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PubMed2002

Cardiac disease outcomes in clinical trials.

Randomized controlled trials (RCTs) are the gold standard for determining causality in medicine. To be considered valid, the efficacy/effectiveness of a new drug must be tested and proved through this type of scientific study. This type of trial will disclose the drug's risk profile as well as the treatment effect magnitude. The proper design, development, and analysis and presentation of results from an RCT is based on a group of well-defined methodological rules, compliance with which assures the trial's internal validity, the relative and absolute importance of the results and its applicability to populations of patients different from those included in the study sample (external validity). Among the structural and methodological components of a clinical trial--randomization, allocation concealment, confounding, similarity of study groups, measures of efficacy, statistical analysis, etc.--disease markers (endpoints, outcomes) are especially important. In the end, what an RCT is good for is to detect changes in the disease process with therapy (or preventive measures), and these changes are defined beforehand based on specific measurements--disease markers. In this paper we will present general principles for the definition of disease markers, their problems and practical use. Caution should be exercised, as this is an area of clinical epidemiology that is somewhat complex, controversial and ill-defined.

Databases, Factual↗
PubMed2003

[Morpho-functional characteristics of lens ciliary body as a key mechanism of accommodation in human eye].

With the aid of ophthalmological, morphological, biomechanical and regulation theory methods the inconsistency of prevalent concepts on the functional interpretation of morphological structure of ciliary zonule was demonstrated and the scheme of functioning of its elements matching clinical and physiological observations was proposed. The role of anterior and posterior portions of ciliary zonule appears to be functionally essential and consistent with accommodation mechanism proposed by Helmholtz, while the role of cilioequatorial fibers of ciliary zonule is functionally auxiliary. Morphological and constructive peculiarities of ciliary zonule structure confirm the validity of Helmholtz concepts of accommodation mechanism.

Accommodation, Ocular↗
PubMed2003

Reliability of digital radiography of interproximal dental caries.

PURPOSE: To compare the effects of different image processing modes (filters) on the reproducibility and validity of the assessment of interproximal carious lesions viewed in digitized radiographic images. MATERIALS AND METHODS: Variables studied were film type, exposure time, and tissue scatter radiation. Images were assessed in relation to film type, exposure time and tissue scatter. Standardized radiographs of 50 extracted teeth were obtained and 44 areas of interproximal caries were detected. Six radiographs were obtained of each tooth and digitized using FRIACOM software. Four were made using D-type film with and without soft tissue scatter equivalent at normal exposure time (0.32 seconds) and underexposed (0.16 seconds). Two were made using E-type film with TSE normal (0.16 seconds) and underexposed (0.08 seconds). On each of the 300 radiographs, the central depth (CD) of each carious lesion was measured at 18x magnification both on the unchanged radiographic image and after use of two different filters. All measurements were repeated after 1 week to estimate reproducibility. RESULTS: Histometric CD assessments provided a gold standard for comparison with the radiographic measurements (validity). Whereas reproducibility was not influenced by one of the filters, filter "structure" improved the overall validity of CD measurements. In this study, digital manipulations of radiographic images resulted in statistically significant improvement of the validity of CD measurements.

Dental Caries↗
PubMed1992

Prosthetic rehabilitation in temporomandibular disorder and orofacial pain patients. Clinical problem solving.

Good clinical decision making represents an integral part of quality care. A definition of the dental problem and its significance from a dental point of view, in combination with a good working hypothesis of the nature of the concurrent TMD condition are prerequisites of any successful clinical problem solving. It is hoped that, with time, we will be in a position to call upon hard data on the probability and utility of successful outcome for each treatment alternative. This will bring the needed structure and scientific validity to a terribly complex albeit clinically important problem.

Decision Trees↗
PubMed2004

"Does skinny mean healthy?" Perceived ideal, current, and healthy body sizes among African-American girls and their female caregivers.

OBJECTIVES: To qualitatively and quantitatively examine body image ideals and perceived weight-related health among African-American girls and their female caregivers to inform intervention development for Girls Rule!, an obesity prevention pilot program. DESIGN, SETTING, AND PARTICIPANTS: Formative study using qualitative data from semi-structured interviews and validated quantitative body image silhouette assessment among girls (N=47) and caregivers (N=44). The participants were a convenience sample of African-American church members from North Carolina. Differences were evaluated between perceived: 1) current and ideal body size; 2) current and unhealthy body size; and 3) ideal and unhealthy body size. RESULTS: Thirty-seven percent of the girls and 77% of the caregivers were overweight or obese. Three body image themes emerged from the qualitative interviews: 1) being fat is unhealthy; 2) caregivers are role models (positive and negative) for body image ideals; and 3) smaller body size is important for wearing fashionable clothing. A series of 9 body silhouettes were used to assess perceptions of both girls and caregivers. Overall, both girls (2.9 +/- 1.4) and caregivers (4.4 +/- 1.4) ideal body size was significantly (P<.01) smaller than their current body size (3.7 +/- 1.3 girls; 6.3 +/- 2.2 caregivers). Both girls (3.7 +/- 1.4) and caregivers (6.7 +/- 2.0) indicated that their current body sizes were statistically significantly (P<.05) smaller that what they considered to be unhealthy (7.9 +/- 1.4 girls; 7.9 +/- 1.2 caregivers). CONCLUSIONS: Results suggest that most of these African-American participants were not satisfied with their current body size and desired a smaller body. At the same time, both girls and caregivers failed to recognize the potential health consequences associated with their current body size. Critical issues for designing obesity prevention programs include positive role modeling within the family and addressing the association of body size with health risk.

Adult↗
PubMedDate not supplied

What do parents of asthmatic children know about asthma?: An Indian perspective.

BACKGROUND: Despite the magnitude of the asthma problem, very little is known about the public perception about asthma. METHODS: This descriptive study was conducted to evaluate the knowledge, attitude and practice about the causation, treatment and prognosis of asthma amongst the parents of children with asthma. Subjects were parents of asthmatic children attending two exclusive paediatric hospitals at Chennai, India. A semi-structured pre-validated questionnaire, which included their general understanding on asthma, its triggers and management, was administered. RESULTS: One hundred parents of asthmatic children participated in this study. A diagnosis of asthma was accepted only by 39%, of which only three knew exactly what asthma means. Perception that asthma is contagious was observed by 26%, and 35% believed asthma to be a hereditary disease. Various dietary items were perceived as triggers. Most of the parents (62%) administered oral beta-agonist medication at home before proceeding to hospital, but majority were using them as cough medication. Only 13 were administering aerosol therapy at home. Nearly one-third of the parents opined that the disease might remit with advancing age. CONCLUSIONS: General awareness of asthma in the community is poor. Patient education programme should augment awareness, eliminate social stigma and misconcepts in the community regarding asthma. Knowledge about the prevailing perception in the community would be the first step in achieving this.

Administration, Inhalation↗
PubMed2005

Psychometric properties of the Chinese Family Assessment Instrument in Chinese adolescents in Hong Kong.

This paper reports evidence on the factor structure, reliability, and validity of the Chinese Family Assessment Instrument (C-FAI), an instrument developed to assess family functioning in Chinese populations. A convenience sample of 1,462 adolescents from junior secondary schools completed the C-FAI and measures of parent-adolescent conflict. Exploratory and confirmatory factor analyses showed that five factors were abstracted from the scale, a finding which was similar to those reported in previous validation studies. Results also showed that the C-FAI was internally consistent and its scores were moderately correlated with measures of conflict with parents, providing support for the convergent validity of the measure. Finally, females perceived family functioning to be better than did males and age was linearly related to perceived family dysfunction. In conjunction with the previous findings, the present study suggests that the C-FAI can be used to objectively assess family functioning in Chinese adolescents.

Adolescent↗
PubMed2006

Change readiness research. A qualitative study of variations in participation.

The Change readiness research method (CRR) has become a well- known method in Denmark to identify issues needed to be discussed on a hospital ward before implementation of a new IT-system and to start a dialogue. A precondition for a constructive dialogue, however, is a high degree of participation. The latest experiences of the CRR method were gained from its use in eight wards in the Danish Gepka project during 2003-4 (The Gepka project was established by The Danish Ministry of the Interior and Health, The National Board of Health, the County Council Society and H:S. Its purpose is to validate the "Basic Structure for The Electronic Health Record" (B-EHR) using prototypes. http://medinfo.dk/epj/proj/gepka/). In the Gepka project the participation varied from 33.3% to 78.9%. The objective of this study is to set out themes by which this variation can be studied. A qualitative explorative research design has been applied, where four instructions from the "Instruction for use" (Instructions for using the CRR method. Can be downloaded the Internet: (http://www.epjobservatoriet.dk/publikationer/forandringsparathed.pdf)) have been studied as themes. The methods used have been telephone interviews and direct observations. The results showed that the seven wards (one was excluded) followed the "Instructions for use" to different degrees. It was found that one instruction, in particular, seems to be especially important to follow to motivate the employees on a ward to participate in the CRR; the management of the ward must be engaged/actively involved in the project, as they are key figures when it comes to motivating the other ward employees. The aim of this study is not to prove a causal relationship between the degree to which the "Instructions for use" are followed and the degree of participation--it is to suggest a qualitative relationship between the two. Neither does this study try to generalize the results, as further research on more wards would be needed to do so. This study does, however, set out themes that can be a useful tool in future CRR projects in order to maximize the degree of participation. In a modified way, these themes can probably be used as a tool in other studies of human-machine interactions.

Denmark↗
PubMed1990

[Erwinia carotovora as a recipient system for the natural hybrid plasmid RP4::Mu cts62].

The plasmid RP4::Mu cts62 is transferred from Escherichia coli cells into a recipient strain Erwinia carotovora 268 by conjugation with the frequency 1.5-5 x 10(-7) per donor cell. The maximal frequencies of transfer are obtained by cultivation of donor and recipient cells for 3-5 h on the filters. Structural and functional validity of the plasmid in transconjugants is expressed in preservation of all antibiotic-resistant markers of RP4, thermosensitivity to growth at 42 degrees C as well as spontaneous and thermally-induced production and zygotic induction of bacteriophage determined by the genome of Mu cts62, total length of the plasmid restricts. Location and orientation of Mu cts62 genome in the plasmid restricts. Location and orientation of Mu cts62 genome in the plasmid RP4::Mu cts62 in Erwinia carotovora transconjugant cells has been determined. A single bacteriophage genome has been shown to transpose into the chromosome of the cell with the elimination of RP4 fragment under the conditions of thermal induction.

Asparaginase↗
PubMed1990

The impact of school-based education on the young child's understanding of death.

The young child's immature understanding of the concepts related to death serves to heighten anxiety about death and interferes with successful adjustment to loss. This study was a randomized trial of the efficacy of a 3-week school-based educational program in the promotion of the concepts of death in 4- to 8-year-old children (prekindergarten through second grade). The Smilansky Death Concept Questionnaire, a validated and published structured interview, was administered pre- and postintervention phase to all study participants (N = 184). The experimental group received three interventions: (1) a series of six 30 to 45-minute presentations about concepts of death, (2) teacher educational presentation, and (3) parent educational presentation. Significant mean gains were noted for the experimental group as compared to the control group in the total death concept score, the total score for human death, the total score for animal death, and two of the four factors studied, that of causality and that of inevitability and old age. The gain in total death concept score as a result of the 3-week educational program was equivalent to the amount of conceptual development that is seen in one year in the absence of intervention.

Attitude to Death↗
PubMed1989

Measurement characteristics of a short form of the questionnaire on resources and stress.

The psychometric integrity of a short form of a measure of ecological stress was evaluated based on data provided by both fathers and mothers representing intact families, half of which included children with handicaps and half of which did not. Alpha reliability, factor structure, and construct validity analyses generally supported the conclusion that the short form of the Questionnaire on Resources and Stress is reasonably reliable and valid.

Adult↗
PubMed1989

[Assessment of temperament in children].

This paper describes the development of a questionnaire to assess the temperament of infants and preschool-children. A German version of the "Toddler Temperament Scale" (Fullard, McDevitt & Carey, 1984) was administered to 80 mothers of children hospitalized to undergo elective surgery. The factor structure of the questionnaire is quite heterogeneous, and it corresponds well with a priori conceptualizations regarding children's temperament structure. The predictive validity of the questionnaire is evidenced by theoretically meaningful temperament related changes in the children's behavior after their dismissal from hospital.

Child, Preschool↗
PubMed1979

Are anaerobic pleuropulmonary infections uncommon or commonly undetected in Britain?

Despite marked and increasing awareness of the clinical significance of pathogenic anaerobes, the role of anaerobes in pleuropulmonary infections is still largely unrecognised in Britain. A considerable literature testifies that this is not so in America. The reasons for this paradox are explored. British anaerobic methodology is briefly reviewed, with special reference to the range of recognised respiratory pathogens and the anaerobes that can be cultured in simple anaerobic jars. The limitations of sampling and transport procedures are considered. Differences in approach are discussed. The technological problems of the isolation and culture of "difficult" pathogenic anaerobes have been largely solved at the laboratory level; effective approaches to sampling and transit of specimens require more positive consideration and the results might influence our choice of specific antimicrobial therapy. If these points are taken and an increased awareness of the role of the anaerobes in certain pathological conditions of the lower respiratory tract is generated, we might hope either to produce a meaningful parallel to the experience of our American colleagues--or to structure a more valid defence to explain our lack of experience of these infections in the lower respiratory tract.

Bacterial Infections↗
PubMed1985

Hospital expenses in a sector model.

This review summarizes the capabilities and contributions of quantitative sector models for understanding trends in hospital expenses and the effects thereon of various public policies. After some brief historical notes on the use of analogous models in other policy areas, the general classes of national, partial, and narrow health sector models are introduced with special attention to method of validation and behavioral structure. Fourteen published models, described and critically reviewed with regard to these criteria, are assessed for their individual application to important policy and behavioral issues. Suggestions are offered for improvements and new initiatives in the use of sector models both in forecasting and in the study of procompetitive policies and reimbursement rule changes.

Economic Competition↗
PubMed1997

[Linguistic confusion about nursing standards. A literature study].

This paper takes a close look at nursing publications that are concerned with the theoretical knowledge of "standards". The central question is: "What are the intentions and characteristics to which standards are linked in nursing literature?" Diverse definitions and synonyms of standards are discussed as well. There is a considerable irregularity in the terminology of standards and similar terms in the investigated literature. Therefore, the term "standard" is treated by the author as a general one that embraces many definitions and has to be differentiated for a closer approach. Thus, four different kinds of features have been developed in the course of the analytic work: "intentions", "range of validity", "contents" and "structure". These four areas form a basis for a more definite description of the various kinds of standards. Based on her findings, the author give recommendations on how the actual linguistic confusion can be effectively dealt with.

Communication Barriers↗
PubMed2003

Objective structured assessment of technical skills for episiotomy repair.

OBJECTIVE: This study was undertaken to estimate the reliability and validity of an objective structured assessment of technical skills (OSATS) for midline episiotomy repair using a lifelike anatomic model. STUDY DESIGN: Eighteen residents were administered an episiotomy OSATS. Two evaluators independently completed an objective score sheet assessing six key components of the repair, seven global surgical skills, and a pass/fail score for each resident. Residents also completed an anonymous self-assessment. RESULTS: Reliability indices were 0.95 for the checklist and global surgical skills rating. Construct validity found significant differences on the checklist, global surgical skills, and pass/fail score sheets by residency level. Residents more often assessed their own global surgical skills performance lower than the independent evaluators. Surprisingly, 61% (11/18) of the residents failed the assessment, including all postgraduate year 1 and postgraduate year 2 residents. CONCLUSION: Episiotomy OSATS that used task-specific and global checklists provide a reliable and valid method of assessing resident skills in this anatomic model, and performance correlates with resident year level of training.

Clinical Competence↗
PubMed2006

Cross-cultural validation of the Brief Social Phobia Scale for use in Portuguese and the development of a structured interview guide.

OBJECTIVE: To present the translation and validation of the Brief Social Phobia Scale for use in Brazilian Portuguese, to develop a structured interview guide in order to systemize its use and to perform a preliminary study of inter-rater reliability. METHOD: The instrument was translated and adapted to Portuguese by specialists in anxiety disorders and rating scales. A structured interview guide was created with the aim of covering all of the items of the instrument and grouping them into six categories. Specialists in mental health evaluated the guide. These professionals also watched the videotaped interviews of patients with and without social anxiety disorders, and, based on the interview guide, they rated the scale to evaluate its reliability. RESULTS: No semantic or linguistic adjustments were needed. For the complete scale, the general evaluation showed a percentage of agreement of 0.84 and intraclass coefficient of 0.91. The mean inter-rater correlation was 0.84. CONCLUSIONS: The Portuguese-language version of the Brief Social Phobia Scale is available for use in the Brazilian population, with rather acceptable indicators of inter-rater reliability. The interview guide was useful in providing these values. Further studies are needed in order to improve the reliability and to study other psychometric properties of the instrument.

Cross-Cultural Comparison↗
PubMed2005

The significant other version of the Pain Catastrophizing Scale (PCS-S): preliminary validation.

Researchers have hypothesized that pain catastrophizing has a social function. Although work has focused on the catastrophizing of individuals with chronic pain (ICPs), little is known about the pain catastrophizing of their significant others. The purpose of this study was to test the validity of a revised version of the original PCS [Sullivan MJL, Bishop S, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 432-524.] in which individuals were instructed to report on their own catastrophizing about their significant other's pain. In Study 1, a confirmatory factor analysis was conducted to determine the factor structure of the PCS-Significant Other (PCS-S) in a diverse sample of university undergraduates (n=264). An oblique second-order 3-factor model with two cross-loadings provided the best fit and this model was invariant across gender and racial groups. This factor structure was cross-validated in Study 2 with a second sample of university undergraduates (n=213). Results indicated that the 3-factor structure with two cross-loadings was a viable model of significant others' pain catastrophizing across gender and racial groups. In Study 3, this factor structure was replicated and the content validity of the PCS-S was examined in a sample of adult ICPs and their spouses (n=111). Spouse catastrophizing was related to ICP pain severity and interference as well as both spouses' depressive symptoms. In addition, ICPs were at a greater risk for psychological distress when both spouses had higher levels of catastrophizing. The PCS-S has the potential to be a useful and valid measure of pain catastrophizing in the significant others of ICPs.

Adult↗