The Effect of Laboratory Test-Based Clinical Decision Support Tools on Medication Errors and Adverse Drug Events: A Laboratory Medicine Best Practices Systematic Review.

BACKGROUND: Laboratory and medication data in electronic health records create opportunities for clinical decision support (CDS) tools to improve medication dosing, laboratory monitoring, and detection of side effects. This systematic review evaluates the effectiveness of such tools in preventing medication-related harm. METHODS: We followed the Laboratory Medicine Best Practice (LMBP) initiative's A-6 methodology. Searches of 6 bibliographic databases retrieved 8508 abstracts. Fifteen articles examined the effect of CDS tools on (a) appropriate dose or medication (n = 5), (b) laboratory monitoring (n = 4), (c) compliance with guidelines (n = 2), and (d) adverse drug events (n = 5). We conducted meta-analyses by using random-effects modeling. RESULTS: We found moderate and consistent evidence that CDS tools applied at medication ordering or dispensing can increase prescriptions of appropriate medications or dosages [6 results, pooled risk ratio (RR), 1.48; 95% CI, 1.27-1.74]. CDS tools also improve receipt of recommended laboratory monitoring and appropriate treatment in response to abnormal test results (6 results, pooled RR, 1.40; 95% CI, 1.05-1.87). The evidence that CDS tools reduced adverse drug events was inconsistent (5 results, pooled RR, 0.69; 95% CI, 0.46-1.03). CONCLUSIONS: The findings support the practice of healthcare systems with the technological capability incorporating test-based CDS tools into their computerized physician ordering systems to (a) identify and flag prescription orders of inappropriate dose or medications at the time of ordering or dispensing and (b) alert providers to missing laboratory tests for medication monitoring or results that warrant a change in treatment. More research is needed to determine the ability of these tools to prevent adverse drug events.

Interventions to prevent iatrogenic anemia: a Laboratory Medicine Best Practices systematic review.

BACKGROUND: As many as 90% of patients develop anemia by their third day in an intensive care unit (ICU). We evaluated the efficacy of interventions to reduce phlebotomy-related blood loss on the volume of blood lost, hemoglobin levels, transfusions, and incidence of anemia. METHODS: We conducted a systematic review and meta-analysis using the Laboratory Medicine Best Practices (LMBP) systematic review methods for rating study quality and assessing the body of evidence. Searches of PubMed, Embase, Cochrane, Web of Science, PsychINFO, and CINAHL identified 2564 published references. We included studies of the impact of interventions to reduce phlebotomy-related blood loss on blood loss, hemoglobin levels, transfusions, or anemia among hospital inpatients. We excluded studies not published in English and studies that did not have a comparison group, did not report an outcome of interest, or were rated as poor quality. Twenty-one studies met these criteria. We conducted a meta-analysis if > 2 homogenous studies reported sufficient information for analysis. RESULTS: We found moderate, consistent evidence that devices that return blood from flushing venous or arterial lines to the patient reduced blood loss by approximately 25% in both neonatal ICU (NICU) and adult ICU patients [pooled estimate in adults, 24.7 (95% CI = 12.1-37.3)]. Bundled interventions that included blood conservation devices appeared to reduce blood loss by at least 25% (suggestive evidence). The evidence was insufficient to determine if these devices reduced hemoglobin decline or risk of anemia. The evidence suggested that small volume tubes reduced the risk of anemia, but was insufficient to determine if they affected the volume of blood loss or the rate of hemoglobin decline. CONCLUSIONS: Moderate, consistent evidence indicated that devices that return blood from testing or flushing lines to the patient reduce the volume of blood loss by approximately 25% among ICU patients. The results of this systematic review support the use of blood conservation systems with arterial or venous catheters to eliminate blood waste when drawing blood for testing. The evidence was insufficient to conclude the devices impacted hemoglobin levels or transfusion rates. The use of small volume tubes may reduce the risk of anemia.

Interventions to Improve Follow-Up of Laboratory Test Results Pending at Discharge: A Systematic Review.

Failure to follow up test results pending at discharge (TPAD) from hospitals or emergency departments is a major patient safety concern. The purpose of this review is to systematically evaluate the effectiveness of interventions to improve follow-up of laboratory TPAD. We conducted literature searches in PubMed, CINAHL, Cochrane, and EMBASE using search terms for relevant health care settings, transition of patient care, laboratory tests, communication, and pending or missed tests. We solicited unpublished studies from the clinical laboratory community and excluded articles that did not address transitions between settings, did not include an intervention, or were not related to laboratory TPAD. We also excluded letters, editorials, commentaries, abstracts, case reports, and case series. Of the 9,592 abstracts retrieved, eight met the inclusion criteria and reported the successful communication of TPAD. A team member abstracted predetermined data elements from each study, and a senior scientist reviewed the abstraction. Two experienced reviewers independently appraised the quality of each study using published Laboratory Medicine Best Practices (LMBP™) A-6 scoring criteria. We assessed the body of evidence using the A-6 methodology, and the evidence suggested that electronic tools or one-on-one education increased documentation of pending tests in discharge summaries. We also found that automated notifications improved awareness of TPAD. The interventions were supported by suggestive evidence; this type of evidence is below the level of evidence required for LMBP™ recommendations. We encourage additional research into the impact of these interventions on key processes and health outcomes.

Communicating risk of hereditary breast and ovarian cancer with an interactive decision support tool.

OBJECTIVE: Women with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk of earlier, more aggressive cancer. Because of HBOC's rarity, screening is recommended only for women with strong cancer family histories. However, most patients do not have accurate history available and struggle to understand genetic concepts. METHODS: Cancer in the Family, an online clinical decision support tool, calculated women's HBOC risk and promoted shared patient-provider decisions about screening. A pilot evaluation (n=9 providers, n=48 patients) assessed the tool's impact on knowledge, attitudes, and screening decisions. Patients used the tool before wellness exams and completed three surveys. Providers accessed the tool during exams, completed exam checklists, and completed four surveys. RESULTS: Patients entered complete family histories (67%), calculated personal risk (96%), and shared risk printouts with providers (65%). HBOC knowledge increased dramatically for patients and providers, and many patients (75%) perceived tool results as valid. The tool prompted patient-provider discussions about HBOC risk and cancer family history (88%). CONCLUSIONS: The tool was effective in increasing knowledge, collecting family history, and sparking patient-provider discussions about HBOC screening. PRACTICE IMPLICATIONS: Interactive tools can effectively communicate personalized risk and promote shared decisions, but they are not a substitute for patient-provider discussions.

Prenatal counseling on seat belt use and crash-related medical care.

Describe the prevalence of and characteristics associated with being hurt in a car accident during pregnancy; the resulting medical care needed; and the association between counseling and the medical care needed after a car accident. Secondary data analysis of PRAMS (Pregnancy Risk Assessment Monitoring System) data, a population based survey of women with a recent live birth. Two percent of women were hurt in a car accident during their pregnancy. Only 57% of them had received counseling on seat belt use. Most women (87%) who were hurt in an accident needed medical care. Being counseled on seat belt use was not associated with the level of care needed. Most pregnant women who are hurt in a car accident require medical care or bed rest. Public health action and research is needed to reduce the burden of motor-vehicle related injuries among pregnant women.

The PhenX Toolkit pregnancy and birth collections.

PURPOSE: Pregnancy and childbirth are normal conditions, but complications and adverse outcomes are common. Both genetic and environmental factors influence the course of pregnancy. Genetic epidemiologic research into pregnancy outcomes could be strengthened by the use of common measures, which would allow data from different studies to be combined or compared. Here, we introduce perinatal researchers to the PhenX Toolkit and the Collections related to pregnancy and childbirth. METHODS: The Pregnancy and Birth Collections were drawn from measures in the PhenX Tooklit. The lead author selected a list of measures for each Collection, which was reviewed by the remaining authors and revised on the basis of their comments. We chose the measures we thought were most relevant for perinatal research and had been linked most strongly to perinatal outcomes. RESULTS: The Pregnancy and Birth Health Conditions Collection includes 24 measures related to pregnancy and fertility history, maternal complications, and infant complications. The Pregnancy and Birth Outcome Risk Factors Collection includes 43 measures of chemical, medical, psychosocial, and personal factors associated with pregnancy outcomes. CONCLUSIONS: The biological complexity of pregnancy and its sensitivity to environmental and genomic influences suggest that multidisciplinary approaches are needed to generate new insights or practical interventions. To fully exploit new research methods and resources, we encourage the biomedical research community to adopt standard measures to facilitate pooled or meta-analyses.

The relationship of socioeconomic status to preterm contractions and preterm delivery.

Spontaneous preterm labor precedes approximately 50% of preterm births. One to 10% of pregnant women are hospitalized for preterm labor. This study examines the relationship of socioeconomic indicators, family income, education and type of insurance, with preterm contractions and subsequent preterm delivery. Data were from the pregnancy risk assessment monitoring system on 107,926 women who had singleton births during 2000-2002. Data on preterm contractions, family income, and type of insurance during pregnancy were from the maternal questionnaire. Maternal education and gestational age were derived from birth certificate data. Predicted marginal probabilities from logistic regression models were used to calculate the adjusted cumulative incidence and cumulative risk ratio of preterm contractions and preterm delivery. Median annual household income was approximately $30,000. More than one-fourth (28.1 95% CI: 27.7, 28.6) of women experienced preterm contractions, and these women were 3 times as likely (18 vs. 5%) to deliver preterm as women without preterm contractions. Only 58% of women who delivered preterm reported contractions. Lower income and Medicaid-paid care were independently associated with an increased risk of preterm contractions but not with preterm delivery. The association of lower income and Medicaid enrollment with preterm contractions but not preterm delivery suggests that SES is associated with the initiation of the pathway to spontaneous preterm delivery rather than access to or the success of interventions to prevent delivery following the onset of contractions.

Racial, ethnic, and economic disparities in the prevalence of pregnancy complications.

OBJECTIVES: Our objective was to use maternal self-reported data to estimate the prevalence of urinary tract infections, placenta disorders, and preterm rupture of the membranes (PROM) and to explore the association between these complications and race, ethnicity, and economic status. METHODS: We used data for the years 2000-2002 from the Pregnancy Risk Assessment Monitoring System (PRAMS), an ongoing survey of women with a recent live birth, to examine the prevalence of and hospitalizations for self-reported urinary tract infections, placenta disorders, and PROM and to investigate differences by maternal race, Hispanic ethnicity, and economic status. Prevalence and hospitalizations were calculated as a percent of the represented population using SUDAAN to account for the sampling design. RESULTS: Urinary tract infections were commonly reported, occurring in more than 17% of women during their pregnancy. Placenta disorders and PROM were each reported by approximately 6% of women. Poverty and race had independent effects on each of the pregnancy complications examined. Fewer than half of the women who experienced these pregnancy complications were hospitalized. CONCLUSIONS: Pregnancy complications are common and not adequately measured by hospitalizations alone. Both more research and improved surveillance are needed to understand the effect of pregnancy complications on women's health and the reasons for the increased risk among poor or black women.

Case management protocol and declining blood lead concentrations among children.

INTRODUCTION: Blood lead concentrations among children aged 6 years and younger become a concern at 10 microg/dL (0.48 micromol/L) or higher. The authors' objective was to determine whether initial blood lead concentrations of 10-19 microg/dL (0.48-0.96 micromol/L) declined among children aged 3 years and younger and whether the magnitude of decline was associated with the case management protocol of the state or local childhood lead poisoning prevention program. METHODS: The authors analyzed childhood blood lead surveillance data from 1994 through 1995 and case management protocols from six states that reported the results of all blood lead tests. The study included 2109 children aged 2 years or younger who had a venous blood lead concentration of 10-19 microg/dL (0.48-0.96 micromol/L) and a follow-up venous blood lead test within 3 to 12 months. RESULTS: Overall, blood lead concentrations increased by 0.25 microg/dL (0.01 micromol/L) between the time of the initial elevated blood lead test and the follow-up test, but concentrations declined by 1.96 microg/dL (0.09 micromol/L) among children covered by a case management protocol that included a home visit and by 0.92 microg/dL (0.04 micromol/L) among those covered by a protocol that included a lead source investigation. The decline remained significant after we adjusted for the child's age. CONCLUSION: These findings suggest that childhood lead prevention programs should consider focusing their efforts on home visits and lead source investigations.

Prevalence and predictors of receipt of prenatal information about genetic screening.

OBJECTIVE: To examine the proportion of women who received information on genetic screening among those who had prenatal care and to determine whether the proportion varied by maternal characteristics. METHODS: We used self-reported data from the Pregnancy Risk Assessment Monitoring System (PRAMS), a population-based survey of recent mothers, for birth years 2000-2002. Logistic regression was used to identify independent predictors of receiving information and to calculate adjusted prevalence ratios. RESULTS: Among women who began prenatal care in the first trimester, 86% received information on genetic screening. The strongest predictors of receiving this information were completing the questionnaire in English and having military health insurance. CONCLUSION: Most women receive information on prenatal genetic screening, but insurance status and language preference may impact women's access to this information.

The feasibility of creating a population-based national twin registry in the United States.

Between 4 to 6 million twins exist in the US today who offer scientists a valuable potential resource for conducting behavioral and biomedical research. However, unlike many other countries, there is no national system in the US for identifying twins and eliciting their participation in these important research programs. Therefore, the National Institute of Environmental Health Sciences (NIEHS) is conducting a study to determine the feasibility of creating a national, population-based twin registry in the US. The major goal is to estimate the potential size and characteristics of a national twin registry based on the current twin population in the US, our ability to ascertain and enroll them, and their willingness to participate. Existing US twin cohorts are also being examined in this study as well as alternatives for improving US twin resources should a national twin registry be deemed infeasible. The various options will be compared in terms of possible source populations, generalizability and adequacy for statistically powering various types of etiological studies. Two expert advisory panels have been assembled to assist in the conduct of this study. The Scientific Advisory Panel is charged with providing expertise concerning study goals, design and methodology, and evaluating the study's conclusion. A separate Ethics Advisory Panel is charged with providing expertise on the ethical, legal, and social issues that might be encountered if a national twin registry is ultimately pursued. Having a national population-based twin registry in the US would be advantageous to US scientists and those worldwide. It would provide ample numbers of twin pairs to conduct various types of environmental genomic studies currently not possible with existing US twin resources. It would also allow US scientists to select for characteristics (race, ethnicity, environments, and so on) inherent in our own population. Finally and foremost, it would help to meet the worldwide demand for twin resources which is expected to increase over time, as new genomic and analytical tools become available and new hypotheses emerge concerning the complex interplay between genes, lifestyles and environment.