Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations.

BACKGROUND: Rater reproducibility of the Bristol Stool Form Scale (BSFS), which categorizes stools into one of seven types, is unknown. We sought to determine reliability and agreement by individual stool type and when responses are categorized by Rome III clinical designation as normal or abnormal (constipation or diarrhea). METHODS: Thirty-four gastroenterology providers from three institutions rated 35 stool photographs using the BSFS. Twenty rerated the photographs. KEY RESULTS: 1190 individual stool type ratings were completed. Though only four photographs had absolute agreement (all Type 1 or Type 7), general agreement was high with 1132 (95.1%) of ratings being within one category type of the modal rating. Inter-rater and intra-rater reliability of the BSFS by individual stool type was excellent with intraclass correlations of 0.88 (95% CI: 0.86-0.90, p < 0.001) and 0.89 (95% CI: 0.86-0.91, p < 0.001), respectively. However, agreement decreased when using Rome III designations with 13 (37%) photographs having significantly diverging classifications (semi-interquartile range = 0.5). These 13 photographs were rated by the majority of raters as either type 2 vs type 3 or type 5 vs type 6 stools, representing the boundaries of normal vs abnormal stools. Inter-rater and intra-rater reliability of the BSFS by Rome III clinical categorization decreased with intraclass correlations of 0.75 (95% CI: 0.69-0.81, p < 0.001) and 0.65 (95% CI: 0.49-0.81, p < 0.001), respectively. CONCLUSIONS & INFERENCES: The Bristol Stool Form Scale has excellent reliability and agreement when used to rate individual stool type by raters. However, BSFS reliability and agreement decreases when determining Rome III stool form categories.

Validation of an instrument measuring patient satisfaction with chest physiotherapy techniques in cystic fibrosis.

OBJECTIVES: Chest physiotherapy (CPT) has been an important part of cystic fibrosis (CF) treatment regimens for > 40 years. Techniques with different perceived costs, benefits, and patient satisfaction exist. An instrument measuring patient satisfaction with CPT has not been reported. Our goal was to develop and validate such an instrument. DESIGN: A cross-sectional survey sent to 349 patients seen at a large, urban, academic CF care center. The two-page survey asked 17 questions related to CPT satisfaction (efficacy, convenience, comfort, overall satisfaction), followed by 4 general CF-care questions (disease severity, importance of therapies, prescribed vs missed therapies). A 5-point Likert-type scale was used for responses. Psychometric analysis included itemetric performance, confirmatory factor analysis, test-retest reliability, and evaluation of subject's responses to the general CF-care questions. RESULTS: One hundred twenty-nine individuals returned completed surveys (39%; 66 males and 63 females; age range, 2 months to 47 years). FEV(1)values were 21 to 155% predicted (mean, 76%; n = 82). Disease severity was as follows: 60 mild, 47 moderate, and 14 severe. Seventy-nine subjects used postural drainage, percussion, and vibration (PDPV), 21 used a flutter device, and 14 used high-frequency chest wall oscillation (HFCWO). Five subjects used more than one technique. Internal consistency analysis found an overall coefficient alpha of 0.87 (range, 0.74 to 0.89 for four domains). Factor analysis demonstrated domains for efficacy, convenience, comfort, and overall satisfaction. Mean total satisfaction scores differed significantly among therapies (R(2) = 0. 118; F[ 2,111] = 7.56; p = 0.0008): PDPV, 3.8 (SD = 0.6); Flutter, 4. 3 (SD = 0.5); and HFCWO, 4.1 (SD = 0.5). Therapies also differed significantly on all subscores. Perceived importance of CPT and compliance with CPT increased linearly with disease severity. Overall satisfaction was positively correlated with CPT compliance. CONCLUSIONS: The CPT satisfaction survey has good reliability and content validity. Significant differences in patient satisfaction exist among therapies. Sicker patients recognize the importance of, and demonstrate better compliance with prescribed CPT. Increased satisfaction is associated with better compliance with therapy.

Measuring self-efficacy expectations for the self-management of cystic fibrosis.

This research developed and determined the psychometric characteristics of a measure of self-efficacy expectations (a social cognitive theory construct) for the self-management of cystic fibrosis (CF). Items for the original instrument were sampled from 150 self-management performance objectives for CF that represented behaviors in eight domains of CF care, including aspects of medical care, coping, and communication. The instrument was administered to 199 parents of children and adolescents with CF from two CF centers. The findings support a multidimensional structure for self-efficacy consistent with the multiple types of behavior required for the management of a chronic illness such as CF. An alpha-factor analysis yielded solutions clearly reflecting five theorized aspects of self-management: medical judgment and communication, coping, family communication, compliance, and acceptance. The first factor of the caretaker's scale most closely represents the underlying conceptualization of self-management as requiring self-monitoring of health status and collaboration with the health care provider in making judgments about treatment. The unit weighted factors exhibited high internal consistencies (Cronbach's alpha-factors ranging from 0.73 to 0.88).

A computer program for microplate reader interface and analysis of kinetic, microclot lysis assays.

This paper describes the development and use of a program for the APPLE IIe computer which records and analyzes data from an automated microplate reader for the purpose of determining the time required for clots formed in microplate wells to half lyse as determined by optical density readings. The use of this software has led to significant savings of technician time over that required for nonautomated systems.

Patterns of adjustment among children of battered women.

Children exposed to interparental violence have been characterized by an array of psychological problems, but findings regarding the precise nature of these problems have been inconsistent. This study used cluster analysis to determine whether distinct patterns of adjustment could be identified in 228 8- to 14-year-old children residing in battered women's shelters. Five such patterns emerged: multiproblem-externalizing, multiproblem-internalizing, externalizing, mild distress, and no problems reported. This solution was cross-validated in independent halves of the sample and was similar for boys and girls. Differences among the clusters on relevant family and demographic variables were examined, and it was found that the clusters could be distinguished on the basis of the frequency of children's exposure to interparental violence, parent-child aggression, and children's appraisals of interparental conflict.

Reducing conduct problems among children of battered women.

This study was an experimental evaluation of an intervention designed to reduce conduct problems among children of battered women. Participants were 36 families (mothers and children) in which the mother had sought shelter because of relationship violence and had at least 1 child (4-9 years old) with clinical levels of conduct problems. The intervention consisted of 2 primary components: (a) providing instrumental and emotional support and (b) teaching child management skills to mothers. Families were randomly assigned to either the intervention condition or the existing services comparison condition and were assessed on 5 occasions over 16 months after shelter departure. Compared with families receiving existing services, children in the intervention condition improved at a faster rate, the proportion of children displaying clinical levels of conduct problems was greatly diminished, and mothers displayed greater improvements in child management skills.

Measuring clinical status in cystic fibrosis: internal validity and reliability of a modified NIH score.

We examined measurement properties of the NIH Clinical Score for Cystic Fibrosis (CF) as an index of disease status. This score is being employed as a research tool for defining study populations and as an outcome measure, yet there are no published data on its reliability or how its items contribute to the overall measure of disease status. Criteria for scoring some items in the original index lack specificity. In this study, we used a modified score to have more clearly specified criteria, while retaining the original weightings and structure. For 200 patients with CF in two centers, we analyzed the total NIH Score and its subscores for internal consistency, interrater reliability, and factor analysis. Internal consistency indicates how inter-related the items are. The pulmonary subscore and overall score had fairly high internal consistency. However, the general subscore had low internal consistency, suggesting that the items are not measuring a single element of disease status and should not be added. Factor analysis provides additional information on the underlying structure and relationships among items. Five factors (groups of items) were identified accounting for 85% of the consistent variance of 14 items. These factors were designated by items accounting for most of their variance: general pulmonary, weight, disability, psychosocial, and acute infiltrate. While inter-rater reliability for the overall index was high, individual items showed less agreement. The results indicate that most of the variability in the NIH Score is attributable to pulmonary items in the first factor. The analyses suggest a new scoring structure for the NIH Score; the general subscore items do not contribute to the reliability or account for significant variance. Therefore, they will likely require further refinement or be eliminated.

Self-management of cystic fibrosis: a structural model for educational and behavioral variables.

One hundred and ninety-nine patients and their primary caregivers at two metropolitan cystic fibrosis centers participated in a clinical trial to evaluate the effectiveness of a health education program designed to help improve self-management skills for the care of CF. The baseline data from the study was used to test a structural model that hypothesized the relationship between educational, behavioral, and health status variables. Controlling for the effects of all other variables, including demographic, self-efficacy (confidence in being able to perform a behavior) was the most important educational factor predicting self-management behavior for monitoring and treating respiratory problems. Knowledge about the management of CF was only related to the ability of caretakers to apply coping skills to problems associated with CF. The more caretakers reported performing monitoring behaviors the more likely they were to report performing self-management treatment behaviors. The findings suggest that educational interventions that focus on increased knowledge alone are not likely to be effective in improving self-management behavior for CF. Based on the structural model analyses, it is recommended that educational programs for CF patients and families address increased self-efficacy and improved monitoring skills to influence the improvement of self-management treatment for CF.

Severity of medical and neurologic complications as a determinant of neurodevelopmental outcome at 6 and 12 months in very low birth weight infants.

Very low birth weight (n = 154) and term infants (n = 119) had neurologic and developmental assessment at 6 and 12 months of age. Preterm infants with severe neonatal complications were considered to be at high risk, and those with milder complications were considered to be at low risk, for neurodevelopmental abnormality. Compared to term infants, high- and low-risk infants had abnormalities at 6 months in total neurologic score, cranial nerves, motor tone, motor coordination, and reflexes (P < .001). At 12 months, all groups had improved. However, high-risk infants had persistent abnormalities in the same subcategories (P < .001), whereas low-risk infants differed from term infants only in motor tone (P < .001). Bayley developmental scores were different for all groups at 6 months (P < .001), but at 12 months only high-risk infants differed from term infants (P < .01). These results demonstrate improvement in neurologic and developmental scores over time in very low birth weight infants. The degree of neurodevelopmental abnormality and improvement over time is related to severity of neonatal complications in preterm infants.

Predicting cognitive-language and social growth curves from early maternal behaviors in children at varying degrees of biological risk.

Growth modeling was used to examine the relation of early parenting behaviors (averaged across 6 and 12 months) with rates of change in children's cognitive-language and social response and initiating skills assessed at 6, 12, 24, and 40 months. Groups of full-term (n = 112) and very low birth weight children, divided into medically low (n = 114) and high risk (HR; n = 73), were included to evaluate whether children who vary in their rate of development are influenced in different ways by early parenting styles. Parenting behaviors that were sensitive to children's focus of interest and did not highly control or restrict their behaviors predicted greater increases and faster rates of cognitive-language and social development, with relations stronger for the HR versus the other two groups. These maternal behaviors may provide the support all infants need to establish an optimal early foundation for later development and the specific support HR children need to learn in spite of early attentional and organizational problems.

Does early responsive parenting have a special importance for children's development or is consistency across early childhood necessary?

The role of early versus ongoing maternal responsiveness in predicting cognitive and social development was examined in home visits for mothers, full-term children (n = 103), and medically low-risk (n = 102) and high-risk (n = 77) preterm children at 5 ages. There were 4 maternal clusters based on warm and contingent responsiveness behaviors observed early (at 6, 12, and 24 months) and late (at 3 and 4 years): high early, high late; high early, low late; low early, moderate late; and low early, low late. Children, especially preterm children, showed faster cognitive growth when mothers were consistently responsive. Social growth was similar in the consistently responsive (high-high) and the early-responsive inconsistent (high-low) clusters, but greater deceleration at 4 years among children with mothers in the inconsistent cluster refuted the notion of a unique role for early responsiveness. The importance of consistent responsiveness, defined by an affective-emotional construct, was evident even when a broader constellation of parenting behaviors was considered.

Self-management of cystic fibrosis: short-term outcomes of the Cystic Fibrosis Family Education Program.

This study tested the efficacy of the Cystic Fibrosis Family Education Program, a cystic fibrosis self-management program, on improving participants' knowledge, self-efficacy, self-management behavior, health, and quality of life. A quasi-experimental pretest-posttest nonequivalent comparison group design was employed. Participants made up 104 patient-primary caregiver dyads from the intervention site cystic fibrosis center and 95 from the usual care comparison center. The intervention, a self-paced print curriculum based on social cognitive theory, targeted behavioral capability, self-efficacy, and outcome expectations and was implemented as an integral part of medical care. Parents, early childhood, middle childhood, and adolescents received separate materials on respiratory, nutrition and malabsorption, communication, and coping issues. Significant intervention effects were found on the knowledge scores for caregivers, adolescents, and children; caregiver and adolescent total self-management scores; Child Behavior Checklist total score; one parent coping scale score; the modified NIH score; NIH pulmonary factor 1; and the Brasfield total score. Significant interaction effects were evident in the self-efficacy scores for caregivers and children.

Association of early bilateral middle ear effusion with language at age 5 years.

OBJECTIVE: This study tested the hypothesis that children with early persistent middle ear effusion (MEE) are at risk for later language deficit. METHOD: We recruited 698 newborns and monitored them for MEE every 2 to 4 weeks at home until age 3 years. Language skills were assessed on 294 subjects at age 5, while controlling for 8 demographic and environmental factors. Language outcomes at age 5 years were studied as a function of duration of bilateral MEE from birth to age 3 years. RESULTS: A significant relation was found between duration of bilateral MEE and speech sound sensitivity (Carrow Elicited Language Inventory) and articulation (Goldman-Fristoe Articulation). Children's ability to discriminate speech sounds in a quiet environment (Carrow Auditory Visual Abilities Test) was less affected by early prolonged MEE in homes that provided more cognitive stimulation. CONCLUSIONS: These exploratory results indicate that prolonged early MEE may predispose children to language deficits at age 5 years. The language deficits are of small magnitude and may or may not be clinically significant. Language stimulation at home may protect against some of the effects of prolonged MEE.

Identification of features of metaplastic cells in sputum for the detection of squamous-cell carcinoma of the lung.

Digitized images of 1,556 squamous metaplastic cells from the sputum of 15 patients with confirmed squamous-cell carcinoma of the lung and 13 subjects without apparent neoplasia were analyzed to determine if features existed within these relatively normal cells that could be used to differentiate between the two populations. Results indicate that such marker features do exist. A cross-validation study using an additional 465 cells confirmed the conclusion that squamous metaplastic cells from patients with squamous-cell carcinoma of the lung do differ from those of subjects without cancer. While such marker features alone are not reliable enough to assist pathologists in the diagnosis of squamous-cell carcinoma of the lung, they might, in sufficient numbers, be used to identify patients for whom follow-up testing would be advised.

Application of cell-image analysis to the diagnosis of cellular atypias in sputum: a review.

The incidence of carcinoma of the lung continues to steadily rise, and attempts at early diagnosis to improve prognosis have not yet been rewarding. The goal of our research is to decrease the incidence of lung cancer by detecting premalignant bronchial dysplasias in individuals in whom development of lung cancer is potentially preventable. To achieve this, we have developed an atypia status index (ASI)--the assignment of numerical values to the various stages of atypical bronchial epithelial cells in sputum, and a cell atypia profile (CAP)--an ASI-generated scale of 200 such atypical bronchial epithelial cells in a single sputum specimen. Computerized cell-image analysis techniques and statistical data analysis are used to generate the ASIs and CAPs for each subject. This study is a step toward the development of an automated cell-image analysis system for mass screening of premalignant atypias in sputum of those considered at high risk for lung cancer (i.e., men and women of 40 yr of age and older, with more than 20 pack-yr of cigarette smoking).

The application of visual cell profiles in the study of premalignant atypias in sputum.

Because the diagnosis of squamous-cell carcinoma of the lung by routine cytologic screening of sputum is often inconclusive, our laboratory is studying the use of cytomorphologic profiles as a reliable diagnostic aid. This study reports the analysis of the profiles of 75 subjects, both cigarette-smoking volunteers and hospitalized patients suspect for lung cancer. Twenty-five of the subjects had been classified as having squamous metaplasia, 25 as having atypias and 25 as having squamous-cell carcinoma. Four slides were made for each subject, with 100 random fields viewed on each slide. The frequency of free alveolar macrophages, metaplastic squamous cells, epithelial atypical cells and malignant squamous cells were noted for each field. The results indicated that, although there were large differences between individual profiles within each diagnostic category, there were significant differences between the average profiles for each diagnostic category. Furthermore, although there were differences in cell frequencies from slide to slide and within slides, the differences were constant across diagnostic categories. The results are supportive of the progressive-atypia hypothesis for squamous-cell carcinoma of the lung and provide a baseline for comparison with subsequent individual profiles.

Visual cell profiles for quantitation of premalignant cells in sputum: a preliminary report.

Visual cell profiles were used to analyze the distribution of atypical bronchial cells in sputum specimens from cigarette-smoking volunteers, cigarette-smoking asbestos workers and cigarette-smoking uranium miners. The preliminary results of these sputum visual cell profile studies have demonstrated distinctive distributions of bronchial cell atypias in progressive patterns of squamous metaplasia, mild, moderate and severe atypias and carcinoma, similar to those the authors have previously reported using cell image analysis techniques to determine an atypia status index (ASI). The information gained from this study will be helpful in further validating this ASI and subsequently achieving the ultimate goal of employing cell image analysis for the rapid and precise identification of premalignant atypias in sputum.

Estimating phonation threshold pressure.

Phonation threshold pressure (PTP) is the minimum subglottal pressure required to initiate vocal fold oscillation. Although potentially useful clinically, PTP is difficult to estimate noninvasively because of limitations to vocal motor control near the threshold of soft phonation. Previous investigators observed, for example, that trained subjects were unable to produce flat, consistent oral pressure peaks during/pae/syllable strings when they attempted to phonate as softly as possible (Verdolini-Marston, Titze, & Druker, 1990). The present study aimed to determine if nasal airflow or vowel context affected phonation threshold pressure as estimated from oral pressure (Smitheran & Hixon, 1981) in 5 untrained female speakers with normal velopharyngeal and voice function. Nasal airflow during /p/occlusion was observed for 3 of 5 participants when they attempted to phonate near threshold pressure. When the nose was occluded, nasal airflow was reduced or eliminated during /p/;however, individuals then evidenced compensatory changes in glottal adduction and/or respiratory effort that may be expected to alter PTP estimates. Results demonstrate the importance of monitoring nasal flow (or the flow zero point in undivided masks) when obtaining PTP measurements noninvasively. Results also highlight the need to pursue improved methods for noninvasive estimation of PTP.

Feeding, medical factors, and developmental outcome in premature infants.

This is a prospective, longitudinal study of premature infants investigating whether the length of time needed to reach full enteral feedings (FEF) or full nipple feedings (FNF) is related to medical complications and/or developmental outcome at 24 months corrected age. Premature infants (n = 161) from three institutions with birth weights less than 1,600 grams were followed up from birth to 24 months corrected age. The infants were stratified into groups by the severity of medical complications. Bayley Scales of Infant Development were performed at 24 months corrected age. Multiple linear regression was used to analyze the association between feeding milestones, medical complications, and developmental outcomes. Our results show that when controlling for birth weight and gestational age (GA), the severity of respiratory complications was significantly related to reaching FEF (p = 0.024) and FNF (p = 0.0014). Furthermore, when controlling for the severity of respiratory complications, GA, and socioeconomic status, an increased length of time to FEF was significantly associated with a poorer mental outcome (p = 0.0013). We conclude that there is an association between the length of time to reach FEF and mental developmental outcome at 24 months corrected age. Infants who reach full enteral feedings at an earlier age appear to have a better developmental outcome despite their GA and severity of respiratory complications.

Parallel line analysis: multifunctional software for the biomedical sciences.

An easy to use, interactive FORTRAN program for analyzing the results of parallel line assays is described. The program is menu driven and consists of five major components: data entry, data editing, manual analysis, manual plotting, and automatic analysis and plotting. Data can be entered from the terminal or from previously created data files. The data editing portion of the program is used to inspect and modify data and to statistically identify outliers. The manual analysis component is used to test the assumptions necessary for parallel line assays using analysis of covariance techniques and to determine potency ratios with confidence limits. The manual plotting component provides a graphic display of the data on the terminal screen or on a standard line printer. The automatic portion runs through multiple analyses without operator input. Data may be saved in a special file to expedite input at a future time.