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Development of a scale to measure discomfort during pregnancy.

During pregnancy fundamental changes occur in a woman's body that make physical discomforts almost unavoidable. Extensive literature searches revealed that there was no psychometrically acceptable tool available to assess accurately maternal physical discomfort. This paper presents the procedures undertaken to develop the Maternal Physical Discomfort Scale (MPDS), an assessment instrument designed to quantify the type and number of maternal physical discomforts. The MPDS, a scale consisting of 36 items, was developed and psychometrically evaluated using factor analysis, item response theory and reliability measures. The initial version of the scale was validated by a sample of 307 pregnant women. Based on the result from this sample, the MPDS was modified to 33 items and validated by a further sample of 125 pregnant women. The MPDS developed in this study was demonstrated to have content and construct validity and to be reliable.

Factor Analysis, Statistical↗

The development of the MMPI-A Immaturity Scale: findings for normal and clinical samples.

The Immaturity (IMM) Scale was developed as a supplementary scale for the Minnesota Multiphasic Personality Inventory-Adolescent (MMPI-A). This study describes the development of the IMM Scale and presents some concurrent validity data derived from the MMPI-A normative sample of 1,620 adolescents and a clinical sample of 122 adolescent inpatients. The IMM Scale was examined in relation to Biographical and Life Events data to identify external correlates for the MMPI-A normative sample. In the clinical sample, external correlates were derived from diagnostic and rating form data provided by the adolescents' treatment staff and by their parents. Current findings were discussed in terms of the relationship of correlate patterns to descriptions of the preconformist and conformist stages of Loevinger's (1976) concept of ego development, and future research directions were suggested.

Adolescent↗

Development and scale-up of a microsphere protein delivery system.

This paper reviews the development path for the ProLease injectable microsphere delivery system for proteins using human growth hormone as an example. The process consists of four stages, the selection of a lead formulation for clinical testing, the preclinical evaluation of the lead formulation including toxicology and stability studies, the manufacture of phase I clinical supplies, and the scale-up for phase II and phase III clinical trials. The approaches used to overcome obstacles during each stage are summarized including ways of stabilizing the protein, obtaining desirable release kinetics, and manufacturing sterile batches for clinical testing. Stability, release, toxicology, and scale-up results for ProLease recombinant human growth hormone (rhGH) are given. The phase I clinical data show that bioactive rhGH was released for about 1 month in humans. This work shows that processes and procedures have been developed that enable the production of microsphere sustained release formulations for proteins suitable for clinical trails and commercialization.

Animals↗

Measuring the impact of multiple sclerosis on psychosocial functioning: the development of a new self-efficacy scale.

OBJECTIVE: To develop a scale to measure self-efficacy in neurologically impaired patients with multiple sclerosis and to assess the scale's psychometric properties. DESIGN: Cross-sectional questionnaire study in a clinical setting, the retest questionnaire returned by mail after completion at home. SETTING: Regional multiple sclerosis (MS) outpatient clinic or the Clinical Trials Unit (CTU) at a large neuroscience centre in the UK. SUBJECTS: One hundred persons with MS attending the Walton Centre for Neurology and Neurosurgery and Clatterbridge Hospital, Wirral, as outpatients. METHODS: Cognitively impaired patients were excluded at an initial clinic assessment. Patients were asked to provide demographic data and complete the self-efficacy scale along with the following validated scales: Hospital Anxiety and Depression Scale, Rosenberg Self-Esteem Scale, Impact, Stigma and Mastery and Rankin Scales. The Rankin Scale and Barthel Index were also assessed by the physician. RESULTS: A new 11-item self-efficacy scale was constructed consisting of two domains of control and personal agency. The validity of the scale was confirmed using Cronbach's alpha analysis of internal consistency (alpha = 0.81). The test-retest reliability of the scale over two weeks was acceptable with an intraclass correlation coefficient of 0.79. Construct validity was investigated using Pearson's product moment correlation coefficient resulting in significant correlations with depression (r= -0.52) anxiety (r =-0.50) and mastery (r= 0.73). Multiple regression analysis demonstrated that these factors accounted for 70% of the variance of scores on the self-efficacy scale, with scores on mastery, anxiety and perceived disability being independently significant. CONCLUSION: Assessment of the psychometric properties of this new self-efficacy scale suggest that it possesses good validity and reliability in patients with multiple sclerosis.

Adult↗

Development and testing of the Urinary Incontinence Scales.

The Urinary Incontinence Scales were developed to measure RNs' attitude, belief, practice, and knowledge about urinary incontinence in adults. The purpose of this article is to introduce the scales and discuss their development and testing. These scales include the Urinary Incontinence Attitude Scale, the Urinary Incontinence Belief Scale, the Urinary Incontinence Practice Scale, and the Urinary Incontinence Knowledge Scale. Evaluation using confirmatory factor analysis showed the attitude, belief, and practice scales to be reliable and valid. Reliability of the knowledge scale was slightly lower than desired using both Cronbach's alpha coefficient and squared multiple correlation. While the hypothesized measurement model demonstrated acceptable goodness-of-fit, further testing is needed for generalizability of findings.

Adult↗

Neighborhood Environment Walkability Scale: validity and development of a short form.

PURPOSE: The aim of this study was to examine the factorial and criterion validity of the Neighborhood Environment Walkability Scale (NEWS) and to develop an abbreviated version (NEWS-A). METHODS: A stratified two-stage cluster sample design was used to recruit 1286 adults. The sample was drawn from residential addresses within eight high- and eight low-walkable neighborhoods matched for socioeconomic status. Subjects completed the NEWS and reported weekly minutes of walking for transport and recreation using items from the International Physical Activity Questionnaire. RESULTS: Multilevel confirmatory factor analysis was used to develop measurement models of the NEWS and NEWS-A. Six individual-level and five blockgroup-level factors were identified. Factors/scales gauging presence of diversity of destinations, residential density, walking infrastructure, aesthetics, traffic safety, and crime were positively related to walking for transport. Aesthetics, mixed destinations, and residential density were associated with walking for recreation. CONCLUSIONS: The NEWS and NEWS-A possess adequate levels of factorial and criterion validity. Alternative methods of scoring for different purposes are presented.

Adult↗

[Development and validation of a sympathy scale].

The authors developed a 22-item scale of interpersonal sympathy that is informed by relevant practices and meanings of contemporary Japanese cultural context. In three independent samples the scale was shown to be reasonably reliable (alpha > .80). Furthermore, the scale had a systematic relationship with related variables, hence exhibiting satisfactory construct validity. Specifically, sympathy was positively correlated with both a reported frequency of prosocial behaviors (Study 1) and emotional empathy (Study 2). Moreover, sympathy formed a higher-order factor with interdependent construal of self, which was orthogonal to another higher-order factor comprised of independent construal of self and self-esteem (Study 3). Finally, some directions for future research are discussed.

Emotions↗

[Development and use of a quality assessment scale specifically constructed for the assessment of studies that compare hemodialysis modalities].

There are currently many hemodialysis modalities that are believed to be superior to conventional hemodialysis. In order to compare the effectiveness and security of the different hemodialysis techniques a systematic review was carried out. Faced with the fact that the scales available mainly focus on study design and tend to ignore external validity, a quality scale was specifically developed to assess the quality of the studies included in the review. The objective of this article is to introduce the quality assessment scale developed and present the results of its usability and applicability. The following databases were searched in order to identify the studies: MEDLINE, EMBASE, Cochrane, HTA, CRD and others. The articles obtained were selected based on previously established inclusion/exclusion criteria. The scale covers three issues: general aspects of the studies, specific aspects of the studies and patient characteristics. This scale allowed for a more accurate classification of the global quality of the studies and was reproducible. In general, those studies classified as high quality studies received the highest score and those studies classified as low quality studies received the lowest scores. The median value was 5,35 (53,5%). The intraclass correlation coefficient was 0,96. As a conclusion of this work it can be stated that currently available scales have serious limitations for the use in studies that compare different hemodialysis modalities and that the use of a scale specifically constructed for this purpose provides more accurate information on the quality of the evidence which is fundamental to interpret results and generate inferences.

Hemodiafiltration↗

A longitudinal follow up of neurodevelopment of high risk newborns--a comparison of Amiel-Tison's method with Bayley Scales of Infant Development.

The neurodevelopment of 42 high risk babies and 7 control babies was assessed longitudinally till the age of 12 months by using two different methods. The method of neurological evaluation described by Amiel-Tison was used, and the results compared with those of a standard developmental test, the Bayley Scales of Infant Development. The Amiel-Tison method was found to be a sensitive test for picking up abnormalities till the age of 9 months, but lost its advantage over the Bayley Scales at 12 months. Besides, the test was quick, simple to learn and did not need a special kit or a trained psychologist and was hence found to be a good screening method.

Child, Preschool↗

Clinimetric and psychometric strategies for development of a health measurement scale.

Clinimetrics and psychometrics, two accepted methods for developing multiitem health measurement scales, have fundamentally different aims and methods that have seldom been compared and never prospectively. The purpose of this study was to determine whether these two methodologies provided comparable scales in the development of an upper extremity disability measure. Psychometric analysis involved field testing a 70-item questionnaire on 407 patients. Equidiscriminatory item total correlation (EITC) was used to select the top 30 items. Clinimetric testing used the mean importance and severity ratings of the 70 items by 76 patients to select the top 30 items. Clinimetric and psychometric analyses were performed independently. Cronbach's alpha was 0.97 for the top 30 items selected by EITC and 0.96 for the items selected based on patient's ratings. The two scales (after clinician modification to improve face validity) shared 16 items in common (P=0.10). The intraclass correlation coefficient of the patient scores on the two 30-item scales was 0.93 before clinician input and 0.97 after. The mean (and standard deviation) difference between scales was 9.1 (8.8) before and 1.7 (5.2) after clinician input. A scale developed with a clinimetric strategy can measure a complex (so-called heterogeneous) clinical phenomenon (thought to be composed of several patient attributes) but still fulfill psychometric criteria for "homogeneity." Thus, these strategies for the development of health measurement scales, which have been considered potentially opposite or conflicting, may be complementary.

Adult↗

Development of a scale to assess Hwa-Byung, a Korean culture-bound syndrome, using the Korean MMPI-2.

This study documents the development of an MMPI-2 scale designed to assess features of the Korean culture-bound syndrome, Hwa-Byung (HB). An American research team and psychiatric practitioners in Korea created an 18-item HB scale via rational item selection and psycho-metric refinement. Principal components analysis of scale items revealed four components, reflecting content domains of general health, gastrointestinal symptoms, hopelessness, and anger. This four-component solution applied well to both Korean men and women, but not to an American sample. Although some findings were encouraging, future studies employing clinical samples are needed to provide further validation of this scale.

Adolescent↗

The correlation of sucking behaviors and Bayley Scales of Infant Development at six months of age in VLBW infants.

The purpose of this study was to identify early predictors of developmental outcomes in infants of very low birth weight (< or = 1,500 g). The sample consisted of 19 infants with a mean birth weight of 1,238 g and a mean gestational age at birth of 29.1 weeks. The instruments used were the Kron Nutritive Sucking Apparatus, the Neonatal Morbidity Scale, and the Bayley Scales of Infant Development (BSID). Mean pressure generated by each suck and the length of sucking bursts were positively correlated (p < .05) with the Psychomotor Scale of the BSID. As a predictor of developmental outcomes at 6 months of age, nutritive sucking demonstrated a 78% specificity and an 80% sensitivity, as compared with neonatal morbidity, 58% and 69%, respectively. In a small sample of relatively healthy preterm infants, their ability to suck helped identify those with questionable early development.

Child Development↗

The discriminative efficiency of the Bayley Scales of Infant Development.

This study was designed to determine the discriminative efficiency of the Bayley Mental and Motor Scales for classifying infants as neurologically suspicious and neurologically normal. The two groups employed in the study were formed on the basis of the results from comprehensive neurological examinations performed at ages 1 and 7. Three discriminant function analyses were conducted, one for each scale separately and a third incorporating both scales using a stepwise procedure. Efficiency was measured in terms of number of correct and incorrect classifications, false positive and false negative errors, and validity coefficients. Comparisons among the analyses were examined by means of relative discrimination power and incremental validity. The findings suggested that the Motor Scale provides the most accurate identification of infants with suspected neurological impairments. A statistically significant likelihood discriminant function derived from both scales yielded some additional discriminative power. The law of parsimony, however, dictated the use of the single Motor Scale.

Child↗

Development of a scale to measure children's metered-dose inhaler and spacer technique.

BACKGROUND: A measure of metered dose inhaler (MDI) and spacer technique would help health care providers to estimate the degree to which technique may confound clinical efficacy of inhaled medications. OBJECTIVE: Our purpose was to extend earlier efforts to develop a rating scale to assess the accuracy of children's technique in using an MDI with three of the newer spacer devices. METHODS: Subjects were children, 7 to 17 years old, with moderate to severe asthma attending a follow-up appointment in an outpatient specialty clinic for asthma. Nurse practitioners and/or physicians completed a rating scale (MDI Check-list) for 50 children using an Optihaler spacer, 29 using Azmacort, and 21 using InspirEase. RESULTS: Depending on the spacer used, 14% to 26% of the children failed to demonstrate the critical skills for delivering medicine to the conducting airways, with the InspirEase group showing the best results. Items vary in difficulty (percent correct). The scale has excellent internal consistency reliability for Optihaler. CONCLUSIONS: The scale can be used (1) by health care providers to instruct patients or colleagues, (2) by parents to monitor and correct their children's MDI/spacer technique, and (3) by researchers to estimate drug delivery in studies of clinical outcome or adherence.

Adolescent↗

Development of the Sternal Wound Infection Prediction Scale.

OBJECTIVE: To develop an instrument to reliably predict the occurrence of sternal wound infection (SWI). DESIGN: Instrument development with retrospective chart review. SETTING: Southwestern university-affiliated medical center. PATIENTS: One hundred eighty-five adults who underwent cardiac surgery. SWI developed in 94 patients, and 91 remained infection free. In phase 1, there were 82 subjects: SWI developed in 41, and 41 remained infection free. In phase 2, there were 103 subjects: SWI developed in 53, and 50 remained infection free. OUTCOME MEASURE: Development of a postoperative SWI. INTERVENTION: The Sternal Wound Infection Prediction Scale (SWIPS) was developed in 2 phases. Phase 1 consisted of designing the SWIPS with use of 19 risk factors most often identified with SWI and revising this scale (SWIPS-R) with use of 21 risk factors. Eighty-two patient records were reviewed. After determining the mean cutscores in phase 1, phase 2 provided cross-validation results with use of 103 additional patient records. RESULTS: The SWIPS produced 62.1% correct predictions of infection and noninfection; whereas the SWIPS-R produced 72.8% correct predictions. Phase 2 cross-validation results for the 21 risk factors demonstrated that 62.1% and 72.8% of the patients were correctly diagnosed using the SWIPS and SWIPS-R, respectively. A multivariate logistic regression was also performed on the risk factors to predict infection/noninfection groups for all 185 patients. A reduced logistic regression model included 9 of the risk factors and correctly classified 76.2% of the subjects. CONCLUSIONS: The SWIPS-R, with 21 risk factors, and the logistic regression model, with 12 risk factors, provided excellent classification rates of infection/noninfection. However, more data need to be collected to further strengthen reliability.

Adult↗

[Development of assessment scales for measuring quality of nurse-patient relations].

This article describes the development of an instrument to audit the nurse-patient relationship based on the nursing philosophy of a Swiss hospital, which describes the nurse-patient relationship using terms such as mutual respect, support, accompaniment and information. Members of the nursing department developed quality criteria for the nurse-patient relationship employing the Nominal Group Technique. The criteria were validated through a review of the relevant literature. In a next step the criteria were operationalized into a normative instrument for evaluating the nurse-patient relationship. Using this instrument data was gathered in five wards both by interviewing patients and nurses and by analysing nursing documents. Data analyses revealed different levels in the quality indicators in the various wards. These differences can be explained on one hand by differences in the quality of the nurse-patient relationship on these wards and on the other hand by errors in the instrument. Suggestions on how to raise validity and reliability of the instrument are stated.

Adult↗

Development of a scale to measure the psychosocial impact of assistive devices: lessons learned and the road ahead.

PURPOSE: In this paper the history of the development and validation of the PIADS is reviewed. Assistive devices (ADs) are extremely prevalent forms of health care intervention for persons who have a disability. There is a consensus that the AD field needs a reliable and valid measure of how users perceive the impact of ADs on their quality of life (QoL) and sense of well-being. The Psychosocial Impact of Assistive Devices Scale (PIADS) is a 26 item self-rating scale designed to fill this measurement gap. The challenges that we encountered are described in attempting to adequately conceptualize QOL impact, and operationalize it in a measure suitable for use with virtually all forms of AD. Current efforts to extend the validation of the PIADS are summarized. CONCLUSIONS: The study concludes by suggesting directions for future research and development of the scale. They include a richer examination of its conceptual relationships to other health care and rehabilitation outcome measures, and further investigation of its clinical utility. The PIADS is a reliable and valid tool that appears to have very significant power to predict AD abandonment and retention. It can and should be used both deductively and inductively to build, discover and test theory about the psychosocial impact of assistive technology.

Health Status Indicators↗

Body scale and the development of prehension.

This study examined whether common dimensionless ratios define the critical point in the shifts in the grip coordination pattern of preschoolers and adults engaged in a displacement grasping activity with cubes that varied in object size. The findings indicated that there was an interaction between task constraints and organismic constraints in determining the grasping pattern utilized. However, when the object size is scaled to hand size there are common dimensionless ratios that correspond to the grasping patterns and the limb orientations employed across the age range utilized. Furthermore, 5 grip configurations accounted for the majority of grip variance in both age groups. The findings suggest a strong role for the impact of body scale on the development of coordination and provide preliminary evidence for the view that the development of prehension is a reflection of the constraints imposed on action.

Adolescent↗