The 16-item Negative Symptom Assessment (NSA-16) scale is a validated tool for evaluating negative symptoms of schizophrenia.The psychometric properties and predictive power of a four-item version (NSA-4) were compared with the NSA-16.Baseline data from 561 patients with predominant negative symptoms of schizophrenia who participated in two identically designed clinical trials were evaluated.Ordered logistic regression analysis of ratings using NSA-4 and NSA-16 were compared with ratings using several other standard tools to determine predictive validity and construct validity.Internal consistency and test-retest reliability were also analyzed.NSA-16 and NSA-4 scores were both predictive of scores on the NSA global rating (odds ratio = 0.83-0.86)and the Clinical Global Impressions-Severity scale (odds ratio = 0.91-0.93).NSA-16 and NSA-4 showed high correlation with each other (Pearson r = 0.85), similar high correlation with other measures of negative symptoms (demonstrating convergent validity), and lesser correlations with measures of other forms of psychopathology (demonstrating divergent validity).NSA-16 and NSA-4 both showed acceptable internal consistency (Cronbach α, 0.85 and 0.64, respectively) and test-retest reliability (intraclass correlation coefficient, 0.87 and 0.82).This study demonstrates that NSA-4 offers accuracy comparable to the NSA-16 in rating negative symptoms in patients with schizophrenia.
Objectives: Postmenopausal women (PMW) can experience side-effects (breast pain/tenderness and vaginal spotting/bleeding) associated with estrogen plus progestin therapies (EPTs). To assess these outcomes, the Breast Pain and Tenderness Daily Diary (BPT-DD) and the Vaginal Bleeding and Spotting Daily Diary (VBS-DD) were developed for electronic completion. This study evaluated the psychometric properties of the diaries. Methods: The eDiaries were completed daily for 28 days by 202 PMW experiencing breast pain/tenderness and/or vaginal spotting/bleeding while on EPTs. Confirmatory factor analysis (CFA) investigated the BPT-DD structure. Response distributions, test–retest reliability (intraclass correlation coefficient [ICC]), internal consistency (BPT-DD only), and construct validity (via known groups and convergent validity analyses) were assessed. Results: Completion rates were high: over 90% of women missed <3 daily entries. CFA supported the BPT-DD unidimensional structure (Bentler’s Comparative Fit Index >0.98). BPT-DD inter-item correlations (r = 0.77–0.89) and internal consistency (Cronbach’s alpha = 0.95–0.97) were high and good test–retest reliability was demonstrated (ICC ≥ 0.70). The diaries correlated moderately (>0.40), in a logical pattern with other instruments, supporting convergent validity. Known-groups analyses indicated both measures demonstrated significant differences between patients of differing severity (pConclusion: The study provides evidence of strong psychometric properties for the BPT-DD and VBS-DD to assess breast pain/tenderness and spotting/bleeding in PMW.
Objective. To assess the ability of mental health professionals to use the 4-item Negative Symptom Assessment instrument, derived from the Negative Symptom Assessment-16, to rapidly determine the severity of negative symptoms of schizophrenia.Design. Open participation.Setting. Medical education conferences.Participants. Attendees at two international psychiatry conferences.Measurements. Participants read a brief set of the 4-item Negative Symptom Assessment instructions and viewed a videotape of a patient with schizophrenia. Using the 1 to 6 4-item Negative Symptom Assessment severity rating scale, they rated four negative symptom items and the overall global negative symptoms. These ratings were compared with a consensus rating determination using frequency distributions and Chi-square tests for the proportion of participant ratings that were within one point of the expert rating.Results. More than 400 medical professionals (293 physicians, 50% with a European practice, and 55% who reported past utilization of schizophrenia ratings scales) participated. Between 82.1 and 91.1 percent of the 4-items and the global rating determinations by the participants were within one rating point of the consensus expert ratings. The differences between the percentage of participant rating scores that were within one point versus the percentage that were greater than one point different from those by the consensus experts was significant (p<0.0001). Participants rating of negative symptoms using the 4-item Negative Symptom Assessment did not generally differ among the geographic regions of practice, the professional credentialing, or their familiarity with the use of schizophrenia symptom rating instruments.Conclusion. These findings suggest that clinicians from a variety of geographic practices can, after brief training, use the 4-item Negative Symptom Assessment effectively to rapidly assess negative symptoms in patients with schizophrenia.
Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.
Objectives: Postmenopausal women (PMW) can experience side-effects (breast pain/tenderness and vaginal spotting/bleeding) associated with estrogen plus progestin therapies (EPTs). To assess these outcomes, the Breast Pain and Tenderness Daily Diary (BPT-DD) and the Vaginal Bleeding and Spotting Daily Diary (VBS-DD) were developed for electronic completion. This study evaluated the psychometric properties of the diaries. Methods: The eDiaries were completed daily for 28 days by 202 PMW experiencing breast pain/tenderness and/or vaginal spotting/bleeding while on EPTs. Confirmatory factor analysis (CFA) investigated the BPT-DD structure. Response distributions, test–retest reliability (intraclass correlation coefficient [ICC]), internal consistency (BPT-DD only), and construct validity (via known groups and convergent validity analyses) were assessed. Results: Completion rates were high: over 90% of women missed <3 daily entries. CFA supported the BPT-DD unidimensional structure (Bentler’s Comparative Fit Index >0.98). BPT-DD inter-item correlations (r = 0.77–0.89) and internal consistency (Cronbach’s alpha = 0.95–0.97) were high and good test–retest reliability was demonstrated (ICC ≥ 0.70). The diaries correlated moderately (>0.40), in a logical pattern with other instruments, supporting convergent validity. Known-groups analyses indicated both measures demonstrated significant differences between patients of differing severity (pConclusion: The study provides evidence of strong psychometric properties for the BPT-DD and VBS-DD to assess breast pain/tenderness and spotting/bleeding in PMW.
Objectives: Postmenopausal women (PMW) can experience side-effects (breast pain/tenderness and vaginal spotting/bleeding) associated with estrogen plus progestin therapies (EPTs). To assess these outcomes, the Breast Pain and Tenderness Daily Diary (BPT-DD) and the Vaginal Bleeding and Spotting Daily Diary (VBS-DD) were developed for electronic completion (eDiaries). This study evaluated the psychometric properties of the eDiaries. Methods: The eDiaries were completed daily for 28 days by 202 PMW experiencing breast pain/tenderness and/or vaginal spotting/bleeding while on EPTs. Confirmatory factor analysis (CFA) investigated the BPT-DD structure. Response distributions, test–retest reliability (intraclass correlation coefficient [ICC]), internal consistency (BPT-DD only), and construct validity (via known groups and convergent validity analyses) were assessed. Results: Completion rates were high: over 90% of women missed <3 daily entries. CFA supported the BPT-DD unidimensional structure (Bentler’s Comparative Fit Index >0.98). BPT-DD inter-item correlations (r = 0.77–0.89) and internal consistency (Cronbach’s alpha = 0.95–0.97) were high and good test–retest reliability was demonstrated (ICC ≥ 0.70). The eDiaries correlated moderately (>0.40), in a logical pattern with other instruments, supporting convergent validity. Known-groups analyses indicated both measures demonstrated significant differences between patients of differing severity (pConclusion: The study provides evidence of strong psychometric properties for the BPT-DD and VBS-DD to assess breast pain/tenderness and spotting/bleeding in PMW.
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