The association of dementia on perioperative complications following primary total hip arthroplasty for femoral neck fractures.

INTRODUCTION: Studies evaluating the association of dementia in patients undergoing total hip arthroplasty (THA) for femoral neck fractures are limited. The aim was to investigate whether patients who have dementia undergoing THA for femoral neck fractures have higher rates of (1) in-hospital lengths of stay (LOS); 2) complications (medical and prostheses-related); and 3) healthcare expenditures. METHODS: A retrospective query using the PearlDiver database from January 1st, 2005 to March 31st, 2014 to identify patients with dementia undergoing primary total hip arthroplasty for the treatment of femoral neck fractures was performed. Dementia patients were 1:5 ratio matched to controls which yielded 22,758 patients in the study with (n = 3,798) and without (n = 18,960) dementia. Primary outcomes included comparing LOS, complications, and costs. A logistic regression was constructed to calculate the odds-ratios (OR) of dementia on complications. A p-value less than 0.004 was significant. RESULTS: Dementia patients had longer LOS (7-days vs. 6-days, p < 0.0001) and higher incidence and odds of medical complications (41.52 vs. 17.77%; OR 3.76, p < 0.0001), including cerebrovascular events (5.66 vs. 1.64%; OR 2.35, p < 0.0001), pneumoniae (9.98 vs. 3.82%; OR 1.82, p < 0.0001), and acute kidney injury (8.37 vs. 3.27%; OR 1.62, p < 0.0001). Study group patients had higher frequency of prostheses-related complications (9.53 vs. 8.31%; OR: 1.16, p = 0.012). The study group had greater total healthcare expenditures ($28,879.57 vs. $26,234.10, p < 0.0001) when analyzing ninety-day episode of care charges. CONCLUSION: Patients with dementia undergoing THA due to femoral neck fracture have increased LOS, medical and prostheses-related complications, and cost of care compared to their counterparts.

Laboratory Computer-Based Interventions for Better Adherence to Guidelines in the Diagnosis and Monitoring of Type 2 Diabetes.

INTRODUCTION: The aim was to present two automated laboratory strategies designed to detect new cases of type 2 diabetes and prediabetes and improve their monitoring. METHODS: To improve diabetes diagnosis, we automatically registered the glycated hemoglobin (HbA1c) levels of every primary care patient between 25 and 46 years old in case of abnormal lipid testing when an HbA1c test had not been requested in the current order or during the previous year and when fasting glucose was > 100 mg/dl. We counted the number of detected cases of diabetes and prediabetes and calculated the cost per identified patient. To improve diabetes monitoring, the levels of HbA1c, total cholesterol, high- and low-density lipoprotein cholesterol and triglycerides and the spot urinary albumin-to-creatinine ratios (ACRs) were automatically registered in patients with diabetes when not ordered according to guidelines. We calculated the total economic costs according to the total number of additional registered tests and reagent cost. RESULTS: Of 103,425 requests, 224 (0.22%) met the inclusion criteria. Seventeen (7.6%) patients were identified as having new cases of diabetes and 149 (66.5%) of prediabetes, at a cost of €15.2 and €2.3, respectively, per case detected. From 13,874 requests in patients with diabetes, 91 HbA1c and 708 lipid tests and 862 ACRs were automatically registered to comply with guidelines, resulting in expenses of €1948.90. CONCLUSIONS: Making use of laboratory technology, it is possible to detect new cases of type 2 diabetes and prediabetes and to improve disease monitoring.

Urinary albumin strip assay as a screening test to replace quantitative technology in certain conditions.

Background The clinical laboratory plays a crucial role in the diagnosis and monitoring of chronic kidney disease. The quantitative measurement of urine albumin in a spot sample, expressed as ratio per creatinine (ACR) is the most frequently used biomarker for such a purpose. Our aim was to evaluate the diagnostic performances of a strip for measuring ACR for differentiating patients who are candidates for subsequent albumin quantification, and to evaluate the economic effects of its implementation. Methods We systematically measured strip analysis when quantitative urinary albumin was requested. Semiquantitative urinary albumin was measured using a UC-3500 (Sysmex, Kobe, Japan), based on the protein error of a pH indicator. We collected and reviewed all the values of quantified urinary albumin and their corresponding results in ACR strip tests. We calculated the diagnostic indicators for ACR at different albumin and creatinine values using the quantitative ACR measurement as a "gold standard". We also studied the economic effects based on both tests prices (€1.31 for quantitative albumin plus creatinine, and €0.04 for an albumin strip). Results The study included 9148 patients (mean age 63, 46.3% men). The results at different albumin and creatinine cutoffs showed the best performance when 10 mg/L and above 50 mg/dL, respectively. Based on our results, we would have saved 3506 urine albumin and creatinine tests in the study period, corresponding to €4226.94. Conclusions The present study supports the use of the ACR strip test to identify pathological albuminuria values to be measured through quantitative methods. Considerable economic savings are possible.

Computer-assisted interventions in the clinical laboratory process improve the diagnosis and treatment of severe vitamin B12 deficiency.

BACKGROUND: Severe vitamin B12 deficiency can result in serious complications if undiagnosed or untreated. Our aim was to test the efficacy of interventions in the laboratory process to improve the detection and the treatment of severe vitamin B12 deficiency. METHODS: Quasi-experimental investigation with a retrospective 7-year pre-intervention period and 29-month post-intervention follow-up in a university hospital. Two interventions were designed to improve the detection and treatment of subjects with vitamin B12 deficiency: the laboratory information system (LIS) automatically added seru vitamin B12 (s-vitamin B12) based on certain conditions; and created a comment in the report and scheduled an appointment with the general practitioner (GP). We calculated the number of new diagnoses of severe vitamin deficiency (s-vitamin B12 <73.8 pmol/L) and the proportion of identified patients that were correctly treated in the pre- and post-intervention periods. We compared the number of tests needed to detect a new case when ordered by GPs vs. added by the strategy. Finally, we investigated the economic cost of each new case. RESULTS: The strategy added 699 s-vitamin B12 and detected 66 new cases of severe vitamin deficiency. The number of tests needed to identify a new case when s-vitamin B12 was ordered by GPs was 187, as opposed to 10 when added through the intervention (p<0.001). The intervention reagent cost was €26.7 per new case. In the post-intervention cohort, 88% of patients were correctly treated, as opposed to 52% in the pre-intervention (p<0.001). CONCLUSIONS: Interventions in the clinical laboratory process improved the diagnosis and treatment of severe vitamin B12 deficiency.

Managing inappropriate requests of laboratory tests: from detection to monitoring.

OBJECTIVES: The main objectives of this study were to show a simple approach to detect inappropriate requests of laboratory tests and to monitor success after establishing interventions. These objectives were monitored through process and outcome indicators customized according to the type and phase of the appropriateness strategy. STUDY DESIGN: Quasi-experimental design. METHODS: Based on evidence regarding laboratory test utilization differences among different geographical areas of Spain, we identified serum calcium (s-Ca) testing to be underrequested and total bilirubin (tBil) testing to be overrequested in primary care patients who undergo testing at the Public University Hospital of San Juan, in San Juan de Alicante, Alicante, Spain. Additionally, the ratio of free thyroxine (FT4) tests to thyrotropin (also called thyroid-stimulating hormone [TSH]) tests was well above the published 0.25 goal in primary care. Finally, numerous laboratory tests were overrequested in hospitalized patients due to repetitive testing. We designed and implemented a variety of strategies to correct such inappropriateness and designed different indicators to monitor the intervention success over time. RESULTS: After implementation of the different strategies, the absolute number of s-Ca tests increased. The number of tBil tests in primary care, and numerous other tests repeated too frequently in hospitalized patients, decreased. The FT4/TSH indicator goal was reached and maintained over time. Regarding the outcome indicators, the strategy of reducing tBil tests in primary care and reducing the aggregate of unnecessary tests in hospitalized patients resulted in savings of $3543.80 and $9825.50, respectively, from January 2012 to December 2014. The s-Ca strategy, from November 2011 to December 2014, detected 62 subjects' primary hyperparathyroidism at a cost of $137.80 per case. CONCLUSIONS: The study demonstrates a simple approach to detect inappropriate requests of laboratory tests, and how to assess the potential success of interventions using process and outcome indicators.

Automatic laboratory-based strategy to improve the diagnosis of type 2 diabetes in primary care.

INTRODUCTION: To study the pre-design and success of a strategy based on the addition of hemoglobin A1c (HbA1c) in the blood samples of certain primary care patients to detect new cases of type 2 diabetes. MATERIALS AND METHODS: In a first step, we retrospectively calculated the number of HbA1c that would have been measured in one year if HbA1c would have been processed, according to the guidelines of the American Diabetes Association (ADA). Based on those results we decided to prospectively measure HbA1c in every primary care patient above 45 years, with no HbA1c in the previous 3 years, and glucose concentration between 5.6-6.9 mmol/L, during an 18 months period. We calculated the number of HbA1c that were automatically added by the LIS based on our strategy, we evaluated the medical record of such subjects to confirm whether type 2 diabetes was finally confirmed, and we calculated the cost of our intervention. RESULTS: In a first stage, according to the guidelines, Hb1Ac should have been added to the blood samples of 13,085 patients, resulting in a cost of 14,973€. In the prospective study, the laboratory added Hb1Ac to 2092 patients, leading to an expense of 2393€. 314 patients had an HbA1c value ≥ 6.5% (48 mmol/mol). 82 were finally diagnosed as type 2 diabetes; 28 thanks to our strategy, with an individual cost of 85.4€; and 54 due to the request of HbA1c by the general practitioners (GPs), with a cost of 47.5€. CONCLUSION: The automatic laboratory-based strategy detected patients with type 2 diabetes in primary care, at a cost of 85.4€ per new case.

Ten years of preanalytical monitoring and control: Synthetic Balanced Score Card Indicator.

INTRODUCTION: Preanalytical control and monitoring continue to be an important issue for clinical laboratory professionals. The aim of the study was to evaluate a monitoring system of preanalytical errors regarding not suitable samples for analysis, based on different indicators; to compare such indicators in different phlebotomy centres; and finally to evaluate a single synthetic preanalytical indicator that may be included in the balanced scorecard management system (BSC). MATERIALS AND METHODS: We collected individual and global preanalytical errors in haematology, coagulation, chemistry, and urine samples analysis. We also analyzed a synthetic indicator that represents the sum of all types of preanalytical errors, expressed in a sigma level. We studied the evolution of those indicators over time and compared indicator results by way of the comparison of proportions and Chi-square. RESULTS: There was a decrease in the number of errors along the years (P<0.001). This pattern was confirmed in primary care patients, inpatients and outpatients. In blood samples, fewer errors occurred in outpatients, followed by inpatients. CONCLUSION: We present a practical and effective methodology to monitor unsuitable sample preanalytical errors. The synthetic indicator results summarize overall preanalytical sample errors, and can be used as part of BSC management system.

Laboratory utilization improvement through a computer-aided algorithm developed with general practitioners.

BACKGROUND: One of the main duties of healthcare workers is to get an appropriate use of diagnostic and therapeutic tools. The aim of this study was to show how strategies can be designed and established in consensus with general practitioners (GPs) to reach an optimal laboratory test request. METHODS: The laboratory serves a population of approximately 235,000 inhabitants, including nine primary care centers. GPs could request every test in profiles and individually. In meetings between the laboratory and GPs our request patterns were compared to other geographic regions, and we investigated the appropriateness of test requesting. The group devised strategies that consisted of removing tests from profiles [aspartate aminotransferase (AST), γ-glutamyltranspeptidase (GGT) and phosphate], removing tests from GPs requests (iron and transferrin), substituting tests (IgA antigliadin antibody), and measuring total bilirubin (tBil) only when the icteric index value was above 34.2 mmol/L (2 mg/dL). We analyzed every test request in the post- (years 2012-2013) and pre-intervention period (years 2010-2011), and the tBil measured in the post-intervention period. We studied if AST/alanine aminotransferase (ALT) and GGT/ALT achieved indicators targets and calculated the economic savings in the post-intervention period. RESULTS: There was a significant drop in every test request in the post-intervention period. AST/ALT achieved the indicator target. GGT/ALT, never achieved the indicator goal. The strategies resulted in a savings of more than €34,000. CONCLUSIONS: The strategies designed between the laboratory and the requesting clinicians and automatically established by using our laboratory information system were successful.

Customising turnaround time indicators to requesting clinician: a 10-year study through balanced scorecard indicators.

AIM: The purpose of this study is, first to present a 10-year monitoring of postanalytical turnaround time (TAT) adapted to different clinicians and patient situations, second to evaluate and analyse the indicators results during that period of time, and finally to show a synthetic appropriate indicator to be included in the balanced scorecard management system. METHODS: TAT indicator for routine samples was devised as the percentage of certain key tests that were verified before a specific time on the phlebotomy day. A weighted mean synthetic indicator was also designed. They were calculated for inpatients at 15:00 and 12:00 and for primary care patients only at 15:00. The troponin TAT of emergency department patients, calculated as the difference between the troponin verification and registration time, was selected as the stat laboratory TAT indicator. RESULTS: The routine and stat TAT improved along the 10-year study period. The synthetic indicator showed the same trend. CONCLUSIONS: The implementation of systematic and continuous monitoring over years, promoted a continuous improvement in TAT which will probably benefit patient outcome and safety.

Strategy to improve the request of uric acid in primary care: preliminary results and evaluation through process and outcome appropriateness indicators.

INTRODUCTION: Alerted by the high rates of request of serum uric acid (UA) in primary care patients, we aimed to design a strategy to improve such an indicator, and to monitor such an intervention through process and outcome appropriateness indicators. METHODS: To design the strategy, several meetings were held between the Laboratory, Rheumatology and Primary Care. The intervention consisted of discharging UA from two laboratory profiles ("Health Check" and "Rheumatology"), making it only possible to request the test in an individualized manner. To assess the intervention effectiveness, the ratio of UA/glucose requests, the quantity of allopurinol prescription and the resulting economic savings were calculated and compared for pre- and post-intervention 12 month periods. RESULTS: There was a 70% decrease in the number of UA requests in the post-intervention period, as compared to the pre-intervention interval. The ratio of UA/glucose requests experienced a significant commensurate drop in the post-intervention period (p<0.01). There was a significant reduction in the prescription of allopurinol (p<0.01). From an economic perspective, the strategy resulted in a savings of 8190 €. CONCLUSION: The strategy resulted in a dramatic drop in the number of UA requests and in the prescription of allopurinol. This highlights a likely existence of prior unnecessary treatment of patients with hyperuricemia in the absence of clinical symptoms.

Patient identification errors: the detective in the laboratory.

BACKGROUND: The eradication of errors regarding patients' identification is one of the main goals for safety improvement. As clinical laboratory intervenes in 70% of clinical decisions, laboratory safety is crucial in patient safety. We studied the number of Laboratory Information System (LIS) demographic data errors registered in our laboratory during one year. METHODS: The laboratory attends a variety of inpatients and outpatients. The demographic data of outpatients is registered in the LIS, when they present to the laboratory front desk. The requests from the primary care centers (PCC) are made electronically by the general practitioner. A manual step is always done at the PCC to conciliate the patient identification number in the electronic request with the one in the LIS. Manual registration is done through hospital information system demographic data capture when patient's medical record number is registered in LIS. Laboratory report is always sent out electronically to the patient's electronic medical record. Daily, every demographic data in LIS is manually compared to the request form to detect potential errors. RESULTS: Fewer errors were committed when electronic order was used. There was great error variability between PCC when using the electronic order. CONCLUSIONS: LIS demographic data manual registration errors depended on patient origin and test requesting method. Even when using the electronic approach, errors were detected. There was a great variability between PCC even when using this electronic modality; this suggests that the number of errors is still dependent on the personnel in charge of the technology.

Serum calcium (S-Ca), the forgotten test: preliminary results of an appropriateness strategy to detect primary hyperparathyroidism (pHPT).

BACKGROUND: With the introduction of automated calcium measurements with multichannel continuous-flow analyzers in the 1970s, primary hyperparathyroidism (pHPT), the silent disease, began to be detected. Years later, with the first appearance of random access analyzers, laboratory tests were requested if the patient had clinical symptoms and pHPT was again overlooked. In this current scenario, serum calcium (s-Ca) is at risk of becoming a forgotten test. In consensus with endocrinologists and general practitioners (GPs), we implemented a strategy to detect asymptomatic pHPT patients. METHODS: During a 9 month period, the Laboratory Information System automatically added s-Ca to every sample of blood from primary care patients older than 45 years, without a s-Ca request in the previous three years. If hypercalcemia was detected (albumin-corrected s-Ca > 2.6 mmol/L), phosphate, 25-hydroxy vitamin D and parathyroid hormone (PTH) were automatically processed in the same sample. We reviewed the medical record of every patient with hypercalcemia. RESULTS: S-Ca was automatically added to 14,461 samples, with 79 hypercalcemia results. 14 hypercalcemia results with PTH levels in the reference range were clinically justified by causes other than pHPT. Of the remaining 65 patients, 41 were referred for evaluation by endocrinology. 34 resulted in a diagnosis of pHPT and 7 are currently in study. 24 patients were not followed by GPs to find out the primary cause of hypercalcemia. After a phone call from the laboratory, they are also currently being studied for hypercalcemia. Each case represented a cost of 110.4 US dollars. CONCLUSION: Our proposed opportunistic screening to discover pHPT seems cost-effective.

Should we customise critical value procedure according to patient origin and laboratory turnaround time?

INTRODUCTION: Our routine laboratory critical value notification procedure is based on a short list of six fundamental critical values. The report system for our Stat laboratory is not based on this 'short list'; instead, critical values are always reported according to the patient clinical context and the previous laboratory results. The aim of our work is to show how a critical value notification procedure based on a rigid list of values and thresholds can result in completely different results depending on whether the tests are requested in a stat or a routine manner. MATERIAL AND METHODS: We reviewed the number of critical value notifications based on the short list for the routine laboratory. For the stat laboratory, we studied the number of real notifications based on the pathologist validation of the individualised situation of the patient and calculated the number of notifications that would have been reported if the routine short list would have been used instead. RESULTS: The number of critical values that would have been reported if using the routine short list in stat laboratory was high when compared with the number of critical values that were really reported. CONCLUSIONS: Using a rigid list of laboratory values to notify critical values resulted in completely different results depending on whether the tests were requested in stat or routine. Reporting only really unexpected values through an individual custom-made reporting procedure may avoid the wasting of time and resources and raising false alarms among referring physicians and patients.

Alert value reporting: a new strategy for patient safety.

OBJECTIVES: The objectives of this study are to introduce the "alert value reporting" concept in primary care setting, to propose a list of chemistry and hematology alert limit tests that can be chosen for that strategy, to show how this notification procedure can be designed and established, and finally to evaluate the effectiveness and physicians' satisfaction regarding the proposed approach. In contrast to critical value reporting, alert value reporting would not allude to a result that may imply a life-threatening situation, but would indicate that an early diagnostic/therapeutic action would improve the patient's management and quality of life. DESIGN AND METHODS: A list of chemistry and hematology alert limit tests to be used for the strategy was agreed upon between laboratory professionals and general practitioners. Next, a retrospective 12-month study involving more than 1 million laboratory tests was made to check how many of these alert values would have been communicated if these theoretical alert values had been applied. A prospective analysis of every reported alert value during 6 months was carried out to assess the intervention effectiveness and the requesting physician's satisfaction with the new strategy. RESULTS: The alert value reporting was successfully executed. 20% of the reported alert values motivated the decision to reschedule the next patient's appointment. 90% of physicians considered alert value reporting as an interesting strategy to be continued. CONCLUSIONS: Alert value reporting strategy motivated changes in patient's management. Further studies are needed to test if this approach can contribute to enhance patient safety and decision-making.

Diagnostic accuracy of icteric index to detect abnormal total bilirubin values.

AIMS: Total bilirubin tests are individually inexpensive but can result in huge costs to healthcare systems worldwide, because they are very commonly requested. The main objective of this study was to evaluate the diagnostic accuracy of the icteric index, a test with zero reagent cost, as a preliminary biomarker to decide when total bilirubin measurement is necessary. METHODS: We retrospectively reviewed all the requested total bilirubin values and their corresponding icteric index results in a 2-year period (2010-11). Receiver operating characteristic (ROC) curve analysis was used to determine the optimal icteric index cut-off value to discriminate between normal and abnormal bilirubin values (>20.5 µmol/l; >1.2 mg/dl). RESULTS: The study included total bilirubin and icteric index results of 100,207 patients. The ROC curve analysis suggested 34.2 µmol/l (2 mg/dl) as the optimal icteric index threshold to identify abnormal bilirubin values. The area under the curve was 0.981. Regardless of the patient population studied (primary care, hospital and different individual hospital departments), sensitivity was greater than 94% and specificity was over 98%. Likelihood ratio values provided strong evidence that total bilirubin is less than 20.5 µmol/l (<1.2 mg/dl) when the icteric index is less than 34.2 µmol/l (<2 mg/dl). CONCLUSIONS: This study supports the use of the icteric index to identify patients with abnormal total bilirubin values. Considerable economic savings can be achieved if this strategy is applied on a clinical daily basis. Its implementation and report should be discussed and planned by laboratory professionals together with requesting physicians.

Group A Streptococcus emm gene types in pharyngeal isolates, Ontario, Canada, 2002-2010.

Group A Streptococcus (GAS) is a human-adapted pathogen that causes a variety of diseases, including pharyngitis and invasive infections. GAS strains are categorized by variation in the nucleotide sequence of the gene (emm) that encodes the M protein. To identify the emm types of GAS strains causing pharyngitis in Ontario, Canada, we sequenced the hypervariable region of the emm gene in 4,635 pharyngeal GAS isolates collected during 2002-2010. The most prevalent emm types varied little from year to year. In contrast, fine-scale geographic analysis identified inter-site variability in the most common emm types. Additionally, we observed fluctuations in yearly frequency of emm3 strains from pharyngitis patients that coincided with peaks of emm3 invasive infections. We also discovered a striking increase in frequency of emm89 strains among isolates from patients with pharyngitis and invasive disease. These findings about the epidemiology of GAS are potentially useful for vaccine research.

Distinct signatures of diversifying selection revealed by genome analysis of respiratory tract and invasive bacterial populations.

Many pathogens colonize different anatomical sites, but the selective pressures contributing to survival in the diverse niches are poorly understood. Group A Streptococcus (GAS) is a human-adapted bacterium that causes a range of infections. Much effort has been expended to dissect the molecular basis of invasive (sterile-site) infections, but little is known about the genomes of strains causing pharyngitis (streptococcal "sore throat"). Additionally, there is essentially nothing known about the genetic relationships between populations of invasive and pharyngitis strains. In particular, it is unclear if invasive strains represent a distinct genetic subpopulation of strains that cause pharyngitis. We compared the genomes of 86 serotype M3 GAS pharyngitis strains with those of 215 invasive M3 strains from the same geographical location. The pharyngitis and invasive groups were highly related to each other and had virtually identical phylogenetic structures, indicating they belong to the same genetic pool. Despite the overall high degree of genetic similarity, we discovered that strains from different host environments (i.e., throat, normally sterile sites) have distinct patterns of diversifying selection at the nucleotide level. In particular, the pattern of polymorphisms in the hyaluronic acid capsule synthesis operon was especially different between the two strain populations. This finding was mirrored by data obtained from full-genome analysis of strains sequentially cultured from nonhuman primates. Our results answer the long-standing question of the genetic relationship between GAS pharyngitis and invasive strains. The data provide previously undescribed information about the evolutionary history of pathogenic microbes that cause disease in different anatomical sites.