer per 100 patients than the national average, thereby lowering costs.</p> <p>Conclusion</p> <p>To our knowledge, this is the first demonstration that an electronic patient record, albeit of particular design, can have a favorable effect on outcomes and cost in chronic disease. That the population studied has many underlying diseases affecting all organ systems suggests that the electronic patient record design may enable application to many fields of medical practice.</p

Everolimus in Anaplastic Thyroid Cancer: A Case Series

Background: Anaplastic thyroid cancer (ATC) is a very aggressive disease and accounts for over 50% of thyroid-cancer related deaths. mTOR inhibition has shown anti-tumor activity in ATC. We report our experience treating patients with ATC with everolimus off-protocol.Methods: Patients with confirmed ATC and treated with everolimus at DFCI were identified and reviewed retrospectively. NexGen sequencing was performed, and radiologic responses were correlated with mutational profile.Results: Five patients were treated from 2013 to 2016. Three patients had a response, which included one patient who achieved a partial response for 27.9 months, and two patients who had stable disease for 3.7 and 5.9 months, respectively. Genomic analysis was available in two patients and revealed that the partial responder had mutations involving the PI3K/mTOR pathway.Conclusion: Everolimus has anti-tumor activity in ATC, and responses may correlate with mutations involving the PI3K/mTOR pathway. Further studies are warranted

The importance of iron in long-term survival of maintenance hemodialysis patients treated with epoetin-alfa and intravenous iron: analysis of 9.5 years of prospectively collected data

<p>Abstract</p> <p>Background</p> <p>In patients treated by maintenance hemodialysis the relationship to survival of hemoglobin level and administered epoetin-alfa and intravenous iron is controversial. The study aim was to determine effects on patient survival of administered epoetin-alfa and intravenous iron, and of hemoglobin and variables related to iron status.</p> <p>Methods</p> <p>The patients were 1774 treated by maintenance hemodialysis in 3 dialysis units in New York, NY from January 1998 to June, 2007. A patient-centered, coded, electronic patient record used in patient care enabled retrospective analysis of data collected prospectively. For survival analysis, patients were censored when transplanted, transferred to hemodialysis at home or elsewhere, peritoneal dialysis. Univariate Kaplan-Meier analysis was followed by multivariate analysis with Cox's regression, using as variables age, race, gender, major co-morbid conditions, epoetin-alfa and intravenous iron administered, and 15 laboratory tests.</p> <p>Results</p> <p>Median age was 59 years, epoetin-alfa (interquartile range) 18,162 (12,099, 27,741) units/week, intravenous iron 301 (202, 455) mg/month, survival 789 (354, 1489) days. Median hemoglobin was 116 (110, 120)g/L, transferrin saturation 29.7 (24.9, 35.1)%, serum ferritin 526 (247, 833) μg/L, serum albumin 39.0 (36.3, 41.5) g/L. Survival was better the higher the hemoglobin, best with > 120 g/L. Epoetin-alfa effect on survival was weak but had statistically significant interaction with intravenous iron. For intravenous iron, survival was best with 1–202 mg/month, slightly worse with 202–455 mg/month; it was worst with no intravenous iron, only slightly better with > 455 mg/month. Survival was worst with transferrin saturation ≤ 16%, serum ferritin ≤ 100 μg/L, best with transferrin saturation > 25%, serum ferritin > 600 μg/L The effects of each of hemoglobin, intravenous iron, transferrin saturation, and serum ferritin on survival were independently significant and not mediated by other predictors in the model.</p> <p>Conclusion</p> <p>Long term survival of maintenance hemodialysis patients was favorably affected by a relatively high hemoglobin level, by moderate intravenous iron administration, and by indicators of iron sufficiency. It was unfavorably influenced by a low hemoglobin level, and by indicators of iron deficiency.</p

Predicting Outcomes in Men With Metastatic Nonseminomatous Germ Cell Tumors (NSGCT): Results From the IGCCCG Update Consortium

Purpose: The classification of the International Germ Cell Cancer Collaborative Group (IGCCCG) plays a pivotal role in the management of metastatic germ cell tumors but relies on data of patients treated between 1975 and 1990. Materials and methods: Data on 9,728 men with metastatic nonseminomatous germ cell tumors treated with cisplatin- and etoposide-based first-line chemotherapy between 1990 and 2013 were collected from 30 institutions or collaborative groups in Europe, North America, and Australia. Clinical trial and registry data were included. Primary end points were progression-free survival (PFS) and overall survival (OS). The survival estimates were updated for the current era. Additionally, a novel prognostic model for PFS was developed in 3,543 patients with complete information on potentially relevant variables. The results were validated in an independent data set. Results: Compared with the original IGCCCG publication, 5-year PFS remained similar in patients with good prognosis with 89% (87%-91%) versus 90% (95% CI, 89 to 91), but the 5-year OS increased from 92% (90%-94%) to 96% (95%-96%). In patients with intermediate prognosis, PFS remained similar with 75% (71%-79%) versus 78% (76%-80%) and the OS increased from 80% (76%-84%) to 89% (88%-91%). In patients with poor prognosis, the PFS increased from 41% (95% CI, 35 to 47) to 54% (95% CI, 52 to 56) and the OS from 48% (95% CI, 42 to 54) to 67% (95% CI, 65 to 69). A more granular prognostic model was developed and independently validated. This model identified a new cutoff of lactate dehydrogenase at a 2.5 upper limit of normal and increasing age and presence of lung metastases as additional adverse prognostic factors. An online calculator is provided (https://www.eortc.org/IGCCCG-Update). Conclusion: The IGCCCG Update model improves individual prognostication in metastatic nonseminomatous germ cell tumors. Increasing age and lung metastases add granularity to the original IGCCCG classification as adverse prognostic factors

Robust estimation of bacterial cell count from optical density

Optical density (OD) is widely used to estimate the density of cells in liquid culture, but cannot be compared between instruments without a standardized calibration protocol and is challenging to relate to actual cell count. We address this with an interlaboratory study comparing three simple, low-cost, and highly accessible OD calibration protocols across 244 laboratories, applied to eight strains of constitutive GFP-expressing E. coli. Based on our results, we recommend calibrating OD to estimated cell count using serial dilution of silica microspheres, which produces highly precise calibration (95.5% of residuals &lt;1.2-fold), is easily assessed for quality control, also assesses instrument effective linear range, and can be combined with fluorescence calibration to obtain units of Molecules of Equivalent Fluorescein (MEFL) per cell, allowing direct comparison and data fusion with flow cytometry measurements: in our study, fluorescence per cell measurements showed only a 1.07-fold mean difference between plate reader and flow cytometry data

Effective Computerized Patient Record Improves Patient Well-Being and Financial Performance

Effective application of information technology has transformed many facets of modern life, such as manufacturing and finance, but has had little measurable effect on medicine in general, or on nephrology and dialysis in particular. The failure of information technology in medicine can, in our opinion, be traced to poor design and implementation of medical software. Even today, nurses and physicians still spend 50% and 33%, respectively, of their time on paperwork. Our approach to computerization of the patient record, begun 24 years ago, treats the patient as the central core of the computerized record system, and makes use of a comprehensive, clinically relevant, time-oriented, digitally coded database. An embedded query tool allows quick and easy organization of the database at the point of care to make knowledge available about individuals and groups of patients, and without delay. In those scenarios where effective computerization has been combined with effective clinical and administrative management, the results have been striking. Demonstrated and published results include: 1) Improved patient welfare, with a decrease in both mortality (20-25% less than the U.S. average) and in morbidity (increased serum albumin and muscle mass, and decreased blood pressure and hospitalization). 2) More efficient and effective use of personnel caring for the patient (5.9 fewer full-time staff per 100 hemodialysis patients than the national average), with consequent increase in patient satisfaction and saving of staff time. 3) Reduction and containment of costs of medical supplies. 4) Effective management of the processes involved in billing, collection, and accounts receivable. 5) Online, continuous quality improvement and effective clinical and administrative management of the dialysis unit based on timely, complete knowledge of relevant information (especially when unexpected events occur). 6) Significantly improved return on investment; net savings of at least $13.69 to$17.40 per hemodialysis treatment have been achieved

Continuous quality improvement in daily clinical practice: a proof of concept study.

Continuous Quality Improvement (CQI) is an iterative process of: planning to improve a product or process, plan implementation, analyzing and comparing results against those expected, and corrective action on differences between actual and expected results. It is little used in clinical medicine. Anemia, a complex problem in End Stage Renal Disease patients, served to test the ability of an unique electronic medical record (EMR) optimized for daily care to empower CQI in practice. We used data collected during daily care, stored in the EMR, and organized to display temporal relationships between clinical, laboratory, and therapeutic events. Our aims were optimal hemoglobin with minimum epoetin, and maintaining stable hemoglobin and epoetin. The study was done on 250 patients treated by maintenance hemodialysis (HD), receiving epoetin prior to February 1, 2010 and followed to July 31, 2011. Repleting iron, ensuring iron sufficiency, slow epoetin reduction, and decision support tools enabling data display over long periods in patient-centered reports were key elements. Epoetin dose, adjusted 6-8 weekly, was based on current clinical conditions and past responses. Hemoglobin increased by months 1-2; epoetin decreased from month 4. By months 16-18, epoetin had decreased 42% to 9,720 units/week while hemoglobin increased 8% to 123.6 g/L. Hemoglobin and epoetin were stable from month 7 onward. New epoetin orders decreased 83%. Transferrin saturation increased after the study start. Individual patient hemoglobin variation decreased by 23%, range by 27%. Mortality, 11.78 per 100 patient years, was 42% less than United States dialysis patient mortality. Allowable epoetin charges decreased by $15.33 per treatment and were$22.88 less than current Medicare allowance. The study validates the hypothesis that an EMR optimized for daily patient care can empower CQI in clinical medicine and serve to monitor medical care quality and cost

A model of a patient-centered EMR that, with a single database, accommodates multiple clinical functions and domains of information.

<p>As shown these include symptoms, physical signs, laboratory tests, medicines, diagnoses, diagnostic and surgical procedures, radiology, medical notes, nutrition, and social work. The single database also accommodates and includes the needs of: caregivers and other staff; data entry and reporting of physicians, nurses, dietitians, social workers, pharmacists, administrators, and clerical, billing, and accounting staff; multiple locations including main and remote dialysis units, peritoneal dialysis unit, home HD, chronic kidney disease, renal and other transplant, physician office, hospital outpatient; non-clinical functions such as insurance, fee tables, charges, physician billing, dialysis unit billing, electronic remittance and explanation of benefits.</p