Quantitative conjunctival provocation test for controlled clinical trials.

BACKGROUND: The conjunctival provocation test (CPT) is a diagnostic procedure for the assessment of allergic diseases. Photographs are taken before and after provocation increasing the redness of the conjunctiva due to hyperemia. OBJECTIVE: We propose and evaluate an automatic image processing pipeline for objective and quantitative CPT. METHOD: After scale normalization based on intrinsic image features, the conjunctiva region of interest (ROI) is segmented combining thresholding, edge detection and Hough transform. Redness of the ROI is measured from 0 to 1 by the average pixel redness, which is defined by truncated projection in HSV space. In total, 92 images from an observational diagnostic study are processed for evaluation. The database contains images from two visits for assessment of the test-retest reliability (46 images per visit). RESULT: All images were successfully processed by the algorithm. The relative redness increment correlates between the two visits with Pearson's r = 0.672 (p < .001). Linear correlation of the automatic measure is larger than the manual measure (r = 0.59). This indicates a higher reproducibility and stability of the automatic method. CONCLUSION: We presented a robust and effective way to objectify CPT. The algorithm operates on low resolution, is fast and requires no manual input. Quantitative CPT measures can now be established as surrogate endpoint in controlled clinical trials.

[Terminology for classifying the porcine reproductive and respiratory syndrome virus (PRRSV) status of swine herds]. / Terminologie zur Klassifizierung des PRRSV-Status von Schweineherden.

Standardized terminology for the porcine reproductive and respiratory syndrome virus (PRRSV) status of swine herds is necessary to facilitate communication between veterinarians, swine producers, genetic companies, and other industry participants. It is also required for implementation of regional and national efforts towards PRRSV control and elimination. The purpose of this paper is to provide a herd classification system for describing the PRRSV status of herds, based upon a set of definitions reflecting the biology and ecology of PRRSV. The herd classification system was developed by a definitions committee formed jointly by the American Association of Swine Veterinarians (AASV) and the United States Department of Agriculture PRRS-Coordinated Agricultural Project, and was approved by the AASV Board of Directors on March 9, 2010. The committee included veterinarians from private practice and industry, researchers, and representatives from AASV and the National Pork Board. Breeding herds, with or without growing pigs on the same premises, are categorized as Positive Unstable (Category I), Positive Stable (Category II), Provisional Negative (Category III), or Negative (Category IV) on the basis of herd shedding and exposure status. Growing-pig herds are categorized as Positive or Negative. Recommended testing procedures and decision rules for herd classification are detailed.

Detection of adverse events in surgical patients using the Trigger Tool approach.

BACKGROUND: Most studies of healthcare complications identify surgery as a major contributor to the overall burden of complicated care that leads to injury or death. Indeed, surgical adverse events account for one-half to three-quarters of all adverse events in these studies. Despite the intensive current focus on improving medical quality and safety, only a minority of quality improvement efforts are focused on surgery. This study reports on the development and testing of a Trigger Tool to detect adverse events among patients undergoing inpatient surgery. METHODS: Rather than relying on traditional voluntary reporting for safety outcome measures such as incident reports, surgical peer review, or morbidity and mortality conferences, the Institute for Healthcare Improvement (IHI) has employed a new method for the detection of surgical adverse events (SAEs). This approach, commonly referred to as the "Trigger Tool", identifies adverse events using a form of retrospective record review that has been developed and implemented in many areas of care. RESULTS: During a 12-month IHI Perioperative Safety Collaborative, 11 hospitals voluntarily submitted data from surgical inpatient record reviews. In 854 patients, 138 SAEs were detected in 125 records for a rate of 16 SAEs per 100 patients or 14.6% of patients; 61 (44%) of these events contributed to increased length of stay or readmission and 12 (8.7%) events required life-saving intervention or resulted in permanent harm or death. Hospital review teams reported verbally that most of the events identified during the Trigger Tool review process had not been detected or reported via any other existing mechanism. CONCLUSIONS: The IHI Surgical Trigger Tool may offer a practical, easy-to-use approach to detecting safety problems in patients undergoing surgery; it can be the basis not only for estimating the frequency of adverse events in an organisation, but also determining the impact of interventions that focus on reducing adverse events in surgical patients.

Development of the Leapfrog methodology for evaluating hospital implemented inpatient computerized physician order entry systems.

The 1999 Institute of Medicine report raised public awareness of the frequency and cost of adverse drug events in medicine. In response, in November 2000 a coalition of healthcare purchasers announced the formation of the Leapfrog Group, an organization dedicated to making "great leaps forward" in the safety and quality of health care in America. Their first target-computerized physician order entry (CPOE)-was selected specifically for its potential to reduce harm to patients from medications. The Leapfrog inpatient CPOE standard included a requirement that the organization operating CPOE should demonstrate via a test that their inpatient CPOE system can alert physicians to at least 50% of common serious prescribing errors. This paper outlines the development of this test which evaluates the ability of implemented CPOE systems to prevent the occurrence of medication errors that have a high likelihood of leading to adverse drug events. A framework was developed to include 12 different categories of CPOE based decision support that could prevent prescribing errors leading to adverse drug events. A scoring system was developed based on the known frequency and severity of adverse drug events. Simulated test patients and accompanying simulated test medication orders were developed to evaluate the ability of a CPOE system to intercept prescribing errors in all 12 decision support categories. The test was validated at a number of inpatient sites using both commercially available and custom developed CPOE systems. A web based application was developed to allow hospitals to self-administer the evaluation.

Methodology and rationale for the measurement of harm with trigger tools.

The growing recognition of harm as an unwelcome and frequently unrecognized byproduct of health care has initiated focused efforts to create highly reliable organizations for safe healthcare delivery. While debate continues over the exact magnitude of harm, there is a general acceptance of the need to improve our ability to deliver care in a safer manner. A major barrier to progress in safety has been the ability to effectively measure harm consistently and thus develop effective and targeted strategies to prevent its occurrence. This has resulted in a shift from initiatives focused exclusively on analysis of errors to those targeting events linked to harm. There is a growing recognition of a distinction between errors and adverse events as they often represent unique concepts fostering different strategies for improvement of safety. Conventional approaches to identifying and quantifying harm such as individual chart audits, incident reports, or voluntary administrative reporting have often been less successful in improving the detection of adverse events. As a result, a new method of measuring harm--the trigger tool--has been developed. It is easily customized and can be readily taught, enabling consistent and accurate measurement of harm. The history, application, and impact of the trigger tool concept in identifying and quantifying harm are discussed.

Clustering of cases of type 1 diabetes mellitus occurring 2-4 years after vaccination is consistent with clustering after infections and progression to type 1 diabetes mellitus in autoantibody positive individuals.

OBJECTIVE: We previously analyzed data from a hemophilus vaccine trial and identified clusters of extra cases of type 1 diabetes mellitus (T1DM) caused by the vaccine that occurred between 36 and 48 months after immunization. Published reports indicate clustering of cases of T1DM occurring approximately 2-4 years after mumps infection. Others have reported a 2-4 year delay between the onset of autoantibodies and the development of T1DM. We attempted to determine whether similar clustering of cases of T1DM occurred after immunization with vaccines other than hemophilus. METHODS: We searched MEDLINE and reviewed references from published papers to find databases on the incidence of T1DM and then searched MEDLINE to determine whether changes in immunization occurred in these regions during the times the incidence of DM was being recorded. RESULTS: Distinct rises in the incidence of T1DM occurred 2-4 years following the introduction of the MMR and pertussis vaccines. A drop in the incidence of T1DM was detected between 3-4 years following discontinuation of pertussis and BCG vaccines. CONCLUSION: The identification of clusters of cases of T1DM occurring in consistent temporal time periods allowed a link between the hemophilus vaccine and T1DM to be established. The current findings indicate the there are also clusters of cases of T1DM occurring 2-4 years post-immunization with the pertussis, MMR, and BCG vaccine. The data are consistent with the occurrence of clusters following mumps infection and the progression to T1DM in patients with antipancreatic autoantibodies.

Vaccines and the risk of insulin-dependent diabetes (IDDM): potential mechanism of action.

Immunization with a number of different vaccines, including live and killed vaccines, has been linked to the development of insulin-dependent (type 1) diabetes in humans and animals. Multiple different mechanisms have been proposed to explain the association between vaccines and diabetes. The current paper reviews multiple different mechanisms by which vaccines are known to manipulate the immune system and can induce an autoimmune disease such as type 1 diabetes. Genetic variability may determine which of these pathways, or possible other pathways, predominate in an individual following immunization.

Free flap coverage of bilateral frostbite of the feet.

The indications, principles of management, and outcomes of free flap transfer for limb salvage in four patients with bilateral frostbite of their feet are presented. A fasciocutaneous flap was used for coverage when the wound involved a single surface of the foot. When multiple surfaces of the foot required free flap coverage, a muscle flap was used because it could more easily improve the shape and contour of the defect. Successful coverage was achieved in all four patients.

Patient safety, thy name is quality.

Trustees must take the lead in communicating the importance of an organization-wide quality program. Patient safety is a natural outgrowth of an aggressive and nonpunitive approach to quality.

Immunization in the first month of life may explain decline in incidence of IDDM in The Netherlands.

A low cumulative incidence of IDDM was reported in Dutch males born in 1962 (Diabetologia 1992: 35: 139-142) compared to males born in previous or later years. The cause for the decreased risk has not been previously explained. We propose that children born in 1962 during an European smallpox epidemic may have received the smallpox vaccine in the first month of life and this may have attributed to the decreased risk of IDDM in these children. We have shown that immunization with several different vaccines starting in the first month of life prevents diabetes in NOD mice and BB rats (Autoimmunity 1996: 24: 137-145) while immunization at birth with the BCG vaccine is associated with an decreased risk of IDDM in humans (Infectious Diseases in Clinical Practice 1997: 6: 449-454). An even bigger decline in diabetes is seen in rodents and associated in humans when one compares immunization starting in the first month of life to immunization starting after 2 months, since the later has been associated with an increased risk of IDDM. Immunization studies in the past have typically followed patients for only several weeks to determine any unplanned affects on autoimmune disease. Due to the potential benefit of reducing the incidence of diabetes by 50% through age 18 we believe clinical trials are warranted to study the effect of timing of immunization on IDDM.

Evaluation of a computer-assisted antibiotic-dose monitor.

OBJECTIVE: To examine the effect of a computer-assisted antibiotic-dose monitor used to reduce the number of days that patients receive excessive dosages of antibiotics and the number of adverse drug events (ADEs) secondary to antibiotics. DESIGN: Descriptive epidemiologic study of a two-year preintervention period and one-year intervention period. SETTING: The LDS Hospital, a tertiary care center in Salt Lake City, UT. PATIENTS: All patients aged > or = 18 years, admitted to LDS Hospital from April 1, 1993, to March 31, 1996, who received at least one of five targeted antibiotics (vancomycin, gentamicin, imipenem, cefazolin, cefuroxime), who had a serum creatinine or a urine creatinine clearance test result before antibiotic therapy, and who were never admitted or transferred to the shock/trauma/respiratory intensive care unit. METHODS: Each morning during the 12-month intervention period, the antibiotic-dose monitor checked the renal function of all patients who were receiving any of the five antibiotics. Pharmacists received a computer listing of patients who may have been receiving excessive dosages. The antibiotic-dose monitor suggested an alternate dosage and a pharmacist contacted the patient's physician if the suggested change in the dosage was appropriate. RESULTS: During the intervention period, 4483 patients received at least one of the five study antibiotics and 1974 (44%) were identified as receiving an excessive dosage, compared with 4494 (50%) of 8901 patients during the preintervention period (p < 0.001). The patients receiving excessive dosages received an excessive dosage for an average of 2.9 days during the intervention period, compared with 4.7 days (p < 0.001) during the preintervention period. In addition, these same patients during the intervention period received fewer doses of antibiotics (10.9 vs. 13.4; p < 0.001), fewer grams of antibiotics (10.4 vs. 12.0; p < 0.02), at less cost ($98 vs. $128; p < 0.004) than the patients during the preintervention period. Moreover, there were 14 ADEs (0.3%) secondary to the five study antibiotics during the intervention period, compared with 82 (0.9%; p < 0.001) for the two-year preintervention period. The study also found that significantly more patients identified as receiving excessive dosages had experienced decreases in renal function, compared with patients who were not identified as receiving excessive dosages (25% vs. 12% during preintervention period and 23% vs. 16% during intervention period; p < 0.001). CONCLUSIONS: Many patients experience decreases in renal function after antibiotics are ordered. The use of the computer-assisted antibiotic-dose monitor appears to be a promising method to help reduce the excessive use and cost of antibiotic therapy and reduce the number of ADEs secondary to antibiotics.

Aplasia cutis congenita associated with fetus papyraceous.

This report describes a healthy infant born with an isolated, truncal cutis aplasia defect in association with a fetus papyraceous. Effective healing of the cutaneous defect occurred over the course of a month. A 2-year follow-up demonstrate stable wound coverage. This rare association of aplasia cutis congenita, with a fetus papyraceous points most likely to the vascular causation of the cutaneous defect.

Clinical and financial impact of intravenous erythromycin therapy in hospitalized patients.

OBJECTIVE: To determine the economic consequences of intravenous erythromycin use in hospital patients in a variety of clinical circumstances. DESIGN: Retrospective cohort study of patients with specified primary diagnosis-related group discharge diagnoses treated from January 1, 1990, to December 31, 1994, who received erythromycin, and a matched cohort group from the same period who did not receive erythromycin. SETTING: LDS Hospital, Salt Lake City, UT, a 520-bed teaching hospital. PATIENTS: A long-term archive of clinical and financial data from a computerized hospital information system was searched for patients meeting a strict case definition. This archive contained information on erythromycin exposure as well as concurrent drug therapy and adverse drug events that had been prospectively evaluated during hospitalization throughout the study and cohort periods. Detailed costs were available for each patient. MAIN OUTCOME MEASURE: Attributable differences in lengths of stay and total costs determined using linear regression modeling. RESULTS: For 797 erythromycin patients and 2771 cohort patients, we found an attributable increased length of stay of 2.14 days and an increased cost of hospitalization of $6061 for erythromycin case patients. Case patients also had a significantly increased risk of adverse drug events. Linear regression modeling showed that erythromycin use was significantly related to increased length of stay and cost of hospitalization. CONCLUSIONS: Intravenous erythromycin use has been associated with significant increases in hospital length of stay and total hospital cost.