Promising pre-clinical validation of targeted radionuclide therapy using a [131I] labelled iodoquinoxaline derivative for an effective melanoma treatment

Targeted internal radionuclide therapy (TRT) would be an effective alternative to current therapies for dissemi- nated melanoma treatment. At our institution, a class of iodobenzamides has been developed as potent melanoma- seeking agents. This review described the preclinical vali- dations of a quinoxaline derivative molecule (ICF01012) as tracer for TRT application. It was selected for its high, specific and long-lasting uptake in tumour with rapid clear- ance from non-target organs providing suitable dosimetry parameters for TRT. Extended in vivo study of metabolic profiles confirmed durable tumoural concentration of the unchanged molecule form. Moreover melanin specificity of ICF01012 was determined by binding assay with syn- thetic melanin and in vivo by SIMS imaging. Then, we showed in vivo that [131I] ICF01012 treatment drastically inhibited growth of B16F0, B16Bl6 and M4Beu tumours whereas [131I] NaI or unlabelled ICF01012 treatment was without significant effect. Histological analysis showed that residual tumour cells exhibit a significant loss of aggres- siveness after treatment. This anti-tumoural effect was associated with a lengthening of the treated-mice survival time and an inhibition of lung dissemination for B16Bl6 model. Results presented here support the concept of TRT using a [131I] labelled iodoquinoxaline derivative for an effective melanoma treatment.

Generic and diabetes-specific well-being in the AT.LANTUS follow-on study : further psychometric validation of the W-BQ28 indicates its utility in research and clinical practice in type 2 diabetes in the UK

Aims  To undertake further psychometric validation of the W-BQ28 to determine its suitability for use in adults with Type 2 diabetes in the UK using data from the AT.LANTUS follow-on study.

Methods  A total of 353 people with Type 2 diabetes participated in the AT.LANTUS Follow-on study, completing measures of well-being (W-BQ28), treatment satisfaction (DTSQ) and self-care (SCI-R). Confirmatory factor analyses was used to confirm the W-BQ28 structure and internal consistency reliability was assessed. Additional statistical tests were conducted to explore convergent, divergent and known-groups validity. Minimal important differences were calculated using distribution and anchor-based techniques.

Results  Structure of the W-BQ28 (seven four-item subscales plus 16-item generic and 12-item diabetes-specific scales) was confirmed (comparative fit index = 0.917, root mean square error of approximation (RMSEA) = 0.057). Internal consistency reliability was satisfactory (four-item subscales: alpha = 0.73–0.90; 12/16-item scales: α = 0.84–0.90). Convergent validity was supported by expected moderate to high correlations (rs = 0.35–0.67) between all W-BQ28 subscales (except Energy); divergent validity was supported by expected low to moderate correlations with treatment satisfaction (rs = −0.03–0.52) and self-care (rs = 0.02–0.22). Known-groups validity was supported with statistically significant differences by sex, age and HbA1c for expected subscales. Minimal important differences were established (range 0.14–2.90).

Conclusions  The W-BQ28 is a valid and reliable measure of generic and diabetes-specific well-being in Type 2 diabetes in the UK. Confirmation of the utility of W-BQ28 (including establishment of minimal important differences) means that its use is indicated in research and clinical practice.

Validation and development of a clinical prediction rule in clinically suspected community-acquired pneumonia

To develop a mathematical model to predict the probability of having community-acquired pneumonia and to evaluate an already developed prediction rule that has not been validated in a clinical scenario.

Validation of the Italian version of the Yale-Brown Obsessive Compulsive Scale-Second Edition (Y-BOCS-II) in a clinical sample

OBJECTIVE: The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the most widely accepted measure of obsessive-compulsive disorder (OCD) symptom severity. Recently, the scale has been revised into a second edition (Y-BOCS-II) in order to improve its measurement properties. The present study aimed to evaluate the psychometric properties of the Italian version of the Y-BOCS-II Severity Scale (SS) in a large clinical sample. METHOD: The original version of the Y-BOCS-II was translated into Italian, which involved forward and back-translation procedures. The Italian Y-BOCS-II-SS was administered to one hundred twenty-five treatment-seeking adults with OCD, together with the original Y-BOCS-SS and a battery of self-report measures assessing OCD symptom severity and depressive and anxious symptomology. The factor structure, internal consistency, temporal stability, and construct validity were investigated on the whole sample, while inter-rater and test-retest reliability were assessed on a subsample of participants. RESULTS: Factor analyses revealed a two-factor structure different from those of the original scale, comprising (1) symptom severity; and (2) interference from symptoms. Internal consistency, test-retest reliability over a 2-week period and inter-rater reliability were satisfactory. The Y-BOCS-II-SS also showed excellent construct validity (and better than the Y-BOCS-SS), with good convergent and discriminant validity when assessed against other OCD symptom measures and measures of depression, anxiety and worry. CONCLUSIONS: These findings suggest that the Italian version of the Y-BOCS-II-SS retains the adequate psychometric properties of the original and that it can be confidently used as an assessment tool of OCD symptoms in both clinical and research settings.

The development and validation of the impact of multiple sclerosis scale and the symptoms of multiple sclerosis scale

Objective

To develop and validate the Impact of Multiple Sclerosis Scale (IMSS) and the Symptoms of Multiple Sclerosis Scale (SMSS) using the Extended Disability Status Scale (EDSS) for construct validity.
Design

Panel design involving test-retest over 4 months.
Setting

A mailed survey.
Participants

Volunteers with a diagnosis of multiple sclerosis (MS) recruited from an MS support service in Australia: 193 people (mean age, 39y) and 150 people participated at time 1 and time 2, respectively.
Interventions

Not applicable.
Main Outcome Measures

Principal components analyses, the Cronbach α, and descriptive statistics for the 2 scales; correlations for construct validity with the EDSS and retest; and confirmatory factor analysis to test the stability of IMSS and SMSS components over time.
Results

The IMSS yielded 5 independent and reliable components; the SMSS yielded 3 components; both component structures were stable over time. These scales showed convergent validity with the EDSS.
Conclusions

The IMSS and SMSS are psychometrically sound scales suitable for clinical and research purposes to assess the symptoms and impact of MS.

Preliminary validation of the Chinese version of the pediatric quality of life inventory

The Pediatric Quality of Life Inventory (PedsQL) is a scale for assessing health-related quality of life of children and adolescents aged 2-18 years. Three reports of PedsQL for the age ranges 2-4 years and 5-7 years were translated into Chinese and their validities were examined. A total of 186 children and parents were involved in the study. Content validity, test-retest reliability, internal consistency reliability and construct validity were assessed. The correlation of parents' and children's reports was also examined. The results showed that the internal consistency is generally good, test-retest reliability ranged from moderate to good, differences between disabled and non-disabled individuals are significant in total scores and in all subscales except for the physical functioning subscale for the children's self-report for the age ranges of 2-4 years and 5-7 years and the correlation between the reports of the parents and children for the age range of 5-7 years is moderate to high. This suggests that the newly translated Chinese PedsQL for children aged 2-4 years and 5-7 years seems to be reliable and valid to be used as a measure of health-related quality of life in Chinese pediatric research and clinical applications.

Validation of comprehensive assessment of activities of daily living in stroke survivors

This study determined whether the Functional Independence Measure (FIM) and the Frenchay Activities Index (FAI) could be used together as a more comprehensive score to assess the activities of daily living (ADL) in stroke survivors. Subjects were recruited from stroke patients consecutively admitted to the inpatient neurology or rehabilitation department at a university hospital in southern Taiwan. We interviewed 209 first stroke survivors at least 1 year after stroke onset during their clinical visits, at home, or in long-term care institutions. Combinations of FIM and FAI as a comprehensive assessment of ADL were measured. All items of the FIM and the FAI were included in a non-parametric factor analysis to determine their underlying constructs. Two comprehensive functional independence scores were then computed as functions of the FIM and FAI scores. The distributional characteristics of the comprehensive scores were examined. Approximately 90% of the total variation was explained by three factors. One single factor comprised all the items from FIM, while the FAI items loaded on two other factors, suggesting that FIM supplements FAI without overlap in content. We further demonstrated that the presence of ceiling or floor effects when either the FIM or the FAI was used could be removed using combined scores of the two instruments. The FIM and the FAI assessed different domains with good construct validity. A comprehensive assessment of functional independence obtained by combining the FIM and the FAI scores is potentially more appropriate and useful for clinical and research applications in stroke patients.

New Zealand development and trial of mental health nursing clinical indicators - a bicultural study

This paper describes the development and validation of bicultural clinical indicators that measure achievement of mental health nursing practice standards in New Zealand (ANZMCHN, 1995, Standards of practice for mental health nursing in New Zealand. ANZCMHN, Greenacres). A four-stage research design was utilised including focus groups, Delphi surveys, a pilot, and a national field study, with mental health nurses and consumers as participants. During the national field study, consumer files (n=327) from 11 District Health Boards, and registered nurses (n=422) completed an attitude questionnaire regarding the regularity of specific nursing and service activities. Results revealed a variation in the mean occurrence of the clinical indicators in consumer case notes of 18.5–89.9%. Five factors with good internal consistency, encompassing domains of mental health nursing required for best practice, were derived from analysis of the questionnaire. This study presents a research framework for developing culturally and clinically valid, reliable measures of clinical practice.

The validation of an Australian sign language instrument for outcome measurement of adults in mental health settings

Objective: There are currently no adult mental health outcome measures that have been translated into Australian sign language (Auslan). Without a valid and reliable Auslan outcome measure, empirical research into the efficacy of mental health interventions for sign language users is unattainable. To address this research problem the Outcome Rating Scale (ORS), a measure of general functioning, was translated into Auslan and recorded on to digital video disk for use in clinical settings. The purpose of the present study was therefore to examine the reliability, validity and acceptability of an Auslan version of the ORS (ORS-Auslan).
Method: The ORS-Auslan was administered to 44 deaf people who use Auslan as their first language and who identify as members of a deaf community (termed ‘Deaf’ people) on their first presentation to a mental health or counselling facility and to 55 Deaf people in the general community. The community sample also completed an Auslan version of the Depression Anxiety Stress Scale-21 (DASS-21).
Results: t-Tests indicated significant differences between the mean scores for the clinical and community sample. Internal consistency was acceptable given the low number of items in the ORS-Auslan. Construct validity was established by significant correlations between total scores on the DASS-21-Auslan and ORS-Auslan. Acceptability of ORS-Auslan was evident in the completion rate of 93% compared with 63% for DASS-21-Auslan.
Conclusions: This is the only Auslan outcome measure available that can be used across a wide variety of mental health and clinical settings. The ORS-Auslan provides mental health clinicians with a reliable and valid, brief measure of general functioning that can significantly distinguish between clinical and non-clinical presentations for members of the Deaf community.

The bipolar depression rating scale (BDRS) : its development, validation and utility

Objectives: Unipolar and bipolar depression differ neurobiologically and in clinical presentation. Existing depression rating instruments, used in bipolar depression, fail to capture the necessary phenomenological nuances, as they are based on and skewed towards the characteristics of unipolar depression. Both clinically and in research there is a growing need for a new observer-rated scale that is specifically designed to assess bipolar depression.

Methods: An instrument reflecting the characteristics of bipolar depression was drafted by the authors, and administered to 122 participants aged 18–65 (44 males and 78 females) with a diagnosis of DSM-IV bipolar disorder, who were currently experiencing symptoms of depression. The Bipolar Depression Rating Scale (BDRS) was administered together with the Hamilton Depression Rating Scale (HAM-D), Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS).

Results: The BDRS has strong internal consistency (Cronbach's alpha = 0.917), and robust correlation coefficients with the MADRS (r = 0.906) and HAM-D (r = 0.744), and the mixed subscale correlated with the YMRS (r = 0.757). Exploratory factor analysis showed a three-factor solution gave the best account of the data. These factors corresponded to depression (somatic), depression (psychological) and mixed symptom clusters.

Conclusions: This study provides evidence for the validity of the BDRS for the measurement of depression in bipolar disorder. These results suggest good internal validity, provisional evidence of inter-rater reliability and strong correlations with other depression rating scales.

Development and validation of the influenza intensity and impact questionnaire (FluiiQ™)

Clinical trials of new agents to reduce the severity and impact of influenza require accurate assessment of the effect of influenza infection. Because there are limited high-quality adult influenza Patient Reported Outcomes (PRO) measures, the aim was to develop and validate a simple but comprehensive questionnaire for epidemiological research and clinical trials.

Validation of the professional practice environment scale in Australian general practice

Purpose: To validate the Professional Practice Environment Scale (PPE) in Australian general practice. Methods: The PPE was modified slightly for appropriateness for the practice setting and administered to a sample of 342 Australian general practice nurses via an online survey tool. The factor structure of the 38-item PPE was examined using principal components analysis with Varimax rotation. Findings: An eight-factor solution accounted for 71.6% of the variance. Low factor loading (<0.3) or cross-component loadings were detected in eight items. A comparison of Cronbach's alpha values demonstrated little change in the deletion of eight items from four of the eight related components. Conclusions: Findings demonstrated that a 30-item version of the PPE was reliable and valid for use to assess the professional practice environment of nurses working in Australian general practice. Clinical Relevance: A tool to measure the professional practice environment in general practice is important as it will assist in monitoring the impact of the work environment on the recruitment, retention, and satisfaction of nurses in this setting.

Psychometric validation of the Self-Care Inventory-Revised (SCI-R) in UK adults with type 2 diabetes using data from the AT.LANTUS follow-on study.

Background:
Achieving optimal outcomes in type 2 diabetes (T2DM) involves several demanding self-care behaviours, e.g. managing diet, activity, medications, monitoring glucose levels, footcare. The Self-Care Inventory-Revised (SCI-R) is valid for use in people with T2DM in the US. Our aim was to determine its suitability for use in the UK.

Fear of self and obsessionality: development and validation of the Fear of Self Questionnaire

Obsessions – particularly those directly relating to causing harm – often contain or imply evaluative dimensions about the self, reflecting a fear as to who the person might be – or might become. Following from research indicating that such beliefs are relevant to OCD, and the wider literature in social psychology regarding ‘feared’ or ‘undesired’ self-guides, the current study describes the development and validation of a new questionnaire—the Fear of Self Questionnaire, in 8- and 20-item versions.

The questionnaire was piloted in two non-clinical samples (n=258; n=292). Exploratory and confirmatory factor analyses supported the unidimensionality of the measure. The questionnaire showed a strong internal inconsistency, and good divergent and convergent validity, including strong relationships to obsessional symptoms and with other processes implicated in cognitive models of OCD (e.g. obsessive beliefs, inferential confusion). Implications are discussed.