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At least 253 records · Page 14Linked to original sources

PubMed2005

Reliability of the Spanish version of a brief questionnaire on patient satisfaction with gastrointestinal endoscopy.

BACKGROUND: There has not been a validated questionnaire available in Spanish to evaluate patient satisfaction with gastrointestinal endoscopy. Our aim was to evaluate the external validity and internal consistency of the Spanish version of a questionnaire on patient satisfaction with gastrointestinal endoscopy elaborated by the American Society for Gastrointestinal Endoscopy. DESIGN: Prospective questionnaire validation study. PATIENTS AND METHODS: A total of 485 consecutive patients referred to two different hospitals for endoscopy were interviewed by telephone. Internal consistency was studied using Cronbach's alfa test and corrected item-total correlations (CITC). External validity was determined using a mailed questionnaire completed by 185 patients-correlations between telephone and postal responses were calculated, as well as the correlation with the total score obtained. RESULTS: Cronbach's alfa was 0.82 and mean CITC was 0.59. Weighted kappa values for the same questionnaire items performed by telephone or mail varied between 0.51 and 0.81. Total score correlation was 0.78. Internal consistency and external validity were not affected by differences in the administration of the questionnaire (mail or by telephone), different interviewers, type of endoscopy, or source of patients. CONCLUSIONS: The Spanish version of the ASGE questionnaire on satisfaction with endoscopy is valid, reliable, and reproducible.

Endoscopy, Gastrointestinal↗

PubMed1997

Nine equivalents of nursing manpower use score (NEMS).

OBJECTIVES: To develop a simplified Therapeutic Intervention Scoring System (TISS) based on the TISS-28 items and to validate the new score in an independent database. DESIGN: Retrospective statistical analysis of a database and a prospective multicentre study. SETTING: Development in the database of the Foundation for Research on Intensive Care in Europe with external validation in 64 intensive care units (ICUs) of 11 European countries. MEASUREMENTS AND RESULTS: Development of NEMS on a random sample of TISS-28 items, cross validation on another random sample of TISS-28, and external validation of NEMS in comparison with TISS-28 scored by two independent raters on the day of the visit to the ICUs participating in an international study. Multivariable regression techniques, Pearson's correlation, and paired sample t-tests were used (significance at p < 0.05 level). Intraclass correlation, rate of agreement, and kappa statistics were used for interrater reliability tests. The TISS-28 items were reduced to NEMS (9 items) in a random sample of 2000 records; the means of the two scores were no different: TISS-28 26.23 +/- 10.38, NEMS 26.19 +/- 9.12, NS. Cross-validation in a random sample of 996 records; mean TISS-28 26.13 +/- 10.38, NEMS 26.17 +/- 9.38, NS; R2 = 0.76. External validation on 369 pairs of TISS-28 and NEMS has shown that the means of the two scores were no different: TISS-28 27.56 +/- 11.03, NEMS 27.02 +/- 8.98, NS; R2 = 0.59. Reliability tests have shown an "almost perfect" interrater correlation. Similar to studies correlating TISS with Simplified Acute Physiology Score (SAPS)-I and/or Acute Physiology and Chronic Health Evaluation II scores, the value of NEMS scored on the first day accounts for 30.4% of the variation of SAPS-II score. CONCLUSIONS: NEMS is a suitable therapeutic index to measure nursing workload at the ICU level. The use of NEMS is indicated for: (a) multicentre ICU studies; (b) management purposes in the general (macro) evaluation and comparison of workload at the ICU level; (c) the prediction of workload and planning of nursing staff allocation at the individual patient level.

Cluster Analysis↗

PubMed2006

[Bioequivalence assessment of pioglitazone hydrochloride oral preparation by limited sampling strategy].

AIM: To develop limited sampling strategy (LSS) for estimation of C(max) and AUC(0-t) and assessing the bioequivalence of two pioglitazone hydrochloride (PGT) preparations. METHODS: Healthy subjects (n = 20), enrolled in a bioequivalence study, were received 30 mg PGT po of reference or test formulation. The plasma concentration of PGT was determined by the validated HPLC method. A multiple linear regression analysis of the Cmax and AUC(0-t) against the PGT concentration for the reference formulation was carried out to develop LSS models to estimate these parameters. The models were internally validated by the Jackknife method and externally validated using simulated sets generated by Monte Carlo method. The best model was employed to assess bioequivalence of the two PGT formulations. RESULTS: The linear relationship between pharmacokinetics parameters and single concentration point was poor. Several models for these parameters estimation met the predefined criteria (r2 > 0.9). The Jackknife validation procedure revealed that LSS models based on two sampling times (C1, C2.5 and C1.5, C2.5 for C(max); C1.5, C9 and C2.5, C9 for AUC(0-t) predict accurately. Mean prediction errors (MPE) were less than 3%, and mean absolute prediction error (MAE) were less than 9%. The prediction error (PE) beyond 20% was less than 5% of total samples. Model external validation by Monte Carlo simulated data indicated that the most informative sampling combinations were C1.5, C2.5 for C(max), and C1.5, C9 for AUC(0-t), respectively. MPE and MAE of the proposed models were less than 5% , and 9% respectively. The PE beyond 20% was less than 5% of the total. Bioequivalence assessment of the two PGT formulations, based on the best LSS models, provided results similar to those obtained using all the observed concentration-time data points, and indicated that the two PGT formulations were bioequivalent. CONCLUSION: The LSS method for bioequivalence assessment of PGT formulations was established and proved to be applicable and accurate. Thus, it could be considered appropriate for PGT bioequivalence study with inexpensive cost of sampling acquisition and analysis. Key words: pioglitazone hydrochloride; limited sampling strategy; Monte Carlo simulation; bioequivalence

Administration, Oral↗

PubMed2006

Olanzapine plasma level in relation to antimanic effect in the acute therapy of manic states.

The aim of this study was to evaluate internal as well as external validity of the two most frequently used mania scales, the Young Mania Rating Scale (YMRS) and the Bech-Rafaelsen Mania Scale (MAS), in patients with DSM-IV mania. Mokken analysis was used to evaluate internal validity in which a coefficient of homogeneity of 0.40 or higher indicates that the total score is a sufficient statistic. The external validity was evaluated by plasma-level relationship of olanzapine. In total, 20 patients with DSM-IV mania were analysed, and the coefficient of homogeneity was acceptable for the MAS, but not for the YMRS. In a subgroup of females who over 2 weeks had received a fixed dose of 20 mg olanzapine daily, a significant association was found between MAS scores and plasma levels, but this association was not obtained with the YMRS. In conclusion, the MAS was found superior to the YMRS in regard to both internal and external validity.

Antimanic Agents↗

PubMed1993

An examination of cluster-based classification schemes for DUI offenders.

This study examines the utility of cluster-based classification schemes for DUI offenders. Variables from previous empirical typologies and multiple domains were used in a series of cluster analyses in order to examine replicability across independent samples, across clustering algorithms and across sets of psychometric indicators. The arbitrary nature of cluster solutions and the external validity of cluster-based schemes, with respect to an outcome criterion constructed synthetically from earlier research, was examined. Only three of eight cluster techniques (Ward's, K means, and complete linkage) yielded meaningful results. For these techniques, replicability was poor across samples, algorithms and sets of psychometric indicators. Results indicated that identified clusters were arbitrary. Although external validity analysis yielded positive results, the possibility that external validity was a function of underlying dimensions was discussed, as were other implications of the findings.

Adult↗

PubMed2003

German multicenter study group for adult ALL (GMALL): recruitment in comparison to ALL incidence and its impact on study results.

Due to eligibility criteria not all patients with the disease under investigation can be recruited for therapeutic studies. Thus, the external validity of study results cannot per se be taken for granted. The representativity of the admitted patients is the most relevant determinant for external validity and has to be assessed. As an example we examined the representativity of the patients recruited for the German multicenter study group for adult acute lymphoblastic leukemia (ALL) (GMALL). Lacking nationwide ALL incidence figures available in Germany, a methodology was developed to estimate incidence figures, too. All relevant study groups, hospitals, and diagnostic labs were asked to provide data about patients with ALL newly diagnosed between 1997 and 1998. A matching procedure was developed, as heterogeneous databases had to be pooled and checked for duplicates. Age- and sex-specific incidences of ALL were estimated and compared with the number of patients recruited for the GMALL in the same time period. The purpose was to develop a methodology for estimating incidence figures and evaluating the representativity of patients of the GMALL. The combination of various data sources allowed estimation of reliable incidence data for ALL in Germany. Comparisons with the incidence figures for ALL in other countries and crosschecks within Germany confirm our results. Sixty-two percent of all ALL patients in Germany were admitted to the GMALL study. The recruitment rate of more than 60% of the annual incidence of ALL to the GMALL suggests a high external validity as well as an impact of the study on the patterns of treatment and referral of ALL in adults in Germany. There is no selection bias of patients admitted to the GMALL compared to those patients not included in the study.

Adolescent↗

PubMed2006

[Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals].

BACKGROUND: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. AIM: To determine methodological quality and internal and external validity of the Macdonald study. MATERIAL AND METHOD: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. RESULTS: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. CONCLUSION: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2006

A prediction rule to identify low-risk patients with pulmonary embolism.

BACKGROUND: A simple prognostic model could help identify patients with pulmonary embolism who are at low risk of death and are candidates for outpatient treatment. METHODS: We randomly allocated 15,531 retrospectively identified inpatients who had a discharge diagnosis of pulmonary embolism from 186 Pennsylvania hospitals to derivation (67%) and internal validation (33%) samples. We derived our rule to predict 30-day mortality using classification tree analysis and patient data routinely available at initial examination as potential predictor variables. We used data from a European prospective study to externally validate the rule among 221 inpatients with pulmonary embolism. We determined mortality and nonfatal adverse medical outcomes across derivation and validation samples. RESULTS: Our final model consisted of 10 patient factors (age > or = 70 years; history of cancer, heart failure, chronic lung disease, chronic renal disease, and cerebrovascular disease; and clinical variables of pulse rate > or = 110 beats/min, systolic blood pressure < 100 mm Hg, altered mental status, and arterial oxygen saturation < 90%). Patients with none of these factors were defined as low risk. The 30-day mortality rates for low-risk patients were 0.6%, 1.5%, and 0% in the derivation, internal validation, and external validation samples, respectively. The rates of nonfatal adverse medical outcomes were less than 1% among low-risk patients across all study samples. CONCLUSIONS: This simple prediction rule accurately identifies patients with pulmonary embolism who are at low risk of short-term mortality and other adverse medical outcomes. Prospective validation of this rule is important before its implementation as a decision aid for outpatient treatment.

Age Factors↗

PubMed2002

Prediction of VO(2peak) in wheelchair-dependent athletes from the adapted Léger and Boucher test.

PURPOSE: :The purpose of this study was to provide a predictive peak oxygen uptake ([V]O(2) peak) equation in wheelchair-dependent athletes using the Adapted Léger and Boucher test. SUBJECTS AND PROTOCOL: :Fifty-six wheelchair-dependent athletes, 47 males and nine females (30.3+/-4 years), underwent a clinical examination to assess their anthropometric characteristics: height, mass, body mass index (BMI), lean body mass, arm length, and muscular arm volume. They performed a deceleration field test to assess the subject-wheelchair resistance defined as a mechanical variable, and they then performed the Adapted Léger and Boucher test to assess physiological data at maximal exercise ([V]O(2) peak, heart rate max) concomitantly with biomechanical (number of pushes) and performance variables (maximal aerobic velocity Va(max) and maximal distance). The [V]O(2) peak was measured directly using a portable telemetric oxygen analyzer. Subjects were then randomly assigned to an experimental group (n=49) to determine the predictive equation, and a validation group (n=7) to check the external validity of the equation. RESULTS: A stepwise multiple regression with [V]O(2) peak (l min(-1)) as the dependent variable led to the following equation: [V]O(2) peak=0.22 Va(max) - 0.63 log(age)+0.05 BMI 0.25 level+0.52, with r(2)=0.81 and SEE=0.01. Paraplegic subjects with high and low lesion level spinal injuries were attributed the coefficient of 1 and 0, respectively. The external validity of the equation was positive since the predicted [V]O(2) peak values did not significantly differ from directly measured [V]O(2) peak (P>0.05). CONCLUSION: We concluded that [V]O(2) peak in wheelchair-dependent athletes was predictable using the equation of the present study and the described incremental test.

Adolescent↗

PubMed2001

Validity of the five-item WHO Well-Being Index (WHO-5) in an elderly population.

BACKGROUND: Depression has a high prevalence in the elderly population; however it often remains undetected. The WHO 5-item Well-Being Index (WHO-5) is a short screening instrument for the detection of depression in the general population, which has not yet been evaluated. The goals of the present study were: 1) to assess the internal and external validity of WHO-5 and 2) to compare the two recent versions of WHO-5. STUDY POPULATION AND METHODS: 367 subjects above 50 years of age were examined with the WHO-5. ICD-10 diagnoses were made using a structured interview (CIDI). The internal validity of the well-being index was evaluated by calculating Loevinger's and Mokken's homogeneity coefficients. External validity for detection of depression was evaluated by ROC analysis. RESULTS: The scale was sufficiently homogeneous (Loevinger's coefficient: version 1 = 0.38, version 2 = 0.47; Mokken coefficient > 0.3 in nearly all items). ROC analysis showed that both versions adequately detected depression. Version 1 additionally detected anxiety disorders, version 2 being more specific for detection of depression. CONCLUSION: The WHO-5 showed a good internal and external validity. The second version is a stronger scale and was more specific for the detection of depression. The WHO-5 is an useful instrument for identifying elderly subjects with depression.

Aged↗

PubMed2006

The outcome of patients presenting to the emergency department with severe sepsis or septic shock.

Although multiple studies of acute myocardial infarction, trauma, and stroke have been translated into improved outcomes by applying diagnosis and therapy at the most proximal stage of hospital presentation (before intensive care unit arrival), this approach to the sepsis patient has been lacking. In response to this, a trial comparing early goal-directed therapy (EGDT) versus standard care was performed using internally and externally validated criteria for early identification of high risk patients, established definitions, and a consensus-derived protocol to reverse the hemodynamic perturbations of hypovolemia, vasoregulation, myocardial suppression and increased metabolic demands. That trial of EGDT resulted in significant reductions in morbidity, mortality, vasopressor use, and health care resource consumption. The end-points used in the protocol and the outcome results were subsequently externally validated, revealing similar or better mortality benefit. This commentary examines the rational and validation for the use of early markers of illness severity. Current evidence support the endpoints in the EGDT protocol, external validity in regards to outcome benefit and the universal need to improve the quality of care for early sepsis.

Emergency Service, Hospital↗

PubMed2003

Methodological index for non-randomized studies (minors): development and validation of a new instrument.

BACKGROUND: Because of specific methodological difficulties in conducting randomized trials, surgical research remains dependent predominantly on observational or non-randomized studies. Few validated instruments are available to determine the methodological quality of such studies either from the reader's perspective or for the purpose of meta-analysis. The aim of the present study was to develop and validate such an instrument. METHODS: After an initial conceptualization phase of a methodological index for non-randomized studies (MINORS), a list of 12 potential items was sent to 100 experts from different surgical specialties for evaluation and was also assessed by 10 clinical methodologists. Subsequent testing involved the assessment of inter-reviewer agreement, test-retest reliability at 2 months, internal consistency reliability and external validity. RESULTS: The final version of MINORS contained 12 items, the first eight being specifically for non-comparative studies. Reliability was established on the basis of good inter-reviewer agreement, high test-retest reliability by the kappa-coefficient and good internal consistency by a high Cronbach's alpha-coefficient. External validity was established in terms of the ability of MINORS to identify excellent trials. CONCLUSIONS: MINORS is a valid instrument designed to assess the methodological quality of non-randomized surgical studies, whether comparative or non-comparative. The next step will be to determine its external validity when used in a large number of studies and to compare it with other existing instruments.

Clinical Trials as Topic↗

PubMed2006

Prediction of target range of intact parathyroid hormone in hemodialysis patients with artificial neural network.

The application of artificial neural network (ANN) to predict outcome and explore potential relationships among clinical data is increasing being used in many clinical scenarios. The aim of this study was to validate whether an ANN is a useful tool for predicting the target range of plasma intact parathyroid hormone (iPTH) concentration in hemodialysis patients. An ANN was constructed with input variables collected retrospectively from an internal validation group (n = 129) of hemodialysis patients. Plasma iPTH was the dichotomous outcome variable, either target group (150 ng/L 300 ng/L). After internal validation, the ANN was prospectively tested in an external validation group (n = 32) of hemodialysis patients. The final ANN was a multilayer perceptron network with six predictors including age, diabetes, hypertension, and blood biochemistries (hemoglobin, albumin, calcium). The externally validated ANN provided excellent discrimination as appraised by area under the receiver operating characteristic curve (0.83 +/- 0.11, p = 0.003). The Hosmer-Lemeshow statistic was 5.02 (p= 0.08 > 0.05) which represented a good-fit calibration. These results suggest that an ANN, which is based on limited clinical data, is able to accurately forecast the target range of plasma iPTH concentration in hemodialysis patients.

Female↗

PubMed1981

[Quasi experimental evaluation of public health interventions (author's transl)].

The classic experiment, the randomised controlled trial, is the best known and most revered of evaluation research methods. Randomization in community-based intervention trials, however, is not always possible because of ethical problems arising from with holding the experimental treatment from the control groups or the difficulties in conducting experiments in field settings which do not approach controlled laboratory conditions. In such circumstances, quasi-experimental or observational designs must be used. Two major principles are involved in using quasi-experimental methods: (1) the logic for establishing causality between treatment and effect is the same as that for randomised experiments, but the problems of assessing causality or internal validity are greater, and (2) assessment of the external validity or generalizability of quasi-experimental findings crucial to the interpretation of results. Selected quasi-experimental designs using time series and comparison groups are described with examples from public health intervention trials where threats to internal validity have been assessed by using different analytic techniques or gathering additional evidence. Quasi-experimental evaluations are most useful when opportunities exist for testing rival hypotheses concerning the internal and external validity, or the findings can be used to complement true experiments.

Epidemiologic Methods↗

PubMed2002

Discriminant and quantitative PLS analysis of competitive CYP2C9 inhibitors versus non-inhibitors using alignment independent GRIND descriptors.

This study describes the use of alignment-independent descriptors for obtaining qualitative and quantitative predictions of the competitive inhibition of CYP2C9 on a serie of highly structurally diverse compounds. This was accomplished by calculating alignment independent descriptors in ALMOND. These GRid INdependent Descriptors (GRIND) represent the most important GRID-interactions as a function of the distance instead of the actual position of each grid-point. The experimental data was determined under uniform conditions. The inhibitor data set consists of 35 structurally diverse competitive stereospecific inhibitors of the cytochrome P450 2C9 and the non -inhibitor data set of 46 compounds. In a PLS discriminant analysis 21 inhibitors and 21 non-inhibitors (1 and 0 as activities) were analyzed using the ALMOND program obtaining a model with an r2 of 0.74 and a cross-validation value (q2) of 0.64. The model was externally validated with 39 compounds (14 inhibitors/25 non-inhibitors). 74% of the compounds were correctly predicted and an additional 13% was assigned to a borderline cluster. Thereafter, a model for quantitative predictions was generated by a PLS analysis of the GRIND descriptors using the experimental Ki-value for 21 of the competitive inhibitors (r2 = 0.77, q2 = 0.60). The model was externally validated using 12 compounds and predicted 11 out of 12 of the Ki-values within 0.5 log units. The discriminant model will be useful in screening for CYP2C9 inhibitors from large compound collections. The 3D-QSAR model will be used during lead optimization to avoid chemistry that result in inhibition of CYP2C9.

Aryl Hydrocarbon Hydroxylases↗

PubMed2026

Risk prediction in patients with heart failure with preserved ejection fraction: the LIFE-Preserved model.

BACKGROUND AND AIMS: Heart failure (HF) with preserved ejection fraction (HFpEF) constitutes a heterogeneous disease with varying prognosis. Given the rising incidence of HFpEF, accurate risk prediction for these patients is needed to identify high-risk individuals, who may benefit the most from preventive treatments. The LIFE-Preserved model was developed and validated for the prediction of individual short-term and lifetime risk for HF hospitalization or cardiovascular (CV) death in patients with HFpEF. METHODS: LIFE-Preserved was derived in 20 332 patients aged 40-90 years with a left ventricular ejection fraction ≥ 50% from the Swedish HF Registry. Cause- and sex-specific Cox models were derived to predict the risk of HF hospitalization or CV death using 14 routinely available predictors. Use of age as the timescale allowed for predictions beyond the maximum follow-up duration in the derivation data, adjusted for competing risks. External validation was performed in two trials (EMPEROR-Preserved and TOPCAT-Americas) and three registries (NHS England Secure Data Environment, Veterans Affairs, and HF-Particles). Model performance was assessed by discrimination and calibration. RESULTS: During a median follow-up of 1.8 years (interquartile range .6-4.2, maximum 19 years), 9341 first HF hospitalizations or CV deaths (46%) were observed in Swedish HF Registry. External validation included data from 28 062 patients with HFpEF [9930 (35%) first HF hospitalizations or CV deaths]. Pooled C-statistics were .714 (95% confidence interval .652-.775) in trials and .658 (95% confidence interval .599-.717 in registries, with adequate calibration in all external validation sources. Performance was similar in men and women. An interactive calculator of the LIFE-Preserved model has been made available here. CONCLUSIONS: The LIFE-Preserved model enables prediction of short-term and lifetime risk of HF hospitalization or CV death in patients with HFpEF. The model could serve as a tool to identify high-risk HFpEF patients, guiding clinical management and shared decision-making.

Humans↗

PubMed2005

Once-a-day extended-release dosage form of divalproex sodium III: development and validation of a Level A in vitro-in vivo correlation (IVIVC).

Defining a quantitative and reliable relationship between in vitro drug release and in vivo absorption is highly desired for rational development, optimization, and evaluation of controlled-release dosage forms and manufacturing process. During the development of a once-daily extended-release (ER) tablet of divalproex sodium, a predictive in vitro drug release method was designed and statistically evaluated using three formulations with varying release rates. In order to establish an internally and externally validated Level A IVIVC, a total of five different ER formulations of divalproex sodium were used to evaluate a linear IVIVC model based on the in vitro test method. For internal validation, a single-dose four-way crossover study (N = 16) was performed using fast-, medium-, and slow-releasing ER formulations and a 12-h IV infusion of valproic acid as reference. To validate the IVIVC externally, a second three-way crossover study (N = 36) was performed using slightly-fast-, medium-, and slightly-slow-releasing ER formulations. The in vivo absorption-time profile was inferred by deconvolution of the observed plasma concentration-time profiles against the unit disposition function (UDF). A linear IVIVC model was established in which the in vivo absorption was expressed as a function of in vitro drug release. Plasma profiles of ER formulations were estimated via convolution of in vitro release profiles with the UDF. Successful internal and external validations of the model were demonstrated by individual and average absolute percent prediction errors of </=9% for both C(max) and AUC(infinity). In conclusion, a Level A IVIVC describing the entire time-course of plasma concentrations was developed and validated, both internally and externally, for ER formulations of divalproex sodium.

Adolescent↗

PubMed2006

Prediction of pulmonary embolism in the emergency department: the revised Geneva score.

BACKGROUND: Diagnosis of pulmonary embolism requires clinical probability assessment. Implicit assessment is accurate but is not standardized, and current prediction rules have shortcomings. OBJECTIVE: To construct a simple score based entirely on clinical variables and independent from physicians' implicit judgment. DESIGN: Derivation and external validation of the score in 2 independent management studies on pulmonary embolism diagnosis. SETTING: Emergency departments of 3 university hospitals in Europe. PATIENTS: Consecutive patients admitted for clinically suspected pulmonary embolism. MEASUREMENTS: Collected data included demographic characteristics, risk factors, and clinical signs and symptoms suggestive of venous thromboembolism. The variables statistically significantly associated with pulmonary embolism in univariate analysis were included in a multivariate logistic regression model. Points were assigned according to the regression coefficients. The score was then externally validated in an independent cohort. RESULTS: The score comprised 8 variables (points): age older than 65 years (1 point), previous deep venous thrombosis or pulmonary embolism (3 points), surgery or fracture within 1 month (2 points), active malignant condition (2 points), unilateral lower limb pain (3 points), hemoptysis (2 points), heart rate of 75 to 94 beats/min (3 points) or 95 beats/min or more (5 points), and pain on lower-limb deep venous palpation and unilateral edema (4 points). In the validation set, the prevalence of pulmonary embolism was 8% in the low-probability category (0 to 3 points), 28% in the intermediate-probability category (4 to 10 points), and 74% in the high-probability category (> or =11 points). LIMITATIONS: Interobserver agreement for the score items was not studied. CONCLUSIONS: The proposed score is entirely standardized and is based on clinical variables. It has sustained internal and external validation and should now be tested for clinical usefulness in an outcome study.

Aged↗