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PubMed2003

Measuring progress in clinical governance: assessing the reliability and validity of the Clinical Governance Climate Questionnaire.

Despite a lack of conceptual clarity, the importance of cultural change to clinical governance is widely accepted. While generic measures of organizational performance, culture and climate are available, their relationship to clinical governance is unclear. Consequently, there is currently no valid and reliable measure of clinical governance climate. This study aimed to address the deficiency by reducing a pool of clinical governance climate indicators developed via previous qualitative research, describing a latent factor structure and assessing the internal consistency and external validity of the factor model. The resultant instrument, the Clinical Governance Climate Questionnaire (CGCQ), attained high internal consistency and external (discriminant and construct) validity in a study population of healthcare Trust staff. It consists of 60 items distributed across six sub-scales of clinical governance: planned and integrated quality improvement; proactive risk management; absence of unjust blame and punishment; working with colleagues; training and development; and organizational learning. The measure enables those charged with leading the clinical governance agenda in UK healthcare organizations to assess the progress of organizational development initiatives, highlighting areas requiring particular attention. They might also be of interest to those concerned about the negative unintended consequences of performance management.

Adult↗
PubMed2006

Validation of an instrument for the documentation of clinical pharmacists' interventions.

OBJECTIVE: To validate an instrument for documentation of clinical pharmacy interventions in French speaking hospitals in France and outside of France. METHOD: A panel of 12 French speaking clinical pharmacists (six from France; six from French speaking countries) was asked to analyse a set of 60 pharmacist's interventions on drug prescription. They used a form including (1) the identification of the drug related problems (DRPs) (10 items), (2) the pharmacist's intervention (7 items). We assessed the level of agreement between the 12 pharmacists on the test DRPs and on the interventions. MAIN OUTCOME MEASURES: Kappa coefficient of concordance was used to assess the level of agreement between experts for DRPs and interventions. We also assessed the userfriendliness of the instrument using Likert scales. RESULTS: The level of concordance observed in the validation was 0.76 for DRPs and 0.89 for the type of intervention. Eleven experts out of 12 were "very satisfied" or "satisfied" and one "not satisfied" with the tool. Ten out of the 12 experts were ready to use it in daily practise. CONCLUSION: The present instrument proposed by the French Society of Clinical Pharmacy (SFPC) is the first coding system for pharmacist's interventions with a French interface. The validation process using a standard statistical methodology helps support the external validity of our tool. The level of concordance between users can be considered as satisfactory, allowing the use of the tool in daily clinical pharmacy practise. To enhance the diffusion of the instrument and of the general process of routine documentation of interventions, a spreadsheet is provided on the French Society of Clinical Pharmacy website.

Documentation↗
PubMed2006

MIA-QSAR modelling of anti-HIV-1 activities of some 2-amino-6-arylsulfonylbenzonitriles and their thio and sulfinyl congeners.

A QSAR method based on MIA (multivariate image analysis) descriptors is applied to a series of 2-amino-6-arylsulfonylbenzonitriles and their thio and sulfinyl congeners, compounds with anti-HIV-1 activity. Two models were built in order to appraise the modelling capability when different drawing programs are used to create the set of molecules. Both models showed good predictive ability, with cross-validated Q2 of 0.712 and 0.624, and Q2 for an external validation set of 0.823 and 0.747. An ADME evaluation, by calculating the topological polar surface area (TPSA) and parameters derived from the rule of five, was also performed to proposed compounds in order to suggest absorption profiles for potential new drugs.

Administration, Oral↗
PubMedDate not supplied

Designing naturalistic prospective studies of economic and effectiveness outcomes associated with novel antipsychotic therapies.

The cornerstone of recent pharmacoeconomic work in schizophrenia is the hypothesis that the improved efficacy of novel antipsychotic medications will lead to a reduction in medical services utilization, thereby reducing direct medical costs associated with treatment. Creating the most valid design to prospectively examine the effectiveness and costs of competing pharmacotherapies requires a dialectic of opposing research paradigms. The final protocol must represent a series of decisions that strike a careful balance between being scientifically sound (internal validity) and generalizable to the real world of clinical treatment (external validity). The results must be useful to decision-makers in determining to what extent reductions in healthcare expenditures can offset higher drug acquisition costs within their type of treatment environment. This article is a review of several methodological challenges in the design of medical effectiveness trials, including whether to blind the study, definition of the patient population, degree of physician discretion in treatment, and how to collect and analyze data for patients who discontinue their originally assigned medication. The article also provides a discussion of how clinical practices can inform decisions made to meet these challenges. The issues are illustrated through a prospective study designed to evaluate the cost-effectiveness of the newer antipsychotics in general and olanzapine in particular. Cost-effectiveness studies of novel antipsychotic medications, particularly those with naturalistic designs, will increase in importance as the use of these second-generation agents continues to expand.

Antipsychotic Agents↗
PubMed1998

A new casemix adjustment index for hospital mortality among patients with congestive heart failure.

OBJECTIVES: Comparative analysis of hospital outcomes requires reliable adjustment for casemix. Although congestive heart failure is one of the most common indications for hospitalization, congestive heart failure casemix adjustment has not been widely studied. The purposes of this study were (1) to describe and validate a new congestive heart failure-specific casemix adjustment index to predict in-hospital mortality and (2) to compare its performance to the Charlson comorbidity index. METHODS: Data from all 4,608 admissions to the Massachusetts General Hospital from January 1990 to July 1996 with a principal ICD-9-CM discharge diagnosis of congestive heart failure were evaluated. Massachusetts General Hospital patients were randomly divided in a derivation and a validation set. By logistic regression, odds ratios for in-hospital death were computed and weights were assigned to construct a new predictive index in the derivation set. The performance of the index was tested in an internal Massachusetts General Hospital validation set and in a non-Massachusetts General Hospital external validation set incorporating data from all 1995 New York state hospital discharges with a primary discharge diagnosis of congestive heart failure. RESULTS: Overall in-hospital mortality was 6.4%. Based on the new index, patients were assigned to six categories with incrementally increasing hospital mortality rates ranging from 0.5% to 31%. By logistic regression, "c" statistics of the congestive heart failure-specific index (0.83 and 0.78, derivation and validation set) were significantly superior to the Charlson index (0.66). Similar incrementally increasing hospital mortality rates were observed in the New York database with the congestive heart failure-specific index ("c" statistics 0.75). CONCLUSION: In an administrative database, this congestive heart failure-specific index may be a more adequate casemix adjustment tool to predict hospital mortality in patients hospitalized for congestive heart failure.

Aged↗
PubMed2001

Importance of individual response in symptom score evaluation.

In making treatment decisions for patients with benign prostatic hyperplasia (BPH), physicians have to rely on the efficacy data published in the literature and adapt this to individual patient's needs. Criticism can be made, however, of the randomised clinical trials (RCTs) that are performed, as the patients enrolled are not an adequate reflection of the general patient population. Although internal validity is high in RCTs with regard to inclusion criteria, external validity is reduced. Another failing of RCTs is the way in which patients are assessed. Typically in many studies, symptom improvement is expressed as a percentage of the Symptom Index improvement. This can be misleading if the results of two trials are compared as this value depends on the pre-treatment Symptom Index. Other methods of evaluation should be considered, such as the presentation of direct symptom outcomes (threshold improvement), the cumulative frequency distribution of threshold improvements or linear regression analysis of individual IPSS. All of these means of expressing the results focus clinical evaluation on the patient himself.

Clinical Trials as Topic↗
PubMed2004

Benchmarking lung cancer mortality rates in current and former smokers.

STUDY OBJECTIVES: To develop and validate a model for estimating the risk of lung cancer death in current and former smokers. The model is intended for use in analyzing a population of subjects who are undergoing lung cancer screening or receiving lung cancer chemoprevention, to determine whether the intervention has altered lung cancer mortality. DESIGN/SETTING/PATIENTS: Model derivation was based on analyses of the placebo arm of the Carotene and Retinol Efficacy Trial. Model validation was based on analyses of three other longitudinal cohorts. MEASUREMENTS: Observed and predicted number of deaths due to lung cancer. RESULTS: In internal validation, the model was highly concordant and well calibrated. In external validation, the model predictions were similar to what was observed in all of the validation analyses. The predicted and observed deaths within 6 years were very similar when assessed in the Johns Hopkins Hospital trial of chest radiography and sputum cytology screening (176 predicted, 184 observed, p = 0.53), the Memorial Sloan-Kettering Cancer Center trial of chest radiography and sputum cytology screening (108 predicted, 114 observed, p = 0.57), and the National Health and Nutrition Evaluation Survey part I (24 predicted, 21 observed, p = 0.52). CONCLUSIONS: The number of lung cancer deaths in a population of current or former smokers can be accurately predicted, making model-based evaluations of prevention and early detection interventions a useful adjunct to definitive randomized trials. We illustrate this potential use with a small example.

Adult↗
PubMed2001

Clinical and cost-effectiveness of donepezil, rivastigmine and galantamine for Alzheimer's disease: a rapid and systematic review.

BACKGROUND: Alzheimer's disease is the most common cause of dementia and is characterised by an insidious onset and slow deterioration. The estimated prevalence of Alzheimer's disease for a standard health authority (500,000 people) is about 3330. Current service involves a wide range of agencies, and drug therapy for some patients. OBJECTIVES: To provide a rapid and systematic review of the clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine in the symptomatic treatment of people suffering from Alzheimer's disease. METHODS: A systematic review of the literature was undertaken. METHODS - DATA SOURCES: Searches were made of electronic databases, including MEDLINE, EMBASE, The Cochrane Library, Database of Abstracts of Reviews of Effectiveness, NHS Economic Evaluation Database, National Research Register, Science Citation Index, BIOSIS, EconLit, MRC Trials database, Early Warning System, Current Controlled Trials, TOXLINE, Index of Scientific and Technical Proceedings, and Getting Easier Access to Reviews. All sources were searched over the period covered by the databases up to March/July 2000. Bibliographies of related papers were assessed for relevant studies and experts were contacted for advice and peer review, and to identify additional published and unpublished references. Manufacturer submissions to the National Institute for Clinical Excellence (NICE) were reviewed. METHODS - STUDY SELECTION: Studies were included if they fulfilled the following criteria: (1) INTERVENTION: donepezil, rivastigmine or galantamine used to treat Alzheimer's disease. (2) PARTICIPANTS: people diagnosed with Alzheimer's disease who meet the criteria for treatment with donepezil, rivastigmine and galantamine. (3) OUTCOMES: measures assessing changes in cognition, function, behaviour and mood, quality of life (including studies assessing carer well-being and carer-input), and time to institutionalisation. (4) DESIGN: systematic reviews of randomised controlled trials (RCTs) and RCTs comparing donepezil, rivastigmine or galantamine with placebo or each other or non-drug comparators were included in the review of effectiveness. Economic studies of donepezil, rivastigmine or galantamine used to treat Alzheimer's disease that included a comparator (or placebo) and both the costs and consequence (outcomes) of treatment were included in the review of cost-effectiveness. Studies in non-English language, and abstracts and conference poster presentations of systematic reviews, RCTs and economic evaluations were excluded. Two reviewers identified studies by independently screening study titles and abstracts, and then by examining the full text of selected studies to decide inclusion. METHODS - DATA EXTRACTION AND QUALITY ASSESSMENT: Data extraction and quality assessment were undertaken by one reviewer and checked by a second reviewer, with any disagreements resolved through discussion. The quality of RCTs was assessed using the Jadad scale and the quality of systematic reviews was assessed using criteria developed by the NHS Centre for Reviews and Dissemination. The quality of economic evaluation studies was assessed by their internal validity (i.e. the methods used) using a standard checklist, and external validity (i.e. the generalisability of the economic study to the population of interest) using a series of relevant questions. METHODS - DATA SYNTHESIS: The clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine were synthesised through a narrative review with full tabulation of results of all included studies. In the economic evaluation, the reviewers assessed whether adjustments could be made to existing models to reflect the current situation in England and Wales. RESULTS - CLINICAL EFFECTIVENESS: (1) Donepezil--three systematic reviews and five RCTs (plus four studies from industry (unpublished data, submitted as commercial in confidence)) were found. Results suggest that donepezil is beneficial when assessed using global and cognitive outcome measures. (2) Rivastigmine--three systematic reviews and five RCTs (plus two studies from industry (unpublished data, submitted as commercial in confidence)) were found. Results suggest that rivastigmine is beneficial in terms of global outcome measures. (3) Galantamine--one systematic review and three RCTs (plus three studies from industry (unpublished data, submitted as commercial in confidence)) were found. Results suggest that galantamine is beneficial in terms of global, cognitive and functional scales. RESULTS - SUMMARY OF BENEFITS: It is difficult to quantify benefits from the evidence available in the literature. Statistically significant improvements in tests such as ADAS-cog (Alzheimer's Disease Assessment Scale cognitive subscale) may not be reflected in changes in daily life. (ABSTRACT TRUNCATED)

Alzheimer Disease↗
PubMed2003

Screening and interventions for obesity in adults: summary of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND: Obesity poses a considerable and growing health burden. This review examines evidence for screening and treating obesity in adults. DATA SOURCES: MEDLINE and Cochrane Library (January 1994 through February 2003). STUDY SELECTION: Systematic reviews; randomized, controlled trials; and observational studies of obesity's health outcomes or efficacy of obesity treatment. DATA EXTRACTION: Two reviewers independently abstracted data on study design, sample, sample size, treatment, outcomes, and quality. DATA SYNTHESIS: No trials evaluated mass screening for obesity, so the authors evaluated indirect evidence for efficacy. Pharmacotherapy or counseling interventions produced modest (generally 3 to 5 kg) weight loss over at least 6 or 12 months, respectively. Counseling was most effective when intensive and combined with behavioral therapy. Maintenance strategies helped retain weight loss. Selected surgical patients lost substantial weight (10 to 159 kg over 1 to 5 years). Weight reduction improved blood pressure, lipid levels, and glucose metabolism and decreased diabetes incidence. The internal validity of the treatment trials was fair to good, and external validity was limited by the minimal ethnic or gender diversity of volunteer participants. No data evaluated counseling harms. Primary adverse drug effects included hypertension with sibutramine (mean increase, 0 mm Hg to 3.5 mm Hg) and gastrointestinal distress with orlistat (1% to 37% of patients). Fewer than 1% (pooled samples) of surgical patients died; up to 25% needed surgery again over 5 years. CONCLUSIONS: Counseling and pharmacotherapy can promote modest sustained weight loss, improving clinical outcomes. Pharmacotherapy appears safe in the short term; long-term safety has not been as strongly established. In selected patients, surgery promotes large amounts of weight loss with rare but sometimes severe complications.

Adult↗
PubMed1984

Perspectives on borderline subtypes--overview of current research.

This paper has reviewed recent efforts to subtype patients within the borderline group. An overview of current definitions of the borderline syndrome was followed by a critical evaluation of recent empirical investigations designed to subtype within the larger domain of borderline pathology. Studies of borderline patients have, in large part, been based on the descriptive-phenomenological approach. It has been argued that while establishing a reliable diagnosis based on signs and symptoms provides internal validation for current theories of the borderline syndromes, studies providing external validating criteria are sorely needed.

Borderline Personality Disorder↗
PubMed1998

Validation of the criteria for DSM diagnosis of cocaine abuse and cocaine dependence.

The concurrent external validity of the diagnosis of cocaine abuse, based on the DSM criteria, is shown to be established to an unexpectedly high degree, based on a method of determining the association between a summary score derived by quantifying the DSM criteria and another summary score derived from weighting several measures of frequency of use of cocaine and a measure of its mode of use. The degree of validity was cross-validated by performing the same analysis on two study samples: one of inpatients (N = 179) and one of urban-community African-Americans (N = 204).

Adult↗
PubMed2002

Sex-related differences in the presentation and outcome of out-of-hospital cardiopulmonary arrest: a multiyear, prospective, population-based study.

OBJECTIVE: To examine whether previously observed sex-related differences in coronary artery disease syndromes also apply to patients with out-of-hospital sudden cardiac arrest, a probable subset of patients with coronary artery disease who are easy to recognize and are treated in a standardized fashion. DESIGN: Prospective, population-based study conducted over a 6-yr period. SETTING: A large urban municipality (population, 1.1 million) served by a single emergency medical services system with centralized medical direction and standardized protocols. PATIENTS: All patients with out-of-hospital, nontraumatic, primary cardiac arrest. INTERVENTIONS: Standardized advanced cardiac life support protocols. MEASUREMENTS AND MAIN RESULTS: During the 6 yrs of the study, 4147 consecutive patients were studied, 42% of whom were women (p <.001). Although women were significantly older than men (mean age, 68.7 +/- 18 vs. 61.7 +/- 17 yrs; p =.001), there were no significant differences for the percentages of witnessed and unwitnessed arrests, response intervals, and the length and type of treatment provided. Although men were more likely to have ventricular fibrillation/ventricular tachycardia on presentation (41% vs. 30%), women had more asystole (8.8% vs. 7%) and (organized) pulseless electrical activity than men (24% vs. 18%; p <.001). Nevertheless, more women were resuscitated (13.5% vs. 10.7%; p =.005), particularly women with non-ventricular fibrillation/ventricular tachycardia presentation (12.6% vs. 9.6%; p <.02). These differences were more pronounced when controlling for age (95% confidence interval, 1.44 [1.25-1.74]). CONCLUSIONS: In cases of out-of-hospital sudden cardiac arrest, women have significantly better resuscitation rates than men, especially when controlling for age, particularly among women with non-ventricular fibrillation/ventricular tachycardia presentations. Additional studies are required to validate these observations, not only for long-term survival and external validity, but also for other potential genetic factors and potential discrepancies with other studies.

Age Factors↗
PubMedDate not supplied

Refinement and use of the approximate similarity in QSAR models for benzodiazepine receptor ligands.

Several considerations for refining the approximate similarity measurements have been introduced in this paper: the use of topological invariants for the calculation of similarity indexes and the development of new similarity correction processes. The quality of the new similarity measurements obtained with the proposed methods has permitted the development of fast, cheap, and simple quantitative structure-activity relationship models for the prediction of biological activities of nonbenzodiazepine gamma-aminobutyric acid(A)/benzodiazepine receptor ligands (58 compounds). Internal and external validations were carried out for the approximate similarity matrices computed using different approaches. Satisfactory results which compare reasonably well with a 3D approach were obtained: Q2= 0.65 and standard error in cross validation SECV= 0.83 for the training stage; r = 0.79 and error in external prediction = 0.82 for the test step. In addition, the method proposed was compared with other topological approaches based on constitutional similarity and on fingerprints. Satisfactory results were obtained.

Journal Article↗
PubMed2006

Evaluation of the Inflammatory Bowel Disease Questionnaire in Swedish patients with Crohn's disease.

OBJECTIVE: Health-related quality of life (HRQoL) is an important measure of inflammatory bowel disease (IBD) health outcome. The Inflammatory Bowel Disease Questionnaire (IBDQ) comprising 32 items grouped into four dimensions is a widely used IBD-specific HRQoL instrument. The purpose of this study was to evaluate the validity, reliability and responsiveness of the Swedish translation of the IBDQ in patients with Crohn's disease (CD). MATERIAL AND METHODS: Four hundred and forty-eight patients with CD completed the IBDQ and three other HRQoL questionnaires (Rating Form of IBD Patient Concerns; Short Form-36; and the Psychological General Well-Being Index) in connection with their regular visit at the outpatient clinic. Disease activity was assessed by the physician on a 4-point Likert scale. Thirty-two patients who were stable in remission completed the questionnaires a second time, 4 weeks later. A total of 418 patients repeated all measurements after 6 months. RESULTS: The dimensional scores were highly correlated with other measures of corresponding aspects of HRQoL and were significantly better in remission than in relapse. High test-retest correlations indicated good reliability. Responsiveness was confirmed in patients whose disease activity changed over time. However, high correlations between the dimensions, poor correlations between items within each dimension, and factor analysis all indicated that the original grouping of the items is not valid for Swedish CD patients. CONCLUSIONS: Although the Swedish IBDQ has good external validity, reliability and responsiveness for patients with CD, our results did not support the original grouping of the items.

Adult↗
PubMed2006

Prediction of risk of death and myocardial infarction in the six months after presentation with acute coronary syndrome: prospective multinational observational study (GRACE).

OBJECTIVE: To develop a clinical risk prediction tool for estimating the cumulative six month risk of death and death or myocardial infarction to facilitate triage and management of patients with acute coronary syndrome. DESIGN: Prospective multinational observational study in which we used multivariable regression to develop a final predictive model, with prospective and external validation. SETTING: Ninety four hospitals in 14 countries in Europe, North and South America, Australia, and New Zealand. POPULATION: 43,810 patients (21,688 in derivation set; 22,122 in validation set) presenting with acute coronary syndrome with or without ST segment elevation enrolled in the global registry of acute coronary events (GRACE) study between April 1999 and September 2005. MAIN OUTCOME MEASURES: Death and myocardial infarction. RESULTS: 1989 patients died in hospital, 1466 died between discharge and six month follow-up, and 2793 sustained a new non-fatal myocardial infarction. Nine factors independently predicted death and the combined end point of death or myocardial infarction in the period from admission to six months after discharge: age, development (or history) of heart failure, peripheral vascular disease, systolic blood pressure, Killip class, initial serum creatinine concentration, elevated initial cardiac markers, cardiac arrest on admission, and ST segment deviation. The simplified model was robust, with prospectively validated C-statistics of 0.81 for predicting death and 0.73 for death or myocardial infarction from admission to six months after discharge. The external applicability of the model was validated in the dataset from GUSTO IIb (global use of strategies to open occluded coronary arteries). CONCLUSIONS: This risk prediction tool uses readily identifiable variables to provide robust prediction of the cumulative six month risk of death or myocardial infarction. It is a rapid and widely applicable method for assessing cardiovascular risk to complement clinical assessment and can guide patient triage and management across the spectrum of patients with acute coronary syndrome.

Epidemiologic Methods↗
PubMed2005

Gene signatures of progression and metastasis in renal cell cancer.

PURPOSE: To address the progression, metastasis, and clinical heterogeneity of renal cell cancer (RCC). EXPERIMENTAL DESIGN: Transcriptional profiling with oligonucleotide microarrays (22,283 genes) was done on 49 RCC tumors, 20 non-RCC renal tumors, and 23 normal kidney samples. Samples were clustered based on gene expression profiles and specific gene sets for each renal tumor type were identified. Gene expression was correlated to disease progression and a metastasis gene signature was derived. RESULTS: Gene signatures were identified for each tumor type with 100% accuracy. Differentially expressed genes during early tumor formation and tumor progression to metastatic RCC were found. Subsets of these genes code for secreted proteins and membrane receptors and are both potential therapeutic or diagnostic targets. A gene pattern ("metastatic signature") derived from primary tumor was very accurate in classifying tumors with and without metastases at the time of surgery. A previously described "global" metastatic signature derived by another group from various non-RCC tumors was validated in RCC. CONCLUSION: Unlike previous studies, we describe highly accurate and externally validated gene signatures for RCC subtypes and other renal tumors. Interestingly, the gene expression of primary tumors provides us information about the metastatic status in the respective patients and has the potential, if prospectively validated, to enrich the armamentarium of diagnostic tests in RCC. We validated in RCC, for the first time, a previously described metastatic signature and further showed the feasibility of applying a gene signature across different microarray platforms. Transcriptional profiling allows a better appreciation of the molecular and clinical heterogeneity in RCC.

Adult↗
PubMed2003

Adherence to research protocols in a clinical context: challenges and recommendations from behavioral intervention trials.

Conducting clinical interventions in a research setting poses numerous challenges to clinicians, researchers, supervisors, and research participants. These issues often reflect a tension between the rigorous demands of a research protocol needed to ensure internal validity of the research and clinical flexibility that is representative of an externally valid intervention. In this paper, we explore difficulties in defining the roles of clinicians and research participants, delineating the scope of the intervention, and problems encountered at the intersection of clinical intervention delivery and such methodological techniques as randomization, blinding, and incentive payments. We provide guidance for setting frames for the intervention and clinical relationship, conducting training and supervision of clinical staff, and structuring quality-assurance procedures in order to meet these challenges.

Biomedical Research↗
PubMed2007

Validating and updating a prediction rule for serious bacterial infection in patients with fever without source.

AIM: To externally validate and update a previously developed rule for predicting the presence of serious bacterial infections in children with fever without apparent source. METHODS: Patients, 1-36 mo, presenting with fever without source, were prospectively enrolled. Serious bacterial infection included bacterial meningitis, sepsis, bacteraemia, pneumonia, urinary tract infection, bacterial gastroenteritis, osteomyelitis/ethmoiditis. The generalizability of the original rule was determined. Subsequently, the prediction rule was updated using all available data of the patients with fever without source (1996-1998 and 2000-2001, n = 381) using multivariable logistic regression. RESULTS: the generalizability of the rule appeared insufficient in the new patients (n = 150). In the updated rule, independent predictors from history and examination were duration of fever, vomiting, ill clinical appearance, chest-wall retractions and poor peripheral circulation (ROC area (95%CI): 0.69 (0.63-0.75)). Additional independent predictors from laboratory were serum white blood cell count and C-reactive protein, and in urinalysis > or = 70 white bloods (ROC area (95%CI): 0.83 (0.78-0.88). CONCLUSIONS: A previously developed prediction rule for predicting the presence of serious bacterial infection in children with fever without apparent source was updated. Its clinical score can be used as a first screening tool. Additional laboratory testing may specify the individual risk estimate (range: 4-54%) further.

Bacterial Infections↗