Leveraging longitudinal clinical laboratory results to improve prenatal care.

OBJECTIVES: To assess the impact of providing laboratory-generated near-real-time clinical insights for pregnant Medicaid members to managed care organization (MCO) care coordinators. STUDY DESIGN: A prospective, nonrandomized feasibility study was conducted over 11 months to examine the benefits of laboratory-generated clinical insights on prenatal care quality metrics and clinical outcomes. Measures included early identification of pregnancy and births to facilitate care, care gaps with prenatal laboratory testing, emergency department (ED) visits, preterm births, and neonatal intensive care unit (NICU) admissions and length of stay. METHODS: Weekly MCO care coordinators were provided a laboratory-generated prenatal targeted intervention module (TIM) to supplement their existing systems in a longitudinal, patient-centric format. Care coordinators contacted patients for enrollment in prenatal or postpartum services based on the TIM, which identified concomitant health conditions, missing prenatal care, and risks. RESULTS: The prenatal TIM identified 1355 pregnant members, 77% (n = 1040) of whom were detected in the first trimester. A total of 488 births were identified within 24 hours of parturition. Sixty-four percent of women had at least 80% of prenatal care gaps associated with laboratory testing closed. Women with ongoing prenatal care had fewer ED visits (17% vs 23%) and NICU admissions (11% vs 18%) compared with those without prenatal care. After adjusting for confounders, ongoing prenatal care had a borderline effect at decreasing the probability of having an ED visit and a NICU admission. CONCLUSIONS: An innovative collaboration between an MCO and a clinical laboratory improved quality measures for prenatal members enrolled in Medicaid.

The Value of Laboratory Information Augmenting a Managed Care Organization's Comprehensive Diabetes Care Efforts in New Mexico.

BACKGROUND: The National Committee on Quality Assurance's Healthcare Effectiveness Data and Information Set on Comprehensive Diabetes Care requires patients with diabetes obtain a hemoglobin A1c (Hb A1c) and urine albumin-to-creatinine ratio (ACR) test every year. To improve these measures, managed care organizations (MCOs) rely on claim and prescription data to identify members for care management. TriCore Reference Laboratories collaborated with Blue Cross Blue Shield of New Mexico (BCBSNM) to determine if laboratory information would augment BCBSNM's diabetes care management services. METHOD: In January 2018, BCBSNM provided its Medicaid enrollment file to TriCore for identifying members and determining their diabetes status by evaluating their recent Hb A1c results. Of the 6,138 members with diabetes, a random sample of 600 was extracted, and half were provided to BCBSNM to perform care management from January 18 to May 1, 2018. Completion of Hb A1c and ACR were measured. RESULTS: Significantly more (P = 0.03) study group members (25%) than control group members (18%) received an Hb A1c test. The study group (14%) also received more ACR tests than the control group (9%; P = 0.07). We then calculated the monetary penalty to which New Mexico Medicaid MCOs are subject, leading to the identification of additional value ($3,693,000) that clinical laboratories provide beyond the cost per test. CONCLUSION: Clinical laboratories play a critical role in healthcare, and this article demonstrates an approach for laboratories to collaborate with MCOs in their care management efforts. In addition, we calculate the value of this novel collaboration, which may play an integral role in laboratories' pursuit of value-based care.

Improving the Delivery of Healthcare through Clinical Diagnostic Insights: A Valuation of Laboratory Medicine through "Clinical Lab 2.0".

BACKGROUND: As healthcare payment and reimbursement begin to shift from a fee-for-service to a value-based model, ancillary providers including laboratories must incorporate this into their business strategy. Laboratory medicine, while continuing to support a transactional business model, should expand efforts to include translational data analytics, proving its clinical and economic valuation. Current literature in this area is limited. CONTENT: This article is a summary of how laboratory medicine can support value-based healthcare. Population health management is emerging as a method to support value-based healthcare by aggregating patient information, providing data analysis, and contributing to clinical decision support. Key issues to consider with a laboratory-developed population health management model are discussed, including changing reimbursement models, the use of multidisciplinary committees, the role of specialists in data analytics and programming, and barriers to implementation. Examples of data considerations and value are given. SUMMARY: Laboratory medicine is able to provide meaningful clinical diagnostic insights for population health initiatives that result in improved short- and long-term patient outcomes and drive cost-effective care. Opportunities include data analysis with longitudinal laboratory data, identification of patient-specific targeted interventions, and development of clinical decision support tools. Laboratories will need to leverage the skills and knowledge of their multidisciplinary staff, along with their extensive patient data sets, through innovative analytics to meet these objectives.

Improving American Healthcare Through "Clinical Lab 2.0": A Project Santa Fe Report.

Project Santa Fe was established both to provide thought leadership and to help develop the evidence base for the valuation of clinical laboratory services in the next era of American healthcare. The participants in Project Santa Fe represent major regional health systems that can operationalize laboratory-driven innovations and test their valuation in diverse regional marketplaces in the United States. We provide recommendations from the inaugural March 2016 meeting of Project Santa Fe. Specifically, in the transition from volume-based to value-based health care, clinical laboratories are called upon to provide programmatic leadership in reducing total cost of care through optimization of time-to-diagnosis and time-to-effective therapeutics, optimization of care coordination, and programmatic support of wellness care, screening, and monitoring. This call to action is more than working with industry stakeholders on the basis of our expertise; it is providing leadership in creating the programs that accomplish these objectives. In so doing, clinical laboratories can be effectors in identifying patients at risk for escalation in care, closing gaps in care, and optimizing outcomes of health care innovation. We also hope that, through such activities, the evidence base will be created for the new value propositions of integrated laboratory networks. In the very simplest sense, this effort to create "Clinical Lab 2.0" will establish the impact of laboratory diagnostics on the full 100% spend in American healthcare, not just the 2.5% spend attributed to in vitro diagnostics. In so doing, our aim is to empower regional and local laboratories to thrive under new models of payment in the next era of American health care delivery.

A toxicology-based review of fentanyl-related deaths in New Mexico (1986-2007).

Since its approval in the United States, fentanyl has become increasingly popular for the medical management of pain and as a substance of abuse. Fentanyl is unique among the opioids in its widespread use with a transdermal delivery system, which contributes to its unique pharmacokinetics and abuse potential. We examined the demographics of deaths with fentanyl identified on toxicologic analysis and reviewed specific challenges in the laboratory detection of postmortem fentanyl levels. The New Mexico Office of the Medical Investigator database was searched for all cases from January 1986 through December 2007 with fentanyl reported as present or quantified. Those deaths with a cause of death identified as drug overdose were then analyzed separately. From 1986 to 2007, 154 cases were identified with fentanyl present in postmortem samples, with 96 of the cases identified as fentanyl-related drug overdoses. The number of fentanyl-related deaths has increased over the past 20 years, corresponding to both statewide increases in the medical use of fentanyl and the abuse of prescription opioids. The demographics of these fentanyl-related overdoses showed that subjects were more likely to be female, white non-Hispanic, and older than those in previously described overdose deaths. Several cases were identified with central and peripheral blood samples and antemortem and postmortem samples available for fentanyl quantification. Given the uncharacteristic demographics of fentanyl-related deaths and the complexity of the laboratory analysis of fentanyl, forensic scientists must use caution in both the detection and interpretation of fentanyl concentrations.

Assessment of the vitamin B12 status of pregnant women in Nigeria using plasma holotranscobalamin.

Maternal vitamin B12 deficiency during pregnancy is an independent risk factor for neural tube defects and other neurological problems in infants. We determined the vitamin B12 status of 143 pregnant women in Nigeria representing all trimesters who presented to an antenatal clinic in Jos, Nigeria, using holotranscobalamin II levels (holoTCII), which is a measure of the vitamin B12 that is available for uptake into tissues. The holoTCII concentration ranged from 13 to 128 pmol/L. Using a cutoff of 40 pmol/L, 36% of the women were classified as vitamin B12-deficient. HoloTCII concentrations correlated negatively with plasma homocysteine levels (r = -0.24, P = 0.003) and positively with red blood cell folate concentrations (r = 0.28, P < 0.001). These data underscore the importance of supplementing pregnant women in Nigeria with vitamin B12 in order to ensure adequate vitamin B12 status and decrease the risk for neural tube defects.

Vitamin D status of seminomadic Fulani men and women.

The purpose of this study was to assess the vitamin D status of Fulani men and women in northern Nigeria. The Fulani are seminomadic pastoralists whose culture, economy, and diet are centered on cattle. Most of the foods consumed by the Fulani are not good sources of vitamin D. Also being Muslim, the women do not derive much benefit from the vitamin D-generating effects of sunlight due to their dress habits. Furthermore, childhood rickets is common in the region. Serum was collected from 22 Fulani men (age, 47.6 +/- 8.3 years; body mass index [BMI], 21.1 +/- 3.2 kg/m2) and 29 women (age, 55.5 +/- 13.5 years; BMI, 21.6 +/- 3.1 kg/m2) in rural northern Nigeria and analyzed for 25-hydroxyvitamin D2 and D3 using ultraperformance liquid chromatography coupled with mass spectrometry Eighty-three percent of the women and 45% of the men had serum 25-hydroxyvitamin D levels in the hypovitaminosis D range (10-30 ng/mL). In the males, there was a strong negative correlation between serum vitamin D and BMI (r = -0.49, p = .022) and percent body fat (r = -0.51, p = .015). No such correlations were observed in the Fulani women. Our main conclusion is that about half the men and most of the women in the Fulani community where this study was conducted are inadequately nourished with respect to vitamin D. A high prevalence of hypovitaminosis D indicates an elevated risk for rickets in children and bone fractures in adults.

Lipid profiles and trans fatty acids in serum phospholipids of semi-nomadic Fulani in northern Nigeria.

The Fulani are semi-nomadic pastoralists of West Africa whose diet, culture, and economy are centred on cattle. Previous studies have shown that the Fulani of northern Nigeria derive 50% of their total calories from fat and 30% of their calories from milk, cheese, yogurt, and butter oil that contain significant amounts of trans fatty acids (TFAs), primarily vaccenic acid, which raise total serum cholesterol and low-density lipoproteincholesterol (LDL-C), and lower high-density lipoprotein-cholesterol (HDL-C). The study was conducted to know how the consumption of relatively large amounts of dairy products by adult Fulani affected the TFA content of their serum phospholipids. Blood samples were collected from 22 male and 29 female Fulani, aged 35-60 years, who were living in rural areas of Gombe state in northeastern Nigeria. The total serum phospholipid fraction was isolated, and its fatty acid composition was determined. Surprisingly, vaccenic acid was not detected, and three other TFAs--18:1-t6, 18:1-t9, and 18:2-t9,t12--together accounted for only 0.16% of the total fatty acid. The mean serum total cholesterol, LDL-C, and triglyceride concentrations of the subjects were within the normal range for populations in developed countries; however, at 32 mg/dL, the mean serum HDL-C concentration of the Fulani males was slightly below the lower limit of the reference range. No correlations were observed between the total TFA percentage or that of the three individual TFAs and any of the parameters of the serum lipid profile. These findings indicate that, with respect to TFAs at least, the fatty acid pattern of the serum phospholipids of Fulani pastoralists does not reflect the high TFA content of their traditional diet. Despite the consumption of rumenic acid-rich dairy products, for unknown reasons, the semi-nomadic Fulani manage to maintain a low level of TFAs in their blood and a relatively healthful serum lipid profile. While the mechanism that accounts for this disconnect between the consumption of TFAs by Fulani pastoralists and the proportion of TFAs in their serum phospholipids is obscure, possibilities include discrimination against rumenic acid during the process of triglyceride synthesis and chylomicron synthesis in the intestine and the preferential oxidation of TFAs by Fulani the people compared to other ethnic groups.

Use of calcaneal ultrasound and biochemical markers to assess the density and metabolic state of the bones of adults with hepatic cirrhosis.

Bone loss has been shown to be associated with chronic liver disease (CLD) caused by ethanol consumption or viral infection, and trabecular bone is affected more than cortical bone. We therefore used calcaneal ultrasound to compare the bone status of 54 males and 20 females with CLD in northern Nigeria with 88 age- and gender-matched healthy controls. Serum levels of bone-specific alkaline phosphatase (BSAP) and the N-terminal telopeptide of type-1 collagen (NTx) were also measured to estimate relative rates of bone synthesis and turnover, respectively. The mean stiffness index (SI) of the males with CLD and the male controls were not different; however, the mean SI of the female subjects with CLD was lower than for the female controls (101 vs. 86, p=0.003). The levels of NTx and BSAP were markedly elevated in the males, but not in the females, with CLD. Liver function tests did not correlate with ultrasound parameters or biochemical markers of bone metabolism. These results show that Nigerian women, but not males, with CLD have decreased bone density as assessed by calcaneal ultrasound; however, the high rate of bone turnover in Nigerian males with CLD indicates that they are at risk for bone loss.

Nutritional factors associated with anaemia in pregnant women in northern Nigeria.

This study was conducted to assess the relative contribution of iron, folate, and B 12 deficiency to anaemia in pregnant women in sub-Saharan Africa. In total, 146 pregnant women, who attended two antenatal clinics in Gombe, Nigeria, were recruited into the study. The majority (54%) of the women were in the third trimester. Blood samples were obtained for determination of haematocrit and for measurement of serum iron, total iron-binding capacity, ferritin, folate, vitamin B12, and homocysteine. Malaria was present in 15 (9.4%) women. Based on a haemoglobin value of<105 g/L, 44 (30%) women were classified as anaemic. The major contributing factor to anaemia was iron deficiency based on the serum concentration of ferritin (<10 ng/mL). The mean homocysteine concentration for all subjects was 14.1 pmol/L, and homocysteine concentrations were inversely correlated with concentrations of folate and vitamin B 12. The serum homocysteine increased markedly at serum vitamin B12 levels below 250 pmol/L. The most common cause of anaemia in the pregnant women in northern Nigeria was iron deficiency, and the elevated concentrations of homocysteine were most likely due to both their marginal folate and vitamin B12 status.

Abnormalities in the fatty-acid composition of the serum phospholipids of stroke patients.

The incidence of cardiovascular diseases, stroke, and myocardial infarction is increasing in sub-Saharan Africa. Since dietary polyunsaturated fatty acids (PUFA) are protective of the cardiovascular system in humans, we were interested in the question of the PUFA status of adults in northern Nigeria who had experienced a recent stroke. We collected blood from 21 consecutive admissions for stroke (15 male patients, mean age 39.3 years and six females, mean age 40.7 years) to the Federal Medical Centre in Gombe, Nigeria and analyzed the fatty-acid composition of the serum phospholipids. Blood was collected from 30 healthy controls for comparison. The contribution palmitic acid made to the fatty-acid total was greatly decreased in the phospholipids of the stroke patients (29.2% versus 37.2 %, p < 0.001). However, the phospholipids of the stroke patients had significantly higher percentages of 20-, 22-, and 24-carbon saturated fatty acids, as well as higher proportions of the omega-6 fatty-acid, arachidonic acid (11.4 versus 8.14%, p < 0.001), and the omega-3 fatty-acid, docosahexaenoic acid (3.21 versus 1.80%, p < 0.001). Using the percentages and melting points of the individual fatty acids, we estimated that the acyl chains of the serum phospholipids of the stroke patients had a lower mean melting point than the controls (27.8 versus 34.6 degrees C, p < 0.001). Assuming that serum phospholipids are surrogates for tissue phospholipids, we conclude that the tissue membranes of the stroke patients may be considerably more fluid than those of the controls.

High-density lipoprotein and homocysteine levels correlate inversely in preeclamptic women in northern Nigeria.

BACKGROUND: Preeclampsia/eclampsia is one of the most common complications of pregnancy. It is a cause of high morbidity for both mother and fetus, especially in developing countries. In a recent survey conducted in Gombe, Nigeria, eclampsia was found to be a major cause of maternal mortality (24.2%), second only to obstetric hemorrhage (27.1%). Previous studies have produced contradictory findings regarding total homocysteine (tHcy) levels in women with preeclampsia/eclampsia and there is little information about the relationship between particular serum lipids and tHcy. The objective of this study in Gombe was to compare the levels of serum lipids and homocysteine in healthy pregnant women and women with preeclampsia/eclampsia in Nigeria. METHODS: The experimental subjects included 43 women with preeclampsia/eclampsia and 130 healthy pregnant women served as controls. The criteria for preeclampsia/eclampsia included the following: hypertension (blood pressure > 140/90 mmHg), total protein (> 190 mg/g creatinine), and edema. Blood sera obtained from patients and controls attending the prenatal clinics at the Specialist Hospital and the Federal Medical Center in Gombe were analyzed for tHcy, total cholesterol, triglycerides, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol, antioxidant capacity, folate, and vitamin B-12. RESULTS: The mean tHcy concentration for the preeclamptic/eclamptic women was greater than that of the controls (10.1 vs. 8.4 micromol/l, respectively, p = 0.01). The mean concentrations of LDL-cholesterol and triacylglycerols were not different between the two groups. However, the mean HDL-cholesterol level was higher in the healthy pregnant women compared with the preeclamptic/eclamptic women (1.64 vs. 1.42 mmol/l, respectively, p = 0.02). The HDL-cholesterol concentration was correlated inversely with the tHcy concentration (p = 0.001, r = 0.51). Total homocysteine was not linked with either serum folate or vitamin B-12. CONCLUSIONS: These results show that preeclampsia/eclampsia is associated with increased tHcy levels and that HDL levels are depressed in Nigerian women with this hypertensive, pregnancy associated disorder.

Serum lipid profiles and homocysteine levels in adults with stroke or myocardial infarction in the town of Gombe in northern Nigeria.

While the incidence of infectious diseases has been on the decline in developing countries, the toll of cardiovascular diseases, including stroke and myocardial infarction, has been increasing. The impression of physicians in certain regions of the western Sahel, including the state of Gombe in northeastern Nigeria, is that macrovascular disease in the indigenous population is on the rise. This study was, therefore, undertaken to compare well-established risk factors for cardiovascular disease in a group of 53 men (n=34) and women (n=19) in the town of Gombe who had suffered a stroke or heart attack with the corresponding parameters in 48 age- and gender-matched healthy adults living in the same environment. The parameters of cardiovascular diseases considered were: overweight and obesity, blood pressure, lipid profiles, and homocysteine. While the male and female patients who had suffered stroke (n=48) or heart attack (n=5) were borderline hypertensive, their mean body mass index values were not different from the corresponding values of their control groups. Although the serum homocysteine levels of the patients and controls were not significantly different, 85% of the stroke patients had serum homocysteine levels greater than 10 microM. These high homocysteine levels could not be accounted for by sub-optimal folate or vitamin B 12 status. The serum levels of HDL-cholesterol and triglyceride were not significantly different between the male and female patients and their respective controls. However, the males, but not the females, with macrovascular disease had significantly higher levels of total cholesterol (161 vs 137 mg/dL, p=0.04) and LDL-cholesterol (91 vs 70 mg/dL, p=0.02). In addition, both female and male stroke/myocardial infarction patients exhibited an elevated LDL-cholesterol/HDL-cholesterol ratio. These results indicate that blood pressure and the LDL-cholesterol/HDL-cholesterol ratio are associated with stroke and myocardial infarction in adults in northern Nigeria, thereby creating potential opportunities for possible public-health interventions.

Risk factors for cardiovascular disease and diet of urban and rural dwellers in northern Nigeria.

Over the last 30 years, cardiovascular diseases (CVDs), including stroke and myocardial infarction, have increased in developing countries. Serum lipids and diet of the Fulani, a rural Nigerian population, were previously studied. Despite their consumption of a diet rich in saturated fat, the overall blood lipid profiles of Fulani men and women are generally favourable. However, Fulani males in the same study had mean serum levels of homocysteine, an emerging risk factor for CVD, that exceeded the upper limit of the homocysteine reference range. The authors were interested in knowing if these findings in the Fulani nomads were representative of the biochemical parameters of CVD risk in other ethnic groups in the same region of Nigeria. To address this question, the nutrient content of diets of 55 men, aged 20-75 years, and 77 women, aged 20-70 years, who were inhabitants of a large urban centre in northern Nigeria, was assessed, and their serum levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, and homocysteine were determined. These data were compared with those of the same rural Fulani population studied previously. Urban subjects consumed more calories than rural subjects (men: 2061 vs 1691 kcal; women: 1833 vs 1505 kcal) and had a significantly higher mean body mass index (BMI) and percentage of body fat than rural subjects. Both urban males and females had carbohydrate intakes that were greater than those of Fulani pastoralists (men: 56% vs 33% total calories; women: 51% vs 38% total calories), but had a significantly lower dietary intake of total fat and saturated fat (men: 36% vs 51% of total calories; women: 40% vs 51% of total calories). With the exception of HDL-cholesterol levels, which were significantly lower in the rural population, the blood lipid profiles of rural subjects were more favourable compared to those of urban subjects. Both urban and rural males had homocysteine levels above the upper limit of the reference range for healthy adults (urban males--12.7 micromol/L; rural males-15.2 micromol/L). The dietary intakes of folate and vitamin B12 were lower for rural Fulani subjects, and this was reflected in their significantly lower serum concentrations of these two vitamins. Results of this study suggest that, although the lipid profiles of urban and rural men and women in northern Nigeria indicate a relatively low risk for CVD, their elevated serum homocysteine levels are a cause for concern. The high homocysteine levels among rural men and women could be explained in part at least by their marginal status with respect to folate and vitamin B12.