Integration of Patient-Generated Test Results with Those from Accredited Laboratories

In response to my note yesterday about direct-access-testing (DAT) (see:New Definition for DTC Lab Testing Prompted by EverlyWell Business Model), Andrea Pitkin, Ph.D., commented in the form of a presentation she had made at the last ASCLS annual meeting. She makes a number of important observations that I hope to comment on in upcoming days. For this note, I will address the following point copied from her comment:How are consumer testing and Patient Generated Health Data (PGHD) integrated and used within the medical record?Some apps allow upload to the physician's EHR. They should not be comingled with laboratory performed testing as they are different. The largest issue is one of trust.Does the physician trust from a medical and legal perspective, results performed by consumers (who may have invalidated the home pregnancy test when dropped in the toilet) versus health professional performed testing? How are results kept separate in EHR modules and clinical displays? These new methods and perhaps specimens or transcutaneous analysis should have different LOINC codes so all users can identify these differences in health data.I personally think that it's time for one of the various lab standards/accreditation agencies to begin to grapple with what Andrea refers to as Patient Generated Health Data (PGHD). To what extent should it be be integrated, but not comingled, with test results generated in accredited clinical laboratories? This topic is not a...
Source: Lab Soft News - Category: Laboratory Medicine Authors: Tags: Clinical Lab Testing Diagnostics Direct Access Testing (DAT) Electronic Health Record (EHR) Health Wearable Healthcare Information Technology Lab Industry Trends Lab Standards Medical Consumerism Point-of-Care Testing Public Health R Source Type: blogs

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Authors: Ericksen K, Fogel J, Verma RP Abstract Background: The etiopathogenesis of late preterm birth is undetermined. Placental histopathology (PH) reflects adverse intrauterine environment and is documented to be associated with preterm labor and neonatal morbidities. The placental histopathology has not been studied in late preterm infants. Purpose: We investigated placental pathological lesion as markers of adverse intrauterine environment during late preterm labor. Methods: In a retrospective case control study following placental histopathological and clinical variables were compared between late pre...
Source: Korean Journal of Pediatrics - Category: Pediatrics Tags: Korean J Pediatr Source Type: research
Aldosterone is the main mineralocorticoid hormone, responsible of the regulation of fluid and electrolyte balance and blood pressure. It acts also as a pro-inflammatory factor responsible of an increased cardiovascular risk, independent from blood pressure values. After the discovery of mineralocorticoid receptor (MR) in mononuclear leukocytes, further studies support its role in inflammatory and even autoimmune mechanisms underlying several diseases. In particular, recent studies reported a possible involvement of aldosterone in some gynecological conditions and diseases, characterized by inflammation, hypertension and in...
Source: Frontiers in Endocrinology - Category: Endocrinology Source Type: research
ConclusionsIVF-OD patients should be considered an independent risk factor for some adverse perinatal outcomes, mainly hypertensive disorders in pregnancy, preeclampsia, and severe preeclampsia. Immunological and hormonal aspects may be involved in these results, and further research focusing in the etiopathogenesis of these pathologies are needed.
Source: Journal of Assisted Reproduction and Genetics - Category: Reproduction Medicine Source Type: research
Abstract Preeclampsia is a pregnancy-induced condition that impairs mother's health and results in pregnancy termination or premature delivery. Elevated levels of placenta-derived extracellular vesicles in the circulation have been consistently associated with preeclampsia, but whether placenta-derived extracellular vesicles induce preeclampsia or are merely the product of preeclampsia is not known. Guided by a small cohort study of preeclampsia patients, we examined the impact of placenta-derived extracellular vesicles on the pathogenesis of preeclampsia in mouse models. We found that placenta-derived extracellul...
Source: Haematologica - Category: Hematology Authors: Tags: Haematologica Source Type: research
Publication date: Available online 20 August 2019Source: Anaesthesia &Intensive Care MedicineAuthor(s): Amanda Zacharzewski, Ross MacnabAbstractCardiac disease is a significant cause of maternal mortality. In the UK in the last maternal mortality report, it was the leading cause of indirect maternal deaths (2.39 deaths per 100,000 maternities). The overall rate of maternal mortality from cardiac disease has significantly increased over the last three decades, with this increase being mostly attributable to deaths from ischaemic heart disease, myocardial infarction and peripartum cardiomyopathy. Conditions such as pulmo...
Source: Anaesthesia and intensive care medicine - Category: Anesthesiology Source Type: research
ConclusionWe assume that these eleven increased placenta derived factors are responsible for LSEC damage which eventually leads to liver failure. This concept shows a possible design of the complicated pathophysiology in HELLP syndrome. However further research is required.
Source: Pregnancy Hypertension: An International Journal of Womens Cardiovascular Health - Category: OBGYN Source Type: research
Publication date: Available online 19 August 2019Source: Pregnancy HypertensionAuthor(s): Alfred O. Osoti, Stephanie T. Page, Barbra A. Richardson, Brandon L. Guthrie, John Kinuthia, Stephen J. Polyak, Carey FarquharAbstractObjectiveWe evaluated the 6-month postpartum risk of metabolic syndrome (MetS), a marker of future cardiovascular disease (CVD) risk, comparing women whose most recent pregnancies were complicated with gestational hypertension (GH) or preeclampsia (PE) versus those who had normotensive pregnancies.Study designThis was a prospective cohort study in which women with GH or PE and normotensive women were ac...
Source: Pregnancy Hypertension: An International Journal of Womens Cardiovascular Health - Category: OBGYN Source Type: research
CONCLUSION: The results confirm the importance of studies involving Social Determinants of Health, since they interfere in the way women choose birth control methods and the risks that this choice may pose to their health. PMID: 31432964 [PubMed - in process]
Source: Revista Brasileira de Enfermagem - Category: Nursing Authors: Tags: Rev Bras Enferm Source Type: research
The objective was to evaluate the association between fetal sex and adverse pregnancy outcome, whilst correcting for fetal growth and gestational age at delivery.Material and MethodsData were used from the Netherlands Perinatal Registry (1999 ‐2010). The study population comprised all white‐European women with a singleton delivery between 25+0 and 42+6 weeks of gestation. Fetuses with structural or chromosomal abnormalities were excluded. Outcomes were antepartum death, intrapartum/neonatal death (from onset of labor until 28 days after birth), perinatal death (antepartum death or intrpartum/neonatal death), a composit...
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: ORIGINAL RESEARCH ARTICLE Source Type: research
Publication date: Available online 16 August 2019Source: European Journal of Obstetrics &Gynecology and Reproductive BiologyAuthor(s): Andrew Sharp, Richard Jackson, Christine Cornforth, Jane Harrold, Mark A. Turner, Louise Kenny, Philip N. Baker, Edward D. Johnstone, Asma Khalil, Peter von Dadelszen, Aris T. Papageorghiou, Zarko AlfirevicAbstractBackgroundSevere early-onset fetal growth restriction (FGR) predisposes to fetal death, neonatal death, neonatal morbidity and neurodisability. The use of placental biomarkers has been proposed for risk stratification in pre-eclampsia, but they could be equally useful in fetal...
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - Category: OBGYN Source Type: research
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