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PubMed1999

A strategy for developing practice guidelines for the ICU using automated knowledge acquisition techniques.

OBJECTIVES: To implement practice guideline entry tools in a reminder system in order to provide decision support to health care workers in clinical care and emergency care environments. To design a knowledge acquisition environment that enables physicians to formulate, update, and verify guidelines without the assistance of a knowledge engineer. METHODS: We developed a knowledge acquisition environment for the Intensive Care Unit (ICU) consisting of 1) a graphical knowledge acquisition tool, 2) tools that perform logical and semantic tests on proposed guidelines, 3) a Patient Data Management System (PDMS) containing clinical patient data, and 4) an expert system that reminds ICU health care workers of inconsistencies between a treatment plan and implemented guidelines. Physicians enter the guidelines using the knowledge acquisition tool, after which consistency and correctness tests are performed on the guidelines. The guidelines are then transferred to the knowledge base of the reminder system and validated by applying the new guidelines to a large stored data set of previous patients. If the new guidelines are approved, they are exported to the reminder system that is used in daily practice. RESULTS: ICU physicians used the knowledge acquisition tool to enter 58 guidelines into the reminder system's knowledge base. These guidelines were tested on a data set consisting of 803 previously admitted patients. As a result, 27 guidelines fired at least once, generating 406 reminders in total. Of the 406 generated reminders, 356 (88%) were issued correctly and 50 (12%) were false alarms. The reminders that were issued correctly involved 3 situations: 1) the database contained inconsistent or incomplete information, 2) the actions or decisions of the health care workers were not the most appropriate ones, and 3) there was a potential risk involved. All false alarms were caused by the fact that the corresponding guidelines were not specific enough to handle certain exceptions. As a result of this analysis, the guidelines could be improved in such a way as to eliminate all false alarms. CONCLUSIONS: These first results demonstrate that this bottom-up knowledge acquisition strategy, implemented by the automated knowledge acquisition tools, enables medical specialists to improve the quality of computer support in an ICU without assistance of a knowledge engineer.

Artificial Intelligence↗
PubMed2004

Insulin pump therapy for 1-6 year old children with type 1 diabetes.

BACKGROUND: The management of diabetes in preschool children poses unique difficulties for both the families and the medical team. OBJECTIVE: To test the feasibility and safety of insulin pump therapy in the 1-6 year age group in order to improve quality of life and metabolic control. METHODS: The study group comprised 15 type 1 diabetic children aged 1-6 years old (mean +/- SD, 3.8 +/- 1.2 years) from three diabetes centers. Insulin pump therapy was applied for 12 months. Data, including insulin dose, hemoglobin A1c, hypoglycemic events, as well as scores on the Diabetes Quality of Life Measure Questionnaire and the Diabetes Treatment Satisfaction Questionnaire, were collected and compared with the multiple daily injection treatment prior to entry into the study, RESULTS: HbA1c was measured at the beginning of the study and at 2, 4, 8 and 12 months later; the respective levels (mean +/- SD) were 8.82 +/- 0.98, 8.45 +/- 1.05, 8.37 +/- 0.85, 8.32 +/- 0.71, 8.18 +/- 0.90%. HbA1c measurements after 12 months were significantly lower than at the beginning of the study (P < 0.05). There were no significant differences in insulin dose and the total number of hypoglycemic events. In both the DQOL and DTSQ scales there were significant differences in scores in favor of the insulin pump period (43.7 +/- 8.0 versus 33.7 +/- 7.9, P < 0.001; and 10.9 +/- 2.3 versus 14.5 +/- 2.3, P < 0.001), respectively. CONCLUSIONS: For very young diabetic children, insulin pump therapy improves quality of life and is feasible and safe. It should be considered as an optional mode of therapy for this age group.

Child↗
PubMed2000

Is there a rationale for the use of creatine either as nutritional supplementation or drug administration in humans participating in a sport?

Even though no unambiguous proof for enhanced performance during high-intensity exercise has yet been reported, the creatine administration is charged to improve physical performance and has become a popular practice among subjects participating in different sports. Appropriate creatine dosage may be also used as a medicinal product since, in accordance with the Council Directive 65/65/CEE, any substance which may be administered with a view to restoring, correcting or modifying physiological functions in human beings is considered a medicinal product. Thus, quality, efficacy and safety must characterize the substance. In biochemical terms, creatine administration enhances both creatine and phosphocreatine concentrations, allowing for an increased total creatine pool in skeletal muscle. In thermodynamics terms, creatine interferes with the creatine-creatine kinase-phosphocreatine circuit, which is related to the mitochondrial function as a highly organized system for the energy control of the subcellular adenylate pool. In pharmacokinetics terms, creatine entry into skeletal muscle is initially dependent on the extracellular concentration, but the creatine transport is subsequently down-regulated. In pharmacodynamics terms, the creatine enhances the possibility to maintain power output during brief periods of high-intensity exercises. In spite of uncontrolled daily dosage and long-term administration, no research on creatine safety in humans has been set up by specific standard protocol of clinical pharmacology and toxicology, as currently occurs in phase I for the products for human use. More or less documented side effects induced by creatine are weight gain; influence on insulin production; feedback inhibition of endogenous creatine synthesis; long-term damages on renal function. A major point that related to the quality of creatine products is the amount of creatine ingested in relation to the amount of contaminants present. During the production of creatine from sarcosine and cyanamide, variable amounts of contaminants (dicyandiamide, dihydrotriazines, creatinine, ions) are generated and, thus, their tolerable concentrations (ppm) must be defined by specific toxicological researches. Creatine, as the nutritional factors, can be used either at supplementary or therapeutic levels as a function of the dose. Supplementary doses of nutritional factors usually are of the order of the daily turnover, while therapeutic ones are three or more times higher. In a subject with a body weight of 70 kg with a total creatine pool of 120 g, the daily turnover is approximately 2 g. Thus, in healthy subjects nourished with a fat-rich, carbohydrate-, protein-poor diet and participating in a daily recreational sport, the oral creatine supplementation should be on the order of the daily turnover, i.e. less than 2.5-3 g per day, bringing the gastrointestinal absorption to account. In healthy athletes submitted daily to high-intensity strength- or sprint-training, the maximal oral creatine supplementation should be on the order of two times the daily turnover, i.e. less than 5-6 g per day for less than 2 weeks, and the creatine supplementation should be taken under appropriate medical supervision. The oral administration of more than 6 g per day of creatine should be considered as a therapeutic intervention because the dosage is more than three times higher than the creatine daily turnover and more than six times higher than the creatine daily allowance. In this case, creatine administration should be prescribed by physicians only in the cases of suspected or proven deficiency, or in conditions of severe stress and/or injury. 2000 Academic Press@p$hr

Administration, Oral↗
PubMed2002

Improving recognition of drug interactions: benefits and barriers to using automated drug alerts.

BACKGROUND: Clinicians' perceptions about decision support systems may impact the effectiveness of these technologies. OBJECTIVE: To explore clinicians' baseline knowledge of common drug interactions and experiences with automated drug alerts within a provider order entry system as a means to better understand the potential benefits and barriers to using this technology. RESEARCH DESIGN: Cross-sectional survey. SUBJECTS: The study population comprised 263 clinicians practicing within a Southern California Veterans Affairs health care system that used VA's Computerized Patient Record System (CPRS). Response rate was 64%. MEASURES: A 67-item survey (19 questions) was developed to elicit information including: (1) computer use for patient-related activities; (2) recognition of drug interactions; and (3) benefits and barriers to using automated drug alerts. RESULTS: Clinicians correctly categorized 44% (range 11-64%) of all drug-drug pairs, 53% of interacting combinations, and 54% of contraindicated pairs. Providers also correctly categorized 55% (range 24-87%) of 11 drug-disease pairs and 62% of interacting combinations, and 53% of contraindicated pairs. Nearly 90% of clinicians thought drug alerts would be helpful to identify interactions yet 55% of clinicians perceived that the most significant barrier to utilizing existing alerts was poor signal to noise ratio, meaning too many nonrelevant warnings. CONCLUSIONS: Automated drug interaction alerts have the potential to dramatically increase clinicians' recognition of selected drug interactions. However, perceived poor specificity of drug alerts may be an important obstacle to efficient utilization of information and may impede the ability of such alerts to improve patient safety.

Attitude of Health Personnel↗
PubMed2003

Understanding hospital readiness for computerized physician order entry.

BACKGROUND: Many hospitals in the United States are in early stages of decision making and planning to implement computerized physician order entry (CPOE) to improve patient safety and quality of care. The targeted processes and the software for CPOE are complex, and implementation is a large-scale change effort for most hospitals. Hospitals can increase the likelihood of success by understanding and addressing gaps in CPOE readiness. ASSESSING CPOE READINESS: A CPOE readiness assessment tool was developed that includes several different components: external environment; organizational leadership, structure, and culture; care standardization;, order management; access to information; information technology composition; and infrastructure. The presence or absence of these indicators in a particular hospital was determined by on-site interviews, walkarounds with direct observations, and document review. RESULTS: Assessment results for the first 17 hospitals (bed size, 75-906 beds) indicated that the lowest average component score was in care standardization, while the highest average component score was in organizational structure and function. Organizational culture and the order management process also had low average scores. CONCLUSIONS: This CPOE readiness assessment revealed significant gaps in all the hospitals examined. Identifying these gaps and addressing them before CPOE implementation can reduce risks. Organizations need to develop expertise at accomplishing and sustaining change; understanding and building CPOE readiness is an important first step.

Attitude of Health Personnel↗
PubMed1999

Foreign body aspiration in children--a persistent problem.

OBJECTIVE: Cough and respiratory distress due to foreign body inhalation in children is a common problem in our society. This study was planned to identify the criteria for early diagnosis and management in suspected cases of foreign body inhalation. SETTING: The study was carried out on indoor patients of Paediatrics Department, Rawalpindi General Hospital (RGH) affiliated with Rawalpindi Medical College (RMC), from January, 1995 to December, 1996. Paediatrics Department has 50-bedded general paediatrics ward, 20-bedded neonatal unit (NNU) and 150-200 daily attendance of outpatient department (OPD). It offers primary to tertiary level care to its patients from whole of Rawalpindi Division. METHODS: This prospective study encompasses profile and immediate outcome of 20 suspected cases of foreign body inhalation. Selection of study subjects and subjection to bronchoscopy was based on symptomatology, clinical and radiological findings and response to treatment. The data with outcome was recorded on a proforma. RESULTS: In 18 cases foreign body was removed successfully by rigid bronchoscope with immediate relief of symptoms and normal chest roentgenograms. Most susceptable age for foreign body inhalation was 1-3 years (n = 14) and male children were at higher risk than females (13 vs 7). Valuable clinical features were sudden onset with respiratory distress, cough, choking, localized poor air entry, crepitations or rhonchi in descending order of frequency. Most common finding in chest roentgenogram was consolidation-collapse and/or emphysema in 50% cases. 30% cases (n = 6) with persistent respiratory tract infection inspite of adequate treatment of recurrent episodes of respiratory distress with wheeze turned out as foreign body inhalation and therefore, such cases need re-evaluation. Betelnut was the most common foreign body removed (n = 7) followed by peanut (n = 6). Most frequent site involved was right main bronchus (n = 7) followed by left main bronchus (n = 5). CONCLUSION: Public awareness through mass media needs attention to prevent foreign body inhalation. High index of clinical suspicion is mandatory for early diagnosis and management to prevent fatal outcome and long term morbidity.

Bronchi↗
PubMed2004

[The 'Beijing clinical database' on severe acute respiratory syndrome patients: its design, process, quality control and evaluation].

OBJECTIVE: To develop a large database on clinical presentation, treatment and prognosis of all clinical diagnosed severe acute respiratory syndrome (SARS) cases in Beijing during the 2003 "crisis", in order to conduct further clinical studies. METHODS: The database was designed by specialists, under the organization of the Beijing Commanding Center for SARS Treatment and Cure, including 686 data items in six sub-databases: primary medical-care seeking, vital signs, common symptoms and signs, treatment, laboratory and auxiliary test, and cost. All hospitals having received SARS inpatients were involved in the project. Clinical data was transferred and coded by trained doctors and data entry was carried out by trained nurses, according to a uniformed protocol. A series of procedures had been taken before the database was finally established which included programmed logic checking, digit-by-digit check on 5% random sample, data linkage for transferred cases, coding of characterized information, database structure standardization, case reviewe by computer program according to SARS Clinical Diagnosis Criteria issued by the Ministry of Health, and exclusion of unqualified patients. RESULTS: The database involved 2148 probable SARS cases in accordant with the clinical diagnosis criteria, including 1291 with complete records. All cases and record-complete cases showed an almost identical distribution in sex, age, occupation, residence areas and time of onset. The completion rate of data was not significantly different between the two groups except for some items on primary medical-care seeking. Specifically, the data completion rate was 73% - 100% in primary medical-care seeking, 90% in common symptoms and signs, 100% for treatment, 98% for temperature, 90% for pulse, 100% for outcomes and 98% for costs in hospital. CONCLUSION: The number of cases collected in the Beijing Clinical Database of SARS Patients was fairly complete. Cases with complete records showed that they could serve as excellent representatives of all cases. The completeness of data was quite satisfactory with primary clinical items which allowed for further clinical studies.

China↗
PubMed2004

[Recommendations for the treatment of severe in-hospital pneumonia. Spanish Society of Critical, Coronary, and Intensive Medicine. Spanish Society for Respiratory Tract Pathology. Spanish Society of Infectious Diseases and Clinical Microbiology].

INTRODUCTION: Given the sanitary repercussion of serious intrahospital pneumonia (SIP), representatives of three scientific societies (SEMICYUC; SEPAR and SEIMC) have developed during 2002 and 2003 a practical guide for its treatment. METHOD: A task force was constituted to value five clinical situations related with the treatment of SIP: 1) critical revision of the existent guidelines and groups of risk definition; 2) entry criteria in ICU for SIP; 3) SIP treatment in function of the groups of risk; 4) special situations in SIP treatment, and 5) control treatment. After the bibliographical revision drafts were developed and discussed until the elaboration of the final document. RESULTS: It is necessary the stratification of the patients according to the presence or not of risk factors in order to make an appropriate use of treatments. SIP without risk factors can be treated with monotherapy with several antibiotics. SIP with risk factors specifies therapy combined with betalactamic plus aminoglycoside. Its substitution for a quinolon is a topic debate. Infections for multiresistance microorganisms require an individualized approach that can end up including the use of topical antibiotics. In SIP without microorganism isolation the use of a score system can be of utility in the taking of decisions. Revision of the therapeutic rule after 72 hours, carrying out the necessary adjustments according to the clinical evolution and microbiological results is necessary in all cases. CONCLUSIONS: Scientific evidence in the treatment of SIP allows the development of different strategies to achieve a higher efficiency both in antibiotic handling and in the control of its evolution.

Algorithms↗
PubMed1992

Predictors of mortality among HIV-infected women in Kigali, Rwanda.

OBJECTIVE: To better characterize the natural history of disease due to human immunodeficiency virus (HIV) infection in African women. DESIGN: Prospective cohort study over a 2-year follow-up period. PARTICIPANTS: A total of 460 HIV-seropositive women and a comparison cohort of HIV-seronegative women recruited from prenatal and pediatric clinics in Kigali, Rwanda in 1988. MEASUREMENTS: Clinical signs and symptoms of HIV disease, AIDS, and mortality. MAIN RESULTS: Follow-up data at 2 years were available for 93% of women who were still alive. At enrollment, many seropositive women reported symptoms listed in the World Health Organization (WHO) clinical case definition of AIDS, but these were nonspecific and often improved over time. The 2-year mortality among HIV-infected women by Kaplan-Meier survival analysis was 7% (95% CI, 5% to 10%) overall, and 21% (CI, 8% to 34%) for the 40 women who fulfilled the WHO case definition of AIDS at entry. In comparison, the 2-year mortality in women not infected with HIV was only 0.3% (CI, 0% to 7%). Independent baseline predictors of mortality in seropositive women by Cox proportional hazards modeling were, in order of descending risk factor prevalence: a body mass index of 21 kg/m2 or less (relative hazard, 2.3; CI, 1.1 to 4.8), low income (relative hazard, 2.3; CI, 1.1 to 4.5), an erythrocyte sedimentation rate exceeding 60 mm/h (relative hazard, 4.9; CI, 2.2 to 10.9), chronic diarrhea (relative hazard, 2.6; CI, 1.1 to 5.7), a history of herpes zoster (relative hazard 5.3; CI, 2.5 to 11.4), and oral candida (relative hazard, 7.3; CI, 1.6 to 33.3). Human immunodeficiency virus disease was the cause of death in 38 of the 39 HIV-positive women who died, but only 25 met the WHO definition of AIDS before death. CONCLUSIONS: Human immunodeficiency virus disease now accounts for 90% of all deaths among child-bearing urban Rwandan women. Many symptomatic seropositive patients may show some clinical improvement and should not be denied routine medical care. Easily diagnosed signs and symptoms and inexpensive laboratory tests can be used in Africa to identify those patients with a particularly good or bad prognosis.

Acquired Immunodeficiency Syndrome↗
PubMed2001

Creatine as nutritional supplementation and medicinal product.

Because of assumed ergogenic effects, the creatine administration has become popular practice among subjects participating in different sports. Appropriate creatine monohydrate dosage may be considered a medicinal product since, in accordance with the Council Directive 65/65/EEC, any substance which may be administered with a view to restoring, correcting or modifying physiological functions in humans beings is considered a medicinal product. Thus, quality, efficacy and safety must characterise the substance. In addition, the European Court of Justice has held that a product which is recommended or described as having preventive or curative properties is a medicinal product even if it is generally considered as a foodstuff and even if it has no known therapeutic effect in the present state of scientific knowledge. In biochemical terms, creatine administration increases creatine and phosphocreatine muscle concentration, allowing for an accelerated rate of ATP synthesis. In thermodynamics terms, creatine stimulates the creatine-creatine kinase-phosphocreatine circuit, which is related to the mitochondrial function as a highly organised system for the control of the subcellular adenylate pool. In pharmacokinetics terms, creatine entry into skeletal muscle is initially dependent on the extracellular concentration, but the creatine transport is subsequently downregulated. In pharmacodynamics terms, the creatine enhances the possibility to maintain power output during brief periods of high-intensity exercises. In spite of uncontrolled daily dosage and long-term administration, no researches on creatine monohydrate safety in humans were set up by standardised protocols of clinical pharmacology and toxicology, as currently occurs in phases I and II for products for human use. More or less documented side effects induced by creatine monohydrate are weight gain; influence on insulin production; feedback inhibition of endogenous creatine synthesis; long-term damages on renal function. A major point that related to the quality of creatine monohydrate products is the amount of creatine ingested in relation to the amount of contaminants present. During the industrial production of creatine monohydrate from sarcosine and cyanamide, variable amounts of contaminants (dicyandiamide, dihydrotriazines, creatinine, ions) are generated and, thus, their tolerable concentrations (ppm) must be defined and made consumers known. Furthermore, because sarcosine could originate from bovine tissues, the risk of contamination with prion of bovine spongiform encephalopathy (BSE or mad-cow disease) can t be excluded. Thus, French authorities forbade the sale of products containing creatine. Creatine, as other nutritional factors, can be used either at supplementary or therapeutic levels as a function of the dose. Supplementary doses of nutritional factors usually are of the order of the daily turnover, while therapeutic ones are three or more times higher. In a subject of 70 kg with a total creatine pool of 120 g, the daily turnover is approximately of 2 g. Thus, in healthy subjects nourished with fat-rich, carbohydrate, protein-poor diet and participating in a daily recreational sport, the oral creatine monohydrate supplementation should be of the order of the daily turnover, i.e., less than 2.5-3 g per day, bringing the gastrointestinal absorption to account. In healthy athletes submitted daily to high-intensity strength or sprint training, the maximal oral creatine monohydrate supplementation should be of the order of two times the daily turnover, i.e., less than 5-6 g per day for less than two weeks, and the creatine monohydrate supplementation should be taken under appropriate medical supervision. The oral administration of more that 6 g per day of creatine monohydrate should be considered as a therapeutic intervention and should be prescribed by physicians only in the cases of suspected or proven deficiency, or in conditions of severe stress and/or injury. The incorporation of creatine into the medicinal product class is supported also by the use in pathological conditions, e.g., some mitochondrial cytopathies, the guanidinoacetate methyltransferase deficiency, etc.

Creatine↗
PubMed2004

Characteristics and consequences of drug allergy alert overrides in a computerized physician order entry system.

OBJECTIVE: The aim of this study was to determine characteristics of drug allergy alert overrides, assess how often they lead to preventable adverse drug events (ADEs), and suggest methods for improving the allergy-alerting system. DESIGN: Chart review was performed on a stratified random subset of all allergy alerts occurring during a 3-month period (August through October 2002) at a large academic hospital. MEASUREMENTS: Factors that were measured were drug/allergy combinations that triggered alerts, frequency of specific override reasons, characteristics of ADEs, and completeness of allergy documentation. RESULTS: A total of 6,182 (80%) of 7,761 alerts were overridden in 1,150 patients. In this sample, only 10% of alerts were triggered by an exact match between the drug ordered and allergy listed. Physicians' most common reasons for overriding alerts were "Aware/Will monitor" (55%), "Patient does not have this allergy/tolerates" (33%), and "Patient taking already" (10%). In a stratified random subset of 320 patients (28% of 1,150) on chart review, 19 (6%) experienced ADEs attributed to the overridden drug; of these, 9 (47%) were serious. None of the ADEs was considered preventable, because the overrides were deemed clinically justifiable. The degree of completeness of patients' allergy lists was highly variable and generally low in both paper charts and the CPOE system. CONCLUSION: Overrides of drug-allergy alerts were common and about 1 in 20 resulted in ADEs, but all of the overrides resulting in ADEs appeared clinically justifiable. The high rate of alert overrides was attributable to frequent nonexact match alerts and infrequent updating of allergy lists. Based on these findings, we have made specific recommendations for increasing the specificity of alerting and thereby improving the clinical utility of the drug allergy alerting system.

Decision Support Systems, Clinical↗
PubMed2002

Extensions to the HISA standard--the SynEx computing environment.

OBJECTIVES: This paper reports on the integration work required to support the delivery of healthcare. Specifically, four elements are included being: the DHE (a standards based distributed healthcare environment), Synapses which is a patient record server, XML as a technology to deliver records, and finally two client applications that facilitate structured data entry (SDE) and the remote booking of specialist services. METHODS: A general motivation for the work is presented and augmented on hand of a clinical scenario. Additionally, the adoption of a middleware approach is reviewed. The role of computerised patient records is described followed by an account of a federated record server. The approach favoured by standards bodies in utilising XML is covered and the tailoring to suit the needs of the integration is explained. The main practical challenges in achieving integration are presented, one of these being the mapping between the DHE data model and the Synapses server record architecture. RESULTS: The described environment has been demonstrated to provide the functionality that is required and in addition it has been shown that the engineering challenges can be met in a controlled and orderly manner. CONCLUSIONS: The role of the DHE middleware component acting as an 'anchor' has been shown to be a valid one onto which other specialised components can be added to provide a richer service environment. Additionally, it has been demonstrated that XML is a good candidate technology that facilitates connectivity to client applications over an extranet. The demands inherent in both the clinical scenario and the computerised patient record can be met by the computing environment described in the paper.

Computer Systems↗
PubMed1998

Availability of software services for a hospital information system.

Hospital information systems (HISs) are becoming more important and covering more parts in daily hospital operations as order-entry systems become popular and electronic charts are introduced. Thus, HISs today need to be able to provide necessary services for hospital operations for a 24-h day, 365 days a year. The provision of services discussed here does not simply mean the availability of computers, in which all that matters is that the computer is functioning. It means the provision of necessary information for hospital operations by the computer software, and we will call it the availability of software services. HISs these days are mostly client-server systems. To increase availability of software services in these systems, it is not enough to just use system structures that are highly reliable in existing host-centred systems. Four main components which support availability of software services are network systems, client computers, server computers, and application software. In this paper, we suggest how to structure these four components to provide the minimum requested software services even if a part of the system stops to function. The network system should be double-protected in stratus using Asynchronous Transfer Mode (ATM) as its base network. Client computers should be fat clients with as much application logic as possible, and reference information which do not require frequent updates (master files, for example) should be replicated in clients. It would be best if all server computers could be double-protected. However, if that is physically impossible, one database file should be made accessible by several server computers. Still, at least the basic patients' information and the latest clinical records should be double-protected physically. Application software should be tested carefully before introduction. Different versions of the application software should always be kept and managed in case the new version has problems. If a hospital information system is designed and developed with these points in mind, it's availability of software services should increase greatly.

Computer Communication Networks↗
PubMedDate not supplied

[Cutaneous loxoscelism with edematous predominance].

Loxoscelism is the clinical condition produced by the venom of spiders belonging to the genus Loxosceles. Human cases of loxoscelism have been observed in diverse countries of different continents in temperate and tropical regions. In Chile loxoscelism is caused by Loxosceles laeta, spider with domestic habits. Loxoscelism can be observed into two well definited clinical variants: cutaneous loxoscelism (CL) and systemic or viscerocutaneous loxoscelism (VCL) which occur in around 83.3 and 16.7% cases respectively. Within the universe of CL patients a clinical modality in which necrotic lesion is not present or is insignificant, but presenting a remarkable edema, particularly when the bite is on the face, which has received the name of CL with an edematous predominance (CLEP). In this paper the individual description and the assambled analysis of 10 cases, four males and six females, age ranging from 6 to 68 years, of CLEP are presented. Nine cases occurred in warm periods spring through fall and one in winter. In six cases the accident causing spider was seen and two of these were identified as L. laeta adult females. In all cases the patients went or were transported to emergency medical services 4-24 h after the bite. The predominant initial symptom was a burning stinging sensation at the site of the bite, followed by intensive pain which expanded the neighbour areas concomitantly with the emerging and progressive edema. In four of the nine patients in who the bite was on the face, the edema involved all of it, closed both eyelids and expanded to the neck and upper part of the thorax. In three cases the enormous edema was the only significant clinical manifestation, whereas in the remaining seven conjunctly with the edema, a small violaceous plaque or a blister of serous content gave place to a little livedoid plaque (diameter 0.3-0.8 cm) which evolved to desquamation without leaving any scarring. The edema was characterized by its brilliant rose color, painful and hard which is not accompanied by regional adenopathy. Treatment of the 10 patients depended on the moment in they were seen by us. It consisted on parenteral administration, according to age and weight, of 5-10 mg of chloroprofenpyridamine maleate every 8 hours for be continued every 12-24 hours until the patient was discharged. Parenteral route was preferred in order that it was going to be adequately absorbed. With the beginning of the antihistaminic treatment a clear diminution of pain and edema was obtained, being possible its total disappearance within 4-10 days. CLEP occurs in about 4% of loxoscelism cases, has a benign prognosis and an early response to adequate medical treatment. Without discarding the sensibility factor of the affected individual, there exist the impression that the edema may abort the necrotic process when it dilutes the enzymatic process produced by L.laeta venom. In Chile, the differential diagnosis must be planted with the following clinical entities: bites of hematophagous insects on the face, bee stings, Chagas' disease with facial port of entry and angioneurotic edema.

Adult↗
PubMed2002

An analysis of the diffusion of new antidepressants: variety, quality, and marketing efforts.

BACKGROUND: We are not aware of any published research that quantifies and compares the importance of effectiveness and side effects for pharmaceutical sales, and that simultaneously incorporates the impacts of marketing efforts on the diffusion of new pharmaceutical agents in the U.S. The overall level and market share success of the various selective serotonin reuptake inhibitors ( SSRIs ) relative to a representative older generation tricyclic (such as amitriptyline) provides a useful focus for studying such issues. AIMS OF STUDY: To model jointly the marketing and sales relationships of the SSRIs in the U.S., to quantify the extent to which marketing efforts are responsive to the availability of new scientific information accompanying changes in quality and increases in product variety, and in turn to assess how the new FDA indication approvals and the enhanced marketing initiatives involving product quality and variety affect sales of the SSRI and other novel antidepressants. METHODS: Quarterly US sales, price, quantity and marketing data 1988Q1-1997Q4 are taken from IMS Health for the eight new antidepressants introduced into the US during this time period. Measures of physician-perceived quality attributes of the antidepressants are drawn from Market Measures, Inc., a medical survey research firm. These data are used to construct measures of product quality (effectiveness and side effect profile), and attribute variety across all antidepressants. Multivariate regression methods are used in estimating parameters of a marketing efforts model, a sales demand model encompassing the aggregate of the newer antidepressants, and a product share model. Simulation methods are employed to quantify elasticities. RESULTS: Since 1988, and relative to amitriptyline, there has been only a rather modest increase in the perceived average effectiveness of the SSRIs and related products, but the side effect profiles have improved substantially. Variety measures for effectiveness show greater increases over time than do those for side effects. Marketing efforts respond to science-based events, such as new FDA indication approvals, and to effectiveness and side-effect quality improvements. Total antidepressant sales are positively and significantly related to price reductions, increased marketing efforts, and the level and variety of side effect profiles involving antidepressants. The level and variety of effectiveness does not significantly affect total antidepressant sales. Order of entry effects are important in affecting product market shares, while marketing efforts and relative quality attributes (particularly a more favorable side effect profile) have positive and significant impacts on relative market shares. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Since patient response to SSRIs and related products is idiosyncratic, greater product variety facilitates better matching of antidepressant with patient. Much of the growth of the SSRIs and related antidepressants since 1988 can be attributed to increased product attribute variety, to improved changes in side effect quality relative to that of the tricyclics, and to the marketing of those improvements. IMPLICATIONS FOR HEALTH POLICIES: Marketing efforts play an important role in diffusing product information. Marketing efforts increase considerably following FDA approval for indications other than depression, and also increase with the average effectiveness and the average side effect rating of the products. IMPLICATIONS FOR FURTHER RESEARCH: Whether the relatively minor role that perceived effectiveness has in affecting sales relative to perceived side effect profile is unique to antidepressants, or generalizes to other therapeutic classes, merits further examination.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Making health care safer: a critical analysis of patient safety practices.

OBJECTIVES: Patient safety has received increased attention in recent years, but mostly with a focus on the epidemiology of errors and adverse events, rather than on practices that reduce such events. This project aimed to collect and critically review the existing evidence on practices relevant to improving patient safety. SEARCH STRATEGY AND SELECTION CRITERIA: Patient safety practices were defined as those that reduce the risk of adverse events related to exposure to medical care across a range of diagnoses or conditions. Potential patient safety practices were identified based on preliminary surveys of the literature and expert consultation. This process resulted in the identification of 79 practices for review. The practices focused primarily on hospitalized patients, but some involved nursing home or ambulatory patients. Protocols specified the inclusion criteria for studies and the structure for evaluation of the evidence regarding each practice. Pertinent studies were identified using various bibliographic databases (e.g., MEDLINE, PsycINFO, ABI/INFORM, INSPEC), targeted searches of the Internet, and communication with relevant experts. DATA COLLECTION AND ANALYSIS: Included literature consisted of controlled observational studies, clinical trials and systematic reviews found in the peer-reviewed medical literature, relevant non-health care literature and "gray literature." For most practices, the project team required that the primary outcome consist of a clinical endpoint (i.e., some measure of morbidity or mortality) or a surrogate outcome with a clear connection to patient morbidity or mortality. This criterion was relaxed for some practices drawn from the non-health care literature. The evidence supporting each practice was summarized using a prospectively determined format. The project team then used a predefined consensus technique to rank the practices according to the strength of evidence presented in practice summaries. A separate ranking was developed for research priorities. MAIN RESULTS: Practices with the strongest supporting evidence are generally clinical interventions that decrease the risks associated with hospitalization, critical care, or surgery. Many patient safety practices drawn primarily from nonmedical fields (e.g., use of simulators, bar coding, computerized physician order entry, crew resource management) deserve additional research to elucidate their value in the health care environment. The following 11 practices were rated most highly in terms of strength of the evidence supporting more widespread implementation. Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk; Use of perioperative beta-blockers in appropriate patients to prevent perioperative morbidity and mortality; Use of maximum sterile barriers while placing central intravenous catheters to prevent infections; Appropriate use of antibiotic prophylaxis in surgical patients to prevent postoperative infections; Asking that patients recall and restate what they have been told during the informed consent process; Continuous aspiration of subglottic secretions (CASS) to prevent ventilator-associated pneumonia; Use of pressure relieving bedding materials to prevent pressure ulcers; Use of real-time ultrasound guidance during central line insertion to prevent complications; Patient self-management for warfarin (Coumadin) to achieve appropriate outpatient anticoagulation and prevent complications; Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and surgical patients; and Use of antibiotic-impregnated central venous catheters to prevent catheter-related infections. CONCLUSIONS: An evidence-based approach can help identify practices that are likely to improve patient safety. Such practices target a diverse array of safety problems. Further research is needed to fill the substantial gaps in the evidentiary base, particularly with regard to the generalizability of patient safety practices heretofore tested only in limited settings and to promising practices drawn from industries outside of health care.

Accreditation↗
PubMed2005

Effect of CPOE user interface design on user-initiated access to educational and patient information during clinical care.

OBJECTIVE: Authors evaluated whether displaying context sensitive links to infrequently accessed educational materials and patient information via the user interface of an inpatient computerized care provider order entry (CPOE) system would affect access rates to the materials. DESIGN: The CPOE of Vanderbilt University Hospital (VUH) included "baseline" clinical decision support advice for safety and quality. Authors augmented this with seven new primarily educational decision support features. A prospective, randomized, controlled trial compared clinicians' utilization rates for the new materials via two interfaces. Control subjects could access study-related decision support from a menu in the standard CPOE interface. Intervention subjects received active notification when study-related decision support was available through context sensitive, visibly highlighted, selectable hyperlinks. MEASUREMENTS: Rates of opportunities to access and utilization of study-related decision support materials from April 1999 through March 2000 on seven VUH Internal Medicine wards. RESULTS: During 4,466 intervention subject-days, there were 240,504 (53.9/subject-day) opportunities for study-related decision support, while during 3,397 control subject-days, there were 178,235 (52.5/subject-day) opportunities for such decision support, respectively (p = 0.11). Individual intervention subjects accessed the decision support features at least once on 3.8% of subject-days logged on (278 responses); controls accessed it at least once on 0.6% of subject-days (18 responses), with a response rate ratio adjusted for decision support frequency of 9.17 (95% confidence interval 4.6-18, p < 0.0005). On average, intervention subjects accessed study-related decision support materials once every 16 days individually and once every 1.26 days in aggregate. CONCLUSION: Highlighting availability of context-sensitive educational materials and patient information through visible hyperlinks significantly increased utilization rates for study-related decision support when compared to "standard" VUH CPOE methods, although absolute response rates were low.

Decision Making, Computer-Assisted↗
PubMed1989

Surgical audit: a review. Proceedings of an audit symposium.

The work of surgical departments involves varying proportions of investigation, diagnosis and treatment and the object of audit is to measure and monitor the outcome of this activity. It also serves as a secondary but important role in education, research and resource planning. The different methods of audit described in this symposium gave varying contributions to the definition of workload and outcome and to the education of the surgical staff. Irrespective of the audit system used, there is little doubt that weekly meetings specifically designed for the purpose are of prime importance, and the contributors used it in a variety of different ways. For Messrs. Eltringham and Espiner this meeting was seen much more as an educational exercise for the firm as a whole than a ritualistic method of collecting numerical information. Where other systems which rather more fastidiously collect numerical information are used, the weekly meeting becomes more important in ensuring the accuracy of the data collected. Some authors review the proforma on which the patient information is collected before it is entered into the computer, a point strongly made by Mr. Dunn and it does seem likely that as audit information is collected and challenged, then considerable efforts will have to be made to ensure the accuracy of the information being entered, for there is little point in defending an audit result by suggesting that the houseman who made the original entry did not do so very accurately. Many auditors used a lunch or coffee break as a convenient time to meet, but in some cases a lot of extra work was required for validation and if clinical audit is to represent a very accurate record of the work of a surgical department, this point requires careful consideration. If audit information is to be easily processed, then its means of collection is important.Most contributors used a single record card on which the information was recorded during the patient's stay and this record card can be designed to make entry into a computer system easy for a secretary.It is alos much easier to take records to a weekly meeting than 30 sets of patients' notes. In broad terms the audit systems discussed fell into 2 groups: those which used computers and those which did not. There is no doubt that the use of a computer helps in marshalling the information collected. Although a card system was very cheap and easy to use,it was very much difficult to retrieve information rapidly from it than from a computer based system.It seems that the use of computer entails the consumption of more time for entry and validation of data than a card based system, and there may be a temptation not to spend so much time on the educational aspects of audit. This problem can be overcome by holding regular meetings at which only results presented, perhaps firm by firm, in a hospital, so that discussions on policies relating to thromboembolic prophylaxis, the use of prophylactic antibiotics and similar topics can be discussed. Indeed if this kind of meeting does not take place, then it would seem that one of the principal objectives of audit is lost. For this meetings to take place a computer based system is almost certainly going to be essential. In setting up a clinical audit there is clearly a requirement for financial investment. This means first buy in a computer based system and several options are open to the prospective auditor. A simple desk top computer with a modified database system can be used but Messrs. Baird and Horrocks found it required a great deal of programming using a database programme that was already commercially available to obtain a workable system.Two or three commercial systems are now available using personal computers and it seems likely that in many hospitals this will be a popular choice. When introduced in Colchester General Hospital by Mr. Motson where such a facility had not existed in the past, computerisation has been well received and has achieved the desired result.As more hospitals develop their own sophisticated information systems, it may be possible to graft clinical audit information onto the hospital programmes in a way outlined by Mr. Marsland and Mrs. Tyndall. The advantage of this system is that there is often experienced help available for the design and implementation of the system and very powerful computers to use. The information yielded by audit needs to be kept in a confidential system. If this fails to occur,then the users of the system will cease to have confidence in it and the accuracy of the information put into the audit will lessen. As the whole object of audit is an attempt to collect accurate and detailed information about patients,then another prime objective could easily be lost. There is little doubt from the experiences presented in this review that audit is feasible.The benefits fall into two broad groups.Firstly by reviewing cases at regular weekly meeting evolving problems can be dealt with so there is an immediate benefit for that one patient and a useful learning experience for the staff.It is important not to lose sight of this in the wish to collect data on a computer.The second benefit is the ease of handling large amounts of information about patient activity. Only the Cambridge experience gave any longer term view and there was an impact on the complications of surgical treatment.It will be most important in the years to come, as audit systems are introduced, that their value is critically regarded because in order to establish and run clinical audit, a considerable amount of time will need to be devoted by everybody involved. The determination fo longer term response to surgical treatment in terms of graft patency,tumour recurrence and patient survival is not possible by any of the methods currently described. It is an undertaking of great importance and proportions and clearly has a bearing on clinical practice. Short term clinical audit will therefore be only one part of the evaluation of surgical care.

Computer Systems↗