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Preliminary study to evaluate the validity of the mini-mental state examination in a normal population in Turkey.

Although the Mini-Mental State Examination (MMSE) is widely used in clinical practice, normative scores for a healthy population have not been documented in Turkey. The aim in this study was to validate the MMSE in a healthy population and to provide normal scores. Internal construct validity of the Turkish version of MMSE among a preliminary sample of 406 normal people was assessed by Rasch unidimensional measurement model. Scores of the normal sample varied according to age and education but not according to sex. The data derived from this sample showed poor fit to the Rasch model (mean item fit, -2.082, SD 3.022). Only four of 11 items met model expectations. There was also differential item functioning by education and age for most items. Thus the internal construct validity of the Turkish MMSE in a normative sample could not be demonstrated by Rasch analysis. The scale failed modern psychometric criteria for scalability. We would therefore suggest other large normative MMSE data sets to be tested in terms of internal construct validity. If these findings are replicated, the validity of MMSE norms and their consequent use in clinical practice should be reconsidered.

Adolescent↗

The reliability and validity of the Adolescent Physical Activity Recall Questionnaire.

PURPOSE: This study assessed the test-retest reliability and validity of the Adolescent Physical Activity Recall Questionnaire (APARQ) among 13- and 15-yr-old Australians. METHODS: Two studies were conducted using the same instrument. Self-reported participation in organized and nonorganized physical activity was summarized into four measures: a three-category measure of activity, a two-category measure, and estimated energy expenditure expressed as a continuous variable and as quintiles. The reliability study (N = 226) assessed strength of agreement for all measures between responses to two administrations of the questionnaire. The validity study (N = 2026) assessed the relationship between the APARQ and performance on the Multistage Fitness Test (MFT). RESULTS: Reliability study: for the three-category measure, percent agreement ranged 67-83% and weighted kappa ranged 0.33-0.71. For the two-category measure, percent agreement ranged 76-90% and kappa ranged 0.25-0.74. For energy expenditure expressed as a continuous variable, the intraclass correlations coefficients were generally greater than 0.6 for grade 10 students, but most were below 0.5 for grade 8 students. Validity study: for the three-category measure, mean laps were higher in the adequately and vigorously active categories than the inactive category for girls, but only the mean laps in the vigorously active and inactive categories were significantly different for boys. For the two-category measure, mean laps were higher in the active category than the inactive category for all groups. Correlations between energy expenditure and MFT laps were 0.15, 0.21, 0.14, and 0.39 for grade 8 boys, grade 8 girls, grade 10 boys, and grade 10 girls, respectively. CONCLUSION: The APARQ has acceptable to good reliability and acceptable validity, but further validation using other methods and in other population groups is required.

Adolescent↗

Model testing for reliability and validity of the Outcome Expectations for Exercise Scale.

BACKGROUND: Development of a reliable and valid measure of outcome expectations for exercise appropriate for older adults will help establish the relationship between outcome expectations and exercise. Once established, this measure can be used to facilitate the development of interventions to strengthen outcome expectations and improve adherence to regular exercise in older adults. OBJECTIVES: Building on initial psychometrics of the Outcome Expectation for Exercise (OEE) Scale, the purpose of the current study was to use structural equation modeling to provide additional support for the reliability and validity of this measure. METHODS: The OEE scale is a 9-item measure specifically focusing on the perceived consequences of exercise for older adults. The OEE scale was given to 191 residents in a continuing care retirement community. The mean age of the participants was 85 +/- 6.1 and the majority were female (76%), White (99%), and unmarried (76%). Using structural equation modeling, reliability was based on R2 values, and validity was based on a confirmatory factor analysis and path coefficients. RESULTS: There was continued evidence for reliability of the OEE based on R2 values ranging from .42 to .77, and validity with path coefficients ranging from .69 to .87, and evidence of model fit (X2 of 69, df = 27, p < .05, NFI = .98, RMSEA = .07). CONCLUSION: The evidence of reliability and validity of this measure has important implications for clinical work and research. The OEE scale can be used to identify older adults who have low outcome expectations for exercise, and interventions can then be implemented to strengthen these expectations and thereby improve exercise behavior.

Aged↗

Validation of the mobility subscale of the Braden Scale for predicting pressure sore risk.

BACKGROUND: The Braden Scale for Predicting Pressure Sore Risk has been tested extensively for reliability and validity, but the validity of each subscale has not been evaluated. Because subscale scores are intended to guide patient care decisions, validity is an important issue. OBJECTIVE: : To establish the convergent construct validity of the mobility subscale of the Braden Scale. METHODS: The study evaluated 16 members at a veterans' home (4 members representing each score on the mobility subscale). Movement, as recorded by a Motionlogger Actigraph, a wristwatch-sized accelerometer and microprocessor that measures physical movement (activity), was measured continuously. Each person wore an Actigraph on the nondominant ankle for 72 hours. RESULTS: The mean activity for each of the four subscale score groups was plotted, producing a histogram in which higher scores were associated with greater activity (F[3, 15] = 31.69;p <.001, one-way analysis of variance), as expected. Pair wise multiple comparisons between groups showed that only the subgroup with a score of 4 was significantly different in mean activity (p <.001) from the other three score groups. CONCLUSIONS: Convergent construct validity for the Braden mobility subscale was supported. A larger sample and establishment of a threshold to eliminate minor, ineffective movements from Motionlogger Actigraph measures may distinguish between significant and nonsignificant movement.

Aged↗

The Quality of Life Impact of Refractive Correction (QIRC) Questionnaire: development and validation.

BACKGROUND: The purpose of the study was to develop a questionnaire that could quantify the quality of life (QOL) of people with refractive correction by spectacles, contact lenses, and refractive surgery in the prepresbyopic age group. METHODS: The questionnaire was developed and validated using traditional methods and Rasch analysis. A 90-item pilot questionnaire was developed through extensive literature search and use of professional and lay focus groups. Pilot study data were obtained from 306 subjects for item reduction to produce the 20-item Quality of Life Impact of Refractive Correction (QIRC) questionnaire. Validity and reliability studies (test-retest reliability with intraclass correlation coefficient and Bland-Altman limits of agreement, and internal consistency with Rasch fit statistics, factor analysis, and Cronbach's alpha) were performed from data of an additional 312 subjects. RESULTS: Rasch analysis demonstrated QIRC has good precision, reliability, and internal consistency (person separation, 2.03; reliability, 0.80; root-mean-square measurement error, 3.25; mean square +/- SD infit, 0.99 +/- 0.38; outfit, 1.00 +/- 0.39; item infit range, 0.70 to 1.24; and item outfit range, 0.78 to 1.32). The items (mean score, 50.3 +/- 7.3) were well targeted to the subjects (mean score, 47.8 +/- 5.5) with a mean difference of 2.45 (scale range, 0 to 100) units. Test-retest reliability (intraclass correlation coefficient, 0.88; coefficient of repeatability, +/-6.85 units), factor loading range (0.40 to 0.76), and Cronbach's alpha (0.78) also indicated the reliability and validity of QIRC. CONCLUSIONS: The 20-item QIRC questionnaire, which quantifies the QOL of people with refractive correction by spectacles, contact lenses, and refractive surgery in the prepresbyopic age group, was developed using Rasch analysis and shown to be valid and reliable. The use of Rasch scaling allows scores to be treated as a valid continuous variable. QIRC has broad applicability for cross-sectional and outcomes research.

Adult↗

Prospectively validated prediction of organ failure and hypotension in patients with septic shock: the Systemic Mediator Associated Response Test (SMART).

Conventional outcomes research provides only percentage risk categories that are not applicable to individual patients, and it predicts only mortality, utilization of resources and/or broad groupings of multiple organ system dysfunction. The purpose of the present study was to determine whether or not the Systemic Mediator Associated Response Test (SMART) methodology could identify interactions among demographics, physiologic parameters, standard hospital laboratory tests, and circulating cytokine concentrations to predict continuous and dichotomous dependent clinical variables, in advance, in individual patients with septic shock and to integrate these into prospectively validated models. Two hundred forty (240) patients with septic shock who were entered into the placebo arm of a multi-institutional clinical trial were randomly separated into a model building training cohort (n = 154) and a predictive cohort (n = 86), which was used to prospectively validate the prognostic models built upon the training cohort database. From baseline patient demographics; hospital laboratory tests; and plasma levels of interleukin-6, interleukin-8, and granulocyte colony stimulating factor, multiple regression models were developed that predicted clinically important continuous dependent variables quantitatively in individual patients. Multivariate stepwise logistic regression was utilized to develop models that prognosticated dichotomous dependent end points. At the completion of the modeling process, baseline data from individual patients in the predictive cohort was inserted into each multivariate model for each day. Prospective validation was accomplished by simple linear regression of individual predicted versus observed values for continuous dependent variables, and by establishing the Receiver Operator Characteristics Area Under the Curve (ROC AUC) for logistic regression models that predicted dichotomous end points. Through seven days, SMART quantitative predictions of selected physiologic and metabolic parameters were validated at r > 0.500 in 51%. Up to seven days after baseline, 31/49 (63%) SMART models for renal and liver function indicators were validated prospectively at the r > 0.700 level. For hematologic/coagulation models, 37/56 (66%) up to seven days had r > 0.900. Among dichotomous models, ROC AUC > 0.700 was achieved in 30/49 (61%) during the first week. SMART integration of demographics, bedside physiology, hospital laboratory tests, and circulating cytokines predicts organ failure and physiologic function indicators in individual patients with septic shock.

Area Under Curve↗

Validation of the German version of the Chronic Liver Disease Questionnaire.

OBJECTIVE: The Chronic Liver Disease Questionnaire is an instrument for the assessment of health-related quality of life in patients with chronic liver diseases. So far it has not been validated for German speaking countries. METHODS: Two hundred and three consecutive patients with chronic liver diseases (age, 52.7 +/- 13.9 years; 47% female; 45% no cirrhosis, 21% Child's class A, 15% Child's class B and 17% Child's class C cirrhosis; 52% with chronic viral hepatitis, 32% with alcoholic and 16% with other liver diseases) of a liver centre completed the German version of the Chronic Liver Disease Questionnaire (CLDQ-D), the Short Form Health Survey SF-36, the Hospital Anxiety and Depression Scale (HADS) and the Giessener Symptom List GBB-24. Fifty stable patients filled in the CLDQ-D a second time within 3 - 8 days. RESULTS: With 97.7% completed items the acceptance by the patients was high. The internal consistency (Cronbach alpha) for the subscales ranged from 0.69 to 0.95, the test-retest reliability ranged from 0.79 to 0.88. The correlation coefficients with similar subscales of the instruments used for validation ranged between 0.5 and 0.9 (convergent validity). Patients with liver cirrhosis Child-Pugh stage C scored significantly lower in the subscales 'Abdominal Symptoms', 'Activity' and 'Worry', indicating a reduced health-related quality of life than in patients without cirrhosis (P < 0.05) (discriminant validity). CONCLUSION: The CLDQ-D is well accepted by patients with chronic liver diseases and has good reliability and satisfactory discriminant validity.

Adult↗

A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis.

OBJECTIVE: To develop and validate a logistic regression model to predict need for admission and length of hospital stay in children presenting to the Emergency Department with bronchiolitis. SETTING: Two children's hospitals in Dublin, Ireland. METHODS: We reviewed 118 episodes of bronchiolitis in 99 children admitted from the Emergency Department. Those discharged within 24 h by a consultant/attending paediatrician were retrospectively categorized as suitable for discharge. We then validated the model using a cohort of 182 affected infants from another paediatric Emergency Department in a bronchiolitis season 2 years later. In the validation phase actual admission, failed discharge, and age less than 2 months defined the need for admission. RESULTS: The model predicted admission with 91% sensitivity and 83% specificity in the validation cohort. Age [odds ratio (OR) 0.86, 95% confidence interval (CI) 0.76-0.97], dehydration (OR 2.54, 95% CI 1.34-4.82), increased work of breathing (OR 3.39, 95% CI 1.29-8.92) and initial heart rate above the 97th centile (OR 3.78, 95% CI 1.05-13.57) predicted the need for admission and a longer hospital stay. CONCLUSION: We derived and validated a severity of illness model for bronchiolitis. This can be used for outcome prediction in decision support tools or severity of illness stratification in research/audit.

Acute Disease↗

Burst fracture in the metastatically involved spine: development, validation, and parametric analysis of a three-dimensional poroelastic finite-element model.

STUDY DESIGN: A finite-element study and in vitro experimental validation was performed for a parametric investigation of features that contribute to burst fracture risk in the metastatically involved spine. OBJECTIVES: To develop and validate a three-dimensional poroelastic model of a metastatically compromised vertebral segment, to evaluate the effect of lytic lesions on vertebral strains and pressures, and to determine the influence of loading and motion segment status (bone density, pedicle involvement, disc degeneration, and tumor size) on the relative risk of burst fracture initiation. SUMMARY OF BACKGROUND DATA: Finite-element analysis has been used successfully to predict failure loads and fracture patterns for bone. Although models for vertebra affected with tumors have been presented, these have not been thoroughly validated experimentally. Consequently, their predictive capabilities remain uncertain. METHODS: A three-dimensional poroelastic finite-element model of the first lumbar vertebra and adjacent intervertebral discs, including a tumor of variable size, was developed. To validate the model, 12 cadaver spinal motion segments were tested in axial compression, in intact condition, and with simulated osteolytic defects. Features of the validated model were parametrically varied to investigate the effects of tumor size, trabecular bone density, pedicle involvement, applied loads, loading rates, and disc degeneration using outcome variables of vertebral bulge and vertebral axial deformation. RESULTS: Consistent trends between the experimental data and model predictions were observed. Overall, the model results suggest that tumor size contributes most toward the risk of initiating burst fracture, followed by the applied load magnitude and bone density. CONCLUSIONS: The parametric analysis suggests that the principal factors affecting the initiation of burst fracture in metastatically affected vertebrae are tumor size, magnitude of spinal loading, and bone density. Consequently, patient-specific measures of these factors should be factored into decisions regarding clinical prophylaxis. Pedicle involvement or disc degeneration was less important according to the outcome measures in this study.

Adult↗

Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis.

STUDY DESIGN: A prospective cross-sectional design was used to evaluate the Scoliosis Quality of Life Index (SQLI). SQLI is a 22-item self-reporting health-related quality-of-life questionnaire for idiopathic scoliosis patients. OBJECTIVE: The goal of this study was to evaluate the psychometric qualities of SQLI. SUMMARY OF BACKGROUND DATA: SQLI, a modification of the Scoliosis Research Society-22 (SRS-22) questionnaire, is intended to be more applicable to patients with adolescent idiopathic scoliosis (AIS) between 10 and 18 years of age. METHODS: Eighty-four subjects with a mean age of 14.9 years participated. We determined reliability, validity, distribution of scores, and clinical utility of SQLI in a hospital setting. Seventy patients were AIS patients (16 postsurgical, 30 braced, 24 unbraced) with a mean Cobb angle of 30.7 degrees, and 14 patients were sibling controls. RESULTS: Reliability: Intraclass correlation coefficient for test-retest reliability of the global index was very good (ICC 2,1 = 0.80); Spearman's rho correlations between items and domains was 0.39 to 0.89 and between domains and global index was 0.55 to 0.78; Cronbach's alpha scores were more than 0.80 (0.82-0.89). VALIDITY: construct validity was established by correlations between SQLI's global index and Quality of Life Profile for Spine Deformities (QLPSD) global index (Spearman's rho, 0.79) and between SQLI domains and QLPSD domains (0.46-0.81); discriminate validity was established by SQLI's global index successfully partitioned controls and AIS subjects (Kruskal-Wallis test, P = 0.0013). Time required by the patient averaged 2.5 minutes per administration. CONCLUSIONS: SQLI is reliable and valid and demonstrates satisfactory distribution of scores. SQLI is a promising instrument in the assessment of AIS patients.

Adolescent↗

Development of validated instrument to measure medical student learning in clinical urology: a step toward evidence based education.

PURPOSE: To date published efforts to assess and improve medical student learning in urology have been limited due to the lack of an assessment tool with which to measure student learning. We report the development of a validated measure of medical student learning in urology. MATERIALS AND METHODS: Four core topics in clinical urology were selected as the focus of the test development, namely prostate cancer, screening with prostate specific antigen, benign prostatic hyperplasia and erectile dysfunction. Detailed curricula and multiple choice questions were created for each topic. Content validity of the curriculum and 28 item examination was established by a panel of 2 urologists and 2 medical physicians. Instrument reliability was determined by administering the test on line to third-year surgery students. Test construct validity was established through its administration to 19 urology residents and attending physicians. RESULTS: Reliability of the 28-item test instrument was measured by Cronbach's alpha at 0.76 and its 1-week test-retest reliability was 0.72. All urology experts performed well on the test. Mean urological expert scores were significantly higher than mean student post-test scores (24.9 +/- 2.1 vs 17.8 +/- 3.8, 2-tailed t test p <0.001). Urological experts with greater urological training had higher scores than those with less residency training. CONCLUSIONS: This study documents the development of a validated measure of medical student learning in urology. This validated instrument has the potential to improve educational quality control at medical schools and facilitate the development of effective, evidence based teaching methods.

Adult↗

A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials.

PURPOSE: Overactive bladder (OAB) is a syndrome consisting of urinary urgency with or without urge incontinence, usually with increased urinary frequency and nocturia. In response to current limitations in OAB clinical research a new patient reported measure of urgency severity associated with OAB has been developed, namely the Indevus Urgency Severity Scale (IUSS). We report the measurement properties of the IUSS. MATERIALS AND METHODS: Validation study data were collected alongside a phase III clinical trial of 20 mg trospium chloride twice daily vs placebo in patients with OAB associated with urge incontinence. We evaluated IUSS item variability, known group, content, criterion and construct validity, test-retest reliability, responsiveness and respondent burden. RESULTS: A total of 658 patients were evaluated at baseline and 579 were reevaluated at week 12. IUSS demonstrated good item variability. Greater urgency severity was associated with increased symptom bother and worse health related quality of life, as measured by the OAB QOL questionnaire. IUSS had a significant positive association with essential clinical and quality of life outcomes, demonstrating content validity. IUSS was highly responsive to a decrease in the average number of patient toilet voids per 24 hours to 7 or fewer toilet voids and average urge incontinence episodes per 24 hours to zero. It discriminated between patients who had above and below the median number of toilet voids and urge incontinence episodes per 24 hours. IUSS also had good test-retest reliability and content validity, and it created minimal respondent burden. CONCLUSIONS: IUSS is a validated patient reported measure of urgency severity for collecting event specific information in the context of a clinical trial.

Adult↗

Casting light on the concept of patient satisfaction by studying the construct validity and the sensitivity of a questionnaire.

PURPOSE: This study aims to explore the construct validity and the sensitivity of a patient satisfaction questionnaire for the purpose of gaining a better understanding of the concept, and of issues surrounding its measurements. DESIGN/METHODOLOGY/APPROACH: Several statistical analyses were used to study the reliability, construct validity, and the sensitivity of a patient satisfaction questionnaire. FINDINGS: The study supported the construct validity, high internal consistency, and homogeneity of the instrument. Two factors were found; one consisted of negatively worded items and the other of positively worded items. The negatively worded items contributed more than the positively worded items to the sensitivity of the instrument. Items were identified that contribute little or nothing to the construct validity and/or the sensitivity of the questionnaire. RESEARCH LIMITATIONS/IMPLICATIONS: The effect of wording on the variability and sensitivity of the instrument can be explained both as a consequence of response set bias and with regard to the theories against which two phenomena were being measured - patient satisfaction and patient dissatisfaction. The development of two kinds of instruments is proposed: those that measure patient dissatisfaction and are sensitive to minute changes in nursing care and those that measure both concepts and capture what patients find important in their care. ORIGINALITY/VALUE: The paper demonstrates how an analysis of the construct validity and the sensitivity of patient satisfaction instrument, can enhance understanding of the concept. It contributes to the debate about whether patient satisfaction and dissatisfaction are opposite ends of the same continuum or two different phenomena that require two different definitions.

Data Interpretation, Statistical↗

International validation of ReQuest in patients with endoscopy-negative gastro-oesophageal reflux disease.

BACKGROUND: Reflux Questionnaire (ReQuest), a newly developed gastro-oesophageal reflux disease-sensitive scale, can be used to reliably evaluate the effect of treatment on gastro-oesophageal reflux disease symptoms. AIM: International validation of this scale, in patients suffering from endoscopy-negative gastro-oesophageal reflux disease. METHODS: In this open, multicentre and multinational clinical trial 840 endoscopy-negative gastro-oesophageal reflux disease patients received pantoprazole 20 mg daily for 28 days. The long and short versions of ReQuest were completed both in the pre-treatment and treatment phases. For scale development an item reduction analysis was performed. Internal consistency, test-retest reliability and responsiveness were calculated for psychometric analysis. Construct validity was evaluated by comparison with the Gastrointestinal Symptom Rating Scale and the Psychological General Well-being questionnaire by means of correlation coefficients. RESULTS: Factor analyses confirmed the content validity of both long and short version of ReQuest. Psychometric calculations proved high internal consistency (Cronbach's alpha: 0.9), test-retest reliability [Intraclass Correlation Coefficient: 0.9 (long vs. long) and 0.8 (short vs. short)], and responsiveness (Responsiveness Index 320.3) of the scale, for which also good construct validity was achieved (correlation coefficient: Gastrointestinal Symptom Rating Scale -0.6; Psychological General Well-being -0.4). CONCLUSION: ReQuest proved valid, reliable, and responsive in this multinational clinical trial to evaluate treatment response in endoscopy-negative gastro-oesophageal reflux disease patients.

Adult↗

Validation of a 7-point Global Overall Symptom scale to measure the severity of dyspepsia symptoms in clinical trials.

BACKGROUND: Currently there is no consensus on the optimal method to measure the severity of dyspepsia symptoms in clinical trials. AIM: To validate the 7-point Global Overall Symptom scale. METHODS: The Global Overall Symptom scale uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem. Validation was performed in two randomized-controlled trials (n = 1121 and 512). Construct validity: Global Overall Symptom was compared with the Quality of Life in Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and 10 specific symptoms using Spearman correlation coefficients. Test-retest reliability: The Intraclass Correlation Coefficient was calculated for patients with stable dyspepsia defined by no change in Overall Treatment Effect score over two visits. Responsiveness: effect size and standardized response mean were also calculated. RESULTS: Construct validity: Change in Global Overall Symptom score correlated significantly with Quality of Life for Reflux And Dyspepsia, Gastrointestinal Symptom Rating Scale, Reflux Disease Questionnaire and specific symptoms (all P < 0.0002). Reliability: The Intraclass Correlation Coefficient was 0.62 (n = 205) and 0.42 (n = 270). Responsiveness: There was a positive correlation between change in Global Overall Symptom and change in symptom severity. The effect size and standardized response mean were 1.1 and 2.1, respectively. CONCLUSION: The Global Overall Symptom scale is a simple, valid outcome measure for dyspepsia treatment trials.

Adolescent↗

Validation of pressure ulcer risk assessment scales: a critique.

AIM: The aim of this paper is to present critical analysis of the validation methods of pressure ulcer risk assessment scales. BACKGROUND: The validation of pressure ulcer risk assessment scales remains a topic of considerable debate and uncertainty. The Braden scale and Norton scale are the most frequently used. Sensitivity and specificity are the recommended and most commonly used epidemiological tools to evaluate the validity of those risk assessment scales. DISCUSSION: The use of preventive measures influences both the sensitivity and specificity of the scales. Analysis of published studies on risk assessment scales reveals that, although some patients received preventive measures and others did not, this was not taken into account. Consequently, generalization of those results is not possible. Some possible alternative designs for studying the validity of risk assessment scales are discussed. CONCLUSIONS: Currently available risk assessment scales are of only limited value, and there use will result in many patients being falsely identified as at risk or not at risk. Sensitivity and specificity criteria are not the most appropriate tools to validate risk assessment scales. A risk assessment scale should be evaluated in combination with the preventive measures used.

Humans↗

Validation of a checklist to assess ward round performance in internal medicine.

BACKGROUND: Ward rounds are an essential responsibility for doctors in hospital settings. Tools for guiding and assessing trainees' performance of ward rounds are needed. A checklist was developed for that purpose for use with trainees in internal medicine. OBJECTIVE: To assess the content and construct validity of the task-specific checklist. METHODS: To determine content validity, a questionnaire was mailed to 295 internists. They were requested to give their opinion on the relevance of each item included on the checklist and to indicate the comprehensiveness of the checklist. To determine construct validity, an observer assessed 4 groups of doctors during performance of a complete ward round (n = 32). The nurse who accompanied the doctor on rounds made a global assessment of the performance. RESULTS: The response rate to the questionnaire was 80.7%. The respondents found that all 10 items on the checklist were relevant to ward round performance and that the item collection was comprehensive. Checklist mean-item scores differed between levels of expertise: junior house officers 1.4 (1.0-1.9); senior house officers 2.0 (1.5-2.9); specialist trainees 2.5 (1.8-2.8), and specialists 2.7 (2.3-3.5); median (range) (P < 0.001). A significant correlation was found between global observer scores and nurse scores (r = 0.56, P < 0.001). CONCLUSION: The checklist, developed for assessing trainees' performance of ward rounds in internal medicine, showed high content validity. Construct validity was supported by the higher scores of experienced doctors compared to those with less experience and the significant correlation between the observer's and nurses' global scores. The developed checklist should be valuable in guiding and assessing trainees on ward round performance.

Clinical Competence↗

Repeated validation of parental self-reported smoking during pregnancy and infancy: a prospective cohort study of infants at high risk for allergy development.

Exposure to environmental tobacco smoke (ETS) during fetal life and infancy is closely related to the smoking habits of the parents. Estimates of exposure to ETS require valid and detailed information on changes in cigarette smoking over time. The objective was to test the validity of self-reported smoking among parents during pregnancy and early childhood in a cohort of children at high risk for allergy development by measurement of exhaled carbon monoxide (CO). The cohort comprised 117 families enrolled from the general population of pregnant women at admission to antenatal care. Data on parental tobacco smoking were obtained by interview and exhaled CO was measured (Micro-Smokerlyzer(R)) in parents twice during pregnancy and when the child was 6 and 18 months old. The median (range) exhaled CO levels were 3 (0-10) parts per million (ppm) for non-smokers and 15 (1-39) ppm for smokers (P < 0.0005). A receiver operating characteristic (ROC) analysis was performed at each examination. The areas under the ROC curve were high for both mothers (between 0.88 and 0.99) and fathers (between 0.87 and 0.89), indicating exhaled CO as a good diagnostic tool for determining smoking status. Comparing the ROC areas obtained for mothers from late pregnancy and during infancy with the area from early pregnancy showed no statistical differences (P = 0.21, 0.43 and 0.44 respectively) and the same was true for fathers during infancy (P = 0.81). The level of 8 ppm was used as the cut-off between smokers and non-smokers, based on data from a pilot study. Using CO as a diagnostic tool for smoker status showed very high specificity (between 97 and 100%), indicating that very few persons claiming to be non-smokers had CO levels higher than 8 ppm. In conclusion, the validity of interview-obtained self-reported smoking among parents during pregnancy and early childhood was high. Repeated interviews and CO measurements in a prospective study design did not change the validity, indicating a low risk of information bias. A structured interview combined with measurement of exhaled CO is a valid and reliable method for estimating ETS exposure to the fetus and young infant.

Breath Tests↗