Dealing with redundant gamma glutamyl transpeptidase in primary care, when requested along with alkaline phosphatase.

The use of gamma glutamyl transpeptidase (GGT) levels as screening test for liver function is controversial. The GGT main utility is in cases in which alkaline phosphatase (ALP) is elevated. We aimed to investigate the request over time for alanine amino transferase (ALT), ALP and GGT, study the effect of a new demand management (DM) intervention for optimal GGT measurement in primary care. Our descriptive study was conducted from January 2010 to December 2020. The intervention was established in November 2019 and consisted of the laboratory information system would automatically remove GGT, if the test had been ordered simultaneously with ALP and there was no prior pathological result on record. We counted the absolute number of measured ALT, ALP and GGT, and calculated the ratios for each of the three markers related to creatinine, and GGT related to ALT in a monthly basis. The number of measured GGT increased slightly and progressively along the study until October 2019, when a decrease was observed. The ALT and ALP request from primary care also increased slightly along years. However, the GGT/ALT ratio never reached the 0.2 goal. Out of the 57,614 GGT requested in primary care patients, 38,167 (66.2%) were not measured. 7633.4€ were saved in reagent. The DM intervention to reduce the measurement of GGT when requested redundantly with ALP in primary care was successful, and the results have been maintained over time as observed by monitoring the GGT/CREA and GGT/ALT indicator results.

Enzymatic diagnosis of Pompe disease: lessons from 28 years of experience.

Pompe disease is a lysosomal and neuromuscular disorder caused by deficiency of acid alpha-glucosidase (GAA), and causes classic infantile, childhood onset, or adulthood onset phenotypes. The biochemical diagnosis is based on GAA activity assays in dried blood spots, leukocytes, or fibroblasts. Diagnosis can be complicated by the existence of pseudodeficiencies, i.e., GAA variants that lower GAA activity but do not cause Pompe disease. A large-scale comparison between these assays for patient samples, including exceptions and borderline cases, along with clinical diagnoses has not been reported so far. Here we analyzed GAA activity in a total of 1709 diagnostic cases over the past 28 years using a total of 2591 analyses and we confirmed the clinical diagnosis in 174 patients. We compared the following assays: leukocytes using glycogen or 4MUG as substrate, fibroblasts using 4MUG as substrate, and dried blood spots using 4MUG as substrate. In 794 individuals, two or more assays were performed. We found that phenotypes could only be distinguished using fibroblasts with 4MUG as substrate. Pseudodeficiencies caused by the GAA2 allele could be ruled out using 4MUG rather than glycogen as substrate in leukocytes or fibroblasts. The Asian pseudodeficiency could only be ruled out in fibroblasts using 4MUG as substrate. We conclude that fibroblasts using 4MUG as substrate provides the most reliable assay for biochemical diagnosis and can serve to validate results from leukocytes or dried blood spots.

Racial and insurance disparities among patients presenting with chest pain in the US: 2009-2015.

BACKGROUND: Nationally representative studies have shown significant racial and socioeconomic disparities in the triage and diagnostic evaluation of patients presenting to the emergency department (ED) with chest pain. However, these studies were conducted over a decade ago and have not been updated amidst growing awareness of healthcare disparities. OBJECTIVE: We aimed to reevaluate the effect of race and insurance type on triage acuity and diagnostic testing to assess if these disparities persist. METHODS: We identified ED visits for adults presenting with chest pain in the 2009-2015 National Hospital Ambulatory Health Care Surveys. Using weighted logistic regression, we examined associations between race and payment type with triage acuity and likelihood of ordering electrocardiography (ECG) or cardiac enzymes. RESULTS: A total of 10,441 patients met inclusion criteria, corresponding to an estimated 51.4 million patients nationwide. When compared with white patients, black patients presenting with chest pain were less likely to have an ECG ordered (adjusted odds ratio [OR] = 0.82, 95% confidence interval [CI] = 0.69-0.99). Patients with Medicare, Medicaid, and no insurance were also less likely to have an ECG ordered compared to patients with private insurance (Medicare: OR = 0.79, CI = 0.63-0.99; Medicaid: OR = 0.67, CI = 0.53-0.84; no insurance: OR = 0.68, CI = 0.55-0.84). Those with Medicare and Medicaid were less likely to be triaged emergently (Medicare: OR = 0.84, CI = 0.71-0.99; Medicaid: OR = 0.76, CI = 0.64-0.91) and those with Medicare were less likely to have cardiac enzymes ordered (OR = 0.84, CI = 0.72-0.98). CONCLUSIONS: Persistent racial and insurance disparities exist in the evaluation of chest pain in the ED. Compared to earlier studies, disparities in triage acuity and cardiac enzymes appear to have diminished, but disparities in ECG ordering have not. Given current Class I recommendations for ECGs on all patients presenting with chest pain emergently, our findings highlight the need for improvement in this area.

[Application of a continual improvement approach to selecting diagnostic markers for acute pancreatitis in an emergency department]. / Aplicación de un método de mejora continua para la selección de los marcadores diagnóstico de pancreatitis aguda en un servicio de urgencias.

OBJECTIVES: To apply a continual improvement model to develop an algorithm for ordering laboratory tests to diagnose acute pancreatitis in a hospital emergency department. MATERIAL AND METHODS: Quasi-experimental study using the continual improvement model (plan, do, check, adjust cycles) in 2 consecutive phases in emergency patients: amylase and lipase results were used to diagnose acute pancreatitis in the first phase; in the second, only lipase level was first determined; amylase testing was then ordered only if the lipase level fell within a certain range. We collected demographic data, number amylase and lipase tests ordered and the findings, final diagnosis, and the results of a questionnaire to evaluate satisfaction with emergency care. RESULTS: The first phase included 517 patients, of whom 20 had acute pancreatitis. For amylase testing sensitivity was 0.70; specificity, 0.85; positive predictive value (PPV), 17; and negative predictive value (NPV), 0.31. For lipase testing these values were sensitivity, 0.85; specificity, 0.96; PPV, 21, and NPV, 0.16. When both tests were done, sensitivity was 0.85; specificity 0.99; PPV, 85; and NPV, 0.15. The second phase included data for 4815 patients, 118 of whom had acute pancreatitis. The measures of diagnostic yield for the new algorithm were sensitivity, 0.92; specificity, 0.98; PPV, 46; and NPV, 0.08]. CONCLUSION: This study demonstrates a process for developing a protocol to guide laboratory testing in acute pancreatitis in the hospital emergency department. The proposed sequence of testing for pancreatic enzyme levels can be effective for diagnosing acute pancreatitis in patients with abdominal pain.

OBJETIVO: Aplicar un ciclo de mejora continua (CMC) para la determinación de un algoritmo de solicitud de pruebas de laboratorio en el diagnóstico de la pancreatitis aguda (PA) en un servicio urgencias hospitalario (SUH). METODO: Estudio cuasiexperimental que aplicó la metodología CMC en dos fase consecutivas en pacientes atendidos en un SUH: en la primera se usaron la amilasa y lipasa para el diagnóstico de PA, y en la segunda solo la lipasa y solo si esta estaba en un rango determinado, se añadía automáticamente la amilasa. Se recogieron datos demográficos, número y valores de amilasa y lipasa, el diagnóstico final, y se realizó una encuesta de satisfacción a los médicos de urgencias. RESULTADOS: El primer ciclo incluyó 517 pacientes, 20 de ellos con PA. Las características de las pruebas diagnósticas fueron: amilasa [sensibilidad (Se): 0,70; especificidad (Es): 0,85; cociente de probabilidad positivo (CPP): 17 y cociente de probabilidad negativo (CPN): 0,31], lipasa (Se: 0,85; Es: 0,96; CPP: 21 y CPN: 0,16) y la determinación de ambas (Se: 0,85; Es: 0,99; CPP: 85 y CPN: 0,15). En el segundo ciclo se incluyeron 4.815 pacientes, de los cuales 118 sufrieron una PA. El nuevo algoritmo propuesto tuvo una Se: 0,92; Es: 0,98; CPP: 46 y CPN: 0,08. CONCLUSIONES: La elaboración de un protocolo de solicitud de marcadores de laboratorio y la estrategia secuencial de solicitud de enzimas pancreáticas pueden ser efectivas para diagnosticar PA en un SUH.

[Current seroprevalence, vaccination and predictive value of liver enzymes for hepatitis B among refugees in Germany]. / Aktuelle Seroprävalenz, Impfstatus und prädiktiver Wert der Leberenzyme für Hepatitis B bei Flüchtlingen in Deutschland.

BACKGROUND: Currently only vague estimates exist for the seroprevalence and vaccination status for viral hepatitis B (HBV) in refugees arriving in Germany during the current refugee crisis. OBJECTIVES: To assess the prevalence of hepatitis B in refugees arriving in northern Germany in 2015. METHODS: In a cross-sectional study in 793 patients from all age groups tests for serological markers of hepatitis B virus infection (HBsAg, anti-HBc) and liver enzymes (ALT, AST, bilirubin, γGT, alkaline phosphatase) were performed in August 2015 at six reception centers in northern Germany. In 258 patients anti-HBs antibodies were assessed additionally. RESULTS: Of the tested refugees, 76.7 % were male, the median age was 28.8 ± 11.4 years, and 7.8 % were children under the age of 18. The overall prevalence of HBsAg and total anti-HBc was 2.3 % and 14.0 % respectively (2.5 % and 14.5 % in men; 1.2 % and 13.5 % in women). Prevalence was highest in 35 to 49-year-old patients for HBsAg (3.1 %) and for refugees over 50 years for anti-HBc (38 %). No immunity to Hepatitis B was found in 62 %, 18.6 % had been vaccinated against Hepatitis B, while 50 % of children aged up to 15 years (n = 12) had been vaccinated. Positive predictive values of elevated AST and ALT for detection of HBsAg was 0 and 0.016, respectively. Only two patients with a positive HBsAg had elevated transaminases. CONCLUSIONS: This study showed a high prevalence of HBsAg in a German refugee sample in comparison to the general German population. Liver enzymes are not an appropriate tool for screening for hepatitis B virus infection.

[Prevalence and risk factors of drug induced liver disease: a survey based study in pharmacies]. / Häufigkeit und Risikofaktoren medikamentös-toxischer Leberschäden: eine umfragebasierte Studie in Apotheken.

AIM: The reported incidence of drug-induced liver injury (DILI) ranges from 1 in 10,000 to 1 in 100,000 patients for most drugs, but the true incidence is expected to be much higher. Several risk factors for DILI susceptibility have been suggested, however there is insufficient data to define an individual risk profile. Therefore it was our aim to study the prevalence of DILI and potential risk factors within adult pharmacy customers in Germany. METHODS: We conducted two 6 week-survey studies in 30 pharmacies in 2011 and 2012, respectively, using a newly developed questionnaire comprising questions on demography, (liver) diseases, liver enzyme activities, and drug history. In each study, anonymized questionnaires were presented to non-selected adult customers taking (non-)prescription drugs. RESULTS: Combining the datasets from the 2011 and 2012 surveys, in total 1098 questionnaires were evaluated (mean age 57.7 ±â€Š17.1 years; 62.6 % females, return rate 15.25 %). Overall, 141 individuals (12.8 %) reported elevated liver enzymes due to drugs, in 65 cases (5.9 %) the medication had to be stopped, and 20 customers (1.8 %) reported that they had been admitted to hospital due to DILI. Compared to individuals without adverse hepatic drug reactions (n = 957), the 141 persons with potential DILI presented more often the following risk factors in multivariate analysis: chronic liver disease (14.4 % vs. 2.4 %, odds ratio [OR] 4.2, 95 % confidence interval [CI] 2.0 - 9.0), chronic renal insufficiency (20.0 vs. 6.8 %, OR 2.2, 95 % CI 1.3 - 3.7), diabetes (34 vs. 15.3 %, OR 2.0, 95 % CI 1.3 - 3.2), family history of chronic liver disease (19.9 vs. 7.7 %, OR 2.1, 95 % CI 1.2 - 3.6), and continuous drug intake for more than 5 years (80.9 vs. 59.3 %, OR 2.1, 95 % CI 1.3 - 3.5). CONCLUSION: These studies show an unexpected high prevalence of DILI in pharmacy customers and identify multiple potential risk factors.

The Application of Six Sigma Techniques in the Evaluation of Enzyme Measurement Procedures in China.

BACKGROUND: Recently, Six Sigma techniques have been adopted by clinical laboratories to evaluate laboratory performance. Measurement procedures in laboratories can be categorized as "excellent", "good", and "improvement needed" based on sigma (σ) metrics of σ ≥ 6, 3 ≤ σ < 6, and σ < 3, respectively. The quality goal index (QGI) was further investigated for measurement procedures with σ ≤ 3. Improvements of the procedures were recommended based on QGI: QGI < 0.8 indicates that the precision of the procedure needs to be improved; QGI > 1.2 indicates that the trueness of the procedure needs to be improved; 0.8 ≤ QGI ≤ 1.2 indicates that both the precision and trueness of the procedure need to be improved. METHODS: Fresh frozen sera containing seven enzymes (ALT, ALP, AMY, AST, CK, GGT, and LDH) were sent to 78 clinical laboratories in China. The biases for measurement procedures in each laboratory (Bias) were calculated based on the target values assigned by 18 laboratories performing IFCC (International Federation of Clinical Chemistry and Laboratory medicine) recommended reference methods. The imprecision of each measurement procedure was represented by coefficient variations (CV) calculated based on internal quality control (IQC) data. The σ and QGI values were calculated as follows: σ = (TEa-Bias)/CV; QGI = Bias/(1.5 x CV). TEa is allowable total error for each enzyme derived from biological variation. RESULTS: Our study indicated that 7.9% (6/76, ALP) to 31.0% (18/58, AMY) of the participating laboratories were scored as "excellent" (σ ≥ 6), 21.1% (16/76, ALP) to 41.3% (31/75, CK) of the laboratories were scored as "good" (3 ≤ σ < 6), and 31.0% (18/58, AMY) to 71.1% (54/76, ALP) of the laboratories need to improve their enzyme measurement procedures (σ < 3). For those with σ < 3, QGIs were further calculated. Based on QGI values, 8.6% (5/58, AMY) to 35.9% (28/78, LDH) of the laboratories (QGI < 0.8) need to improve the precision of the procedures, 8.0% (6/75, CK) to 52.6% (40/76, ALP) of the laboratories (QGI ≤ 1.2) need to improve the trueness of the procedures; and 2.7% (2/75, AST) to 16.3% (8/49, GGT) of the laboratories (0.8 ≤ QGI ≤ 1.2) need to improve both the precision and trueness of the procedures. CONCLUSIONS: Even though rapid progress has been made to standardize serum enzyme measurements in China in recent years, our study using Six Sigma techniques still suggested that approximately 31.1% to 71.0% of the laboratories need to improve their enzyme measurement procedures, either in terms of precision, trueness, or both.

The antenatal identification of funisitis with a rapid MMP-8 bedside test.

AIMS: The purpose of this study was to determine if a bedside test, the MMP-8 PTD Check, can be of value in the antenatal identification of funisitis. This test can be performed in 15 min without any laboratory equipment. METHODS: The relationship between the presence or absence of funisitis and the results of an MMP-8 PTD Check was examined in 139 patients who delivered preterm singleton neonates (gestational age <35 weeks) within 72 h of amniocentesis. Amniotic fluid (AF) was cultured for aerobic and anaerobic bacteria and for genital mycoplasmas. AF was analyzed for white blood cell (WBC) count, interleukin-6 (IL-6) and an MMP-8 PTD Check. The IL-6 concentration was also determined in umbilical cord plasma collected at birth. Funisitis was diagnosed in the presence of neutrophil infiltration into the umbilical vessel walls or Wharton's jelly. RESULTS: 1) Funisitis was present in 27% (38/139) of cases; 2) A positive MMP-8 PTD Check had a sensitivity of 97% (37/38), a specificity of 63% (64/101), a positive predictive value of 50% (37/74) and a negative predictive value of 99% (64/65) in the identification of funisitis; 3) Among cases without funisitis, patients with a positive MMP-8 PTD Check had a significantly higher median AF IL-6 concentration, AF WBC count, and umbilical cord plasma IL-6 concentration at birth than those with a negative MMP-8 PTD Check (P<0.05 for each). CONCLUSIONS: The MMP-8 PTD Check is a rapid, simple and sensitive bedside test which allows assessment of the risk of funisitis.

Reference intervals for eight enzymes in blood of adult females and males measured in accordance with the International Federation of Clinical Chemistry reference system at 37 degrees C: part of the Nordic Reference Interval Project.

As part of the Nordic Reference Interval Project we present reference intervals for alanine transaminase (ALT), aspartate transaminase (AST), creatine kinase (CK), lactate dehydrogenase (LD), alkaline phosphatase (ALP), gamma-glutamyltransferase (GT), amylase (AMY) and pancreatic type of AMY in blood of adult males and females. A total of 3036 reference persons, all of whom considered themselves to be in good health, were recruited by 102 Nordic clinical biochemical laboratories. Exclusions were undertaken on the basis of predefined biochemical and clinical criteria. Enzyme activities in serum and plasma were measured in the different laboratories using various commercially available routine measurement systems at 37 degrees C. Only results obtained with the International Federation of Clinical Chemistry (IFCC) compatible measuring systems were selected for estimation of the enzyme reference intervals. The final number of results on each enzyme varied from 459 (LD) to 2300 (ALT). The 2.5 and 97.5 percentile reference limits were calculated by a non-parametric method in accordance with the IFCC recommendations, using the Refval 4.0 data program. Statistical partitioning testing was undertaken to decide whether the reference intervals ought to be partitioned according to gender and/or age. For most of the enzymes, but not for all, the upper reference limits were found to be higher than those that have been in general use until now.

Fecal elastase-1 is superior to fecal chymotrypsin in the assessment of pancreatic involvement in cystic fibrosis.

OBJECTIVE: Exocrine pancreatic function in patients with cystic fibrosis (CF) can be evaluated by direct and indirect tests. In pediatric patients, indirect tests are preferred because of their less invasive character, especially in CF patients with respiratory disease. Fecal tests are noninvasive and have been shown to have a high sensitivity and specificity. However, there is no comparative study in CF patients. Therefore, the aim of the present study was to compare the sensitivity and the specificity of the fecal elastase-1 (E1) test with the fecal chymotrypsin (ChT) test in a large cohort of CF patients and healthy subjects (HS). DESIGN: One hundred twenty-three CF patients and 105 HS were evaluated. In all subjects, E1 concentration and ChT activity were measured. In the CF group, fecal fat excretion was also determined. The sensitivity and specificity of the fecal E1 test and ChT test were compared. RESULTS: With a cutoff level of 3 U/g, ChT specificity in HS was similar to that of E1, but E1 sensitivity in CF patients was significantly higher (90.2% vs 81.3%). With a cutoff level of 6 U/g, ChT and E1 sensitivity in CF patients was identical, but E1 specificity in HS was again significantly higher (98.1% vs 90.5%). In all CF patients with severe steatorrhea (>15 g/d), E1 concentrations were abnormal and ChT activity was lower than 3 U/g. In contrast, in pancreatic-sufficient patients and patients with mild steatorrhea (< or =15 g/d), the E1 sensitivity was significantly higher compared with ChT (69.2% vs 41.0%). CONCLUSIONS: The fecal E1 test is superior to fecal ChT determination in the assessment of CF pancreatic involvement in pancreatic-sufficient patients and those patients with mild steatorrhea.

[Viral hepatitis B and C in users of psychotropic preparations parenterally administered]. / Virusnye gepatitidy B i C u potrebitelei psikhotropnykh preparatov, vvodimykh parenteral'no.

The dynamic study of 198 patients having virus hepatitides B and C was carried out. The etiological diagnosis in these patients had been made on the basis of serological investigation and the determination of markers with the use of the polymerase chain reaction. The manifestations of the disease were compared in 98 drug addicts and 100 patients stating they used no drugs. In addicts practicing the parenteral introduction of drugs acute virus hepatitides took, in most cases, the moderate course with the pain syndrome in the liver, abstinence symptoms, hepatomegaly, the elevated level of ALT in the blood. The convalescence period is characterized by the prolonged course with the slow restoration of the liver function.

[Antibody enzymes in Helicobacter pylori-associated infection]. / Antitela-fermenty pri Helicobacter pylori-assotsiirovannoi infektsii.

The amidase activity of a fraction of IgG antibodies to H. pylori in cases of bacterial persistence in the antral section of the stomach and the duodenal bulb and the role of enzyme antibodies in the pathogenesis of this infection were evaluated. 113 patients were examined under clinical conditions. Diagnosis was made with the use of the morphological method, the rapid urease test (Jatrox-H.p.-Test, Germany) and ELISA (Diagnostic Automation Inc., USA). The amidase activity of serum IgG was determined. As proteolytic substrate benzoylarginine-p-nitroanilide (BAPNA) was used. The study revealed that in the blood serum of patients with chronic gastritis and/or duodenitis, caused by H. pylori, and the active persistence of H. pylori in the mucous membrane IgG antibodies to H. pylori having BAPNA-amidase activity could be detected.

[A marker and prognostic test for phospholipase A2 in periodontal inflammatory diseases]. / Markernyi i prognosticheskii test na fosfolipazu A2 pri vospalitel'nykh zabolevaniiakh parodonta.

Phospholipase A2 is one the main enzymes determining cell membranes morphological and functional condition. Close correlation has been revealed between the activity of this enzyme and clinical state of inflammatory process in periodontium. According to the obtained data phospholipase A2 can be a precise diagnostic and prognostic marker of the periodontal tissues condition in pathology.

Coronary heart disease surveillance: field application of an epidemiologic algorithm.

This report describes the performance of a surveillance system and computerized algorithm for the assignment of definite or probable hospitalized cardiac events for large epidemiologic studies. The algorithm, developed by the Coordinating Committee for Community Demonstration Studies (CCCDS), evolved from the Gillum criteria, and included selected ICD-9-CM codes including codes 410 through 414 for discharge record screening, plus creatine kinase. For the small percentage of cases in which enzyme analysis was inconclusive (8%), presence of pain and/or Minnesota-coded electrocardiograms were included to define the outcome. All data items were easily obtained from medical records by trained lay record abstractors and required no interpretation. From January 1980 through December 1991, 21,183 medical records were screened for ICD-9-CM codes 410 through 414. Of all 410 to 411 ICD-9-CM codes (n = 9026), 36.9% (n = 3220) were classified as definite cardiac events and 10.6% (n = 1057) as probable events. Of all 412 through 414 codes (n = 9070), only 1.8% (n = 227) were classified as definite cardiac events and 5.4% (n = 716) as probable events. The epidemiologic diagnostic algorithm presented in this article used computerized data to assign diagnoses in a standard, objective manner, and was a lower cost alternative to classification of cardiac events on the basis of clinical review and/or more complex record abstraction approaches.

The influence of ketoacids on plasma creatinine assays in diabetic ketoacidosis.

OBJECTIVE: Analysis of the interference of ketoacids on various routine plasma creatinine assays during a clinical episode of diabetic ketoacidosis (DKA). DESIGN: Observational study. Blood samples were drawn before, during and after standard in-hospital treatment. Plasma creatinine was measured with two dissimilar enzymatic assays (creatininase PAP + and creatinine iminohydrolase Serapak), a kinetic alkaline picrate method (Jaffé) and a high-performance liquid chromatography (HPLC) procedure. Acetoacetate and beta-hydroxybutyrate were analysed by enzymatic methods. SETTING: Department of Medicine, University Hospital. SUBJECTS: Nine patients who experienced 10 episodes of DKA. MAIN OUTCOME MEASURES: Agreement of the routine plasma creatinine assays with HPLC and analysis of possible interferents. RESULTS: At presentation, the Jaffé assay gave falsely high values of plasma creatinine (median 99 micromol L(-1)), in contrast to the PAP+ (median 60.5 micromol L(-1)) and HPLC assays (median 67.5 micromol L(-1)). This positive error decreased during treatment. This was due to a decrease in acetoacetate, as the positive error by the Jaffé method correlated with the acetoacetate concentration (r = 0.79, P < 0.0001). In the multiple regression analysis, beta-hydroxybutyrate caused no additional interference by the Jaffé assay, confirmed by in vitro experiments. Analysis of agreement showed that the difference between PAP+ and HPLC creatinine was -4.6 +/- 3.0 micromol L(-1) (mean +/- SD), and 2.0 +/- 5.3 micromol L(-1) between Serapak and HPLC. This was statistically significant, but clinically negligible. CONCLUSION: Acetoacetate caused severe interference of the alkaline picrate (Jaffé) assay, which might influence therapeutic decisions at the start of diabetic ketoacidosis. Enzymatic assays lack this interference.

ASSENCE (assessment of cost-effectiveness of several strategies of early diagnosis in patients with acute chest pain and non-conclusive electrocardiogram).

Clinical, economical, organizative, and medico-legal issues raised by management of citizens who come to Emergency Department with acute chest pain and non diagnostic electrocardiogram are well known. Data from the Italian Health Ministry show that, in 1996, 37,444 patients had been discharged from Italian hospitals with the main diagnosis of chest pain. To obtain this "non-diagnosis", it was needed a mean hospital stay of 4.2 days with estimated costs close to $57,000,000. The ASSENCE study is a randomized, multicenter, international trial aimed at comparing three strategies of handling citizens presenting to emergency department for unexplained chest pain in terms of cost/effectiveness ratio and quality of patients' life. The three strategies that will be compared are: 1. current clinical protocols, prescribing an in-hospital observation period and discharge after several hours/days; 2. performing a dobutamine-atropine stress echocardiography between 0 and 18 hours after randomization (at 6 hours after index chest pain onset) and discharging the patients (if negative) immediately thereafter; 3. performing an electrocardiographic exercise stress test between 0 and 18 hours after randomization and discharging the patients (if negative) immediately thereafter. The main ASSENCE study end-point will be assessment of cost/effectiveness of the 3 strategies tested. Costs will be assessed taking into account: hospital stay length, performed diagnostic procedures and treatments during index admission, in-hospital and 2-month follow-up events (cardiac death, myocardial infarction, definite unstable angina, coronary angioplasty, by-pass surgery, re-admission to hospital for chest-pain). A secondary ASSENCE study end-point will be to assess the effect on patient quality of life of the use of the 3 strategies tested. Sample size estimation calculated in order to detect an absolute difference of at least 10% and based on a 30% expected rate of events, was of 186 patients for each strategy tested.

Problem drinkers in acute care settings: validation of an assessment instrument.

This article reports a validation study of a screening procedure for detecting those patients whose patterns of alcohol consumption places them at risk of developing alcohol-related health problems. The sample comprised 998 patients who were admitted to the wards of a general hospital for treatment of conditions which were not primarily alcohol-related. Twenty-six per cent of patients reported drinking more than published guidelines for low-risk drinking. The use of a diary was found to be a valid means of assessing patients' levels of alcohol consumption, and its reliability and validity was confirmed as a method of distinguishing potential problem drinkers from those whose level of alcohol consumption does not place them at risk. As such, the diary is recommended as an assessment tool which can readily be incorporated into standard assessment procedures.